chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Pharyngeal swelling, Restlessness
Clinical narrative: Often not breathing; Cheeks and throat are little bit puffy; Cheeks and throat are little bit puffy; Headache; Tiredness; Restlessness; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced often not breathing, cheeks and throat are little bit puffy, headache, tiredness, restlessness all on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Often not breathing; Cheeks and throat are little bit puffy; Cheeks and throat are little bit puffy; Headache; Tiredness; Restlessness; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced often not breathing, cheeks and throat are little bit puffy, headache, tiredness, restlessness all on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pulmonary congestion, Pyrexia, Rash
Clinical narrative: lung got congested; temperature was 102 degrees for 3 days; Rash; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2 single for covid-19 immunization. (Reason for no lot number: of Covid vaccine: Complainant hung up abruptly/transfer incomplete). Medical history included issue with her heart from 2021 to an unknown date (she went to the doctor because she was still having issues and they noticed she had an issue with her heart. It's been going on about 6 months now). The patient's concomitant medications were not reported. This report is related to a study or programme. Patient previously took first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date in 2021 after second dose of BNT162B2, the patient's lung got congested, temperature was 102 degrees for 3 days and she also experienced rash. The patient reported that she got both doses of the Covid vaccine, but after the second dose, about 20 minutes later her lung got congested. She went out to her vehicle and used her inhaler and still noticed the problem when she went home that night. She got the regular symptoms and her temperature was 102 degrees for 3 days. Patient had a rash and that all got better, but her lung was still congested. She went to the doctor because she was still having issues and they noticed she had an issue with her heart. It's been going on about 6 months now. Patient went to the emergency room and everything checked out to be fine as far as her heart and lungs. She noticed there was Polyethylene Glycol in the Covid vaccine, and she was wanting to know if this could have caused the issues, if someone else had reported this, or if Pfizer had any recommendations on how to get this all fixed. The patient underwent lab tests and procedures which included body temperature: 102 degree for 3 days on an unspecified date in 2021. Therapeutic measures were taken as a result of lung got congested. The outcome of the event lung got congested was not resolved, and rash was resolving, and outcome of the events temperature was 102 degrees for 3 days was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: the patient on the like 3rd day was knocked out a few seconds and almost brought her to the emergency room; This is a spontaneous report from a contactable consumer (caller is the husband of the patient). This is the second of 2 reports.  A 27-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the beginning of May2021 (Batch/Lot number was not reported) as single dose (at the age of 27) for covid-19 immunisation. Medical history included ongoing genital herpes (reporter does not know when she was diagnosed with genital herpes but states it was many years ago and was before the Pfizer Covid vaccine), caesarean section (she had their 2nd son and had C-sections with both children). There were no concomitant medications. The patient experienced the patient on the like 3rd day was knocked out a few seconds and almost brought her to the emergency room  in May2021. It was reported 'she does take anything like one Tylenol in her case she would be fine but she cannot handle strong doses of any medication and had an epidural shot and can't handle over doses of any medication and states that he has no lots, expiry dates, medication names for medications that she cannot handle the doses of including Tylenol to provide'. The outcome was unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Movement disorder, Pain in extremity, Paraesthesia
Clinical narrative: Involuntary movement in right arm and head; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; Numbness and tingling with severe pain in hands feet and lower legs with joint pain; This is a spontaneous report from a contactable consumer (patient). A 13-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Ew0196; Expiry date was unknown), via an unspecified route of administration in the right arm on 14Jun2021 (at the age of  13-years-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was not reported. Patient had known allergies. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. The patient had no other medications in two weeks. Historical vaccine included first dose of BNT162B2 (Lot number: Ew0172; Expiry date was unknown), via unspecified route of administration at right arm on 22May2021 (at the age of  13-years-old) as dose 1, single for COVID-19 immunization. On 17Jun2021 at 02:00, after second vaccination, the patient experienced numbness and tingling with severe pain in hands feet and lower legs with joint pain and involuntary movement in right arm and head. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Disability or permanent damage. Therapeutic measures were taken as a result of involuntary movement in right arm and head, numbness and tingling with severe pain in hands feet and lower legs with joint pain. Outcome of the events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort, Neuropathy peripheral, Off label use, Pain in extremity
Clinical narrative: nerves are just all over the place in legs; legs have been throbbing and aching; legs are feeling really heavy; dose 1 was given in Jun2021; dose 2 was given on 25Aug2021; dose 1 was given in Jun2021; dose 2 was given on 25Aug2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 25Aug2021 (Batch/lot number: FC3184, Expiration date unknown), at age 60 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history includes being paraplegic on a wheelchair from an unknown date and ongoing. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, in Jun2021 (Bath/lot number: EW0150), at age 60 years old, as dose 1, single, for COVID-19 immunization and had some really bad side effects. The patient did not receive any other vaccines within 2 weeks prior to the first BNT162B2 shot. It was reported that the patient received dose 1 in Jun2021. The patient was supposed to receive dose 2 on 21Jul2021 but did not receive it. The patient received dose 2 on 25Aug2021. On 26Aug2021, 1 day after dose 2, the patient's legs have been throbbing and aching, nerves are just all over the place in legs are feeling really heavy. So, the patient went to the ER on 26Aug2021 and they gave the patient an unspecified shot to calm the nerves down. The patient reported that it has been over a week and the patient was still having problems. The patient does not understand why the hurting does not stop. The patient states that it has gotten better but still hurts, the physician said it would last 4-5 days, but it has been past 7 days already. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Depression, Post-traumatic stress disorder, Suicidal ideation
Clinical narrative: suicidal thougths; Severe depression; tgen my c-ptsd got so severe; This is a spontaneous report from a Non-contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration (Age at time of vaccination: 34) on 03Sep2021, 03.45 PM in left arm as dose 1, single dose for COVID-19 immunisation. Patient medical history reported as C-pstd, migraines, concussions, fibromyalgia, pmdd, endometriosis, diabetes type 2, high blood pressure from an unknown start and stop dates. Patient's known allergies were too many to list. Concomitant medication reported as Vitamin B12, folic acid, fluvoxamine, buisperone. No other vaccine administered within four weeks. COVID prior vaccination was reported as no and COVID test post vaccination reported as no. On 05Sep2021 03:30 AM, patient experienced Severe depression and suicidal thoughts increase and tgen c-ptsd got so severe. On unspecified date patient underwent lab test and procedure included Blood pressure measurement: high. Treatment was not taken. The clinical outcome of all events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia, Suspected COVID-19, Throat irritation
Clinical narrative: Weakness; Low grade fever; Itch throat; trying to find out so that he doesn't know infect anybody else the COVID; got symptoms of COVID; This is a spontaneous report received from a contactable consumer (patient's wife) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiry Date: Unknown), via an unspecified route of administration on 26Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was calling on behalf of her husband who got the first dose of the Pfizer COVID-19 Vaccine last 26Aug2021 and after getting it, the husband got symptoms of COVID which was weakness, low grade fever and itch throat actually he was asking if, was it possible that these are the side effects of vaccine. The patient's wife did not know, he was not in here with me, she was trying to find out so that he doesn't know infect anybody else the COVID (Further clarification unknown). Reporter seriousness for all events were unspecified. The outcome of the events was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Syncope, Tunnel vision
Clinical narrative: Fainted, Could not get up for 30 minutes; Tunnel vision; Clammy Skin; Headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164), dose 1 via an unspecified route of administration, administered in Arm Left on 22Aug2021 at 16:00 (at the age of 12-year-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history was none. The patient had no COVID prior vaccination. Known allergies was reported as unknown. There were no concomitant medications. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had not been COVID tested post vaccination. On 22Aug2021 at 04:15 AM, the patient experienced fainted, tunnel vision, clammy skin, headache and could not get up for 30 minutes. No treatment was received to treat the events. The patient outcome of the events was Unknown at the time of this report.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Atrial fibrillation, Diarrhoea, Fatigue
Clinical narrative: atrial fibrillation; Systemic inflammation; headache; fatigue; stuffy nose; joint pain; nerve tingling; irregular heart rhythm; high blood pressure; diarrhea; nausea; insomnia; anxiety; stress; panic; This is a spontaneous report from a contactable consumer (Patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 01Sep2021 10:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 44 years). The patient's medical history included High blood pressure, atrial fibrillation, inflammation, sensitive to animal foods, gluten and dairy. The concomitant medications were not reported. It was reported that he did not took other vaccine in four weeks prior COVID vaccine. Other medications in two weeks included anti-Inflammatory supplements. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 01Sep2021 at 20:00, the patient experienced atrial fibrillation, systemic inflammation, headache, fatigue, stuffy nose, joint pain, nerve tingling, irregular heart rhythm, high blood pressure, diarrhea, nausea, insomnia, anxiety, stress and panic. Patient did not receive any treatment as a result of events. the seriousness of the event atrial fibrillation was considered always serious and medically significant and for all the other events was non-serious. The outcome of the events was recovering.   Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate irregular, Hypertension, Inflammation, Insomnia
Clinical narrative: atrial fibrillation; Systemic inflammation; headache; fatigue; stuffy nose; joint pain; nerve tingling; irregular heart rhythm; high blood pressure; diarrhea; nausea; insomnia; anxiety; stress; panic; This is a spontaneous report from a contactable consumer (Patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 01Sep2021 10:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 44 years). The patient's medical history included High blood pressure, atrial fibrillation, inflammation, sensitive to animal foods, gluten and dairy. The concomitant medications were not reported. It was reported that he did not took other vaccine in four weeks prior COVID vaccine. Other medications in two weeks included anti-Inflammatory supplements. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 01Sep2021 at 20:00, the patient experienced atrial fibrillation, systemic inflammation, headache, fatigue, stuffy nose, joint pain, nerve tingling, irregular heart rhythm, high blood pressure, diarrhea, nausea, insomnia, anxiety, stress and panic. Patient did not receive any treatment as a result of events. the seriousness of the event atrial fibrillation was considered always serious and medically significant and for all the other events was non-serious. The outcome of the events was recovering.   Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Panic disorder, Paraesthesia, Stress
Clinical narrative: atrial fibrillation; Systemic inflammation; headache; fatigue; stuffy nose; joint pain; nerve tingling; irregular heart rhythm; high blood pressure; diarrhea; nausea; insomnia; anxiety; stress; panic; This is a spontaneous report from a contactable consumer (Patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 01Sep2021 10:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 44 years). The patient's medical history included High blood pressure, atrial fibrillation, inflammation, sensitive to animal foods, gluten and dairy. The concomitant medications were not reported. It was reported that he did not took other vaccine in four weeks prior COVID vaccine. Other medications in two weeks included anti-Inflammatory supplements. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 01Sep2021 at 20:00, the patient experienced atrial fibrillation, systemic inflammation, headache, fatigue, stuffy nose, joint pain, nerve tingling, irregular heart rhythm, high blood pressure, diarrhea, nausea, insomnia, anxiety, stress and panic. Patient did not receive any treatment as a result of events. the seriousness of the event atrial fibrillation was considered always serious and medically significant and for all the other events was non-serious. The outcome of the events was recovering.   Follow-up attempts have been completed and no further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Haemoglobin, Haemoglobin decreased, Heavy menstrual bleeding, Tachycardia
Clinical narrative: shortness of breath; tachycardia; My hemoglobin dropped to 6.6; 24 hours after my second vaccine dose I started having a heavy period.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ep6955, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 27Mar2021 16:00 (at the age of 43-years-old) as dose 2, single for covid-19 immunisation. Medical history included hyperthyroidism. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE); methimazole (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN), all for an unspecified indication and from an unspecified date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number En6199, Expiry date: unknown) via an unspecified route of administration, administered in Left arm on 05Mar2021 17:45 (at the age of 43-years-old) as dose 1 for covid-19 immunisation. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 16:00 24 hours after my second vaccine dose the patient experienced a heavy period. Not normal with the birth control she was taking because she would only spot monthly. The bleeding became so heavy that she was passing large clots and soaking through sanitary pads every 2 hours. She visited her Obgyn, and he stopped her birth control and prescribed a medication to stop the bleeding. This did not work. She went to ER with shortness of breath and tachycardia 6 days later. She lost 2 litres of blood. She required a d and c procedure. Her haemoglobin dropped to 6.6 and she received a blood transfusion. She spent 4 days in the hospital. She never had anything like this prior. The patient was hospitalized for shortness of breath and tachycardia for 4 days.  The patient underwent lab tests and procedures which included haemoglobin: 6.6 (haemoglobin dropped to 6.6) on 28Mar2021. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Eructation, Extra dose administered, Off label use
Clinical narrative: chest pain and in my back; burping a lot; I got my third Pfizer booster shot; I got my third Pfizer booster shot; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 31Aug2021 16:00 as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced I got my third Pfizer booster shot on 31Aug2021, chest pain and in my back on 01Sep2021, burping a lot on 01Sep2021. The outcome of the events chest pain, eructation, extra dose administered, off label use was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chest pain, Dyspnoea, Glossodynia, Nausea
Clinical narrative: Shortness of breath; Chest pain; Tongue swelled up; I started to lose my voice; my tongue swelled up and it was 'paining' very bad; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2587, patient was 39-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 03Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included asthma, bronchitis. The patient's concomitant medications were not reported. Historical vaccines included Flu shot and Pneumonia shot for immunization and experienced allergic with that. No prior vaccination within 4 weeks of COVID Vaccine, no family history for the same adverse event. On 03Sep2021, the patient experienced shortness of breath, chest pain, tongue swelled up, i started to lose my voice, my tongue swelled up and it was 'paining' very bad, on an unspecified date in 2021, the patient experienced nausea. AE resulted in to visit emergency for reported events. Therapeutic measures were taken for all events with Albuterol, I got Benadryl twice, and then they gave me Pepcid, they also gave me Methylprednisolone. It was reported that patient got the Pfizer Vaccine yesterday and told to wait for like 30 minutes and I waited for like '15' minutes and I feel like I was okay, so I pull it up and as I started driving, and experienced events, so I went to the emergency room, I was treated there, they gave me 2 doses Benadryl. I took my EpiPen (treatment) that I have in the car. They gave me steroid, and they gave me something else 'Pepcid'." Reported that same day patient came back from the emergency room. The outcome of event (Nausea) was not recovered, and outcomes of rest all reported events were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Shortness of breath; Chest pain; Tongue swelled up; I started to lose my voice; my tongue swelled up and it was 'paining' very bad; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2587, patient was 39-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 03Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included asthma, bronchitis. The patient's concomitant medications were not reported. Historical vaccines included Flu shot and Pneumonia shot for immunization and experienced allergic with that. No prior vaccination within 4 weeks of COVID Vaccine, no family history for the same adverse event. On 03Sep2021, the patient experienced shortness of breath, chest pain, tongue swelled up, i started to lose my voice, my tongue swelled up and it was 'paining' very bad, on an unspecified date in 2021, the patient experienced nausea. AE resulted in to visit emergency for reported events. Therapeutic measures were taken for all events with Albuterol, I got Benadryl twice, and then they gave me Pepcid, they also gave me Methylprednisolone. It was reported that patient got the Pfizer Vaccine yesterday and told to wait for like 30 minutes and I waited for like '15' minutes and I feel like I was okay, so I pull it up and as I started driving, and experienced events, so I went to the emergency room, I was treated there, they gave me 2 doses Benadryl. I took my EpiPen (treatment) that I have in the car. They gave me steroid, and they gave me something else 'Pepcid'." Reported that same day patient came back from the emergency room. The outcome of event (Nausea) was not recovered, and outcomes of rest all reported events were recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Pain
Clinical narrative: sick, terrible body ache, headache; Terrible body ache; Can't get well; Headache; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration in 2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced Sick; Terribly sick; I can't work, I cannot work now because all I am is sick, Terrible body ache, Headache, Can't get well. It was reported that she has been sick since the day injection the night she got sick, of the night of the injection on the 4th, after a month ago she have been sick like that sounding like a sick terrible body ache, headache, then severe med checked she have been to my family doctor, she have been to the emergency room. She don't know what else to do, no one is helping me they don't know what to, what do I do. She was terribly sick, and she was not getting the second one. Her pharmacist has known all this, she 'got all this checked in' and he has told me she need to call on Pfizer number on paper work and let you know that she sick and she can't get well, she don't know what's wrong she mean she have problems with getting sick easy and immune inefficiency (voice not clear), she should never got it, wish she would never got it, did not wanted to get it, pushed in to it by  family because they think that it would make me (voice not clear) from the COVID (Voice not clear). she can't work, she cannot work now because all she was sick.  Comment: Reporter type not probed hence captured by default as consumer or other non-health professional in tab. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from 1-31Aug2021); Extremely irregular menstrual cycles; August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from 1-31Aug2021); This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Jun2021 11:00 (Lot Number: EW0180) as single dose (at the age of 23-years-old) for COVID-19 immunization (Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store). Medical history included none. The patient was not pregnant. The 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. Concomitant medications included drospirenone, ethinylestradiol (LORYNA) and ethinylestradiol (NIKKI): both taken for contraception, start and stop dates were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 11:00 AM (Lot Number: EW0178) as single dose (at the age of 23-years-old) for COVID-19 immunization. On 05Jul2021, the patient experienced Extremely irregular menstrual cycles: July - cycle began 2 weeks early. August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from August 1-31). The patient was not hospitalized. No treatment received. The outcome of the events was recovered on an unspecified date in 2021. The events were considered as non-serious. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Muscle spasms, Nausea, Pain
Clinical narrative: pain all over her body; pain that was hurting her so bad/achiness; cramping in her hands, feet and facehands were completely cramped up; Nausea; This is a spontaneous report from a contactable Nurse. A 27-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 29Aug2021 (at the age of 27-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for achiness. The patient medical history was not reported. There were no concomitant medications. Patient previously took first dose of bnt162b2 on an unspecified date in 2021 for covid-19 immunisation. On 30Aug2021, the patient experienced pain all over her body. Like out of ten she had stated then with pain that was hurting her so bad/achiness, she was hyperventilating so she had cramping in her hands, feet and face. Before they act they drew up and nausea (medically significant). It was reported that afterwards she experienced the little bit of the achiness she took Ibuprofen but it became, It got worse in the morning 30Aug2021. Nurse stated that we gave her treatment in response to adverse events which included steroid, Solu Medrol, gave her Benadryl. Norflox to relax her muscles cause her hands were completely cramped up. Zofran for Nausea. Solu Medrol, steroids, famotidine, fluids and then we gave her, she was given the steroid started taking the next day (on reporting date). The action taken in response to the events for ibuprofen was unknown. Outcome of all events were unknown.    The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pain, Muscle spam, and Nausea and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Investigation
Clinical narrative: Couldn't walk; Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer, the patient.   A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FA6780), via an unspecified route of administration, administered in arm left on 03Aug2021 as dose number unknown, single (at the age of 59-years-old) for covid-19 immunization. Medical history included ongoing hypertension, neuropathy peripheral and ongoing skin cancer. Concomitant medications included amlodipine orotate;olmesartan medoxomil taken for hypertension, bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HYDROCHLOROTHIAZIDE) taken for hypertension and anastrozole. It was reported that the patient got the vaccine on 03Aug2021 and then on 08Aug2021, the patient could not walk. The patient had to go to the emergency room the following Sunday, on the 08, he had to go the hospital, could not walk. The patient was in hospital for 11 days and then went to a rehab for 5 days. The patient reported that when he was in hospital, they gave him 5 IVIG bags, 5 days in a row and did vitalis test and then spinal test to confirmed that was GBS (Guillain-Barre syndrome) given for. Consumer stated, "When patient was in hospital they gave me these bags, it was called IVIG, they gave patient 5 bags so they did a vitalis test then they did a spinal test to confirm that was GBS given for. They did a spinal test to confirm that and they confirm that's what I had and they treated me with the 'people' calls it IVIG, they were IV bag and they gave me 5, 5 days in a row they gave me a bag. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.  Follow-up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Electrocardiogram, Hypersomnia, Myocarditis
Clinical narrative: COVID arm/great big huge lump; COVID arm/ she had a circle rash; red rash on her arm; sleeping a lot; she was weak; Myocarditis; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration in the arm on 18Aug2021 in the late afternoon or early evening (at the age of 64-year-old), dose 1, single for COVID-19 immunisation. Medical history included aneurysm in 2015 (it has not changed, it was diagnosed 6 years ago), obesity (weighed the same for over 20 years) and COVID (Feb2021) and got an infusion. The patient did not have diabetes. The patent did not have family history. The patient did not receive any concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. On 18Aug2021, the patient developed myocarditis right away after first shot. The patient did not know that was what it was. The patient thought it was normal and related to the shot. The patient had all symptoms of myocarditis. On 19Aug2021, the patient got COVID arm which started with a lump in her arm and then she had a circle rash from it at first. That was her biggest concern at first. She noticed it about 10:00 or 10:30. The patient got ready to take a shower and saw a red rash on her arm and she had great big huge lump. The was sleeping a lot and she was weak. The patient had to wait 90 days after to get her shot. The patient went to the doctor on 01Sep2021. The patient's doctor was referring the patient to a cardiologist and said for patient not to get second dose. The patient had an electrocardiogram (EKG) after COVID virus and her heart was fine. The EKG on 01Sep2021 showed irregular and she was going to the cardiologist. They did bloodwork and were sending her to a cardiologist because it was beyond what her primary care does. The patient could not have the second shot or a booster ever. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event myocarditis was not recovered. The outcome of the events sleeping a lot and 'she was weak' was unknown and outcome of other events was recovered.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site mass, Vaccination site rash
Clinical narrative: COVID arm/great big huge lump; COVID arm/ she had a circle rash; red rash on her arm; sleeping a lot; she was weak; Myocarditis; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration in the arm on 18Aug2021 in the late afternoon or early evening (at the age of 64-year-old), dose 1, single for COVID-19 immunisation. Medical history included aneurysm in 2015 (it has not changed, it was diagnosed 6 years ago), obesity (weighed the same for over 20 years) and COVID (Feb2021) and got an infusion. The patient did not have diabetes. The patent did not have family history. The patient did not receive any concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. On 18Aug2021, the patient developed myocarditis right away after first shot. The patient did not know that was what it was. The patient thought it was normal and related to the shot. The patient had all symptoms of myocarditis. On 19Aug2021, the patient got COVID arm which started with a lump in her arm and then she had a circle rash from it at first. That was her biggest concern at first. She noticed it about 10:00 or 10:30. The patient got ready to take a shower and saw a red rash on her arm and she had great big huge lump. The was sleeping a lot and she was weak. The patient had to wait 90 days after to get her shot. The patient went to the doctor on 01Sep2021. The patient's doctor was referring the patient to a cardiologist and said for patient not to get second dose. The patient had an electrocardiogram (EKG) after COVID virus and her heart was fine. The EKG on 01Sep2021 showed irregular and she was going to the cardiologist. They did bloodwork and were sending her to a cardiologist because it was beyond what her primary care does. The patient could not have the second shot or a booster ever. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event myocarditis was not recovered. The outcome of the events sleeping a lot and 'she was weak' was unknown and outcome of other events was recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation/ had atrial fibrillation 7/24; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient).     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced atrial fibrillation for two days after the first dose and had atrial fibrillation 7/24 for four months after the second dose. This necessitated ablation surgery. The outcome of the event was reported as recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: I'm in unbearable pain in my lower back; feel like I am dragging my right leg; This is a spontaneous report from a Regulatory Authority. A female consumer (patient) of an unspecified age received second 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 on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously 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 on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, patient was in horrible reaction to the second dose of the COVID shot she was in unbearable pain in lower back and feel like she was dragging her right leg on an unspecified date. The outcome of both the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 positive; COVID-19 positive/symptoms: nasal congestion, fatigue, loss of taste and smell.; This is a spontaneous report from a contactable consumer. A 53-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EP7533, Expiry date was not reported), intramuscular, administered in Arm Right on 06Apr2021 15:30 (at the age of 53-years-old) as dose 2, single for covid-19 immunisation (Pharmacy or Drug Store). Medical history included hashimoto thyroiditis from an unknown date and unknown if ongoing and known allergies: penicillin, mycin/micin types of antibiotics, kiwi fruit. The patient's concomitant medications were not reported. Prior vaccination, the patient had not received any other vaccine within 4 weeks. The patient had been covid tested post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6055, Expiry date was not reported), intramuscular, administered in arm right on 16Mar2021 13:00 as dose 1 for covid-19 immunisation. The patient had breakthrough COVID-19 positive case with these symptoms: nasal congestion, fatigue, loss of taste and smell. The patient tested positive. Symptoms began on Monday 30Aug2021 with congestion and then progressed with fatigue and loss of taste and smell on 31Aug2021. Took a nasal swab test on Thursday 02Sep2021 and learned positive result on Sunday 05Sep2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test/ nasal Swab: positive on 02Sep2021. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Angina pectoris, Chest discomfort, Pain, Pyrexia
Clinical narrative: he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine; he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine; pain started the next morning the vaccine shot; he had fever for few hours; stomachache; vomiting; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FC3181), second dose via an unspecified route of administration, administered in left arm on 03Sep2021 at 04:30 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. No concomitant medications were not reported. No known allergies were reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3180), first dose via an unspecified route of administration, administered in left arm on 10Aug2021 at 09:15 (at the age of 12-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medication within 2 weeks was reported as none. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 04Sep2021 at 16:00,It was reported that he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine(Friday 4pm) the paint started the next morning the vaccine shot. each times the pain last at least 5 minutes. beside heart pain, he had fever for few hours, stomachache, vomiting. all these symptoms stop on 3rd day (Monday morning). the symptom about the heart pain worry me that is one of the rare side effects that Inwould like it be tracked. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was reported as unknown.