chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Colonoscopy, Diarrhoea
Clinical narrative: Microscopic Colitis; Diarrhea/watery stool; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS MICROSCOPIC (Microscopic Colitis) and DIARRHOEA (Diarrhea/watery stool) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles and Hepatitis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DIARRHOEA (Diarrhea/watery stool) (seriousness criterion intervention required). On an unknown date, the patient experienced COLITIS MICROSCOPIC (Microscopic Colitis) (seriousness criterion medically significant). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and Budesonide at a dose of 9 mg. At the time of the report, COLITIS MICROSCOPIC (Microscopic Colitis) and DIARRHOEA (Diarrhea/watery stool) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Colonoscopy: microscopic colitis (Inconclusive) Microscopic Colitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also takes an unknown "eye supplement."  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gout, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: gout attack/gout flare up, it lasted a week then went away but came back worse after that; Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose; arm pain/Soreness for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout attack/gout flare up, it lasted a week then went away but came back worse after that) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gout attack.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain/Soreness for 2 days). On 23-May-2021, the patient experienced GOUT (gout attack/gout flare up, it lasted a week then went away but came back worse after that) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose). The patient was hospitalized from 23-May-2021 to 26-May-2021 due to GOUT. The patient was treated with CELERY SEED EXTRACT at an unspecified dose and frequency; BETULA LENTA (CHERRY FRUIT) at an unspecified dose and frequency and APPLE CIDER VINEGAR for Gout attack, at an unspecified dose and frequency. On 16-May-2021, PAIN IN EXTREMITY (arm pain/Soreness for 2 days) had resolved. At the time of the report, GOUT (gout attack/gout flare up, it lasted a week then went away but came back worse after that) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose) outcome was unknown.            No concomitant medication was reported. Patient got back gout, a condition he only experienced once before in his life. The patient claims that he also experienced a sore arm.  Company Comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # 026621A and with no associated AEs.   This case was linked to MOD-2021-201425, MOD-2021-246801 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional events and updated treatment medications.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # 026621A and with no associated AEs.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizzy; light-headed; bad headache; This is a spontaneous report from a contactable consumer.  A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), via an unspecified route of administration, administered in left arm on 05Feb2021 at 03:45 (at the age 41-years-old) as unknown single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Patient did not have allergies. No other medical and concomitant medication history were reported. On 05Feb2021 about 2 to 3 hours after receiving the vaccine, patient became very dizzy and light-headed and got a very bad headache. Patient went to bed, slept about 10 hours and got up feeling fine the next morning. The event was not treated. The outcome of the events were recovered on 06Feb2021.   Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Diarrhoea, Fatigue
Clinical narrative: feel Terrible; head cold; Diarrhea; really bad pains in my back and joints; very tired; Nausea; feel fluish; very upset stomach; really bad pains in my back and joints/my back is really really sore, my Lower back; This is a spontaneous report from a contactable Other HCP(patient). A 71-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Right on 02Feb2021 at 13:00 (vaccinated at the age of 71 years) as DOSE 2, SINGLE for COVID-19 immunization. No known allergies. Other medical history included lymphoma, thyroid cancer, Afib. The patient's concomitant medications and past drug(s) were not reported. No prior COVID vaccination. No vaccine received in 4 weeks. Other unspecified medications received in 2 weeks. He was not tested COVID post vaccination. Previously Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 12Jan2021 at 16:00 (vaccinated at the age of 71 years) as DOSE 1, SINGLE for COVID-19 immunization. After the second shot on 03Feb2021 (next Morning) at 10:00AM, he started to feel fluish. Then he started to have a very upset stomach, diarrhea, really bad pains in his back and joints and by day five(08Feb2021), he felt terrible. He felt like he had a head cold and his back was really really sore, specifically his lower back. Nausea and diarrhea continued and he was very tired. No treatment received. On 07Feb2021, Covid test type post vaccination was nasal swab and Covid test result was negative. The outcome of all events was not recovered.  Information regarding batch and lot number requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Nasopharyngitis, Nausea, SARS-CoV-2 test
Clinical narrative: feel Terrible; head cold; Diarrhea; really bad pains in my back and joints; very tired; Nausea; feel fluish; very upset stomach; really bad pains in my back and joints/my back is really really sore, my Lower back; This is a spontaneous report from a contactable Other HCP(patient). A 71-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Right on 02Feb2021 at 13:00 (vaccinated at the age of 71 years) as DOSE 2, SINGLE for COVID-19 immunization. No known allergies. Other medical history included lymphoma, thyroid cancer, Afib. The patient's concomitant medications and past drug(s) were not reported. No prior COVID vaccination. No vaccine received in 4 weeks. Other unspecified medications received in 2 weeks. He was not tested COVID post vaccination. Previously Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 12Jan2021 at 16:00 (vaccinated at the age of 71 years) as DOSE 1, SINGLE for COVID-19 immunization. After the second shot on 03Feb2021 (next Morning) at 10:00AM, he started to feel fluish. Then he started to have a very upset stomach, diarrhea, really bad pains in his back and joints and by day five(08Feb2021), he felt terrible. He felt like he had a head cold and his back was really really sore, specifically his lower back. Nausea and diarrhea continued and he was very tired. No treatment received. On 07Feb2021, Covid test type post vaccination was nasal swab and Covid test result was negative. The outcome of all events was not recovered.  Information regarding batch and lot number requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Maternal exposure during pregnancy, Oropharyngeal pain
Clinical narrative: Is pregnant: Yes; Tired; sore arm; headache; sore throat; flushed but no fever; This is a spontaneous report from a contactable consumer (Patient). A 32-years-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 19Jan2021 12:00 as dose 1, single and received bnt162b2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:00 (Lot Number: EL9269) as dose 2, single for covid-19 immunization (age at vaccination was 32years old). Medical history included ongoing pregnancy. Concomitant medication included escitalopram oxalate (LEXAPRO); and minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]). No known allergies ware reported. No Covid tested post vaccination. No Covid prior vaccination. No other vaccine in four weeks. It was reported that patient was pregnant on an unspecified date. It was reported that patient experienced tired, sore arm, sore throat, headache, and flushed but no fever on 08Feb2021 20:00. Patient did not receive any treatment for events. It was reported that patient Last menstrual period was 28Aug2020. The mother was 23 Weeks pregnant at the onset of the event. The mother's due date for delivery was on 04Jun2021. The outcome of events was resolving.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Is pregnant: Yes; Tired; sore arm; headache; sore throat; flushed but no fever; This is a spontaneous report from a contactable consumer (Patient). A 32-years-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 19Jan2021 12:00 as dose 1, single and received bnt162b2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:00 (Lot Number: EL9269) as dose 2, single for covid-19 immunization (age at vaccination was 32years old). Medical history included ongoing pregnancy. Concomitant medication included escitalopram oxalate (LEXAPRO); and minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]). No known allergies ware reported. No Covid tested post vaccination. No Covid prior vaccination. No other vaccine in four weeks. It was reported that patient was pregnant on an unspecified date. It was reported that patient experienced tired, sore arm, sore throat, headache, and flushed but no fever on 08Feb2021 20:00. Patient did not receive any treatment for events. It was reported that patient Last menstrual period was 28Aug2020. The mother was 23 Weeks pregnant at the onset of the event. The mother's due date for delivery was on 04Jun2021. The outcome of events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Pain in extremity, Pustule, Rash
Clinical narrative: raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; experienced a sore arm for a day and half that soon; generalized outbreak consisting of raised, pimple-like; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; This is a spontaneous report from a contactable Nurse. A 38-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced raised red area, pustule, and rash at the injection site on an unspecified date. It was reported that Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose 2 weeks ago later report experiencing a "raised red area, pustule, and rash at the injection site. It was reported that the morning after she experienced a sore arm for a day and half that soon went away but returned a week later. Yesterday she noticed that there was a red raised pimple with a white head at the injection site. And for 4-5 days had a generalized outbreak consisting of raised, pimple-like areas on her face. She mentioned that her physician advised her to take Benadryl or Zyrtec for these reactions considering that it may be allergic in nature. The outcome of events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pustule, Vaccination site rash
Clinical narrative: raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; experienced a sore arm for a day and half that soon; generalized outbreak consisting of raised, pimple-like; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; raised red area, pustule, and rash at the injection site.; This is a spontaneous report from a contactable Nurse. A 38-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced raised red area, pustule, and rash at the injection site on an unspecified date. It was reported that Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose 2 weeks ago later report experiencing a "raised red area, pustule, and rash at the injection site. It was reported that the morning after she experienced a sore arm for a day and half that soon went away but returned a week later. Yesterday she noticed that there was a red raised pimple with a white head at the injection site. And for 4-5 days had a generalized outbreak consisting of raised, pimple-like areas on her face. She mentioned that her physician advised her to take Benadryl or Zyrtec for these reactions considering that it may be allergic in nature. The outcome of events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Soreness in arm; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiry date not reported, age at vaccination: 67-year-old), via an unspecified route of administration, in Arm Right on 08Feb2021 12:00 PM as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (COVID-19 positive prior vaccination). Concomitant medications included Irbesartan and amlodipine taken for an unspecified indication, start and stop date were not reported. On 08Feb2021at 12:15 AM, the patient experienced soreness in arm, headache and fatigue. The patient did not receive any corrective treatment. The patient did not receive any other vaccine in four weeks. The patient was not tested COVID positive post vaccination. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dyspepsia, Heart rate, Heart rate increased, Migraine
Clinical narrative: Severe heartburn; Migraine; Vomiting; Elevated heart rate; Feeling clammy; This is a spontaneous report from a contactable consumer or other non- healthcare professional (Reporter's daughter). A female patient of an unspecified age (Age: 30; units: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, daughter, speech therapist, aged 30, received Pfizer vaccine this past Friday (05Feb2021). She had severe heartburn, migraine, vomiting starting around 6 am, elevated heart rate, and feeling clammy on unknown date in Feb2021. The reporter enquired should the patient need to visit emergency department. The patient underwent lab tests and procedures which included heart rate: elevated on an unknown date in Feb2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe heartburn; Migraine; Vomiting; Elevated heart rate; Feeling clammy; This is a spontaneous report from a contactable consumer or other non- healthcare professional (Reporter's daughter). A female patient of an unspecified age (Age: 30; units: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, daughter, speech therapist, aged 30, received Pfizer vaccine this past Friday (05Feb2021). She had severe heartburn, migraine, vomiting starting around 6 am, elevated heart rate, and feeling clammy on unknown date in Feb2021. The reporter enquired should the patient need to visit emergency department. The patient underwent lab tests and procedures which included heart rate: elevated on an unknown date in Feb2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Swelling face
Clinical narrative: swollen face; allergic reaction to her first dose; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 74-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 19Jan2021 as SINGLE DOSE for covid-19 immunization. Medical history included eye operation and diabetes from an unknown date and unknown if ongoing. No concomitant medications were not reported. It was reported that she received the first dose of the pfizer covid 19 three weeks ago and her second dose is tomorrow. she reported that she experienced a swollen face 3 days after the vaccine and wants to know if she should get the second dose. She also wanted to know if the second shot had to be in the same arm as the first. Upon date 09Feb2021 iI was reported that she had an allergic reaction to her first dose, where her face was swollen, so her primary care doctor gave her some antihistamines, and now she feels fine. She was worried about getting the second dose after what happened with the first, and she is wondering if there are recommendations for if people should get the second dose after an allergic reaction to the first. Patent received treatment for the events with antihistamines. The outcome for the events was reported as unknown.   Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity
Clinical narrative: right arm has not stopped hurting since the first shot; This is a spontaneous report from a contactable consumer. A (Age: 74; Unit: Unknown) female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Right on 12Jan2021 as single dose and second dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 (Batch/Lot Number: EL3247) as single dose for (at the age of 74-years-old) covid-19 immunisation. Medical history included diabetic, blood pressure high and cancer all three since 20 years and bad back. There were no concomitant medications. Patient reported that she received the 1st dose of the Pfizer covid vaccine on the 12Jan2021. She took her last shot of the Pfizer covid vaccine on the 03Feb2021, her right arm has not stopped hurting since the first shot. She had cancer on her left side, so everything she had to do has to be administered on her right side. The only thing that eases the pain was ice, and she used the sleeve that she used in her left arm, it relieves the pain, but when she remove the sleeve the pain comes back. She said that she did the ice, rested her arm, and wore sleeves that she used to wear years ago and those stop the pain while she was wearing them but when she takes the sleeves off, it starts hurting again. She stated that her arm is still hurting like the dickens, and actually never stopped hurting from the first shot. She said that she has done everything that the sheet said to try to help it, like using ice and resting it. She questioned how long will this continue to hurt, or what do she need to do, does she need to call her doctor. Later, she stated that the vaccine card was handwritten, and they did not provide NDC/EXP. She said that she had her last labs done in December. No further details provided about those lab results. She stated that she had not seen her doctor about her arm hurting. She stated that she did take some tramadol made by manufacturer Unichem Pharmac, which she got through Pharmacy in a brownish pharmacy bottle and is 50mg. She says she has a bad back, which is what that is prescribed for back ache. She said that she also took some Aleve PM with EXP May2022 and LOT NAA84DR. She said that there was no barcode on the bottle to provide UPC. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Stomatitis
Clinical narrative: Sores inside and outside of mouth; This is a spontaneous report from a contactable consumer or other non healthcare professional.  A 79-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EL9264), via an unspecified route of administration, administered in Arm Right on 02Feb2021 as DOSE 1, SINGLE for covid-19 immunization (at Public health clinic). Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, cardiac failure congestive from an unknown date and unknown if ongoing, cerebrovascular accident from an unknown date and unknown if ongoing, drug hypersensitivity for Sulfonamide allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Patient didnot received other vaccinations within 4 weeks prior to vaccination. Patient didnot had Covid prior to vaccination. Patient was tested for Covid under post vaccination. On 05Feb2021, the patient experienced sores inside and outside of mouth. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 09Feb2021. Therapeutic measures were taken as a result of sores inside and outside of mouth. The outcome of the event stomatitis was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash
Clinical narrative: Terrible rash all over her body; Eczema; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated she received the COVID vaccine on the 01Feb2021 and from 02Feb2021 she started experiencing terrible rash all over her body. She said she did not have difficulty in breathing. She saw her doctor and her doctor said it was eczema. She said she wanted to know if she could take the second dose of the vaccine. The outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Nausea
Clinical narrative: Temple and jaw headache; Injection site pain; Slight chills; Joint pain; Nausea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: EN9581), dose 1 single via an unspecified route of administration, administered in Arm Left on 02Feb2021 16:00 as single dose for COVID-19 immunization. Medical history included vascular graft from, coronary artery disease, double bypass, CAD, colostomy due to diverticulitis, cholecystectomy, appendectomy, osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included atenolol (ATENOLOL), fenofibrate (FENOFIBRATE), clopidogrel bisulfate (PLAVIX), ramipril (RAMIPRIL), ezetimibe, simvastatin (VYTORIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took flagyl [metronidazole] and cipro [ciprofloxacin] experienced drug hypersensitivity. The patient not vaccinated prior to COVID-19 vaccine. Post vaccination the patient was not tested for COVID-19. The patient not received any other vaccines in fourweeks after COVID-19 vaccine. The patient experienced temple and jaw headache, injection site pain, slight chills, joint pain, nausea, swollen lymph nodes on 03Feb2021. No treatment was received for the reported events. The outcome of events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Temple and jaw headache; Injection site pain; Slight chills; Joint pain; Nausea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: EN9581), dose 1 single via an unspecified route of administration, administered in Arm Left on 02Feb2021 16:00 as single dose for COVID-19 immunization. Medical history included vascular graft from, coronary artery disease, double bypass, CAD, colostomy due to diverticulitis, cholecystectomy, appendectomy, osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included atenolol (ATENOLOL), fenofibrate (FENOFIBRATE), clopidogrel bisulfate (PLAVIX), ramipril (RAMIPRIL), ezetimibe, simvastatin (VYTORIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took flagyl [metronidazole] and cipro [ciprofloxacin] experienced drug hypersensitivity. The patient not vaccinated prior to COVID-19 vaccine. Post vaccination the patient was not tested for COVID-19. The patient not received any other vaccines in fourweeks after COVID-19 vaccine. The patient experienced temple and jaw headache, injection site pain, slight chills, joint pain, nausea, swollen lymph nodes on 03Feb2021. No treatment was received for the reported events. The outcome of events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Nausea, Pyrexia
Clinical narrative: nauseousness; diarrhea; ended up with horrible fever 102 degree Fahrenheit but went away; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported herself that a female patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unspecified), via an unspecified route of administration on 05Feb2021 (Friday) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She received first dose (Pfizer-BioNTech COVID-19 Vaccine) on Friday 05Feb2021 and ended up with horrible fever 102-degree Fahrenheit on unknown date in Feb2021 but went away; lasted all night long, she felt fine the next day. On 08Feb2021, (yesterday) she had diarrhoea it was bad, just wondering because she has not had nausea like this, it sorts of hit her this morning. On 09Feb2021, (today) had nauseousness. So, should she get the second dose. The outcome of the adverse event "ended up with horrible fever 102-degree Fahrenheit but went away" was resolved on Feb2021, while outcome of the remaining events was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: a red rash and itching around the injection site; a red rash and itching around the injection site; red doughnut like area around the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EL9263) via an unspecified route of administration in left arm (upper left shoulder area) on 25Jan2021 at 19:00 as single dose for COVID-19 immunisation. There were no additional vaccines administered on same date of the Pfizer Suspect and prior vaccinations (within 4 weeks). The patient's medical history had pacemaker. Patient's Medical History (including any illness at time of vaccination) was none. No historical vaccination, he has never had a reaction to a vaccine. Concomitant medications were not reported. On Saturday 06Feb2021, the patient started experiencing a red rash doughnut like area and itching around the injection site. He was due for his second dose and wants to know if he should be concerned. The patient explains he got a shot about 3 weeks ago and thinks he was having a reaction. He explains he has a red doughnut like area around the injection site. It is round and with little dots and was red. He was wondering if that was something to worry about and was this serious. He was scheduled for the second dose in the next 2 or 3 weeks and wants to know should he get the second dose. Adverse event following prior vaccinations was none. There was no family medical history and tests relevant to adverse event. His wife put a little cortisone cream as treatment to help with the itching. The outcome of the event was not recovered.  Follow-up (09Feb2021): New information from same consumer included: Patient details, Relevant medical history, Product and events details and clinical information added.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Middle insomnia
Clinical narrative: Woke up in the middle of the night; flu-like symptoms (fever, chills, body aches, and slight nausea); This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247) via an unspecified route of administration and administered in right arm on 04Feb2021 15:00 (at the age of 42-year-old), as single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) and was antibiotics for a UTI at the time of the 2nd shot, and allergies to sulphur drugs. There was no other vaccine in four weeks. No covid prior vaccination and not tested post vaccination. The patient's concomitant medication included ciprofloxacin hydrochloride monohydrate (CIPRO [CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE]) as other medications in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247) via an unspecified route of administration and administered in right arm on 14Jan2021 03:00 pm (at the age of 42-year-old), as single dose for, COVID-19 immunization. On 05Feb2021 at 02:00 AM, the patient woke up in the middle of the night after the vaccination with flu-like symptoms (fever, chills, body aches, and slight nausea). The symptoms got better by the end of the next day. The patients were not treated for the reported events. The outcome of events was resolved, on 06Feb2021.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin abnormal, Neutrophil count, Neutrophil count abnormal, Platelet count
Clinical narrative: WBC 1.7/WBC 2.9; Hgb 11.5; ANC 0.1/ANC 0.6; This is a spontaneous report from a contactable physician reported for male patient. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration (Age at vaccination: 76 Years) on 24Jan2021 as dose 2, single for COVID-19 immunisation. Medical history included Grade 3A Follicular Non-Hodgkin lymphoma from an unknown date and unknown if ongoing, stage III CKD from an unknown date and unknown if ongoing, benign prostatic hyperplasia from an unknown date and unknown if ongoing, abnormal LFTs from an unknown date and unknown if ongoing, Follicular NHL, Stage IV from Jun2020 to an unknown date, had Bendamustine/Rituxan x 4, began Rituxan maintenance in 21Oct2020 and last given in Dec2020. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 on 24Dec2020 for COVID-19 immunisation. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Feb2021, the patient experienced wbc 1.7/wbc 2.9, hgb 11.5, anc 0.1/anc 0.6. He had not received growth factors and had no symptoms from the immunization. The patient underwent lab tests and procedures which included haemoglobin resulted as 10.1 on 11Dec2020, 11.5 on 05Feb2021, neutrophil count resulted as 3.0 on 11Dec2020, 0.1 on 05Feb2021, neutrophil count resulted as 0.6 on 08Feb2021, platelet count resulted as 197 on 11Dec2020, 156 on 05Feb2021, white blood cell count resulted as 3.8 on 11Dec2020, 1.7 on 05Feb2021, 2.9 on 08Feb2021. No treatment received for the adverse event. The clinical outcome of the event was resolving.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell disorder
Clinical narrative: WBC 1.7/WBC 2.9; Hgb 11.5; ANC 0.1/ANC 0.6; This is a spontaneous report from a contactable physician reported for male patient. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration (Age at vaccination: 76 Years) on 24Jan2021 as dose 2, single for COVID-19 immunisation. Medical history included Grade 3A Follicular Non-Hodgkin lymphoma from an unknown date and unknown if ongoing, stage III CKD from an unknown date and unknown if ongoing, benign prostatic hyperplasia from an unknown date and unknown if ongoing, abnormal LFTs from an unknown date and unknown if ongoing, Follicular NHL, Stage IV from Jun2020 to an unknown date, had Bendamustine/Rituxan x 4, began Rituxan maintenance in 21Oct2020 and last given in Dec2020. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 on 24Dec2020 for COVID-19 immunisation. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Feb2021, the patient experienced wbc 1.7/wbc 2.9, hgb 11.5, anc 0.1/anc 0.6. He had not received growth factors and had no symptoms from the immunization. The patient underwent lab tests and procedures which included haemoglobin resulted as 10.1 on 11Dec2020, 11.5 on 05Feb2021, neutrophil count resulted as 3.0 on 11Dec2020, 0.1 on 05Feb2021, neutrophil count resulted as 0.6 on 08Feb2021, platelet count resulted as 197 on 11Dec2020, 156 on 05Feb2021, white blood cell count resulted as 3.8 on 11Dec2020, 1.7 on 05Feb2021, 2.9 on 08Feb2021. No treatment received for the adverse event. The clinical outcome of the event was resolving.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Paraesthesia oral
Clinical narrative: strong tingling in my tongue/tongue started tingling badly; Lip tingling and burning; lips tingling and burning; This is a spontaneous report from a contactable consumer (patient reported for herself). A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9Z63), via an unspecified route of administration, administered in Arm Right on 08Feb2021 (on Monday, at the age of66-year-old), as single for covid-19 immunisation. Medical history included nerve damage on right side of tongue from wisdom teeth removal and nerve damage on right side of lip from root canal. she had nerve damage near there from 30 years ago from wisdom teeth. The patient had root canal 3 years ago in 2018. There were no concomitant medications. On 08Feb2021, about less than 20 minutes after the vaccine, the patient started having strong tingling in her tongue badly, Lip tingling and burning. The clinical course of the events as follows: patient reported that she received her first vaccine dose on Monday, 08Feb2021, for the first 15 minutes she was fine. As soon as got in the car, her tongue started tingling badly. It was a really strong tingle but did not swell. She reported that she has nerve damage near there from 30 years ago from wisdom teeth pulled. It barely tingles usually. She also reported Lip tingling and burning, but again reported a history of nerve damage from a past root canal. There was something going on with the nerve there. She got the shot on her right arm, and all her nerve damage was on the right side of her tongue and lips too. She stated that these symptoms lasted for about 30 minutes. Her lips started that night and it had not been bad. She was scared it might swell. She had some tingling off and on. Her lips were tingling and burning some. It had gotten better, but she still has it some. She was concerned about the second vaccine. she was two hours from home, so this was scary. She was wondering if this is common. The patient was asking if her symptoms were a common finding after receiving the vaccine and if she should get the second vaccine dose or not. She stated that she might have a strong reaction. There was no Investigation Assessment provided. The patient was resolving from all the events at the time of this report.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Depression, Tremor
Clinical narrative: Uncontrollable shaking; Felt sadness; Very depressed; This is a spontaneous report from a contactable consumer (patient). A 96-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267) via an unspecified route of administration, administered in right arm on 10Feb2021 at 10:45 (at the age of 96-year-old) as dose 2 single for covid-19 immunisation in doctor's office/urgent care. Medical history included congestive heart failure, 4 way bypass. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, on an unknown date Jan2021 (four weeks prior to suspect vaccine), as dose 1 single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 17:30, the patient experienced uncontrollable shaking lasted for 3 hours, the patient felt well enough to go to bed. Patient took 2 tylenol and slept through the night until 9:00. Along with the shaking patient felt sadness and very depressed. The patient took 2 tylenol as treatment for the event uncontrollable shaking. No treatment medication was received for the events felt sadness and very depressed. Post vaccination, the patient had not tested for COVID-19. The outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: A tingling in the face; This is a spontaneous report from a non-contactable consumer (patient). An elderly (65+ years) non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 12Feb2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient received any other vaccine within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for covid-19 post vaccination. On 12Feb2021, the patient experienced a tingling in the face (similar to a dental novocaine injection) that started 2 hours after dosing and has now subsided. No treatment was received for the event. Outcome of event was recovered on Feb2021.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I had tingling and pins and needles on the left side of my face and inside my mouth on my tongue on the left side; This is a spontaneous report from a contactable other hcp. This Other-HCP (patient) reported that a 39-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via intramuscular route, in left arm on 05Feb2021 11:30 (at 39-years age) as dose 1, single for covid-19 immunisation. Medical history included covid-19. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient had tingling and pins and needles on the left side of her face and inside her mouth on her tongue on the left side. Patient did not received treatment for event. Since the vaccination, patient has been not tested for COVID-19. Patient was not received other medications in two weeks. The clinical outcome of event was not resolved.  Information of Lot/Batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.