Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fatigue, Headache, Illness, Myalgia
Clinical narrative: just felt super sick; Had diarrhea twice this morning so far.; General fatigue; headache; chills; heart racing; weakness; dizziness; Had a significant reaction to Prevnar 20; Redness at injection site; swelling at site of injection; Quite Painful: Persisted in the localized area to the injection but her joint pain resolved and her muscle pain is still there but about the same.; upper part of her arm is swollen, red, and warm; Persisted in the localized area to the injection but her joint pain resolved and her muscle pain is still there but about the same.; Persisted in the localized area to the injection but her joint pain resolved and her muscle pain is still there but about the same.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in arm for immunisation. The patient's relevant medical history included: "Soy Allergy" (ongoing), notes: I have a soy allergy, I am super sensitive to soy, both in food and topically.; "Had pneumonia previously" (unspecified if ongoing), notes: Had pneumonia previously. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer unknown.), for COVID-19 immunization. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 25Jan2023, outcome "not recovered", described as "Had a significant reaction to Prevnar 20"; MYALGIA (non-serious) with onset 25Jan2023, outcome "not recovered", ARTHRALGIA (non-serious) with onset 25Jan2023, outcome "recovered" and all described as "Persisted in the localized area to the injection but her joint pain resolved and her muscle pain is still there but about the same."; VACCINATION SITE PAIN (non-serious) with onset 25Jan2023, outcome "not recovered", described as "Quite Painful: Persisted in the localized area to the injection but her joint pain resolved and her muscle pain is still there but about the same."; VACCINATION SITE ERYTHEMA (non-serious) with onset 25Jan2023, outcome "not recovered", described as "Redness at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 25Jan2023, outcome "not recovered", described as "swelling at site of injection"; VACCINATION SITE WARMTH (non-serious) with onset 25Jan2023, outcome "not recovered", described as "upper part of her arm is swollen, red, and warm"; FATIGUE (non-serious) with onset 26Jan2023, outcome "recovering", described as "General fatigue"; CHILLS (non-serious) with onset 26Jan2023, outcome "recovered" (27Jan2023); DIZZINESS (non-serious) with onset 26Jan2023, outcome "recovering"; HEADACHE (non-serious) with onset 26Jan2023, outcome "recovered" (27Jan2023); PALPITATIONS (non-serious) with onset 26Jan2023, outcome "recovered" (27Jan2023), described as "heart racing"; ASTHENIA (non-serious) with onset 26Jan2023, outcome "recovering", described as "weakness"; DIARRHOEA (non-serious) with onset 27Jan2023, outcome "unknown", described as "Had diarrhea twice this morning so far."; ILLNESS (non-serious), outcome "recovering", described as "just felt super sick".  Additional information: The patient highly allergic to soy and I understand the serovars are grown in a soy broth. The patient was questioning if there a chance there are soy components in the final product. The patient submitted an email regarding ingredients in Prevnar 20 and had a significant reaction to it. I have a soy allergy, I am super sensitive to soy, both in food and topically, and wondering if there is soy in the ingredients. The patient reported: "My upper arm where injection was, is like softball size. I had a shot of Prevnar 20 on Wednesday (25Jan2023) late afternoon and within a couple of hours, had redness and swelling at site of injection. By yesterday (26Jan2023), I woke up with headache, chills, heart racing, weakness, dizziness, and just felt super sick. Today (27Jan2023), I woke up with the whole top of my arm swollen and red and painful. I am feeling better as far as the other symptoms go but my arm is quite painful. This seems like it is more of an allergic reaction than a typical vaccine reaction where your immune system is responding. This is worse than anything that I have ever had, even with a covid vaccine, I have never had this kind of reaction. I checked with my provider, and they said they did not see it in your information. It is hidden and took me a while to look through there and did see that portion in the description section of the PI. It should be more clear for those sensitive to soy." Soy allergy Diagnosed: Many years ago, probably in her mid-20s when she was tested. Very sensitive. Not only food reactions it is also reactions to any cosmetic products with any kind of soy product even if somewhat diluted or in an oil. The patient had a significant reaction to Prevnar 20. Has a soy allergy. Looked through Pfizer prescribing information as well as pamphlet and didn't see anything about it. Her doctors didn't see anything either. Should be more clear. Upper arm where injection was given is softball sized. Got the shot on late Wednesday afternoon and within a couple hours had redness and swelling at site of injection. By yesterday woke up with headache, chills, heart racing, weakness, dizziness, felt super sick. The day of reporting the patient woke up with top of arm swollen and red and quite painful. Other symptoms are better. Had diarrhea twice this morning so far. Never in her whole life had any reaction like this to a vaccine. Was feeling badly yesterday and her arm was sore. Could see it swelling yesterday but was shocked when she woke up this morning and realized the area had grown to where the entire upper part of her arm is swollen, red, and warm. Never had this after a vaccine before. Clarified the most she ever had with a vaccine was redness or swelling. With this vaccine it grew very quickly in size over 24 hours.   Prescribing information/pamphlet: Clarified she doesn't know if HCP looked at it or not before administering her the vaccine. Assumed it was something that was safe to take. Never had any other vaccine reaction. When she reached out to the HCP this morning about what she experienced she told her HCP she is not certain there are any soy components and her HCP said there was no soy. Her HCP Didn't seem to pick up on the fact it is grown in soy broth and manufactured with soy. Tried to look at an online product insert and read about the broth. HCP didn't seem to be aware of it, not clearly obvious for the physician when administering these things. Sometimes the things are not obvious to them. Not specifically called out about the process it is made or ingredients. Clarified and confirmed it was an online component not the actual included package insert with her Prevnar 20 injection and she was not sure if her HCP looked at any package insert or otherwise for the product.  Redness at injection site: Started not long after the injection, an hour or so after. Not long after the redness started that the welt grew outside of the injection site and her arm started getting sore. Next day the welt was more red and more significant and then the headache started. Clarified redness started Wednesday, 25Jan2023, late afternoon. Her appointment was at 2:30pm, got the injection at the end of the appointment around 3:30pm and by the time she got home within an hour or so it looked red, sore, and started to swell incrementally by the next day it was maybe bigger than quarter sized and still starting to grow. Woke up this morning and the area is super swollen, whole area is hard, really red, really hot. Entire arm in a radius around the injection site was and is still really sore. Clarified that her arm is at it's worst but it has persisted and stayed the same as this morning.  Quite Painful: Persisted in the localized area to the injection but her joint pain resolved and her muscle pain is still there but about the same. Headache: Started yesterday and persisted all day into the early hours of this morning. Chills: Started yesterday and resolved this morning. Heart Racing: Started yesterday evening when she was feeling badly with headache and chills, went to lay down in early evening around 5pmish then started noticing she could really feel her heart racing and beating faster than normally. Was like that for at least a couple of hours and knows she was up around midnight and still feeling it. Sometime between midnight and when she woke up this morning she was no longer detecting it. Is feeling fine today. Weakness: Started last night and definitely feeling a little off today. Started with diarrhea today and had two episodes of that since 10am. Still feels off. Think the weakness was the joint pain and feeling the effects of the other symptoms. Went to go to stand up and felt a little weakness or dizziness due to headache and joint pain. Has general fatigue. Clarified her soy allergy started before receiving Prevnar 20. Diarrhea: Thought it was resolved after first bout then happened again. Clarified she doesn't know what will happen the rest of the day. Had no issues prior to the vaccine and felt fine before the vaccine. Hasn't started any new medications.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.