Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: she wasn't sleeping like she was; felt really really bad/; kept taking her temperature and felt warm and had a low grade; weird and strange feelings/ not hungry; not hungry; black and blue where she got the vaccine; stomach ache; mouth tasted awful; chills; headache; diarrhea; Nauseous; had a bruise on her arm; no energy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Lot Number: EN6201 and expiration date was not reported), first dose via an unspecified route of administration on 12Mar2021 (age at vaccination 66-years-old) as single for covid-19 immunization. Medical history included she had surgeries from an unknown date a year ago, covid-19 from an unknown date in November all month and a couple weeks of December stayed in for 6 weeks and she had a terrible cough with Covid. Concomitant medication(s) included the patient receiving omeprazole DR (OMEPRAZOLE) since 30 years for hiatus hernia with acid reflux from an unspecified start date and ongoing; losartan potassium since 8 years for high blood pressure from an unspecified start date and ongoing and she also receiving amitriptyline hcl anti-depressant this year ago and her doctor upped her dose in 2013 for feeling down and patient took esmoprazole sodium (NEXIUM (ESMOPRAZOLE SODIUM)) for unspecified indication from unknown date and ongoing. On 13Mar2021, after the first vaccination, for a whole week she felt awful with chills and thought she would give it a week and call her doctor and see if it was normal. Stated her husband told her to call and let us know. Stated it scared her and everyone she knew felt bad for 1-2 days after getting it. Stated she felt really really bad, that she got the 1st dose Friday late afternoon and then woke up with a headache on Saturday and felt terrible as the day went on and for that whole next week she felt awful with headache, chills, stomach ache, diarrhea, just felt really really bad. Stated it didn't feel like when they had Covid, she had no fatigue. Stated it will be 2 weeks this Friday since she had the 1st dose and she still has a bruise on her arm. Stated she had Covid. Reporter stated her question was does her having these symptoms had anything to do with her having Covid in November. Reporter provides that she talked to other people and one said she had bloodwork done and had antibodies and was told not to get the shot. Caller states she was afraid for the second one and doesn't want to go through those symptoms again but doesn't want to get Covid again it was awful. Reporter stated the reason she didn't log a report online was that she was not good on computers. Reporter stated her height was 5 feet 7 and a half inches. Reporter stated during her not feeling well she was not hungry either and it was so weird. Reporter stated she woke up with a headache on saturday 13Mar2021 morning and took Tylenol. Stated she was going to go babysit her granddaughters saturday afternoon and her daughter called and asked if she was okay to still come and she said yeah she just has a headache. Stated she felt great friday night and was like thank god no side effects from the shot. Stated she got the shot around 3:30pm on friday. Stated the chills and upset stomach started around 3:30 - 4pm saturday 13Mar2021 and by that night she had to call her daughter and her husband and say she was not feeling good and don't want to rush them but come back as she felt awful. Stated she was going to spend the night and her husband came and picked her up and these symptoms lasted for a week. Reporter clarifies that the diarrhea and no energy and feeling awful also started on Saturday. Reporter stated she knows when they stopped because her neighbour wanted to walk with her on friday and she said no that she felt better but didn't feel good. Reporter relays that on saturday she got up and her husband was getting mad at her because she kept taking Tylenol and she felt a little better and stayed home and rested that day. Reporter stated on sunday she felt really good and her stomach didn't hurt anymore. Reporter stated this was on 21Mar2021. Reporter stated with Covid she was exhausted and slept non-stop and she thought this can't be Covid because she wasn't sleeping like she was. Stated she felt awful and can't describe it better, it was weird. Reporter provides that the diarrhea started that Saturday also in the evening and a little bit with the stomach, she was nauseous and her mouth tasted awful and she kept brushing her teeth. Reporter clarifies that all her symptoms started Saturday 13Mar2021. Reporter stated she would say she was completely recovered and all her symptoms had resolved by Sunday 21Mar2021. Reporter stated she doesn't know if she can get the second shot and would had said no way she could had gotten it if she had been offered it on the week she was sick. Reporter relays that she doesn't want the same feelings again and she was a little scared and was going to call her doctor and decided to wait it out thinking it was maybe because she had Covid in November. Stated that everyone else she had talked to said their symptoms were for maybe a day or 2. Reporter relays that the bruise on her left arm was right away, on 13Mar2021 and was still there. States it was black and blue where she got the vaccine and it still looks dark and they didn't think it would be dark this long still. Reporter stated it was the Pfizer Covid vaccine and she can't tell by the guys writing on the card but thinks it says EN6201. Stated it was either a 6 or a G. Reporter stated it was funny she thought when she didn't feel good with her stomach and she felt like she was going to throw up she thought maybe there was a connection with the acid reflux and hiatal hernia as this hasn't bothered her since she had been on the medication. No further information was provided or obtained. Reporter stated she didn't call her healthcare provider and was going to wait a week and call on monday if she wasn't better, just wait it out and then thought if still has by monday something isn't right. Reporter stated with Covid they went and did the Covid test and that came back positive and they stayed in for 6 weeks and she had a terrible terrible cough with Covid. Reporter stated she doesn't know if there was a link with Covid and getting the vaccine. Stated she had called her doctor and said the cough was really really bad and should she get a chest xray and they said no wait it out. States they did call in a cough medicine with codeine that helped a little and she waited it out. States between her cough and her husbands high fever they could had gone to the hospital but they instead waited it out as they didn't want to go and not come back. Reporter clarified this as being during their illness with Covid. Reporter stated she thinks it was weird, she was scared to get the second shot and she doesn't want to feel like that again but also doesn't want to get Covid again either. Reporter was asking if that can happen with getting sick for a whole week. Stated she was second guessing if it was from the shot since it started a day later. Stated it was weird and strange feelings and she doesn't know what to do. Reporter enquired was it a reaction to it and Don't know if should get the second shot. Stated her question was that she had Covid in November all month and a couple of weeks in December and was asking does that put antibodies in your system and was the shot shooting antibodies in. Reporter was wondering about bruising, thought that would had shown, was that normal, reporter was asking if there are different dosages of the Covid vaccine. Stated they gave her papers on the vaccine about the vaccine but it doesn't say anything about dosage. Stated her husband got it and was perfectly fine. Reporter relays that she also kept taking her temperature and felt warm and had a low grade the whole week starting on Saturday also. Stated this also resolved by 21Mar2021. Reporter asking if she handler thinks she should take the next one and doesn't understand why she got sick what was in the vaccine and other people don't get sick. Stated one girl she knows had Covid in September and caller said last week she told her she still didn't feel good and said it was weird. Stated her friend did not get the shot and had had bloodwork done and had antibodies and her doctor told her not to get the Covid shot right now. Reporter was asking was it because she had the Covid that she got sick from the shot. Stated she was not on aspirin or blood thinners and doesn't usually get bruises from the flu shot. States for the cough medicine with codeine she threw that away and does not had any information to provide, NDC, lot, expiry date or name. Stated it was in Nov2021 and thinks she tested positive on either 7Nov2021 or 9Nov2021. No further information provided. Reporter stated the thing right now was she doesn't know if she should get the next vaccine again, she wants to prevent Covid but doesn't want to do it and feel bad for a week but it was nothing compared to the feeling of Covid. Stated her doctor will probably say yes. Reporter stated if she got the Covid vaccine again and fine to go get again if she starts having the same symptoms does she need to call and report them. Reporter was wondering if there was a correlation between having Covid and getting the vaccine and feeling bad like that. Reporter was wondering if that was considered an allergic reaction or if it was side effects. Stated she thinks she should call and tell them. Reporter stated she didn't want Covid again and she was feeling better now and last week would had said she was not getting the Covid vaccine again but she was feeling back to normal. The patient received treatment of Tylenol for headache. The outcome of the events had a bruise on her arm and black and blue where she got the vaccine was unknown and remaining all the events was recovered on 21Mar2021.  Description of Product Complaint: PC#1 cough syrup with codeine. cough was really really bad and should she get a chest x-ray and they said no wait it out. States they did call in a cough medicine with codeine that helped a little and she waited it out states she threw that away and does not had any information to provide, NDC, lot, expiry date or name. States it was in Nov2021. No further information provided. PC#2 Omeprazole DR. Caller states it was funny she thought when she didn't feel good with her stomach and she felt like she was going to throw up she thought maybe there was a connection with the acid reflux and hiatal hernia as this hasn't bothered her since she had been on the medication. No further information was provided or obtained. No outbound call made to obtain NDC, lot or expiry day due to Omeprazole DR being a non Pfizer product.  Follow-up attempts completed. No further information expected.