chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Migraine, Panic attack, Psychotic disorder, SARS-CoV-2 test
Clinical narrative: Migraines; brain fog; Panic attacks; Psychosis; This is a spontaneous report from a contactable consumer, the patient. This 26-year-old male patient reported that he received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0182 59267-1000-01) via an unspecified route in the right arm on 05May2021 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to apples. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 06May2021, the patient experienced migraines, brain fog, panic attacks, and psychosis; all serious for hospitalization. Patient was hospitalized for 5 days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of the events migraines, brain fog, panic attacks, and psychosis was not recovered. Since the vaccination, patient has been tested for COVID-19, result was unknown.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Ear swelling, Pruritus, Urticaria
Clinical narrative: She is itching all over and it's bad itching.; Started to break out in hives all over her body/ Hives was reported as worsened; Ear was puffy and itchy; Ear was puffy and itchy; This is a spontaneous report from a contactable consumer (patient grandmother). A 13-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left upper arm on 27May2021 12:30 (Batch/Lot Number: EW0182) as single dose for covid-19 immunisation at the age of 13-year-old. Medical history ongoing depression. Concomitant medications included dimenhydrinate (DRAMAMINE) taken for an unspecified indication from an unspecified start date to 23May2021; fluoxetine (FLUOXETINE) taken as antidepressant therapy from an unspecified start date and ongoing. Her mom says she takes allergy pills Benadryl, clarified to be the CVS Allergy relief brand (Lot# P123696, Exp date: Jan2024). The consumer reported her granddaughter received the COVID Vaccine yesterday at 12: 30. Last night her granddaughter started to break out in hives all over her body. It is on her arms, legs, belly, back, all over. She came in her room last night saying her ear was puffy and itchy. Her granddaughter is itching all over and it's bad itching. she applied Hydrocortisone Cream to the spots to help the itching and the itching is better. The hives have gotten worse. She mentioned she has recently done her grand-daughters laundry and washed her bedding/clothing in Tide. Caller contacted the patients mom and found out she normally does not use Tide. Therefore, she does not know if its from the shot itself or the change that occurred with the use of Tide. The outcome of itching all over was recovering. Outcome of other events was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), intramuscular, administered in the right arm on 16Mar2021 15:00 (at the age of 79 years old) as second dose at a single dose for COVID-19 immunization. Medical history included Essential thrombocythaemia from 2013 and ongoing, ongoing Acid reflux (esophageal) which was diagnosed at least 10 years ago. No other vaccinations was given within four weeks prior to the first administration date of the suspect vaccine. Concomitant medications included hydroxycarbamide (HYDREA) for Essential thrombocythaemia from 2013 and ongoing; ongoing omeprazole (PROTONIX) for Acid reflux (esophageal). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) intramuscular in the right arm on 23Feb2021 (at the age of 79 years old) for COVID-19 immunization. The patient experienced extreme heart palpitations on 16May2021 23:00. The patient reported that she wanted to call and report an adverse event with the COVID-19 vaccine. When she used the website, it was not working correctly. When she get 95 percent done, it would not accept. She would hit submit and it would not do anything and the email would show up in red. She said that it was the second vaccine. She experienced extreme heart palpitations. She had the vaccine at 3pm and the heart palpitations started that night around 11 and continued for hours. She almost went to the ER. She said that it continued for a good week and into the second week. In the meantime, she had a surgery. She noticed the heart palpitations a little bit then. She said that she is still having it now. She is on medication for it now to try and take care of it and it has only been 3 days though. No further details provided about the surgery. She never had any heart palpitations. She stated that the heart palpitations have subsided and when she has them they are pounding palpitations, but they do not last as long. This was the only thing that happened to her. It was all after the second vaccine. She had no other side effects. Treatment was metoprolol tartrate 25 mg 1/2, twice daily and it has not helped so far. The event required a visit to phyisician office for which they gave her a halter monitor about a month ago on 10May2021. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Illness, Loss of consciousness, Nausea
Clinical narrative: Passed out in the shower; knock himself out; He is sick; Cannot even get up; Nausea; This is a spontaneous report from a contactable consumer (parent).   A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced passed out in the shower (medically significant), knock himself out, he is sick, cannot even get up, and nausea; all on an unspecified date.  Reporter stated, My son went to the doctor yesterday to get the COVID vaccine. Today he is sick, he passed out in shower, he cannot even get up, and he is sick, nausea. The outcome of all the events was unknown.   Information on the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: severe chest pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0179, expiration date unknown) via an unspecified route of administration in the arm left on 28May2021 at 11:45 AM at age of 16-year-old at single dose for COVID-19 immunization. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0171, expiration date unknown) via an unspecified route of administration in the left arm on 07May2021 at 02:30 PM at age of 16-year-old for COVID-19 immunisation. Patient had no known allergies. Medical history and concomitant medications were not reported. On the night of day 1 into day 2 following the second vaccine, patient woke up with severe chest pain and shortness of breath that lingered for hours after onset. Events onset date was reported as 30May2021 at 02:00 AM. Events didn't result in emergency room visit or physician office visit. Outcome of the events was recovering. No treatment received for the events. Patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination.  Follow up needed, further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic, Blood pressure systolic increased, Discomfort, Disorientation, Dizziness
Clinical narrative: systolic blood pressure went up during the first 24 hours./Went up to 154; lightheaded; disoriented; Mild injection site soreness; did not feel comfortable driving for two days; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on an unspecified date at age of 67-year-old at single dose, unknown dose number for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included gastrooesophageal reflux disease (GERD), high blood pressure, obesity and fatty liver. Concomitant medication was none. Patient felt lightheaded and disoriented for three days. Worse after first 24 hours. Patient did not feel comfortable driving for two days. Patient's systolic blood pressure went up during the first 24 hours, which was usually in 120-130 range with medication but went up to 154. Patient had mild injection site soreness for two days. Onset date of event "did not feel comfortable driving" was unknown, of the other events was reported as 26May2021. Outcome of event systolic blood pressure went up was recovered in May2021, of lightheaded was recovered on 29May2021, of disoriented was recovered on 29May2021, of injection site soreness was recovered on 28May2021, of did not feel comfortable driving was unknown. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: systolic blood pressure went up during the first 24 hours./Went up to 154; lightheaded; disoriented; Mild injection site soreness; did not feel comfortable driving for two days; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on an unspecified date at age of 67-year-old at single dose, unknown dose number for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included gastrooesophageal reflux disease (GERD), high blood pressure, obesity and fatty liver. Concomitant medication was none. Patient felt lightheaded and disoriented for three days. Worse after first 24 hours. Patient did not feel comfortable driving for two days. Patient's systolic blood pressure went up during the first 24 hours, which was usually in 120-130 range with medication but went up to 154. Patient had mild injection site soreness for two days. Onset date of event "did not feel comfortable driving" was unknown, of the other events was reported as 26May2021. Outcome of event systolic blood pressure went up was recovered in May2021, of lightheaded was recovered on 29May2021, of disoriented was recovered on 29May2021, of injection site soreness was recovered on 28May2021, of did not feel comfortable driving was unknown. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: psoriasis seems to be healing and clearing up; This is a spontaneous report received from a contactable consumer (patient) via Pfizer's Corporate.  A patient of unspecified age and gender started to receive bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received the COVID-19 vaccine and psoriasis seems to be healing and clearing up. Patient had it on every part of my body and thought it might help in research. Not sure if it's a cure or a medicine. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Swollen lymph nodes; Chills; Soreness at injection site; This is a spontaneous report from Non-Contactable consumer(patient).A 44-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EW10161), via an unspecified route of administration in right arm on 28May2021 at 16:15 as a single dose for COVID-19 immunisation at doctor office.  Medical history included Acid Reflux and COVID-19 from an unknown date. Concomitant medication(s) included omeprazole taken for an unspecified indication, start and stop date were not reported and elderberry taken for an unspecified indication, start and stop date were not reported.  The patient previously took Erythromycin, flu vaccine, flexeral and experienced allergy. On 29May2021, patient experienced swollen lymph nodes, chills, soreness at injection site. No treatment drug was given for the event. Patient was not hospitalized for the events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Apr2021.Since the vaccination, the patient had not been tested for COVID-19. The reporter assessed the event as non serious. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Nausea, Vomiting
Clinical narrative: he/she can't smell anything, he/she had no taste buds; he/she can't smell anything, he/she had no taste buds; he/she felt nauseating from time to time; he/she felt nauseating after he/she ate like he/she wanted to throw up but he/she didn't he/she meant he/she did throw up twice; really tired; throw up twice; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 via an unspecified route of administration on 17May2021 (Batch/Lot number was not reported) as 2nd dose single dose for covid-19 immunization. Historic vaccine was bnt162b2 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as 1st dose single dose for covid-19 immunization. Concomitant medications were not reported. The patient had shot (Unspecified vaccine) on 17th of this month (17May2021) and it had been 2 weeks and on May2021 he/she can't smell anything, he/she had no taste buds, he/she felt nauseating from time to time and he/she was really tired and rested and he/she thought he/she was as far as he/she was going to the bathroom he/she was ok with that, it was that several time he/she felt nauseated at the as he/she can't, he/she can't taste what he/she was eating and the fact that he/she felt like. he/she felt like pretty much during the day he/she felt nauseating after he/she ate like he/she wanted to throw up but he/she don't he/she meant he/she did throw up twice but that was he/she did it twice but he/she did not know if that had anything to do with the vaccine. he/she did have can't smell anything and it had been over 2 weeks and it was really getting weird because he/she got feel healthy but he/she felt tired of that too. He/she was wondering if we heard of anyone with the same deal like sometimes people's body react to it to vaccine little bit different and he/she did have one question he/she was a road truck driver and he/she was supposed to take his/her shot on the 11 (11May2021)which was would have been 21 days after he/she had his/her first one but he/she got it 30 days after he/she got his/her first shot was that still good or did he/she wait too long. The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: his bottom lip started to swell up very bad; This is a spontaneous report received from a contactable consumer(patient). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm at the age of 22-year-old on 28May2021 17:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history was none. There was no known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. About two days (30May2021 12:00) after the vaccine dose his bottom lip started to swell up very bad. The swelling went down after using ice and he was currently monitoring if any additional swelling occurs in his lips and throat area.  Treatment received for the event included diphenhydramine hydrochloride (Benadryl). The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint stiffness, Neck pain, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 40-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0185 and Expiration date was un-known), via unknown route of administration, in left arm on 16May2021 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. The concomitant medications included Ibuprofen for neck pain. The patient also received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171 and Expiration date was unknown), via unknown route of administration in left arm on 25Apr2021 at 14:00, as a single dose for COVID-19 immunisation and experienced a headache and Neck stiffness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. The patient received within 2 weeks of vaccination was Ibuprofen for the neck pain from the vaccine. The vaccine received within 4 weeks PRIOR was Pfizer (dose 1) Left Arm. The patient neck stiffened up and it was difficult to move it. She couldn't check her blind spot when driving she had to turn her shoulders to turn her neck. Sometimes it caused terrible headaches at the base of her neck. This occurred a few days after 1st dose lasted 2 1/2 weeks. She was excited it was going away. She took ibuprofen for it and do not take medications regularly, the last time was after she had a child 6 years ago. She went for her 2nd dose not thinking the vaccine caused it. The pain came back a day later it was severe she wore a heat pad on her neck. The severe pain took 4 days to go away sometimes it would cause terrible headaches and cause my throat to be sore sometimes the neck pain hindered her jaw and she couldn't easily open it all the way. This lasted 3 days after the severe neck pain went away. She still has dull neck pain and it is sore to turn my head but it is nothing like before. She can turn it rather than having to turn her shoulders to look different directions. This has been 4 weeks of pain. Treatment Chiropractic care was received for neck pain. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lip swelling, Malaise, Pain, Peripheral swelling
Clinical narrative: right hand swelled up around the size(twice the size of his normal hand would be); Scrotum was swollen; Bottom lips swelled; Normal flu like symptoms; He was sore; Didn't feel well; This is a spontaneous report from a contactable nurse (patient's mother). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscularly, administered in left arm at the age of 18-year-old on 24May2021(around 1 PM) (Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscularly, administered in left arm at the age of 18-year-old on 03May2021(around 1 PM) (Lot Number: ER8737) as single dose for covid-19 immunization. The patient hadn't taken any vaccine 4 weeks prior to the COVID 19 Vaccine. There was no family history relevant to the adverse event. Nurse stated her son had the normal flu like symptoms afterwards when he was sore and didn't feel well in May2021. A day later(in May2021) his bottom lips swelled just his bottom lips there was no oropharyngeal response on the side of the lips. He took Benadryl and about 8 to 12 hours later it went down. On Thursday(27May2021), his right hand swelled up around the size, she meant twice the size of his normal hand would be, that also lasted around 12 hours or so. Today(in May2021) he called her from work and his scrotum was swollen. And she was trying to find out if this was a normal,  she was a nurse working in an emergency department and this was not a normal response in anyone else that she had heard of who had gotten the vaccine but she wanted to call to see if this was something maybe somebody else has experienced, or one of the doctor, one of the doctor that she work with prescribed a Medrol dose pack for him just in case.  The outcome of the event 'bottom lips swelled was recovering, of the event right hand swelled up around the size(twice the size of his normal hand would be) was recovered in May2021, of the other events was unknown.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Scrotal swelling
Clinical narrative: right hand swelled up around the size(twice the size of his normal hand would be); Scrotum was swollen; Bottom lips swelled; Normal flu like symptoms; He was sore; Didn't feel well; This is a spontaneous report from a contactable nurse (patient's mother). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscularly, administered in left arm at the age of 18-year-old on 24May2021(around 1 PM) (Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscularly, administered in left arm at the age of 18-year-old on 03May2021(around 1 PM) (Lot Number: ER8737) as single dose for covid-19 immunization. The patient hadn't taken any vaccine 4 weeks prior to the COVID 19 Vaccine. There was no family history relevant to the adverse event. Nurse stated her son had the normal flu like symptoms afterwards when he was sore and didn't feel well in May2021. A day later(in May2021) his bottom lips swelled just his bottom lips there was no oropharyngeal response on the side of the lips. He took Benadryl and about 8 to 12 hours later it went down. On Thursday(27May2021), his right hand swelled up around the size, she meant twice the size of his normal hand would be, that also lasted around 12 hours or so. Today(in May2021) he called her from work and his scrotum was swollen. And she was trying to find out if this was a normal,  she was a nurse working in an emergency department and this was not a normal response in anyone else that she had heard of who had gotten the vaccine but she wanted to call to see if this was something maybe somebody else has experienced, or one of the doctor, one of the doctor that she work with prescribed a Medrol dose pack for him just in case.  The outcome of the event 'bottom lips swelled was recovering, of the event right hand swelled up around the size(twice the size of his normal hand would be) was recovered in May2021, of the other events was unknown.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Approximately 48 hours after shot hives appeared on arms. The next day they were larger and are on neck, arms, torso, and legs.; This is a spontaneous report received from a contactable consumer (patient). A 14-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COIVD-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in arm left on 27May2021 at 13:15 (at the age of 14-year-old) as single dose for COVID-19 immunisation. Medical history included Wolf Parkinson White syndrome, ADHD, ODD, mold allergy, pollen allergy and pet dander allergy. Concomitant medications included atomoxetine hydrochloride (STRATTERA), fluoxetine, montelukast and hydroxyzine. Patient was not diagnosed with COVID prior to vaccination and was not tested for COVID since the vaccination. On 29May2021, approximately 48 hours after shot hives appeared on arms, the next day they were larger and are on neck, arms, torso, and legs. Patient did not receive any treatment for the adverse event. The outcome of the event was resolving.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Muscular weakness, Product use issue
Clinical narrative: the patient stated that she could barely lift her arm past her shoulder; Her arm just drops down and she couldn't control it; The patient had other vaccine on the same date when the second dose was administered; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 27May2021 10:00 (at the age of 57 years old) as second dose, single dose for COVID-19 immunisation in the pharmacy. Medical history included high blood pressure and depression. The patient has no known allergies. Concomitant medications included venlafaxine, amlodipine, trazodone, and bupropion. The patient previously received first dose of BNT162B2, administered in the left arm, on 06May2021, at 11:00. The patient had other vaccine on the same date when the second dose was administered. No other vaccine was received within four weeks before vaccination. On 27May2021 at 10:00 (also reported as three days after the second dose), the patient stated that she could barely lift her arm past her shoulder. Her arm just drops down and she couldn't control it. The patient had no COVID prior vaccination and was not COVID tested since vaccination. The patient has not recovered from the events.  Information about lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Musculoskeletal disorder, Sensory loss
Clinical narrative: I had no muscles in my fingers in my right hand; I have no muscles in my fingers/ I have trouble with my hand; I cannot feel anything in my fingers; I can't push anything back/ have no strength in my fingers; My whole hand was numb; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 30May2021 13:00 (Batch/Lot number was not reported) as first dose, single dose at the age of 66-years-old for COVID-19 immunization. Medical history enlarged heart, "fibro" (as reported) in chest and arthritis in the patient's right side of hip and it goes to the patient's arm. The patient's mother has arthritis, not in the hand, in the hip like the patient but not in the hand. Concomitant medications included carvedilol, prazosin and benazepril; all taken for an unspecified indication, start and stop date were not reported.  Patient reported that on the questionnaire, he didn't have his glasses and he thought it was all, usually at the doctor's office, asking about allergies and he don't have no allergies, so he put "No", but he forgot to tell them that he has arthritis in right side of his hip and it goes to his arm so he had them give him the shot on his left arm and he knew this, when he tried to put the chain on his dog (the walker), the patient couldn't push the button to get the chain on the hook. The patient has no feelings in his fingers. So he was wondering if that's a side effect from the BNT162B2. The patient had no strength in his fingers. The patient further stated that he has no muscles in his fingers ("clarification unknown" as reported). He had no strength in his fingers. The patient never had trouble with his hand before but after this shot he have trouble with his hand now on the right side only. Saturday night when he tried to walk the dog. He couldn't get the chain on the collar. Patient stated "I had no muscles in my fingers in my right hand. I have no muscles in my fingers I can't push anything back." The patient also stated , "I have a side effect from the shot. I cannot feel anything in my fingers. Like when I push the button downside I cannot feel it.". The patient's whole hand was numb. No treatment received or administered for the events reported.  The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pruritus
Clinical narrative: I have red itchy spots that are raised on the back of my calf; I have red itchy spots that are raised on the back of my calf; I have red itchy spots that are raised on the back of my calf; This is a spontaneous report from a contactable consumer (patient).  An unspecified age and gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unknown date as 2nd dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an 07May2021 as 1st dose, single dose for COVID-19 immunisation and experienced nausea, had no appetite, little bit tired, little red welt, started developing little red welt or greyish circular spot-on patient neck and on the back of patient calf on patient right leg, it was very itchy and red and grey. It was reported that the patient went on last Friday to have second vaccination done and it was the same as the first dose has now (at the time of reporting) worst, Patient had red itchy spots that are raised on the back of the calf and did not know what to do about it, patient did not know what to put on it and need somebody to tell what to put on it. The reporter did not specify the seriousness. The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: extremely long periods; This is a spontaneous report from a contactable consumer (patient).  This non-pregnant 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18May2021 at 12:00 (Lot number ER8731) as single dose for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. No other vaccine in four weeks and no other medications in two weeks. The patient reported that her menstrual cycle was completely off, she normally was right on time and had not been. The patient was experiencing extremely long periods that are resulting in large clots. The event onset date was reported on "08Apr2021 at 12:00". The events did not result in emergency room visit and physician office visit. It was unknown if patient received treatment or not. The outcome of the events was not resolved.  COVID was not tested post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Neck mass, Swelling
Clinical narrative: after 4 weeks still have lump on neck; next morning swelling and redness was in neck.; next morning swelling and redness was in neck.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 10:00 (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. Patient age at vaccination was 48 years old. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included other medications within 2 weeks of vaccination. The patient previously took fluconazole (DIFLUCAN) and experienced allergy. Historical vaccine included 1st dose of BNT162B2 (lot number=ER8733) on 01Apr2021 in left arm for COVID-19 immunization at age of 48 years old. After 6 hours (29Apr2021 16:00)- left side of face was hot, swelled and numb feeling. Next morning (30Apr2021), swelling and redness was in neck. After 4 weeks, patient still had lump on neck. The events resulted in emergency room visit. Patient received treatment for the events included diphenhydramine hydrochloride (BENADRYL) and steroids. The events were not resolved at the time of reporting.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: after 4 weeks still have lump on neck; next morning swelling and redness was in neck.; next morning swelling and redness was in neck.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 10:00 (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. Patient age at vaccination was 48 years old. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included other medications within 2 weeks of vaccination. The patient previously took fluconazole (DIFLUCAN) and experienced allergy. Historical vaccine included 1st dose of BNT162B2 (lot number=ER8733) on 01Apr2021 in left arm for COVID-19 immunization at age of 48 years old. After 6 hours (29Apr2021 16:00)- left side of face was hot, swelled and numb feeling. Next morning (30Apr2021), swelling and redness was in neck. After 4 weeks, patient still had lump on neck. The events resulted in emergency room visit. Patient received treatment for the events included diphenhydramine hydrochloride (BENADRYL) and steroids. The events were not resolved at the time of reporting.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysgeusia, Eating disorder, Retching, SARS-CoV-2 test
Clinical narrative: Initially the sensation was mild but intensified 2 days later; Intense smell and taste of chlorine bleach/metallic taste in mouth and nose that started the day of the vaccine (5/27/21).; This side effect has prevent me from eating food or drinking liquids as the smell and taste results in gagging and repulsion/difficult to eat or drink.; This side effect has prevent me from eating food or drinking liquids as the smell and taste results in gagging and repulsion.; This is a spontaneous report from a contactable other Healthcare Professional (patient) reported for herself. A 54-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0169, Expiry Date: unknown) intramuscular, administered in left arm on 27May2021 at 09:00 am (age at vaccination was 54 years) as 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had known allergies to chlorine bleach and mayonnaise. The patient did not receive any concomitant medications or any other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 27May2021 at 15:00 pm, the patient had an intense smell and taste of chlorine bleach/metallic taste in mouth and nose that started the day of the vaccine. Initially the sensation was mild but intensified 2 days later (30May2021) and was still intense and present that day (on 01Jun21). She had continuous metallic taste and smell since day of vaccine. Nine days after the vaccine the metallic taste and smell persisted with the same intensity. That side effect had prevented her from eating food or drinking liquids as the smell and taste resulted in gagging and repulsion. It was difficult to eat or drink as the intense taste and smell resulted in a gagging reflex. The patient received smell training therapy for the adverse event. The device date was reported as 05Jun2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.  Follow up (05Jun2021): New information received from a contactable other Healthcare Professional (patient) reported for himself included: Updated the clinical course, adverse event start time (from 18:00 to 15:00 pm) and device date (from 01Jun2021 to 05Jun2021).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: dizziness so bad he almost fainted; a very bad headache; shortness of breath; coughing; dizziness so bad he almost fainted; elevated heartbeat; he could not eat; had watery eyes; sneezes; His triceps (in the left arm) would shake a lot/shaking on the muscles if his face; general weakness; that this situation is very scary; This is a spontaneous report from a contactable consumer (patient). A male 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. The patient's medical history and concomitant medications were not reported.  Caller wants to know if the side effects that he is presenting with the first dose of the Pfizer COVID-19 vaccine, two weeks after he received the first dose he started to develop: a very bad headache, shortness of breath, coughing, dizziness so bad he almost fainted, elevated heartbeat (specially at night), these side effects were so bad that he could not eat at all, he also had watery eyes, sneezes, his triceps (on the left arm) would shake a lot, general weakness, shaking on the muscles if his face, he stated that he never had these type of problems before the vaccination and that this situation is very scary. Caller stated that her sister called Pfizer and his information was captured by a nurse, during the call he was contacted back by (Name) and accepted to get contacted by them in the future.  Response: Per fact sheet: what are the risks of Pfizer- Biontech covid-19 vaccine? There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. Signs of a severe allergic reaction can include:  Difficulty breathing, swelling of your face and throat, a fast heartbeat, a bad rash all over your body, dizziness and weakness. Refer to his physician for treatment recommendations. The patient underwent lab tests and procedures which included heart rate: elevated on unknown date. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fear, Headache, Heart rate, Heart rate increased, Lacrimation increased
Clinical narrative: dizziness so bad he almost fainted; a very bad headache; shortness of breath; coughing; dizziness so bad he almost fainted; elevated heartbeat; he could not eat; had watery eyes; sneezes; His triceps (in the left arm) would shake a lot/shaking on the muscles if his face; general weakness; that this situation is very scary; This is a spontaneous report from a contactable consumer (patient). A male 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. The patient's medical history and concomitant medications were not reported.  Caller wants to know if the side effects that he is presenting with the first dose of the Pfizer COVID-19 vaccine, two weeks after he received the first dose he started to develop: a very bad headache, shortness of breath, coughing, dizziness so bad he almost fainted, elevated heartbeat (specially at night), these side effects were so bad that he could not eat at all, he also had watery eyes, sneezes, his triceps (on the left arm) would shake a lot, general weakness, shaking on the muscles if his face, he stated that he never had these type of problems before the vaccination and that this situation is very scary. Caller stated that her sister called Pfizer and his information was captured by a nurse, during the call he was contacted back by (Name) and accepted to get contacted by them in the future.  Response: Per fact sheet: what are the risks of Pfizer- Biontech covid-19 vaccine? There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. Signs of a severe allergic reaction can include:  Difficulty breathing, swelling of your face and throat, a fast heartbeat, a bad rash all over your body, dizziness and weakness. Refer to his physician for treatment recommendations. The patient underwent lab tests and procedures which included heart rate: elevated on unknown date. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Sneezing, Tremor
Clinical narrative: dizziness so bad he almost fainted; a very bad headache; shortness of breath; coughing; dizziness so bad he almost fainted; elevated heartbeat; he could not eat; had watery eyes; sneezes; His triceps (in the left arm) would shake a lot/shaking on the muscles if his face; general weakness; that this situation is very scary; This is a spontaneous report from a contactable consumer (patient). A male 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. The patient's medical history and concomitant medications were not reported.  Caller wants to know if the side effects that he is presenting with the first dose of the Pfizer COVID-19 vaccine, two weeks after he received the first dose he started to develop: a very bad headache, shortness of breath, coughing, dizziness so bad he almost fainted, elevated heartbeat (specially at night), these side effects were so bad that he could not eat at all, he also had watery eyes, sneezes, his triceps (on the left arm) would shake a lot, general weakness, shaking on the muscles if his face, he stated that he never had these type of problems before the vaccination and that this situation is very scary. Caller stated that her sister called Pfizer and his information was captured by a nurse, during the call he was contacted back by (Name) and accepted to get contacted by them in the future.  Response: Per fact sheet: what are the risks of Pfizer- Biontech covid-19 vaccine? There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. Signs of a severe allergic reaction can include:  Difficulty breathing, swelling of your face and throat, a fast heartbeat, a bad rash all over your body, dizziness and weakness. Refer to his physician for treatment recommendations. The patient underwent lab tests and procedures which included heart rate: elevated on unknown date. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Ischemic stroke; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:30 (at age of 73 years old)(Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included low grade prostate cancer, No known allergies, The patient was diagnosed with COVID-19 prior to vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left on 23Feb2021 13:30 (at age of 73 years old) (Lot Number: en6201) as single dose for covid-19 immunisation. The patient's concomitant medications received within 2 weeks of vaccination was No.  The patient experienced ischemic stroke on 02May2021 06:00 with outcome of recovering. The event resulted in Emergency room/department or urgent care. The patient was hospitalized for ischemic stroke from May2021 to May2021(reported as 4 days).  Medication received as treatment for event. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts possible. No further information expected.