chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: Small blister right on the injection site; This is a spontaneous report from contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient stated, I just got the vaccine the other day and I have a symptoms that I haven't seen anywhere, it's a small blister right on the injection site. Have you been hearing anything about those? Is that common. When informed about Pfizer Medical Information department, consumer added, No, I have just wasted a lot of time. Can you just tell me if it was common or not. was there anything I should worry about. When again informed about  Medical Information Department, consumer stated, but you said you were Pharmacist, that was enough for me. Consumer hung up the call abruptly, hence, product details (LOT#, expiration date, NDC# and UPC#) and other details were unknown. Limited information was available over the call. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Rhinorrhoea, Sneezing, Suspected COVID-19
Clinical narrative: in contact with COVID 19 positive in his school; Very congested; Coughing; Sneezing; Runny nose; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient's mother) reported for a 13-year-old patient (reporter's son). A 13-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date Aug2021, after receiving second dose patient experienced that he was very congested, coughing, sneezing and has a runny nose. His mother was not sure if withheld is in contact with COVID 19 positive in his school because there is a lot of COVID 19 positive in his school (further clarification unknown) and stated that I am trying to figure out if this is potential side effects from the vaccine or do I need to go get him tested to see if he was along the way to get actual COVID. Further probing could not be done as the reporter was unwilling to share any further information. Hence limited information available over the call. The clinical outcome of the events was unknown.  Information on the lot/batch has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Gait disturbance, Insomnia, Limb discomfort, Muscle spasms
Clinical narrative: May be it is a blood clot on my leg, possibly a blood clot because my legs are jammed , I can hardly walk; Cramps; May be it is a blood clot on my leg, possibly a blood clot because my legs are jammed , I can hardly walk; Stiffness; my legs are jammed; because her legs were jammed, I could hardly walk, very rare she sleep and so much pain; I don't sleep at night; Needle like pain in my muscle; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EW853, EWA58), via an unspecified route of administration, administered in arm left on 08Apr2021 11:00 (age at vaccination was 54 years)as DOSE 2, SINGLE and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EN6Z08), via an unspecified route of administration, administered in arm left on 08Mar2021 11:00 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included that she was disable and memory getting worse. The patient's concomitant medication was not reported. She had no prior vaccination. The patient stated that she had cramps, needle like pain in her muscle, she did not know she suppose to go for CT scan for might be it was a blood clot on her leg, stiffness and possibly a blood clot because her legs were jammed, I could hardly walk, very rare she sleep and so much pain in Apr2021. She also stated that it was getting worse. She took tablets for her to fall asleep and to relax her muscles. She was taking Tylenol and she took another medicine for the pain. The patient underwent blood test on 08Apr2021 and result was unknown. The outcome of events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity, Thrombosis
Clinical narrative: May be it is a blood clot on my leg, possibly a blood clot because my legs are jammed , I can hardly walk; Cramps; May be it is a blood clot on my leg, possibly a blood clot because my legs are jammed , I can hardly walk; Stiffness; my legs are jammed; because her legs were jammed, I could hardly walk, very rare she sleep and so much pain; I don't sleep at night; Needle like pain in my muscle; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EW853, EWA58), via an unspecified route of administration, administered in arm left on 08Apr2021 11:00 (age at vaccination was 54 years)as DOSE 2, SINGLE and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EN6Z08), via an unspecified route of administration, administered in arm left on 08Mar2021 11:00 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included that she was disable and memory getting worse. The patient's concomitant medication was not reported. She had no prior vaccination. The patient stated that she had cramps, needle like pain in her muscle, she did not know she suppose to go for CT scan for might be it was a blood clot on her leg, stiffness and possibly a blood clot because her legs were jammed, I could hardly walk, very rare she sleep and so much pain in Apr2021. She also stated that it was getting worse. She took tablets for her to fall asleep and to relax her muscles. She was taking Tylenol and she took another medicine for the pain. The patient underwent blood test on 08Apr2021 and result was unknown. The outcome of events was not recovered.  Follow-up attempts were completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He received the first dose on 07Aug2021 and today he is supposed to have the second dose. However, after getting the first dose he tested positive for COVID; He received the first dose on 07Aug2021 and today he is supposed to have the second dose. However, after getting the first dose he tested positive for COVID; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown), via an unspecified route of administration on 07Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he received the first dose on 07Aug2021 and today (date unspecified) he was supposed to have the second dose. On an unspecified date in Aug2021, after getting the first dose, the patient had tested positive for Covid. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Aug2021. The outcome of the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Headache, Hypersensitivity, Nausea, Near death experience
Clinical narrative: nearly died yesterday; itching all over my body especially in my throat, around my throat; itching all over my body especially in my throat, around my throat; Coughing; Runny nose; Headache; Nausea; throat closed up; Allergic reaction; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0183) via an unspecified route of administration, administered in Arm Left on 2021 as Dose Number Unknown, Single for covid-19 immunisation; hydrochlorothiazid (HYDROCHLOROTHIAZID), route of administration, start and stop date, batch/lot number and dose were not reported for blood pressure abnormal. Medical history included blood pressure abnormal and stress. The patient's concomitant medication included vitamin. It was reported that, patient had a reaction to the vaccine on an unspecified date. It was reported that patient had to go to the urgent care yesterday and also spoke with his doctor patient had throat closed up and had itching all over body especially in the throat and around the throat. There was some coughing, runny nose, headache, nausea that was the most severe reaction patient had. The patient received treatment of Steroids Benadryl. Steroids and Benadryl were given by IM. Reporter further stated, that he nearly died yesterday (27Aug2021). Therapeutic measures were taken as a result of events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Rhinorrhoea, Throat irritation, Throat tightness
Clinical narrative: nearly died yesterday; itching all over my body especially in my throat, around my throat; itching all over my body especially in my throat, around my throat; Coughing; Runny nose; Headache; Nausea; throat closed up; Allergic reaction; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0183) via an unspecified route of administration, administered in Arm Left on 2021 as Dose Number Unknown, Single for covid-19 immunisation; hydrochlorothiazid (HYDROCHLOROTHIAZID), route of administration, start and stop date, batch/lot number and dose were not reported for blood pressure abnormal. Medical history included blood pressure abnormal and stress. The patient's concomitant medication included vitamin. It was reported that, patient had a reaction to the vaccine on an unspecified date. It was reported that patient had to go to the urgent care yesterday and also spoke with his doctor patient had throat closed up and had itching all over body especially in the throat and around the throat. There was some coughing, runny nose, headache, nausea that was the most severe reaction patient had. The patient received treatment of Steroids Benadryl. Steroids and Benadryl were given by IM. Reporter further stated, that he nearly died yesterday (27Aug2021). Therapeutic measures were taken as a result of events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Polymenorrhoea, SARS-CoV-2 test, Suspected COVID-19, Vomiting
Clinical narrative: Started period 2 weeks early; suffered extreme fitness and throw up many times; covid test result Positive; covid test result Positive; This is a spontaneous report from a non-contactable consumer or other non hcp (female patient). A non-pregnant female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration, administered in Arm Left on 19May2021 08:00 (at age 20-year-old) as dose 1, single for covid-19 immunisation. Medical history included no from an unknown date and unknown if ongoing.There were no concomitant medications. No known allergies. Patient did not receive other vaccine in four weeks. The patient experienced started period 2 weeks early, suffered extreme fitness and throw up many times, covid test result positive on an unspecified date. The patient was hospitalized for started period 2 weeks early (menstrual disorder) for 3 days. The patient was hospitalized for suffered extreme fitness and throw up many times (vomiting) for 3 days. The patient underwent lab tests and procedures which included nasal Swab (sars-cov-2 test) : positive (if covid tested post vaccination Yes) on an unknown date. Outcome of the events such as Started period 2 weeks early, suffered extreme fitness and throw up many times was recovered with sequelae and covid test result Positive was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Pyrexia, Suspected COVID-19
Clinical narrative: COVID like symptoms already I have fever; have like COVID like symptoms already I have fever and stuff; I have fever; This is a spontaneous report from a contactable consumer (patient reported for self). A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number and Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced covid like symptoms already and had fever. This was considered as drug ineffective. It was reported that patient had second appointment like today (unspecified day) like for the second dose but cant make it because she had covid like symptoms already and had fever. The patient hung up the call abruptly before retrieving. Hence further probing could not be done and limited information available over the call. At the time of this report, the outcome of events was unknown.  No follow up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer or other non-health care professional (reporting for son-in-law). A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 28Aug2021 as dose number unknown, single for COVID-19 immunization (Age at Vaccination was 32years). The patient's medical history and concomitant medications were not reported. It was stated that, the patient was diagnosed with COVID-19 prior to vaccination and Unknown whether been tested for COVID-19 since the vaccination. The information about patient received any other vaccines within 4 weeks prior to the COVID vaccine and received any other medications within 2 weeks of vaccination was unknown. On 28Aug2021, it was reported that, the patient experienced stroke after getting vaccinated. The seriousness of the event was serious and was hospitalized. The hospitalization was not prolonged for the event and treatment received was unknown. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Discomfort, Fatigue, Haemoptysis
Clinical narrative: swollen lymph nodes; swollen tonsils; body chills; body aches; the tonsil on the opposite side of injection is far more swollen noting it is blackish red; she woke up in the middle of the night; my tonsil is completely swollen and inflamed; a lot of discomfort; bloody tonsils / when she spits, it is bloody / dry blood; bloody tonsils / when she spits, it is bloody / dry blood; headache; sore arm; low grade fever of 99.6/ fever is not breaking 100.5; Fatigue; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Aug2021 (lot FC3182), as the first single dose, in right arm (shoulder), for COVID-19 immunisation. Medical history included problems with her tonsils when she was in her teens and had mono. Concomitant medications were not reported. On an unspecified date in Aug2021, reported as the first two days, she experienced typical side effects mentioning headache, sore arm, low grade fever of 99.6, fatigue and were tolerable. All of a sudden, on 27Aug2021, she had swollen lymph nodes and swollen tonsils. For the following 4 days she had swollen lymph nodes on the opposite side of the vaccine. She also reported bloody tonsils, body chills and body aches. The tonsil on the opposite side of injection was far more swollen noting it was blackish red. When she spitted, it was bloody, it was dry blood. She had to take deeper breaths because of the swollen tonsils. Since an unspecified date in Aug2021 she woke up in the middle of the night where her tonsil was completely swollen and inflamed. It was causing her a lot of discomfort. She has never had problems with her tonsils except when she was in her teens and had mono. Her throat was not sore, just her lymph nodes and tonsils. She was taking Tylenol and Advil around the clock. The fever was not breaking 100.5. The fever was worse now then when she received the vaccine. On 30Aug2021 her tonsils were swollen and getting worse, the lymph nodes on both side of her neck were swollen and specially her left tonsil was just getting bigger. She got the vaccine in her right arm, and that tonsil on her left side was actually bleeding, spitting of blood and everything too. And she still had headache and the fever. She also went to her Doctor. She stated this was way too much of a coincidence and did not know if this was the norm. She stated she did not want to get the vaccine but had to for work because she was a healthcare. The final events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Middle insomnia, Pain, Pain in extremity
Clinical narrative: swollen lymph nodes; swollen tonsils; body chills; body aches; the tonsil on the opposite side of injection is far more swollen noting it is blackish red; she woke up in the middle of the night; my tonsil is completely swollen and inflamed; a lot of discomfort; bloody tonsils / when she spits, it is bloody / dry blood; bloody tonsils / when she spits, it is bloody / dry blood; headache; sore arm; low grade fever of 99.6/ fever is not breaking 100.5; Fatigue; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Aug2021 (lot FC3182), as the first single dose, in right arm (shoulder), for COVID-19 immunisation. Medical history included problems with her tonsils when she was in her teens and had mono. Concomitant medications were not reported. On an unspecified date in Aug2021, reported as the first two days, she experienced typical side effects mentioning headache, sore arm, low grade fever of 99.6, fatigue and were tolerable. All of a sudden, on 27Aug2021, she had swollen lymph nodes and swollen tonsils. For the following 4 days she had swollen lymph nodes on the opposite side of the vaccine. She also reported bloody tonsils, body chills and body aches. The tonsil on the opposite side of injection was far more swollen noting it was blackish red. When she spitted, it was bloody, it was dry blood. She had to take deeper breaths because of the swollen tonsils. Since an unspecified date in Aug2021 she woke up in the middle of the night where her tonsil was completely swollen and inflamed. It was causing her a lot of discomfort. She has never had problems with her tonsils except when she was in her teens and had mono. Her throat was not sore, just her lymph nodes and tonsils. She was taking Tylenol and Advil around the clock. The fever was not breaking 100.5. The fever was worse now then when she received the vaccine. On 30Aug2021 her tonsils were swollen and getting worse, the lymph nodes on both side of her neck were swollen and specially her left tonsil was just getting bigger. She got the vaccine in her right arm, and that tonsil on her left side was actually bleeding, spitting of blood and everything too. And she still had headache and the fever. She also went to her Doctor. She stated this was way too much of a coincidence and did not know if this was the norm. She stated she did not want to get the vaccine but had to for work because she was a healthcare. The final events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tonsillar erythema, Tonsillar haemorrhage, Tonsillar hypertrophy, Tonsillar inflammation
Clinical narrative: swollen lymph nodes; swollen tonsils; body chills; body aches; the tonsil on the opposite side of injection is far more swollen noting it is blackish red; she woke up in the middle of the night; my tonsil is completely swollen and inflamed; a lot of discomfort; bloody tonsils / when she spits, it is bloody / dry blood; bloody tonsils / when she spits, it is bloody / dry blood; headache; sore arm; low grade fever of 99.6/ fever is not breaking 100.5; Fatigue; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Aug2021 (lot FC3182), as the first single dose, in right arm (shoulder), for COVID-19 immunisation. Medical history included problems with her tonsils when she was in her teens and had mono. Concomitant medications were not reported. On an unspecified date in Aug2021, reported as the first two days, she experienced typical side effects mentioning headache, sore arm, low grade fever of 99.6, fatigue and were tolerable. All of a sudden, on 27Aug2021, she had swollen lymph nodes and swollen tonsils. For the following 4 days she had swollen lymph nodes on the opposite side of the vaccine. She also reported bloody tonsils, body chills and body aches. The tonsil on the opposite side of injection was far more swollen noting it was blackish red. When she spitted, it was bloody, it was dry blood. She had to take deeper breaths because of the swollen tonsils. Since an unspecified date in Aug2021 she woke up in the middle of the night where her tonsil was completely swollen and inflamed. It was causing her a lot of discomfort. She has never had problems with her tonsils except when she was in her teens and had mono. Her throat was not sore, just her lymph nodes and tonsils. She was taking Tylenol and Advil around the clock. The fever was not breaking 100.5. The fever was worse now then when she received the vaccine. On 30Aug2021 her tonsils were swollen and getting worse, the lymph nodes on both side of her neck were swollen and specially her left tonsil was just getting bigger. She got the vaccine in her right arm, and that tonsil on her left side was actually bleeding, spitting of blood and everything too. And she still had headache and the fever. She also went to her Doctor. She stated this was way too much of a coincidence and did not know if this was the norm. She stated she did not want to get the vaccine but had to for work because she was a healthcare. The final events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient that tested positive with COVID after getting the COVID vaccine; Patient that tested positive with COVID after getting the COVID vaccine; This is a spontaneous report from a non-contactable consumer or other non-health care professional received from a Pfizer-sponsored program.  A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA 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 number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient tested positive with COVID after getting the COVID vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 on Aug 27, despite being vaccinated; Tested positive for Covid 19 on Aug 27, despite being vaccinated; This is a spontaneous report from a contactable consumer or other non-health care professional. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration (at the age of 72-years) on Jan2021 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an intramuscular route of administration (at the age of 72-years) on Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered in hospital. 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. Since the vaccination, the patient was tested for COVID-19. On 27Aug2021, the patient experienced tested positive for covid 19 on 27Aug, despite being vaccinated. On unspecified date in Aug2021, experienced tested positive for covid 19 on aug 27, despite being vaccinated (drug ineffective). The treatment was not received for all the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, UNK, COVID19
Symptoms: Angina pectoris, Asthenia, Malaise, Muscle spasms
Clinical narrative: Mild like pain in my heart; I haven't been feeling well, I am feeling very weak today; I haven't been feeling well, I am feeling very weak today; Spasms in my foot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old patient of an unspecified gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for inejction, Batch/Lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on 21Aug2021 as DOSE 1, SINGLE for covid-19 immunisation; gabapentin (GABAPENTIN "PCD", Batch/Lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on an unspecified date for an unspecified indication.  The patient's medical history and concomitant medications were not reported. The reporter stated 'I had a shot (Covid-19 Vaccine) but I am calling to find out if you have to have that shot in your system and ever since then I haven't been feeling well, I am feeling very weak today but, because I took, are you supposed to take, I have to take a Gabapentin, I tried it today and I am really super dizzy today, like really dizzy, am I not allowed? Should I not take that pill more'. The patient also stated 'Well, wonder if you should mix that drug after you had a Pfizer shot because I had it a week ago, like last Saturday and I actually had some spasms in my foot and I had mild like pain in my heart and I am 60 years old, I am going to be 61, so that concerns me that I should be mixing the drug right now, just after a week, because I was kind of sick from that, a little sick and I have to have the second shot and I am kind of afraid to have it and I am living on street, I am living in my car and no body is helping me out'. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of GABAPENTIN in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of GABAPENTIN has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, UNK, COVID19
Symptoms: Fatigue, Illness, Malaise
Clinical narrative: Mild like pain in my heart; I haven't been feeling well, I am feeling very weak today; I haven't been feeling well, I am feeling very weak today; Spasms in my foot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old patient of an unspecified gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for inejction, Batch/Lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on 21Aug2021 as DOSE 1, SINGLE for covid-19 immunisation; gabapentin (GABAPENTIN "PCD", Batch/Lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on an unspecified date for an unspecified indication.  The patient's medical history and concomitant medications were not reported. The reporter stated 'I had a shot (Covid-19 Vaccine) but I am calling to find out if you have to have that shot in your system and ever since then I haven't been feeling well, I am feeling very weak today but, because I took, are you supposed to take, I have to take a Gabapentin, I tried it today and I am really super dizzy today, like really dizzy, am I not allowed? Should I not take that pill more'. The patient also stated 'Well, wonder if you should mix that drug after you had a Pfizer shot because I had it a week ago, like last Saturday and I actually had some spasms in my foot and I had mild like pain in my heart and I am 60 years old, I am going to be 61, so that concerns me that I should be mixing the drug right now, just after a week, because I was kind of sick from that, a little sick and I have to have the second shot and I am kind of afraid to have it and I am living on street, I am living in my car and no body is helping me out'. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of GABAPENTIN in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of GABAPENTIN has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Extra dose administered, Heart rate increased, Malaise
Clinical narrative: not feeling well; I am super dizzy like I am going to faint; I checked my heart rate seems to be elevated; I am kind of anxious; I checked my oxygen level is good it is like 98; I had my third shot; I had my third shot; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 3 via an unspecified route of administration on 27Aug2021 as DOSE 3, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration on unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 2 via an unspecified route of administration on unspecified date for covid-19 immunisation. On 27Aug2021, Patient had his third shot (Further clarification unknown) yesterday (Confirmed as 27Aug2021) and patient just had like a normal shot nothing major and next day morning patient woke up feeling pretty well and mean  progressively started not feeling well which kind of anxious with the third shot but like completely dizzy like super dizzy like I am going to faint and  checked oxygen level is good it is like 98 and checked  heart rate seems to be elevated, that is 101 for resting heart rate which normally is like 70 or 80, like 75-80 so patient's just little concerned is this like a side effect of the vaccine or is it something  need to go to hospital for or not finding anything regarding the dizziness. The patient underwent lab tests and procedures which included heart rate increased: 101 on 28Aug2021, oxygen saturation normal: 98 % on 28Aug2021.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Oxygen consumption decreased, Oxygen saturation normal
Clinical narrative: not feeling well; I am super dizzy like I am going to faint; I checked my heart rate seems to be elevated; I am kind of anxious; I checked my oxygen level is good it is like 98; I had my third shot; I had my third shot; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 3 via an unspecified route of administration on 27Aug2021 as DOSE 3, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration on unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 2 via an unspecified route of administration on unspecified date for covid-19 immunisation. On 27Aug2021, Patient had his third shot (Further clarification unknown) yesterday (Confirmed as 27Aug2021) and patient just had like a normal shot nothing major and next day morning patient woke up feeling pretty well and mean  progressively started not feeling well which kind of anxious with the third shot but like completely dizzy like super dizzy like I am going to faint and  checked oxygen level is good it is like 98 and checked  heart rate seems to be elevated, that is 101 for resting heart rate which normally is like 70 or 80, like 75-80 so patient's just little concerned is this like a side effect of the vaccine or is it something  need to go to hospital for or not finding anything regarding the dizziness. The patient underwent lab tests and procedures which included heart rate increased: 101 on 28Aug2021, oxygen saturation normal: 98 % on 28Aug2021.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: I had a stroke; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 16Mar2021 (Lot number was not reported) as single dose (at age of 41-year-old) for covid-19 immunisation. Medical history included covid-19 (prior to vaccination, the patient was diagnosed with COVID-19). Patient had no known allergies. Concomitant medication within 2 weeks of vaccination included ethinylestradiol, ferrous fumarate, norethisterone acetate (MINASTRIN 24 FE) taken for birth control. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 11:00 patient had a stroke. Event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for the event for 3 days. Since the vaccination, the patient has been tested for COVID-19, patient underwent laboratory tests and procedures which included sars-cov-2 test Pcr (Nasal Swab): negative on 23Aug2021. Patient was recovering from the event.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Pain
Clinical narrative: She is experiencing, her right eyes is sort of swelling and it's burning; right eye got swelling and is burning; She is hurting; She is experiencing, her right eyes is sort of swelling and it's burning; right eye got swelling and is burning; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's wife).  A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 26Aug2021 (Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she is experiencing her right eyes is sort of swelling and it's burning; right eye got swelling and is burning and she is hurting on an unspecified date. The clinical course reported as follows, reporter stated, "My wife and I both get the 2nd dose of the Covid Vaccine yesterday and she is experiencing, her right eyes is sort of swelling and it's burning. The caller was wondering that something which should we be concern about or what.  While confirming the concern, consumer further stated, "Her right eye got swelling and is burning." The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: she also stated her mother has an autoimmune disease; This is a spontaneous report from a non-contactable consumer (patient daughter) from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Solution for injection) 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 was not reported. The patient's concomitant medications were not reported. The patient experienced an autoimmune disease on an unspecified date. Caller wanted to know if it's true that the Pfizer covid-19 vaccine had been already approved or not. Caller mentioned her mother who had 1st dose and wanted to know about the approval of the vaccine because she was worried and she also stated her mother has an autoimmune disease. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Pain
Clinical narrative: same pains flared up; severe pain across back, arms/hands, feet/legs; back pain started; same pains flared up; severe pain across back, arms/hands, feet/legs; This is a spontaneous report from a contactable consumer. This 46-year-old male consumer (patient) reported that:  A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: FA6780), via an unspecified route of administration on Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Patient medical history included migraine from an unknown date and unknown if ongoing (other medical history migraines, kidney stones), Kidney stones (nephrolithiasis) from an unknown date and unknown if ongoing (other medical history migraines, kidney stones). Patient concomitant medication(s) included Topiramate (Topiramate) taken for an unspecified indication, start and stop date were not reported; Clomid (Clomifene Citrate) taken for an unspecified indication, start and stop date were not reported; Vitamin C (ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (VITAMIN D 2000) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin, morphine and experienced drug hypersensitivity (Known allergies erythromycin and morphine-based medications). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection;Lot number: unknown), via an unspecified route of administration, administered on unspecified date as single dose for COVID-19 immunisation .It was reported that  If other vaccine in four weeks was no. Covid prior vaccination was no. Covid tested post vaccination was no. The patient experienced same pains flared up; severe pain across back, arms/hands, feet/legs and back pain started on 15Apr2021. After second dose, same pains flared up. 3 weeks ago, back pain started. Became so bad 1 week ago that I was rushed to the emergency room (Friday). Went home that night after pain medications. Had to go back Sunday morning - no relief. Was in the hospital until Thursday with severe pain across back, arms/hands, feet/legs. The patient was hospitalized for same pains flared up; severe pain across back, arms/hands, feet/legs for 5 days. Therapeutic measures were taken with Pain medications as a result of same pains flared up; severe pain across back, arms/hands, feet/legs and back pain started. The outcome of events was Not recovered.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : PFIZER INC-202101119239 same patient/drug, different dose/event
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: I refer there is Myocarditis thing; When he took a deep breath in, he had, it is like chest pain like it is crampy; This is a spontaneous report from a contactable consumer (parent). This consumer reported for his son. A 13-year-old male patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EW0168 and expiration date was 30Nov2021), via an unspecified route of administration on 25Aug2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EW0168), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The reporter stated that when his son took a deep breath in, he had, it was like chest pain like it was crampy. Reporter referred there was Myocarditis thing and patient had same thing in next morning like when he took a deep breath in there was some like chest pain in there. The outcome of events was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: lost her baby; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reported stated that the patient lost her baby.  The mother reported she became pregnant while taking bnt162b2. It was reported that the doctors said that can't prove it was from the vaccine but they say they are pretty damn sure it was because of the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: A knot by my collar bone; a knot and it hurts and it is on the same side with the shot.; A knot by my collar bone; a knot and it hurts and it is on the same side with the shot.; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, "I got the shot the other day and it was just started I had a knot by my collar bone. There was a knot, and it hurts, and it was on the same side with the shot was put on. I never had this knot before until I have gotten the shot and I did not know what it was (General Statement)." The clinical outcome of the event was unknown at the time of report.  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.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: she also stated her mother has an autoimmune disease.; This is a spontaneous report. A non-contactable consumer (Patient's daughter) reported for a female patient. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date as a dose 1, single for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date the reporter stated that her mother who had 1st dose and wants to know about the approval of the vaccine because reporter was worried and stated that her mother had an autoimmune disease. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: shoulder pain where the site is; swelling up under my arms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: FC3183) 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 had first dose of BNT162B2 (Lot number: EW0176) on an unknown date for COVID-19 immunization. The patient experienced shoulder pain where the site is, swelling up under my arms on an unspecified date. Patient stated, received second Pfizer vaccine yesterday and had the shoulder pain where the site was but had swelling up under arms. Patient didn't have that the first time. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.