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Tinnitus, anaphylaxis or paresthesia, new side effects of covid vaccines

Although it is less present in the day to day, covid is still active and its treatment continues to be a source of unknowns that health organizations try to analyze in depth. The latest Pharmacovigilance report on vaccines against covid-19 published by the Spanish Agency for Medicines and Health Products (AEMPS) records 75,978 notifications of adverse events in the 102,480,101 doses of vaccines that have been administered in Spain until July 10which corresponds to a total of 41,243,255 people who have received at least one dose (65% from Pfizer, 23% from Moderna, 10% from AstraZeneca and 2% from Janssen).

In addition, the subvariants of omicron BA.4 and BA.5 accounted for 75.5% of covid cases during the week of July 11 to 17, according to the report of the ‘Update of the epidemiological situation of SARS-CoV-2 variants in Spain’, published last Tuesday by the Ministry of Health. Extremadura is at the top, with 98.8%, in the presence of BA.4 and BA.5. Behind are País Vasco (98.4%) and Cantabria (97.9%), with Aragón in tenth place (93.2%). Getting vaccinated is still the best option to prevent infection or attenuate it in these new highly contagious variants.

However, also Secondary effects of vaccines continue to be detected and there is no shortage of allusions to those currently less used. Among the most frequently reported are fever and pain in the vaccination area, of the nervous system (headache and dizziness) and the musculoskeletal system (myalgia and arthralgia). Nevertheless, The dossier reveals that in the Moderna vaccine (Spikevax) extensive inflammation in the vaccinated limb has been identified as a possible adverse reaction. Of course, this disorder does not require treatment and resolves spontaneously in a few days.

In that of AstraZeneca (Vaxzevria) have been identified tinnitus, paresthesia and hypoesthesia as possible adverse reactions and in Nuvaxovid anaphylaxis, paresthesia and hypoesthesia have been identified. On the other hand, the possible relationship with the heavy menstrual bleeding with Pfizer and Moderna. Of course, it is confirmed that there is not enough evidence to associate amenorrhea (absence of menstruation) with both vaccines.

Pfizer Side Effects

In Spain, 66,653,390 doses of Comirnaty (Pfizer) have been administered, corresponding to 28,811,334 people, until July 10. During this period there have been a total of 40,708 notifications of adverse events (74% in women and 83% in people between 18 and 65 years old). 7,579 were considered serious. The ten most reported side effects are:

  • Pirexia 13,040 cases, 32%
  • Headache 8,662 cases, 21%
  • Myalgia 6,237 cases, 15%
  • Vaccination site pain 5,288 cases, 13%
  • Discomfort 4,778 cases, 12%
  • Fatigue 3,054 cases, 8%
  • lymphadenopathy 2,827 cases, 7%
  • nausea 2,588 cases, 6%
  • Shaking chills 2,339 cases, 6%
  • Asthenia 2,290 cases, 6%

On the other hand, until July 10, 2022, of the 40,708 notifications registered after the Comirnaty administration, 421 correspond to children. Until that date, more than 3.2 million doses were administered in Spain, so the notification rate is estimated at 13 registered notifications per 100,000 doses administered. The ten most reported side effects in children are:

  • Pirexia 80 cases, 19%
  • lymphadenopathy 71casos, a 17%
  • Headache 58 cases, 13%
  • Vaccination site pain 35 cases, 8%
  • vomiting 29 cases, 7%
  • Discomfort 27 cases, 6%
  • Diarrhea 21 cases, 5%
  • Urticaria 20 cases, 5%
  • Rash 15 cases, 4%
  • Fatigue 15 cases, 4%
  • Abdominal pain 13 cases, 3%
  • Dizziness 12 cases, 3%

Side Effects of Moderna

Until July 10, 2022, a total of 24,053,326 doses of this vaccine (5,342,870 people) were administered in Spain. In this period, a total of 16,856 reports of adverse events following administration of the Spikevax vaccine (72%) in women and 2,285 were considered serious.

The ten most reported adverse events with Moderna are:

  • Pirexia 7,316 cases, 43%
  • Headache 3,810 cases, 23%
  • Myalgia 2,965 cases, 18%
  • Vaccination site pain 2,461 cases, 15%
  • Discomfort 2,348 cases, 14%
  • Fatigue 1,283 cases, 8%
  • Shaking chills 1,241 cases, 7%
  • nausea 1,188 cases, 7%
  • lymphadenopathy 994 cases, 6%
  • Arthralgia 917 cases, 5%

Side effects with AstraZeneca

As of June 26, 2022, around 69 million doses of Vaxzevria have been administered in adults in the European Economic Area (EEA). In Spain, until July 10, 2022, there had been registered 119 notifications of Tinnitus or tinnitus after administration with this vaccine and about 9.8 million doses had been administered. . Tinnitus is a medical term for the phenomenon of ‘hearing’ continuous noise in the ears. It is not a disease, it is described asor a persistent ringing, ringing, or whistling in the ears. The frequency is less than 1 in 100 vaccinated people.

Other rare adverse effects published in the latest report are paresthesia (sensitivity disorder that manifests with abnormal sensations without prior stimulation, such as tingling) and hypoesthesia (decreased skin sensitivity). In Spain, until July 10, 2022, 765 notifications of paresthesia or hypoesthesia had been registered after the administration of the vaccine, having administered nearly 9.8 million doses of this vaccine.

Nuvaxovid Vaccine Side Effects

As of June 26, 2022, around 216,000 doses of Nuvaxovid have been administered in adults in the EEA. Adverse reactions identified up to June have been some cases of anaphylaxis (severe allergic reaction). Until May 31, 189 cases of paresthesia and 67 of hypoesthesia had been reported worldwide and more than 1.5 million doses of Nuvaxovid had been distributed.

Side effects of the third dose of the covid vaccine

Of the total of 40,708 registered notifications of events that occurred after the Comirnaty administration, it has been possible to identify 932 reports in people who received a third dose with this vaccine:

  • Pirexia 207 cases, 22%
  • lymphadenopathy 186 cases, 20%
  • Headache 94 cases, 10%
  • Discomfort 75 cases, 8%
  • Myalgia 67 cases, 7%
  • Fatigue 57 cases, 6%
  • Vaccination site pain 45 cases, 5%
  • Dyspnoea 44 cases, 5%
  • Arthralgia 36 cases, 4%
  • Shaking chills 36 cases, 4%

Instead, of the total 16,856 registered notifications of events that occurred after the administration of Moderna, 1,483 notifications have been identified in people who received a third dose with this vaccine. The most frequent are:

  • Pirexia 530 cases, 36%
  • Headache 279 cases, 19%
  • lymphadenopathy 244 cases, 16%
  • Myalgia 212 cases, 14%
  • Discomfort 181 cases, 12%
  • Shaking chills 141 cases, 9%
  • Fatigue 130 cases, 9%
  • Vaccination site pain 126 cases, 8%
  • nausea 114 cases, 8%
  • Arthralgia 101 cases, 7%

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