chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pruritus, Wound complication
Clinical narrative: If a cat or dog scratches her it itches; Red itchy bumps on her hands and a few other places; Red itchy bumps on her hands and a few other places; Inflamed and itches; This is a spontaneous report from a contactable consumer or other non hcp.  An 18-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 30Apr2021 12:45 (Batch/Lot Number: EW0170) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in right arm13:30 (Batch/Lot Number was ER0729) as single dose for covid-19 immunisation.It was reported that, Caller stated she is calling about the COVID 19 vaccine,Caller stated a few days after the second dose she started getting red itchy bumps on her hands and a few other places which was very spontaneous and the only time she had this happen before was when she had mono. Caller stated she also is not allergic to cats or dogs but now if a cat or dog scratches her it itches. The outcome of the events erythema wound complication and pruritis was not recovered the event inflammation was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101, today her fever, it went down later in the evening, today her fever was at 99; This is a spontaneous report from a contactable consumer (patient's brother). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever of 101, today her fever, it went down later in the evening, today her fever was at 99. It was reported that she got her vaccination on Saturday. Sunday, she had a fever of 101, today her fever, it went down later in the evening, today her fever was 99. The patient underwent lab tests and procedures which included body temperature: 101 and 99. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Abdominal pain; Was tired and stuff for a couple of days/ Fatigue; She had brain fogginess after the first one; She couldn't remember her husband or dog's name; Diarrhea; Joint pain in elbow; This is a spontaneous report from a contactable other hcp (nurse).  A 49-years-old female patient received bnt162b2 (BNT162B2) (Formulation: Solution for injection, Batch/Lot Number was EL9262, Expiration Date: Unknown) dose 1, single via an unspecified route of administration, administered in Arm Right on 07Mar2021 13:30 (Age at Time of Vaccination 49 years) for covid-19 immunisation.  Medical history included from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.Patient also received bnt162b2  (Formulation: Solution for injection, Batch/Lot Number was EL9262, Expiration Date: Unknown) dose 2, single via an unspecified route of administration on 28Mar2021 for covid-19 immunisation. Not receive any vaccine prior to vaccination. On 07Mar2021 the patient  was tired and stuff for a couple of days/ fatigue, she had brain fogginess after the first one on, she couldn't remember her husband or dog's name and It lasted 3-4 days as well . On 08Mar2021 patient experience abdominal pain, On an unknown date patient also experience diarrhea, joint pain in elbow. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on She has tested negative 13 times. She has been taking Voltaren with expiration Aug2023, and Lot number 3L2E. The treatment was completed. The outcome of events tired and stuff for a couple of days and fatigue, abdominal pain and diarrhoea was recovered on unknown date in Mar2021. The events she had brain fogginess after the first one on, she couldn't remember her husband or dog's name, and It lasted 3-4 days as well was recovered on 07Mar2021. The outcome of joint pain in elbow was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, SARS-CoV-2 test
Clinical narrative: Abdominal pain; Was tired and stuff for a couple of days/ Fatigue; She had brain fogginess after the first one; She couldn't remember her husband or dog's name; Diarrhea; Joint pain in elbow; This is a spontaneous report from a contactable other hcp (nurse).  A 49-years-old female patient received bnt162b2 (BNT162B2) (Formulation: Solution for injection, Batch/Lot Number was EL9262, Expiration Date: Unknown) dose 1, single via an unspecified route of administration, administered in Arm Right on 07Mar2021 13:30 (Age at Time of Vaccination 49 years) for covid-19 immunisation.  Medical history included from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.Patient also received bnt162b2  (Formulation: Solution for injection, Batch/Lot Number was EL9262, Expiration Date: Unknown) dose 2, single via an unspecified route of administration on 28Mar2021 for covid-19 immunisation. Not receive any vaccine prior to vaccination. On 07Mar2021 the patient  was tired and stuff for a couple of days/ fatigue, she had brain fogginess after the first one on, she couldn't remember her husband or dog's name and It lasted 3-4 days as well . On 08Mar2021 patient experience abdominal pain, On an unknown date patient also experience diarrhea, joint pain in elbow. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on She has tested negative 13 times. She has been taking Voltaren with expiration Aug2023, and Lot number 3L2E. The treatment was completed. The outcome of events tired and stuff for a couple of days and fatigue, abdominal pain and diarrhoea was recovered on unknown date in Mar2021. The events she had brain fogginess after the first one on, she couldn't remember her husband or dog's name, and It lasted 3-4 days as well was recovered on 07Mar2021. The outcome of joint pain in elbow was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat and a cough; Sore throat and a cough; Mild regular cold symptoms; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1 SIN-GLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore throat and a cough and mild regular cold symptoms. It was reported that patient and her mother scheduled to receive the second dose of the Pfizer-BioNTech COVID-19, it was specified that they had no fever, and were tested for COVID but they don't have the results yet. Consumer was asked if they could get the second dose of the vaccine when symptomatic and if the vaccination series of the Pfizer-BioNTech COVID-19 vac-cine need to be repeated when the second dose was given beyond 40 days after the first and re-ceived response as in the Pfizer-BioNTech COVID-19 Vaccine clinical study, the second dose was al-lowed to be given 19-23 days after the first dose. Per CDC if the second dose was given later than 6 weeks (42 days), the vaccination series does not need to be repeated. The patient underwent lab tests and procedures which included COVID-19 test with an unknown result on an unknown date in 2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate, Heart rate increased
Clinical narrative: near black outs when sitting or standing (not lying down); Shortness of breath with little activity; elevated heart rate after little activity (eating breakfast, washing dishes, etc.); fuzzy vision; dizziness; headaches when lying down.; heart racing; patient pregnant and received BNT162b2 vaccine; This is a spontaneous report from a contactable consumer. A 28-year-old pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 11May2021 16:00 (Batch/Lot number was not reported) at the age of 28 years old as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, zinc (PRENATAL); triticum aestivum germ oil (WHEAT GERM OIL); rubus idaeus leaf (RASPBERRY LEAF); all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included BNT162B2 received by the patient on 19Apr2021 09:30 AM administered in the right arm intramuscularly, at the age of 28 years, as dose 1, single for COVID-19 immunization. On 12May2021 07:00 AM, the patient experienced shortness of breath with little activity, elevated heart rate after little activity (eating breakfast, washing dishes, etc.), fuzzy vision, dizziness, and near black outs when sitting or standing (not lying down), headaches when lying down. She also experienced heart racing on the same day (12May2021). There were no treatments for the events. The patient has no history of COVID-19 infection prior to vaccination and has not been tested for it post vaccination. The mother was 18 weeks pregnant at the onset of the event. The mother was due to deliver on 08Oct2021 as the patient LMP (last menstrual period) was 31Dec2020. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 2021. No apparent previous infection or expose prior to vaccination. Outcome of dizziness, heart racing, near blackouts, headache was recovered on an unspecified date, while outcome of the remaining events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Palpitations, Presyncope, SARS-CoV-2 antibody test, Vision blurred
Clinical narrative: near black outs when sitting or standing (not lying down); Shortness of breath with little activity; elevated heart rate after little activity (eating breakfast, washing dishes, etc.); fuzzy vision; dizziness; headaches when lying down.; heart racing; patient pregnant and received BNT162b2 vaccine; This is a spontaneous report from a contactable consumer. A 28-year-old pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 11May2021 16:00 (Batch/Lot number was not reported) at the age of 28 years old as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, zinc (PRENATAL); triticum aestivum germ oil (WHEAT GERM OIL); rubus idaeus leaf (RASPBERRY LEAF); all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included BNT162B2 received by the patient on 19Apr2021 09:30 AM administered in the right arm intramuscularly, at the age of 28 years, as dose 1, single for COVID-19 immunization. On 12May2021 07:00 AM, the patient experienced shortness of breath with little activity, elevated heart rate after little activity (eating breakfast, washing dishes, etc.), fuzzy vision, dizziness, and near black outs when sitting or standing (not lying down), headaches when lying down. She also experienced heart racing on the same day (12May2021). There were no treatments for the events. The patient has no history of COVID-19 infection prior to vaccination and has not been tested for it post vaccination. The mother was 18 weeks pregnant at the onset of the event. The mother was due to deliver on 08Oct2021 as the patient LMP (last menstrual period) was 31Dec2020. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 2021. No apparent previous infection or expose prior to vaccination. Outcome of dizziness, heart racing, near blackouts, headache was recovered on an unspecified date, while outcome of the remaining events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes on her arms and chest area; This is a spontaneous report from a contactable pharmacist. This pharmacist reported that a 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on 11May2021 (age at vaccination:29-Year-old) as dose 1, single for COVID-19 immunisation. The patient 's medical condition and concomitant medications were not reported. On unspecified date in May2021, the patient experienced rashes on her arms and chest area. Patient was not allergic to shellfish. Want to know the plant source where the lipid was derived and if there is soy on the list of ingredients. All lipid excipients used in the vaccine are either from plant-derived sources or are synthetic and have no animal products. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dermatitis, Gait inability, Lip swelling, Pruritus
Clinical narrative: First dose - lower lip and chin swelling; First dose - lower lip and chin swelling; Itchy chest and bumps; Woke up week later unable to walk- left knee severe joint pain.; Woke up week later unable to walk- left knee severe joint pain.; Itchy chest and bumps; This is a spontaneous report from a contactable consumer (patient).   A 58-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0158, Expiry date not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 10:15 (at the age of 58 years) as dose 1, single for COVID-19 immunization. Medical history included high heart rate, blood pressure, prediabetic, and known allergy to Valium, all from an unknown date and unknown if ongoing. Concomitant medications taken within 2 weeks of vaccination included atorvastatin (LIPITOR); hydrochlorothiazide, triamterene (MAXZIDE); and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lower lip and chin swelling; itchy chest and bumps; and woke up week later unable to walk- left knee severe joint pain on an unknown date. Patient took second dose of bnt162b2 (Lot number: EW0172, Expiry date not reported) via an unspecified route of administration, administered in left arm on 06May2021 14:45 as dose 2, single for COVID-19 immunization. The patient underwent lab tests and procedures which included Nasal Swab COVID test: negative on 09May2021. The event lower lip swelling was not recovered, and the outcome of rest events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling face
Clinical narrative: First dose - lower lip and chin swelling; First dose - lower lip and chin swelling; Itchy chest and bumps; Woke up week later unable to walk- left knee severe joint pain.; Woke up week later unable to walk- left knee severe joint pain.; Itchy chest and bumps; This is a spontaneous report from a contactable consumer (patient).   A 58-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0158, Expiry date not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 10:15 (at the age of 58 years) as dose 1, single for COVID-19 immunization. Medical history included high heart rate, blood pressure, prediabetic, and known allergy to Valium, all from an unknown date and unknown if ongoing. Concomitant medications taken within 2 weeks of vaccination included atorvastatin (LIPITOR); hydrochlorothiazide, triamterene (MAXZIDE); and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lower lip and chin swelling; itchy chest and bumps; and woke up week later unable to walk- left knee severe joint pain on an unknown date. Patient took second dose of bnt162b2 (Lot number: EW0172, Expiry date not reported) via an unspecified route of administration, administered in left arm on 06May2021 14:45 as dose 2, single for COVID-19 immunization. The patient underwent lab tests and procedures which included Nasal Swab COVID test: negative on 09May2021. The event lower lip swelling was not recovered, and the outcome of rest events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Auricular swelling, Biopsy, Oncocytoma, SARS-CoV-2 test, Salivary gland mass
Clinical narrative: Oncocytic neoplasm; Swollen area on the right auricula area; a complex hypodense mass noted inferior to the right ear at the level of the parotid gland; This is a spontaneous report from a contactable pharmacist (patient). A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3246, expiry date: unknown) via an unspecified route of administration, administered in Right Arm on 20Jan2021 17:00 as dose 1, single (age at vaccination:75-Years-old) for COVID19 immunization. Medical history included High blood pressure, and Known allergies to Penicillin. Concomitant medications included Enalapril 5mg, Simvastin 20mg, and Omega 3 2000 mg [FISH OIL]. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 before and tested post vaccination. On 16Feb2021 16:00 the patient experienced oncocytic neoplasm, swollen area on the right auricula area, and a complex hypodense mass noted inferior to the right ear at the level of the parotid gland. Caller stated, this mass demonstrates a lobular appearance there are internal septations noted. The mass is not completely anechoic consistent with a simple cyst. Mass measures 3.8cm x 2.2cm x 2.8. On 03May2021 the patient underwent lab tests and procedures which included Nasal Swab, SARS-CoV-2 test: negative; on 04May2021 underwent biopsy: oncocytic neoplasm, negative for lymphoma; and on an unspecific date underwent ultrasound scan: a complex hypodense mass, showed a complex hypodense mass noted inferior to the right ear at the level of the parotid gland. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which includes Anti biotic Motrin referred for ultrasound. The outcome of the events was not recovered.  No follow-up attempts are required. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Oncocytic neoplasm; Swollen area on the right auricula area; a complex hypodense mass noted inferior to the right ear at the level of the parotid gland; This is a spontaneous report from a contactable pharmacist (patient). A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3246, expiry date: unknown) via an unspecified route of administration, administered in Right Arm on 20Jan2021 17:00 as dose 1, single (age at vaccination:75-Years-old) for COVID19 immunization. Medical history included High blood pressure, and Known allergies to Penicillin. Concomitant medications included Enalapril 5mg, Simvastin 20mg, and Omega 3 2000 mg [FISH OIL]. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 before and tested post vaccination. On 16Feb2021 16:00 the patient experienced oncocytic neoplasm, swollen area on the right auricula area, and a complex hypodense mass noted inferior to the right ear at the level of the parotid gland. Caller stated, this mass demonstrates a lobular appearance there are internal septations noted. The mass is not completely anechoic consistent with a simple cyst. Mass measures 3.8cm x 2.2cm x 2.8. On 03May2021 the patient underwent lab tests and procedures which included Nasal Swab, SARS-CoV-2 test: negative; on 04May2021 underwent biopsy: oncocytic neoplasm, negative for lymphoma; and on an unspecific date underwent ultrasound scan: a complex hypodense mass, showed a complex hypodense mass noted inferior to the right ear at the level of the parotid gland. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which includes Anti biotic Motrin referred for ultrasound. The outcome of the events was not recovered.  No follow-up attempts are required. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Job dissatisfaction, Vaccination site reaction
Clinical narrative: small amount of pain at the injection site of left shoulder; experienced small amount of pain at the injection site of left shoulder; not going to be a very productive day and that was the case; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8735, Expiry date: unknown ) (age at the time of vaccination was 61 years), via an unspecified route of administration, administered in Arm Left on 22Apr2021 around 13:00-13:30 as dose 1, single for COVID-19 immunization. Medical history included, had positive COVID-19 test from exposure that occurred between best guess 25Nov2021-30Nov2020. Had no symptoms and had digital thermometer was periodically taking temperature even though had no symptoms, works from home-took test because it was close by at the apartment complex, but was completely asymptomatic. Acute Bronchitis as a child from an unknown date and unknown if ongoing. Other vaccine prior to COVID vaccine with in 4 weeks was reported as second dose of Shingrix Vaccine shot, 2 weeks and 1 day prior to first Pfizer COVID-19 Vaccine. Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. Shingrix Vaccine second dose vaccine hurt a lot, but he was fully recovered from the Shingrix Vaccine and feeling fine by the time he got the first Pfizer COVID-19 Vaccine. Shingrix Vaccine first dose caller thinks was administered on 30Dec2020 or 31Dec2020: Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533, Expiry date: unknown ) (age at the time of vaccination was 58 years), via an unspecified route of administration, administered in Arm Left on 02Apr2021 around 13:00-13:30 as dose 1, single for COVID-19 immunization. On 23Apr2021, when he woke up, the patient was anticipating that and told his manager basically not going to be a very productive day and that was the case. That was more than just a little bit of pain at injection site, it was not being able to work the entire next day. The patient completely recovered and would say by a day later. Treatment received included Advil, may be he should have taken Tylenol. The patient underwent lab tests and procedures, which included Covid-19 test in Nov2020: showed positive. The outcome of the event experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy was resolved in Apr2021, and outcome of the events should pain and work problem was unknown.  No follow-up attempts were needed. No further information was expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0150, expiry date: not specified), at the vaccination age of 68, via an unspecified route of administration, in right arm, on May 4, 2021, at 09:15, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# ER8734, expiry date: not specified), at the vaccination age of 68, via an unspecified route of administration, in right arm, on Apr 13, 2021, single dose, for COVID-19 immunization. There was no prior vaccination within 4 weeks, no additional vaccines administered on same date of the Pfizer suspect. The patient noticed his face was swollen on May 8, 2021, and he just wanted to report that. The event didn't require a visit to emergency room or physician office. Patient did not receive any treatment for the event. Outcome of event: not recovered. No follow-up attempts needed. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Inflammation
Clinical narrative: inflammation on her collarbone; paining on her collarbone; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot Number was not reported) via an unspecified route of administration on 10May2021 (at the age of 27 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced inflammation on her collarbone and paining on her collarbone. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Non-itchy rash on the same arm that I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 10May2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced non-itchy rash on the same arm that I got the vaccine. The patient was just wondering, took the vaccine yesterday (a day before reporting), first dose, was this normal to get a non-itchy rash on the same arm that the patient got the vaccine. The clinical outcome of the event was unknown.  Limited information was available over the call as consumer hung up abruptly. , product details (LOT, expiration date,), purchase details and other details were unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I received my first dose, I got a rash; I have it in my legs and in my arm; This is a spontaneous report received from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient never had rashes in the past. On an unspecified date, after receiving first dose, the patient got a rash and had it in legs and in arm. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: exacerbated her Arthritis; This is a spontaneous report from a contactable other hcp (patient) via Medical Information Team.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. it was unknown that patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were unknown. On an unspecified date, after first dose the patient experienced exacerbated her arthritis. the event was no Life threatening, no Disabling/Incapacitating, no Intervention/Medically Important, no Congenital Anomaly/Birth Defect. The event was non serious. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pyrexia
Clinical narrative: now experiencing, dizziness, headache, shills, and fever; now experiencing, dizziness, headache, shills, and fever; now experiencing, dizziness, headache, shills, and fever; now experiencing, dizziness, headache, shills, and fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 57-year-old female patient 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 11May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced dizziness, headache, chills, and fever. Patient did go to the emergency room last night because she was scared. Patient would like to know how long these side effects might last for. Patient was referred to HCP for further treatment recommendations. The outcome of all the events was not recovered.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome, Vertigo
Clinical narrative: Extreme restless legs (couldn't stop moving legs); Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 08May2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hysterectomy due to ovarian cyst and signs of ovarian cancer, kidney stones and vertigo. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion XL (MANUFACTURER UNKNOWN) and topiramate (MANUFACTURER UNKNOWN); both for an unknown indication, on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 17Apr2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 09May2021 at 00:00, 1 day after the vaccination, the patient experienced extreme restless legs (couldn't stop moving legs) and vertigo which began 24 hours after vaccination. The events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of events extreme restless legs (couldn't stop moving legs) was resolved on 10May2021 at 00:00 after the duration of 24 hours, while vertigo was resolved on 11May2021 at 00:00, after the duration of 48 hours.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Night sweats, Pyrexia
Clinical narrative: night sweats; fatigue; chills/fever; terrible headaches; chills; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced night sweats, fatigue chills, fever and terrible headaches. Outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Itching in hands, arms, fingers, legs and sometimes ankles:; tiny bumps in both arms; arm was a little tiny sore; hives; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).  A 64-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection Batch No: not available/Lot Number: ER8736) via an unspecified route of administration, administered in Left Arm on 21Apr2021 at 15:15 (at the age of 64 years old) as dose 2, single for covid-19 immunization. Medical history included ongoing hypertension from an unknown date. The patient's Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from an unspecified start date and ongoing; acetylsalicylic acid, ascorbic acid (ASPIRIN C) taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection Batch No: not available/Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 64 years old) as dose 1, single for covid-19 immunization. No other vaccinations administered within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations was unknown. No Family Medical History Relevant to AE(s). No other Additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that patient was calling about the Pfizer, and that she took two vaccine shots for the Pfizer Covid 19 vaccine. On an unspecified date in APR2021 (about the end of the month of April) for the last 2 weeks, patient experienced hives, has had itching at night. She had itching in her hands, arms, and sometimes ankles and feet. There are tiny bumps in both arms and it was weird and cannot see them or itch during the day. They are still the same but sometimes there will be tiny little bumps and can barely see them. Looks like they maybe rubbing them all of the time. Her arm was a little tiny sore, got over that and was feeling fine. The itching was at night and then she feels it and starts itching. For the last 2 weeks, she started itching all the time that lasted 2 weeks and felt little fine. She stated that, her breathing and everything was okay. She had no fever or anything, just itching. AE did not require visit to physician room or emergency room. The relevant test was none. Treatment was tried Cortisone cream and has tried some Rapid Relief Gold Bond Anti-itch Cream for the itching in hands, arms, fingers, legs and sometimes ankles which was persisting. Was trying to see if it would help stop itching. Was itching for 2 weeks, has had enough and was sked anything there to take or help with the itching. The outcome of the events "arm was a little tiny sore" was recovered and all other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Inflammation and pain in arm pit, left arm, after second vaccine; Inflammation and pain in arm pit, left arm, after second vaccine; This is a spontaneous report from a contactable consumer(patient). A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO158) via an unspecified route of administration, administered in left arm on 11May2021 at 08:30 as DOSE 2, SINGLE for COVID-19 immunization(age at vaccination 25 years old). The patients medical history included melanoma from Feb2019 to Apr2019 she stated that it was diagnosed about 2 years ago, in Feb2019 and the Melanoma was fully removed by Apr2019. The patient's concomitant medications was not reported. The patient previously took contraceptives from an unknown date and for an unspecified reason. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733) via an unspecified route of administration, administered in left arm on 20Apr2021 at 08:30 as DOSE 1, SINGLE for COVID-19 immunization. No additional vaccines administered on same date of the Pfizer Suspect. No emergency room visit and physician office visit was reported. The patient did not receive any vaccine 4 weeks prior vaccination. On 12May2021 the patient experienced inflammation and pain in arm pit, left arm, after second vaccine. Additional Context: Caller is calling about the Pfizer Covid 19 vaccine. she experienced an inflammation and pain, in the arm pit, of the arm that she got her vaccine. Caller stated she read online that it was a common side effect, and 15 percent of people experienced swelling of the lymph notes. Caller reported that she has a history of melanoma, and she wanted to know if she should call her Oncologist. Caller asked should she be concerned or is there any action that she would need to take? Caller agrees to complete a safety report. The outcome of the event was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Paraesthesia, Skin discolouration
Clinical narrative: her fingertips were white; redness, burning and tingling in her toes; redness, burning and tingling in her toes; redness, burning and tingling in her toes; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 16Apr2021 as dose 2, single for covid-19 immunization. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced redness, burning and tingling in her toes and patient noticed her fingertips were white. The patient still was experiencing, but she indicated that she was saw some improvement. The patient had seen her doctor about this (physician office visit). The outcome of the events was recovering.  No follow attempts were needed; information about lot/batch number could not be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Productive cough, Upper respiratory tract congestion
Clinical narrative: a lot of congestion since and is coughing and coughing up a lot of phlegm; a lot of congestion since and is coughing and coughing up a lot of phlegm; a lot of congestion since and is coughing and coughing up a lot of phlegm; This is a spontaneous report received from a contactable consumer. This 80-year-old male consumer (patient) reported for himself.  An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE (at the age of 80-years-old) for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported. The patient had his first dose on the 22Apr2021. Ever since then the patient has had a lot of congestion since and was coughing and coughing up a lot of phlegm. The patient was due for second shot on 13May2021 at 10:30 hours but was not in the condition to get it so the patient did not receive it. The Patient has a COPD problem but was not coughing up phlegm before the vaccine. The patient was thinking about getting the second dose at a later date and queried whether the need to restart the series to get the second dose. The patient knew that the timing of the two doses was 3 weeks and queries whether he have to restart the series since the patient did not get the second dose. The patient could not say whether the vaccine was the reason for the congestion but reported that it did start after the first dose. The patient mentioned that he will reach out to his primary care provider to see about getting the second dose there. The clinical outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Blood glucose, Full blood count, Glycosylated haemoglobin increased, Urine analysis
Clinical narrative: Lost all sense of taste, I can't taste anything; This is a spontaneous report from a contactable consumer (Patient).  A 63-year-old patient of unknown gender received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0171 and expiry date: Not reported), via an unspecified route of administration into the left arm on 13May2021 at 08: 00 as dose 2, single (Age at vaccination: 62-year-old) for COVID-19 immunization. Medical history included: Diabetes mellitus (ongoing). Concomitant medications included: Dulaglutide (TRULICITY) one shot once week and Metformin for Diabetes mellitus. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EW0171 and expiry date: Not reported), via an unspecified route of administration into the left arm on 22Apr2021 as dose 1, single (Age at vaccination: 62-year-old) for COVID-19 immunization. On 13May2021, the patient had shot at 08: 00 O'clock and started noticing symptoms 4 hours after getting the shot. The patient was having a strange reaction. The patient had lost all sense of taste everything. Tried 'soda', every kind and variety 'of soda', they were all taste like salsa. The patient could not taste anything. The patient had lab work done about 2 weeks ago between the 2 shots. The patient had a doctor visit last week. Laboratory date included: Hemoglobin A1C, CBC (complete Blood Count), Urinalysis and diabetic test. The results were not reported. The patient did not receive any treatment for adverse events. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Inflammation, White blood cell count
Clinical narrative: Tired; numb and limpy; numb and limpy; This is a spontaneous report based on information received by Pfizer from  non-contactable consumer or other non hcp. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 25Feb2021 (age at vaccination was 64 years) as dose 1, single for COVID-19 immunization. The patient's medical history included mycotic allergy, white blood cell count decreased and disorientation from an unknown date and unknown if ongoing. Concomitant medication included ocrelizumab, furosemide, spironolactone, baclofen, lubiprostone (AMITIZA) and isoleucine, leucine, levocarnitine, valine (BCAA & L CARNITINE) taken for an unspecified indication, start and stop date were not reported. On 25Feb2021 the patient experienced tired, numb and limpy. The patient underwent lab tests and procedures which included white blood cell count which showed low result (Low white blood cells, Disoriented) on an unspecified date. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.