chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Illness, Mental disorder, Pain in extremity, Somnolence
Clinical narrative: anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; mental problem; so sick; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation.   Medical history included bipolar from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported. On 22Mar2021, the patient experienced sleepiness. On an unspecified date, the patient experienced anxiety, they felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine, mental problem, so sick. She had really serious problem, had to leave work and go to the hospital and get treated for anxiety in the emergency room.  Causing her anxiety to go crazy. After taking the Vistaril yesterday it calmed the girlfriend down. Outcome of events anxiety, felt soreness in the arm, mental problem, so sick was unknown. Outcome of Sleepiness was recovered in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Dyspnoea, Pulmonary embolism, Tremor
Clinical narrative: Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI.  On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Says she got her first dose on 03/5 and tested positive for covid on 03/27; Says she got her first dose on 03/5 and tested positive for covid on 03/27; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at first dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient wanted to know if her covid vaccine was effective. Said she got her first dose on 05Mar2021and tested positive for covid on 27Mar2021; she rescheduled her second shot and got it on 27Apr2021. Outcome of the event was unknown.  Information on batch number has been request.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; This is a spontaneous report from a contactable consumer (patient). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 17:30 (Lot Number: EW0171) as SINGLE DOSE for covid-19 immunisation.  Medical history included colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication included linaclotide (LINZESS) taken for an unspecified indication, start and stop date were not reported; mesalazine (CANASA) taken for an unspecified indication, start and stop date were not reported; mesalazine (APRISO) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19.  covid The patient was tested for COVID post vaccination.On 25Apr2021 17:00, the patient experienced severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion."The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care". The patient underwent lab tests and procedures which included chest x-ray: unknown result on unknown date, Rapid test Nasal Swab: negative on 26Apr2021.  Therapeutic measures were taken as a result of severe chest pain, shortness of breath, inability to breathe which included Prednisone, at home nebulizer. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; This is a spontaneous report from a contactable consumer (patient). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 17:30 (Lot Number: EW0171) as SINGLE DOSE for covid-19 immunisation.  Medical history included colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication included linaclotide (LINZESS) taken for an unspecified indication, start and stop date were not reported; mesalazine (CANASA) taken for an unspecified indication, start and stop date were not reported; mesalazine (APRISO) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19.  covid The patient was tested for COVID post vaccination.On 25Apr2021 17:00, the patient experienced severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion."The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care". The patient underwent lab tests and procedures which included chest x-ray: unknown result on unknown date, Rapid test Nasal Swab: negative on 26Apr2021.  Therapeutic measures were taken as a result of severe chest pain, shortness of breath, inability to breathe which included Prednisone, at home nebulizer. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Thrombosis, Vascular test, Weight
Clinical narrative: Blood clot in leg - first dose; This is a spontaneous report received from a contactable consumer, the patient. A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: CR2613), via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 77-years-old) as a single dose for COVID-19 immunization. Medical history included broke femur of right leg on 09Nov2020 and hospitalized from 09Nov2020 until 15Nov2020 or 16Nov2020, surgery to repair broken right femur on 12Nov2020, rehabilitation following hospital discharge and got out of the rehab facility on 14Dec2020, been in either a walker or a wheelchair and still not fully recovered (ongoing); chronic obstructive pulmonary disease (COPD), asthma diagnosed at least 13-14 years ago,  bronchitis, all ongoing from an unspecified date diagnosed at least 13-14 years ago. Concomitant medications were not reported. There were no other vaccinations within 4 weeks of the vaccine. On an unspecified date, the patient experienced a blood clot in the leg. The clinical course was follows: After he was discharged from rehab, the patient went to his own family doctor on 30Mar2021 because his ankle and leg were still swollen. The physician sent him to have a vascular done, on an unspecified date after 30Mar2021, with unknown results. The patient reported that the physician determined that he had blood clots in his leg. The patient was sent to the emergency room and started "that stuff" for about a week until he went to a regular vascular doctor and the physician determined what the patient should be doing. The patient reported that he was diagnosed with the blood clots after he got out of rehab. The patient received apixaban (ELIQUIS) from Apr2021 for blood clot in leg. The clinical outcome of blood clot in leg was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021478767 same patient, different dose/event
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her Husband who had COVID at that time; her Husband who had COVID at that time; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. Medical history included Type 2 Diabetic from 1995. The patient's concomitant medications were not reported. The reporter suspected that she was infected by her husband who had COVID at that time. While reporting adverse event for herself, she mentioned that her husband also was positive for the COVID virus after receiving the COVID vaccine. She mentioned that her husband was healthier than her that's why he got the 2nd dose 6 and a half weeks after the 1st one. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Wrong technique in product usage process
Clinical narrative: he noticed a large amount of blood when the needle was removed/quite a bit of blood came out of the injection site; the person giving him the vaccine, may have nicked an artery in his arm; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program Support. A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation and experienced pain at the injection site, low grade temp, fatigue and sore arm. On an unspecified date, the patient reported that when he received his second Pfizer Covid 19 Vaccine he noticed a large amount of blood when the needle was removed. The patient also reported no side effects from the second vaccine. He's concerned he didn't receive the full dose. The patient got both doses of the Pfizer Covid vaccine and at his 2nd dose during administration quite a bit of blood came out of the injection site, he believes they may have hit a blood vessel, so he wants to know if that means he didn't get his full vaccination. The patient stated that the person giving him the vaccine, may have nicked an artery in his arm. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs; This is a spontaneous report received from a contactable female consumer (patient). A 57-years-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via unspecified route of administration on 23Apr2021 00:00, as a SINGLE DOSE for COVID-19 immunization. Patient has history with past dose of BNT162B2 on an unspecified date. Concomitant medication of the patient was not reported. Patient received second dose on 23Apr2021, then on Monday she developed little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs. Her two sisters who live with her aged 56 (INT 227111) and 55 (INT 227113) also developed a similar rash after developing symptoms. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Musculoskeletal stiffness
Clinical narrative: The consumer called on behalf of her daughter who received the first dose of the Pfizer-Biontech Covid19 vaccine, 2 weeks ago. The patient developed stiffness in her neck, and they thought maybe she had "pulled her back out" because she was experiencing pain on the right side of her back. The medical staff at the Clinic (also reported as urgent care (pending clarification), where she was seen, think that she's experiencing "shingles without the rash" and indicated that they'd had "a lot of people" present this way after vaccination. The patient will be having bloodwork done to confirm shingles and will know in the next 72 hours. The reporter asked if there had been reports of shingles following vaccination. The reporter indicated that she does not want her daughter to receive a second dose of vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Investigation
Clinical narrative: Left side of face froze up/Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (batch/lot number and expiry date not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced left side of face froze up/Bell's palsy on an unspecified date.  The patient underwent lab tests and procedures which included test in the emergency room: unknown result on 24Apr2021. Therapeutic measures were taken as a result of left side of face froze up/Bell's palsy (unspecified medication). The patient has not recovered from the event.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history includes hearing disability, diagnosed about 3 years ago, so she uses speakerphone so she can hear instead of wearing a hearing aid. Concomitant medications were not reported.  The patient experienced shingles on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body height, Head injury, Syncope, Weight
Clinical narrative: she fainted; hit her head; This is a spontaneous report from a contactable consumer (patient's mother) reported that a 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171), via an unspecified route of administration, administered in arm left on 23Apr2021 (at the age of 16-years-old) as 1st dose, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Apr2021, she fainted and hit her head. Clinical course details was reported as the patient got her Pfizer COVID vaccine on Friday (23Apr2021), and she fainted on Saturday (24Apr2021), knocked her head on counter and was knocked out. The doctor was taking her to ER. The patient was not yet admitted to the hospital, since when the patient's mother called they were going there (hospital) now. The doctor had her blood drawn to find out what was going on. The patient underwent lab tests and procedures included weight: 58.97 (no unit), and height: 157 (no unit) both on an unspecified date. The patient was scheduled on 15May2021 for 2nd vaccine. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: A male patient received the second dose of BNT162B2 (Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 09Apr2021 15:00  as single dose for COVID-19 immunization. Medical history included allergy with NSAID, narcotics, cloves, wheat, soy, corn, scallops, peanuts, tree nuts, environmental allergens; lupus; C2 deficiency. Concomitant medications included prednisone. The patient previously took tetracycline, minocycline, doxycycline, azithromycin, clindamycin and experienced drug allergy. The patient previously received the first dose of BNT162B2 (Lot Number: 6208) administered in left arm on 19Mar2021 15:30 as single dose for COVID-19 immunization. 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 has not been tested for COVID-19. Exactly two weeks after the second vaccine, the patient developed an extremely mild case of Herpes zoster virus on 23Apr2021 04:00. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included 1000mg valacyclovir 3x/day. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Facial twitching on the left side of his face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8735; NDC number: unknown, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 21Apr2021 09:00 as single dose for COVID-19 immunisation (Because he travels internationally for work once that opens up and for safety purposes). There was no patient medical history (no diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity). There was no family medical history relevant to AE, they all were pretty healthy. The patient did not take concomitant medications (no other products). There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). There was no AE following prior vaccinations. On 22Apr2021 he noticed facial twitching on the left side of his face, which is same side that he was administered the Pfizer Covid Vaccine injection given in his left arm. He does not have any droopiness, just the facial twitching on the left side of his face. He asked for further information regarding this event relative to the Pfizer Covid Vaccine. Facial twitching on the left side of his face: outcome persistent, about the same, just annoying. Onset time is unknown, just sometime on 22Apr2021. He mentioned that he read some clinical reports where people you know ended up getting the bell's palsy on the second one, so if he is already getting twitching he does not want to get the second dose of the Pfizer Covid Vaccine and end up with this for 6 months or bell's palsy. His second dose was going to be 13May2021, but he has permanently stopped product in response to this event. There was no emergency room or physician office visit. There was no relevant test. Seriousness for event was unspecified. The patient was not hospitalized. There was no investigation assessment. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable other health professional reporting similar events under the same suspect product for 4 patients. This is second of 4 reports.   An elderly patient of unspecified age and gender 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 unknown dose, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was one of the 4 seniors that the doctor knewof that has had developed shingles on an unspecified date with Pfizer vaccine for COVID 19. The outcome was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481986 same reporter/drug, similar events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Neuralgia, Pain, Paraesthesia, Polymenorrhoea
Clinical narrative: Tingling all over my body; Started having pain and then it started messing with my nerve and it got really bad; Started having pain and then it started messing with my nerve and it got really bad; Three days after I got the first vaccine, my period came even though I already had period in that month; common cold; This is a spontaneous report from a contactable consumer (patient). This is the report for the first dose. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8736) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the first day the patient got the vaccine about two to three hours after getting the vaccine, she started having tingling all over her body and by Friday, she started having pain and then it started messing with her nerve and it got really bad. She went to the emergency room and they tried to give her some medication and she took some. So, she didn't like the way she felt, so she stopped thinking that. When she went to Emergency Room (ER), the doctor told her that these are the unknown side effects because these are not the ones that they heard of but she heard that they talk about that you could have a rare side effect. The patient commented that she was told that was the only thing that she heard, this was what happened to her. Also, three days after she got the first vaccine, her period came even though she already had period in that month and they said it could be a coincidence. So, they automatically set up her second shot four weeks later and she was using a natural stuff for the pain and the tingling and all that sort of things. Three weeks after, everything was the same, nothing has changed, it was like common cold.  Therapeutic measures were taken as a result of tingling, 'pain and then it started messing with my nerve and it got really bad'. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484668 same patient, same event;different vaccine doses
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hypersomnia, Pain, Pain in extremity
Clinical narrative: slept for 2-3 days; Body was Sore; First Dose: Diarrhea; worn out; Arm was sore; This is a spontaneous report received from a contactable consumer (patient's husband). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Jan2021 13:45 at 61 years old (Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included ongoing seizure, seizures began when she was 5 years old, minor seizures. Seizures were under control in 1984, possibility configuration it is the right cocktail; Nerve injury; swelling on the wound leg; Blood pressure abnormal. Family history was none, states her Dad died last year, he was old, died of old age and natural causes. As people get older their body falls apart, nothing that is cancerous. States her Mother died of her heart, something to do with the heart and that was before they got married in 1984, he never met her mom. Concomitant medications included ongoing gabapentin taken for Nerves, she has been taking that for the last 7 years, states she has a wound on her left leg and that was being treated by a wound doctor for the last 7 years, states he got tired of what the wound doctor was doing so he drove her to (withheld) to be treated. Caller states the wound doctor at (withheld) made a suggestion on how to bandage it up and medicate it and it went from 8Jan2021 length was 7.5mm by 10mm and with (withheld) suggestion yesterday it was 1mm by 0.7 mm, so half the size of a penny, states he anticipated within the next week or two weeks that it will be healed; ongoing valproate semisodium (DIVALPROEX) taken for seizure, states she has been taking for at least 20 years; ongoing furosemide taken for Water Pill, states she takes it to reduce swelling on the wound leg; states he gives it to her on the odd day of the month; ongoing metoprolol taken for Blood pressure abnormal, start and stop date were not reported; ongoing zinc taken for an unspecified indication, start and stop date were not reported; ongoing acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; ongoing pramipexole taken for seizure, start and stop date were not reported, states she takes it at 6pm, because it makes her drowsy and so the best time is at night time when she goes to bed; ongoing Vitamin C taken for an unspecified indication. No other vaccines were administered on same Date of the Pfizer Suspect, every year they get the flu shot and everything is normal. Caller states his wife got her first shot on 09Jan2021. States the effects started immediately, her arm was sore and then the next day (10Jan2021) her body was sore and she had diarrhea for 2-3 days and she also slept for 2-3 days, she was worn out. On the 3rd or 5th day she said she feels good, lets go. Caller states, then they were okay. The outcome of the events was recovered on 12Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Polymenorrhoea
Clinical narrative: the tingling came back and it was very intense; I got my period down again, three days after exactly like the first vaccine and my period has been worse; This is a spontaneous report from a contactable consumer.   A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8736) as 2nd dose, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on an unspecified date (Batch/Lot Number: ER8736) for COVID-19 immunisation and experienced as stated, "the first day, I got the vaccine about two to three hours after getting  the vaccine, I started having tingling all over my body and by Friday, I started having pain and then it started messing with my nerve and it got really bad. I went to the emergency room and they tried to give me some medication and I took some. So, I didn't like the way I felt, so I stopped thinking that. When I went to Emergency Room (ER), the doctor are telling me that these are the unknown side effects because these are not the ones that they heard of but I heard that they talk about that you could have a rare side effect and I am telling you that, that is the only thing that I heard, this is what happened to me. Also, three days after I got the first vaccine, my period came even though I already had period in that month and they said it could be a coincidence. So, they automatically set up my second shot four weeks later and I was using a natural stuff for the pain and the tingling and all that sort of things. Three weeks after, everything was the same, nothing has changed, it was like common cold and then I felt better because of that natural stuff that I was using, it helped me feel better.  So, I went and got my second vaccine and this was on this last Saturday, I got my second vaccine, the tingling came back and it was very intense and then I got my period down again, three days after exactly like the first vaccine and my period has been worse. So, I am calling you, I even called CDC trying to get information and everything, then I got this number to call you guys and I called." The outcome of tingling was unknown and other event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484439 same patient, similar event, different dose
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable nurse reporting same event under the same suspect product for 4 patients. This is third of 4 reports.   A elderly patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Apr2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was one of the 4 seniors that the doctor knew of that has developed shingles on an unspecified date with Pfizer vaccine for COVID 19. The outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481986 same reporter/drug/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable nurse. This nurse reported same event for four patients. This is the fourth of four reports.  An elderly patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number was not reported) at unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was one of the 4 seniors that the doctor knew that has had developed shingles on an unspecified date with Pfizer vaccine for COVID 19. Outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481986 same reporter/drug/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for # COVID19; tested positive for #COVID19 / come down with Covid is that I'm 11 weeks out since my @pfizer vaccine; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient tested positive for covid-19. The patient reported that "I, unfortunately, tested positive for COVID19 today. What sets me apart from millions of others who have come down with Covid is that I'm 11 weeks out since my Pfizer vaccine". The patient stated "please do not let your guard down even after the vaccine". My symptoms was or now are pretty mild. I will quarantine in my home until next Wednesday and I encourage you all to take this seriously and continue practicing Covid protocols. Be courteous to your colleagues and loved ones who are more susceptible. The pandemic has not come to an end. Be safe, take care do not let your guard down even after you have been vaccinated." The patient had tests which included sars-cov-2 test: positive on 28Apr2021.  The clinical outcome of the event was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: herpes zoster/Shingles; This is a spontaneous report from a contactable consumer (parent).  A 29-year-old female patient received BNT162B2, via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) at the age of 28 years old as 2nd dose, single for COVID-19 immunization. Medical history included anxiety; psychogenic non-epileptic seizures (PNES); polycystic ovary syndrome (PCOS); was previously diagnosed as being bipolar, but that diagnosis was changed; had chicken pox at age 2 and did not get the varicella vaccine. Concomitant medications included clonazepam (KLONOPIN) taken for anxiety, and on birth control for PCOS. The patient previously took BNT162B2 1st dose on an unspecified date for COVID-19 immunization. The patient received her second dose of the Pfizer COVID vaccine on 08Apr2021 (Thursday). On 26Apr2021 (Monday, 18 days later), she reported hives and blisters on her leg. At time of report, her primary care physician diagnosed her as having herpes zoster. Parent has no idea if patient's shingles is related to the vaccine but reported it as a possible adverse event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Vomiting
Clinical narrative: Shingles; Severe headaches; Vomiting; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's sister) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine and then got shingles and experienced severe headaches and vomiting on an unspecified date. The second dose is scheduled for tomorrow (29Apr2021) and they are wondering if she should take it. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date  as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1st dose of vaccine and now she has pneumonia. She was told by her doctor to wait to receive her 2nd dose she was calling to cancel 2nd appointment in till she finishes her antibiotic. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: His girlfriend developed a high temperature after first shot of vaccine; This is a spontaneous report from a Pfizer sponsored program . A non-contactable consumer (patient's boyfriend) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced a high temperature after first shot of vaccine. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Skin discharge
Clinical narrative: experiencing a "red, itchy" rash around her neck, face, and chest; experiencing a "red, itchy" rash around her neck, face; Some of them started having sticky water coming out of them. She confirmed like a drainage from the rashes; This is a spontaneous report from a contactable consumer (patient).   A 25-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Apr2021 (Lot Number: EW0173) at left arm as 0.3ml single dose for covid-19 immunisation.  The patient medical history included allergic to shrimp and she had no allergies to medications. There were no relevant concomitant medications. The patient reported on 29Apr2021 14:00 she started experiencing a "red, itchy" rashes around her neck, face, and chest. Some of them started having sticky water coming out of them. She confirmed like a drainage from the rashes. She didn't know what it was but it was so itchy last night she took Benadryl (expiration Mar2022 and lot number SJF001, strength 25 mg) and it was helping for an hour or 2 and it helped her to sleep but when she up woke up this morning on 30Apr2021 all the itchiness came back and was the same as yesterday. She did not know if she can continue taking Benadryl or if it will affect the vaccine or what effect will happen. Due to these side effects, she would like to know if she can receive the second dose of the vaccine. She was concerned about what the signs of a severe allergic reaction could be. The outcome of the events was not resolved and reported as "on going and persisting about the same".
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/got COVID; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: EW0150) as 1st dose, single (at the age of 39-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 31Mar2021, she was scheduled for second dose on 30Apr2021, however she wanted to know if she is okay to receive her second dose on 30Apr2021because on 08Apr2021 she tested positive for COVID-19, she got COVID and then tested negative for COVID-19 on 18Apr2021. The patient underwent lab tests and procedures which included Covid-19 Test: positive on 08Apr2021, Covid-19 Test: negative on 18Apr2021. The outcome of event was recovered on 18Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Compression fracture
Clinical narrative: compression fracture; she had back injury; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient medical history was not reported. Concomitant medications were not reported.  On an unknown date, after taking the first dose, the patient experienced back injury and compression fracture. Therapeutic measures were taken as a result of the events and included cyclobenzaprine hydrochloride (FLEXERIL), a muscle relaxer. The patient was originally scheduled for the 2nd dose on 15Apr2021 but was rescheduled on 29Apr2021 because of the injury, and the patient asked if it is okay to take the vaccine when taking Flexeril. The clinical outcome of the events back injury and compression fracture was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had covid and got the vaccine; I had covid and got the vaccine; This is a spontaneous report from a contactable other hcp. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as unknown, dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from Jan2019 (expiration date: 30Jan2021) at 11 mg, daily for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. Concomitant medications included denosumab (PROLIA); methotrexate sodium; estradiol (VIVELLE-DOT); pilocarpine hydrochloride; paracetamol, tramadol hydrochloride (ULTRAM); hydroxychloroquine phosphate (PLAQUENIL); ciclosporin (RESTASIS); pantoprazole; alendronate sodium (FOSAMAX); calcium carbonate, colecalciferol (CALTRATE 600 + D); chondroitin sulfate; meloxicam (MOBIC); glucosamine sulfate; acyclovir [aciclovir]; tizanidine hcl. The patient previously took Betadine swabstick, codeine phosphate 30 mg tab, sulfa drugs CEP ID 54550 and acetaminophen, experienced allergies. The patient stated she had covid and got the vaccine. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The events are unlikely related to the suspected drug of  Xeljanz XR.   The case will be reassessed if additional information becomes available.  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.,Linked Report(s) : US-PFIZER INC-2021487323
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the first dose of the Covid vaccine on Monday 26Apr2021. On Wednesday 28Apr2021 he was tested positive for Covid-19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for her husband and herself. This is the second of two reports for her husband. A 65-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation.  The patient medical history included ongoing exposed prior to getting the vaccine. Concomitant medications were not reported.  The patient received the first dose of the Covid vaccine on Monday 26Apr2021. On Wednesday 28Apr2021 he was tested positive for Covid-19. He didn't know he had been exposed prior to getting the vaccine. He was exposed and didn't know it and then he got the symptoms. Patient's second shot was due 18 MAY 2021 and he will be cleared by the 08May2021.the outcome of the event was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Lymphadenopathy, Neck pain, Pain of skin
Clinical narrative: (thinking it's swollen neck lymph nodes); sore neck; Shingles; upper torso skin HURTS; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 27Apr2021 at 09:15 (at the age of 57-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included psoriasis, migraine and known allergies to some medications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EW0150), on 06Apr2021 at 14:00 for COVID-19 immunisation and experienced sore arm. The day the patient received the second dose, she felt fine. Woke up on the 2nd day (28Apr2021 04:30) to sore neck (thinking it was swollen neck lymph nodes) and upper torso skin hurts (she feels like it's the shingles again). Two (2) ibuprofen (MOTRIN) has helped, but the MOTRIN is wearing off. Therapeutic measures were taken as a result of neck pain and skin pain; no treatment received for other events. The outcome of the events was recovering.