chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache
Clinical narrative: Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:00 (at the age of 61years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 06Mar2021 12:00 (at the age of 61years) for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Bell's Palsy 10 days later. It was further reported that the patient had a persistent headache from date of second vaccine to now (pending clarification), including onset of Bell's Palsy. The onset date of adverse events was 07Apr2021 (11:00 AM) (as reported). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with steroids and anti-viral. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian enlargement, Skin warm, Swelling
Clinical narrative: swelling of her ovaries; hot to the touch; on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch; This is spontaneous report from a contactable consumer(patient) reported for herself. A 46-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE, dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced swelling of her ovaries, hot to the touch, on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch, all on 18Mar2021 with outcome of not recovered. Patient has received both the first and second dose of the Pfizer Covid Vaccine. Stated she got her second dose yesterday and with both dose of the vaccine, she had swelling of her ovaries and they were hot to the touch. Stated it was more on the right than the left. Stated it was worse the first time. States on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch. The patient experienced events after first dose from 18Mar2021 and recovered on 20Mar2021, experienced same events after second dose on 08Apr2021 and ongoing. Time of Onset (24-hour clock) reported as noticed it this morning and got up around 05:40. The events reported as non-serious.  No Emergency Room visit. No Physician Office visit, stated she worked for a dentist and she consulted with her and the dentist said to watch it and wait 48 hours. Treatment received included Ibuprofen.   No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Electrocardiogram, Investigation, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's wife) Pfizer Sponsored Program.   A 65-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in upper left arm on 20Mar2021 14:00 (Lot Number: EN6205), at age 65-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid Virus on 27Mar2021 after receiving first dose Pfizer Covid Vaccine 20Mar2021. The reporter took husband to the Emergency Room.  It was technically 0100 Tuesday morning on 30Mar2021.  The patient was taken the emergency room because of Covid, caller's husband had a fever of 103-104, never would go below 103.  The reporter stated everything was fine with her husband, his vitals, EKG, everything look good. They are asking, should the reporter and her husband get their second dose Pfizer Covid Vaccine on this coming Saturday,10Apr2021 as scheduled or wait a longer period of time until they have no symptoms. The patient had nasal swab left and right at two different CVS pharmacies. After testing positive for Covid both the patient used Tylenol and Ibuprofen pills. The Tylenol was extra strength 250 or 200 each pill. Both the caller and her husband took Ibuprofen 200 sometimes 2 pills, sometimes 3 pills, sometimes 4 pills, depending on the level of the fever. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021387474 same reporter/drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Fatigue, Pain, Poor quality sleep
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included vitamin d3 and multivitamins and some other supplement. The patient previously received first dose of bnt162b2 on 12Mar2021 at single dose for Covid-19 immunization. Reported as: She is in a delicate health situation that was discovered, she is losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021, they saw some-thing like an ulcer on the pancreas head, with cancer cells, it is localized, it is serious, and she received chemo after the first dose. The patient experienced she feels tired today, she's in pain and she's barely adjusting on an unspecified date. Reported as: This came up from an accident she had in January, the airbag opened and hit her stomach. She didn't sleep well last night, she feels tired today, they did an endoscopy, she's in pain and she's barely adjusting. Yesterday she was given her first strong medicine, but she usually takes as little medicine as possible. The outcome of the event was unknonw.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: arm is a little heavy; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication from 08Apr2021 to an unspecified stop date.  The patient got her first dose a few hours ago on 08Apr2021 and she took 400mg of Ibuprofen after her first dose. Patient said that she was advised by her friend to take it. Patient asked if it would affect the efficacy of the vaccine. Patient also mentioned that her arm is a little heavy on 08Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: A couple of lymph nodes swollen, one above the clavicle and another one closer to the neck, both on the left side; Touching them feels tender and a little pain; This is a spontaneous report received from a contactable consumer (patient).  A 52-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 09:00 AM (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation.  Medical history included Seasonal allergies due to pollen and dust mites from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (lot number=Pfizer EL3247) at Left arm on 16Mar2021 for covid-19 immunization. The medication the patient received within 2 weeks of vaccination was Dulcera inhaler for seasonal allergies. The patient experienced a couple of lymph nodes swollen, one above the clavicle and another one closer to the neck, both on the left side on 05Apr2021 with outcome of recovering, touching them feels tender and a little pain on 05Apr2021 with outcome of recovering.  The events was non-serious. Reported a couple of lymph nodes swollen, one above the clavicle and another one closer to the neck, both on the left side. Touching them feels tender and a little pain. After 3 days the swollen nodes seem to be fading. No treatment received. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: started feeling faint/feel extremelydizzy and faint/felt some light headedness; This is a spontaneous report received from a contactable consumer (who is also the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 08Apr2021 16:15, as single dose, for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not have COVID-10 prior to vaccination and was not tested for COVID-10 post vaccination. Concomitant medication included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE); gabapentin; and "plenity" (as reported); all taken for unspecified indications, start and stop dates were not reported. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 16:15, after getting the vaccine, the patient started feeling faint. She continued to feel extremely dizzy and faint for a half hour. She felt some light headedness ever since. The patient did not receive treatment for the event. The patient was recovering from the event.  Information on lot number/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Iridocyclitis
Clinical narrative: anterior uveitis in left eye; This is a spontaneous report from a non-contactable consumer (patient).   A 41-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left Arm on 05Apr2021 11:00 (Lot Number: 8734), at the age of 41-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included asthma, mild heart murmur, 1 instance of resolved heart failure from postpartum preeclampsia in 2017, uveitis in both eyes, occurred between Nov2013-May2014. Historical vaccine includes dose 1 of BNT162B2 received on 15Mar2021 10:00am on left arm (Lot number: En6208). The patient is not pregnant at the time of vaccination. Concomitant medications included azelastine; ciclosporin (RESTASIS); cetirizine hydrochloride (ZYRTEC); propranolol, all were taken for unspecified indication, start and stop date were not reported.  The patient previously took Vicodin and experienced itching; Advil and experienced hives.  On 07Apr2021 16:00, patient experienced anterior uveitis in left eye, diagnosed by opthalmologist on 08Apr2021.  The patient underwent lab tests and procedures which included body mass index: 30. The outcome of the event was not recovered. Therapeutic measures were taken as a result for the event which includes Prednisolone AC 1% Eye Drop.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Dyspnoea, Pyrexia
Clinical narrative: low grade fever; felt pressure on chest; slight difficulty breathing; This is spontaneous report received from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:45 (Lot Number: EP6955) (Age at vaccination: 49 Years) as single dose for covid-19 immunisation. Medical history included Psoriasis; psoriatic arthritis; No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included rosuvastatin; valacyclovir [valaciclovir]; finasteride; vitamin d [vitamin d nos]; cetirizine hydrochloride (ALLERTEC, OTC allergy medication)). The patient previously received the first dose of bnt162b2 (lot number: EP6955) in Left arm on 17Mar2021 10:00 for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr2021 14: 00 (also reported as 13 minutes post injection), the patient felt pressure on chest/slight difficulty breathing for 15-20 minutes. On 08Apr2021 20:00 (one day post injection) had a low grade fever. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of events felt pressure on chest/slight difficulty breathing was recovered on 07Apr2021, of low grade fever was recovered on 08Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Head injury, Loss of consciousness
Clinical narrative: I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 12:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Thyroidectomy. Concomitant medications included pravastatin sodium (PRAVASTATIN SODIUM); levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received first dose of BNT162B2 on 27Feb2021 at 74-years-old for COVID-19 immunization: lot number=EN6203, lot unknown=False, administration date=27Feb2021, vaccine location=Left arm, dose number=1. On 22Mar2021 16:00, the patient fainted and hit her head. On 21Mar2021, the patient had stomach cramps, diarrhea and chills. I was wondering if passing out was an uncommon side effect. The outcome of the events was recovered. The patient received treatment for the events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: I fainted and hit my head.; I fainted and hit my head.; passing out; stomach cramps; diarrhea; chills; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Mar2021 12:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Thyroidectomy. Concomitant medications included pravastatin sodium (PRAVASTATIN SODIUM); levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient received first dose of BNT162B2 on 27Feb2021 at 74-years-old for COVID-19 immunization: lot number=EN6203, lot unknown=False, administration date=27Feb2021, vaccine location=Left arm, dose number=1. On 22Mar2021 16:00, the patient fainted and hit her head. On 21Mar2021, the patient had stomach cramps, diarrhea and chills. I was wondering if passing out was an uncommon side effect. The outcome of the events was recovered. The patient received treatment for the events.
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Cough, Diverticulitis, Irritable bowel syndrome, Nausea
Clinical narrative: Caller has "IBS and diverticulitis and gets nausea from it".; itching in the throat; coughing; she gets it on and off due to the weather/pollen; she gets it on and off due to the weather/pollen; Caller has "IBS and diverticulitis and gets nausea from it".; Caller has "IBS and diverticulitis and gets nausea from it".; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age (reported as age: 79 unit: unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history included colonoscopy on an unspecified date in 2021. The patient's concomitant medications were not reported. Patient wanted to know if its ok to take the second dose of the Pfizer Covid vaccine today (09Apr2021). She was experiencing itching in the throat and coughing on an unknown date which was also reported that "it stated last night and she gets it on and off due to the weather/pollen". Patient had a colonoscopy done on the last Wednesday, on an unspecified date 2021 (unknown results). Patient has "IBS and diverticulitis and gets nausea from it" since an unknown date. Patient stated it's not unusual for her to get this. Patient wanted to know if she cancels her appointment, how long she has to take her second dose. The outcome of the events reported was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy, Sensitivity to weather change, Throat irritation
Clinical narrative: Caller has "IBS and diverticulitis and gets nausea from it".; itching in the throat; coughing; she gets it on and off due to the weather/pollen; she gets it on and off due to the weather/pollen; Caller has "IBS and diverticulitis and gets nausea from it".; Caller has "IBS and diverticulitis and gets nausea from it".; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age (reported as age: 79 unit: unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history included colonoscopy on an unspecified date in 2021. The patient's concomitant medications were not reported. Patient wanted to know if its ok to take the second dose of the Pfizer Covid vaccine today (09Apr2021). She was experiencing itching in the throat and coughing on an unknown date which was also reported that "it stated last night and she gets it on and off due to the weather/pollen". Patient had a colonoscopy done on the last Wednesday, on an unspecified date 2021 (unknown results). Patient has "IBS and diverticulitis and gets nausea from it" since an unknown date. Patient stated it's not unusual for her to get this. Patient wanted to know if she cancels her appointment, how long she has to take her second dose. The outcome of the events reported was unknown.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: I had appendicitis and had my appendix removed with surgery at the hospital.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 52 years of age), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 12:00 (Batch/Lot Number: EN6204) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included metoprolol, lisinopril, apixaban (ELIQUIS) and amiodarone, all taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient had no known allergies. It was reported that on 05Apr2021 the patient had appendicitis and had his appendix removed with surgery at the hospital. The event resulted to Emergency room/department or urgent care. The patient was hospitalized for the event with a duration of 1 day. Therapeutic measures were taken as a result of the event with surgery. He had a covid test post vaccination through nasal swab on 07Apr2021 with negative result.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from a contactable consumer (patient). 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 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was due to receive second dose of Pfizer BioNTech Covid 19 the week before but was sick in the hospital 2 days before (unspecified date) and was prescribed antibiotics for 10 days. They were asking how long she can wait to receive the second dose. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysphagia, Eye irritation, Eye pain, Headache
Clinical narrative: horrible headache; sore throat; congestion; tons of phlegm; sinus pressure; very sensitive to touch; eyes are burning and red; pain back of the eyes; sore throat can barely swallow; eyes are burning and red; This is a spontaneous report from a contactable consumer via Medical Information Team. This consumer reported for a 16-year-old male patient (son) that the 16 year old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection) intramuscularly as a single dose for COVID-19 immunization. The patient previously had COVID only 2 days of congestion. The patients concomitant medications were not reported. The reporter mentioned that the patient woke up with a horrible headache, sore throat can barely swallow has a lot of congestion and tons of phlegm. Also felt like sinus pressure and the inner lining of the nose is like a scar very sensitive to touch, eyes were burning and red and complaining about pain back of the eyes. The patient took Motrin, oxygen level and temperature are fine. The patient was supposed to drive to meet family group members who are vaccinated. The reporter wanted to know whether he could be contagious and wanted to know whether to keep him in quarantine and be concerned about protecting. The reporter wanted to know whether the patient could take any medications and what point the patient should be taken to the ER.The patient also previously had COVID only 2 days of congestion. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Ocular hyperaemia, Oropharyngeal pain, Paranasal sinus discomfort, Productive cough
Clinical narrative: horrible headache; sore throat; congestion; tons of phlegm; sinus pressure; very sensitive to touch; eyes are burning and red; pain back of the eyes; sore throat can barely swallow; eyes are burning and red; This is a spontaneous report from a contactable consumer via Medical Information Team. This consumer reported for a 16-year-old male patient (son) that the 16 year old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection) intramuscularly as a single dose for COVID-19 immunization. The patient previously had COVID only 2 days of congestion. The patients concomitant medications were not reported. The reporter mentioned that the patient woke up with a horrible headache, sore throat can barely swallow has a lot of congestion and tons of phlegm. Also felt like sinus pressure and the inner lining of the nose is like a scar very sensitive to touch, eyes were burning and red and complaining about pain back of the eyes. The patient took Motrin, oxygen level and temperature are fine. The patient was supposed to drive to meet family group members who are vaccinated. The reporter wanted to know whether he could be contagious and wanted to know whether to keep him in quarantine and be concerned about protecting. The reporter wanted to know whether the patient could take any medications and what point the patient should be taken to the ER.The patient also previously had COVID only 2 days of congestion. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: horrible headache; sore throat; congestion; tons of phlegm; sinus pressure; very sensitive to touch; eyes are burning and red; pain back of the eyes; sore throat can barely swallow; eyes are burning and red; This is a spontaneous report from a contactable consumer via Medical Information Team. This consumer reported for a 16-year-old male patient (son) that the 16 year old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection) intramuscularly as a single dose for COVID-19 immunization. The patient previously had COVID only 2 days of congestion. The patients concomitant medications were not reported. The reporter mentioned that the patient woke up with a horrible headache, sore throat can barely swallow has a lot of congestion and tons of phlegm. Also felt like sinus pressure and the inner lining of the nose is like a scar very sensitive to touch, eyes were burning and red and complaining about pain back of the eyes. The patient took Motrin, oxygen level and temperature are fine. The patient was supposed to drive to meet family group members who are vaccinated. The reporter wanted to know whether he could be contagious and wanted to know whether to keep him in quarantine and be concerned about protecting. The reporter wanted to know whether the patient could take any medications and what point the patient should be taken to the ER.The patient also previously had COVID only 2 days of congestion. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Accident at work, Inappropriate schedule of product administration
Clinical narrative: a work related injury; did not receive a second dose/first dose of the covid-19 vaccine on 04Jan2021; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number unknown), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the covid-19 vaccine on 04Jan2021. The patient did not receive a second dose due to a work related injury on an unknown date. The patient stated it was not due to the vaccine. The patient was inquiring if she needs to have the second dose or start over, or needs it at all for work. States work said she needed to have to come back to work. The patient has first appointment today to see about going back to work. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, there was not a reasonable possibility that the event "a work related injury" was related to bnt162b2. Event is due to work.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: antibody test that came back negative; This is a spontaneous report from a contactable physician. A 58-year-old female patient received both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), both via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated she had a patient who received both doses of the Pfizer COVID vaccine and then received an antibody test that came back negative. The outcome of the event was unknown. The case was non-serious.   information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Dysuria
Clinical narrative: Received  first shot of pfizer covid vaccine on monday and then the next developed burning when urinating; Believes it is a bladder infection; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first shot of pfizer covid vaccine on Monday and then the next she developed burning when urinating. She believed it was a bladder infection as it was ongoing so she went to her HCP for follow up and was prescribed antibiotics. Reporter confirmed she was reporting this as a potential side effect of the vaccine, also confirmed she has no medical inquiry. There was no PQC present. The outcome of the events was unknown.    No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Hypotension, Pyrexia
Clinical narrative: hypotension (blood pressure 89/54mmHg); fever; chills; severe vomiting; arthralgia; This is a spontaneous report from a contactable consumer. A 40 something female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included coronary artery disease (CAD) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. Historical vaccine information included BNT162B2, dose 1, for covid-19 immunisation on unknown date. 15 hours post second dose of COVID-19 Pfizer vaccine on unspecified date, the patient experienced symptoms of fever, chills, severe vomiting, arthralgia, and hypotension (blood pressure 89/54mmHg). Resolution of symptoms took approximately 1 week. The patient spoke with her healthcare professional (HCP). The patient underwent lab tests and procedures which included blood pressure: hypotension 89/54 mmhg on unknown date.   Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: hypotension (blood pressure 89/54mmHg); fever; chills; severe vomiting; arthralgia; This is a spontaneous report from a contactable consumer. A 40 something female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included coronary artery disease (CAD) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. Historical vaccine information included BNT162B2, dose 1, for covid-19 immunisation on unknown date. 15 hours post second dose of COVID-19 Pfizer vaccine on unspecified date, the patient experienced symptoms of fever, chills, severe vomiting, arthralgia, and hypotension (blood pressure 89/54mmHg). Resolution of symptoms took approximately 1 week. The patient spoke with her healthcare professional (HCP). The patient underwent lab tests and procedures which included blood pressure: hypotension 89/54 mmhg on unknown date.   Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Dry mouth, Dysgeusia, Loss of consciousness
Clinical narrative: I had blacked out or passed out while driving; Shortly afterwards while driving I suddenly started to not feel well.; Horrible dry, metallic taste in my mouth; Horrible dry, metallic taste in my mouth; VERY dizzy; My whole body started to tingle and I knew I needed to pull over as fast as possible; I feel very "off/extremely upset; This is a spontaneous report from a contactable consumer. This 35-year-old male consumer (patient) reported for himself.  A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8729) via an unspecified route of administration in left arm on 08Apr2021 11:00 as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. 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. The patient had no allergy to medications, food or other product. The patient receives other medication in two weeks include probiotics. After patient received first dose and waited 15 minutes as directed before leaving.  He felt fine at this point. Shortly afterwards while driving I suddenly started to not feel well. Horrible dry, metallic taste in my mouth and started getting VERY dizzy. My whole body started to tingle and I knew I needed to pull over as fast as possible. I turned my signal on to turn right onto a side road and the next thing I know, I woke up in the woods. I had blacked out or passed out while driving and trying to pull off to safety. I was blacked out for at least 15 minutes. Now I feel very "off" and not myself. My car is damaged, and I don't have the means to get it fixed. I'm extremely upset. Adverse events start time: 01:30 AM. Patient didn't received treatment for the events. The clinical outcome is not recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Paraesthesia
Clinical narrative: I had blacked out or passed out while driving; Shortly afterwards while driving I suddenly started to not feel well.; Horrible dry, metallic taste in my mouth; Horrible dry, metallic taste in my mouth; VERY dizzy; My whole body started to tingle and I knew I needed to pull over as fast as possible; I feel very "off/extremely upset; This is a spontaneous report from a contactable consumer. This 35-year-old male consumer (patient) reported for himself.  A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8729) via an unspecified route of administration in left arm on 08Apr2021 11:00 as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. 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. The patient had no allergy to medications, food or other product. The patient receives other medication in two weeks include probiotics. After patient received first dose and waited 15 minutes as directed before leaving.  He felt fine at this point. Shortly afterwards while driving I suddenly started to not feel well. Horrible dry, metallic taste in my mouth and started getting VERY dizzy. My whole body started to tingle and I knew I needed to pull over as fast as possible. I turned my signal on to turn right onto a side road and the next thing I know, I woke up in the woods. I had blacked out or passed out while driving and trying to pull off to safety. I was blacked out for at least 15 minutes. Now I feel very "off" and not myself. My car is damaged, and I don't have the means to get it fixed. I'm extremely upset. Adverse events start time: 01:30 AM. Patient didn't received treatment for the events. The clinical outcome is not recovering.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Foot fracture, Malaise
Clinical narrative: She has a broken foot; isn't feeling well from it; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization, on an unspecified date pregabalin (LYRICA), route of administration, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated she has a broken foot (foot fracture) and both her and her husband got COVID vaccine shot and husband (not patient) isn't feeling well from it. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary function test, Vaccination site pain
Clinical narrative: pain that arm from the injection site down to her hand; whole arm is hurting all the way to the hand and arm started aching; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER2739), via an unspecified route of administration on left arm on 05Apr2021 (at the age of 59-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing asthma (Diagnosed in November or December of 2020 while she had the COVID virus; went for a lung test in January 2021). Concomitant medications were not reported. Patient reports that she did have a hard time when she got COVID virus in 2020. Patient reports she had a lot of breathing problems when she had the COVID virus and she went to a lung specialist and was diagnosed with asthma. Patient reported that she received the COVID vaccine at 5:30 or 6:00 pm on 5Apr2021 and then her arm started aching. She states that to treat the pain, she is putting ice on it and everything but that the pain is not going away. She reports that the pain began around 8:30 or 9pm on 05Apr2021. She reports that she had to take her rings off of her hand because it is hurting so much. Patient reports the pain is staying the same except it gets better when ice is on it and that she is taking ibuprofen to help with the pain as well. Patient states that if she doesn't do ice and ibuprofen the pain is at a 10. Additional Vaccines Administered on Same Date of the Pfizer Suspect Additional Administered Vaccines were none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was not recovered from the events.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal discomfort, Oropharyngeal pain, Urticaria
Clinical narrative: I developed hives to my left jaw; woke up with a sore throat yesterday and this morning; throat feeling tight; I feel like I am getting sick; This is a spontaneous report from a contactable consumer (Patient).   A 21-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated that, she developed hives to her left jaw, woke up with a sore throat yesterday (a day before this report) and this morning (on the day of this report) and throat feeling tight, and she felt like she was getting sick. The patient asked these symptoms that are common and reported. Patient was asked about the second dose that she should get the second dose of the vaccine since she developed hives and response was should not. At the time of this report the event outcome was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. This consumer reported same event for three patients. This is the third of three reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; hydrocortisone, neomycin sulfate, polymyxin b sulfate (CORTISPORIN), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported.  The patient had first covid vaccine and she ended up with UTIs within 24 hours. The reporter wanted to know if that was a side effect. The action taken in response to the event for hydrocortisone, neomycin sulfate, polymyxin b sulfate was unknown. The outcome of the event 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-2021391050 Same reporter/suspect product/event, different patient.;US-PFIZER INC-2021391028 Same reporter/suspect product/event, different patient.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Vaccine first dose on 28Feb2021; on 10Mar2021 she started developing COVID-19 symptoms, she then tested positive for COVID-19 infection on 19Mar2021; Vaccine first dose on 28Feb2021; on 10Mar2021 she started developing COVID-19 symptoms, she then tested positive for COVID-19 infection on 19Mar2021; This is a spontaneous report from a contactable pharmacist. A 40-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, Patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 28Feb2021; on 10Mar2021 she started developing COVID-19 symptoms, she then tested positive for COVID-19 infection on 19Mar2021. Second dose is scheduled for next week. The pharmacist stated that the patient came in last night and asked if it is appropriate to get second dose. Outcome of the events was unknown.  Follow-up attempt completed, information about batch/lot number cannot be obtained.; Sender's Comments: The events drug ineffective and COVID-19 symptoms were considered probably related to suspect product.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Malaise, Pyrexia
Clinical narrative: fever; chills; mental disorientation; felt sick for a whole week; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and patient's concomitant medications were not reported. Patient got first dose on 22Mar2021. She got side effects. she had a fever, chills, and mental disorientation. She felt sick for a whole week. she didn't know if she can go through this again. The event outcome for events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Feeling abnormal, Heart rate increased, Paraesthesia
Clinical narrative: tingling in both of my feet and felt spaced out/I had tingling in my fingers; tingling in both of my feet and felt spaced out; My blood pressure was way up 179/93 and my pulse rate was up; My blood pressure was way up 179/93 and my pulse rate was up; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she visited site for second vaccine and had an issue with the first one. The first one she ended up in ER because she had some tingling in both of her feet and felt spaced out. Her blood pressure was way up 179/93 and pulse rate was up. She had tingling in fingers. The events were considered as serious (hospitalization) by reporter. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulties with breathing; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored Program. A female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Lung disease and a heart condition. The patient's concomitant medications were not reported. The patient started to experience difficulties with breathing on Apr2021, used nebulizer and took medication like Ventolin and few more other medicines. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.