chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Nausea, Vomiting
Clinical narrative: Frequent dizziness; nausea; vomiting; falling; This is a spontaneous report from a non-contactable consumer (patient). A 79-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318, Expiration date: Unknown), via an unspecified route of administration on 01Feb2021 17:45 as 1st dose, single dose for covid-19 immunisation at other facility. Medical history included mild dementia. The patient was prescribed with medications and dietary supplements within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Feb2021, the patient experienced frequent dizziness, nausea, vomiting and falling. The events result in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events with IV hydration. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm for a week; headache for 1.5 days; This is a spontaneous report from a contactable other hcp (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number; unknown), dose 1 via an unspecified route of administration on an unspecified as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included meloxicam (MELOXICAM) and metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. Caller stated he received both doses of the Pfizer-BIONTECH COVID-19 vaccine while being on Meloxicam and Metformin. He explained yesterday, he read on Medical News Today that taking anti-inflammatory drugs interferes with the body's immune response to the COVID-19 vaccine. Caller then stated he had a headache for 1.5 days after the first injection of the vaccine, along with a sore arm for a week. He compared his arm as being hit by a baseball bat. He also mentioned being wiped out for 3 days following the second dose. He also described it as being exhausted. The outcome of the event headache was recovered and outcome for sore arm for a week was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: severe diarrhea and it was the worst he had ever experienced; feverish; felt achy; chills; sweaty; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 54-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported ), dose 1 via an unspecified route of administration on an unspecified date as sigle dose for covid-19 immunisation. Medical history included diarrhoea. The patient mother has dementia. The patient's concomitant medications were not reported.   On an unspecified date, 36 hours after vaccine administration, the patient experienced severe diarrhea and it was the worst he had ever experienced, feverish, felt achy, chills and sweaty. The patient stated that he got first dose of Pfizer COVID vaccine and had severe reaction 36 hours afterwards. Caller states he got severe diarrhea and it was the worst he had ever experienced. He stated that he was feverish but never checked his temperature. Also, he felt achy, had chills, sweaty and this lasted for 18-24 hours at a severe level. The patient would like to know if there is any reason to be concerned with getting the vaccine and possibly having neurological issues in the future. He would further like to know if the higher your immune system and the younger you are if you are more likely to have a reaction to the Pfizer COVID vaccine. He also wanted to know if he received first dose of Pfizer COVID vaccine and had a reaction can he receive second dose of Johnson and Johnson vaccine. Outcome of the events severe diarrhea and feverish was unknown and outcome of the events felt achy, chills and sweaty was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Sleeplessness; This is a spontaneous report from a contactable other Health Care Professional (patient). A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in left arm on 30Jan2021 at 12:00 (at the age of 47 years old) as single for covid-19 immunization. Medical history was None. Patient had no known allergies. There were no concomitant medications.  Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 09Jan2021 at 12:00 PM (at the age of 47 years old) for covid-19 immunization. The patient had no other vaccine in four weeks. The patient did not receive other medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 30Jan2021, patient experienced sleeplessness. The patient did not received treatment to the event. The outcome of event was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Flatulence, Pain
Clinical narrative: gas; fatigued; chills; loose stools; slight body aches; slightly right sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Right arm on 29Jan2021 (at the age of 78-year-old) as single dose for covid-19 immunisation. Medical history were none. There were no concomitant medications. The patient experienced chills on 03Feb2021 slightly loose stools on 03Feb2021, gas on an unspecified date, fatigued on 03Feb2021, slightly right sore arm on 29Jan2021, slight body aches on 03Feb2021. Therapeutic measures were taken with a couple of Tylenol and Pepto Bismol as a result of event chills, loose stools, gas, fatigued, slightly right sore arm, slight body aches. The outcome of event gas was unknown and for event slightly right sore arm was recovered on 30Jan2021 and slight body aches was recovered on 07Feb2021 and for rest all event outcome was recovering.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: gas; fatigued; chills; loose stools; slight body aches; slightly right sore arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Right arm on 29Jan2021 (at the age of 78-year-old) as single dose for covid-19 immunisation. Medical history were none. There were no concomitant medications. The patient experienced chills on 03Feb2021 slightly loose stools on 03Feb2021, gas on an unspecified date, fatigued on 03Feb2021, slightly right sore arm on 29Jan2021, slight body aches on 03Feb2021. Therapeutic measures were taken with a couple of Tylenol and Pepto Bismol as a result of event chills, loose stools, gas, fatigued, slightly right sore arm, slight body aches. The outcome of event gas was unknown and for event slightly right sore arm was recovered on 30Jan2021 and slight body aches was recovered on 07Feb2021 and for rest all event outcome was recovering.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: achy; felt unwell; diarrhea (her stomach was not right); malaise; chills; felt like the flu; really fatigued; This is a spontaneous report received from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-NBIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982), intramuscular in left arm on 13Jan2021 at 11:30 (at the age of 71-years-old) as first dose, single for COVID-19 immunization. The patient received his second dose of bnt12b2 (PFIZER-NBIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9810) on 3Feb2021 for COVID-19 immunization.  Medical history included hip bursitis on 21Dec2020. She had a cortisone shot in her hip before to treat her hip bursitis. Patient family history relevant to AE was reported as none. Concomitant medications were not reported. Patient did not receive any other vaccine 4 weeks prior to the vaccine and did not receive any other vaccine on the same date of Pfizer vaccine. On an unspecified date in Jan2021, the patient experienced diarrhea (her stomach was not right), malaise, chills, felt like the flu and really fatigued and on an unspecified date, she felt unwell and achy. She was about 75-80 percent better with the symptoms and stated that the diarrhea resolved on Friday. Patient reported that she went to see her doctor about it and they did blood tests and the blood tests did not show anything significant. She was going back to the physician tomorrow 09Feb2021. The patient underwent lab tests and procedures which included blood test: negative on 29Jan2021. Patient reported that she was about 75-80 percent better with the symptoms Patient reported that while in the line for her second dose she overheard someone reading the possible side effects of vaccine, she realized that she had a lot of the symptoms. Patient reported that she had symptoms after getting her first dose that lasted for 3 weeks. Patient wanted to know if that duration of time was normal and also wanted to know if anyone else reported side effects lasting for 3 weeks. The outcome of diarrhea was recovered on 05Feb2021, outcome of felt unwell and achy was unknown while for the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain
Clinical narrative: achy; felt unwell; diarrhea (her stomach was not right); malaise; chills; felt like the flu; really fatigued; This is a spontaneous report received from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-NBIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982), intramuscular in left arm on 13Jan2021 at 11:30 (at the age of 71-years-old) as first dose, single for COVID-19 immunization. The patient received his second dose of bnt12b2 (PFIZER-NBIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9810) on 3Feb2021 for COVID-19 immunization.  Medical history included hip bursitis on 21Dec2020. She had a cortisone shot in her hip before to treat her hip bursitis. Patient family history relevant to AE was reported as none. Concomitant medications were not reported. Patient did not receive any other vaccine 4 weeks prior to the vaccine and did not receive any other vaccine on the same date of Pfizer vaccine. On an unspecified date in Jan2021, the patient experienced diarrhea (her stomach was not right), malaise, chills, felt like the flu and really fatigued and on an unspecified date, she felt unwell and achy. She was about 75-80 percent better with the symptoms and stated that the diarrhea resolved on Friday. Patient reported that she went to see her doctor about it and they did blood tests and the blood tests did not show anything significant. She was going back to the physician tomorrow 09Feb2021. The patient underwent lab tests and procedures which included blood test: negative on 29Jan2021. Patient reported that she was about 75-80 percent better with the symptoms Patient reported that while in the line for her second dose she overheard someone reading the possible side effects of vaccine, she realized that she had a lot of the symptoms. Patient reported that she had symptoms after getting her first dose that lasted for 3 weeks. Patient wanted to know if that duration of time was normal and also wanted to know if anyone else reported side effects lasting for 3 weeks. The outcome of diarrhea was recovered on 05Feb2021, outcome of felt unwell and achy was unknown while for the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: achy; felt unwell; diarrhea (her stomach was not right); malaise; chills; felt like the flu; really fatigued; This is a spontaneous report received from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-NBIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982), intramuscular in left arm on 13Jan2021 at 11:30 (at the age of 71-years-old) as first dose, single for COVID-19 immunization. The patient received his second dose of bnt12b2 (PFIZER-NBIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9810) on 3Feb2021 for COVID-19 immunization.  Medical history included hip bursitis on 21Dec2020. She had a cortisone shot in her hip before to treat her hip bursitis. Patient family history relevant to AE was reported as none. Concomitant medications were not reported. Patient did not receive any other vaccine 4 weeks prior to the vaccine and did not receive any other vaccine on the same date of Pfizer vaccine. On an unspecified date in Jan2021, the patient experienced diarrhea (her stomach was not right), malaise, chills, felt like the flu and really fatigued and on an unspecified date, she felt unwell and achy. She was about 75-80 percent better with the symptoms and stated that the diarrhea resolved on Friday. Patient reported that she went to see her doctor about it and they did blood tests and the blood tests did not show anything significant. She was going back to the physician tomorrow 09Feb2021. The patient underwent lab tests and procedures which included blood test: negative on 29Jan2021. Patient reported that she was about 75-80 percent better with the symptoms Patient reported that while in the line for her second dose she overheard someone reading the possible side effects of vaccine, she realized that she had a lot of the symptoms. Patient reported that she had symptoms after getting her first dose that lasted for 3 weeks. Patient wanted to know if that duration of time was normal and also wanted to know if anyone else reported side effects lasting for 3 weeks. The outcome of diarrhea was recovered on 05Feb2021, outcome of felt unwell and achy was unknown while for the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got ill for three weeks after the first dose. The patient also received second dose on an unknown date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain
Clinical narrative: ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got ill for three weeks after the first dose. The patient also received second dose on an unknown date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got ill for three weeks after the first dose. The patient also received second dose on an unknown date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain of skin, Peripheral swelling, Pruritus
Clinical narrative: I began with leg swelling in both legs from the ankle to the knee I thought my thighs were swollen but not sure.; Starting today with itchy skin from my both feet to my  knee caps.; I am still experiencing Itchy and redness, not sure if red; I am still experiencing Itchy and redness, not sure if red, because of the lighting in my apartment but it is itchy and painful.; This is a spontaneous report from a non-contactable consumer or other non hcp.    A 62-years-old female patient received First Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EK4176) via an unspecified route of administration on 03Feb2021 as SINGLE DOSE for an unspecified indication. Medical history included drug hypersensitivity from an unknown date if ongoing.The patient's concomitant medications were not reported. On the 05Feb2021,patient stated that, I began with leg swelling in both legs from the ankle to the knee I thought my thighs were swollen but not sure. Starting today with itchy skin from my both feet to my  knee caps. I went to Clinic and they gave me a prescription for the later pill, I can't remember the name,  if it was lasix, patient said yes. Patient stated that, because my legs were swollen, and they didn't see any reason to give me anything else. I am still experiencing Itchy and redness, not sure if red, because of the lighting in my apartment but it was itchy and painful. Is this a side effect. If he gives me an antibiotic is it advisable. The outcome of the events was not resolved on Feb 2021.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Lot of hair loss; This is a spontaneous report received from a contactable consumer (patient husband). An elderly (reported Age: 77; Unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, 7-10 days after the first vaccine, started experiencing lot of hair loss. Reporter wanted to know if it was reported in the clinical trials for the vaccine and strongly suspects that it was related to the vaccine. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Aches; Pains/soreness in the arm; Headaches; This is a spontaneous report from Pfizer sponsored program Pfizer First connect. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 21Jan2021 as single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that patient was scheduled to receive his second dose of the vaccine on 11Feb2021. Patient and his friends all experienced some side effects, "aches, pains, soreness in the arms and headaches." As per report it was reported that, "Caller stated that he was hearing people say that the side effects after the second dose of the Pfizer COVID-19 vaccine can be worse and he would like to know if that was true. Patient took Anocin (an aspirin). The outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: Respiratory capacity gradually returned to "Long-Haul" condition after each respite.; This is a spontaneous report from a contactable consumer or other non hcp. A adult non pregnant female patient received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on Dec2020 as dose number unknown, single for covid-19 immunisation. Medical history included covid-19 in 2020 if Covid prior vaccination: Yes. The patient's concomitant medications were not reported. In Dec 2020, the patient experienced respiratory capacity gradually returned to long-haul condition after each respite. Reduced respiratory capacity limits and ability to run. Patient received vaccine through workplace program as job requires frequent travel. Patient regained respiratory capacity after each of the two immunizations. Patient was able to run again. The outcome of event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Poor peripheral circulation
Clinical narrative: Initially circulation lost in 3 fingers on my right hand; Numbness from the elbow to thumb on my right arm; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en5318) via an unspecified route of administration, administered in right arm on 31Jan2021 at 09:00 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization. Vaccination Facility type was School or Student Health Clinic. Medical history included penicillin allergy. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included plantago afra (COLON CLEANSER); atorvastatin (LIPITOR); omeprazole and lisdexamfetamine mesilate (VYVANSE); all taken for an unspecified indication, start and stop date were not reported. On 31Jan2021 at 09:15 (15-minutes after vaccination), patient initially circulation lost in his three fingers in right hand followed by numbness from elbow to thumb in right arm. The patient did not receive any treatment. Post vaccination, the patient had not been tested for COVID-19. The outcome of both the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: tired; pain in arm; Fever; This is a spontaneous report from a contactable consumer or other non hcp. An elderly (65+Years) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date, dose number unknown as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that after receiving the dose of vaccine on 07Feb2021 the patient experienced pain in arm and stated that it was virtually painless if relaxed in the right position so sleep unaffected and it hurts some on using the arm or putting any pressure on it and also experienced fever and stated that patient never got an official fever but had a fever in the sense that his temperature was up from his normal level and patient was tired and slept about 10 or 11 hours on last night. Today the worst was over, and patient was starting to get back to normal. On 07Feb2021, the patient underwent lab tests and procedures which included body temperature which result showed temperature was up from normal level. The outcome of all the events was recovering.   Information on the lot/batch number has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Pain, Pain in extremity, Weight, Weight decreased
Clinical narrative: is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse; he has lost some weight; He is having trouble with his memory; is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse/He has pain down his right side into his crotch and down his leg; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: 2L3247) intramuscularly into the right arm on 20Jan2021 15:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient's medical history included diabetic, COPD, prostrate cancer. He has a hard time breathing and was on oxygen. Concomitant medications were not reported. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN5318) intramuscularly into the right arm on 17Feb2021 10:30 AM as single dose for COVID-19 immunisation. On an unspecified date, the reporter stated that her husband had the first dose of the Pfizer covid 19 vaccine on 20Jan2021 and was in a lot pain going down the right side into his crotch and legs and screams out in pain. Pain was getting worse and wanted to know if this was a side effect of the vaccine. He was not getting the second dose of the Pfizer covid 19 vaccine because of the adverse event he experienced with the first dose. He was on oxygen and had to carry an oxygen tank. He was due to get the second shot on Wednesday. She wanted to check and make sure. It may be a muscle thing. It seems to be getting worse and worse. He can hardly get up. He cannot hardly sleep in the bed. He does not want to get the next shot and his left side be in pain. Then he would not be able to do anything. He had lost some weight around 230 pounds. He has the first stages of Alzheimer's and clarified that has not been diagnosed yet with Alzheimer's. He had a test a couple years ago and it was normal. He was having trouble with his memory. He got the flu shot on 01Sep2020. He takes two cases full of medication. He was diabetic. He took shots in his stomach. It was changed over. No further details provided. Pain on right side started two days later. She does not know, but was assuming it was the muscle, going to be a little sore. It had progressively worsened. He could hardly move to go to the bathroom. He had prostate cancer a few years ago and has to wear underpants. He cannot bend over to put on his underpants or socks. He screams in pain. He does not do well with pain. No prior vaccinations within 4 weeks. Relevant tests included X-Ray on 26Feb2021 with unknown results. Outcome was unknown for all the events.  Follow-up attempts are completed. No further information was expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse; he has lost some weight; He is having trouble with his memory; is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse/He has pain down his right side into his crotch and down his leg; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: 2L3247) intramuscularly into the right arm on 20Jan2021 15:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient's medical history included diabetic, COPD, prostrate cancer. He has a hard time breathing and was on oxygen. Concomitant medications were not reported. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN5318) intramuscularly into the right arm on 17Feb2021 10:30 AM as single dose for COVID-19 immunisation. On an unspecified date, the reporter stated that her husband had the first dose of the Pfizer covid 19 vaccine on 20Jan2021 and was in a lot pain going down the right side into his crotch and legs and screams out in pain. Pain was getting worse and wanted to know if this was a side effect of the vaccine. He was not getting the second dose of the Pfizer covid 19 vaccine because of the adverse event he experienced with the first dose. He was on oxygen and had to carry an oxygen tank. He was due to get the second shot on Wednesday. She wanted to check and make sure. It may be a muscle thing. It seems to be getting worse and worse. He can hardly get up. He cannot hardly sleep in the bed. He does not want to get the next shot and his left side be in pain. Then he would not be able to do anything. He had lost some weight around 230 pounds. He has the first stages of Alzheimer's and clarified that has not been diagnosed yet with Alzheimer's. He had a test a couple years ago and it was normal. He was having trouble with his memory. He got the flu shot on 01Sep2020. He takes two cases full of medication. He was diabetic. He took shots in his stomach. It was changed over. No further details provided. Pain on right side started two days later. She does not know, but was assuming it was the muscle, going to be a little sore. It had progressively worsened. He could hardly move to go to the bathroom. He had prostate cancer a few years ago and has to wear underpants. He cannot bend over to put on his underpants or socks. He screams in pain. He does not do well with pain. No prior vaccinations within 4 weeks. Relevant tests included X-Ray on 26Feb2021 with unknown results. Outcome was unknown for all the events.  Follow-up attempts are completed. No further information was expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: arm is red around where he got the shot/ arm is all red; It feels a little warm.; This is a spontaneous report from a contactable consumer(wife).  A 86-years-old male patient received bnt162b2 (PFIZER-BIONTECH, COVID-19 vaccine, formulation: solution for injection) via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medication were not reported. In Feb2021, the patient's arm was red around where he got the shot and it felt a little warm. It was about a 4-inch circle.The reporter stated that It was not red Saturday and don't know about it on Sunday,but when he got out of the shower on 08feb201 (day of reporting) his arm was all red. The patient's wife asked was this normal, is there anything she should be aware of for him. The reporter explained it was on the left arm and this was the side that he got the shot on. Outcome of the events were unknown.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: dizziness; nausea; headache; This is a spontaneous report from a contactable female Nurse (patient). A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EN5318) via an unspecified route of administration on 06Feb2021 11:45 as dose 1, single for COVID-19 immunisation. The patient medical history included ongoing high blood pressure had this for years, ongoing high cholesterol, ongoing allergies had for at least 20 years, perennial allergy from an unknown date and unknown if ongoing she has perineal allergies. also, she has an allergy to penicillins and erythromycin with penicillin being an anaphylaxis reaction. Caller has no NDC, Lot, or Expiry for any of the products which caused these reactions, this was a long time ago, cancer from an unknown date and unknown if ongoing, swine flu from an unknown date and unknown if ongoing AE(s) following prior vaccinations: In the 1970's with the swine flu, she was given the vaccine and right after she felt like she was going to pass out. EMS gave her oxygen, and she was fine. No NDC, Lot, manufacturer, or expiry. Concomitant medications included lisinopril (LISINOPRIL) 40 mg taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. No prior Vaccinations within 4 weeks. On 06Feb2021, less than 48 hours ago the patient experienced after she had the first shot, she has had a headache and mild nausea for 2 days. On 08Feb2021, this morning she has been very dizzy and so she was wondering if this was normal; she didn't see it on the side effect list, but I am not having weakness or anything really bad and asked if this dizziness could be from the COVID-19 vaccine. When she eats, she feels sick to her stomach, in regard to the nausea. She gets a flu shot every year and has never had a problem. The clinical outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Muscular weakness, Paraesthesia, Tinnitus
Clinical narrative: ringing in her ears/ringing in ears that is worse than others; tingling like pains and needles on top of her head; arms and legs like jell-O and weak; pulse elevated at times; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown, Expiration Date: unknown),via an unspecified route of administration, administered in Arm Right on 29Jan2021 at 09:00 as dose 1, single for COVID-19 immunization. Medical history was none. There were no concomitant medications.The patient did not have any history of previous immunization with the Pfizer vaccine and not received any additional vaccines administered on same date of the Pfizer suspect. No adverse event prior to vaccinations. No problems with vaccines in the past. She does not even get a flu shot. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Patient did not had Illness. In Jan2021, the Patient had side effects since she got the first dose of what she calls Pfizer Biotech Covid-19 vaccine. Patient also went to the doctor and also was a little concerned, Patient had ringing in ears that is worse than others, has tingling like pins and needles like it would have in the toes, but it was on top of head, Legs and arms were like jello and they were weak are slightly better, but still had it. Symptoms started a few days after the vaccine, her pulse also was elevated at times, was really bad at one point and was better than it was, but still there. Adverse event resulted in physician visited physician office and not visited emergency room. The patient underwent lab tests which included pulse: elevated in Jan2021. The outcome of event pulse elevated at times was unknown and not yet recovered for rest of the events.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Bladder infection; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received first dose of the Pfizer vaccine on 05Feb2021, however he may or may not had bladder infection for which he may or may not require antibiotics. He stated he does not believed that it was related to vaccine at all. He wanted to know whether antibiotics will have an effect on covid vaccine. He was informed on how to report AE for future reference. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Defaecation urgency, Diarrhoea, Flatulence, Muscle spasms
Clinical narrative: neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of gas; a bloating abdomen with a lot of gas; feeling severe muscle pain in the stomach; This is a spontaneous report from a contactable consumer. This 78-year-old female consumer (patient) reported.   A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: 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 immunization. The patient called to report her symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. On 06Feb2021, the patient started having neck spasms, diarrhoea, and the urge to go to the bathroom all day long, also a bloating abdomen with a lot of gas, feeling severe muscle pain in the stomach. She stated her symptoms were not putting her on risk based on the information that she received about the vaccine when it was administered to her. Outcome of the events was unknown.   Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of gas; a bloating abdomen with a lot of gas; feeling severe muscle pain in the stomach; This is a spontaneous report from a contactable consumer. This 78-year-old female consumer (patient) reported.   A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: 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 immunization. The patient called to report her symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. On 06Feb2021, the patient started having neck spasms, diarrhoea, and the urge to go to the bathroom all day long, also a bloating abdomen with a lot of gas, feeling severe muscle pain in the stomach. She stated her symptoms were not putting her on risk based on the information that she received about the vaccine when it was administered to her. Outcome of the events was unknown.   Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Balance disorder, Fatigue, Gait disturbance
Clinical narrative: she felt very tired; weak for about two weeks; difficult for her to walk; she did not feel dizzy but unbalanced; she has a pacemaker and that she had a previous stroke /she is concerned about having another stroke; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: not reported), via an unspecified route of administration on 19Jan2021 20:00 as Ist dose, single for covid-19 immunisation. Medical history included cerebrovascular accident from an unknown date and unknown if ongoing She has a pacemaker and that she had a previous stroke. The patient's concomitant medications were not reported.  The patient experienced she felt very tired, weak for about two weeks, difficult for her to walk, she did not feel dizzy but unbalanced, she has a pacemaker and that she had a previous stroke /she is concerned about having another stroke on 20Jan2021. Outcome of the events were recovering.   Information on the lot/batch number has been requested. .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chromaturia, Faeces discoloured, Headache, Productive cough
Clinical narrative: severe abdominal pain; clay colored stool; tea colored urine; a intensely burning, exploding headache; productive cough; This is a spontaneous report from a contactable Nurse (Patient).  A 66-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EKT231), via an unspecified route of administration, administered in Arm Left on 24Dec2020 14:15 (age at vaccination: 66-year-old) as single dose for covid-19 immunization. (vaccination facility: Hospital). The patient medical history was not reported. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported, metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported, dulaglutide (TRULICITY) 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. patient did not receive other vaccine in four weeks. Patient also took second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Left deltoid on 14Jan2021 as single dose for covid-19 immunization. No covid prior vaccination. No known allergies. It was reported that on 29Dec2020 06:30 PM 5 days after, severe abdominal pain, clay colored stool, tea colored urine and intensely burning, exploding headache, productive cough. patient tested nasal swab positive for covid-19 post vaccination on 29Jan2021. Patient was not received any treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Nasal Swab) on 29Jan2021. Outcome for the event was reported as Resolved with Sequel on unspecified date.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severe abdominal pain; clay colored stool; tea colored urine; a intensely burning, exploding headache; productive cough; This is a spontaneous report from a contactable Nurse (Patient).  A 66-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EKT231), via an unspecified route of administration, administered in Arm Left on 24Dec2020 14:15 (age at vaccination: 66-year-old) as single dose for covid-19 immunization. (vaccination facility: Hospital). The patient medical history was not reported. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported, metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported, dulaglutide (TRULICITY) 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. patient did not receive other vaccine in four weeks. Patient also took second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Left deltoid on 14Jan2021 as single dose for covid-19 immunization. No covid prior vaccination. No known allergies. It was reported that on 29Dec2020 06:30 PM 5 days after, severe abdominal pain, clay colored stool, tea colored urine and intensely burning, exploding headache, productive cough. patient tested nasal swab positive for covid-19 post vaccination on 29Jan2021. Patient was not received any treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Nasal Swab) on 29Jan2021. Outcome for the event was reported as Resolved with Sequel on unspecified date.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.