chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram, Gait inability, Muscular weakness, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient of an unspecified age received BNT162B2, via an unspecified route of administration on 20Feb2021, at the age of 73-years-old, (Batch/Lot Number: EN6201) as DOSE 2, SINGLE for COVID-19 immunization.  The patient's medical history includes sciatica and cataracts. Concomitant medications were not reported. Historical vaccine include dose 1 of BNT162B2 received on 30Jan2021 (Lot Number: EL9269). The patient stated after her first dose she had no problems, then after her second dose, 6 days later when she got out of her car she can hardly walk which gets worse after that. She says she went to see her daughter because they were gonna leave for the city and she wanted to see her, and it was a 2.5 hour car ride, after which she could hardly walk, which her husband said will go away. She says she has been relying on Tylenol and Advil to get by. She says it is a long story. She says she decided she can't take anymore and went to the emergency room on 12Apr2021, and waited all day to be seen in the ER, and when they finally saw her the doctor took a CAT scan and sent her to physical therapy, which she had 4 visits. She says that she did her therapy, and she had to do Tylenol before her PT visits or she would have been in pain when she does the stuff. She says she has been doing therapy religiously, but she can't do it every day because if she does it, that day she is shot. She says she has to take Tylenol, and sometimes when she bends over cooking she gets a terrible pain in her back. She says everyone says oh it's a coincidence, but she doesn't think so, she thinks that is the story of her life now. She says she was in pretty good physical shape before all this. The outcome of the events was not recovered. Treatment was received for the events.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Sciatica
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient of an unspecified age received BNT162B2, via an unspecified route of administration on 20Feb2021, at the age of 73-years-old, (Batch/Lot Number: EN6201) as DOSE 2, SINGLE for COVID-19 immunization.  The patient's medical history includes sciatica and cataracts. Concomitant medications were not reported. Historical vaccine include dose 1 of BNT162B2 received on 30Jan2021 (Lot Number: EL9269). The patient stated after her first dose she had no problems, then after her second dose, 6 days later when she got out of her car she can hardly walk which gets worse after that. She says she went to see her daughter because they were gonna leave for the city and she wanted to see her, and it was a 2.5 hour car ride, after which she could hardly walk, which her husband said will go away. She says she has been relying on Tylenol and Advil to get by. She says it is a long story. She says she decided she can't take anymore and went to the emergency room on 12Apr2021, and waited all day to be seen in the ER, and when they finally saw her the doctor took a CAT scan and sent her to physical therapy, which she had 4 visits. She says that she did her therapy, and she had to do Tylenol before her PT visits or she would have been in pain when she does the stuff. She says she has been doing therapy religiously, but she can't do it every day because if she does it, that day she is shot. She says she has to take Tylenol, and sometimes when she bends over cooking she gets a terrible pain in her back. She says everyone says oh it's a coincidence, but she doesn't think so, she thinks that is the story of her life now. She says she was in pretty good physical shape before all this. The outcome of the events was not recovered. Treatment was received for the events.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: I've had herpes simplex since I was a child. In the past, I've had maybe 1 outbreak every year or so, but since I received the Covid vaccine, I've had 4 outbreaks.; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP6955, Expiration date not reported), via an unspecified route of administration, administered in arm left on 20Mar2021 13:00 (at the age of 47-year-old) as single dose and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170, Expiration date not reported), via an unspecified route of administration, administered in arm left on 17Apr2021 13:00 as single dose for COVID-19 immunisation. Medical history included hypertension, eosinophilic oesophagitis, spondylolisthesis, herpes simplex since child; all from an unknown date an unknown if ongoing. The patient had no known allergies. Concomitant medication(s) included lysine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN); all taken for an unspecified indication, from unknown start date and all received within 2 weeks of vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 04May2021, the patient reported that in the past, she had maybe 1 outbreak every year or so, but since she received the covid vaccine, she has had 4 outbreaks. The seriousness of the event was reported as non-serious. No treatment received for the event. The clinical outcome of events was resolving.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, Pneumonia, SARS-CoV-2 test
Clinical narrative: deathly ill; tested positive for COVID/the Pfizer didn't work; tested positive for COVID; pneumonia; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's ex-wife). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the first and second Pfizer vaccine and was deathly ill and tested positive for COVID. The reporter wanted him to have Johnson and Johnson booster shot because the Pfizer didn't work. The patient got the covid vaccine and ended up getting covid. The reporter reported he probably won't make it. He had pneumonia. He was on an antibiotic for pneumonia and also on oxygen. If he passes away there will be a real problem. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date.  The outcome of the events was unknown.  Information about lot/batch number was requested.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Movement disorder
Clinical narrative: Joints are in pain; I cannot moved normally/ I can not do any job with my hands; This is a spontaneous report from a contactable consumer. A 58-years-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified rout of administration on an unspecified date (at the age of 58-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joints are in pain and can not moved normally. It was reported that "after my second doses of the covid vaccination my joints are in pain. My blood test are fine but I can not moved normally. My joints are in pain even after a take a pain medicine. I am 58 years and never had any conditions to be worried but is been 6 month after my shot that I can not do any job with my hands". Treatment for joints are in pain was given. Outcome of the events was not recovered.   Information on lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing problem; This is a spontaneous report from a contactable consumer (Patient's husband). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 15Feb2021(at the age of 80 years old) and dose 2 via an unspecified route of administration on 05Mar2021(at the age of 80 years old) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced coughing problem on an unspecified date on 2021. Reporter stated, "I am calling for my wife (consumer). She was vaccinated for first shot (dose) on 15Feb2021 and second dose vaccine on 05Mar2021 and since then she is having coughing problems and she keeps going to Doctors, Pulmonologist specialist, Nose Throat and Ear specialist. I have a list of all the medicines that she was prescribed in the last 4-5 months. She is still coughing and came to make a solution, she can have sort of problem, so she is concerned that it could be a problem that she got the vaccine. Adverse event resulted in physician office visit. Therapeutic measures were taken as a result of coughing problem. Outcome of the event was not recovered.  Information about Lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Insomnia, Lymphadenopathy, Pain in extremity
Clinical narrative: heart rate accelerated, still happening; Arm pain up to chest, still present; hard to sleep now; Swollen glands in left arm; Arm pain up to chest, still present; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left arm on 27Apr2021 14:00 (at the age of 48-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroid, GERD, obesity and known allergy to latex. Concomitant medications included thyroid (ARMOUR THYROID); omeprazole; aminobenzoic acid, biotin, choline bitartrate, folic acid, inositol, lecithin, vitamin b nos (B100); and multivitamins. The patient previously took sulfa drugs and experienced allergies, and historical vaccine included first dose of BNT162B2 (Lot Number not reported) via an unspecified route of administration, administered in left arm on 30Mar2021 15:00 at a single dose for COVID-19 immunization. Prior to vaccination, the patient did not have COVID and had no other vaccines within four weeks. The patient experienced heart rate accelerated, still happening, arm pain up to chest, still present, which made it hard to sleep for her and swollen glands in left arm on 27Apr2021 15:00.  The patient underwent lab tests and procedures which included COVID-19 nasal swab test which was negative on 01Jul2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was given for the events, also reported that swollen glands in left arm eventually received ant. The outcome of the events was reported as not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: heart rate accelerated, still happening; Arm pain up to chest, still present; hard to sleep now; Swollen glands in left arm; Arm pain up to chest, still present; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left arm on 27Apr2021 14:00 (at the age of 48-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroid, GERD, obesity and known allergy to latex. Concomitant medications included thyroid (ARMOUR THYROID); omeprazole; aminobenzoic acid, biotin, choline bitartrate, folic acid, inositol, lecithin, vitamin b nos (B100); and multivitamins. The patient previously took sulfa drugs and experienced allergies, and historical vaccine included first dose of BNT162B2 (Lot Number not reported) via an unspecified route of administration, administered in left arm on 30Mar2021 15:00 at a single dose for COVID-19 immunization. Prior to vaccination, the patient did not have COVID and had no other vaccines within four weeks. The patient experienced heart rate accelerated, still happening, arm pain up to chest, still present, which made it hard to sleep for her and swollen glands in left arm on 27Apr2021 15:00.  The patient underwent lab tests and procedures which included COVID-19 nasal swab test which was negative on 01Jul2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was given for the events, also reported that swollen glands in left arm eventually received ant. The outcome of the events was reported as not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood grouping, Death
Clinical narrative: patient died after receiving the 1st dose of the vaccine; This is a spontaneous report from a non-contactable consumer (patient's sister) via a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient died after receiving the 1st dose of the vaccine on an unspecified date. The patient underwent lab tests and procedures which included blood grouping: AB negative on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: patient died after receiving the 1st dose of the vaccine
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive covid result, same day. get a runny nose, woke up very tired and congested; positive covid result, same day. get a runny nose, woke up very tired and congested; This is a spontaneous report from a contactable Pharmacist, the Patient.   A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL3247; Expiration Date: Unknown), as dose 2, via intramuscular route of administration, on Arm Left on 15Mar2021 09:00, dose 1 (Lot Number: EL3247), (at the age of 49 years) as dose 1, via intramuscular route of administration, on Arm Left on 22Feb2021 09:00 as single dose for COVID-19 immunisation. The patient medical history was none and concomitant medications were not reported. On 26Jul2021, patient experienced runny nose, on 27Jul2021, he woke up with very tired and congested. He took a COVID PCR test on 27Jul2021. No Known allergies reported. No other vaccine administered in four weeks. Other medications in two weeks were none. No COVID vaccination prior. Post vaccination patient was not diagnosed with COVID-19. Patient did not received treatment. The outcome of the event was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 . The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: she feels like her toes are numb,; This is a spontaneous report from a contactable consumer or other non-HCP. A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 21Jul2021 as DOSE 2, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jul2021, the patient experienced she feels like her toes are numb. The outcome of event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: whole arm is swollen; The whole arm is not sore, only the upper part where she received the vaccination; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in arm on 27Jul2021 19:00 (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing blood pressure high (this for quite a few years/mother had high blood pressure along with her sisters), macular degeneration (diagnosed a couple of years ago), heart murmur and cancer (dad had cancer). The caller has a ton of allergies so she was hesitant about getting the vaccine. Prior to vaccinations, no medication received within 4 weeks. Investigation Assessment was no. When the caller takes the flu vaccine she gets the regular one, not the one that the elderly people get because of all of her allergies. Concomitant medications included allopurinol (ELAVIL); lorazepam (MANUFACTURER UNKNOWN); omeprazole magnesium (PRILOSEC); folic acid (MANUFACTURER UNKNOWN); pyridoxine hydrochloride/riboflavin (VITAMIN B2 + B6); all for an unspecified indication, from an unspecified date and unknown if ongoing, lisinopril (MANUFACTURER UNKNOWN) for blood pressure high, start and stop date were not reported; carvedilol (MANUFACTURER UNKNOWN) for blood pressure, start and stop date were not reported; telmisartan (MANUFACTURER UNKNOWN) for blood pressure high, start and stop date were not reported; dicycloverine hydrochloride (BENTYL) for stomach, start and stop date were not reported; paracetamol (TYLENOL) for aches and pain, start and stop date were not reported; ondansetron (ZOFRAN MELT) for nausea, start and stop date were not reported. The patient received her first dose of the Pfizer COVID-19 Vaccine yesterday, 27Jul2021 19:00. This morning her arm was sore and swollen all the way down the arm. The whole arm was not sore, only the upper part where she received the vaccination but the whole arm was swollen. Caller would like to know if this was normal. Caller states that she would see her Nurse Practitioner tomorrow, she comes there twice a week. Patient has taken her blood pressure medication and states she could take Tylenol and anything else she can do. The caller was calling about the Pfizer covid vaccine. The caller had the vaccine around 7:00 last night. The caller knows the arm being sore was normal but her whole arm was swollen. This event happened after the first dose. These events started this morning. When the caller lifted her sleeve she noticed her whole arm was swollen. This was the same arm that she received the vaccine in. The event does not require a visit to emergency room and physician office. The outcome of events was not resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Tinnitus
Clinical narrative: Pain in the arm grew and got worse; Pain in the arm grew and got worse; Pain in the arm grew and got worse.  Spread up arm to shoulders; Severe tennitis; This is a spontaneous report from a contactable consumer or other non hcp. A 65-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 13Apr2021 12:00 (at the age of 65-years) (Batch/Lot Number: EW0153) as dose 1, single for covid-19 immunisation. Medical history was reported as none. The patient had no concomitant medications. 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 13Apr2021 at 01:00 PM the patient expereinced pain in the arm grew and got worse. Spread up arm to shoulders. Severe tennitis. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with pain killers, exercise. The outcome of the events were not recovered.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Fall, Hypoaesthesia, Paraesthesia
Clinical narrative: Started on her right side and that numbness going up to her breast, went up into shoulders and down arms and whole side was numb, on the right-side, starting at hip and and going directly to toes; Fell down after losing her balance and thought she had a blood clot or stroke; Fell down after losing her balance and thought she had a blood clot or stroke; She was tingly; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This female consumer (patient) reported that.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry was not reported) via an unspecified route of administration on 29Jun2021 as a dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date was not reported) via unspecified route of administration on unspecified date as a dose 1, single for covid-19 immunisation. It was reported that on an unspecified date, the patient had numbness in her hip that went directly to her toes and immediately, after that it started on her right side and that numbness going up to her breast, went up into her shoulders and down her arms and her whole side was numb again on the right side. She fell down after losing her balance and thought she had a blood clot or stroke and then she was tingly after that and she went to the emergency room, they did a CAT scan, and they did CAT scan with contrast and they were looking for the blood clot and then they did ultrasound of her right leg and found nothing. She never had anything like this happened before and she believe that could possibly be a side effect of the vaccine and that was why she called and left me that message today. The reporter was asking what happens after that and will she get contacted or what happens. Caller stated She went to the hospital and I do not know what they gave her at the hospital. (further clarification about hospitalization was unknown). The patient underwent lab tests and procedures which included computerised tomogram was unknown result, CAT scan with contrast'they were looking for the blood clot, ultrasound scan was found nothing ultrasound of her right leg on an unspecified date. Outcome of the events was unknown.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Started on her right side and that numbness going up to her breast, went up into shoulders and down arms and whole side was numb, on the right-side, starting at hip and and going directly to toes; Fell down after losing her balance and thought she had a blood clot or stroke; Fell down after losing her balance and thought she had a blood clot or stroke; She was tingly; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This female consumer (patient) reported that.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry was not reported) via an unspecified route of administration on 29Jun2021 as a dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date was not reported) via unspecified route of administration on unspecified date as a dose 1, single for covid-19 immunisation. It was reported that on an unspecified date, the patient had numbness in her hip that went directly to her toes and immediately, after that it started on her right side and that numbness going up to her breast, went up into her shoulders and down her arms and her whole side was numb again on the right side. She fell down after losing her balance and thought she had a blood clot or stroke and then she was tingly after that and she went to the emergency room, they did a CAT scan, and they did CAT scan with contrast and they were looking for the blood clot and then they did ultrasound of her right leg and found nothing. She never had anything like this happened before and she believe that could possibly be a side effect of the vaccine and that was why she called and left me that message today. The reporter was asking what happens after that and will she get contacted or what happens. Caller stated She went to the hospital and I do not know what they gave her at the hospital. (further clarification about hospitalization was unknown). The patient underwent lab tests and procedures which included computerised tomogram was unknown result, CAT scan with contrast'they were looking for the blood clot, ultrasound scan was found nothing ultrasound of her right leg on an unspecified date. Outcome of the events was unknown.  Information on lot/ batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Extreme pain in my right knee and thigh/extreme pain my left ankle and calve; Extreme pain in my right knee and thigh/extreme pain my left ankle and calve; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in arm right on 21Mar2021 13:00 (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Known allergies was none. Prior to vaccination, the patient had not detected with Covid. Post vaccination, the patient had not tested Covid. No other vaccine in four weeks. Concomitant medications included ticagrelor (BRILINTA); naproxen (MANUFACTURER UNKNOWN); boswellia serrata/resin/colecalciferol/collagen (OSTEO BI-FLEX); ascorbic acid (VIT C); vitamin d3 (MANUFACTURER UNKNOWN); vitamin b complex (B COMPLEX); acetylsalicylic acid (LOW DOSE ASPIRIN); atorvastatin calcium (LIPITOR), all for an unspecified indication, start and stop date were not reported. The patient experienced extreme pain in my right knee and thigh. Got the second shot on 04Mar2021 and 2 days later developed extreme pain my left ankle and calve on 24Mar2021. Pain has not left yet. Had prednisone twice, methyl prednosolone, diclofenac sodium tablets, tramadol again. The pain has not gone away yet. The orthopaedist said something was keeping his tendon inflamed. Bear in mind she had no pain anywhere prior to getting the first shot. The adverse event resulted in doctor or other healthcare professional office or clinic visit. The patient received treatment as prednisone and tramadol for adverse event. Therapeutic measures were taken as a result of events. The outcome of event resolved with sequel on 2021.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: fever; sore throat; chills/woke up today shivering; Chill/woke up today shivering; This is a spontaneous report from a contactable consumer (patient).    A 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA7485) via an unspecified route of administration, administered in Deltoid Left on 28Jul2021 at 14:00(age at time of vaccination 37-years-old) as dose 2, single dose for covid-19 immunisation. The patient had no other medical history and no concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0202) via an unspecified route of administration, administered in Deltoid Left on 07Jul2021(age at time of vaccination 37-years-old) as dose 1, single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Caller stated that on 29Jul2021 the patient experienced chills, fever and sore throat after receiving second dose Pfizer Covid 19 Vaccine. The caller also stated that woke up today shivering, 29JUL2021. The caller took his wife to work at the hospital at 0700 and the shivering started off pretty, well wouldn't say horrible but decent. The caller stated that he took Tylenol and Ibuprofen and four hours later the chills started getting really bad again. caller stated that he was watching the time. He took second dose of Tylenol and this seems to have curved the chills. The patient took his temperature after taking Tylenol. Caller's normal resting temperature was 97.2. The patient took his temperature 30 minutes after taking Tylenol and his temperature was 98.6. The caller is assuming the temperature was 99 but doesn't know to be honest. The patient did not visit Emergency Room/Physician Office. Therapeutic measures were taken as a result of events included treatment with Tylenol 500mg took twice, once in the morning and once at 14:00 (lot number: 1683583, Expiration: Mar2023) and Ibuprofen 400mg, took twice, 1600 and before bed last night (Lot number: P88291, Expiration: FEB2016). The caller stated that Ibuprofen may have been super week because the expiration date was 2016 and he stated the Ibuprofen worked but seemed too maybe be weaker. The patient underwent lab tests and procedures which included body temperature: 97.2 on Jul2021 Normal resting temperature is 97.2, body temperature: 98.6 on Jul2021. The outcome of the events fever, sore throat, chills was not recovered and woke up today shivering was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neuropathy peripheral
Clinical narrative: Couldn't walk and was evaluated and told it was a "neuropathy"; Intermittent headaches; This is a spontaneous report from a contactable consumer. A female consumer (patient) of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications. The patient previously took bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on unspecified date in 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient had a reaction to the Pfizer Covid vaccine after the second dose, she couldn't walk and was evaluated and told it was a "neuropathy" (medically significant) on 04Jun2021. She had recovered somewhat, although she still had stabbing pain and intermittent headaches. And she says she had to get Hip MRIs done, although she did not say why. The clinical outcome of event was recovered with sequelae.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; she got a cold pretty much; they did the PCR test and the patients came back as positive; had a sore arm; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on 21Jul2021 as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. Her daughter and herself had an appointment to get the first shot of the Pfizer COVID-19 vaccine at 13:00. Patient stated that on 26Jul2021, five days after receiving the vaccine the caller tested positive for Covid. She stated she got a few symptoms nothing drastic. She stated she got a cold pretty much. She stated that the day of reporting was the first day that she was fever free. She stated that she can pretty much state that she will be fine in the next couple of days. On 22Jul2021, patient had a sore arm the other than that she was fine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jul2021. The outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Odynophagia, Pyrexia, Thyroiditis subacute
Clinical narrative: Thyroiditis subacute; Neck pain; Odynophagia; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 39-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 an unspecified date as DOSE 2, SINGLE for covid-19 immunization. A safety signal of subacute thyroiditis following vaccination with the novel mRNA- and vector-based COVID-19 vaccines was found during a screening of the database of individual case safety reports. There were 29 ICSRs reporting SAT following the immunization with COVID-19 vaccines entered in the database. Most of the reports contained Pfizer/BioNTech's and Moderna's mRNA-based vaccines as suspected. This is case one of 29 reports.  The patient medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date, (Calculated Time-to-onset (TTO): 2 days), the patient experienced thyroiditis subacute, neck pain, odynophagia and pyrexia. The events were reported as non-serious. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974884 ;US-PFIZER INC-202100974885 ;US-PFIZER INC-202100974886 ;US-PFIZER INC-202100974887 ;US-PFIZER INC-202100974888 ;US-PFIZER INC-202100974889 ;US-PFIZER INC-202100974890 ;US-PFIZER INC-202100974891 ;US-PFIZER INC-202100974892
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis subacute
Clinical narrative: Thyroiditis subacute; This is a spontaneous report received from a contactable consumer or other non-health care professional. A contactable consumer reported different events for 29 patients. This is 3 of 29 reports. A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 44-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thyroiditis subacute on an unspecified date. Calculated Time to onset: 2 Months. Summary: Subacute thyroiditis (SAT) was a typically painful inflammatory condition of the thyroid. A safety signal of subacute thyroiditis following vaccination with the novel mRNA and vector-based COVID-19 vaccines was found during a screening of the regulatory authority database of individual case safety reports. Subacute thyroiditis (SAT) was an inflammatory disease of the thyroid caused by viral infections or autoimmune reactions. Up to 08Jun2021, VigiBase, the regulatory authority database of individual case safety reports, contained 29 reports of SAT (MedDRA preferred term (PT): thyroiditis subacute) following immunisation with the novel COVID-19 vaccines. Furthermore, VigiBase comprised 50 cases reporting the PT autoimmune thyroiditis and another 50 cases reporting the PT thyroiditis following COVID-19 vaccination up to 08Jun2021. In 30 of the 50 cases reported the PT autoimmune thyroiditis. The cases reported the MedDRA PT thyroiditis subacute as it was the only PT found to be disproportionately reported. In-depth analysis of the other mentioned PTs can be made available on demand. The radioactive iodine uptake (RAIU) test was a reliable test to differentiate between causes of hyperthyroidism. Low uptake suggests thyroiditis and high uptake suggests Grave's disease. In the current case series, RAIU was performed in three cases confirming the diagnosis of SAT. The presented signal was aimed to increase patient's and healthcare professional's awareness of the will be necessary. The potential benefit of the COVID-19 vaccines was considered to outweigh the possible associated risk of subacute thyroiditis. The outcome of the event was reported as not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis subacute
Clinical narrative: Thyroiditis subacute; This is a spontaneous report from a non-contactable consumer or other non health care professional.A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history included thyroid disorder. Concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient experienced thyroiditis subacute on an unspecified date. She stopped her thyroid medication and the symptoms resolved. The outcome of the event was resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :PFIZER INC-202100974883
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, C-reactive protein, C-reactive protein increased, Pyrexia
Clinical narrative: Thyroiditis subacute; C-reactive protein increased; Pyrexia; Blood thyroid stimulating hormone C-reactive protein increased; This is a spontaneous report from a non-contactable consumer. A 38-years-old female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (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. On an unspecified date, the patient experienced thyroiditis subacute, blood thyroid stimulating hormone, C-reactive protein increased and pyrexia. The lab data included on an unspecified date SARS-CoV-2 test was negative, Tri-iodothyronine was normal, ultrasound scan was abnormal, blood thyroid stimulating hormone was increased C-reactive protein increased and white blood cell count was normal. The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thyroiditis subacute, Tri-iodothyronine, Ultrasound scan, White blood cell count
Clinical narrative: Thyroiditis subacute; C-reactive protein increased; Pyrexia; Blood thyroid stimulating hormone C-reactive protein increased; This is a spontaneous report from a non-contactable consumer. A 38-years-old female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (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. On an unspecified date, the patient experienced thyroiditis subacute, blood thyroid stimulating hormone, C-reactive protein increased and pyrexia. The lab data included on an unspecified date SARS-CoV-2 test was negative, Tri-iodothyronine was normal, ultrasound scan was abnormal, blood thyroid stimulating hormone was increased C-reactive protein increased and white blood cell count was normal. The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Goitre, Headache, Odynophagia
Clinical narrative: Thyroiditis subacute; Goitre; Headache; Odynophagia; Tenderness; Blood thyroid stimulating hormone increased; Thyroxine decreased; Triiodothyronine decreased; This is a spontaneous report from a non-contactable consumer. A contactable consumer reported different events for 29 patients. This is 10 of 29 reports.   A 55-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 an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension. No pharmacotherapy. Uncertain diagnosis. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergic reaction to codeine. On an unspecified date, the patient experienced thyroiditis subacute, blood thyroid stimulating hormone increased, goitre, headache, odynophagia, tenderness, thyroxine decreased, triiodothyronine decreased and SARS-CoV-2 test and results was unknown. Time to onset for the events for 4days. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883 Same reporter/product and different patients/events
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tenderness, Thyroiditis subacute, Thyroxine, Thyroxine decreased
Clinical narrative: Thyroiditis subacute; Goitre; Headache; Odynophagia; Tenderness; Blood thyroid stimulating hormone increased; Thyroxine decreased; Triiodothyronine decreased; This is a spontaneous report from a non-contactable consumer. A contactable consumer reported different events for 29 patients. This is 10 of 29 reports.   A 55-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 an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension. No pharmacotherapy. Uncertain diagnosis. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergic reaction to codeine. On an unspecified date, the patient experienced thyroiditis subacute, blood thyroid stimulating hormone increased, goitre, headache, odynophagia, tenderness, thyroxine decreased, triiodothyronine decreased and SARS-CoV-2 test and results was unknown. Time to onset for the events for 4days. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883 Same reporter/product and different patients/events
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine, Tri-iodothyronine decreased
Clinical narrative: Thyroiditis subacute; Goitre; Headache; Odynophagia; Tenderness; Blood thyroid stimulating hormone increased; Thyroxine decreased; Triiodothyronine decreased; This is a spontaneous report from a non-contactable consumer. A contactable consumer reported different events for 29 patients. This is 10 of 29 reports.   A 55-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 an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension. No pharmacotherapy. Uncertain diagnosis. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergic reaction to codeine. On an unspecified date, the patient experienced thyroiditis subacute, blood thyroid stimulating hormone increased, goitre, headache, odynophagia, tenderness, thyroxine decreased, triiodothyronine decreased and SARS-CoV-2 test and results was unknown. Time to onset for the events for 4days. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883 Same reporter/product and different patients/events
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Antinuclear antibody, Blood thyroid stimulating hormone, Dysphagia, Full blood count
Clinical narrative: Thyroiditis subacute; Dysphagia/Difficulty swallowing,; Lymph node pain; Lymphadenopathy/significant lymph node; pain; swelling worsening over a week; This is a spontaneous report from a non-contactable consumer. This is case 11 of 29. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration in 2021 (at the age of 50-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had no past medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in 2021 (at the age of 50-years-old) (Batch/Lot number was not reported) for COVID-19 immunization. It was reported that the patient experienced thyroiditis subacute, dysphagia, lymph node pain, lymphadenopathy. She had difficulty swallowing, pain and significant lymph node, swelling worsening over a week. Calculated TTO (Time-to-onset) was reported as 21 days. On an unspecified date in 2021, the patient underwent lab tests and procedures which included Antinuclear antibody, Anti-thyroid antibody, Blood thyroid stimulating hormone, Full blood count, Metabolic function Test, Thyroxine free, Ultrasound thyroid (results were unknown for all). Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883