chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Flu-like symptoms; fever; pain in joints; infection site pain warm; General tiredness and soreness; loss of appetite; General tiredness and soreness; This is a spontaneous case received from a consumer (Patient). A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732), via an unspecified route of administration in right arm on 29Mar2021 at 09:45 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history included COVID 19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 01:00, the patient experienced flu-like symptoms, fever, pain in joints, infection site pain warm, general tiredness and soreness, loss of appetite, general tiredness, and soreness. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was reported as resolving.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash over the body and itching; Rash over the body and itching; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced side effects rash over the body and itching. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dysphagia, Dyspnoea, Feeling abnormal
Clinical narrative: penny taste in her mouth; chills; bad sore throat; swollen lymph nodes; heaviness in her chest; I had a lot of trouble swallowing; I had very difficult time trying to as I was gasping for air; I started feeling really bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6208 and expiration date was not reported), via an unspecified route of administration on 29Mar2021 at 15:00 hours (Age at vaccination was 62 years) as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 29Mar2021 the patient was stated, She was just wondering as she had got her first Covid vaccine and while she was sitting up there, she started having real bad tangy taste in her mouth and she called the nurse over she said that is normal as some people do say that they taste the tin taste afterwards and she said just sit for few more minutes and then they went to dinner and come home and it was about 3 hours later she started feeling really bad, she had chills and like a heaviness in her chest and then could not swallow, she had a lot of trouble swallowing and her lymph nodes were real swollen and she had very difficult time trying to as she was gasping for air. So, her husband and she sat up for the whole night as something can happen but it was okay by morning but she still have little bit of swelling in throat but all the heaviness just went away. So she was just wondering she is scheduled for second dose on 19Apr2021. Patient wanted to know if she was going to experience, or should she watch over as it was going to be worse than I experienced. Patient stated that it was like a delayed reaction. She was concerned about it as it was little scary to experience that. On 29Mar2021 patient was recovered from Gasping and on 30Mar2021 patient was recovered from Chest heaviness, the outcome of rest of all events was unknown.   No follow up attempts are needed .No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366798 same reporter/drug/AE, different patients
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Taste disorder
Clinical narrative: penny taste in her mouth; chills; bad sore throat; swollen lymph nodes; heaviness in her chest; I had a lot of trouble swallowing; I had very difficult time trying to as I was gasping for air; I started feeling really bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6208 and expiration date was not reported), via an unspecified route of administration on 29Mar2021 at 15:00 hours (Age at vaccination was 62 years) as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 29Mar2021 the patient was stated, She was just wondering as she had got her first Covid vaccine and while she was sitting up there, she started having real bad tangy taste in her mouth and she called the nurse over she said that is normal as some people do say that they taste the tin taste afterwards and she said just sit for few more minutes and then they went to dinner and come home and it was about 3 hours later she started feeling really bad, she had chills and like a heaviness in her chest and then could not swallow, she had a lot of trouble swallowing and her lymph nodes were real swollen and she had very difficult time trying to as she was gasping for air. So, her husband and she sat up for the whole night as something can happen but it was okay by morning but she still have little bit of swelling in throat but all the heaviness just went away. So she was just wondering she is scheduled for second dose on 19Apr2021. Patient wanted to know if she was going to experience, or should she watch over as it was going to be worse than I experienced. Patient stated that it was like a delayed reaction. She was concerned about it as it was little scary to experience that. On 29Mar2021 patient was recovered from Gasping and on 30Mar2021 patient was recovered from Chest heaviness, the outcome of rest of all events was unknown.   No follow up attempts are needed .No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366798 same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Malaise, Nasopharyngitis, Sneezing
Clinical narrative: colds; sneezing; loss in her taste and smell for a short period of time; loss in her taste and smell for a short period of time; began to feel unwell; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) via Pfizer sponsored program. A female patient of unspecified age (Unknown pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no/ Lot Number: unknown; expiration date: unknown) via an unspecified route of administration on 20Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no/ Lot Number: unknown; expiration date: unknown), via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. On 24Mar2021, patient reported began to feel unwell. On 26Mar2021 patient began experiencing a loss in her taste and smell for a short period of time. Then, patient also reported having colds and sneezing on 27Mar2021. Outcome of the events began to feel unwell, colds and sneezing was unknown and loss in her taste and smell for a short period of time was recovered on an unknown date in Mar2021  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Rash
Clinical narrative: sore arms; rash on neck; nauseated; dizzy; This is a spontaneous report from a contactable consumer (patient) received through reporting system. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history was, and concomitant medications were not reported. On an unspecified date in 2021, After the first dose the patient experienced sore arms, after a few days she got a rash on the neck, feeling nauseated and dizzy intermittently. The event outcome was Unknown.  The second dose scheduled on 10Apr2021.  Medical Information:  Were any unaddressed medical questions referred or forwarded to Medical Information? No
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthmatic symptoms; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 28Mar2021, patient experienced asthmatic symptoms afterward first vaccine. Patient would like to know if it was okay to take cortisone. 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: Myalgia, Pyrexia
Clinical narrative: muscle aches; Fever; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included renal transplant, immunosuppressant drug therapy, covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. on Mar2021 the patient experienced muscle aches, fever, and other side effects. she wants to know if she should be concerned about these side effects and if she should get second dose. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide increased, Coagulopathy, Paraesthesia, Rash, Rash papular
Clinical narrative: Developed a rash at ankle, about the size of a quarter/On the back of right thigh, a much bigger rash, small raise, red dots/Rash looks like the rash people were getting from COVID itself; observed a small red raised bumps- rash on her  ankle, legs and back thigh; CP is concerned that she might have problems in blood clotting; felt some prickling sensation on this area/Pricking sensation in ankle; This is a spontaneous report from a contactable consumer or other non hcp.   A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP7534) via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. The patient's medical history included mast cell activation syndrome from 2018: Mast cell activation syndrome, gastrointestinal bacterial overgrowth from 2019 to an unknown date Verbatim: Small intestinal bacterial overgrowth, methylenetetrahydrofolate reductase gene mutation from an unknown date and unknown if ongoing Verbatim: Genetic Mutation (MTHFR). The patient's concomitant medications included gabapentin; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ciclosporin (CEQUA); naltrexone (NALTREXONE); duloxetine hydrochloride (CYMBALTA); montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 after her first dose of vaccine about 10 hours later, the patient observed a small red raised bumps- rash on her  ankle, legs and back thigh. She also felt some prickling sensation on this area, we are cancelling it, 15Apr2021 but the patient cancelling it, developed a rash at ankle, about the size of a quarter/on the back of right thigh, a much bigger rash, small raise, red dots/rash looks like the rash people were getting from covid itself, observed a small red raised bumps- rash on her ankle, legs and back thigh, cp was concerned that the patient might have problems in blood clotting, felt some prickling sensation on this area/pricking sensation in ankle on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included carbon dioxide increased was not too high ppm. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer (patient) reported in response to the non-HCP letter sent. A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3246; Expiration date was not reported), via intramuscular, administered in Left arm (left shoulder) on 15Jan2021 15:00 (at the age of 72-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. Concomitant medication(s) included lisinopril (LISINOPRIL); amlodipine (AMLODIPINE); hydralazine (HYDRALAZINE) taken for hypertension; allopurinol (ALLOPURINOL) taken for gout from an unspecified start date and ongoing. Family medical History; prior Vaccinations: (within 4 weeks); relevant tests included none. The patient experienced soreness at injection site on the same day of vaccination, 15Jan2021. Event was not serious. The event did not require the initiation of new medication/other treatment/procedure. Date of recovery was about 3 days. Clinical outcome of event was recovered on 18Jan2021.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: she is on an antibiotic for bronchitis; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bronchitis and is on antibiotics for bronchitis. Therapeutic measures were taken for bronchitis with antibiotics. Patient was scheduled to have the second dose of the vaccine and she was on an antibiotic for bronchitis. 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: Asthenia, Body temperature, Diarrhoea, Dyspepsia, Pyrexia
Clinical narrative: Feeling weak; throwing up; throwing up, diarrhea; Stomach felt hot; fever of 99.1 degree F; This is a spontaneous report from a contactable consumer received from program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 21Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the vaccine on 21Mar2021, and She called to report the symptoms she experienced on an unspecified date in 2021, after receiving the first dose like feeling weak, throwing up, diarrhea, stomach felt hot, and fever of 99.1 degree F for two days. The patient wanted to know when to receive the second dose. The patient underwent lab tests and procedures which included body temperature 99.1 Fahrenheit on an unspecified date in 2021. There was not any unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feeling weak; throwing up; throwing up, diarrhea; Stomach felt hot; fever of 99.1 degree F; This is a spontaneous report from a contactable consumer received from program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 21Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the vaccine on 21Mar2021, and She called to report the symptoms she experienced on an unspecified date in 2021, after receiving the first dose like feeling weak, throwing up, diarrhea, stomach felt hot, and fever of 99.1 degree F for two days. The patient wanted to know when to receive the second dose. The patient underwent lab tests and procedures which included body temperature 99.1 Fahrenheit on an unspecified date in 2021. There was not any unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhoea; Developed this fever today it's normal, it's like 99; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6199, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 10Mar2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced diarrhoea and developed this fever today it was normal, it's like 99. Reporter stated, so I got my first Pfizer shot 3 weeks ago shot, I get it from Pfizer. I am due to go back tomorrow but I have developed this fever today it was normal, it's like 99. I have had little bit of diarrhea but that's gone, it was okay if I get the shot tomorrow because I have a like a low-grade fever. Reporter seriousness for the events were unspecified. Outcome of the event diarrhoea was resolved on an unspecified date whereas, developed this fever today it's normal, it's like 99 was unknown.  No follow-up attempts are needed. Information about Lot/Batch number is provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Inappropriate schedule of product administration, Nerve block, Platelet count, Platelet count decreased
Clinical narrative: The platelets were clotting together/ a clotting problem; his platelets were low; delayed nerve block; his first Pfizer covid vaccine on 05Feb and his second on 21Feb; This is a spontaneous report from a contactable consumer or other non hcp (Patient). An 82-years-old male patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot number: EL9266) via an unspecified route of administration, administered in Arm Left on 21Feb2021 as dose 2, single (at the age of 82-years-old) for covid-19 immunisation. Medical history included had knee, shoulder, neck, prostate operations, shoulder operation which were prior to vaccine from an unknown date and unknown if ongoing and has never had issues with his blood levels. There were no concomitant medications. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9269) via an unspecified route of administration on 05Feb2021 in left shoulder as dose 1, 0.3 ml single (at the age of 82-years-old) for COVID-19 immunization. The patient stated that his first pfizer covid vaccine on 05feb2021 and his second dose on 21feb2021, states he was scheduled to have a nerve block on his back on Friday 26Feb2021, that he went in that following Tuesday, 23Feb2021 his doctor is putting off the nerve block and he is in tremendous pain, cannot turn head from side to side. Confirms the pain began prior to the vaccines, nerve block was scheduled prior to vaccines.He went to his physician who did another test and was told his platelets were low. The platelets were clotting together so they could not get an accurate count. He has had many surgeries in the past and was never told he had platelet issues and never had a clotting problem. He has had not other side effects and if he had not needed to get bloodwork for his nerve block, he would not have known about the clotting problem.  His doctor was scheduling an appointment for him with a cancer and blood specialist. They have delayed the nerve block due to the platelet issues. the platelets were clotting together/ a clotting problem, his platelets were low on an unspecified date and delayed nerve block on 26Feb2021. Stated they told him his platelets were clotting together, he is thinking this must be a side of the vaccine. The patient underwent lab tests and procedures after the second dose of vaccine which included platelet count as low, sars-cov-2 test with unknown results and weight:170-175 lbs on an unspecified date. The outcome of all the events was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Weight
Clinical narrative: The platelets were clotting together/ a clotting problem; his platelets were low; delayed nerve block; his first Pfizer covid vaccine on 05Feb and his second on 21Feb; This is a spontaneous report from a contactable consumer or other non hcp (Patient). An 82-years-old male patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot number: EL9266) via an unspecified route of administration, administered in Arm Left on 21Feb2021 as dose 2, single (at the age of 82-years-old) for covid-19 immunisation. Medical history included had knee, shoulder, neck, prostate operations, shoulder operation which were prior to vaccine from an unknown date and unknown if ongoing and has never had issues with his blood levels. There were no concomitant medications. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9269) via an unspecified route of administration on 05Feb2021 in left shoulder as dose 1, 0.3 ml single (at the age of 82-years-old) for COVID-19 immunization. The patient stated that his first pfizer covid vaccine on 05feb2021 and his second dose on 21feb2021, states he was scheduled to have a nerve block on his back on Friday 26Feb2021, that he went in that following Tuesday, 23Feb2021 his doctor is putting off the nerve block and he is in tremendous pain, cannot turn head from side to side. Confirms the pain began prior to the vaccines, nerve block was scheduled prior to vaccines.He went to his physician who did another test and was told his platelets were low. The platelets were clotting together so they could not get an accurate count. He has had many surgeries in the past and was never told he had platelet issues and never had a clotting problem. He has had not other side effects and if he had not needed to get bloodwork for his nerve block, he would not have known about the clotting problem.  His doctor was scheduling an appointment for him with a cancer and blood specialist. They have delayed the nerve block due to the platelet issues. the platelets were clotting together/ a clotting problem, his platelets were low on an unspecified date and delayed nerve block on 26Feb2021. Stated they told him his platelets were clotting together, he is thinking this must be a side of the vaccine. The patient underwent lab tests and procedures after the second dose of vaccine which included platelet count as low, sars-cov-2 test with unknown results and weight:170-175 lbs on an unspecified date. The outcome of all the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Ultrasound scan
Clinical narrative: very small nodule; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 via unspecified route of administration in the arm right on 13Mar2021 10:30 (lot number: EN6208), at the age of 45-years-old, at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism, cutaneous lupus erythematosus and allergy to sulfa (rashes, heated). Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) for hypothyroidism and hydroxychloroquine for cutaneous lupus erythematosus; both ongoing. On unspecified date in 2021, patient developed very small nodule; patient thought something was wrong with her lymph nodes in neck area or thyroid but went for ultrasound, found very small nodule. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face swollen too after vaccination; This is a spontaneous report from a contactable consumer or other non hcp.  This consumer (Patients wife) reported for a male patient (Reporters husband) that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, dose 1 via an unspecified route of administration, dose 1 administered in Arm Left on 03Apr2021 11:00 AM (Batch/Lot Number: ER8134, expiry date: unknown) as Dose 1 SINGLE for covid-19 immunization. Medical history included heart arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received Iron, prenatal vitamins, magnesium, probiotics within 2 weeks of vaccination. The patient was not diagnosed with covid-19 before or after vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine.  On 03Apr2021, patient experienced face swollen too after vaccination (swelling face) Within 30 minutes (including 15minutes of wait after vaccination). The patient had not received any treatment for the event. On an unspecified date outcome of the event was recovered with sequelae.   Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021407080 same drug/AE, different patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Headache, Muscle spasms
Clinical narrative: Fever; chills; body aches; muscle cramps; headache; vomiting; diarrhea; loss of bladder control; labored breathing; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0161, expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 14:30 (at the age of 45-years-old) as dose 2, single for covid-19 immunization at pharmacy or drug store. The patient medical history included breast cancer survivor, currently suffering PLC body rash, drug Known allergies: Sulfa drug, body rash. Concomitant medication included valaciclovir hydrochloride (VALTREX), lorazepam, citalopram.  Other medications patient received in two weeks included valtrex, lorazapram, citralopram. The patient historical vaccine included first dose of BNT162B2 (lot number: ER8730, expiration date was not reported), via an unspecified route of administration, administered in left arm on 22Mar2021 02:30 PM (at the age of 45-years-old) as dose 1, single for covid-19 immunization. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.It was reported that on 13Apr2021 12:30 AM the patient experienced fever, chills, body aches, muscle cramps, headache, vomiting, diarrhea, loss of bladder control, immediate onset of period, labored breathing. No treatment received for adverse events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Urinary incontinence, Vomiting
Clinical narrative: Fever; chills; body aches; muscle cramps; headache; vomiting; diarrhea; loss of bladder control; labored breathing; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0161, expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 14:30 (at the age of 45-years-old) as dose 2, single for covid-19 immunization at pharmacy or drug store. The patient medical history included breast cancer survivor, currently suffering PLC body rash, drug Known allergies: Sulfa drug, body rash. Concomitant medication included valaciclovir hydrochloride (VALTREX), lorazepam, citalopram.  Other medications patient received in two weeks included valtrex, lorazapram, citralopram. The patient historical vaccine included first dose of BNT162B2 (lot number: ER8730, expiration date was not reported), via an unspecified route of administration, administered in left arm on 22Mar2021 02:30 PM (at the age of 45-years-old) as dose 1, single for covid-19 immunization. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.It was reported that on 13Apr2021 12:30 AM the patient experienced fever, chills, body aches, muscle cramps, headache, vomiting, diarrhea, loss of bladder control, immediate onset of period, labored breathing. No treatment received for adverse events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache
Clinical narrative: Headache; extreme exhaustion; sometimes short of breath; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot Number: EP7534), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 13:15 as a single dose for covid-19 immunization at the age of 56-years-old. Medical history included Primary lateral sclerosis, Ehlers Danlos Syndrome, Gastroparesis, known allergies of Penicillin, sulfa, and latex. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6202), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 at 01:15 PM as a single dose for COVID-19 immunization at the age of 56-years-old. Concomitant medications included Gabapentin, Meloxicam, Vitamin D, and Baclofen taken for an unspecified indication. The patient previously took Tylenol and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had not taken any treatment for reported events. On 23Mar2021 (at 02:00), the patient experienced headache, extreme exhaustion, and sometimes short of breath. The outcome of all the events was unknown.  No follow-up attempts are required. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients (Herself and Two Other Patients). This is 1st of 3 reports. This report for a 47-year-old female patient (Reporter Herself). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number - Er2613 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 17:00 (at the age of 47-years-old) as a single dose for covid-19 immunization. Medical history included drug hypersensitivity- Penicillin. There were no concomitant medications. On 10Apr2021, the patient got shingles in the same arm as the vaccine 9 days later. She happen to know two other people who also got shingles after their vaccine. It could be a coincidence but thought it was worth reporting for your tracking purposes. AE resulted in doctor or other healthcare professional office/clinic visit. The patient was received treatment with anti-viral medication. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021433882 same reporter/AE/drug, different patient;-PFIZER INC-2021433881 same reporter/AE/drug, different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy menstrual bleeding for 18 days after first vaccination; This is a spontaneous report from a contactable other hcp (patient/nurse). A 53-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6206, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:15 as DOSE 1, SINGLE for covid-19 immunization (53 year when vaccinated) at Pharmacy or Drug Store.  Medical history included asthma from an unknown date, anaemia from an unknown date, drug hypersensitivity from an unknown date (allergy from sulfa and PCN). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. On an unknown date in Mar2021, the patient developed heavy menstrual bleeding for 18 days after first vaccination. The patient did not receive any treatment for the event. The patient had to visit doctor due to the event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was reported as recovered.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Herpes zoster, Investigation, Nausea
Clinical narrative: shingles; Felt drugged and tired; I woke up with pain in my lower left back below my ribs - thought it might be kidney stones; rash "bloomed" up like poison oak, but it had three stripes to it. It felt extremely itchy; I felt nauseous; chills; This is a spontaneous report from a contactable consumer. This 41-year-old female consumer reported that:  A 41-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Right on 31Mar2021 12:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. There were no concomitant medications. Patient had no known allergies and other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021 22:00, the patient experienced felt drugged and tired, i woke up with pain in my lower left back below my ribs - thought it might be kidney stones, rash bloomed up like poison oak, but it had three stripes to it. it felt extremely itchy, i felt nauseous, chills, shingles. It felt extremely itchy but also like it had tentacles of shooting pain beneath it Night of 14Apr2021 into 15Apr2021 I woke up to intense pain again in same spot. She felt nauseous, and had chills. A hot shower and Tylenol made me feel better the next morning. That day she felt twinges of pain In the same spot and eating made it worse 16Apr2021 she worked out and felt a little better but the pain now wrapped around my side to the front. The patient underwent lab tests and procedures which included shingles: diagnosed it as shingle on  went to doctor for kidney stones and poison oak and she diagnosed it as Shingles. Therapeutic measures were taken as a result of felt drugged and tired, i woke up with pain in my lower left back below my ribs - thought it might be kidney stones, rash "bloomed" up like poison oak, but it had three stripes to it. it felt extremely itchy, i felt nauseous, chills, shingles. Patient received treatment with valtrex for events. The clinical outcome of events were recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Renal pain
Clinical narrative: shingles; Felt drugged and tired; I woke up with pain in my lower left back below my ribs - thought it might be kidney stones; rash "bloomed" up like poison oak, but it had three stripes to it. It felt extremely itchy; I felt nauseous; chills; This is a spontaneous report from a contactable consumer. This 41-year-old female consumer reported that:  A 41-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Right on 31Mar2021 12:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. There were no concomitant medications. Patient had no known allergies and other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021 22:00, the patient experienced felt drugged and tired, i woke up with pain in my lower left back below my ribs - thought it might be kidney stones, rash bloomed up like poison oak, but it had three stripes to it. it felt extremely itchy, i felt nauseous, chills, shingles. It felt extremely itchy but also like it had tentacles of shooting pain beneath it Night of 14Apr2021 into 15Apr2021 I woke up to intense pain again in same spot. She felt nauseous, and had chills. A hot shower and Tylenol made me feel better the next morning. That day she felt twinges of pain In the same spot and eating made it worse 16Apr2021 she worked out and felt a little better but the pain now wrapped around my side to the front. The patient underwent lab tests and procedures which included shingles: diagnosed it as shingle on  went to doctor for kidney stones and poison oak and she diagnosed it as Shingles. Therapeutic measures were taken as a result of felt drugged and tired, i woke up with pain in my lower left back below my ribs - thought it might be kidney stones, rash "bloomed" up like poison oak, but it had three stripes to it. it felt extremely itchy, i felt nauseous, chills, shingles. Patient received treatment with valtrex for events. The clinical outcome of events were recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Menstrual disorder, Muscle spasms
Clinical narrative: menstrual cycle to start 4 days early; excessive clotting from my period; i also had cramping; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 24-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration (at the age of 24-years), administered in arm left on 22Mar2021 at 18:00 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On an unspecified date, the patient experienced menstrual cycle to start 4 days early and excessive clotting from my period. On 22Mar2021, experienced I also had cramping. It was further stated that, for the first vaccine it caused my menstrual cycle to start 4 days early and I also had cramping the day I got the shot. The second vaccine caused my menstrual cycle to start 10 days early. Both times I had excessive clotting from my period which is not something I experience with my usual cycle. The treatment was not received for all the events. The clinical outcome for all the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Herpes zoster, Pyrexia
Clinical narrative: rashes on left flank /the physician called these out as shingles; chills; shivering; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in Arm Left on 09Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks, patient didn't receive other medications within 2 weeks of vaccination. Patient didn't had covid prior to vaccination. The patient medical history and concomitant medications were not reported. Patient had no allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN60207) via unspecified route of administration on 19Mar2021 in Arm left as DOSE 1, SINGLE for covid-19 immunisation. On 09Apr2021 the patient experienced rashes on left flank /the physician called these out as shingles, chills, shivering, fever. Patient had physician office visits for the events physician recommended to wait for 72 hours before starting antivirals and anti-inflammatory medications. Therapeutic measures were taken as a result of chills, shivering, fever was 3 Advil's, every 8 hours. Patient was not tested with covid to post vaccination. The outcome of the events, herpes zoster, chills, pyrexia was recovering.  No follow-up attempts are possible; No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Herpes zoster, Pain, Peripheral swelling
Clinical narrative: itchy bumps around the injection site; redness and swelling in two places on and around my left hand; redness and swelling in two places on and around my left hand; Rash; shingles; soreness; tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:15 (at age of 45-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included irritable bowel syndrome, food allergy; sensitive to bananas, dairy products, varicella; she have been exposed to chicken pox as a child from an unknown date and unknown if ongoing. Concomitant medications included xylometazoline hydrochloride (NASAL SPRAY II) taken for an unspecified indication. The patient previously took augmentine [amoxicillin;clavulanic acid] and experienced hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient received first Pfizer vaccine on the evening of 26Mar2021. She experienced soreness, tiredness on same day 26Mar2021. On the morning of 27Mar2021, she woke up with itchy bumps around the injection site and down her arm. As well as redness and swelling in two places on and around her left hand. The rash then spread to forearm, left side, small clusters on her right shoulder blade and little spots near both ankles. 5 days later she went to the doctors because the itchiness and the unbearable pain was not letting up. Her doctor treated her for shingles. He prescribed two medications (not specified). Unfortunately, she developed more rashes on right arm, the underside of her bicep and forearm. Her doctor recommended she should get the second shot. It took 13 days for all of it to stop spreading and itching. It was unknown if patient had received any treatment for AEs. Patient did COVID test (Nasal Swab) post vaccination on 18Apr2021 with unknown results. The outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Vaccination site pruritus
Clinical narrative: itchy bumps around the injection site; redness and swelling in two places on and around my left hand; redness and swelling in two places on and around my left hand; Rash; shingles; soreness; tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:15 (at age of 45-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included irritable bowel syndrome, food allergy; sensitive to bananas, dairy products, varicella; she have been exposed to chicken pox as a child from an unknown date and unknown if ongoing. Concomitant medications included xylometazoline hydrochloride (NASAL SPRAY II) taken for an unspecified indication. The patient previously took augmentine [amoxicillin;clavulanic acid] and experienced hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient received first Pfizer vaccine on the evening of 26Mar2021. She experienced soreness, tiredness on same day 26Mar2021. On the morning of 27Mar2021, she woke up with itchy bumps around the injection site and down her arm. As well as redness and swelling in two places on and around her left hand. The rash then spread to forearm, left side, small clusters on her right shoulder blade and little spots near both ankles. 5 days later she went to the doctors because the itchiness and the unbearable pain was not letting up. Her doctor treated her for shingles. He prescribed two medications (not specified). Unfortunately, she developed more rashes on right arm, the underside of her bicep and forearm. Her doctor recommended she should get the second shot. It took 13 days for all of it to stop spreading and itching. It was unknown if patient had received any treatment for AEs. Patient did COVID test (Nasal Swab) post vaccination on 18Apr2021 with unknown results. The outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.