chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: lip tingling; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route administration on unspecified date as dose 1, single for covid-19 immunization (at the age of 50years). The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date the patient experienced lip tingling that lasted for 15 minutes following the first dose. Consumer received the first dose of the vaccine and is expected to receive the second dose tomorrow. It was explained that lip tingling may be associated to an allergic reaction. Patient HCP and vaccination provided to discuss this before receiving the second dose. The outcome of the event was unknown.  Information on lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: she had pruritus after taking the first dose.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced she had pruritus after taking the first dose on 18Feb2021. Patient was asking how to make an appointment for today's second dose schedule. Also the patient is reporting that she had pruritus after taking the first dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (PRD/SRD 12May2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Tachycardia
Clinical narrative: I am 28 weeks pregnant and received the Covid-19 vaccine yesterday; NICU for Tachycardia; This is a spontaneous report from a contactable consumer (patient). This consumer or other non hcp reported information for both mother and foetus/baby.   A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 17Feb2021 as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunization. Medical history included gestational diabetes, hypertension, self-carrier for cerebral palsy all from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for gestational diabetes, start and stop date were not reported, loratadine (CLARITINE), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (EXIPRO), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient is 28 weeks pregnant and received the covid-19 vaccine. The baby was delivered full-term. The baby weighed 3174.5grams. Full time live birth. Date of outcome of pregnancy: 23Apr2021 Gestation age at birth in weeks: 37 weeks Tachycardia treated for 3 days in NICU Infant Details: Gender: Male Length at birth: 18 in Head circumference at birth: Unknown. Upon follow-up received on 25Jun2021 included First Day of last menstrual period was 07Aug2020. Estimated date of conception was 24Aug2020-28Aug2020. Estimated delivery date was 14May2021. Gestational period at the time of initial exposure: 27 weeks 6 days 31 weeks. Mother did not smoke, drink alcohol, use illicit drugs during this pregnancy. Previous pregnancies was reported as 2 and other children was 1. Outcome of previous pregnancies was reported as 1(Elective termination), 2 (Live birth C- section), no any problems during deliver. Yes problems before delivery (Gestational Diabetes/ Hypertension. Delivery by C-section at 37 weeks). The outcome for the events was unknown.   Follow-up (25Jun2021): New information received from a contactable consumer. This consumer (patient) reported in response to EDP letter sent via follow-up letter which included that: concomitant medications added, relevant medical history added, pregnancy details added, baby details added. First dose and second dose details added.   Follow-up attempts are completed. No further information is expected.  Follow-up (05Jul2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: I am 28 weeks pregnant and received the Covid-19 vaccine yesterday; NICU for Tachycardia; This is a spontaneous report from a contactable consumer (patient). This consumer or other non hcp reported information for both mother and foetus/baby.   A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 17Feb2021 as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunization. Medical history included gestational diabetes, hypertension, self-carrier for cerebral palsy all from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for gestational diabetes, start and stop date were not reported, loratadine (CLARITINE), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (EXIPRO), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient is 28 weeks pregnant and received the covid-19 vaccine. The baby was delivered full-term. The baby weighed 3174.5grams. Full time live birth. Date of outcome of pregnancy: 23Apr2021 Gestation age at birth in weeks: 37 weeks Tachycardia treated for 3 days in NICU Infant Details: Gender: Male Length at birth: 18 in Head circumference at birth: Unknown. Upon follow-up received on 25Jun2021 included First Day of last menstrual period was 07Aug2020. Estimated date of conception was 24Aug2020-28Aug2020. Estimated delivery date was 14May2021. Gestational period at the time of initial exposure: 27 weeks 6 days 31 weeks. Mother did not smoke, drink alcohol, use illicit drugs during this pregnancy. Previous pregnancies was reported as 2 and other children was 1. Outcome of previous pregnancies was reported as 1(Elective termination), 2 (Live birth C- section), no any problems during deliver. Yes problems before delivery (Gestational Diabetes/ Hypertension. Delivery by C-section at 37 weeks). The outcome for the events was unknown.   Follow-up (25Jun2021): New information received from a contactable consumer. This consumer (patient) reported in response to EDP letter sent via follow-up letter which included that: concomitant medications added, relevant medical history added, pregnancy details added, baby details added. First dose and second dose details added.   Follow-up attempts are completed. No further information is expected.  Follow-up (05Jul2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: difficulty of breathing; chest pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included he had a lot of issues because he had a very rare disease called Von Hippel-Lindau (VHL) Disease. This disease causes him to be screened for tumors every single year. He already had 2 craniotomies to remove tumors, 2 radiation surgeries, a pancreas full of tumors and cysts which causes him to be diabetic, a few close calls, a history of a blood infection 2 years ago, and a recently broken neck. He was immunocompromised. Concomitant medications included ciclosporin (NEORAL) and prednisone (PREDNISONE) (He is immunocompromised because he takes Neoral and prednisone for life due to a kidney transplant 35 years ago). On an unspecified date, the patient experienced difficulty of breathing and chest pain. The patient was advocated to get the vaccine. The patient was scheduled for a nuclear stress test for his heart because he has been showing symptoms like difficulty of breathing, and chest pains that might be related to reflux. They wanted to know if the test may affect the vaccine and when would it be best to get the 2nd dose. It was originally thought that he would be getting the Moderna vaccine, but he got the Pfizer vaccine and that was great. The patient would love to help with the research especially because they have read that the vaccine has not been tested yet on immunocompromised people. A V-safe report has been filed. No treatment received for difficulty of breathing and an unspecified treatment received for chest pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Headache, Heart rate increased, Presyncope, Tremor
Clinical narrative: shakiness; increased heart rate; horrible headache; i have almost passed out multiple times; slurred speech; This is a spontaneous report from a contactable other HCP. A 19-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL3247) via an unspecified route of administration, administered in arm left on 04Mar2021 at 11:00 for COVID-19 immunisation. The patient medical history not reported. The patient concomitant medications included alprazolam (XANAX), ascorbic acid, beta vulgaris root, iron amino acid chelate, rosa canina fruit, rubus idaeus leaf (IRON SUPPLEMENT). The patient historical vaccine included first dose on 09Feb2021 at 07:00 PM (lot number: EL3241) as single dose for COVID-19 immunisation. Prior to 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 4 weeks prior to the COVID vaccine. The patient received birth control, xanax, iron supplement medications within 2 weeks of vaccination. On 04Mar2021 at 11:00 AM, the patient experienced the same reaction that get anemic, shakiness, increased heart rate, horrible headache and patient had almost passed out multiple times, had slurred speech. These happened directing after the vaccine. No treatment was received. The outcome of the event was resolving.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Chills; Temperature of 100.8F; Diarrhea; Nausea; Fatigue; she was sick; blood sugar got up to 258; This is a spontaneous report received from a contactable consumer (Patient). A 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 26Feb2021 at 11:15 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient medical history included ongoing diabetes mellitus (diagnosed 25 yrs ago. She was keeping control with medication and started insulin in Jun2020), arthritis, pain, ache, blood pressure, blood sugar and blood cholesterol (abnormal). Patient did not receive any prior vaccinations within 4 weeks and did not experienced any AEs following prior vaccinations. Concomitant medications included paracetamol (TYLENOL, once a day, started it probably 10 years ago) taken for arthritis, meloxicam (15mg, tablet once a day by mouth, has been taking for 5-6 years) taken for aches/pain, enalapril (20mg twice a day tablet by mouth) taken for blood pressure (abnormal), glipizide (10mg, 1 tablet in the morning and 1/2 a tablet in the evening with meal by mouth) taken for diabetes mellitus, saxagliptin hydrochloride (ONGLYZA, 5mg once a day by mouth, started about 2 years ago) taken for diabetes/to help with blood sugar, atorvastatin (40mg, once a day, by mouth, started taking it years ago) taken for blood cholesterol, insulin (10units once a day, injection, subcutaneous) taken to control her blood sugar/diabetes from Jun2020 and paracetamol (TYLENOL ARTHRITIS, 2 tablets a day by mouth, started it 10 years ago) taken for arthritis and all were ongoing. The patient family medical history relevant to AE and pertinent details (Include surgical procedures and dates) was none. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) administered in left upper arm on 05Feb2021 (at the age of 80-year-old) as a single dose for Covid-19 immunization. On 27Feb2021 at 13:30, the patient experienced chills, temperature of 100.8 F, diarrhea, nausea, fatigue (she could not even get out of bed) and when she was sick her blood sugar got up to 258 and on sunday (28Feb2021) came back down to 96. Chills ended 9 hours after they started, and she was back to normal. Patient received 2 regular Tylenol as a treatment for the events. Patient did not visit emergency room or physician office due to adverse events. The outcome of the event sick was recovered on an unspecified date in 2021, diarrhea, fatigue, her blood sugar got up to 258 was recovered on 28Feb2021 and rest of the events were recovered on 27Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Nausea
Clinical narrative: Chills; Temperature of 100.8F; Diarrhea; Nausea; Fatigue; she was sick; blood sugar got up to 258; This is a spontaneous report received from a contactable consumer (Patient). A 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 26Feb2021 at 11:15 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient medical history included ongoing diabetes mellitus (diagnosed 25 yrs ago. She was keeping control with medication and started insulin in Jun2020), arthritis, pain, ache, blood pressure, blood sugar and blood cholesterol (abnormal). Patient did not receive any prior vaccinations within 4 weeks and did not experienced any AEs following prior vaccinations. Concomitant medications included paracetamol (TYLENOL, once a day, started it probably 10 years ago) taken for arthritis, meloxicam (15mg, tablet once a day by mouth, has been taking for 5-6 years) taken for aches/pain, enalapril (20mg twice a day tablet by mouth) taken for blood pressure (abnormal), glipizide (10mg, 1 tablet in the morning and 1/2 a tablet in the evening with meal by mouth) taken for diabetes mellitus, saxagliptin hydrochloride (ONGLYZA, 5mg once a day by mouth, started about 2 years ago) taken for diabetes/to help with blood sugar, atorvastatin (40mg, once a day, by mouth, started taking it years ago) taken for blood cholesterol, insulin (10units once a day, injection, subcutaneous) taken to control her blood sugar/diabetes from Jun2020 and paracetamol (TYLENOL ARTHRITIS, 2 tablets a day by mouth, started it 10 years ago) taken for arthritis and all were ongoing. The patient family medical history relevant to AE and pertinent details (Include surgical procedures and dates) was none. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) administered in left upper arm on 05Feb2021 (at the age of 80-year-old) as a single dose for Covid-19 immunization. On 27Feb2021 at 13:30, the patient experienced chills, temperature of 100.8 F, diarrhea, nausea, fatigue (she could not even get out of bed) and when she was sick her blood sugar got up to 258 and on sunday (28Feb2021) came back down to 96. Chills ended 9 hours after they started, and she was back to normal. Patient received 2 regular Tylenol as a treatment for the events. Patient did not visit emergency room or physician office due to adverse events. The outcome of the event sick was recovered on an unspecified date in 2021, diarrhea, fatigue, her blood sugar got up to 258 was recovered on 28Feb2021 and rest of the events were recovered on 27Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Insomnia, Pruritus, Tremor
Clinical narrative: tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Headache, Hypoaesthesia, Vision blurred
Clinical narrative: burning in her chest; cough; Currently Feet feel kind of numb; her vision was blurred; head ache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 05Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization and experienced rash and urinary tract infection. Patient received cipro [ciprofloxacin hydrochloride] for urinary tract infection, benadryl for rash. Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she had her second dose on Friday 05Mar2021. She said that she may have done some thing wrong and reported that she was on an antibiotic for a urinary tract infection and took her last pill finished them on Friday morning. Caller was experiencing side effects, when the caller got the vaccine her vision was blurred for a little bit and had a headache, currently feet feel kind of numb. She clarified the rash was almost gone when she got her second vaccine. Her daughter, who was a nurse, sent her to get the Covid-19 vaccine and her daughter told her that she did not need to mention the rash. She said that the rash was just about gone and she did not think that the vaccine did anything to the rash. Caller mentioned that she did have some other side effects though. The caller clarified that as soon as she got the vaccine and was in the 15 minute holding area, she tried to look at her cellphone and the letters were blurry. Caller said that she had blurred vision. Then she had a headache. When she got in the car she relaxed the rest of the way home and went to bed. The next day she had a little bit of a headache, she had cough, and burning in her chest (on 06Mar2021). She said that she stayed in bed and put a heating pad on her chest. She said that she was getting better everyday. The outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea; diarrhea; throwing up; This is a spontaneous report from a contactable reporter. This consumer reported for a 68-year-old patient (Husband).   A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6200; Expiration Date: Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:00 (age at the time of vaccination was 68-year-old) as dose 2, single for COVID-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication (has to do with his heart) from an unspecified start date and ongoing; rosuvastatin calcium (ROSUVASTATIN CALCIUM) and losartan potassium (LOSARTAN POTASSIUM) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication (heart doctor gave it to him, started taking after the heart attack) from an unspecified start date and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9809; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on11Feb2021 as dose 1, single for COVID-19 immunization. The caller (wife) reported that her husband experienced diarrhea, throwing up (started at 9 am or 10 am) on 10Mar2021 which was not quite as bad as it was but he still felt awful and nausea on 11Mar2021. Stated yesterday he woke up with diarrhea and throwing up. She wondered if those were side effects or if it was a stomach virus; she knew there was a stomach virus going around. Treatment medication included Imodium 2 mg for the events. Outcome of all the events was reported as recovering.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Pain
Clinical narrative: Diarrhea; Head was hurting; Light-headed/about to pass out; Body was aching; This is a spontaneous report from a contactable consumer (reporting herself). This 65-year-old female received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: EJ020) via an unspecified route of administration and administered in right arm on 12Mar2021 (age at the time of vaccination was 65-year-old) as single dose for COVID-19 immunization. The patient's medical history included diabetes, blood pressure high. The patient's concomitant medications include amlodipine, atorvastatin, famotidine, atorvastatin (LIPITOR [ATORVASTATIN]), metformin, omeprazole, ziprasidone, fluoxetine, metoprolol tartrate, vitamin d NOS and paracetamol (tylenol extra strength), all drugs were taken for an unspecified indication, start and stop date were not reported. On an unknown date, the patient went to work on this morning (on the day of reporting), the patient experienced diarrhea, body was aching, headache and had to come home. The patient has to take off work because having light-headed and about to pass out. The patient head was hurting. Therapeutic measures were taken as a result of event and the body was aching with Tylenol extra strength and that it did not help. Product details for Tylenol extra strength included LOT# and expiration was 2/19, the LOT number was GSJAJC and 2/19. Its 2/19, that was the date on it. There was no number. When probed for confirmation about 2/19 as expiration date, consumer stated, no, it did not say date on it, it just said 2/19 and regarding NDC number patient stated that whole lot of numbers wrote here at the bottom. That was a 12 number. The patient stated that can I get a letter that the patient talked to the representative. Consumer was provided with the reference number. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash, Rash pruritic, Urticaria, Vomiting
Clinical narrative: hives; the rash is from her head all the way down to her ankles and it is very itchy; the rash is from her head all the way down to her ankles and it is very itchy; diarrhea; vomiting; The rash started in a small section on her arms and now it's moved down to her chest and up to her neck and head and down to her legs and ankles.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 12Mar2021 11:00 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient previously received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, on 19Feb2021 as dose 1, single for COVID-19 immunization. It was reported that Patient was calling about the Covid 19 vaccine. She received her second shot on Friday, 12Mar2021. By Saturday,13Mar2021 she had broken all out. She had hives, a rash, diarrhea and vomiting. And now the rash was from her head all the way down to her ankles and it was very itchy. The rash started in a small section on her arms and now it's moved down to her chest and up to her neck and head and down to her legs and ankles. On Sunday, 14Mar2021 the diarrhea and vomiting was bad. Monday, 15Mar2021 she had diarrhea. The vomiting had stopped on Sunday 14Mar2021. She went to the emergency room on Sunday, 14Mar2021 and was discharged from the emergency room. On Monday, 15Mar2021 she went to her primary care physician. Benadryl take 2 pills she doesn't know the dosage, she was also prescribed Prednisone, when querying dosage, she states she doesn't have the package with her. The outcome for the rash started in a small section on her arms and now it's moved down to her chest and up to her neck and head and down to her legs and ankles was unknown, for event diarrhea was recovering and for event vomiting was recovered on 14Mar2021 and rest all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Anxiety, Cerebral disorder, Nervousness, Screaming
Clinical narrative: Strange and crazy dreams/It's like you can't tell reality from a dream. This is very scary to me. I'm worried I might do something in my sleep like leave my house or anything; This is very scary to me; Strange and crazy dreams/It's like you can't tell reality from a dream. This is very scary to me. I'm worried I might do something in my sleep like leave my house or anything; Seems almost like this vaccine is messing with your brain; Woke up screaming; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENG207), via an unspecified route of administration, administered in right arm on 19Mar2021 at 15:30 (Age at vaccination was 61 years) as single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. No concomitant medications were reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ENG198) in right arm on 24Feb2021 at 04:00 (Age at vaccination was 61 years) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that on 19Mar2021 at 11:30 PM, she was having strange and crazy dreams. This started the night of her second dose. she woke up during the night and remember strange dreams. Last night she woke up screaming. She had never done this before. It was like you can't tell reality from a dream. This was very scary to her. She worried that she might do something in sleep like left her house or anything. This seems almost like this vaccine was messing with our brain. She did not see this listed as a side effect. Her daughter was having strange dreams as well since her second dose of the Pfizer vaccine. This had to be related to this vaccine. This was causing her lots of concern about this vaccine. She was asking for explanation why this was happening and how long it will last. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the all events was not recovered.  No follow-up attempts are needed. No further information is expected.  (Follow-up 28Jun2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: confirmation on  receipt of inquiry.  (Follow-up 28Jun2021): This is a follow-up spontaneous report contactable consumer. This 61-years-old female consumer (Patient) reported for herself that: clinical information added.  No Follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Blood test, Chest X-ray normal, Computerised tomogram normal, Depressed mood
Clinical narrative: On initial shot, felt very spacey and out of it , I had to sit down for a while . A few hours after felt shortness of breathe . Blurred vision. Was unable to sleep full night , woke up with brain fog , tinnitus ,. Following day terrible brain fog , tinnitus, shortness of breathe even when laying down . Doctor recommended 36 hours later to go to ER. Went to ER- did tons of tests and cat scan of chest and x ray. No negative scans . Discharged me with no remedy , doctor confirmed adverse reaction. On the 4th day today, tinnitus has gotten worse . Mental brain fog worse . Cannot sleep. Do not feel like myself . Feel depressed , like a cloud is following me in my head .cannot remember things . Brain is not processing and functioning normally . Ringing won?t stop. Feel like I am losing my mind . Shortness of breathe is slowly getting better , but still very prevalent .
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Feeling abnormal, Memory impairment, Scan with contrast
Clinical narrative: On initial shot, felt very spacey and out of it , I had to sit down for a while . A few hours after felt shortness of breathe . Blurred vision. Was unable to sleep full night , woke up with brain fog , tinnitus ,. Following day terrible brain fog , tinnitus, shortness of breathe even when laying down . Doctor recommended 36 hours later to go to ER. Went to ER- did tons of tests and cat scan of chest and x ray. No negative scans . Discharged me with no remedy , doctor confirmed adverse reaction. On the 4th day today, tinnitus has gotten worse . Mental brain fog worse . Cannot sleep. Do not feel like myself . Feel depressed , like a cloud is following me in my head .cannot remember things . Brain is not processing and functioning normally . Ringing won?t stop. Feel like I am losing my mind . Shortness of breathe is slowly getting better , but still very prevalent .
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: On initial shot, felt very spacey and out of it , I had to sit down for a while . A few hours after felt shortness of breathe . Blurred vision. Was unable to sleep full night , woke up with brain fog , tinnitus ,. Following day terrible brain fog , tinnitus, shortness of breathe even when laying down . Doctor recommended 36 hours later to go to ER. Went to ER- did tons of tests and cat scan of chest and x ray. No negative scans . Discharged me with no remedy , doctor confirmed adverse reaction. On the 4th day today, tinnitus has gotten worse . Mental brain fog worse . Cannot sleep. Do not feel like myself . Feel depressed , like a cloud is following me in my head .cannot remember things . Brain is not processing and functioning normally . Ringing won?t stop. Feel like I am losing my mind . Shortness of breathe is slowly getting better , but still very prevalent .
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Pain in extremity
Clinical narrative: Headache; Exhausted; Sore arm; stuffy; This is a spontaneous report received from a non-contactable consumer. An adult (non-pregnant) female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 20Mar2021, at dose 2, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown), via an unspecified route of administration on 27Feb2021 at dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19. On an unspecified date, the patient experienced headache, stuffy, exhausted and pain in arm/ sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received treatment for the reported events. The clinical outcome of events headache, stuffy, exhausted and pain in arm/sore arm was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment (01Jul2021): This follow-up report is being submitted to amend previously reported information: Country of patient added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, SARS-CoV-2 test, Swelling
Clinical narrative: significant swelling between collarbone and neck on the side of injection; pain in collarbone; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205), via an unspecified route of administration in left arm on 17Mar2021 at 13:00 (at the age of 53-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included allergy to bixin, asthma, antiphospholipid syndrome and raynauds. Concomitant medications included acetylsalicylic acid (ASPRIN), gabapentin, pantoprazole, cetirizine hydrochloride (CETRIZINE), unspecified medication. The patient previously received rofecoxib (VIOXX) and experienced allergy to Vioxx. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 16:15, the patient experienced significant swelling between collarbone and neck on the side of injection, pain in collarbone area. Also moderate swelling in the same area on the other side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test and procedure which included PCR (other): Unknown results on 22Mar2021. No treatment medications were taken for the events. The clinical outcome for the swelling neck and bone pain was not resolved.  No follow-up attempts needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: VAERS Primary Reporter Addl Qualification updated to patient, age at vaccination updated to 53 years old, narrative relevant sentence updated, past drug event #5 reaction added and coded as drug allergy, allergies to bixin added as relevant med history, vaccine start date/time updated to 17Mar2021 at 13:00, vaccine facility information added, concomitant drug vita removed, then concomitant therapy checked, final sentence in analysis tab updated to no follow-up attempts needed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: paresthesia down right arm.; This is a spontaneous report from a non-contactable other healthcare professional. A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route of administration on 18Mar2021 (at the age of 30-year-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: unknown) via an unspecified route of administration on an unknown date, for COVID-19 immunization. On 18Mar2021, during 15 min of waiting period after the injection, the patient experienced paraesthesia down right arm. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling, tongue swelling and weakness in arm. The patient's treatment included ice pack and the follow up response to treatment was fair. The patient was stable to go home and follow up with primary care physician. The clinical outcome of the event paraesthesia was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Country added in patient tab, Dose Number/ Dose Description updated to 2nd dose, and Lot number updated as unknown in narrative for 1st dose.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Cramping; Diarrhea; This is a spontaneous report from a contactable nurse (the patient). A 77-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route on left arm on 11Feb2021 at 14:00 (at age of 77-year-old at vaccination) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had medical history of hypertensive. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE); biotin; glucosamine; metoprolol succinate (TOPROL XL); fish oil for unknown indications within 2 weeks prior to the COVID vaccine. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient previously took scopolamine [hyoscine butylbromide] and demerol and experienced drug allergy. On 18Feb2021 at 12:15 PM, the patient experienced cramping and diarrhea starting a week after first shot and lasting 2 weeks after second shot. Doctor or other healthcare professional office/clinic visit for the events. The events were treated with Imodium and Bentyl. The outcome of the events of cramping and diarrhea was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives (1 hive on chest); This is a spontaneous report received from a non-contactable other healthcare professional. A 54 years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205, Solution for injection) via an unspecified route administration on 22Mar2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 22Mar2021 (during 15 minutes waiting period after the injection), the patient experienced hives; she complained about 1 hive on chest. The patient denied difficulty breathing, difficulty swallowing, wheezing and throat tight-ness. Therapeutic measures were taken as a result of hives and included treatment with antihistamines (unspecified). Follow up response to treatment was good. The patient was stable to go home and followed up with PCP (primary care provider). The clinical outcome of the event hive on chest was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information:  Event term "hive on chest" updated as "hives (1 hive on chest)" per source reported; Outcome previously captured as "Recovering/Resolving" per verbatim "Stable to go home", pending PSSR review and Final sentence "No follow-up attempts are needed. No further information was expected." updated as "No follow-up attempts are possible. No further information is expected."
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Painful respiration, Pulmonary pain, Throat irritation
Clinical narrative: I expected fever and tiredness but no where online or in person has anyone said anything about throat and lung pain. Ever since I woke up the next morning after receiving the vaccine my throat burns and my lungs ache with each breath I take. Hot beverages stop it for a short amount of time and ibuprofen (though it is child ibuprofen but I am not good at taking pills) worked at first and hasn't really since the first time. In theory my brother has also been experiencing this sort of pain but all he is saying in regards to it is that his chest hurts.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout flare-up left foot second toe and ball.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: fear of 104. Muscle pain.  Severe headache
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Circumoral oedema, Condition aggravated, Immunology test normal, Oesophageal pain, Oesophageal spasm
Clinical narrative: Peri-oral edema, hives, esophageal spasm/pain. Avoiding NSAIDs and taking fexofenadine have been preventive.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: Peri-oral edema, hives, esophageal spasm/pain. Avoiding NSAIDs and taking fexofenadine have been preventive.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Muscle fatigue, Pain in extremity
Clinical narrative: Lower body muscle fatigue, hip/knee/feet skeletal pain, body joint inflammation, energy loss.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Pt stated she was nervous getting shot before shot was given due to side effects. while being observed,she said she felt hot and dizzy. gave apple juice and told her to sit and be observed as long as she felt comfortable. left after feeling better. tried calling to follow up but # not valid.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Missed a period (menstruation cycle) the following month but returned twice as heavy the month after
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain in extremity
Clinical narrative: Fatigue, soreness of arm, lost of appetite, 12 hours later 8am
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chest discomfort, Chest pain, Dizziness, Fatigue
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient felt dizzy and asked to lay down. Had patient lay down on the ground and monitored patient. Asked if she needed EMT/911, patient declined. Patient then asked pharmacy to call 911. Patient was taken to ER and tests were ran. Physician said patient had an adverse reaction, but would not call it an allergic reaction. Patient had no anaphylaxis. Patient showed up back to pharmacy to pick-up card and finish report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypertension, Lethargy, Nausea
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient felt dizzy and asked to lay down. Had patient lay down on the ground and monitored patient. Asked if she needed EMT/911, patient declined. Patient then asked pharmacy to call 911. Patient was taken to ER and tests were ran. Physician said patient had an adverse reaction, but would not call it an allergic reaction. Patient had no anaphylaxis. Patient showed up back to pharmacy to pick-up card and finish report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Visual impairment
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient felt dizzy and asked to lay down. Had patient lay down on the ground and monitored patient. Asked if she needed EMT/911, patient declined. Patient then asked pharmacy to call 911. Patient was taken to ER and tests were ran. Physician said patient had an adverse reaction, but would not call it an allergic reaction. Patient had no anaphylaxis. Patient showed up back to pharmacy to pick-up card and finish report.