chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Syncope
Clinical narrative: I felt as though I was going to faint several times a day; My heart fluttered, pounded, raced and skipped beats.; My heart fluttered, pounded, raced and skipped beats.; My heart fluttered, pounded, raced and skipped beats.; and the fluttering made me nauseous; My resting heart rate dropped; This is a spontaneous report from a contactable consumer (patient).   This 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ewo0153), via intramuscular administered in the left arm, on 04May2021 (at the age of 52-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ewo151) administered in the right arm, on 13Apr2021 (at the age of 52-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. No known allergies. Relevant concomitant medications included metoprolol, cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID), VITAMIN D3 and valsartan. The patient verbally reported 'on 16Jul2021, my heart fluttered, pounded, raced and skipped beats. My resting heart rate dropped and I felt as though I was going to faint several times a day, and the fluttering made me nauseous''. The events required physician office-visit. The patient was not treated for the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Ultrasound scan
Clinical narrative: Swollen lymph nodes on left side of neck the size of marbles day 6 until now; Headache for 5 days; This is a spontaneous report from a contactable consumer (patient).   This 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration administered in the left arm, on 29Aug2021 at 09:00 (at the age of 47-year-old) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have a relevant medical history. The patient did not have known allergies. The patient did not receive concomitant medications. On 29Aug2021 at 15:00, the patient had headache for 5 days. On 04Sep2021, the patient had swollen lymph nodes on left side of neck the size of marbles. On unknown date, a sonogram was done but results were not provided. No seriousness criterion was provided. The events required physician office visit. Therapeutic measures taken as result of the events included steroids and painkillers. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had recovered from headache in Sep2021 while she had not recovered from the other event.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have gotten Covid post-vaccination; have gotten Covid post-vaccination; This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included and concomitant medications were not reported. The patient experienced have gotten Covid post-vaccination on an unspecified date. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  Additional information:  Individual claims to have gotten Covid post-vaccination. Unsure which vaccination had been received. They also shared a post from regarding Covid break through cases: "it was expected we would see breakthrough infections, especially in places where we are seeing a lot of community transmission of the virus. In #, for example, which has the highest rates of transmission in the country, if you're vaccinated, your risk of getting COVID are equivalent to somebody who is not vaccinated here. And that is simply because there is so much more virus circulating right now in # that, even with the protection of the vaccine, you would still get infected." This may also speak to general vaccine efficacy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine
Clinical narrative: horrible migraines; I feel like the intensity of the migraines has gotten worse as well as the duration that they last; This is a spontaneous report from contactable other HCP reporting for himself.   A 35-year-old male patient received bnt162b2 (BNT162B2), at the age of 35 years dose 1 via an unspecified route of administration on 09Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 30Jan2021 15:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Vaccination Facility Type Hospital. Medical history included gastric bypass in 2014, diabetes mellitus and covid-19. There were no concomitant medications. The patient previously took Z-pak and experienced drug hypersensitivity. The patient experienced horrible migraines on 09Jan2021 15:30 with outcome of recovered and "I feel like the intensity of the migraines has gotten worse as well as the duration that they last" on 09Jan2021 15:30 with outcome of unknown. No treatment received. Description as reported: "I had horrible migraines after both of my vaccination shots within 6 to 8 hours after the shots were administered. Both of which lasted easily over about 24 hours. Since I got my shots I have not increased in the number of migraines but I feel like the intensity of the migraines has gotten worse as well as the duration that they last". The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event migraine and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Hypertension; This is a spontaneous report from a contactable nurse or other health care professional.   A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an intramuscular route of administration (at the age of 53-years), in deltoid right on 30Apr2021 as single dose for COVID-19 immunization. The patient's medical history included cyst of kidney and surgery to remove cyst from 2017 to an unknown date, bells palsy from 1992, 2002 to an unknown date, hypogonadism from 2018 to an unknown date, hypertension from 2005 to an unknown date, hyperlipidemia and hernia surgery from 2018 to an unknown date, gerd, allergy and blood pressure from an unknown date and unknown if ongoing. Patient family history included MI (myocardial infarction), Heart disease (Father) and hypertension, diabetes (Mother) from an unknown date and unknown if ongoing. The patient's concomitant medications included metoprolol succinate (TOPROL XL) taken for blood pressure as 50 mg per oral route starting from 2015 and ongoing, pantoprazole taken for gastrooesophageal reflux disease as 40 mg per oral from 2015 and ongoing, lisinopril taken for blood pressure measurement from 2020 as 20 mg per oral and ongoing, testosterone cipionate (DEPO TESTOSTERONE) taken for an unspecified indication from 2018 as 80 mg weekly intramusculary and ongoing, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergy from 2020 as 10 mg daily per oral and ongoing. On 01May2021, the patient experienced hypertension. The treatment was not received for the event. The adverse events resulted in physician office visit. The clinical outcome for the events was reported as recovered on 10Jun2021.  The Pfizer product did not have a causal effect to the adverse events.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be established as the patient is a known hypertensive
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Colon cancer, Lethargy
Clinical narrative: lethargic; weak; colon cancer; This is a spontaneous report from a contactable consumer.  A 77-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: unknown) in Jan2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. The patient had received the first shot in Dec2020.  Relevant medical history included Spinocerebellar ataxia for 20 years. The patient had Covid in Apr2020 and after he had Covid he had a flare up of prostatitis which is something he never had before. Concomitant drugs were unknown. The consumer reported that  after the first 2 vaccines in May2021, the patient was diagnosed with colon cancer.   Currently he was getting chemotherapy. The patient has had 2 treatments of chemo, and did wonderful after both.  After the vaccine he was lethargic and weak. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101183820 Same patient, same drug, different dose/event
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Blood shed during menstrual cycle has increased VERY significantly both flow rate and overall amount; This is a spontaneous report from a contactable consumer.  A 30-year-old female consumer (Patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0173) in the Left arm on 30Apr2021 at 02:00 PM (at the age of 30-year-old ) as single dose and the second dose (lot EW0187) on 24May2021 at 02:00 PM in the Left arm at single dose for COVID-19 immunization. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had known allergies to Sulfa drugs. No concomitant drugs. The patient reported that blood shed during menstrual cycle has increased very significantly since first round of vaccination (both flow rate and overall amount). Onset date reported as 15May2021. The patient was not COVID tested post vaccination. No treatment was received. The outcome was not recovered.  Follow-up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This is a spontaneous report from a contactable consumer (Patient's parent). A female patient of an unknown age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number FD0809 ), on Sep2021 as single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The patient received the vaccine dose in Sep2021 and she just passed out for like 10 minutes. The outcome of the event was unknown.  Follow up (17Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary sepsis
Clinical narrative: she has a long problem and that she was in a hospital for 4 days. She also has sepsis in the lungs.; This is a spontaneous report from a contactable consumer. A 83-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 10Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on an unknown date in Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that She had the first dose of the vaccine on Jan2021 and the second dose on 10Feb2021. She said that she has a long problem and that she was in a hospital for 4 days. She also has sepsis in the lungs on an unspecified date in 2021. Caller said that she as happy about her vaccination but she is worried it has been so long since she had it. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Injury, Pain, Vitamin D deficiency
Clinical narrative: had a mini stroke; I have an injury with chronic pain; I have an injury with chronic pain; vitamin D deficiency; This is a spontaneous report from a contactable consumer (patient). A 61-years-old patient of an unspecified gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 61-Years-old) as dose number unknown, single for COVID-19 immunization. Medical history included hydrocephalus, reported that, part of patient's disability is memory; from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified dates, the patient had a mini stroke, and also an injury with chronic pain, and experienced vitamin d deficiency. It was reported that, patient had predicament with health they automatically gave Medicare and patient did not provide the name of the medication they are seeking assistance with. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Chills, Cough, Drug ineffective
Clinical narrative: chills; coughing; tested positive for COVID; tested positive for COVID; tired; She did not feel good the second day; The arm hurt her a little bit; stomach ache; nauseous; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 71-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 28Jul2021 as dose 1, single for COVID-19 immunization. Medical history included knee pain; she takes a pain pill for her knees when they flare up, but she had not taken any because her knees were good. Concomitant medication(s) included vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin D NOS (VITAMIN D NOS), Multivitamin. It was reported that consumer on the phone calling to see when she is able to get second COVID vaccine. She was scheduled to get second one on 18Aug2021 but tested positive for COVID on 17Aug2021. She had antibody infusion on 21Aug2021. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. She had cortisone shots for her knees three months back. She is due for more but hasn't had them yet. They were due in Jul2021, but she didn't get them. Her Rheumatoid doctor wants to give her gel shots. She will gets one in each knee and then go back in one week and get one in each again. Caller doesn't know the name of the gel shot, it starts with an "N". They last for three or four months. She doesn't want to get knee replacement. She will switch back to cortisone after that. On 17Aug2021, he patient experienced tested positive for covid, chills, coughing, on 29Jul2021, the patient experienced tired, she did not feel good the second day, the arm hurt her a little bit, stomach ache, nauseous. Reported that she gets tired quickly. She didn't know she had it on the seventeenth. She was afraid to get Moderna. She heard you get more sick from the Moderna. The doctor that told her to take a Baby Aspirin every day for a month to keep the blood from clotting. She was not taking Baby Aspirin prior to getting COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021 as she took the home test, positive on 20Aug2021 as they did a test and confirmed it was positive. Therapeutic measures were taken as a result of tested positive for covid (covid-19), tested positive for covid (drug ineffective). The outcomes of events were unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: chills; coughing; tested positive for COVID; tested positive for COVID; tired; She did not feel good the second day; The arm hurt her a little bit; stomach ache; nauseous; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 71-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 28Jul2021 as dose 1, single for COVID-19 immunization. Medical history included knee pain; she takes a pain pill for her knees when they flare up, but she had not taken any because her knees were good. Concomitant medication(s) included vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin D NOS (VITAMIN D NOS), Multivitamin. It was reported that consumer on the phone calling to see when she is able to get second COVID vaccine. She was scheduled to get second one on 18Aug2021 but tested positive for COVID on 17Aug2021. She had antibody infusion on 21Aug2021. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. She had cortisone shots for her knees three months back. She is due for more but hasn't had them yet. They were due in Jul2021, but she didn't get them. Her Rheumatoid doctor wants to give her gel shots. She will gets one in each knee and then go back in one week and get one in each again. Caller doesn't know the name of the gel shot, it starts with an "N". They last for three or four months. She doesn't want to get knee replacement. She will switch back to cortisone after that. On 17Aug2021, he patient experienced tested positive for covid, chills, coughing, on 29Jul2021, the patient experienced tired, she did not feel good the second day, the arm hurt her a little bit, stomach ache, nauseous. Reported that she gets tired quickly. She didn't know she had it on the seventeenth. She was afraid to get Moderna. She heard you get more sick from the Moderna. The doctor that told her to take a Baby Aspirin every day for a month to keep the blood from clotting. She was not taking Baby Aspirin prior to getting COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Aug2021 as she took the home test, positive on 20Aug2021 as they did a test and confirmed it was positive. Therapeutic measures were taken as a result of tested positive for covid (covid-19), tested positive for covid (drug ineffective). The outcomes of events were unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Rash
Clinical narrative: fluttering heart; couldn't catch her breath for a second; rash that is still persisting; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 27Aug2021 13:00 (at the age of 49 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing diabetes and ongoing High Blood Pressure. Concomitant medications included glimepiride for diabetes, metformin for diabetes and amlodipine for High Blood Pressure; all ongoing. No other vaccinations was received within four weeks prior to the first administration date of the suspect vaccine. The patient received the first dose of the Pfizer vaccine and is due to have her second dose on Friday. She stated she has a rash on an unspecified date that is still persisting but was also aware that this was a potential adverse reaction to the vaccine. She stated she also had a "fluttering heart, a little" which she stated was weird. She could not explain it. It was like her heart would have a really "hard beat then she could not catch her breath for a second, like her heart got off track and then back on track". She stated that she would have seen her doctor if the side effects were severe. She did not go to the doctor regarding these concerns. She waited it out and eventually, it went away on the third day; although noted again that the rash persists. Her heart did that throughout the day for 2 to 3 days. She told herself on the third day if it doesn't go away, she'll go to the doctor but it went away. She would like to know if there is any guidance on getting her second shot after having experienced the side effects she experienced after the first dose. She stated that she had some friends pass away from COVID and that opened her eyes that she doesn't need to play around with the COVID virus and she just needs to get vaccinated. She also stated that none of her medications have ever given her a rash before. She states she is diabetic and does have high blood pressure. When asked for adverse events with other vaccines, she reported that she has not had any other vaccines since childhood and as far as she knows, she has never had any reactions. The events did not require visit to emergency room and physician office. The outcome of the event rash was not recovered while for the rest of the events was recovered on an unspecified date. The reporter assessed the events as non-serious.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriage; This is a spontaneous report from a Pfizer-sponsored program reported by a contactable consumer (patient's mother). A female patient unspecified age received BNT162B2 (COMIRNATY, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Reporter stated that both reporter and her husband received both doses of product. No side effects, "everything was good". Travelled to visit daughter, daughter experienced a miscarriage. Daughter did not receive product, or "anyone else". Her daughter is pregnant and had a misscarriage while the mom went to visit her daughter, after receiving the vaccine. She wants to know if the vaccine causes shedding. She has ben hearing different stories about that.   Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Eating disorder, Electrocardiogram, Oesophagitis
Clinical narrative: Chest pain, inability to eat food.; Chest pain, inability to eat food.; Very painful to drink any fluid; Inflammation of the esophagus, esophagitis,; Inflammation of the esophagus, esophagitis,; This is a spontaneous report from a contactable consumer. This 13-Year-old male contactable consumer reported for himself. A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3184), dose 1 via an unspecified route of administration, administered in Arm Right on 07Sep2021 16:00 (at the age of 13-years-old) as a single dose for covid-19 immunization. Medical history included covid-19. There were no concomitant medications. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Sep2021 16:00, the patient experienced chest pain, inability to eat food. Very painful to drink any fluid. Inflammation of the esophagus, esophagitis, hospitalization, ER, pediatric GI. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room /department or urgent care. The patient recevied treatment with ECG, chest X-Ray, ER monitoring, pediatric GI. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chest pain, inability to eat food.; Chest pain, inability to eat food.; Very painful to drink any fluid; Inflammation of the esophagus, esophagitis,; Inflammation of the esophagus, esophagitis,; This is a spontaneous report from a contactable consumer. This 13-Year-old male contactable consumer reported for himself. A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3184), dose 1 via an unspecified route of administration, administered in Arm Right on 07Sep2021 16:00 (at the age of 13-years-old) as a single dose for covid-19 immunization. Medical history included covid-19. There were no concomitant medications. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Sep2021 16:00, the patient experienced chest pain, inability to eat food. Very painful to drink any fluid. Inflammation of the esophagus, esophagitis, hospitalization, ER, pediatric GI. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room /department or urgent care. The patient recevied treatment with ECG, chest X-Ray, ER monitoring, pediatric GI. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: Symptoms of headache; This is a spontaneous report from a contactable physician.   A 42-years-old female patient received bnt162b2 (BNT162B2) at age of 42 years, dose 2 intramuscular on 05May2021 (Batch/Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation. Vaccination facility type :Other. Medical history included gastrooesophageal reflux disease Stable, vitamin d deficiency Unstable, blood cholesterol increased nstable , seasonal allergy stable, mineral supplementation. Concomitant medications included iron polysaccharide complex (FERREX) taken for mineral supplementation from 09Mar2021 to an unspecified stop date; colecalciferol (VIT D [COLECALCIFEROL]) taken for vitamin supplementation from 13Nov2020 to an unspecified stop date. The patient went to the emergency room on 10May2021with symptom of headache as was hospitalized with outcome of unknown. Treatment received: Alpha Lipoic Acid. The patient underwent lab tests and procedures which included on 15Jun2021 magnetic resonance imaging head: mild small vessel disease No mass and magnetic resonance imaging neck: cervical disc disease severe spinal stenosis. No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021798632 same patient and drug, different dose.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dizziness, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Chest pains; Dizziness; Slight cough; Some breathing difficulties.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient reported for himself that he received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ewo187), via an unspecified route of administration, administered in arm left on 31May2021 at 11:00 AM (age at vaccination was 68 years) as DOSE 1, SINGLE for covid-19 immunisation at pharmacy or drug store. The patient medical history and concomitant medications were not reported. No other vaccines were received within four weeks prior to the administration of bnt162b2. The patient received unspecified blood pressure medication within 2 weeks of vaccination. On 01Jun2021 at 12:00 PM, the next day of vaccination, the patient experienced chest pains, dizziness, slight cough and some breathing difficulties. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: results not reported on an unspecified date. No treatment was received for the events. The outcome of the events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: had a side effect; lower back pain just one side, the right side and the pain goes through my leg so just one side pain; pain in right lower back through her legs; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not sure if the first letter is a F or an E then C3180, so it is either FC3180 or EC3180; expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 30Aug2021 (at the age of 37-years-old) as dose 2, single for covid-19 immunization. The patient had no medical history and concomitant medications. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7487; expiration date: not reported) on 06Aug2021 (at the age of 37-years-old), via an unspecified route of administration, administered in Arm Left as dose 1, single for covid-19 immunization and had no side effects. The patient received second dose of BioNTech Covid-19 vaccine on 30Aug2021 and since that day she had a side effect. She says that the side effect was pain in her right lower back that goes through her legs. Then got worse over the 3rd and 4th days until now when it comes and goes. Tylenol and Motrin were taken as therapeutic measures for all the events. Caller says she had been trying to get over the counter Motrin and Tylenol, but the pain was not going away, the pain was sometimes better and sometimes not. She says that she took both of them together sometimes, the Motrin and the Tylenol. She says for the Tylenol, those were 500mg each. Tylenol Exp: Aug2024, Lot: SLA081. She says for this medication she sometimes took two to three times a day, it depends. She says for the Motrin she thinks those were 400mg each. She says she took this one sometimes twice or once a day, depending on the pain, if it was moderate or severe pain. Consumer stated, she got the vaccine the second dose two weeks ago and still have some lower back pain just one side, the right side and the pain goes through her leg so just one side pain. Her pain had not gone away, it was not worse, it was mild and was still there. Caller says she was not sure if this was a common side effect or if it has happened to anyone else. She says it started the day of getting the second dose of the vaccine, it was mild and not that severe, then got worse than the first couple days, and she started taking the medications which slowed down the pain. Caller says she would like to know if this could be a common side effect, a way to know if it was from the vaccine, or if anyone else has reported it and how long it may last. Outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Extra dose administered, Malaise, Off label use
Clinical narrative: Patient reports that she got her 3rd covid vaccine on Thurs 09Sep2021; Patient reports that she got her 3rd covid vaccine on Thurs 09Sep2021; has not been feeling well since; diarrhea; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Sep2021 (at the age of 56-year-old) as dose 3, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included tofacitinib citrate (XELJANZ XR) taken for an unspecified indication from 01May2020 to 13Sep2021. Patient previously took two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 56-year-old) as dose 1 and dose 2, single for covid-19 immunisation. On 09Sep2021, the patient experienced patient reports that she got her 3rd covid vaccine on Thursday. On an unspecified date in Sep2021, patient experienced has not been feeling well since, diarrhea. Patient believed she was not feeling well due to covid vaccine and not missed doses of Xeljanz. Discussed missed doses and returning to regular dosing schedule. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure was taken before I had it was fine it was normal and now ever since I have taken it, ever since I have it is been high; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration on 13Sep2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's blood pressure was taken before patient had it was fine it was normal and then ever since patient had taken it, ever since patient had it had been high in Sep2021. Patient just got the vaccine yesterday, the Pfizer vaccine. The patient underwent lab test and procedure of blood pressure measurement, and it was fine on unspecified date, and it was high on unspecified date in Sep2021. The outcome of event was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: throwing up; headaches are so bad; so much pain; chest hurts; burning sensations throughout her body; arm, chest, head are on fire; can't eat, can't do anything, and can't move; does not feel good; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route of administration on 14Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not feel good, had chest hurts, burning sensations throughout the body, arm, chest and head are on fire, can't eat, can't do anything, and can't move, headaches are so bad on an unknown date in Sep2021 and throwing up on 14Sep2021. Consumer was in a hurry because she was in so much pain, and she wanted to know what she should do about the side effects that she is experiencing. The clinical outcome for throwing up was not recovered and outcome for the other events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin burning sensation, Vomiting
Clinical narrative: throwing up; headaches are so bad; so much pain; chest hurts; burning sensations throughout her body; arm, chest, head are on fire; can't eat, can't do anything, and can't move; does not feel good; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route of administration on 14Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not feel good, had chest hurts, burning sensations throughout the body, arm, chest and head are on fire, can't eat, can't do anything, and can't move, headaches are so bad on an unknown date in Sep2021 and throwing up on 14Sep2021. Consumer was in a hurry because she was in so much pain, and she wanted to know what she should do about the side effects that she is experiencing. The clinical outcome for throwing up was not recovered and outcome for the other events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: it's not just pain; still has swelling in her arm--like a knot; like a knot/it's not just pain, it's a knot and it looks like it's gotten bigger over the day, I couldn't lift my arm because it was so swollen. It's going from my arm to my breast area; This is a spontaneous report from a contactable consumer(patient) via Medical Information Team. A 36-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Expiry Date, NDC number: not provided), dose 1 via an unspecified route of administration on 12Sep2021 at around 12pm (Sunday) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and other products were not provided. The patient stated, on an unspecified date of 2021, she still has swelling in her arm-like a knot, it was not just pain, it was a knot and it looks like it was gotten bigger over the day, she could not lift my arm because it was so swollen, it was going from her arm to breast area and asked was this normal. The patient further stated that her arm was still swollen really really big, and she asked if it was normal for arm to be swollen and a knot on her arm was supposed to be this big. The patient took (treatment) Tylenol and Motrin for events. The outcome of events was not recovered.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: went sick/got sick again; This is a spontaneous report from a contactable pharmacist (patient) received via a Pfizer-sponsored program.  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Patient said she received both doses of BNT162B2 in Jan2021. In Jun2021, she went sick, but tested negative for COVID-19. She had an antibody test, and it came out positive for IgG. Then, she got sick again and tested negative for COVID-19. This time, when she got tested in Sep2021 for antibodies, it came out negative. Patient wanted to know if that meaned she didn't have antibodies to protect her. She wanted to know how to calculate antibodies. Event was reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive in Jun2021, COVID-19 antibody test: negative in Sep2021, COVID-19 test: negative in Jun2021, COVID-19 test: negative in Sep2021.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Endocarditis
Clinical narrative: infectious endocarditis; cardiac symptoms; This is a spontaneous report received from a contactable Pharmacist reported for a female patient.  A female patient of late 50's-early 60's received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) received via unspecified route of administration on 30Dec2020 as dose 1, single for covid-19 immunization and bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) received via unspecified route of administration on 20Jan2021 as dose 2, single for covid-19 immunization. Patient medical history included heavy smoker and she had a pericardial window placed in her heart. It was reported that patient experienced cardiac symptoms approximately 2 months following the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine. Patient was hospitalized due to events caused and she was admitted to the ICU and placed on a ventilator. Patient had a pericardial window placed in her heart and she received antibiotics at one point during her care and for what they thought could be an infectious Endocarditis, but no organism grew on culture. Treatment received for the events caused. Event took place after use of product. Outcome of the events was unknown.  The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow-up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Broke out in shingles; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received first dose of bnt162b2 (bnt162b2, PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: FC3180, expiry date: unknown), via an unspecified route of administration on 26Aug2021 as DOSE 1, SINGLE for covid-19 immunisation (age at the time of vaccination was 36 years). The patient's medical history and concomitant medications was not reported. The patient experienced broke out of shingles on 09Sep2021. It was reported that the patient called to report an adverse reaction for that she went to emergency room. She got this shot on 26th and then on Saturday, she broke out in shingles but did not know where those came from at that time, so she had to go to an emergency doctor's appointment to see what was going on, from where she got the shingles. The treatment received was valtrex 500 mg every 8 hours. The clinical outcome of the event was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Colleague is now COVID positive and ill with cold symptoms, fever, aches, cough, headache; Colleague is now COVID positive and ill with cold symptoms, fever, aches, cough, headache; This is a spontaneous report from a contactable Other Health Professional. A 30-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular on 04Feb2021 (at the age of 29-year-old) (Batch/Lot Number: EL3247) as DOSE 1, SINGLE, dose 2 intramuscular on 25Feb2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. It was unknown if the patient was pregnant at time of vaccination. The patient underwent lab tests and procedures which included COVID 19 test: positive on 12Sep2021. The patient was covid positive and ill with cold symptoms, fever, aches, cough, headache (vaccination failure and covid-19) (medically significant) on 15Sep2021. It was unknown if patient received treatment for events. Outcome of events were not recovered.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Yesterday the patient tested positive using a rapid/"instant" test for COVID-19 as well as again today using an "instant" test resulting as positive.; Yesterday the patient tested positive using a rapid/"instant" test for COVID-19 as well as again today using an "instant" test resulting as positive.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer(patient) reported that a 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection) via an unspecified route of administration (batch number/lot number: FC3182), in left arm on 30Aug2021 12:00 PM (at the age of 69-years-old) as dose 3, single, via an unspecified route of administration (batch number/lot number: EL9262), in left arm on 02Feb2021 12:00 PM (at the age of 68-years-old) as dose 2, single and via an unspecified route of administration (batch number/lot number: EH9859), in left arm on 12Jan2021 12:00 PM (at the age of 68-years-old) as dose 1, single and all for covid-19 immunization . Medical history included ongoing high cholesterol from ten years. Ongoing concomitant medication included rosuvastatin for high cholesterol from ten years. The patient received his 1st dose of the Pfizer COVID vaccine on 12Jan2021, 2nd dose 02Feb2021, & 3rd dose received on 30Aug2021. On 15Sep2021 the patient tested positive using a rapid/"instant" test for COVID-19 as well as again on 16Sep2021 using an "instant" test resulting as positive. The patient was waiting on the PCR testing results. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Sep2021 and sars-cov-2 test: positive on 16Sep2021. The outcome of the events was unknown.