chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for the Covid 19 virus; This is a spontaneous report from a contactable consumer (patient) from marketing programme. A 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number and expiration date unknown), via an unspecified route of administration administered in Arm Left on 06Mar2021 12:15 as single dose for covid-19 immunization. The patient medical history and concomitant medications were none. Caller stated that he received first shot of Covid vaccine on 06Mar2021 and tested positive for the Covid 19 virus (sars-cov-2 test positive) (medically significant) on 12Mar2021.  The caller further mentioned that he is scheduled for the second shot this weekend on 27Mar2021 and was asking if it is ok to get the second vaccine. He called the main number for Pfizer and was transferred to Pfizer Drug Safety. He has also called his doctor and his doctor did not have an answer regarding whether he should get the second vaccine. The patient underwent lab tests which included on 12Mar2021, he underwent rapid Covid 19 test and in Mar2021, an unspecified Covid 19 test; both results were positive.The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blister, Herpes zoster, Immunodeficiency
Clinical narrative: immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not feeling well; blistering; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 07Mar2021 18:00 as 1st dose, single for COVID-19 immunization. The patient has no medical history and concomitant medications. No history of previous vaccinations. No vaccinations in four weeks.  On 13Mar2021, 6 days after vaccination, the patient had nerve pain, back ache, hip ache, was not feeling well, and had blistering. The patient went to the urgent care/emergency room because of the back pain and was given Capscian which burned and acyclovir. On 17Mar2021, the patient had pain and rash. The patient's visited a dermatologist due to symptoms and was diagnosed with shingles which developed on the right side of her body on 21Mar2021. The dermatologist changed the acyclovir to valacyclovir at 1 gram three times a day and Triamcinolone Acetonide: ointment Dose: 0.1%, twice a day both starting on 23Mar2021. The patient was also given Lidocaine patch and Biofreeze. Patient states steroid ointment was very amazing and that was just yesterday it was started, already her rash is disappearing, blistering is going away. Dermatologist also said she hadn't been given the right antiviral. The patient requested reassurance that the first dose received would still be effective even though the patient thinks her immune system is obviously compromised (no treatment was reported), says her immune system took away guard for other virus, triggered but not caused it. Maybe just a theory my immune system is working overtime to produce antibodies from having received vaccine and maybe wasn't protecting from dormant chicken pox virus. Patient wanted to make sure the efficacy of first shot is still intact. Patient also stated second dose is scheduled for 29Mar2021 and she was wondering if she would be able to receive the second dose or if she would have to wait a period of time. The outcome of the event immune system is obviously compromised was unknown while for the rest of the events was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Neuralgia, Pain, Rash
Clinical narrative: immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not feeling well; blistering; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 07Mar2021 18:00 as 1st dose, single for COVID-19 immunization. The patient has no medical history and concomitant medications. No history of previous vaccinations. No vaccinations in four weeks.  On 13Mar2021, 6 days after vaccination, the patient had nerve pain, back ache, hip ache, was not feeling well, and had blistering. The patient went to the urgent care/emergency room because of the back pain and was given Capscian which burned and acyclovir. On 17Mar2021, the patient had pain and rash. The patient's visited a dermatologist due to symptoms and was diagnosed with shingles which developed on the right side of her body on 21Mar2021. The dermatologist changed the acyclovir to valacyclovir at 1 gram three times a day and Triamcinolone Acetonide: ointment Dose: 0.1%, twice a day both starting on 23Mar2021. The patient was also given Lidocaine patch and Biofreeze. Patient states steroid ointment was very amazing and that was just yesterday it was started, already her rash is disappearing, blistering is going away. Dermatologist also said she hadn't been given the right antiviral. The patient requested reassurance that the first dose received would still be effective even though the patient thinks her immune system is obviously compromised (no treatment was reported), says her immune system took away guard for other virus, triggered but not caused it. Maybe just a theory my immune system is working overtime to produce antibodies from having received vaccine and maybe wasn't protecting from dormant chicken pox virus. Patient wanted to make sure the efficacy of first shot is still intact. Patient also stated second dose is scheduled for 29Mar2021 and she was wondering if she would be able to receive the second dose or if she would have to wait a period of time. The outcome of the event immune system is obviously compromised was unknown while for the rest of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Bell's palsy, Herpes zoster, Magnetic resonance imaging
Clinical narrative: Bells Palsy type sensory reaction; Spots on her chin and cheek leftover from Shingles; This is a spontaneous report from a contactable consumer (another friend of daughter). A 27-year-old female patient received first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE formulation: Solution for injection, lot number: unknown), via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bells palsy type sensory reaction and spots on her chin and cheek leftover from shingles on 23Jan2021. The reported stated that the patient took the first dose of the vaccine and because of the adverse events she experienced, her doctors have told her she cannot take the second dose. Reporter added that her daughter had a quantitative antibody test done after the first shot and the count results were 77.74 milliliters. Reporter wants to know how much protection from Covid does this result give her daughter. She had Spots on her chin and cheek leftover from Shingles. She had an appt. today with the dermatologist. They gave her almost like a bleaching thing and something for the itch. She developed Bells Palsy type sensory reaction was a reaction to the reaction. She was so sick the first 3 days and the 4 day she developed the shingles, bells palsy type reaction. She never had chickenpox. She was the first age group that got Varicella before kindergarten. She never got chicken pox so to get shingles and never had chicken pox, only 22% of the population gets that. 78% of the people that get the vaccine don't get shingles. But yet her antibodies for the varicella zoster was off the roof after the vaccine. It was over 3000 and her face is proof of it. The patient underwent lab tests and procedures which included antibody test: 77.74 milliliters and magnetic resonance imaging: unknown result. Therapeutic measures were taken as a result of spots on her chin and cheek leftover from shingles. The outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Illness, Pain
Clinical narrative: 3 days sick; Threw up; Headache; 101.8 Fever; Ached all over; Very tired; This is a spontaneous report from a contactable consumer (reporting herself). This 74-Year-old Female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in arm on 01Mar2021 at 14:50 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ph9264), via an unspecified route of administration in arm on 09Feb2021 at 10:00 as a single dose for COVID-19 immunization. The patient's medical history reported as MONO-EBU started one year ago and its ongoing. The concomitant medication were not reported. On 01Mar2021, the patient experienced three days sickness, very tired, threw up, headache, 101.8 fever, ache all over in bed 3-day. The outcome of the event three days sickness was recovering, very tired was recovered and other events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: 3 days sick; Threw up; Headache; 101.8 Fever; Ached all over; Very tired; This is a spontaneous report from a contactable consumer (reporting herself). This 74-Year-old Female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in arm on 01Mar2021 at 14:50 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Ph9264), via an unspecified route of administration in arm on 09Feb2021 at 10:00 as a single dose for COVID-19 immunization. The patient's medical history reported as MONO-EBU started one year ago and its ongoing. The concomitant medication were not reported. On 01Mar2021, the patient experienced three days sickness, very tired, threw up, headache, 101.8 fever, ache all over in bed 3-day. The outcome of the event three days sickness was recovering, very tired was recovered and other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 07Mar2021: he received the first dose of the vaccine. Last Monday, he came down with COVID-19; he came down with COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route of administration on 07Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The report stated as, on 07Mar2021: he received the first dose of the vaccine. Last Monday, he came down with COVID-19, which he says he has recovered from now. His second dose is scheduled on 28Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test and tested positive on 22Mar2021. Outcome for the event he came down with COVID-19 was recovered on an unspecified date and remaining event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable healthcare professional from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 22Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on 22Mar2021. The reporter wanted to know if it is okay for the patient to take second dose of COVID-19 vaccine after being treated for shingles with Val acyclovir medication. The reporter stated that the patient received first dose on 22Mar2021 and contracted shingles on the same day. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Herpes virus infection, Pruritus
Clinical narrative: She had a severe outbreak of herpes rash on her bottom that started several days ago; itching; uncomfortable; she has a drug called Acyclovir and she is wondering if that drug has been negative effect on her second dose of vaccine.; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation; and acyclovir sodium (ACYCLOVIR SODIUM), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included His wife has a history of herpes and tends to break out when she is nervous, upset, or anxious. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 for COVID-19 immunisation. On an unspecified date, she had a severe outbreak of herpes rash on her bottom that started several days ago.  It is usually only one spot but currently she has at least 3 or 4 spots.  It is itching and very uncomfortable. She typically uses acyclovir for breakouts but has not used it yet and just enduring the discomfort at the moment. The patient asked about the interaction between the Pfizer vaccine and acyclovir, she has a drug called Acyclovir and she is wondering if that drug has been negative effect on her second dose of vaccine. The outcome of the events was unknown.  Information about lot/batch no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 1st dose of the Pfizer Covid19 Vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose; 1st dose of the Pfizer Covid19 Vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history concomitant medications were not reported.  The patient experienced 1st dose of the Pfizer Covid19 Vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose on 2021. The events assessed as serious (Medically significant). The reporter also mentioned that she does not know why she needed to call back because she already received information for her query regarding the spacing of the 2nd dose and 1st dose of the Pfizer Covid19 vaccine because she and her father received the 1st dose but tested positive for COVID before receiving the 2nd dose. They were referred to their HCP. She mentioned that she will be receiving the 2nd dose by next Monday. Reporter mentioned that patient already made a safety report, E-transferring to DSU, Possible AE Duplicate. The outcome of the events was unknown.  Information on lot/ batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be totally excluded,Linked Report(s) : US-PFIZER INC-2021329898 same reporter/ AE/ Drug, different pt.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Fatigue, Myalgia
Clinical narrative: Fatigue; severe muscle pain; joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 36-year-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: En6203; Expiration date was unknown), via intramuscular, administered in Arm Left upper on 13Mar2021 09:00 (age at vaccination 36-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Facility type for vaccination was hospital. Medical history included Ulcerative colitis from 1998 and ongoing and have not had flare up in years, high blood pressure from 2015 and ongoing and controlled with medicine, anxiety from 2015 and ongoing and controlled with medicine, Degenerative Disc Disease from 2004 and ongoing and controlled with marijuana, acid reflux from 2015 and ongoing, back pain from 2019 and ongoing. Patient had historical vaccine of first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: En9581; Expiration date was unknown), via intramuscular, administered in left upper arm on 15Feb2021 17:45 (at the age of 36-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Concomitant medications included sertraline 50 mg (SERTRALINE) taken for anxiety from 2015 and ongoing; losartan potassium 25 mg (LOSARTAN POTASSIUM) taken for high blood pressure from 2016 and ongoing; lansoprazole 30 mg (LANSOPRAZOLE) taken for acid reflux from 2015 and ongoing; marijuana (MARIJUANA) taken for back pain from 2019 and ongoing. There were no prior vaccinations (within 4 weeks). On 14Mar2021 the patient experienced severe muscle pain, joint pain and on an unspecified date patient had fatigue. The reporter assessed the event severe muscle and joint pain as serious with seriousness criteria Persistent / Significant disability / Incapacity and fatigue as non-serious. On Mar2020 the patient underwent lab tests and procedures which included blood test: normal. Therapeutic measures were taken as a result of severe muscle pain, joint pain tried Aleve CBD Lotion, medical marijuana-no relief at all. The outcome of event Severe muscle and joint pain was Recovering but for event fatigue outcome of event was recovered.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; severe muscle pain; joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 36-year-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: En6203; Expiration date was unknown), via intramuscular, administered in Arm Left upper on 13Mar2021 09:00 (age at vaccination 36-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Facility type for vaccination was hospital. Medical history included Ulcerative colitis from 1998 and ongoing and have not had flare up in years, high blood pressure from 2015 and ongoing and controlled with medicine, anxiety from 2015 and ongoing and controlled with medicine, Degenerative Disc Disease from 2004 and ongoing and controlled with marijuana, acid reflux from 2015 and ongoing, back pain from 2019 and ongoing. Patient had historical vaccine of first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: En9581; Expiration date was unknown), via intramuscular, administered in left upper arm on 15Feb2021 17:45 (at the age of 36-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Concomitant medications included sertraline 50 mg (SERTRALINE) taken for anxiety from 2015 and ongoing; losartan potassium 25 mg (LOSARTAN POTASSIUM) taken for high blood pressure from 2016 and ongoing; lansoprazole 30 mg (LANSOPRAZOLE) taken for acid reflux from 2015 and ongoing; marijuana (MARIJUANA) taken for back pain from 2019 and ongoing. There were no prior vaccinations (within 4 weeks). On 14Mar2021 the patient experienced severe muscle pain, joint pain and on an unspecified date patient had fatigue. The reporter assessed the event severe muscle and joint pain as serious with seriousness criteria Persistent / Significant disability / Incapacity and fatigue as non-serious. On Mar2020 the patient underwent lab tests and procedures which included blood test: normal. Therapeutic measures were taken as a result of severe muscle pain, joint pain tried Aleve CBD Lotion, medical marijuana-no relief at all. The outcome of event Severe muscle and joint pain was Recovering but for event fatigue outcome of event was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: she had an outbreak of shingles; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 1st dose, single for COVID-19 immunisation. Medical history included cancer before and there is a "weak spot" in the past radiation site. The patient's concomitant medications were not reported. The patient had an outbreak of shingles on an unspecified date with outcome of unknown. The event was assessed as non-serious.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ear swelling, Herpes zoster reactivation, Swelling
Clinical narrative: diagnosed with shingles/had shingles in the past; Swolen neck and ears; Swolen neck and ears; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. Medical history included shingles in the past, 10 years ago, and had the vaccine for shingles on an unspecified date for immunization. The patient's concomitant medications were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date for Covid-19 immunisation. On 28Mar2021, the patient felt discomfort in neck area, it was swollen. Swollen neck and ears. The patient went to the urgent care and was diagnosed with shingles. The events were assessed as non-serious. Outcome of the events was unknown. Events resulted in Emergency Room Visit.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Rash morbilliform, Rash pruritic
Clinical narrative: I felt tired and my head was felt foggy; I felt tired and my head was felt foggy; a little itchy/rash all over that is raised and itchy; Measles-like rash; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported receiving her first dose of BNT162B2 on 02Apr2021. She stated she felt tired and her head was a little foggy. After the second day she reported feeling a little itchy, which continued into a "full-blown " rash all over that was raised and itchy on her entire body. She reported she still had it as of 13Apr2021. She further reported it was little raised bumps (not hives), that itched; it looked like a measles-like rash. When she scratched it, she stated it went away. The patient reported she had it on her leg, chest, stomach, arms, and neck; the only place she didn't have it was on her face. She was unsure if this was a common occurrence and inquired if it was safe to do another vaccine. The patient's doctor told her to call Pfizer. The pharmacist said it was a reaction and some people were reporting a reaction days after the vaccine and not immediately after. The reporter asked for the protocol to follow and about what her doctor should do, further inquiring how well she was covered from the first dose if she did not get the second dose. The clinical outcome of she felt tired and her head was felt foggy were unknown; the outcomes of a little itchy/rash all over that is raised and itchy, and measles-like rash were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: itching and pink rash in her skin under and around her breast, in the back of her neck, in her belly, in he arm and in her flank; itching and pink rash in her skin under and around her breast, in the back of her neck, in her belly, in he arm and in her flank; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (Sunday) around 10:30 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date (the next day) the patient experienced itching and pink rash on her skin under and around her breast, on the back of her neck, on her belly, in the arm and on her flank. The rash was itching constantly and she scratched constantly. The outcomes of itching and pink rash were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis; This is a spontaneous report from a contactable consumer (parent). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that their son received the first dose of BNT162B2 on 07Apr2021 and was supposed to receive an adalimumab (HUMIRA) shot for his psoriasis on that Friday, 09Apr2021, but was told that the two were not good with each other. The patient's skin doctor said to give the patient the adalimumab, and the primary care physician told them the patient should wait 14 days. The reporter was not sure what to do and inquired if the patient should get the adalimumab shot. She reported that the patient had now (as of 13Apr2021) missed a dose of the adalimumab. The clinical outcome of psoriasis was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced arm pain; on the third day she had almost no discomfort. The outcome of arm pain was recovering. It was also reported that the patient received dose 2 of BNT162B2 on 10Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: flu like symptoms; body aches; headache; swollen sore throat like strep throat; swollen sore throat like strep throat; runny nose; some stomach issues; chills; fever; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. Medical history included COVID from Dec2020 and unknown if ongoing. Concomitant medications were not reported. The patient called about information on how long symptoms would last and if there was anything that could be taken. She reported having flu-like symptoms; she stated she went to the doctor and they didn't help and wouldn't suggest anything. The patient reporting having body aches, headache, swollen sore throat like strep throat, and a runny nose. She stated she got the vaccine first on 07Apr (2021) and the following day is when she started feeling like she had corona again. She reported that as time went by she started having some stomach issues that went away. She reported that chills and fever went away and that now (as of 13Apr2021) the headache and swollen throat and like a flu were "trying to catch on." The clinical outcomes of flu like symptoms, body aches, headache, swollen sore throat like strep throat, and runny nose were unknown. The outcomes of some stomach issues, chills and fever were recovered in Apr2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal swelling, Pyrexia, Rhinorrhoea
Clinical narrative: flu like symptoms; body aches; headache; swollen sore throat like strep throat; swollen sore throat like strep throat; runny nose; some stomach issues; chills; fever; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. Medical history included COVID from Dec2020 and unknown if ongoing. Concomitant medications were not reported. The patient called about information on how long symptoms would last and if there was anything that could be taken. She reported having flu-like symptoms; she stated she went to the doctor and they didn't help and wouldn't suggest anything. The patient reporting having body aches, headache, swollen sore throat like strep throat, and a runny nose. She stated she got the vaccine first on 07Apr (2021) and the following day is when she started feeling like she had corona again. She reported that as time went by she started having some stomach issues that went away. She reported that chills and fever went away and that now (as of 13Apr2021) the headache and swollen throat and like a flu were "trying to catch on." The clinical outcomes of flu like symptoms, body aches, headache, swollen sore throat like strep throat, and runny nose were unknown. The outcomes of some stomach issues, chills and fever were recovered in Apr2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; headache; severe myalgia; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number E8729) via an unspecified route of administration on 11Apr2021 (at the age of 45-years-old)  as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. In Apr2021, 8 hours after the second dose of BNT162B2, the patient experienced chills, headache, and severe myalgia. The outcomes of chills, headache, and severe myalgia were unknown.                            No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid oedema, Rash, Rash erythematous, Rash pruritic, Skin bacterial infection
Clinical narrative: His face is now 'puffy'.  The puffiness is in the frontal part of his face, part of forehead, eyelids and cheeks.; His face is now 'puffy'.  The puffiness is in the frontal part of his face, part of forehead, eyelids and cheeks.; raised red rash and slightly itchy; raised red rash and slightly itchy; rash on his face; possible bacterial infection; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient, also reported as 68-years-old, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 17Mar2021 (at the age of 58-years-old), and the second dose of BNT162B2 (lot number unknown) via an unspecified route of administration on 07Apr2021 (at the age of 58-years-old), as single doses for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that her husband received the first dose of BNT162B2 on 17Mar2021 and the second dose on 07Apr2021 and approximately 5 to 6 days after the first dose of the vaccine, her husband developed a rash on his face, but it was mild. She reported that as time went by the rash had gotten worse; further stating he went to the doctor on 08Apr2021 the day after the second dose and was told it was a possible bacterial infection and prescribed erythromycin. The reporter stated that as of 13Apr2021 the rash was considerably worse, and his face was puffy. The puffiness was in the frontal part of his face, part of forehead, eyelids, and cheeks, and the rash was now a "full-blown rash," it was a raised red rash and slightly itchy. The reporter stated they had an appointment with the doctor that afternoon (as of 13Apr2021). The events were reported as non-serious. The clinical outcomes of rash on his face, possible bacterial infection, his face was puffy, the puffiness was in the frontal part of his face, part of forehead, eyelids and cheeks, raised red rash and slightly itchy were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: His face is now 'puffy'.  The puffiness is in the frontal part of his face, part of forehead, eyelids and cheeks.; His face is now 'puffy'.  The puffiness is in the frontal part of his face, part of forehead, eyelids and cheeks.; raised red rash and slightly itchy; raised red rash and slightly itchy; rash on his face; possible bacterial infection; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient, also reported as 68-years-old, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 17Mar2021 (at the age of 58-years-old), and the second dose of BNT162B2 (lot number unknown) via an unspecified route of administration on 07Apr2021 (at the age of 58-years-old), as single doses for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that her husband received the first dose of BNT162B2 on 17Mar2021 and the second dose on 07Apr2021 and approximately 5 to 6 days after the first dose of the vaccine, her husband developed a rash on his face, but it was mild. She reported that as time went by the rash had gotten worse; further stating he went to the doctor on 08Apr2021 the day after the second dose and was told it was a possible bacterial infection and prescribed erythromycin. The reporter stated that as of 13Apr2021 the rash was considerably worse, and his face was puffy. The puffiness was in the frontal part of his face, part of forehead, eyelids, and cheeks, and the rash was now a "full-blown rash," it was a raised red rash and slightly itchy. The reporter stated they had an appointment with the doctor that afternoon (as of 13Apr2021). The events were reported as non-serious. The clinical outcomes of rash on his face, possible bacterial infection, his face was puffy, the puffiness was in the frontal part of his face, part of forehead, eyelids and cheeks, raised red rash and slightly itchy were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: coughing; Fever; Chills; This is a spontaneous report from a contactable consumer (daughter). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced coughing, fever, and chills on an unspecified date. Therapeutic measures were taken as a result of the events, which included paracetamol (TYLENOL) and unspecified steroids. The clinical outcome of coughing, fever, and chills was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Application site acne, Vaccination site erythema, Vaccination site scar
Clinical narrative: Has redness with pimples that started 2-3 weeks later and made a scar on injection site.; Has redness with pimples that started 2-3 weeks later and made a scar on injection site.; Has redness with pimples that started 2-3 weeks later and made a scar on injection site.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date, dose 2 via an unspecified route of administration on an unspecified date, each as a single dose for as covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the rabies vaccines for rabies.  The patient has redness with pimples that started 2-3 weeks later and made a scar on injection site on an unspecified date with outcome of unknown.  Details were as follows: the patient received two dose series. The patient underwent lab tests and procedures which included antibody test after 25 days and showed negative. The patient had redness with pimples that started 2-3 weeks later and made a scar on injection site. The outcome of has redness with pimples that started 2-3 weeks later and made a scar on injection site was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Myalgia, Vaccination site pain
Clinical narrative: pain in her bicep muscle; right arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history Lyme disease from 2020 and knee pain. The patient's concomitant medications were not reported. The patient experienced right arm pain at the injection site on 25Feb2021 and pain in her bicep muscle in Mar2021. The events were reported as non-serious. The clinical course was reported as follows: The patient received the first dose on 25Feb2021, and she had right arm pain at the injection site. Then the week went on and she started feeling pain in her bicep muscle and three weeks later it was still bothering her. The patient stated she had taken ibuprofen (MANUFACTURER UNKNOWN) to help treat the pain. She also went to her physician and he thought it could be post Lyme disease symptoms, but her blood tests came back negative on an unspecified date. The patient stated she had been in physical therapy for knee pain and now they are giving her exercises for her arm pain. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of right arm pain at the injection site and pain in her bicep muscle was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Head discomfort, Hypertension, Malaise
Clinical narrative: Diffuse body aches; head congestion; H/A; poor appetite; chills; malaise; This is a spontaneous report from a contactable healthcare professional.   A 28-year-old non-pregnant  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE),  dose 2 via an unspecified route of administration, administered in left arm on 12Apr2021, at 10:30, dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021, at 15:45, each as a s single dose for covid-19 immunization.  Medical history included anxiety from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Concomitant medications included sertraline hcl (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported.  The patient had a known allergy to codeine. On 13Apr2021, at 05:00, the patient experienced diffuse body aches, head congestion , h/a (hypertension), poor appetite, chills, malaise. Treatment received for the adverse events included unspecified over the counter cold medicine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient  has not been tested for COVID-19. The outcome of diffuse body aches, head congestion , h/a (hypertension), poor appetite, chills, malaise was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Diffuse body aches; head congestion; H/A; poor appetite; chills; malaise; This is a spontaneous report from a contactable healthcare professional.   A 28-year-old non-pregnant  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE),  dose 2 via an unspecified route of administration, administered in left arm on 12Apr2021, at 10:30, dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021, at 15:45, each as a s single dose for covid-19 immunization.  Medical history included anxiety from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Concomitant medications included sertraline hcl (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported.  The patient had a known allergy to codeine. On 13Apr2021, at 05:00, the patient experienced diffuse body aches, head congestion , h/a (hypertension), poor appetite, chills, malaise. Treatment received for the adverse events included unspecified over the counter cold medicine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient  has not been tested for COVID-19. The outcome of diffuse body aches, head congestion , h/a (hypertension), poor appetite, chills, malaise was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: body aches; rashes; This is a spontaneous report from a contactable consumer, reporting for father. A 63-year-old male patient received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on 23Mar2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. In 2021, a week after the vaccination¸ the patient experienced body aches and rashes, which were non-serious. Therapeutic measures were taken as a result of body aches and rashes. The patient was currently taking infliximab (REMICADE) for Adult Still disease. He received infliximab on 06Apr2021 and the doctor also prescribed prednisone. The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash on her body; This is a spontaneous report from a contactable consumer (patient's daughter). A 52-year-old female patient (reporter's mother) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as 1st dose, single for COVID-19 immunisation. The patient has no significant past medical history. Concomitant medication included aciclovir (CYCLOVIR) taken for an unspecified indication, start and stop date were not reported. The patient received the 1st dose of the vaccine (date not provided) and she was scheduled to receive the 2nd dose yesterday but they did not give her the vaccine because 1 week after getting the first dose she had shingles, had a rash on her body, it was mild but was given aciclovir, although she is better now. Patient asked if she should she get her 2nd dose and if someone was fighting an infection would there be a time frame to wait to give time for their immune system to be up again. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed shingles on an unspecified date. The reporter was asking if has anyone else reported getting shingles after receiving the Pfizer COVID vaccine. He stated that he had a patient who came in to get the Pfizer COVID vaccine and developed shingles a week later and is due to receive the second dose of the vaccine. The reporter was asking if it is okay for the patient to be prescribed an antiviral prior to getting the second dose of the vaccine and said that he has already reported the adverse event. The reporter was asking if why prescribing antiviral considered off label. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: patient reported having a rash which was likely to be shingles; patient reported having a rash which was likely to be shingles; This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient came to see one of their primary care providers. The patient reported having a rash which was likely to be shingles, 3-4 days after getting the BNT162B2 first dose. The reporter inquired on what was the recommendation for the second dose with the active shingles infection. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.