Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Rash
Clinical narrative: Coughing; Not feeling myself; Weakness; Rash all over my body; rash is awful; Tiredness; Headache; Muscle pain; Nausea; Feeling unwell; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247, Expiration Date: unknown, NDC number: unknown) via an unspecified route of administration, administered in Arm Right on an unspecified date (at the age of 78-year-old) as single dose for COVID-19 immunisation. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History relevant to AE(s) was none. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None. No additional vaccines was administered on same date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. The patient did not have any AEs following prior vaccinations. On an unspecified date in Feb2021, the patient experienced bad body rash at 09:00, muscle pain at 10:00, dizziness and weakness at 11:00, tiredness, headache, nausea and feeling unwell at 13:00. The events tiredness, muscle pain, nausea, feeling unwell, bad body rash and weakness were worsened. The patient did not require a visit to Emergency Room/Physician Office. Caller stated that she got her shot. Stated that she was supposed to get second shot Friday 12Feb2021. Stated that she had side effects ever since the shot. Stated that she had tiredness, headache, muscle pain, nausea, feeling unwell, has a bad body rash, dizziness and weakness. Stated that she was having trouble tasting. Stated that she thought it would go away but it got worst. Is for the Covid 19 shot. Stated that she was in the bed for three days. Wanted to know when would it go away. Stated that she will not get the other shot on Friday. Later clarified that she could taste but as soon as she does that she was nauseous. Stated that most of this started when they got the first shot. Stated that nausea started that day or the day after. Stated that the rash started a few days after and is on her arms, back, chest, neck and is now going to her face. Stated that the dizziness and weakness started the day after. The patient did not receive any treatment. The patient reported that the day that she got the shot she was very tired. She was just feeling unwell, not normal; she had not felt well for 2 weeks. Rash all over her body; rash was awful. She was not feeling herself. Consumer stated that, "She had several side effects and she need to talk about them. She was supposed to get her second shot Friday it is, the 12th. She thought some of these will go away but they have not and she wanted to know what to do about them." When confirmed talking about Pfizer's COVID-19 Vaccine, consumer stated that, "Yes she had." When probed for the side effects, consumer stated, "Okay yes you may do that. The first one, the day that I got the shot I was very tired, the next day I was just feeling unwell, not normal and now I have a rash all over my body. I am dizzy and weak, just headache, tiredness and just not feeling myself. And I have had some coughing and headache." When clarified if consumer wanted to know about getting the second dose, consumer stated, "That is one of them yes." Consumer was informed about Pfizer Medical Information. Consumer stated, "I have been holding for 2 hours, am I going to be talking to a person. And it will tell me what to do with these, I mean I have not felt well for 2 weeks, I need some help and this rash is awful. And I don't have to hold another 2 hours, will I?" Consumer was provided with the number of Pfizer Medical Information as # option 3, timings as 8 am to 8 pm Monday to Sunday. Consumer stated, "I have been holding for 2 hours and it's very hard. The thing about it, I called this number yesterday and they told me that they had a huge load of people and that they would call me but they never did, so I have been holding on this phone for 2 hours and 5 minutes so are you telling me I can get somebody if I hang up and call again. Talk to somebody that I can get some help. This is not right I have got all these side effects, I don't know what to do I have called these numbers and on this one I held 2 hours and 5 minutes and you are telling me to call the same number again that I have been holding on." Consumer was informed that the consumer need to choose option 3 to get into Pfizer Medical Information. Consumer stated, "So you want me to hang up and dial this number again and push number 3. Okay I have done everything so far and I am getting very very tired and this is awful when you can't get a hold of somebody to help you with these things, with these side effects." When asked to probe further questions, consumer stated, "Yes I have and I have already reported, I have talked to a nurse, she has put down all of that and then she gave me this number to call and get me some help." (Further not clarified and hung up the call abruptly). No investigation assessment. Relevant Tests: None. Outcome of the events tiredness, headache, muscle pain, nausea, feeling unwell, rash all over my body; rash is awful, dizziness, weakness was not recovered, coughing and not feeling myself was unknown.