On 1 December, the Ministry of Health published the latest Pharmacovigilance report on vaccines against Covid-19 in which they are collected new adverse reactions identified for each vaccine after the periodic evaluation of the data, as well as the cases reported in Spain of adverse events after vaccination.
Since September 29, the Spanish Medicines and Health Products Agency (AEMPS) did not update the side effects of vaccines and one of the innovations highlighted in the Pharmacovigilance document is that it confirms the relationship between the profuse menstrual bleeding and vaccinations type of mRNA (Modern and, above all, Pfizer).
The report makes it clear that there is no evidence to suggest this these menstrual disorders in every way affect the reproduction or fertility of the woman. Thus, it amounts to 9,000 reported cases of heavy menstrual bleeding worldwide after the administration of any of the vaccines. In Spain, until October 9, 2022, the reported cases amount to 921 after vaccination with Pfizer, while 299 cases were recorded after the administration of Modernain women aged 12 to 49 years.
Adverse events after vaccination in Spain
Through November 13, 2022, a total of 83,093 adverse events after administration of any of the vaccines against Covid-19 (Pfizer or Moderna); i.e. 76 notifications for every 100,000 doses administered. 65% of them correspond to health professionals and 35% to citizens. Furthermore, the majority of reports were made by women (73%) and by people aged 18-65 years (82%).
Urticaria, a new side effect of Moderna
The most frequently reported disorders are fever, pain in the vaccination site, headache, dizziness, myalgia and arthralgia. In the case of the Moderna vaccine, the urticaria it appears as a new reaction after receiving the injection, although its occurrence is rare (less than 1 in 100 vaccinated people). In Spain, until November 13, 2022, they were registered 292 reports of urticaria after administration of the Moderna vaccine.
The ten most reported adverse events with Comirnaty Original (Pfizer)
This is the list with the ten most reported adverse events after receiving the Pfizer vaccine, as well as its percentage of the total reported reports. From the Ministry of Health they clarify that the adverse events that occurred after vaccination Adverse reactions cannot be considered vaccine derivatives until a causal relationship to its administration is confirmed.
- Pyrexia 14,286 cases, 33%
- Headache 9,232 cases, 21%
- myalgia 6,604 cases, 15%
- Pain in the vaccination area 5,650 cases, 13%
- Unease 5,389 cases, 12%
- Fatigue 3,308 cases, 8%
- lymphadenopathy 3,080 cases, 7%
- nausea 2,762 cases, 6%
- Chills that make you tremble 2,465 cases, 6%
- Asthenia 2,404 cases, 5%
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Top ten most reported adverse events with bivalent Comirnaty (Original/Omicron BA.4-5)
These are the ten most frequently reported adverse events following the administration of the new Pfizer vaccines adapted to the Omicron variant.
- Pyrexia 24 cases, 21%
- Unease 23 cases, 20%
- myalgia 14 cases, 12%
- Headache 10 cases, 9%
- He retched 8 cases, 7%
- Dyspnea 7 cases, 6%
- Pain in the vaccination area 7 cases, 6%
- Dizziness 7 cases, 6%
- Diarrhea 6 cases, 5%
- Arthralgia 5 cases, 4%
- lymphadenopathy 5 cases, 4%
- nausea 5 cases, 4%
- Syncope 5 cases, 4%
Top 10 side effects reported with Spikevax Original (Moderna)
- Pyrexia 8,646 cases, 44%
- Headache 4,298 cases, 22%
- myalgia 3,366 cases, 17%
- Unease 2,994 cases, 15%
- Pain in the vaccination area 2,862 cases, 14%
- Fatigue 1,484 cases, 8%
- Chills that make you tremble 1,418 cases, 7%
- nausea 1,355 cases, 7%
- lymphadenopathy 1,125 cases, 6%
- Arthralgia 1,002 cases, 5%
Top 10 Side Effects Reported with Spikevax Bivalent (Original/Omicron BA.1)
- Pyrexia 27 cases, 60%
- Pain in the vaccination area 17 cases, 38%
- Headache 15 cases, 33%
- myalgia 14 cases, 31%
- Chills that make you tremble 11 cases, 24%
- Arthralgia 9 cases, 20%
- Fatigue 8 casesand 18%
- Hardship 6 casesand 13%
- Asthenia 5 casesand 11%
- Nausea 4 casesand 9%
