chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: dizziness; Severe shortness of breath; fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: Ep 7533), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:30 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. Medical history included none. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient not experienced COVID prior vaccination. On 08Apr2021, the patient experienced dizziness, severe shortness of breath, fever and body aches. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 13Apr2021. The outcome of the events was not Recovered.  No follow up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Dizziness, Fatigue, Gait disturbance
Clinical narrative: She's been having side effects and can't get out of bed; dizziness; Couldn't walk straight; headache; joint pain/hips really hurting her; nausea; hot/cold flashes; tiredness; muscle pain; can't get out of bed to sit up; This is a spontaneous report received from a contactable consumer (son) reporting for his old mother (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 at the age of 48-years-old as dose 1, single for covid-19 immunisation. Medical history included breast cancer from an unknown date, ongoing MS (multiple sclerosis) from an unknown date, hernia repair on an unknown date and she recently had a vasectomy on an unknown date. she has a history of different immunocompromised things. Concomitant medications included gabapentin (GABAPENTIN) taken 400mg a day for an unspecified indication from an unspecified start date and ongoing, unspecified Allergy Pills on a daily basis from an unspecified date and there are more, but he can't remember what they are. The reporter was calling on behalf of his mother, who got the first vaccine, the previous day. On 14Apr2021, the patient experienced, she's been having side effects and can't get out of bed. She's been experiencing dizziness, couldn't walk straight, headache, joint pain, hips really hurting her, nausea, hot/cold flashes, tiredness and muscle pain. The reporter asked, what should she do? Should she see a doctor? He states his mom had the vaccine, the previous day and later yesterday on 14Apr2021, she started having really bad side effects and she can't get out of bed to sit up. States he wants to know if this is a normal reaction or he doesn't know if needs to take her somewhere? Caller handler asked for clarification on what the caller stated after hernia repair, and he stated again, vasectomy. He clarified this was his mom's first dose of the vaccine. Treatment included Ibuprofen, Acetaminophen. Reporter seriousness for Dizziness, couldn't walk straight, Headache, Joint Pain, hips really hurting her, Nausea, Hot/Cold Flashes, Tiredness, Muscle pain and can't get out of bed to sit up was unspecified. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Myalgia, Nausea, Sitting disability
Clinical narrative: She's been having side effects and can't get out of bed; dizziness; Couldn't walk straight; headache; joint pain/hips really hurting her; nausea; hot/cold flashes; tiredness; muscle pain; can't get out of bed to sit up; This is a spontaneous report received from a contactable consumer (son) reporting for his old mother (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 at the age of 48-years-old as dose 1, single for covid-19 immunisation. Medical history included breast cancer from an unknown date, ongoing MS (multiple sclerosis) from an unknown date, hernia repair on an unknown date and she recently had a vasectomy on an unknown date. she has a history of different immunocompromised things. Concomitant medications included gabapentin (GABAPENTIN) taken 400mg a day for an unspecified indication from an unspecified start date and ongoing, unspecified Allergy Pills on a daily basis from an unspecified date and there are more, but he can't remember what they are. The reporter was calling on behalf of his mother, who got the first vaccine, the previous day. On 14Apr2021, the patient experienced, she's been having side effects and can't get out of bed. She's been experiencing dizziness, couldn't walk straight, headache, joint pain, hips really hurting her, nausea, hot/cold flashes, tiredness and muscle pain. The reporter asked, what should she do? Should she see a doctor? He states his mom had the vaccine, the previous day and later yesterday on 14Apr2021, she started having really bad side effects and she can't get out of bed to sit up. States he wants to know if this is a normal reaction or he doesn't know if needs to take her somewhere? Caller handler asked for clarification on what the caller stated after hernia repair, and he stated again, vasectomy. He clarified this was his mom's first dose of the vaccine. Treatment included Ibuprofen, Acetaminophen. Reporter seriousness for Dizziness, couldn't walk straight, Headache, Joint Pain, hips really hurting her, Nausea, Hot/Cold Flashes, Tiredness, Muscle pain and can't get out of bed to sit up was unspecified. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: She has a lot of allergies; Dermographia of the skin, commented she gets issues with getting hives and things like that.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 09Apr2021 as dose 1, single for covid-19 immunisation and fexofenadine hydrochloride (ALLEGRA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history included Dermographia of the skin from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date on Apr2021, the patient had a lot of allergies and dermographia of the skin (she got issues with getting hives and things like that). She has a lot of allergies and needs to take Allegra everyday. She already had the first dose, but she didn't take her medicine the day of the vaccine. However, she had to start taking it a day or two later. She confirmed she has not had a reaction as far as she knows. She has Dermographia of the skin, commented she gets issues with getting hives and things like that. The reporter asked will it interfere with the potency with vaccine, She also wanted to know if it will cause masking of symptoms if she should have an reaction or if anything to worry about. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heavy menstrual bleeding, Lethargy
Clinical narrative: body aches; period (two weeks early) and heavy; period (two weeks early) and heavy; lethargic; fever; chills; headache; nausea; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (administration time: 09:00 AM) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Known allergies to codeine, DURICEFF; other medical history was none. The patient's concomitant medications were not reported. No covid prior vaccination, no covid tested post vaccination. On 18Mar2021, 18:00, the patient experienced fever, chills, body aches, headache, nausea, lethargic, extremely tired, period (two weeks early) and heavy after 1st shot. No treatment received for events. Outcome for all events was recovering.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Nausea, Pain, Pyrexia
Clinical narrative: body aches; period (two weeks early) and heavy; period (two weeks early) and heavy; lethargic; fever; chills; headache; nausea; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (administration time: 09:00 AM) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Known allergies to codeine, DURICEFF; other medical history was none. The patient's concomitant medications were not reported. No covid prior vaccination, no covid tested post vaccination. On 18Mar2021, 18:00, the patient experienced fever, chills, body aches, headache, nausea, lethargic, extremely tired, period (two weeks early) and heavy after 1st shot. No treatment received for events. Outcome for all events was recovering.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Localised oedema, Neck pain, SARS-CoV-2 test, Swelling
Clinical narrative: Severe pain in right side of neck.; Fluid build up in right side of neck.; Swelling in right side of neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Concomitant medication(s) included lisinopril, and metformin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (at the age of 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 01:15 AM (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. On 10Apr2021 at 12:00 PM, the patient had fluid build-up in right side of neck. Severe pain in right side of neck. Swelling in right side of neck. All behind right ear. Started day after vaccine on 10Apr2021. The patient had emergency room (ER)/department or urgent care visit on 12Apr2021. The patient not required treatment for the events. Symptoms resolved 13Apr2021. On an unspecified date in 2021, post vaccination, the patient was covid tested, nasal swab taken, and the result was negative. The outcome of the events was resolved on 13Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Lymph node pain, Lymphadenopathy
Clinical narrative: muscle aches; pain; fatigue; severe headache; lethargy; swollen and painful lymph node in left armpit the size of a golf ball; swollen and painful lymph node in left armpit the size of a golf ball; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 10:15 (at the age of 45 year) as dose 2, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included Hashimoto's syndrome. The patient had no known allergies. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Concomitant medication(s) included thyroid (ARMOUR THYROID), acetylsalicylic acid (BABY ASPIRIN) and Vitamins. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8727), dose 1 via an unspecified route of administration in Left arm on 26Mar2021 at 16:00 (at the age of 45 year) for COVID-19 immunisation. On 16Apr2021 at 19:00 within 10 hours patient experienced muscle aches, pain, fatigue. On an unspecified date in Apr2021, in 24 hours severe headache, muscle pain, and lethargy. In 36 hours, swollen and painful lymph node in left armpit the size of a golf ball. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was not recovered  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: muscle aches; pain; fatigue; severe headache; lethargy; swollen and painful lymph node in left armpit the size of a golf ball; swollen and painful lymph node in left armpit the size of a golf ball; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 10:15 (at the age of 45 year) as dose 2, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included Hashimoto's syndrome. The patient had no known allergies. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Concomitant medication(s) included thyroid (ARMOUR THYROID), acetylsalicylic acid (BABY ASPIRIN) and Vitamins. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8727), dose 1 via an unspecified route of administration in Left arm on 26Mar2021 at 16:00 (at the age of 45 year) for COVID-19 immunisation. On 16Apr2021 at 19:00 within 10 hours patient experienced muscle aches, pain, fatigue. On an unspecified date in Apr2021, in 24 hours severe headache, muscle pain, and lethargy. In 36 hours, swollen and painful lymph node in left armpit the size of a golf ball. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was not recovered  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 3 days after 1st injection I started with severe tinnitus that I still have 3 weeks later.; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional.A 59-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number and Expiration date was not reported) (at the age of 59-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have covid prior to vaccination and was not tested for covid post vaccination. On 24Mar2021, the patient experienced 3 days after 1st injection i started with severe tinnitus that i still have 3 weeks later. The clinical outcome of the event was not recovered.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Nausea, Pain
Clinical narrative: Severe Chills/Fever; Severe Chills/Fever; Nauseous; Severe Migraine; Body Ache; Major fatigue; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 13:45 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies. No other vaccines received in four weeks. There were no concomitant medications. The patient had covid prior vaccination. The patient was not pregnant at the time of vaccination. On 17Apr2021, the patient experienced severe chills, fever, nauseous, severe migraine, body ache, major fatigue. The migraine was so bad, she almost went to the hospital for relief. She was seriously concerned about the effects of the second shot, as this was terrible. The patient did not receive any treatment for events. The patient was not tested for covid post vaccination. The patient underwent lab tests and procedures which included covid test: positive on an unspecified date. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe Chills/Fever; Severe Chills/Fever; Nauseous; Severe Migraine; Body Ache; Major fatigue; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 13:45 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies. No other vaccines received in four weeks. There were no concomitant medications. The patient had covid prior vaccination. The patient was not pregnant at the time of vaccination. On 17Apr2021, the patient experienced severe chills, fever, nauseous, severe migraine, body ache, major fatigue. The migraine was so bad, she almost went to the hospital for relief. She was seriously concerned about the effects of the second shot, as this was terrible. The patient did not receive any treatment for events. The patient was not tested for covid post vaccination. The patient underwent lab tests and procedures which included covid test: positive on an unspecified date. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy
Clinical narrative: continuous watery stools; lethargic; This is a spontaneous report from a contactable other health professional (patient) reported for herself. A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in arm right on 09Apr2021 15:15 (at the age of 31-years-old) as DOSE 1, SINGLE for covid-19 immunisation (Lot unknown reason: Misplaced/discarded) at other facility. Medical history included asthma, chronic back and knee pain, obesity, known allergies to penicillin (PCN) and Pork. No other vaccine in four weeks. No Covid prior vaccination, no Covid tested post vaccination Concomitant medications included antihistamines (other medications in two weeks). On 09Apr2021 17:15, the patient felt lethargic within 2 hours of getting vaccine and remained lethargic for 2 days. Also, might be unrelated, on 10Apr2021 at 10:00, the patient had continuous watery stools, since 24hours post her vaccine. No fever or other symptoms. No treatment received for the events. The outcome for lethargic was recovered on 11Apr2021 and for rest another event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe back pain starting 2 weeks after vaccine and still going on for 2 weeks.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 16:00 (at the age of 54-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took Penicillin and experienced Known allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 03:00 PM (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient was not covid tested post vaccination. On 11Apr2021, at 04:00 PM, the patient had severe back pain starting 2 weeks after vaccine and still going on for 2 weeks. The patient not required treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Diarrhea; fever; nausea; full body aches; sore arm; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 30-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 12:15 (Batch/Lot number and Expiration date was not reported) (at the age of 30-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history was reported as none. There were no known allergies reported. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date was not reported) for covid-19 immunisation. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any vaccination within 4 weeks of covid vaccine. On 21Apr2021 12:30, the patient experienced diarrhea, fever, nausea, full body aches, sore arm and headache. It was reported as diarrhea, fever, nausea, full body aches and sore arm and nonstop headache I've taken meds but It won't go away its 1am and I can't stop with but pee. The patient did not receive any treatment for the reported events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; fever; nausea; full body aches; sore arm; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 30-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 12:15 (Batch/Lot number and Expiration date was not reported) (at the age of 30-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history was reported as none. There were no known allergies reported. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date was not reported) for covid-19 immunisation. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any vaccination within 4 weeks of covid vaccine. On 21Apr2021 12:30, the patient experienced diarrhea, fever, nausea, full body aches, sore arm and headache. It was reported as diarrhea, fever, nausea, full body aches and sore arm and nonstop headache I've taken meds but It won't go away its 1am and I can't stop with but pee. The patient did not receive any treatment for the reported events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: severe joint and muscle pain; severe joint and muscle pain ans stiffness 3 weeks after first injection.; severe joint and muscle pain; muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 65-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), via an unspecified route of administration on 30Mar2021 09:30 (at the age of 65-year-old) as dose 1, single for COVID-19 immunisation. Medical history included post treatment lyme disease syndrome, milk allergy, food allergy. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient did not had covid prior vaccination. There were no concomitant medications. The patient previously took monosodium glutamate. On an unspecified date, the patient experienced severe joint and muscle pain and stiffness 3 weeks after first injection. The outcome of all the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: At the injection site I have the first time around I just had some soreness; This is a spontaneous report from a contactable consumer (patient). This is one of two reports with first dose details. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included that suffered from allergies on a regular basis from an unknown date and unknown if ongoing. Concomitant medication(s) included loratadine, pseudoephedrine sulfate (CLARITIN-D); diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient experienced at the injection site which patient had the first time around, just had some soreness on an unspecified date. Clinical outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Headache, Rash
Clinical narrative: severe reaction to Keflex; I had a severe rash on my feet and my palm; headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, UPC number, expiry date was reported as unknown) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for covid-19 immunization and cefalexin (KEFLEX [CEFALEXIN] NDC number, UPC number, expiry date was reported as unknown), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After receiving second vaccine on Saturday, the patient experienced severe rash on feet and palm, two hours later. The patient seek medical attention because of that. The patient had headache and severe reaction to Keflex and had same reaction with the Keflex that the patient had with the vaccine and the patient didn't knew if the two have any similarity. The patient thought it would be important for information because the peoples who were not included in clinical going on and there were different people who react to vaccine and if there would be similarity then the people should be cautious because they probably would grow rash. The patient knew the clinical trials did not include autoimmune people and it was important to feed information regarding the patient. Consumer was informed about Pfizer medical information department and was provided with the number. the outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: The next day had vomiting and severe diarrhea for 12 hours/then, 6 days later, I had a repeat of the vomiting and diarrhea for another 12 hours; The next day had vomiting and severe diarrhea for 12 hours/then, 6 days later, I had a repeat of the vomiting and diarrhea for another 12 hours; The following day I became nauseous; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 15Apr2021 14:45 (at the age of 69-years-old) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; primidone taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; paroxetine taken for an unspecified indication, start and stop date were not reported; all these medications were in two weeks. No known allergies. No other vaccine in four weeks. No COVID prior vaccination and no covid tested post vaccination. On 16Apr2021, 13:00 (the following day), the patient became nauseous, and then on 17Apr2021 (the next day) had vomiting and severe diarrhea for 12 hours. Then, 6 days later, the patient had a repeat of the vomiting and diarrhea for another 12 hours. No treatment received for events. Outcome of events were recovering.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; A little alarmed, feels like patient have Covid again; This is a spontaneous report from a contactable other HCP (Nurse/patient). A 40-years-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 13:30 (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included COVID-19 in Jul2020. There were no concomitant medications. The patient had no other vaccine in four weeks. The patient was not covid tested post vaccination. The patient previously took Codeine and experienced Known allergies. Adverse event: On 24Apr2021 11:00 AM, the patient had severe body pain to the bones, chills, nausea and diarrhea. Temperature102. Very weak and tired. The patient did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feels like patient have Covid again. The patient not required treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Suspected COVID-19
Clinical narrative: Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; Severe body pain to the bones, chills, nausea And diarrhea. Temperature 102. Very weak and tired. I did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feel; A little alarmed, feels like patient have Covid again; This is a spontaneous report from a contactable other HCP (Nurse/patient). A 40-years-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 13:30 (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included COVID-19 in Jul2020. There were no concomitant medications. The patient had no other vaccine in four weeks. The patient was not covid tested post vaccination. The patient previously took Codeine and experienced Known allergies. Adverse event: On 24Apr2021 11:00 AM, the patient had severe body pain to the bones, chills, nausea and diarrhea. Temperature102. Very weak and tired. The patient did have covid-19 in July 2020. Reporting side effects to help with research. A little alarmed, feels like patient have Covid again. The patient not required treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: experience severe flu-like symptoms; Ache/entire body aches; Fever; nausea; chills; extreme fatigue; lightheadedness; headache; diarrhea; This is a spontaneous report from a contactable pharmacist. A 52-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:45 (Batch/Lot Number: EW0161, Expiration date was not reported) (at the age of 52-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no known allergies reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 15:00 (Batch/Lot Number: ER8732, Expiration date was not reported) for covid-19 immunisation. The patient did not have covid prior to vaccination and was not tested for covid post vaccination. On 17Apr2021 10:30 am, the patient experienced experience severe flu-like symptoms, fever, nausea, chills, extreme fatigue, lightheadedness, headache and diarrhea. It was reported as approximately 18 hours after dose 2 (Saturday 17Apr2021 10:30am), the patient began to experience severe flu-like symptoms including entire body aches, fever, nausea, chills, extreme fatigue, lightheadedness, headache, diarrhea that lasted 3 days. Recovered at 90% by tuesday, 20Apr2021. Lingering lightheadness and headache on day 4. The patient received treatment with Tylenol 1000mg q6h x 4 days. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: experience severe flu-like symptoms; Ache/entire body aches; Fever; nausea; chills; extreme fatigue; lightheadedness; headache; diarrhea; This is a spontaneous report from a contactable pharmacist. A 52-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:45 (Batch/Lot Number: EW0161, Expiration date was not reported) (at the age of 52-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no known allergies reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 15:00 (Batch/Lot Number: ER8732, Expiration date was not reported) for covid-19 immunisation. The patient did not have covid prior to vaccination and was not tested for covid post vaccination. On 17Apr2021 10:30 am, the patient experienced experience severe flu-like symptoms, fever, nausea, chills, extreme fatigue, lightheadedness, headache and diarrhea. It was reported as approximately 18 hours after dose 2 (Saturday 17Apr2021 10:30am), the patient began to experience severe flu-like symptoms including entire body aches, fever, nausea, chills, extreme fatigue, lightheadedness, headache, diarrhea that lasted 3 days. Recovered at 90% by tuesday, 20Apr2021. Lingering lightheadness and headache on day 4. The patient received treatment with Tylenol 1000mg q6h x 4 days. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Seasonal allergy, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0153, Expiry date: not reported), via an unspecified route of administration in right arm on 13Apr2021 (at age of 54-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiry date: not reported), via an unspecified route of administration in left arm on 23Mar2021 (at age of 54-years-old) as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced ears ringing bothering me, hay fever, allergy. Since about 17th patient suppose, started with headaches and then Monday woke up with headache and ringing in my ears. "When probed for any (treatment) medication, consumer stated that he took Ibuprofen, Zyrtec and Tylenol. Ibuprofen and Tylenol for the headache and Zyrtec for having some allergy Hay fever but stopped Zyrtec when he had ringing in his ears which was on Monday (unspecified date), so he had been taking the Tylenol since then before that (ringing in ears) he was taking Ibuprofen and Zyrtec. Those the only medicines that he had taken. The consumer stated that ears ringing was really bothering him, Tylenol helped to relief his headache. Consumer stated, was there any other thing he could do to treat those conditions. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Ulnar nerve injury
Clinical narrative: ulnar nerve was compromised; tingling and numbness down my arm and in my ring finger and pinkyfinger for a few days; tingling and numbness down my arm and in my ring finger and pinkyfinger for a few days; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 19Apr2021 12:30 (at the age of 41-year-old) as dose 2, single COVID-19 immunisation. Medical history included none. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. Concomitant medication(s) included fluoxetine. On 20Apr2021, the patient experienced ulnar nerve was compromised, tingling and numbness down my arm and in my ring finger and pinkyfinger for a few days. The outcome of all the events was recovered on Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Testicular pain
Clinical narrative: headache; fatigue; muscle aches; I also had pain at my left testicle; lymph node under my left arm (but not right arm) was noticeably swollen to the size larger then a golf ball but smaller; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 21Apr2021 09:15 (at the age of 27-year-old) as dose 2, single, and dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:15 (Batch/Lot Number: EP7534) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced headache, fatigue, muscle aches, i also had pain at my left testicle, lymph node under my left arm (but not right arm) was noticeably swollen to the size larger then a golf ball but smaller. No treatment was taken as a result of events. The outcome of the events headache, fatigue, muscle aches was recovering whereas outcome of  i also had pain at my left testicle, lymph node under my left arm (but not right arm) was noticeably swollen to the size larger then a golf ball but smaller was recovered with sequelae and recovered on an unspecified date in 2021 respectively.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Excessively heavy period with huge clots between my first and second shot/So much blood that I soaked through tampon and pad in an hour; This is a spontaneous report received from a contactable consumer (patient). A 23-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 14:00 (at the age of 23-years) as dose 1, single for covid-19 immunization. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. There were no concomitant medications. The patient has no covid prior vaccination. The patient was not pregnant at the time of vaccination. On 31Mar2021 at 12:00, the patient experienced excessively heavy period with huge clots between first and second shot. So much blood that she soaked through tampon and pad in an hour. Ended up going to the emergency room. Now, about 3 weeks after second shot it was happening again. Up until this point, she has never missed a cycle or had any issues with her period. She was not on any medications or birth control. The patient was not tested for covid post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.