chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Insomnia
Clinical narrative: I have numbness from my forehead down to, down to my neck on my right side; it also feels like have food stuck between my cheek and gum; I didn't sleep; It just feels weird; the other side of my face where I got the vaccinated on that started going numb as well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Formulation: solution for injection; manufacturer: Unspecified; Lot number; NDC number; UPC number and Expiry Date: Unknown), dose 1 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. Patient got the vaccine on Saturday (unknown date) and had numbness from forehead down to, down to the neck on the right side and it also feels like have food stuck between the cheek and gum, and checked last night, patient did not sleep on an unknown date and checked last night and did not have any food stuck in there because patient brush teeth before going to bed and gargle and everything else what the patient do every night and it just feels weird and the other side of the face where patient got the vaccinated on that started going numb as well, on an unknown date. The reaction to the vaccine, that the patient should be concerned about or not. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement
Clinical narrative: Severe increase in BP and anxiety, he never had these issues; Severe increase in BP and anxiety, he never had these issues; This is a spontaneous report from a contactable physician. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 26Apr2021 at 13:00 (Age at vaccination: 48 years) as dose number unknown, single for COVID-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. Allergies were reported as None. On 12May2021 at 15:00, the patient experienced severe increase in bp and anxiety, he never had these issues. The patient underwent lab tests and procedures which included blood pressure abnormal: severe increase in bp on 12May2021. Facility type where vaccine administered was Pharmacy or Drug Store. Procardia was given as a treatment for the events. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained; No fur-ther information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Vomiting
Clinical narrative: throwing up; nauseated; I am unable to eat but I drank some Sprite; This is a spontaneous report from a contactable consumer via. A 63-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 06May2021 11:00 (at the age 63-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included obesity from an unknown date (Verbatim: Obesity). The patient's concomitant medications were not reported. The patient previously took BNT162B2 (lot number ER8733) dose 1, administered in Arm Left on 15Apr2021 for covid-19 immunization. The patient experienced throwing up and nauseated on 10May2021, i am unable to eat but i drank some sprite in May2021. It was stated that "Caller is calling because she got her second COVID vaccine the 6 May 2021, by Pfizer. Since Monday, she has been throwing up since Monday evening around 730 or 8pm. She began to throw up. The sad thing is even to today, she hasn't thrown up, but she is so nauseated she can't eat. She was able to drink sprite and eat a saltine. She is hoping it will help. She is just not sure what is going on. She did not have a prescribing doctor. She could sit up today which is an improvement". Outcome of the event i am unable to eat but i drank some sprite was unknown and other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Photophobia, Pyrexia
Clinical narrative: Fever/Fever of 102 degrees Fahrenheit that went down to 100 degrees Fahrenheit last night; Light sensitivity; Headache; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for himself. A 29-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11May2021 (age at vaccination was 29 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 18Apr2021 (age at vaccination was 29 years) as dose 1, single for COVID-19 immunization. The caller wanted to report the sides effects after the 2nd dose of the vaccine. On an unspecified date, the patient experienced fever of 102 degrees Fahrenheit that went down to 100 degrees Fahrenheit last night, some light sensitivity and headache due to the fever and the light sensitivity. The caller stated that he would just call his doctor later. The patient underwent lab test which included body temperature: 102 Fahrenheit (fever of 102 degrees Fahrenheit that went down to 100 degrees Fahrenheit last night) on an unspecified date in May2021.The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported.   A 35-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, Solution for injection,  Lot number: EW0161) via an unspecified route of administration on 18Apr2021 at 10AM, as dose 1, Single for COVID-19 immunization. Medical history included she has dermatitis and her skin was very sensitive. Had vaccinations long before. She never experienced skin rashes or allergic reaction. In general she has dermatitis and sensitive skin. PRIOR VACCINCATIONS WTIHIN 4 WEEKS: none. AEs FOLLOWING PRIOR VACCINATIONS: no. Since 28Apr2021, the patient was not on any concomitant medications (Other Products: No). Experienced full body rash. Dermatologist described rash as morbilli, a very tiny rash all over the body. Began 10 days after the vaccine. Didn't happen immediately. Wasn't itchy and took two weeks to clear (till 10May2021). It was stated that she had symptoms after both dosages of Pfizer COVID-19 Vaccine. Had different side effects after each dose. Spoke with different doctors after each dose. Confirmed she had no other symptoms after the first dose besides the full body rash. She did not undergo any Investigation Assessment. As of now, she has no symptoms. Provided LD or 1D from patient record card. Stated she can't read the writing on the card well. The event resulted in visit to physician office. Dermatologist prescribed Triamcinolone acetonide cream (NDC: 67877-251-30, LOT: W0127 EXP: Jan2024 0.1 percent 30 gram tube) for the full body rash to relive the skin. Cream wasn't very helpful because it took two weeks to clear up. Expected it would help the rash within a week, but stated she was mistaken. It didn't work as fast as she expected. As of day of this report (stated as today) 11May2021, she had no symptoms. The event did not require visit to emergency room. It was stated that she has had side effects for both first and second covid vaccine. The event was resolved on 10May2021.   Reporter seriousness for First dose: Full body rash: Unspecified   No follow-up attempts were needed. No further information was expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Euphoric mood
Clinical narrative: She is running into a big issue basically, her body temperature dropped down to 91 degree; She is feeling high; This is a spontaneous report from a contactable consumer. A 58-years-old female patient (mother) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/Lot Number: EW0172; Expiration Date: 31Aug2021), intramuscular, administered in right arm on 11May2021 (at the age of 58-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The medical history included depression, gout, and high blood pressure. The patient's concomitant medications included colchicine, carvedilol and duloxetine hydrochloride (CYMBALTA). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Batch/Lot Number not reported), via unspecified route administered on 20Apr2021 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 11May2021, 12 hours after the vaccination, it was reported that my mother was running into a big issue basically, her body temperature dropped down to 91 degree and it is from past 12 hours but she is feeling high. The patient underwent lab tests and procedures which included temperature dropped down: 91 on 11May2021. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myalgia, Pain in extremity
Clinical narrative: Sore muscle pain feels like a Charlie horse; Sharp stabbing pain near the top of my arm; Sharp stabbing pain near the top of my arm that radiated down towards my chest; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration was not reported), second dose via an unspecified route of administration, administered in arm left on 25Apr2021 13:00 (at the age of 53 years) as single for covid-19 immunization. Medical history included Past Multiple back surgeries, neck surgeries from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no reported allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration was not reported), first dose via an unspecified route of administration, administered in arm left on 29Mar2021 16:00 (at the age of 53 years) as single for covid-19 immunization. On 25Apr2021 16:00 the patient experienced Sharp stabbing pain near the top of my arm that radiated down towards my chest and Sore muscle pain feels like a Charlie horse all nonstop since the second vaccine. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Adverse events treatment was Medication and a follow up which is not yet scheduled. 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.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart is racing; This is a spontaneous report from a Non contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Says she has an appointment with her doctor. She had the Pfizer Vaccine 2 Thursdays ago. States she hasnt had problems except that her heart is racing. The patient experienced heart is racing on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest discomfort, Dizziness, Gait disturbance, Headache
Clinical narrative: Fever; body pain; bone pain; dizziness; headache; sound in chest when breathing; hands numbness; difficulty walking; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0169, Expiry date was not reported), via an unspecified route of administration on 17Apr2021 17:00 (at the age of 39-years-old) in Arm right as dose 1, single for COVID-19 immunization. The patient Medical history included thyroid disorder from an unknown date and unknown if ongoing , Lactose from an unknown date and unknown if ongoing. Concomitant medications included losartan (LOSARTAN); levothyroxine (LEVOTHYROXINE); ascorbic acid, betacarotene, biotin, calcium phosphate dibasic, calcium stearate, chromic chloride hexahydrate, copper sulfate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, panax ginseng, pantothenic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, sodium molybdate, sodium selenate, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc oxide (CENTRUM ACTIVE); pantoprazole (PANTOPRAZOLE) all taken for an unspecified indication, start and stop date were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not tested for COVID-19. On 09May2021 12:00, the patient experienced fever, body pain, bone pain, dizziness , headache, sound in chest when breathing , hands numbness, difficulty walking. The patient did not received treatment for the adverse events. The outcome for the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Fever; body pain; bone pain; dizziness; headache; sound in chest when breathing; hands numbness; difficulty walking; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0169, Expiry date was not reported), via an unspecified route of administration on 17Apr2021 17:00 (at the age of 39-years-old) in Arm right as dose 1, single for COVID-19 immunization. The patient Medical history included thyroid disorder from an unknown date and unknown if ongoing , Lactose from an unknown date and unknown if ongoing. Concomitant medications included losartan (LOSARTAN); levothyroxine (LEVOTHYROXINE); ascorbic acid, betacarotene, biotin, calcium phosphate dibasic, calcium stearate, chromic chloride hexahydrate, copper sulfate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, panax ginseng, pantothenic acid, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, sodium molybdate, sodium selenate, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc oxide (CENTRUM ACTIVE); pantoprazole (PANTOPRAZOLE) all taken for an unspecified indication, start and stop date were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not tested for COVID-19. On 09May2021 12:00, the patient experienced fever, body pain, bone pain, dizziness , headache, sound in chest when breathing , hands numbness, difficulty walking. The patient did not received treatment for the adverse events. The outcome for the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Arm pain; This is a spontaneous report from a contactable reporter consumer who is the patient received through a Communication Pfizer Colleague who is patient's friend. This is the second of two reports provided by the same Pfizer employee (Communication Pfizer Colleague).   A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unspecified) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever and arm pain. Outcome of events fever and arm pain was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Linked Report(s) : GB-PFIZER INC-2021540134 Different patient, same suspect product, reported trough the same Pfizer employee
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Vaccination site erythema, Vaccination site infection
Clinical narrative: Injection site was swelling and itching; Injection site was swelling and itching; site is very red with minor swelling; Feeling "tired but not lethargic"; Her head "was a little fuzzy that morning and I didn't want to get up, and I wasn't hungry"/Brain fog; Injection site reactions including pain, redness, swelling, and itching; she may have an infection at the injection site; Felt off: described as fuzzy in head, no ambition, not hungry, but she could taste.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on 03May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included osteoporosis from an unknown date and unknown if ongoing, (she was diagnosed 5 years ago. she was diagnosed with a bone density test), latex allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. After first dose of COMIRNATY on 11May2021 patient experienced injection site was swelling and itching, site was very red with minor swelling, feeling "tired but not lethargic", her head "was a little fuzzy that morning and she didn't want to get up, and she wasn't hungry"/brain fog, injection site reactions including pain, redness, swelling, and itching, she may have an infection at the injection site, felt off and described as fuzzy in head, no ambition, not hungry, but she could taste on an unspecified date in 2021. The outcome of the event vaccination site pruritus was recovering, foggy feeling in head was recovered on 12May2021 and unknown for another events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site was swelling and itching; Injection site was swelling and itching; site is very red with minor swelling; Feeling "tired but not lethargic"; Her head "was a little fuzzy that morning and I didn't want to get up, and I wasn't hungry"/Brain fog; Injection site reactions including pain, redness, swelling, and itching; she may have an infection at the injection site; Felt off: described as fuzzy in head, no ambition, not hungry, but she could taste.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on 03May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included osteoporosis from an unknown date and unknown if ongoing, (she was diagnosed 5 years ago. she was diagnosed with a bone density test), latex allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. After first dose of COMIRNATY on 11May2021 patient experienced injection site was swelling and itching, site was very red with minor swelling, feeling "tired but not lethargic", her head "was a little fuzzy that morning and she didn't want to get up, and she wasn't hungry"/brain fog, injection site reactions including pain, redness, swelling, and itching, she may have an infection at the injection site, felt off and described as fuzzy in head, no ambition, not hungry, but she could taste on an unspecified date in 2021. The outcome of the event vaccination site pruritus was recovering, foggy feeling in head was recovered on 12May2021 and unknown for another events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in both feet.; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 25Apr2021 (age at vaccination: 62 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, 4 days later, the patient experienced numbness in both feet. They are better but are still numb. She was supposed to get the second dose on Sunday. The outcome of the event was unknown. There was no product quality complaint (PQC) present.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Diarrhoea, Migraine, Nausea, Pain
Clinical narrative: Severe migraines; nauseousness; diarrhea; body aches; This is a spontaneous report from a contactable consumer (patient herself) via. A 65-year-old (non-pregnant) female patient received first dose of bnt162b2 (Solution for injection; Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 10:00 (at the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included type 1 diabetes and vascular disease. Concomitant medication included insulin for unspecified indication. Patient did not receive any vaccine in 4 weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 24Apr2021 at 01:00, patient experienced severe migraines, 6 total starting 40 hrs, nauseousness, diarrhea and body aches. The patient underwent lab tests and procedures which included computerised tomogram scan results of which was unknown. Therapeutic measures were taken as a result of the events and patient was treated with nauseous medication and Axert for migraines. Outcome of the events was not recovered.  No follow-up attempts are Possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Migraine
Clinical narrative: Severe migraines; nauseousness; diarrhea; body aches; This is a spontaneous report from a contactable consumer (patient herself) via. A 65-year-old (non-pregnant) female patient received first dose of bnt162b2 (Solution for injection; Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 10:00 (at the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included type 1 diabetes and vascular disease. Concomitant medication included insulin for unspecified indication. Patient did not receive any vaccine in 4 weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 24Apr2021 at 01:00, patient experienced severe migraines, 6 total starting 40 hrs, nauseousness, diarrhea and body aches. The patient underwent lab tests and procedures which included computerised tomogram scan results of which was unknown. Therapeutic measures were taken as a result of the events and patient was treated with nauseous medication and Axert for migraines. Outcome of the events was not recovered.  No follow-up attempts are Possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dysstasia, Pain, Pyrexia
Clinical narrative: severe knee pain has persisted/can't barely stand or walk my knees Ache/extreme soreness in all my joints; had cold chilies was extreme uncomfortable; can't Barely stand or walk my knees Ache and are just uncomfortable at all times; Fever; body aches all over; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8729, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. Medical history included underactive thyroid. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had severe knee pain has persisted (considered serious for disability/incapacitating) and has not improved whatsoever/can't barely stand or walk my knees ache and are just uncomfortable at all times, and extreme soreness in all my joints (reported to primary care physician and orthopedic physician repeatedly), had cold chilies was extreme uncomfortable, fever, and body aches all over on 16Apr2021 at 15:00. The events resulted in a physician office visit. Treatment for the events included celecoxib (CELEBREX) and cortisone injections in knee. The outcome of the events knee pain, chills, can't barely stand was not recovered. The outcome of the events fever and pain was recovered in Apr2021. COVID test post vaccination via Nasal Swab was negative in 2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pain, Pyrexia, Walking aid user
Clinical narrative: severe knee pain has persisted/can't barely stand or walk my knees Ache/extreme soreness in all my joints; had cold chilies was extreme uncomfortable; can't Barely stand or walk my knees Ache and are just uncomfortable at all times; Fever; body aches all over; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8729, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. Medical history included underactive thyroid. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had severe knee pain has persisted (considered serious for disability/incapacitating) and has not improved whatsoever/can't barely stand or walk my knees ache and are just uncomfortable at all times, and extreme soreness in all my joints (reported to primary care physician and orthopedic physician repeatedly), had cold chilies was extreme uncomfortable, fever, and body aches all over on 16Apr2021 at 15:00. The events resulted in a physician office visit. Treatment for the events included celecoxib (CELEBREX) and cortisone injections in knee. The outcome of the events knee pain, chills, can't barely stand was not recovered. The outcome of the events fever and pain was recovered in Apr2021. COVID test post vaccination via Nasal Swab was negative in 2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: severe knee pain has persisted/can't barely stand or walk my knees Ache/extreme soreness in all my joints; had cold chilies was extreme uncomfortable; can't Barely stand or walk my knees Ache and are just uncomfortable at all times; Fever; body aches all over; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8729, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. Medical history included underactive thyroid. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had severe knee pain has persisted (considered serious for disability/incapacitating) and has not improved whatsoever/can't barely stand or walk my knees ache and are just uncomfortable at all times, and extreme soreness in all my joints (reported to primary care physician and orthopedic physician repeatedly), had cold chilies was extreme uncomfortable, fever, and body aches all over on 16Apr2021 at 15:00. The events resulted in a physician office visit. Treatment for the events included celecoxib (CELEBREX) and cortisone injections in knee. The outcome of the events knee pain, chills, can't barely stand was not recovered. The outcome of the events fever and pain was recovered in Apr2021. COVID test post vaccination via Nasal Swab was negative in 2021.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: the outer part of her right thigh went completely numb, leg was numb; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route in the left arm on 11May2021 (age at vaccination: 20-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), as a single dose of covid-19 immunization. On 12May2021 around 11:30, patient stated that outer part of her right thigh went completely numb and states that it has been like that for a little over 24 hours now. She got the shot in left arm but, she is not sure why her leg was numb. Patient would like to know if this is normal with the vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Cardiac disorder
Clinical narrative: taking Metoprolol, for blood pressure and his heart; taking Metoprolol, for blood pressure and his heart; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0164 or EW0184, Expiration date: 31Aug2021), via an unspecified route of administration on 22Apr2021 as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. Medical history included allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY, Batch/lot number: 1771730) via unspecified route of administration on 13May2021 as 10 mg, daily for allergies, fluticasone propionate via unknown route on 13May2021 as usually one puff, sometimes two puff in each nostril. Patient received first COVID-19 Vaccine on 22Apr2021. Patient was taking metoprolol, for blood pressure and his heart on 13May2021. Patient wants to know if it is ok to get his second COVID-19 Vaccine today since patient took Zyrtec and Flonase nasal spray this morning. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral, Influenza like illness
Clinical narrative: Flu like symptoms; Body ache; My left arm upper left arm in muscle stacks, It is still hurts, when I am lift up my arm is painful.; Sweaty and hot like a fever; Sweaty and hot like a fever; Sweaty and hot like a fever; muscle ache; i can't get out of bed; In my mouth started feeling numb, my cheek on my face is feeling numb.; In my mouth started feeling numb, my cheek on my face is feeling numb.; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0168; Expiration Date: Aug2021), dose 1 via an unspecified route of administration in arm left on 11May2021 at 11:05(age at the vaccination 56-years-old) as single dose for COVID-19 immunisation. Medical history included anxiety, ongoing cardiac disorder (heart condition), diabetes mellitus patient reported she was earlier diagnosed with diabetes but her not any more diabetic. Concomitant medications included clonazepam (MANUFACTIURER UNKNOWN) taken for anxiety, calcium carbonate, cholecalciferol (VITAMIN D 2000). The consumer stated that after the vaccine was administered to her then after three or five minutes, her mouth started feeling numb, she cheek on her face started feeling numb. So, she had to wait to be observed and she need to see her physician for follow up primary but, also the side effects like the next day almost like she had a flu like symptoms these are side effects. Consumer also stated that sweaty and hot like a fever and body ache and she can't get up of bed, a body ache, that's not giant like a muscle ache, and it hurts, and then her arm was like; she can't move it, but that was last night but she okay, she walking around, she alive and alright, it's just that she had to follow what doctor told her at the clinic, where they, not the clinic, IOG, where they gave me the shot, the vaccine, that she have to follow up with her primary doctor and today was second date, second date of vaccine. She had not feeling like before so that's why she here at the doctor clinic waiting for it to open. She just sharing that with you because she was told to by the physician. She primary doctor told her to take Vitamins long ago and Vitamin D taken once a day Vitamin that's all she takes and wanted to take Clonazepam if she really needs it. Therapeutic measures were taken as a result of events included treatment with Only took Tylenol. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Flu like symptoms; Body ache; My left arm upper left arm in muscle stacks, It is still hurts, when I am lift up my arm is painful.; Sweaty and hot like a fever; Sweaty and hot like a fever; Sweaty and hot like a fever; muscle ache; i can't get out of bed; In my mouth started feeling numb, my cheek on my face is feeling numb.; In my mouth started feeling numb, my cheek on my face is feeling numb.; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0168; Expiration Date: Aug2021), dose 1 via an unspecified route of administration in arm left on 11May2021 at 11:05(age at the vaccination 56-years-old) as single dose for COVID-19 immunisation. Medical history included anxiety, ongoing cardiac disorder (heart condition), diabetes mellitus patient reported she was earlier diagnosed with diabetes but her not any more diabetic. Concomitant medications included clonazepam (MANUFACTIURER UNKNOWN) taken for anxiety, calcium carbonate, cholecalciferol (VITAMIN D 2000). The consumer stated that after the vaccine was administered to her then after three or five minutes, her mouth started feeling numb, she cheek on her face started feeling numb. So, she had to wait to be observed and she need to see her physician for follow up primary but, also the side effects like the next day almost like she had a flu like symptoms these are side effects. Consumer also stated that sweaty and hot like a fever and body ache and she can't get up of bed, a body ache, that's not giant like a muscle ache, and it hurts, and then her arm was like; she can't move it, but that was last night but she okay, she walking around, she alive and alright, it's just that she had to follow what doctor told her at the clinic, where they, not the clinic, IOG, where they gave me the shot, the vaccine, that she have to follow up with her primary doctor and today was second date, second date of vaccine. She had not feeling like before so that's why she here at the doctor clinic waiting for it to open. She just sharing that with you because she was told to by the physician. She primary doctor told her to take Vitamins long ago and Vitamin D taken once a day Vitamin that's all she takes and wanted to take Clonazepam if she really needs it. Therapeutic measures were taken as a result of events included treatment with Only took Tylenol. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Hypoaesthesia oral, Wheezing
Clinical narrative: Slight numbness on my upper part of my mouth; Felt aching joints; Wheezing; Headache; Cough; This is a spontaneous report from a contactable consumer (patient). A 59-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0167, Expiration Date: Aug2021), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included Hypertension (Blood pressure high), Antiphospholipid syndrome, Seizures. Concomitant medication(s) included oxcarbazepine (TRILEPTAL) taken for seizure; metoprolol taken for an unspecified indication; simvastatin taken for an unspecified indication; warfarin taken for an unspecified indication. On an unspecified date patient experienced slight numbness on my upper part of my mouth, felt aching joints, wheezing, headache, cough. Consumer stated, "I think it was, it was Friday the 28th of April (year not clarified), believe that was the day I got my Pfizer Vaccine and it like within a few minutes I felt like a slight numbness on my upper part of my mouth and then it went on from there and later that day I just felt aching joints like all of my joints. I had a wheezing, cough, it just kept progressively getting worse and worse, until it's still that way right now. I take Tylenol. My doctor said that it's alright because I already have like a blood sickness problem. I have to take Coumadin to keep my blood thin enough so I will not have a seizure or stroke. Those are the two things. So, I was supposed to call and tell you according to my doctor's office that I should tell the company what my reaction was and it just, it is not what I expected. I never thought it would bother me at all and it also covered my daughter too (Further clarification unknown). She felts better now, I don't. When I have a headache every time the Tylenol wears off and that's what like, you know the whiplashes like if you get ruined in the car and your head snaps back and you get your head hurt usually after you get in an accident, at the back of my neck it's like that, that's what I had everyday I wake up, without Tylenol. I just feel so terrible so I don't know what you wanna do with reaction I just was recommended to tell that to you so the company (incomplete sentence.)" When probed for the treatment, consumer stated, "Just Tylenol. Consumer stated, "I don't think I can take the last shot if that one hit me this hard. I don't think I'm going to take it. I will not be taking the second shot of the vaccination. I just can't risk that. I can't have it, not worth the reaction. I'm not going to do it." The outcome of all events was unknown.  QR comment: This case might be a split. However, split case not made by the call handler.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Heart rate increased
Clinical narrative: Feeling chest pains- tightness and high pressure and quicker heartbeat.; Feeling chest pains- tightness and high pressure and quicker heartbeat.; Feeling chest pains- tightness and high pressure and quicker heartbeat.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 at 11:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was reported that the patient had no allergies to medications, food, or other products. Concomitant medications taken within two weeks prior to vaccination included biotin (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 16:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 15:30, the patient started feeling chest pains- tightness and high pressure and quicker heartbeat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events feeling chest pains- tightness and high pressure and quicker heartbeat was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported, NDC number, UPC number, expiry date were reported as unknown) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever and chills on an unspecified date. The events were reported as non-serious. The patient asked if there was a need to visit the hospital, or this were common side effect which will eventually subside. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Menstruation irregular
Clinical narrative: Early ovulation resulted in pregnancy; Shift in menstrual cycle, approximately 8 days early.; The initial case was missing the following minimum criteria: [unspecified AE]. Upon receipt of follow-up information on 26Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). This is a maternal report. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via intramuscular, route, administered in left deltoid on 19Mar2021 at 10:15 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via intramuscular, route, administered in left deltoid on 19Feb2021 at 15:15 (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. On 10Apr2021, the patient experienced shift in menstrual cycle, approximately 8 days early and mentioned that early ovulation resulted in pregnancy on an unknown date. The patient was trying to get pregnant so she was happy about it but wanted to report the possible issue so that women who do not want to be pregnant can be informed if this was not coincidental. Thank you for your time and attention to this matter. An unspecified therapeutic measure was taken because of shift in menstrual cycle, approximately 8 days early. The outcome was recovering for the reported event.  Follow-up (26Jul2021): Follow-up spontaneous report received from a contactable consumer (patient) includes: events added, case updated as valid.  Information about lot/batch number has been requested.