chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I have severe joint pain in hands andankles; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 08Jan2021 (at the age of 47-year-old) as DOSE 2, SINGLE for covid-19 immunization in hospital. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID) and omeprazole. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EK5730, expiration date: not reported), via intramuscular, on Left arm, on 18Dec2021 (at the age of 47-year-old) as DOSE 1, SINGLE for covid-19 immunization in Hospital.  The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 17Jan2021, after second dose, the patient had severe joint pain in hands and ankles to the point where patient can't open a jar without pain and cannot exercise because of ankle. The patient further reported that she never had joint pain as she was only 47 yrs. old. It was reported that events result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. The outcome of the event was not recovered at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Defaecation urgency, Dysgeusia, Dyspnoea, Flushing, Heart rate
Clinical narrative: I felt as if i needed to poop; rapid heartrate; difficulty catching my breath; my face became flush; my face became flush with reddish rash; shakiness/trembling; strange taste in my mouth; tongue started to swell; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EP6955 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 06Mar2021 at 11:30 (at the age of 34-year-old) as DOSE 1, SINGLE for covid-19 immunization at Pharmacy or Drug Store.  The patient had allergy to Reglan. The concomitant medication included Elderberry with VitC&Zinc Daily. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 06Mar2021 at 11:30, Immediately upon receipt of  first dose, patient felt as if she needed to poop, had rapid heartrate, difficulty catching breath, face became flush with reddish rash, had developed shakiness/trembling and had a strange taste in mouth, tongue started to swell and patient immediately took 25mg of Benadryl. The outcome of the events was recovered in Mar2021.  No follow-up attempts are Possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Rash erythematous, Swollen tongue, Tremor
Clinical narrative: I felt as if i needed to poop; rapid heartrate; difficulty catching my breath; my face became flush; my face became flush with reddish rash; shakiness/trembling; strange taste in my mouth; tongue started to swell; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EP6955 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 06Mar2021 at 11:30 (at the age of 34-year-old) as DOSE 1, SINGLE for covid-19 immunization at Pharmacy or Drug Store.  The patient had allergy to Reglan. The concomitant medication included Elderberry with VitC&Zinc Daily. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 06Mar2021 at 11:30, Immediately upon receipt of  first dose, patient felt as if she needed to poop, had rapid heartrate, difficulty catching breath, face became flush with reddish rash, had developed shakiness/trembling and had a strange taste in mouth, tongue started to swell and patient immediately took 25mg of Benadryl. The outcome of the events was recovered in Mar2021.  No follow-up attempts are Possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain in extremity, Photosensitivity reaction, Rash macular
Clinical narrative: arm pain; Difficulty breathing; sun sensitivity with blotches form on her stomach red blotches; sun sensitivity with blotches form on her stomach red blotches; extremely tired; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 67-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in left arm, on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took ZYRTEC (cetirizine hydrochloride) (lot number and expiry date were unknown) for allergy and had blotches on stomach occasionally when patient took Zyrtec years ago (start date was unknown and stopped taking it 10 to 15 years ago). On 07Mar2021, the patient experienced sun sensitivity with blotches form on her stomach red blotches, extremely tired and difficulty breathing. On 07Mar2021 at 02.00, the patient experienced arm pain. The patient reported that after receiving the vaccine she felt extremely tired and had a sun reaction reporting that while laying in the sun she started seeing blotches form on her stomach red blotches. She did not normally react to the sun. She had blotches on her stomach occasionally when she took Zyrtec years ago. Today (08Mar2021) while sitting in the sun she did not blotch but she got so tired. She had difficulty breathing when she walked around too much. The arm pain woke her at 2.00 and it was throbbing. She also reported that when she started feeling tired she went inside to lay down and after resting she felt better and the blotching went away. The patient was asking if this was a common reaction and if these reactions were heard by Pfizer. The patient also asking that should she be concerned. The outcome of the event extremely tired, arm pain and difficulty breathing were recovering. The outcome of the event sun sensitivity with blotches on her stomach was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over my chest and Shoulders; This is a spontaneous report from a contactable consumer. A 61-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 06Mar2021 09:15 (at the age of 61-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included none. Concomitant medication(s) included lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rash all over my chest and shoulders on 07Mar2021 with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Pain in extremity, Rotator cuff syndrome, Sneezing
Clinical narrative: My arm as so sore I couldn't lift it.; My arm as so sore I couldn't lift it.; Felt like I had rotator cuff issues; I sneezed about 200 times; Couldn't sleep for two nights; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EH6201 and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 05Mar2021 at 09:15 hours as dose 1, single (at the age of 69 years old) for Covid-19 immunisation. Patient had no medical history and had no known allergies. Patient did not receive any other vaccine in four weeks. Concomitant medication within two weeks included hydrochlorothiazide and atorvastatin (both taken for an unspecified indication, start and stop date were not reported). Patient was not diagnosed with Covid-19, prior to vaccination and had not been tested for Covid-19, post vaccination. On 05Mar2021, at 11:00 hours, patient arm was so sore as she could not lift it, felt like she had rotator cuff issues, sneezed about 200 times and stated that she was not exaggerating, and patient could not sleep for two nights. Patient received no treatment for all the events. The outcome of all the events was recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular
Clinical narrative: blotchy face that turned red; blotchy face that turned red; This is a spontaneous report from a contactable physician. A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 15Feb2021, (at the age of 67-year-old) as single dose for COVID-19 immunization. Medical history included allergies to sulfa, Allergy multiple, IV dye, Penicillin and also allergic to the food corn. Concomitant medication(s) included vitamin c, a multivitamin, fish oil, Amlodipine 5mg daily, Lipitor 10mg daily, Nexium 20mg daily, Aspirin 325mg daily, and cobalamin or vitamin B12 gummies that are 250mcg of which she takes 3 gummies once a day were taken for unspecified indication and start and stop dates were not reported. Patient previously took Demerol and got hypersensitivity. Caller says they have not had any other recent vaccinations or started any new medications. On 15Feb2021 got a blotchy face that turned red and took Benadryl and it got better within 15 minutes time. Reporter called today (08Mar2021) with the question of whether this patient should get the second dose or not. Reporter only knows that the patient had facial redness that got better within 15 minutes from taking Benadryl. Reporter told that says that doesn't know what time the patient received the vaccine or which site it was given in, the vaccine facility was a different site. The Benadryl given as treatment at the site where patient got vaccination and dose was unknown. Reporter think that it was significant, there was no rash or anything. Patient have second dose of vaccination today but reporter told that hold off until information got from Pfizer. This case assessed as non-serious by the reporter. Therapeutic measures were taken with Benadryl. The clinical outcome of events was recovered on 15Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: rash on hands, face and neck; Quite red; minimally itchy; This is a spontaneous report from a contactable consumer (daughter). A non-pregnant 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: not reported, Expiration date: not reported, Age at vaccination: 82-year-old) via an unspecified route of administration on 21Feb2021 06:15 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Mar2021, patient experienced rash (rash on hands, face, neck), quite red and minimally itchy. Treatment was not received for adverse events. No other vaccine in four weeks. Adverse event: rash (rash on hands, face and neck). Quite red and minimally itchy, after 2 weeks. Adverse event start date: 01Mar2021 Covid was not present prior vaccination. Covid was not tested post vaccination. Known allergies was none. Query was: Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Please help to confirm who reported the events to you. Is it patient self or other people. Response was: event onset date as 08Mar2021 in evening and reporter was patient's daughter. The outcome of events was not recovered.  Follow-up (12Mar2021, 15Mar2021 and 18Mar2021): New follow up information received in response to mail received in response to query sent regarding confirmation of event onset date and reporter included: query and response from reporter, event onset date as 08Mar2021 in evening and reporter was patient's daughter, event onset date as 08Mar2021 in evening and reporter was patient's daughter.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness; hot to the touch; swelling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced redness, hot to the touch, swelling, and "it's getting bigger," at the injection site on an unspecified date. She stated it was then the 4th day of experiencing the side effects and paracetamol (TYLENOL) wasn't working. She asked if she could take an antihistamine instead. It was further reported that she was having redness from the COVID vaccine. It was day 4 and it was very warm, and she took just paracetamol and cold compress aren't helping it.  The redness started on third day. Outcome of the events was unknown.  No follow-up attempts are possible; no further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Rash
Clinical narrative: presented with a rash the next day; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. A male patient of an unspecified age received 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 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated he had a patient who received the Pfizer-Biontech covid19 vaccine and presented with a rash the next day on an unspecified date. He stated the patient also tested positive for antibodies. The reporter was asking if the patient need the second dose. The patient underwent lab tests and procedures which included antibody test: positive on an unspecified date. The outcome of event rash was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Peripheral swelling, Pruritus
Clinical narrative: arm is now swollen; arm is kind of swollen and there is a knot in there, a hard knot; Arm Itches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 65-year-old, via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she got the shot and her arm was kind of swollen and there was a knot in there, a hard knot, and the arm itches on 09Mar2021. She states that she noticed the swelling today, 09Mar2021. She has just been scratching it. The patient wanted to know if this was normal or a normal reaction. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Fever with Temp of 101.5; chills; body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 57-year-old, via an unspecified route of administration, administered in left arm on 08Mar2021 17:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (Covid prior vaccination). The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included other medications (unspecified) within two weeks. The patient experienced fever with temp of 101.5, chills, and body ache on 09Mar2021 12:00. The patient did not receive treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: she broke out all over her body in a rash; splotches all over her body, feet, and hands; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6206), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 15:15 (received at the age of 75-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included heart disease, copd (chronic obstructive pulmonary disease), diabetes, and known allergies: adhesives, latex, strawberries. The patient was not pregnant. Concomitant medication(s) included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; potassium (POTASSIUM) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; rhodiola rosea (RHODIOLA ROSEA) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; vitamin k2 [menaquinone] (VITAMIN K2 [MENAQUINONE]) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:15 (received at the age of 75-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient also received an unspecified "eye injection" in the left arm, in four weeks prior to receiving bnt162b2. The patient previously took phenobarbital and experienced allergy (known allergies: phenobarbital). The patient reported that she broke out all over her body in a rash and splotches all over her body, feet, and hands on 07Mar2021 15:00. Therapeutic measures were taken as a result of the adverse events which included prednisone, famotidine, over the counter antihistamine. Outcome of the events was recovering. The adverse events resulted into doctor or other healthcare professional office/clinic visit. The patient had no covid prior to vaccination and was not tested for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pruritus
Clinical narrative: hot, flush all over; itchy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in arm left on 08Mar2021 at 10:30 at the age of 44-years-old as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient experienced hot, flush all over and itchy on 09Mar2021 at 15:00. Therapeutic measures were taken as a result of both events which included BENADRYL. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: rash skin on my both legs/they were just rising up and bumpy skin; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right at the age of 56 years old on 05Mar2021 12:00 (Batch/Lot Number: EN6205) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 06Mar2021, after 27 hours of first dose vaccine, the patient experienced rash skin on her both legs, they were not itching, they were just rising up and bumpy skin. No treatment was received. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Recurring fever on and off since vaccine; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19Feb2021 13:30 (Batch/Lot Number: EN6200), at the age of 68 years old, as dose 1, single for covid-19 immunisation. Medical history included headache, tiredness, pancreatic condition, and hip back issues, all from unknown dates and unknown if ongoing. No COVID prior to vaccination and was not tested post vaccination. No known allergies. Concomitant medications included pancreatin (CREON), oxycodone, omeprazole (PROTONIX), metoprolol succinate (TOPROL), alprazolam (XANAX), and sertraline hydrochloride (ZOLOFT), all taken for unspecified indications, start and stop date were not reported. On 20Feb2021, the patient experienced recurring fever on and off since vaccine. Treatment not given. The patient has not recovered from the event.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever; chills; extreme fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 08Mar2021 at 02:00 PM (Lot Number: EN6204) (at the age of 43 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19. The patient has known allergies to codeine, beef, chicken, tomatoes, cucumbers, eggs, and hormones. The patient was not pregnant at the time of vaccination. Concomitant medications included olmesartan; cetirizine hydrochloride (ZYRTEC), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, and extreme fatigue on 08Mar2021 at 10:00 PM. The patient has not been tested for COVID-19 since the vaccination. The patient has not taken any treatment for the events. The outcome of events fever, chills, and extreme fatigue was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Influenza like illness
Clinical narrative: At bedtime that night - Chills; felt like I had the flu; muscle and joint aches; muscle and joint aches; severe headache; no appetite; slight fever 99-100; This is a spontaneous report from a contactable consumer or other non hcp. A 65-year-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 01Feb2021 10:00 am (at age of 65 years) as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin d3 (VITAMIN D3); calcium (CALCIUM); fish oil (FISH OIL); bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, with ania somnifera root (PROTANDIM) taken for an unspecified indication, start and stop date were not reported. No covid prior to vaccination and was not tested for covid post vaccination. The patient had no known allergies. The patient previously took first dose of (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Batch/Lot number: EL1283) via an unspecified route of administration, administered in arm left on 09Jan2021 02:30 PM as single for COVID-19 immunisation. On 01Feb2021 23:00, the patient experienced at bedtime that night  chills and on the next am muscle and joint aches, severe headache, no appetite, slight fever 99- 100, felt like she had the flu which lasted all day, at 5pm she took Tylenol for headache then again at 11 pm and for the next 2 days she just had a slight headache which got a little better each day. On 01Feb2021 the patient underwent lab tests and procedures which included pyrexia:99 and 100 fahrenheit. Therapeutic measures were taken as a result of severe headache and was treated with tylenol. The outcome of events was recovered on unspecified date in 2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: At bedtime that night - Chills; felt like I had the flu; muscle and joint aches; muscle and joint aches; severe headache; no appetite; slight fever 99-100; This is a spontaneous report from a contactable consumer or other non hcp. A 65-year-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 01Feb2021 10:00 am (at age of 65 years) as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin d3 (VITAMIN D3); calcium (CALCIUM); fish oil (FISH OIL); bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, with ania somnifera root (PROTANDIM) taken for an unspecified indication, start and stop date were not reported. No covid prior to vaccination and was not tested for covid post vaccination. The patient had no known allergies. The patient previously took first dose of (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Batch/Lot number: EL1283) via an unspecified route of administration, administered in arm left on 09Jan2021 02:30 PM as single for COVID-19 immunisation. On 01Feb2021 23:00, the patient experienced at bedtime that night  chills and on the next am muscle and joint aches, severe headache, no appetite, slight fever 99- 100, felt like she had the flu which lasted all day, at 5pm she took Tylenol for headache then again at 11 pm and for the next 2 days she just had a slight headache which got a little better each day. On 01Feb2021 the patient underwent lab tests and procedures which included pyrexia:99 and 100 fahrenheit. Therapeutic measures were taken as a result of severe headache and was treated with tylenol. The outcome of events was recovered on unspecified date in 2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on torso and hand; This is a spontaneous report from a contactable consumer. A 49-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm in Jan2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 49-years-old) for Covid-19 immunisation. There was no medical history, no known allergies and no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm in Jan2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 49-years-old) for Covid-19 immunisation. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination and unknown if the patient was tested for Covid post vaccination. In Feb2021, the patient had a rash on torso and hand appearing approximately 2 weeks after the second dose. No treatment was administered for the event. The outcome of the event was not resolved.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Bone pain, Chills, Confusional state
Clinical narrative: Chills; fever; confusion; vomiting; diarrhea; insomnia; could not get out of bed; low energy; intense headache; shoulders and neck muscles very tight; spasming level 10 bone pain; spasming level 10 bone pain; dehydration from vomiting; exhaustion & fatigue from illness; My right arm continues to be very sore; I also have blisters in my mouth and my gums are very inflamed; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in right arm on 03Mar2021 at 12:45 (at the age of 64 years), as dose 2, single for COVID-19 immunisation. Medical history included contrast dye allergy from an unknown date. The patient did not receive any other drugs within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient previously took Tylenol, morphine, codeine, percocet and had allergy to drug. The patient previously received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 12Feb2021 at 12:00 (at the age of 64 years), as dose 1, single for COVID-19 immunisation. On 03Mar2021 at 23:00, the patient experienced Chills, fever, confusion, vomiting, diarrhea, insomnia, could not get out of bed, low energy, intense headache, shoulders and neck muscles very tight and spasming level 10 bone pain, dehydration from vomiting, exhaustion & fatigue from illness and lack of sleep. Patient also have blisters in her mouth and her gums are very inflamed, this continues to today, 08Mar2021. Headache and low energy lasted through Saturday, 06Mar2021. Patient right arm continues to be very sore. Patient have only been this violently ill one other time in my life and that was with the flu when she was 17 years old. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given for the events. The outcome of all the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Fatigue, Gingival blister, Headache
Clinical narrative: Chills; fever; confusion; vomiting; diarrhea; insomnia; could not get out of bed; low energy; intense headache; shoulders and neck muscles very tight; spasming level 10 bone pain; spasming level 10 bone pain; dehydration from vomiting; exhaustion & fatigue from illness; My right arm continues to be very sore; I also have blisters in my mouth and my gums are very inflamed; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in right arm on 03Mar2021 at 12:45 (at the age of 64 years), as dose 2, single for COVID-19 immunisation. Medical history included contrast dye allergy from an unknown date. The patient did not receive any other drugs within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient previously took Tylenol, morphine, codeine, percocet and had allergy to drug. The patient previously received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 12Feb2021 at 12:00 (at the age of 64 years), as dose 1, single for COVID-19 immunisation. On 03Mar2021 at 23:00, the patient experienced Chills, fever, confusion, vomiting, diarrhea, insomnia, could not get out of bed, low energy, intense headache, shoulders and neck muscles very tight and spasming level 10 bone pain, dehydration from vomiting, exhaustion & fatigue from illness and lack of sleep. Patient also have blisters in her mouth and her gums are very inflamed, this continues to today, 08Mar2021. Headache and low energy lasted through Saturday, 06Mar2021. Patient right arm continues to be very sore. Patient have only been this violently ill one other time in my life and that was with the flu when she was 17 years old. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given for the events. The outcome of all the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms, Muscle tightness, Pain in extremity, Pyrexia
Clinical narrative: Chills; fever; confusion; vomiting; diarrhea; insomnia; could not get out of bed; low energy; intense headache; shoulders and neck muscles very tight; spasming level 10 bone pain; spasming level 10 bone pain; dehydration from vomiting; exhaustion & fatigue from illness; My right arm continues to be very sore; I also have blisters in my mouth and my gums are very inflamed; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in right arm on 03Mar2021 at 12:45 (at the age of 64 years), as dose 2, single for COVID-19 immunisation. Medical history included contrast dye allergy from an unknown date. The patient did not receive any other drugs within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient previously took Tylenol, morphine, codeine, percocet and had allergy to drug. The patient previously received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 12Feb2021 at 12:00 (at the age of 64 years), as dose 1, single for COVID-19 immunisation. On 03Mar2021 at 23:00, the patient experienced Chills, fever, confusion, vomiting, diarrhea, insomnia, could not get out of bed, low energy, intense headache, shoulders and neck muscles very tight and spasming level 10 bone pain, dehydration from vomiting, exhaustion & fatigue from illness and lack of sleep. Patient also have blisters in her mouth and her gums are very inflamed, this continues to today, 08Mar2021. Headache and low energy lasted through Saturday, 06Mar2021. Patient right arm continues to be very sore. Patient have only been this violently ill one other time in my life and that was with the flu when she was 17 years old. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given for the events. The outcome of all the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; fever; confusion; vomiting; diarrhea; insomnia; could not get out of bed; low energy; intense headache; shoulders and neck muscles very tight; spasming level 10 bone pain; spasming level 10 bone pain; dehydration from vomiting; exhaustion & fatigue from illness; My right arm continues to be very sore; I also have blisters in my mouth and my gums are very inflamed; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in right arm on 03Mar2021 at 12:45 (at the age of 64 years), as dose 2, single for COVID-19 immunisation. Medical history included contrast dye allergy from an unknown date. The patient did not receive any other drugs within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient previously took Tylenol, morphine, codeine, percocet and had allergy to drug. The patient previously received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 12Feb2021 at 12:00 (at the age of 64 years), as dose 1, single for COVID-19 immunisation. On 03Mar2021 at 23:00, the patient experienced Chills, fever, confusion, vomiting, diarrhea, insomnia, could not get out of bed, low energy, intense headache, shoulders and neck muscles very tight and spasming level 10 bone pain, dehydration from vomiting, exhaustion & fatigue from illness and lack of sleep. Patient also have blisters in her mouth and her gums are very inflamed, this continues to today, 08Mar2021. Headache and low energy lasted through Saturday, 06Mar2021. Patient right arm continues to be very sore. Patient have only been this violently ill one other time in my life and that was with the flu when she was 17 years old. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was given for the events. The outcome of all the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After taking the first shot I broke out in house; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender 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 dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 9 days after taking the first shot on an unspecified date, the patient broke out in the house. The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a non-contactable other health professional (patient). This report was received via a sales representative.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date he had fever, chills, and had to stay home from work "for a couple of days." The patient has since completed the two-dose series with the Pfizer COVID-19 mRNA vaccine (BNT162) (date unspecified). The outcome of events was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: bruising and pain around vaccination site; pain around vaccination site; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Mar2021 at 09:45 (Batch/Lot number was not reported) as dose 2, single at the age of 23 years old for COVID-19 immunisation.  Medical history included known allergies to scallops. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced bruising and pain around vaccination site on 07Mar2021. No other vaccine in four weeks. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. The patient did not receive treatment for the events. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Minor rash on left forearm; This is a spontaneous report from a contactable consumer (patient) received via Agency. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 03Mar2021 at 09:15 (Lot Number: EL3248) (at the age of 51 years old) as dose 1, single for COVID-19 immunisation in a workplace clinic. Medical history included asthma. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. Concomitant medications included low-dose aspirin (acetylsalicylic acid) and an unspecified multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Mar2021, the patient experienced minor rash on left forearm. Rash did not appear anywhere else on the body. Rash appeared to be going away. The patient did not receive any treatment for the event. The patient was recovering from the event on the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 08Mar2021 (at the age of 40-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever on 08Mar2021. Therapeutic measures were taken as a result of fever and included treatment with Tylenol. She said that she heard that taking Tylenol might make vaccine less effective, so she wanted to find out if this is true. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: dizziness; low grade fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness and low grade fever on an unspecified date that lasted for 3 days. People she talked with said they have gotten reactions after 2nd dose of vaccine but not first. She was wondering if she should get 2nd of Covid vaccine. She was also scheduled for yearly blood work tomorrow, and was wondering if she should reschedule blood work. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a non-contactable consumer (patient) via a Pfizer-sponsored program, COVAX US Support. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (batch/lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side effects with her first dose of the COVID-19 vaccine. She was not sure if she had an allergic reaction to it or not. She also wanted to know if she should take the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.