chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe muscle aches; This is a spontaneous report from a non-contactable consumer (Patient). A 59-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 at 08:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included estradiol (ESTROGEN); Progesterone; Rizatriptan; Nortriptyline. Patient did not receive any other vaccines in 4 weeks. Patient did not have Covid prior vaccination. Patient did not tested Covid post vaccination. Patient did not have allergies. The patient experienced severe muscle aches on 06Apr2021. AE resulted in doctor or other healthcare professional office. Patient received Fluconazole, Nystatin as a result of adverse event. Patient received dose 2 on 02Apr2021, at 08:15 AM, Vaccine location: Left arm, Dose number=2, Lot number: EP6955, for Covid-19 immunization. 1 & 2nd doses had severe muscle aches on day 2 post shot. The outcome of the event was not recovered.  No Follow-up attempts are possible. No Further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Investigation, Mental disorder, Pain
Clinical narrative: Headache; sore arm; felt fatigued; mental cloudy; body aches 3 on 10 scale/extreme body ache 8 on 10 scale; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0171), via an unspecified route of administration on 23Apr2021 09:00 as dose number unknown, single for covid-19 immunisation. Medical history included Migraine periodically, not chronic. The patient had no known allergies.  The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 (lot number: Er8737) as dose 1 on 02Apr2021 for Covid-19 immunization (at the age of 62-years-old). On 23Apr2021 at 12:00, the patient experienced headache, sore arm, felt fatigued, mental cloudy, body aches 3 on 10 scale/extreme body ache 8 on 10 scale. The patient underwent lab tests and procedures which included investigation: 3 on 10 scale, and 8 on 10 scale. Therapeutic measures were taken as a result of the events. Treatment drug included ibuprofen self-treated. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Approx 4 hrs post jab, the patient had Headache sore arm. As day continued felt fatigued, mental cloudy, body aches 3 on 10 scale, ibuprophen helped some but still felt off. In morning extreme body ache 8 on 10 scale, headache, fatigue. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache; sore arm; felt fatigued; mental cloudy; body aches 3 on 10 scale/extreme body ache 8 on 10 scale; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0171), via an unspecified route of administration on 23Apr2021 09:00 as dose number unknown, single for covid-19 immunisation. Medical history included Migraine periodically, not chronic. The patient had no known allergies.  The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 (lot number: Er8737) as dose 1 on 02Apr2021 for Covid-19 immunization (at the age of 62-years-old). On 23Apr2021 at 12:00, the patient experienced headache, sore arm, felt fatigued, mental cloudy, body aches 3 on 10 scale/extreme body ache 8 on 10 scale. The patient underwent lab tests and procedures which included investigation: 3 on 10 scale, and 8 on 10 scale. Therapeutic measures were taken as a result of the events. Treatment drug included ibuprofen self-treated. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Approx 4 hrs post jab, the patient had Headache sore arm. As day continued felt fatigued, mental cloudy, body aches 3 on 10 scale, ibuprophen helped some but still felt off. In morning extreme body ache 8 on 10 scale, headache, fatigue. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This is a spontaneous report received from a contactable consumer (patient reported for self). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported experiencing severe diarrhea since 2 AM this morning (as reported). The consumer reported his diarrhea was currently improved. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I has a large rash that started 2 days after the 1st dose and lasted 10 days.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 10:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 the patient experienced large rash that started 2 days after the 1st dose of vaccine and lasted 10 days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. On 06May2021, the clinical outcome of the event large rash that started 2 days after the 1st dose of vaccine and lasted 10 days was recovered.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Rash, Vision blurred
Clinical narrative: Blurred vision; Nausea; Headache; Rash; Dose 1 on 28Apr2021 and Dose 2 on 16May2021; This is a spontaneous report received from a contactable consumer or other non health care professional, the patient.  A 50-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via an unspecified route of administration in the right arm on 16May2021 at 16:45 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and rheumatoid arthritis (RA) on an unknown date and unknown if ongoing. The patient had no known allergies. Historical vaccine included as the patient previously received the first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: unknown) via an unspecified route of administration in the right arm on 28Apr2021 at 14:30 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021, the patient experienced blurred vision, nausea, headache and rash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events blurred vision, nausea, headache and rash was not recovered at the time of this report.  Information about lot/ batch have been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scab, Scar, Swelling
Clinical narrative: Received "bumps" after 4 days after first dose,; extremely itchy; crusted; dark scars; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: ER8732 and expiry date was not provided) via an unspecified route of administration in arm left on 24Mar2021 at 15:00 (at the age of 54-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was reported as none. The patient's concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) 37.5mg, from an unknown date to an unknown date, for an unknown indication. On an unknown date, the patient previously took sulfamethoxazole (MANUFACTURER UNKNOWN), trimethoprim (SEPTRA); both for an unknown indication and experienced drug allergy on an unspecified date. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021(4 days after the first vaccination), the patient experienced bumps, extremely itchy, crusted and dark scars. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of all events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Cold; Chills all night; Fatigue; Redness; Swelling of any arthritic joints; swelling and pain for 4 days; swelling and pain for 4 days; Lack of appetite; Brain fog- ongoing; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17May2021 at 12:00 (at the age of 52-years-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patients medical history and concomitant medications was not reported. The patient had no known allergies to medications, food or other products. Patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced a cold within 2 hours, chills all night, fatigue. The patient reported that she could not go to work due to the chills and fatigue. On an unknown date in May2021, the patient also experienced redness, swelling of any arthritic joints, swelling and pain for 4 days, redness for days, lack of appetite and brain fog-ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cold within 2 hours, chills all night, fatigue, redness, swelling of any arthritic joints, swelling for four days, pain for four days, redness for days and lack of appetite was recovered with lasting effects. The clinical outcome of the event brain fog was ongoing not recovered at the time of this report.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.  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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Nasopharyngitis, Pain, Swelling
Clinical narrative: Cold; Chills all night; Fatigue; Redness; Swelling of any arthritic joints; swelling and pain for 4 days; swelling and pain for 4 days; Lack of appetite; Brain fog- ongoing; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17May2021 at 12:00 (at the age of 52-years-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patients medical history and concomitant medications was not reported. The patient had no known allergies to medications, food or other products. Patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced a cold within 2 hours, chills all night, fatigue. The patient reported that she could not go to work due to the chills and fatigue. On an unknown date in May2021, the patient also experienced redness, swelling of any arthritic joints, swelling and pain for 4 days, redness for days, lack of appetite and brain fog-ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cold within 2 hours, chills all night, fatigue, redness, swelling of any arthritic joints, swelling for four days, pain for four days, redness for days and lack of appetite was recovered with lasting effects. The clinical outcome of the event brain fog was ongoing not recovered at the time of this report.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.  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: Cough, Headache, Nausea, Saliva altered, Throat irritation
Clinical narrative: feels like throat blocked (not inhibiting airway); coughing; stalling saliva; Mild to moderate headache; Mild nausea; injection site sore; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19; solution for injection, Lot Number: EW0167) via an unspecified route of administration in the left arm on 19May2021 at 20:00 (at the age of 66-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included severely broken nose/ deviated nasal septum (waiting to repair), migraine headache, allergy to Sulfa drugs, and the patient concomitant medication included SUMATRIPTAN SUCCINATE (IMITREX) for unknown indication. The patient previously took Sulfa (unspecified) for an unknown indication, from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 at 21:00, approximately 1 to 2 hours after vaccination the patient experienced patient feels like throat is blocked, mild nausea, stalling saliva causing intermittent coughing, headache, injection site sore. It was reported that after 24 hours later and same symptoms continued and injection site sore was expected. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken a result of the adverse event. At the time of this report outcome of all events were not recovered. Information on the lot/batch number has been requested
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feels like throat blocked (not inhibiting airway); coughing; stalling saliva; Mild to moderate headache; Mild nausea; injection site sore; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19; solution for injection, Lot Number: EW0167) via an unspecified route of administration in the left arm on 19May2021 at 20:00 (at the age of 66-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included severely broken nose/ deviated nasal septum (waiting to repair), migraine headache, allergy to Sulfa drugs, and the patient concomitant medication included SUMATRIPTAN SUCCINATE (IMITREX) for unknown indication. The patient previously took Sulfa (unspecified) for an unknown indication, from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 at 21:00, approximately 1 to 2 hours after vaccination the patient experienced patient feels like throat is blocked, mild nausea, stalling saliva causing intermittent coughing, headache, injection site sore. It was reported that after 24 hours later and same symptoms continued and injection site sore was expected. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken a result of the adverse event. At the time of this report outcome of all events were not recovered. Information on the lot/batch number has been requested
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dysmenorrhoea, Eye irritation, Loss of personal independence in daily activities, Nasal discomfort
Clinical narrative: My menstrual cramps were excruciating; severe allergies; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; restraining my ability to do my daily activities; This is a spontaneous report received from a contactable consumer (patient herself). A 19-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EW0171, Expiry date: Unknown) via an unspecified route of administration in the left arm on 10May2021 05:45 PM, (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number EW0161, Expiry date: Unknown), via an unspecified route of administration, in the left arm on 19Apr2021 05:30 PM, (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 14May2021, the patient experienced menstrual cramps excruciating, after the second dose she began having severe allergies, something she never had before. Intense burning of the eyes, nose, and throat and non-stop sneezing. These allergies are very severe, and it is restraining her ability to do daily activities. On 19May2021 the patient underwent lab tests and procedures which included Influenza and Covid-19 test results negative, Technique: Nasal Swab. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient did not receive any treatment for adverse events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing, Throat irritation
Clinical narrative: My menstrual cramps were excruciating; severe allergies; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; Intense burning of the eyes, nose, and throat and non-stop sneezing; restraining my ability to do my daily activities; This is a spontaneous report received from a contactable consumer (patient herself). A 19-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EW0171, Expiry date: Unknown) via an unspecified route of administration in the left arm on 10May2021 05:45 PM, (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number EW0161, Expiry date: Unknown), via an unspecified route of administration, in the left arm on 19Apr2021 05:30 PM, (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 14May2021, the patient experienced menstrual cramps excruciating, after the second dose she began having severe allergies, something she never had before. Intense burning of the eyes, nose, and throat and non-stop sneezing. These allergies are very severe, and it is restraining her ability to do daily activities. On 19May2021 the patient underwent lab tests and procedures which included Influenza and Covid-19 test results negative, Technique: Nasal Swab. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient did not receive any treatment for adverse events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Sore arm; Headache; This is a spontaneous report from a contactable consumer (patient). A 16-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) in Arm Right via unspecified rout of administration as dose 2, single on 22May2021 03.30 PM (at age of vaccination 16-year-old) for covid-19 immunization in Pharmacy or Drug Store. The patient medical history included anemia and anorexia. The patient had no known allergies. The patient concomitant medications included Prozac (FLUOXETINE HYDROCHLORIDE), multi-vitamin, iron and vitamin d. Historical vaccination included BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) in left arm via unspecified rout of administration as dose 1, single on 01May2021 03.30 PM (at age of vaccination 16-years old) for covid-19 immunization in Pharmacy or Drug Store. The patient experienced sore arm with first shot. On 23May2021 06.00 AM, the patient experienced fever of 101.2 less than 24 hours after injection, headache and sore arm. The patient did not receive other vaccine in four weeks. The patient did not receive treatment for any adverse event. The patient had no covid prior vaccination. The patient had no covid test post vaccination. The outcome of events was reported as recovering.   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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: period 2 weeks early; very heavy period; extreme back pain; bad headache; tired; This is a spontaneous report from a contactable consumer. This 46-year-old-female consumer reported that A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0168), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 12:00 (age at the time of vaccination was 46-year-old) as dose 2, single for COVID-19 immunization. Medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EW0167), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 12:00 PM as dose 1, single for COVID-19 immunization and after first dose, period was late, bad headache for a week, fatigue for a week and just overall not feeling well for a week. Facility type vaccine was Workplace clinic. No known allergies were reported. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that after second dose, patient experienced started period 2 weeks early, very heavy period, extreme back pain, bad headache, tired on 20May2021 20:00 but not as bad as after first dose. No treatment was received for all the reported events. Outcome of all the events was reported as not recovered at this time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: A very tender swollen lymph node in armpit (same side as shot); Swollen lymph node in armpit (same side as shot).; Shortness of breath; Severe nausea; Diarrhea 12 hours after second shot; This is a spontaneous report from a contactable consumer, the parent.   A 17-year-old non-pregnant female patient (not pregnant at the time of vaccination) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unspecified date in 2021 (at the age of 17 years-old) as dose 2, single for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 10Apr2021 (at the age of 17-years-old) as dose 1, single for COVID-19 immunisation and experienced a tender swollen lymph node in her armpit (same side as the shot) that began a day or two after the first vaccine. On an unspecified date in 2021, the patient had experienced a very tender swollen lymph node in her armpit (same side as shot), shortness of breath for about a week after the second vaccine, severe nausea and diarrhea 12 hours after the second vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Malaise, Pruritus, Vomiting
Clinical narrative: Felt slightly itchy; immediately felt sick; Dizzy; Arms and legs felt numb; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: unknown) via an unspecified route of administration in the right arm on 21May2021 at 14:45 (at the age of 57-years-old and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included high cholesterol and once hospitalized for an arrhythmia, egg allergy, sulfite allergy and chocolate allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 15:00, after fifteen minutes the patient immediately felt sick, dizzy, arms and legs felt numb, vomiting and dizzy. On 21May2021 at 16:00, after one hour and fifteen minutes, felt slightly itchy. Since the vaccination, the patient had not been tested for COVID-19. The events did result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and was monitored by EMT. The clinical outcome of the events felt sick, dizzy, arms and legs felt numb, vomiting and felt slightly itchy was resolving at the time of this report.   The lot number for the vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; swollen lymph nodes; fatigue; This is a spontaneous report from a contactable consumer (patient herself) or other non HCP. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021, as a single dose for COVID-19 immunization. It was unknown if the patient was pregnant. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021, as a single dose for COVID-19 immunization. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021, the patient experienced Pyrexia, swollen lymph nodes and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events Pyrexia, swollen lymph nodes and fatigue was recovered on an unknown date in May2021.   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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Weight
Clinical narrative: he is coughing a lot; This is a spontaneous report from a contactable consumer (friend). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0185), via an unspecified route of administration on 21May2021 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient got vaccinated second dose like two days ago, on 21May2021(Friday) and he was coughing a lot (May2021). The reporter checked side effect leaf and it didn't appear coughing, so the reporter was kind of worry. The patient took Ibuprofen as treatment for cough. Reporter stated about weight as, "He was around 62 kg, No Sorry 92." The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Lip swelling
Clinical narrative: Derma filler swell on top lip  that went away about a week later. But also had filler that bubbled up onthe water line of lip. It almost looks like blisters but  can visual tell it was derma filler.; Have these 3 lumps inside my lips that now need to dissolve; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 at 18:00 as DOSE 1, SINGLE for covid-19 immunization. Medical history included very sensitive skin to products and the patient had reactions to products so it might have something to do with skin sensitivity. The patient had been getting fillers for over 18 years though and never had this happen until the day after the first vaccine. The patient had skin allergies to fake jewelry, allergy to metals, and allergic to nickel, sensitive skin from an unknown date and unknown if ongoing, but patient had no medications of any kind. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine (BUPRENORPHINE) and alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported. On 30Mar2021 the patient experienced derma filler swell on top lip that went away about a week later. but also had filler that bubbled up on the water line of lip. it almost looks like blisters but can visually tell it was derma filler and have these 3 lumps inside my lips that now need to dissolve. It was not that big of a deal and if the patient had to go back in time to get the vaccine again knowing this would happen, she would still get the vaccine. she just thought it should be reported for educational purposes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events derma filler swell on top lip and had three lumps inside her lips that now needed to be dissolved was recovering at the time of this report.  The lot number for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Lethargy, Paranasal sinus discomfort, Vaccination site pain
Clinical narrative: Some sinus pressure (started day after receiving dose and lasted approximately 24 hours); Including a minor nosebleed; General feeling of lethargy for about 36 hours after receiving dose; Sore arm at the injection site; This is a spontaneous report from a contactable consumer. A male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced some sinus pressure day after receiving dose and lasted approximately 24 hours, minor nosebleed, general feeling of lethargy for about 36 hours after receiving dose and sore arm at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. On an unspecified date, the event some sinus pressure was recovered after approximately 24 hours of onset and also general feeling of lethargy was recovered 36 hours after receiving dose in 2021. The outcome of minor nosebleed and sore arm at the injection sit was unknown at the time of this report.   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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Frequent nose bleeds; This is a spontaneous report from a contactable consumer. This 33-year-old non-pregnant female consumer (patient) reported for herself. The patient received first dose of bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an right arm of administration on 08Apr2021 (at the age of 33-year-old), at 9:30 AM as dose 1, single for COVID-19 immunisation. The patient relevant medical history included Asthma. The Concomitant medication's included Sertraline 50 mg. The patient has no known allergies. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021, the patient experienced Frequent nose bleeds. It was reported that, the patient did not receive any treatment. The clinical outcome of the event unknown.  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: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Pain in left arm; Fatigue; Temp 99.8; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 24May2021 at 16:30 (at the age of 12-years-old), as a dose 1, single for COVID-19 immunisation. The patient medical history included attention deficit hyperactivity disorder (ADHD), anxiety and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food or other products The patient did not receive any other vaccines within four weeks prior to the vaccination.The Concomitant medications included guanfacine hydrochloride (INTUNIV) 2 mg from an unknown date for unspecified indication. The Patient was experienced pain in left arm, fatigue and temperature 99.8 on 25May2021 at 07:00, Therapeutic measures were taken and included treatment with ibuprofen. The outcome of events pain in left arm, fatigue, and temp 99.8 was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Really bad headache; Fever; Chills; Nausea; Fatigue; nausea (including vomiting); This is a spontaneous report from a contactable consumer, the patient or other non hcp.  An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 19May2021 16:30 as DOSE 2, SINGLE (at the age of 18-year-old) for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 28Apr2021 at 16:30, the patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171) via an unspecified route of administration in the left arm on (at the age of 18-year-old) as a single dose for COVID-19 immunisation. On 20May2021 01:00, the patient experienced really bad headache, fever, chills, nausea, fatigue and nausea continuing for three days after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of all events was recovering.   Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Really bad headache; Fever; Chills; Nausea; Fatigue; nausea (including vomiting); This is a spontaneous report from a contactable consumer, the patient or other non hcp.  An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 19May2021 16:30 as DOSE 2, SINGLE (at the age of 18-year-old) for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 28Apr2021 at 16:30, the patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171) via an unspecified route of administration in the left arm on (at the age of 18-year-old) as a single dose for COVID-19 immunisation. On 20May2021 01:00, the patient experienced really bad headache, fever, chills, nausea, fatigue and nausea continuing for three days after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of all events was recovering.   Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: fatigue; fever; cold sweat; loose stool; mild body ache before bed; This is a spontaneous report from a contactable consumer (patient) or Other non-HCP. A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number were unknown) via an unspecified route of administration, administered in Arm Right on 23May2021 12:00 (at the age of 32-year-old) as Dose 2, Single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included lamotrigine (LAMOTRIGINE) and quetiapine fumarate (SEROQUEL) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number were unknown) via an unspecified route of administration in the right arm on 25Apr2021 at 12:00 (at the age of 32-year-old), as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 23May2021 at 21:30, the patient experienced mild body ache before bed. On 24May2021, the patient experienced fatigue, fever, body ache, cold sweat and loose stool. On 25May2021, the patient felt good as new. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events.The patient did not receive treatment for the events.The outcome of the events were recovered on 25May2021.  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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, SARS-CoV-2 test, Skin discolouration
Clinical narrative: Skin broken open; Purple; My lips are extremely swollen; This is a spontaneous report from a contactable consumer or other non HCP. A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2 formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 17:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced drug hypersensitivity. The patient experienced, my lips are extremely swollen, skin broken open, purple on 24May2021 23:30, about 6 hours after receiving vaccine. Patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab on Jan2021, Feb2021, Mar2021 for which results were negative. The clinical outcomes of extremely swollen lip, purple and skin broken were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.