chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Pyrexia
Clinical narrative: Could not work for about 24 hours; He was achy; After the second shot, the patient reported a fever; This is a spontaneous report from a non-contactable consumer. A male 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 on 01May2021 as a single dose for COVID-19 immunisation. Medical history, past drug allergy and concomitant medications were not reported. 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 Apr2021 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. Unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 02May2021 after second vaccination, the patient experienced fever and could not work for about 24 hours, was achy and feverish. The clinical outcome of the events could not work for about 24 hours was resolved on 03May2021, while that of events fever and achy was resolved on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout flare; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male 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 29Apr2021 at 09:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included gout, asthma and overweight. Concomitant medications included varicella zoster vaccine rgE (CHO) (SHINGRIX) in the right arm for unknown indication on 14Apr2021, ibuprofen (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (MANUFACTURER UNKNOWN) for unknown indication from unknown dates. 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 01May2021, the patient experienced gout flare. The clinical outcome of the event gout flare was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling, Ultrasound scan
Clinical narrative: Big, swollen lump, at the top of her leg, almost to the bend in the thigh, on her right leg; Patient was diagnosed with a swollen lymph node; This is a spontaneous report from a contactable consumer or other non hcp reported for patient (sis-ter-in-law). A 64-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration in arm left on 18Mar2021 (at the age of 64-years-old) as 2nd dose, single for COVID-19 immunisation. The medical history of the patient included ongoing stroke. The concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 25Feb2021 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Investigation Assessment was reported as yes. The additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. No prior vaccines within 4 weeks prior to the COVID vaccine. The AE(s) following prior vaccinations were reported as no. The family medical history Relevant to AE(s) was not provided. On 20Apr2021 the patient was diagnosed with a swollen lymph node and experienced big, swollen lump, at the top of her leg, almost to the bend in the thigh, on her right leg on an unspecified date. The reporter stated the patient had a side effect, stated the patient went to the doctor, where they did an ultrasound, and the patient was diagnosed with a swollen lymph node. The reporter stated she called for her sister-in-law because sometimes she cannot find her words, from a previous stroke, but she was able to talk on the phone. She states they had made an appointment to see another doctor next week. She stated that the patient had noticed the lump for a couple of weeks but brought it to the reporter attention on 16Apr2021 and because the patient did not showed the lump for a couple of weeks, she assumed the lump happened after the second vaccine. The patient underwent lab tests and procedures which included ultrasound: was diagnosed with a swollen lymph node on 20Apr2021. The outcome of the event Big, swollen lump, at the top of her leg, almost to the bend in the thigh, on her right leg was reported as not resolved and the outcome of the event patient was diagnosed with a swollen lymph node was re-ported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Left arm pain persists and not resolve after a few months; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El3249) via an unspecified route of administration in the arm left on 22Jan2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685) via an unspecified route of administration in the arm left on an unspecified date (unspecified age), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was tested for COVID-19. On 25Jan2021, the patient experienced left arm pain. The pain persisted and not resolved after a few months, still had the pain when the arm was moved backwards and up at the time of this report.  No therapeutic measures were taken as a result of the event. On an unknown date, the patient underwent SARS-CoV-2 test through nasal swab and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event left arm pain was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-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 30Apr2021 at 12:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient past drug therapy included penicillin (MANUFACTURER UNKNOWN) taken for unknown indication on unknown date. 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 right arm on 09Apr2021 at 16:30 (at the age of 29-years-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. On 30Apr2021 at 19:00, the patient experienced fever, chills, body aches, headache and fatigue. The clinical outcome of the events fever, chills, body aches, headache and fatigue were recovered on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Acute onset supraclavicular lymphadenopathy left side clavicle; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0171) via an unspecified route of administration in the left arm on 01May2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LO ESTRIN FE) from an unknown date and for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ew0158) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 48-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 COVID-19 vaccination. On 02May2021, the patient experienced acute onset of supraclavicular lymphadenopathy on left side clavicle. The clinical outcome of the event supraclavicular lymphadenopathy on left side clavicle was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Sore throat; Cough; Loss of appetite; Body aches; Brain fog; Fever of 100.8; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 30Mar2021 at 13:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 27Apr2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unspecified date, prior to vaccination. Concomitant medications included calcium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and loratadine (MANUFACTURER UNKNOWN) all from an unspecified date, for unknown indication. 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 receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, after the first dose of vaccine, the patient experienced sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog. On 27Apr2021 at 12:00 after the second dose, the patient experienced sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog. Body temperature was found to be 100.8 (unit not specified) on an unknown date in 2021 after first dose and on 27Apr2021 at 12:00, found to be 100.8 (unit not specified). The clinical outcome of the events sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat; Cough; Loss of appetite; Body aches; Brain fog; Fever of 100.8; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 30Mar2021 at 13:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 27Apr2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unspecified date, prior to vaccination. Concomitant medications included calcium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and loratadine (MANUFACTURER UNKNOWN) all from an unspecified date, for unknown indication. 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 receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, after the first dose of vaccine, the patient experienced sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog. On 27Apr2021 at 12:00 after the second dose, the patient experienced sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog. Body temperature was found to be 100.8 (unit not specified) on an unknown date in 2021 after first dose and on 27Apr2021 at 12:00, found to be 100.8 (unit not specified). The clinical outcome of the events sore throat, cough, body aches, fever of 100.8, chills, fatigue, loss of appetite and brain fog was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hangover, Headache, Menstruation irregular, Nausea, Nervousness
Clinical narrative: felt shakey; nasty hangover; menstrual cycle had just finished and it has started again; kept falling asleep; Horrible headache; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female 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 06Apr2021 at 13:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) for unspecified indication and fluticasone propionate (FLONASE) for allergy; both from unknown dates. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and adhesive and cats (as reported); all for unspecified indication from 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 21Apr2021 at 09:00, the patient experienced horrible headache for at least 12hrs, felt shakey, nasty hangover, nauseous, kept falling asleep and menstrual cycle had just finished and it started again after being off of it for 3 days. The patient had bleeding again, and the blood was a darker color than usual. The clinical outcomes of the events headache, shaky feelings, hangover, nauseous, sleepy and irregular menstruation were recovered with sequelae on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: felt shakey; nasty hangover; menstrual cycle had just finished and it has started again; kept falling asleep; Horrible headache; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female 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 06Apr2021 at 13:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) for unspecified indication and fluticasone propionate (FLONASE) for allergy; both from unknown dates. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and adhesive and cats (as reported); all for unspecified indication from 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 21Apr2021 at 09:00, the patient experienced horrible headache for at least 12hrs, felt shakey, nasty hangover, nauseous, kept falling asleep and menstrual cycle had just finished and it started again after being off of it for 3 days. The patient had bleeding again, and the blood was a darker color than usual. The clinical outcomes of the events headache, shaky feelings, hangover, nauseous, sleepy and irregular menstruation were recovered with sequelae on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Aches; Chills; Headache; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 48-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 22Apr2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID-19 vaccination. On 22Apr2021 at 16:00, the patient experienced headache, nausea, fatigue, aches and chills for 11 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event chills, headache, nausea, fatigue and aches was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Flu-like symptoms; fFever; Chills; This is a spontaneous report from a contactable consumer (Pfizer Colleague). A 40-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. On unspecified date in Apr2021 the patient experienced flu-like symptoms, fever, chills. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: moderate vaginal bleeding / spotting that occurs overnight; This is a spontaneous report from a contactable Other HCP via Pfizer Sales Representative. A 59 years old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 13Apr2021 as dose 2, single for COVID-19 immunisation. The medical history of the patient included 10 years post-menopausal from an unknown date and unknown if ongoing. The concomitant medications of the patient were not reported. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN) on 23Mar2021 as dose 1, single for COVID-19 immunisation. On 26Apr2021, the patient woke with moderate vaginal bleeding. Persisted for past 2 weeks bleeding/ spotting that occurs overnight. No clots. Spotting was continued. No previous spotting for past 10 years. The outcome of the events was reported as not recovered.  Case comment: Based on close temporal relationship the causal association between the reported event postmenopausal bleeding and the usage of the vaccine BNT162B2 cannot be excluded. The case will be reassessed if there is any new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: constant nausea; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 25Apr2021 at 15:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing thyroid disorder (states she has half a thyroid and was diagnosed with thyroid problems at age 11), diverticulum (2018 and ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced constant nausea on 25Apr2021. No treatment was received by the patient for the event. Caller states she was just curious about getting her 2nd shot of the Pfizer COVID vaccine and heard people say not to get the 2nd dose because it was dangerous and if she had the 1st one and she was freaking out because she is not feeling well. Outcome of the event was not recovered.  Follow-up (14May2021): This is a follow up spontaneous report from a contactable consumer.  No follow up attempt are needed: No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Herpes zoster, Pain
Clinical narrative: Shingles on the right side of my butt; Chills; Aches all over my body; Hard, sore blisters on the right side of my ass; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 28Apr2021 (age at the time of vaccination 42-year-old) as single dose for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history and concomitant was reported as none. The patient had not known allergies. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID infection prior vaccination. On 07May2021, the patient experienced shingles on the right side of her butt, chills, and aches all over her body, hard, sore blisters on the right side of her ass. These adverse events resulted the patient to doctor or other healthcare professional office/clinic visit. The patient received prescription drugs as treatment medication for the resulted events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Chills, Dyspnoea, Feeling abnormal
Clinical narrative: I keep getting chills; I get hot; I have a headache; My arms I cant move its really sore and pain goes to my breast; My arms I cant move its really sore and pain goes to my breast; I was experiencing tightening in my breast; I felt terrible today; Earlier this morning I had trouble breathing and but it hasn't came back again I am not sure about 20 minutes; This is a spontaneous report from a contactable consumer reporting for herself. This report was not related to a study or programme. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0182; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 30-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history, investigation assessment included none. Concomitant medications included ibuprofen (IBUPROFEN); elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) taken for an unspecified indication, start and stop date were not reported. Patient stated she was taking both medications. The patient previously took first dose of BNT162B2 on 26Apr2021 for covid-19 immunisation in left arm. Patient stated that lot number for first one was EW0170, and she think it was 00 and not sure. Patient stated that there was no expiration date on there. The patient experienced keep getting chills, get hot, had a headache, arms cant move its really sore and pain goes to breast, was experiencing tightening in breast on unspecified date; earlier this morning had trouble breathing and but it hasn't came back again, not sure about 20 minutes, felt terrible today on 18May2021. Patient reported that she had second shot the day before this report and just getting, wanted to know the side effects that are possible because she felt terrible on the day of this report and wanted to think it was necessary for her to go to the hospital because she heard that you could get a side effect like lost it off because it was her second day as whatever as she did not know if it was true. Patient asked they usually what we put the shot you get a side effect that will last a day and patient asked if that was true. Patient reported that she keeps getting chills, get hot. Had a headache. Her arms cannot move it was really sore and pain goes to her breast. earlier on the morning of this report, she had trouble breathing and, but it hadn't come back again it was just for about 20 minutes. Patient thought it went away that morning her side effects came back again. Patient was just curious on when she should go to the hospital, or should she wait on it. Patient stated that she was experiencing tightening in her breast. Consumer was informed about Pfizer Medical Information Department. It was reported that due to poor internet connectivity issue voice did not get through and hence patient disconnected the call. Clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain in extremity
Clinical narrative: I keep getting chills; I get hot; I have a headache; My arms I cant move its really sore and pain goes to my breast; My arms I cant move its really sore and pain goes to my breast; I was experiencing tightening in my breast; I felt terrible today; Earlier this morning I had trouble breathing and but it hasn't came back again I am not sure about 20 minutes; This is a spontaneous report from a contactable consumer reporting for herself. This report was not related to a study or programme. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0182; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 30-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history, investigation assessment included none. Concomitant medications included ibuprofen (IBUPROFEN); elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) taken for an unspecified indication, start and stop date were not reported. Patient stated she was taking both medications. The patient previously took first dose of BNT162B2 on 26Apr2021 for covid-19 immunisation in left arm. Patient stated that lot number for first one was EW0170, and she think it was 00 and not sure. Patient stated that there was no expiration date on there. The patient experienced keep getting chills, get hot, had a headache, arms cant move its really sore and pain goes to breast, was experiencing tightening in breast on unspecified date; earlier this morning had trouble breathing and but it hasn't came back again, not sure about 20 minutes, felt terrible today on 18May2021. Patient reported that she had second shot the day before this report and just getting, wanted to know the side effects that are possible because she felt terrible on the day of this report and wanted to think it was necessary for her to go to the hospital because she heard that you could get a side effect like lost it off because it was her second day as whatever as she did not know if it was true. Patient asked they usually what we put the shot you get a side effect that will last a day and patient asked if that was true. Patient reported that she keeps getting chills, get hot. Had a headache. Her arms cannot move it was really sore and pain goes to her breast. earlier on the morning of this report, she had trouble breathing and, but it hadn't come back again it was just for about 20 minutes. Patient thought it went away that morning her side effects came back again. Patient was just curious on when she should go to the hospital, or should she wait on it. Patient stated that she was experiencing tightening in her breast. Consumer was informed about Pfizer Medical Information Department. It was reported that due to poor internet connectivity issue voice did not get through and hence patient disconnected the call. Clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak -2 weeks after vaccine. I do not have any underlying conditions.; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 30-years-old female patient received bnt162b2 (COVID-19 VACCINE ,Batch/Lot Number: EWO158), via an unspecified route of administration on an unspecified date as Dose number unknown, single for covid-19 immunization .The patient medical history and concomitant medications were not reported.The patient experienced shingles outbreak 2 weeks after vaccine. Patient doesn't have any underlying conditions.Therapeutic measures were taken as a result of shingles outbreak -2 weeks after vaccine.The outcome of the events was recovering.The treatment received for shingles was Antiviral (Valtrex).The adverse event was non serious not requiring emergency room or hospitalization.Prior and since the vaccination, the patient was not tested or diagnosed for COVID-19. Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Off label use, Product use issue, Ulcer
Clinical narrative: Ulcers in vaginal and anal area; I am breastfeeding; I am breastfeeding; sleep deprived; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 36-year-old female patient received BNT162B2 (Batch/Lot Number: Ew0173), dose 2 via an unspecified route of administration, administered in Arm Left on 08May2021 at 12:00 as DOSE 2, SINGLE (at the age of 36-year-old) for covid-19 immunisation. Medical history included rosacea, psoriasis, polycystic ovaries. Concomitant medication included nystatin (NYSTATIN) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (CALCIFEROL VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline, bnt162b2 for covid-19 immunisation. It was reported that, on 10May2021, the patient experienced ulcers in vaginal and anal area (ulcer), i am breastfeeding (off label use), (product use issue), sleep deprived (insomnia). The outcome of events was not recovered.  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021573472 Same reporter/drug, different patients/events
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Bronchitis, Chest X-ray, Dyspnoea, Epistaxis
Clinical narrative: Platelets are at 20 & normal is 150-400; Has mild asthma; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; slightly elevated RDW SD; 16May2021 1:30am dyspnea - can't get satisfying deep breathe; bronchial inflammation on chest X-ray; Bloody nose 9:30am next day; This is a spontaneous report from a contactable consumer. This 15-year-old male consumer (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 16:15 (at the age of 15-years-old) (Batch/Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Asthma, migraines, small right sinus, ear tube hole in left eardrum and allergic to Weed, cat, dust, tree nuts, (nasonex, nasacort, dimetapp, topamax, amitriptyline, cyproheptadine) drug allergy from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ibuprofen (MOTRIN [IBUPROFEN]) 2x, sodium alginate (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) 1x and flinstone gummy taken for an unspecified indication, start and stop date were not reported. The patient had mild asthma. 14May2021 Bloody nose 9:30am next day, 16May2021 1:30am dyspnea - can't get satisfying deep breathe, 16May2021  Urgent Care  - bronchial inflammation on chest X-ray, 4 puffs Albuterol followed by Decadron 16mg, then 2 more Albuterol puffs. No improvement. CBC shows the following are slightly low: RBC, Hgb, & Hct. Following are slightly elevated RDW SD. Platelets are at 20 & normal is 150-400 (medically significant). Alert & stable but tires easily going up/downstairs. Dr visit scheduled to recheck platelets on 20May2021. Patient underwent lab test chest X-ray which showed bronchial inflammation on 16May2021. CBC showed slightly low: RBC, Hgb, & Hct, Platelets are at 20 & normal is 150-400 and slightly elevated RDW SD on unspecified date. The patient had not received any other vaccine in four weeks, the patient took no treatment for events except bronchial inflammation. The patient prior to this had not received any covid vaccine, patient had not done covid test post vaccination. Outcome of the events CBC shows the following are slightly low: RBC, Hgb, & Hct, slightly elevated RDW SD, and Platelets are at 20 & normal is 150-400 was unknown. The outcome of other events was not recovered.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Haematocrit, Haematocrit decreased, Haemoglobin, Haemoglobin decreased
Clinical narrative: Platelets are at 20 & normal is 150-400; Has mild asthma; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; slightly elevated RDW SD; 16May2021 1:30am dyspnea - can't get satisfying deep breathe; bronchial inflammation on chest X-ray; Bloody nose 9:30am next day; This is a spontaneous report from a contactable consumer. This 15-year-old male consumer (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 16:15 (at the age of 15-years-old) (Batch/Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Asthma, migraines, small right sinus, ear tube hole in left eardrum and allergic to Weed, cat, dust, tree nuts, (nasonex, nasacort, dimetapp, topamax, amitriptyline, cyproheptadine) drug allergy from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ibuprofen (MOTRIN [IBUPROFEN]) 2x, sodium alginate (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) 1x and flinstone gummy taken for an unspecified indication, start and stop date were not reported. The patient had mild asthma. 14May2021 Bloody nose 9:30am next day, 16May2021 1:30am dyspnea - can't get satisfying deep breathe, 16May2021  Urgent Care  - bronchial inflammation on chest X-ray, 4 puffs Albuterol followed by Decadron 16mg, then 2 more Albuterol puffs. No improvement. CBC shows the following are slightly low: RBC, Hgb, & Hct. Following are slightly elevated RDW SD. Platelets are at 20 & normal is 150-400 (medically significant). Alert & stable but tires easily going up/downstairs. Dr visit scheduled to recheck platelets on 20May2021. Patient underwent lab test chest X-ray which showed bronchial inflammation on 16May2021. CBC showed slightly low: RBC, Hgb, & Hct, Platelets are at 20 & normal is 150-400 and slightly elevated RDW SD on unspecified date. The patient had not received any other vaccine in four weeks, the patient took no treatment for events except bronchial inflammation. The patient prior to this had not received any covid vaccine, patient had not done covid test post vaccination. Outcome of the events CBC shows the following are slightly low: RBC, Hgb, & Hct, slightly elevated RDW SD, and Platelets are at 20 & normal is 150-400 was unknown. The outcome of other events was not recovered.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, Red blood cell count, Red blood cell count decreased, Red cell distribution width
Clinical narrative: Platelets are at 20 & normal is 150-400; Has mild asthma; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; slightly elevated RDW SD; 16May2021 1:30am dyspnea - can't get satisfying deep breathe; bronchial inflammation on chest X-ray; Bloody nose 9:30am next day; This is a spontaneous report from a contactable consumer. This 15-year-old male consumer (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 16:15 (at the age of 15-years-old) (Batch/Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Asthma, migraines, small right sinus, ear tube hole in left eardrum and allergic to Weed, cat, dust, tree nuts, (nasonex, nasacort, dimetapp, topamax, amitriptyline, cyproheptadine) drug allergy from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ibuprofen (MOTRIN [IBUPROFEN]) 2x, sodium alginate (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) 1x and flinstone gummy taken for an unspecified indication, start and stop date were not reported. The patient had mild asthma. 14May2021 Bloody nose 9:30am next day, 16May2021 1:30am dyspnea - can't get satisfying deep breathe, 16May2021  Urgent Care  - bronchial inflammation on chest X-ray, 4 puffs Albuterol followed by Decadron 16mg, then 2 more Albuterol puffs. No improvement. CBC shows the following are slightly low: RBC, Hgb, & Hct. Following are slightly elevated RDW SD. Platelets are at 20 & normal is 150-400 (medically significant). Alert & stable but tires easily going up/downstairs. Dr visit scheduled to recheck platelets on 20May2021. Patient underwent lab test chest X-ray which showed bronchial inflammation on 16May2021. CBC showed slightly low: RBC, Hgb, & Hct, Platelets are at 20 & normal is 150-400 and slightly elevated RDW SD on unspecified date. The patient had not received any other vaccine in four weeks, the patient took no treatment for events except bronchial inflammation. The patient prior to this had not received any covid vaccine, patient had not done covid test post vaccination. Outcome of the events CBC shows the following are slightly low: RBC, Hgb, & Hct, slightly elevated RDW SD, and Platelets are at 20 & normal is 150-400 was unknown. The outcome of other events was not recovered.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Red cell distribution width increased
Clinical narrative: Platelets are at 20 & normal is 150-400; Has mild asthma; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; slightly elevated RDW SD; 16May2021 1:30am dyspnea - can't get satisfying deep breathe; bronchial inflammation on chest X-ray; Bloody nose 9:30am next day; This is a spontaneous report from a contactable consumer. This 15-year-old male consumer (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 16:15 (at the age of 15-years-old) (Batch/Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Asthma, migraines, small right sinus, ear tube hole in left eardrum and allergic to Weed, cat, dust, tree nuts, (nasonex, nasacort, dimetapp, topamax, amitriptyline, cyproheptadine) drug allergy from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ibuprofen (MOTRIN [IBUPROFEN]) 2x, sodium alginate (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) 1x and flinstone gummy taken for an unspecified indication, start and stop date were not reported. The patient had mild asthma. 14May2021 Bloody nose 9:30am next day, 16May2021 1:30am dyspnea - can't get satisfying deep breathe, 16May2021  Urgent Care  - bronchial inflammation on chest X-ray, 4 puffs Albuterol followed by Decadron 16mg, then 2 more Albuterol puffs. No improvement. CBC shows the following are slightly low: RBC, Hgb, & Hct. Following are slightly elevated RDW SD. Platelets are at 20 & normal is 150-400 (medically significant). Alert & stable but tires easily going up/downstairs. Dr visit scheduled to recheck platelets on 20May2021. Patient underwent lab test chest X-ray which showed bronchial inflammation on 16May2021. CBC showed slightly low: RBC, Hgb, & Hct, Platelets are at 20 & normal is 150-400 and slightly elevated RDW SD on unspecified date. The patient had not received any other vaccine in four weeks, the patient took no treatment for events except bronchial inflammation. The patient prior to this had not received any covid vaccine, patient had not done covid test post vaccination. Outcome of the events CBC shows the following are slightly low: RBC, Hgb, & Hct, slightly elevated RDW SD, and Platelets are at 20 & normal is 150-400 was unknown. The outcome of other events was not recovered.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test
Clinical narrative: This is a spontaneous report from two contactable consumer (Patient and patient's wife). A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 at 09:30 as dose 2, single (at the age of 84 years) for COVID-19 immunisation. Medical history included ongoing hypertension About 20 years, ongoing biliary obstruction started about 20 years ago (Bile ducts prone to being clogged), Sees a doctor every 3 months and has blood tests every 3 months, ongoing prostatomegaly about 10 years (prostate enlargement that has been for about 10 years.), ongoing pressure in eyes about 15 years and was on medicine for all of that. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiry Date: unknown), dose 1 via an unspecified route of administration in right arm on 26Jan2021 as dose 1, single (at the age of 84 years) for COVID-19 immunisation. On an unspecified date in 2021, reporter stated that patient had his blood pressure taken and it seems to be up. Patient has been on a high blood pressure medicine, and it just shot up. Reporter doesn't know when it first started. Patient went to the dentist and they took it there on 03May2021 and the dentist said it was a little bit high. Patient went to the doctor again this past Monday and it was up to 170. His appointment at the dentist was at 10:30, and the appointment at the doctor's office was at 14:30. They have also been taking his blood pressure several times a day. They increased his blood pressure medicine. When asked if it is ongoing, reporter said his blood pressure has been running between 140/79 and 164/89. Patient has some different medications, but nothing has changed. Patient mom had diabetes and passed away, and his dad had throat cancer. The patient underwent lab tests and procedures which included blood pressure measurement: between 140/79 and 164/89 on 03May2021, blood test: unknown on an unspecified date. He has had it for quite a long time, about 20 years. The outcome of event was unknown. Follow-up attempts are needed. Further information is expected.