chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Night sweats, Pain
Clinical narrative: Extreme night sweats; Very sore and achy; Bad cough; Fatigue; Vomiting; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient.   A 23-year-old male patient 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 03May2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151), via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. 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 03May2021 at 17:00, the patient experienced very sore and achy, bad cough, fatigue, vomiting, fever, headache and extreme night sweats. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very sore and achy, bad cough, fatigue, vomiting, fever, headache and extreme night sweats were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: treatment received was ticked/selected as no and following information was added in narrative: No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Extreme night sweats; Very sore and achy; Bad cough; Fatigue; Vomiting; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient.   A 23-year-old male patient 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 03May2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151), via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. 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 03May2021 at 17:00, the patient experienced very sore and achy, bad cough, fatigue, vomiting, fever, headache and extreme night sweats. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very sore and achy, bad cough, fatigue, vomiting, fever, headache and extreme night sweats were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: treatment received was ticked/selected as no and following information was added in narrative: No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Ear pain, Facial pain, Neck pain
Clinical narrative: aching in right side of neck; aching in right shoulder; Soreness and aching in right side of face; ear ache; jaw ache; tooth ache; cheek bone ache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 15Apr2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cats. Concomitant medications included collagen peptides (MANUFACTURER UNKNOWN), multi-vitamin (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 17Apr2021 at 12:00, the patient experienced soreness and aching in right side of face...ear, jaw, teeth, cheek bone, as well as in right side of neck and right shoulder. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported adverse events and included treatment with filed teeth, ibuprofen (MANUFACTURER UNKNOWN) and BENGAY. On an unknown date, the patient underwent lab test which included dental x- rays and results were unknown. The clinical outcome of the events soreness and aching in right side of face, ear ache, jaw ache, teeth ache, cheek bone ache, pain in right side of neck and right shoulder were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event description as reported was updated to aching in right side of neck and narrative was updated as follows: soreness and aching in right side of face, ear ache, jaw ache, teeth ache, cheek bone ache, pain in right side of neck and right shoulder' was updated to Soreness and aching in right side of face...ear, jaw, teeth, cheek bone, as well as in right side of neck and right shoulder'.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Toothache, X-ray dental
Clinical narrative: aching in right side of neck; aching in right shoulder; Soreness and aching in right side of face; ear ache; jaw ache; tooth ache; cheek bone ache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 15Apr2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cats. Concomitant medications included collagen peptides (MANUFACTURER UNKNOWN), multi-vitamin (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 17Apr2021 at 12:00, the patient experienced soreness and aching in right side of face...ear, jaw, teeth, cheek bone, as well as in right side of neck and right shoulder. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported adverse events and included treatment with filed teeth, ibuprofen (MANUFACTURER UNKNOWN) and BENGAY. On an unknown date, the patient underwent lab test which included dental x- rays and results were unknown. The clinical outcome of the events soreness and aching in right side of face, ear ache, jaw ache, teeth ache, cheek bone ache, pain in right side of neck and right shoulder were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event description as reported was updated to aching in right side of neck and narrative was updated as follows: soreness and aching in right side of face, ear ache, jaw ache, teeth ache, cheek bone ache, pain in right side of neck and right shoulder' was updated to Soreness and aching in right side of face...ear, jaw, teeth, cheek bone, as well as in right side of neck and right shoulder'.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Headache, Pain, Periorbital swelling
Clinical narrative: Felt achy; puffy/dry eyes that felt like I'd been swimming in a chlorinated pool; puffy/dry eyes that felt like I'd been swimming in a chlorinated pool; headache; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170) on 19Apr2021 at 13:45 (age at the time of vaccination was 62-year-old) as dose 2, single and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FR8732) on 29Mar2021 at 13:45 as dose 1, single both via an unspecified route of administration, administered in left arm for COVID-19 immunisation. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing (generally good health). Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), 100 mg, daily, taken for an unspecified indication with no start and stop dates reported. On 20Apr2021 at 12:00 patient felt achy, she had puffy/dry eyes that felt like i'd been swimming in a chlorinated pool and headache. It was reported that patient had puffy/dry eyes that felt like I'd been swimming in a chlorinated pool after 24 hours of vaccine which lasted another day or two (maybe longer?). Patient also had a headache that second day, which she did not get, normally. Additionally, patient felt achy and went to bed early that second day. The patient was not pregnant at the time of vaccination. There were no known allergies reported. She had been taking 100 mg Levothyroxin daily within two weeks of vaccination. There were no other vaccines administered in four weeks. She had not been diagnosed with COVID-19 prior to vaccination and tested since the vaccination. Patient had not received any treatment as a result of events. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Fatigue, Headache, Pain
Clinical narrative: Pain and soreness in left armpit; Prolonged (multi day) head ache; Slight temperature increase (3 degrees); Body aches; Exhaustion/tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736), via an unspecified route of administration in the left arm on 03May2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles, eczema and high blood pressure. Concomitant medications included Atenolol and Chlorthalidone both taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received Sulfa for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration in the left arm on 12Apr2021 at 12:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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. On 03May2021 at 16:30, the patient experienced exhaustion/tiredness approximately after 4 hours post vaccination. On 04May2021, a day after the vaccination, the patient experienced prolonged (multi day) head ache , body aches with slight temperature increase (3 degrees) by the evening. On 05May2021 at 04:30, approximately 40 hours after the second shot, the patient experienced pain and soreness in left armpit. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events exhaustion, prolonged (multi day) head ache, slight temperature increase (3 degrees), body aches and pain and soreness in left armpit was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated relevant history data (Allergy sulfa), treatment was updated as no for the events, lab data updated (temperature), event onset date updated for "Pain and soreness in left armpit" to 05-MAY-2021 04:30 and concomitant data updated. closure statement updated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain and soreness in left armpit; Prolonged (multi day) head ache; Slight temperature increase (3 degrees); Body aches; Exhaustion/tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736), via an unspecified route of administration in the left arm on 03May2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles, eczema and high blood pressure. Concomitant medications included Atenolol and Chlorthalidone both taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received Sulfa for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration in the left arm on 12Apr2021 at 12:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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. On 03May2021 at 16:30, the patient experienced exhaustion/tiredness approximately after 4 hours post vaccination. On 04May2021, a day after the vaccination, the patient experienced prolonged (multi day) head ache , body aches with slight temperature increase (3 degrees) by the evening. On 05May2021 at 04:30, approximately 40 hours after the second shot, the patient experienced pain and soreness in left armpit. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events exhaustion, prolonged (multi day) head ache, slight temperature increase (3 degrees), body aches and pain and soreness in left armpit was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated relevant history data (Allergy sulfa), treatment was updated as no for the events, lab data updated (temperature), event onset date updated for "Pain and soreness in left armpit" to 05-MAY-2021 04:30 and concomitant data updated. closure statement updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: after second does I have had a racing heart and shortness of breath.; after second does I have had a racing heart and shortness of breath.; This is a spontaneous report from a contactable consumer (Patient) via Regulatory Authority.   A 54-year-old female patient (non-pregnant) received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWO170), via an unspecified route of administration, administered in left arm on 24Apr2021 at 12pm (at the age of 54-year-old) for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient did not received any other vaccine in four weeks and received other medications in two weeks. The patient was not diagnosed with covid prior to vaccination and not been tested for covid post vaccination. No known allergies. The patient medical history reported as none. Historical Vaccine include bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in right arm on 02Apr2021 at 13:15 for COVID-19 immunisation and experienced extreme pain in opposite armpit of vaccine site. On an unknown date in May2021, the patient had a racing heart and shortness of breath. Treatment received for the event was unknown. The reporter further stated that today (on the day of this report) was 10 days after and her gym workout was extremely hard due to shortness of breath. Patient stated she was fit and this was not normal. The clinical outcome of both the events was not recovered.  No follow up attempts are possible. No further information is expected
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Nasal congestion, Off label use, Oropharyngeal pain
Clinical narrative: Slight swollen throat; swollen lymph nodes about 24 hours after vaccination; Drug use in unapproved population; off label use; throat/lymph nodes were swollen and hurting a bit; throat/lymph nodes were swollen and hurting a bit; nasal congestion began to occur; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old adult female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ewo161 and expiry date was not reported), via an unspecified route of administration in left arm, on 28Apr2021 at 03:15 PM (age at vaccination was 31 years), as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reportedly the patient had no allergies and had no illness, but the patient was breastfeeding (ongoing). The patient was not pregnant at the time of vaccination. It was reported that the patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient also did not have other vaccine in four weeks. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ER8734 and expiry date was not reported), via an unspecified route of administration in left arm, on 31Mar2021 at 03:15 PM (age at vaccination was 31 years), as a dose 1, single for COVID-19 immunization. On 29Apr2021 at 07:00 PM about 24 hours after vaccination the patient had slight swollen throat/lymph nodes. 36 hours after vaccination, throat/lymph nodes were swollen and hurting a bit (Apr2021). After 48 hours, nasal congestion began to occur  (Apr2021). It was 5 days after receipt of the vaccine, the patient had a slight swollen throat and nasal congestion. It was reported that the patient did not receive treatment for the adverse events (slight swollen throat, swollen lymph nodes about 24 hours after vaccination, throat/lymph nodes were swollen and hurting a bit, nasal congestion began to occur). Outcome of the events (swollen lymph nodes about 24 hours after vaccination, throat/lymph nodes were swollen and hurting a bit) was recovering and events slight swollen throat, nasal congestion began to occur was not recovered.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021511243 Maternal/Child
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Product use issue
Clinical narrative: Slight swollen throat; swollen lymph nodes about 24 hours after vaccination; Drug use in unapproved population; off label use; throat/lymph nodes were swollen and hurting a bit; throat/lymph nodes were swollen and hurting a bit; nasal congestion began to occur; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old adult female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ewo161 and expiry date was not reported), via an unspecified route of administration in left arm, on 28Apr2021 at 03:15 PM (age at vaccination was 31 years), as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reportedly the patient had no allergies and had no illness, but the patient was breastfeeding (ongoing). The patient was not pregnant at the time of vaccination. It was reported that the patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient also did not have other vaccine in four weeks. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ER8734 and expiry date was not reported), via an unspecified route of administration in left arm, on 31Mar2021 at 03:15 PM (age at vaccination was 31 years), as a dose 1, single for COVID-19 immunization. On 29Apr2021 at 07:00 PM about 24 hours after vaccination the patient had slight swollen throat/lymph nodes. 36 hours after vaccination, throat/lymph nodes were swollen and hurting a bit (Apr2021). After 48 hours, nasal congestion began to occur  (Apr2021). It was 5 days after receipt of the vaccine, the patient had a slight swollen throat and nasal congestion. It was reported that the patient did not receive treatment for the adverse events (slight swollen throat, swollen lymph nodes about 24 hours after vaccination, throat/lymph nodes were swollen and hurting a bit, nasal congestion began to occur). Outcome of the events (swollen lymph nodes about 24 hours after vaccination, throat/lymph nodes were swollen and hurting a bit) was recovering and events slight swollen throat, nasal congestion began to occur was not recovered.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021511243 Maternal/Child
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Migraine, Nausea, Pyrexia
Clinical narrative: vomiting sporadically for a full day with queasiness; vomiting sporadically for a full day with queasiness; lightheadedness; Fever; hives; Migraine accompanied by limited appetite; Migraine accompanied by limited appetite; Migraine accompanied by limited appetite;  This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 26-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 29Apr2021 17:30 (at the age of 26-year-old) as dose 2, single for covid-19 immunization. Patient's relevant medical history included ongoing hormonal migraines, depression and anxiety from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, patient was not diagnosed with covid-19 and post vaccination, patient was not tested for covid-19. Concomitant medications included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included, patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 08Apr2021 18:15 (at the age of 26-year-old) as dose 1, single for covid-19 immunization and experienced after the first shot, had migraine for 2 days. The patient did not receive any other vaccine in four weeks. On 30Apr2021 07:00 after second shot, patient experienced vomiting sporadically for a full day with queasiness, lightheadedness, fever, small of hives, migraine accompanied by limited appetite for at least 4 days. The patient did not receive any treatment for adverse events. Outcome of the events was recovering.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: vomiting sporadically for a full day with queasiness; vomiting sporadically for a full day with queasiness; lightheadedness; Fever; hives; Migraine accompanied by limited appetite; Migraine accompanied by limited appetite; Migraine accompanied by limited appetite;  This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 26-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 29Apr2021 17:30 (at the age of 26-year-old) as dose 2, single for covid-19 immunization. Patient's relevant medical history included ongoing hormonal migraines, depression and anxiety from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, patient was not diagnosed with covid-19 and post vaccination, patient was not tested for covid-19. Concomitant medications included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included, patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 08Apr2021 18:15 (at the age of 26-year-old) as dose 1, single for covid-19 immunization and experienced after the first shot, had migraine for 2 days. The patient did not receive any other vaccine in four weeks. On 30Apr2021 07:00 after second shot, patient experienced vomiting sporadically for a full day with queasiness, lightheadedness, fever, small of hives, migraine accompanied by limited appetite for at least 4 days. The patient did not receive any treatment for adverse events. Outcome of the events was recovering.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: First dose: Sore arm: Caller reported that her arm was sore for 2 days after she received the first dose of the Covid-19 vaccine on 06Apr2021; First dose: Black spot on arm; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0151, Expiry date: unknown), via an unspecified route of administration, administered in right arm on 06Apr2021 (63-year-old at the time of vaccination), as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing High Blood pressure from 2002, Anxiety attack (she used to have anxiety attacks but hasn't for a while Investigation) and hypertension (she has a family history of high blood pressure, and she has a sister that is in remission from cancer). Concomitant medication includes unspecified blood pressure pill for the indication of high blood pressure from an unknown start date. On 06apr2021, after the first dose of vaccination, the patient experienced sore arm. It was reported that her arm was sore for 2 days after she received the first dose of the covid-19 vaccine and on an unspecified date in Apr2021, she experienced black spot-on arm. It was reported that patient arm was sore for 2 days after she received the first dose of the Covid-19 vaccine on 06Apr2021. Patient reported that she could feel the tension and soreness in her arm but within 2 days it had disappeared. First dose: Black spot-on arm: patient reported that within the first two days of receiving her first dose of the Covid-19 vaccine on 06Apr2021, a small black spot appeared on her arm. The black spot disappeared after about 5 days. Patient reported that she received the Covid-19 vaccine because she wants to be around her family. She has not really been around her family because she has an elderly mother at 93. There are a lot of people in her family, and she just wants to be safe. She has newborns and babies coming in her family and she just wants to be safe. Patient was queried for concomitant products twice. She was instructed to take vitamin D by her physician, but she has not started taking it yet. Patient reported later in call that she only takes a blood pressure pill. No details provided. On an unspecified date in Apr2021, the patient resolved from the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021486009 similar report from same reporter
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Muscle spasms
Clinical narrative: heavy period; cramping/spotting; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 27-years-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EP7533) via an unspecified route of administration, administered in left arm on 06Apr2021 at 14:00 (age at the time of vaccination was 27-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included was just being treated for very bad allergies to nature. Concomitant medications which were taken in 2 weeks included birth control, antihistamine and allergy injections. The patient had no known allergies. The patient did not have COVID prior to vaccination and was not treated for COVID post vaccination. The patient had no other vaccine in 4 weeks. On 22Apr2021, the patient experienced heavy period and cramping/spotting. A few days after the first dose, experienced cramping/spotting and had some bleeding, but on the 22Apr2021, a heavy period began which was early and experienced heavy bleeding for over a week. This included large clots and bleeding through pads/tampons. Lighter bleeding continued after the clots stopped. She was still spotting some when had second dose. Two days after, had light bleeding and now she experienced more heavy bleeding with quarter sized clots. Prior to this birth control, had her periods very regular and nowhere near as heavy as this bleeding. Now her cycle was completely off from the pills. No treatment was received for the adverse events. The clinical outcome of events was Not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Neck pain
Clinical narrative: Severe muscle aches and Pains from neck to hips to point in tears; Severe muscle aches and Pains from neck to hips to point in tears; Severe muscle aches and Pains from neck to hips to point in tears; Second shot-first afternoon fatigue; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Apr2021 09:30 as DOSE 2, SINGLE (at the age of 58-year-old) for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Prior and post vaccination, the patient was not tested for covid. The patient had no other vaccine in four weeks.The patient had no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN), dexlansoprazole (DEXILANT) all taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced only pain in arm where injection given. On 07Apr2021 15:00, the patient experienced second shot-first afternoon fatigue. On 08Apr2021, the patient experienced severe muscle aches and pains from neck to hips to point in tears (myalgia, neck pain, arthralgia). The patient had not received treatment.On an unspecified date in 2021, outcome of the events was recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Swelling face, Urticaria, Visual impairment
Clinical narrative: Severe vertical double vision after second dose lasting three days.; Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; Blotchy facial redness and puffiness, almost like hives, after both doses lasting two days.; This is a spontaneous report from a contactable consumer (patient), Reported for himself.  A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, batch/lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 30Apr2021 14:30, as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store (Age at vaccination: 43 years). The patient medical history included high blood pressure and depression from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE), cetirizine hydrochloride (ZYRTEC ALLERGY) and propranolol hydrochloride (INDERAL LA) all were taken for unspecified indication, start and stop date was not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had past drug Wellbutrin and (Allergies: Wellbutrin) on an unknown date. Patient previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, batch/lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 08Apr2021 at 14:00 (at the age of 43-years-old), as DOSE 1, SINGLE for COVID-19 immunization and experienced blotchy facial redness and puffiness and almost like hives. On 01May2021 08:00, the patient experienced severe vertical double vision after second dose lasting three days and blotchy facial redness and puffiness, almost like hives, after both doses lasting two days. The patient did not received treatment for the events. The outcome of event Severe vertical double vision after second dose lasting three days was recovered on 04May2021, while the outcome of other events was recovered on 03May2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine, Haematuria, Menstrual disorder, Muscle spasms, Urinary tract infection
Clinical narrative: Blood in urine; Urinary Tract Infections after first and second shots.; Also skipped period after first shot. Got second shot 4 weeks later, till no period; Also incredibly painful cramps after second shot, lasted 1 hr and happened 12 hrs after second shot.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0167) via an unspecified route of administration, administered in Arm Left on 02May2021 14:30 (at the age of 38-years-old) as dose 2, single for COVID-19 immunization. Medical history included urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication/other medications in two weeks included ciprofloxacin (CIPRO [CIPROFLOXACIN]) taken for urinary tract infection, start and stop date were not reported. No known allergies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0151) via an unspecified route of administration, administered in Arm Left on 05Apr2021 12:00 PM (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. No other vaccine in four weeks. No COVID prior to the vaccination. No COVID tested post vaccination. On 03May2021 02:30 AM, the patient experienced blood in urine, urinary tract infections after first and second shots; but negative culture tests. Also skipped period after first shot. Got second shot 4 weeks later, till no period and incredibly painful cramps after second shot, lasted 1 hour and happened 12 hours after second shot. Concerned with taking antibiotics after second shot with fear of interaction. The patient underwent lab tests and procedures which included culture urine: negative and urine analysis: blood in urine on an unspecified date. Therapeutic measures were taken as a result of adverse events. Adverse event treatment: Cipro antibiotics for 10 days. None for second UTI. The outcome of the events was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Blood in urine; Urinary Tract Infections after first and second shots.; Also skipped period after first shot. Got second shot 4 weeks later, till no period; Also incredibly painful cramps after second shot, lasted 1 hr and happened 12 hrs after second shot.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 38-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0167) via an unspecified route of administration, administered in Arm Left on 02May2021 14:30 (at the age of 38-years-old) as dose 2, single for COVID-19 immunization. Medical history included urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication/other medications in two weeks included ciprofloxacin (CIPRO [CIPROFLOXACIN]) taken for urinary tract infection, start and stop date were not reported. No known allergies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0151) via an unspecified route of administration, administered in Arm Left on 05Apr2021 12:00 PM (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. No other vaccine in four weeks. No COVID prior to the vaccination. No COVID tested post vaccination. On 03May2021 02:30 AM, the patient experienced blood in urine, urinary tract infections after first and second shots; but negative culture tests. Also skipped period after first shot. Got second shot 4 weeks later, till no period and incredibly painful cramps after second shot, lasted 1 hour and happened 12 hours after second shot. Concerned with taking antibiotics after second shot with fear of interaction. The patient underwent lab tests and procedures which included culture urine: negative and urine analysis: blood in urine on an unspecified date. Therapeutic measures were taken as a result of adverse events. Adverse event treatment: Cipro antibiotics for 10 days. None for second UTI. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Aphonia, Cough, Flatulence, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8737, Expiration date was not reported), via an unspecified route of administration in arm left on 20Apr2021 at 14:00 (at the age of 50-years-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included known allergies (unspecified), fibromyalgia, lupus. The patient's concomitant medications received within 2 weeks of vaccination included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), taken for an unspecified indication. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, on 20Apr2021 at 14:05, the patient throat started burning about 5 minutes after the injection and on 20Apr2021 at 14:15, the patient had upset stomach with gas. Stated that, within 24 hrs, on an unspecified date in Apr2021, the patient had chest congestion with a cough and stated that, she lost her voice for two days, sore left arm, headache and body aches. The patient received the second dose in arm left on 07May2021 at 14:00, with lot number: ER8737. Treatment was not received for the events. The outcome of the events for she lost her voice for two days was recovered on an unspecified date in Apr2021 while for the other events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465327 Same drug/reporter/patient, different dose
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Respiratory tract congestion, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8737, Expiration date was not reported), via an unspecified route of administration in arm left on 20Apr2021 at 14:00 (at the age of 50-years-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included known allergies (unspecified), fibromyalgia, lupus. The patient's concomitant medications received within 2 weeks of vaccination included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), taken for an unspecified indication. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, on 20Apr2021 at 14:05, the patient throat started burning about 5 minutes after the injection and on 20Apr2021 at 14:15, the patient had upset stomach with gas. Stated that, within 24 hrs, on an unspecified date in Apr2021, the patient had chest congestion with a cough and stated that, she lost her voice for two days, sore left arm, headache and body aches. The patient received the second dose in arm left on 07May2021 at 14:00, with lot number: ER8737. Treatment was not received for the events. The outcome of the events for she lost her voice for two days was recovered on an unspecified date in Apr2021 while for the other events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465327 Same drug/reporter/patient, different dose
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, SARS-CoV-2 test, Swollen tongue
Clinical narrative: Tingling and mild swelling of tongue; Tingling and mild swelling of tongue; This is a spontaneous report from a contactable other health-care professional (Patient). A 34-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Er8730), via an unspecified route of administration, administered in right arm on 22Apr2021 at 09:45 hours as DOSE 1, SINGLE (at the age of 34-years-old) for COVID-19 immunization. The patient's medical history included systemic lupus, COVID-19 (COVID-19 prior to vaccination). The patient's concomitant medications were not reported. The patient had no known allergies. The patient took no other vaccine in four weeks  but took other medications in two weeks. The patient has not been tested for COVID post vaccination. On 22Apr2021 at 10:30 hours, the patient experienced tingling and mild swelling of tongue. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date, COVID-19 prior to vaccination. The adverse event did not result in emergency room/doctor/physician/other health care office visit. The patient received no treatment for the adverse event. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Movement disorder, Pain in extremity, Polymerase chain reaction
Clinical narrative: severe site pain, left arm, radiated to my scapula through to the front of my shoulder where it is difficult to move my arm; After the first vaccine it started with severe site pain; difficult to move my arm; radiated to my scapula through to the front of my shoulder; This is a spontaneous report from a contactable other health care professional (patient). A 62-year-old non pregnant female patient received bnt162b2 ((PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: #EL0140), dose 1 via an unspecified route of administration, administered in Left Arm on 26Jan2021 03:15 (at age of 62-year-old) as dose 1, single for covid-19 immunization. The patient had no known allergies. Medical history included breast cancer, breast biopsy. Concomitant medications included SERTRALINE, ATORVASTATIN on an unknown date for unspecified indication. No other vaccine in four weeks. No covid prior vaccination and also no covid tested post vaccination. On an unspecified date, the patient experienced severe site pain, left arm, radiated to my scapula through to the front of my shoulder where it is difficult to move my arm, after the first vaccine it started with severe site pain, difficult to move my arm, radiated to my scapula through to the front of my shoulder. It was reported that she had to have a breast biopsy where a benign growth was removed. As of October where she had a breast MRI my breasts were clear from any growths. Treatment received for all the events included with cortisone injections and anti imflamatories. Adverse events resulted in physician or other health care professional office visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on an unspecified date (my breasts were clear from any growths), polymerase chain reaction: negative on 04Jan2021 Nasal Swab. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.