chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Parosmia
Clinical narrative: phantom scents that were rancid smelling; heavy period; extremely bad period cramps; This is a spontaneous report from a contactable consumer, the patient. A 17-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 11May2021 at 13:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and ethinylestradiol, norgestimate (MILI) for birth control from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 13:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 28May2021, at 14:00 the patient experienced phantom scents that were rancid smelling and this went on for a few days and stopped; 2 weeks after getting the vaccine patient had heavy period and extremely bad period cramps. The patient was on period for 5 days. The patient reported that she was on birth control because she was not supposed to have period due to how much it hurts and how much blood loss she had. The patient never spotted or started period while on this birth control but after the vaccination she was on period. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. 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 phantom scents that were rancid smelling was recovered on an unknown date in 2021; while that of heavy period and extremely bad period cramps was not recovered at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Temporomandibular joint syndrome
Clinical narrative: Increased TMJ tightness; Brain fog; Light-headed feeling; Slight nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 39-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 arm right on 27May2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC), thyroid NP (MANUFACTURER UNKNOWN) and supplements (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm right on 06May2021 (at the age of 39-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 30May2021, the patient experienced increased TMJ tightness, brain fog/light-headed feeling and slight nausea. No therapeutic measures were taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events increased TMJ tightness, brain fog/light-headed feeling and slight nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Diarrhoea, Fatigue
Clinical narrative: about an hour after shot my heart felt  a fast heartbeat  Days after i felt these symptoms:; weird feeling in throat.; tiredness; weak; headache 2x; muscle pain; chills; cold sweat; nausea; diarrhea; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0183) via an unspecified route of administration in the left arm on 12May2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), peripheral neuropathy, asthma,  drug allergy steroids. and hypertension. The patient had known allergies to penicillin, sulfa and steroids. The patient previously received prednisone (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, about an hour after shot the patient experienced her heart felt a fast heartbeat and weird feeling in throat. On an unknown date in May2021, days after she felt these symptoms: tiredness, weak, headache 2x, muscle pain, chills, cold sweat, nausea, diarrhea and vomiting. On 21Mar2020, the patient underwent nasal swab test and the result was negative. On 23Dec2020, the patient underwent nasal swab test and the result was negative. On 28Jan2021, the patient underwent nasal swab test and the result was negative. On 24May2021, the patient underwent nasal swab test and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events heart felt a fast heartbeat, weird feeling in throat, tiredness, weak, headache 2x, muscle pain, chills, cold sweat, nausea, diarrhea and vomiting were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate irregular, Myalgia, Nausea, Oropharyngeal discomfort
Clinical narrative: about an hour after shot my heart felt  a fast heartbeat  Days after i felt these symptoms:; weird feeling in throat.; tiredness; weak; headache 2x; muscle pain; chills; cold sweat; nausea; diarrhea; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0183) via an unspecified route of administration in the left arm on 12May2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), peripheral neuropathy, asthma,  drug allergy steroids. and hypertension. The patient had known allergies to penicillin, sulfa and steroids. The patient previously received prednisone (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, about an hour after shot the patient experienced her heart felt a fast heartbeat and weird feeling in throat. On an unknown date in May2021, days after she felt these symptoms: tiredness, weak, headache 2x, muscle pain, chills, cold sweat, nausea, diarrhea and vomiting. On 21Mar2020, the patient underwent nasal swab test and the result was negative. On 23Dec2020, the patient underwent nasal swab test and the result was negative. On 28Jan2021, the patient underwent nasal swab test and the result was negative. On 24May2021, the patient underwent nasal swab test and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events heart felt a fast heartbeat, weird feeling in throat, tiredness, weak, headache 2x, muscle pain, chills, cold sweat, nausea, diarrhea and vomiting were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: about an hour after shot my heart felt  a fast heartbeat  Days after i felt these symptoms:; weird feeling in throat.; tiredness; weak; headache 2x; muscle pain; chills; cold sweat; nausea; diarrhea; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0183) via an unspecified route of administration in the left arm on 12May2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), peripheral neuropathy, asthma,  drug allergy steroids. and hypertension. The patient had known allergies to penicillin, sulfa and steroids. The patient previously received prednisone (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, about an hour after shot the patient experienced her heart felt a fast heartbeat and weird feeling in throat. On an unknown date in May2021, days after she felt these symptoms: tiredness, weak, headache 2x, muscle pain, chills, cold sweat, nausea, diarrhea and vomiting. On 21Mar2020, the patient underwent nasal swab test and the result was negative. On 23Dec2020, the patient underwent nasal swab test and the result was negative. On 28Jan2021, the patient underwent nasal swab test and the result was negative. On 24May2021, the patient underwent nasal swab test and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events heart felt a fast heartbeat, weird feeling in throat, tiredness, weak, headache 2x, muscle pain, chills, cold sweat, nausea, diarrhea and vomiting were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: One day after receiving first dose (9Apr2021), patient's heart would race for about 10 minutes.; patient had difficulty breathing and had to sit down to rest; This is a spontaneous report from a contactable consumer (Pfizer colleague) and a non-contactable consumer. A 87-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 on 01Apr2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 both as a single dose at the age of 87-year-old for COVID-19 immunisation. Medical history included heart conditions (not specified) and had pacemaker (cardiac pacemaker insertion). Concomitant medications included warfarin sodium (COUMADIN) and blood pressure medication(unspecified), all from unknown dates and for unknown indications. It was unknown whether the patient had any allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 09Apr2021 one day after receiving first dose, patient's heart would race for about 10 minutes. During this time, patient had difficulty breathing and had to sit down to rest. The reporter noted that the patient had a pacemaker device and was on coumadin and BP medications. The device would sizzle and then symptoms would settle. These episodes had occurred about 4 times a day since first dose. The reporter noted that the same episodes was occurred after the second dose, but increased to 6 times a day. Therapeutic measures were not taken as a result of the reported events. The adverse 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 heart race and difficulty breathing were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache,; Nausea; This is a spontaneous report from a non contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of 0.3 ML of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 01Jun2021 at 17:45 (at the age of 29-year-old) as a single dose for COVID-19 immunization. Medical history included and concomitant medications were reported as no. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jun2021 at 17:45 after 1 hour of vaccination, the patient had headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with tylenol. The clinical outcome of the event headache and nausea was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 01Jun2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jun2021, the patient experienced extreme tiredness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme tiredness was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate; Chest pain; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 09:40 (at the age of 35-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included asthma like condition but not severe and allergy from an unknown date and unknown if ongoing. The patient previously received BNT162B2 on 23Mar2021 (Batch/ lot number: ER8730) as dose 1 single for COVID-19 immunisation. The patient's concomitant medications were not reported. The patient experienced rapid heart rate and (heart rate chest pain on an unspecified date. Patient got second vaccine and that was on 20Apr of this year and she have gotten the vaccine few hours later, she had rapid heart rate and she had not thought too much about it within the 48 hour. She thought it was just normal her body was reacting through it and four days later she started getting rapid heart rate, and she had chest pain since. Since, she got vaccine Pfizer she had, definitely have seen her doctor and she did have to wear a heart monitor for 14 days and so there was not any concern beside rapid heart rate. The condition was reported as persistent. The outcome of the events was reported as not recovered.  Follow-up (07Jul2021): Follow-up attempts completed. No further information expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021641291 similar report from same reporter
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: Ears popped; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179), via an unspecified route of administration in the left arm on 01Jun2021 at 19:30 (at the age of 16-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had a history of allergy to sinuses. Concomitant medications included cetirizine hydrochloride (CETIRIZINE), montelukast (MANUFACTURER UNKNOWN) and fluticasone propionate (MANUFACTURER UNKNOWN) all 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: EW0179), via an unspecified route of administration in the right arm on 11May2021 at 19:30 (at the age of 16-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. It was reported as unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 02Jun2021 at 06:30, the patient woke up the at morning with ears popped and has not gone away since an hour. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event ears popped was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Headache, Lymphadenopathy
Clinical narrative: Stong back pain through entire back; headache; chills; fever; weakness; vomiting; pain in arm; swollen lymph nodes in armpit on side of vaccine; rash in injection area; Injection area that hurts; Injection area warm to the touch.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration in the left arm on 29May2021 at 09:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypothyroidism. The patient had a history of allergy to poultry, mucinex and red dye in food. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and collagen (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176), via an unspecified route of administration in the left arm on 08May2021 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021, the patient experienced strong back pain through entire back, headache, chills, fever, weakness, vomiting, pain in arm, swollen lymph nodes in armpit on side of vaccine, rash in injection area that hurts and warm to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of strong back pain through entire back, headache, chills, fever, weakness, vomiting, pain in arm, swollen lymph nodes in armpit on side of vaccine, rash in injection area that hurts and warm to the touch were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: Stong back pain through entire back; headache; chills; fever; weakness; vomiting; pain in arm; swollen lymph nodes in armpit on side of vaccine; rash in injection area; Injection area that hurts; Injection area warm to the touch.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration in the left arm on 29May2021 at 09:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypothyroidism. The patient had a history of allergy to poultry, mucinex and red dye in food. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and collagen (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176), via an unspecified route of administration in the left arm on 08May2021 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021, the patient experienced strong back pain through entire back, headache, chills, fever, weakness, vomiting, pain in arm, swollen lymph nodes in armpit on side of vaccine, rash in injection area that hurts and warm to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of strong back pain through entire back, headache, chills, fever, weakness, vomiting, pain in arm, swollen lymph nodes in armpit on side of vaccine, rash in injection area that hurts and warm to the touch were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Stong back pain through entire back; headache; chills; fever; weakness; vomiting; pain in arm; swollen lymph nodes in armpit on side of vaccine; rash in injection area; Injection area that hurts; Injection area warm to the touch.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration in the left arm on 29May2021 at 09:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypothyroidism. The patient had a history of allergy to poultry, mucinex and red dye in food. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and collagen (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176), via an unspecified route of administration in the left arm on 08May2021 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021, the patient experienced strong back pain through entire back, headache, chills, fever, weakness, vomiting, pain in arm, swollen lymph nodes in armpit on side of vaccine, rash in injection area that hurts and warm to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of strong back pain through entire back, headache, chills, fever, weakness, vomiting, pain in arm, swollen lymph nodes in armpit on side of vaccine, rash in injection area that hurts and warm to the touch were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Skin reaction, Urticaria
Clinical narrative: Rashes appear then disappear after a few hours, comes and goes.; Rashes all over body; 4 days after 2nd shot started getting skin reaction; burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18May2021 at 15:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), collagen (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) from unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 18:00 (at the age of 42-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. On 22May2021, four days after the vaccination, the patient experienced a skin reaction that looked like scratch marks and occasionally in random blotches all over the body (rash all over), including legs, arms, stomach, back, neck, and face, rashes appeared then disappeared after a few hours, comes and goes. On an unknown date of May2021, after a week after onset of rashes, the patient experienced burning sensation from rashes. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rash all over body, legs arms, stomach back, neck, face and rashes started burning sensation was not recovered at the time of this report.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Slight itch/rash; Rash as patches in various parts of the body; This is a spontaneous report from a contactable pharmacist. A 22-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 30Apr2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via intramuscular route of administration in the left arm on 21May2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Other medical history was unknown. It was unknown whether the patient was pregnant. The patient had no known allergies to food, medications, or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021, 2-3 days before the second vaccination, the patient experienced slight itch/rash and that rash got worse since receiving her second dose. The patient described the rash as patches in various parts of the body, but not too severe at the time. The patient had no breathing difficulties, oral rashes, or anaphylaxis symptoms. The patient was advised to contact prescriber if they got worse and take benadryl if the rash bothered her. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events slight itch/rash and rash as patches in various parts of the body was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscle twitching, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 40, via an unspecified route of administration, left arm, on Mar 6, 2021, single dose, for COVID-19 immunisation. Medical history included penicillin allergy. The patient has not received any concomitant medication. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On Mar 22, 2021, patient experienced muscle twitching and weakness. On May 25, 2021, patient underwent COVID-19 test, which included nasal swab and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the muscle twitching and weakness: not recovered (at the time of this report). No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Menstrual disorder, Pregnancy test, Vomiting
Clinical narrative: My first period started 01Feb and that was on time and lasted 5 days like normal.; I was fine one 1 day and then I started tothrow up every morning and throughout the day I had a sour stomach; I was fine one 1 day and then I started tothrow up every morning and throughout the day I had a sour stomach; This is a spontaneous report from a contactable other HCP. This 28-year-old non-pregnant female other HCP (patient) reported that she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302) via an unspecified route of administration on 04Feb2021 (at 28-year-old) on left arm, as dose 1, single for COVID-19 immunization. Medical history of the patient included anxiety, depression and hyperhidrosis from an unknown date and unknown if ongoing. The patient received anxiety and depressions meds and sweat pills. It was mentioned that patient had no covid prior to the vaccination and was not tested for covid post vaccination. She had no allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249) via Intramuscular route of administration on 14Jan2021 as dose 1, single (at 28-year-old) on left arm as dose 1, single for COVID-19 immunization. On an unknown date in Apr2021 it was reported that her first period started 01Feb and that was on time and lasted 5 days like normal. She got my second vaccine on 04Feb. Her period started on time in March and April again but my May period started a week early she did not have any symptoms at all (cramps, headache etc.) it lasted 4 days, she was fine one 1 day and then she started to throw up every morning and throughout the day she had a sour stomach. Her June period started a week early again just like the other and now she was am throwing up every morning and had a sour stomach throughout the day. She have taken 2 pregnancy tests and they were negative. No treatment was received for events. The patient was recovering. The device timestamp:02Jun2021.  Follow-Up (19Jul2021): Follow-up attempts were completed. No further information was expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Nausea
Clinical narrative: Dizziness; weakness; headache began within on hour of vaccination; nausea began the next day; This is a spontaneous report from a contactable consumer or other non hcp.   A 36-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 31May2021 18:15 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included migraines, drug hypersensitivity, food allergy, food allergy, rubber sensitivity, allergy to arthropod sting. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, the patient experienced dizziness, weakness, headache and nausea began within one hour of vaccination on 31May2021 19:00 with outcome of not recovered.  Follow-up attempts are needed; Information about lot/batch number has been requested.  Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: left arm are sore; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 46-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 11May2021 at 17:15, as a single dose for COVID-19 immunisation. Medical history included allergy to pineapples and some shellfish. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 17:15, as a single dose for COVID-19 immunisation. On 14May2021, the muscles in the patient back that connect his left arm were sore almost every day. He worked in front of the computer. He did not notice it much when he was moving around. If he was stationary for more than an hour, he needed to do lots of stretching. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of left arm sore and included treatment with TYLENOL. The clinical outcome of the event left arm sore was not recovered at the time of this event.  The information on lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Could not keep my balance when walking; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: En6198), via an unspecified route in left arm on 02Mar2021 at 10:00 AM (at the age of 74 years) as dose 2, single for Covid-19 immunization. The patient medical history included Just high blood pressure which is under control and allergic to penicillin. The concomitant medications was Azor, pot Chlor tabs. No other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, the patient has not been tested for Covid-19. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: El9269), via an unspecified route in right arm on 09Feb2021 at 10:00 AM as dose1, single for Covid-19 immunization. On 02Mar2021 at 11:00 AM, the patient  reported that after one hour taking the second shot he could not keep his balance when walking have been this way exactly 3 months never had this before the vaccine. Events assessed as non-serious. The clinical outcome of the events were not resolved.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Bad itchy; red rash on hands and arms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176), via an unspecified route of administration on 22May2021 at 12:45 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced bad itchy, red rash on hands and arms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events bad itchy, red rash on hands and arms were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Palpitations
Clinical narrative: Chest pain; Shortness of breath; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12May2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medication. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient experienced chest pain, shortness of breath and heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of the events chest pain, shortness of breath and heart palpitations was not resolved.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Gingival swelling, Paraesthesia, Rash
Clinical narrative: Rash on trunk of body; Rash on trunk of body that was tingly; Rash on trunk of body that was painful; Nose bleed; swollen gums; This is a spontaneous report from a non-contactable pharmacist. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration on 08Apr2021(at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient previously received Vistaril and experienced drug allergy. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and iron (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date and unknown if ongoing and sertraline hydrochloride (ZOLOFT) for unknown indication from an unknown date and was ongoing. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 21May2021 the patient experienced rash on trunk of body that was tingly and painful and on an unknown date in May2021 patient experienced nose bleeds and swollen gums. The patient had been out of  Zoloft five day prior to events. Patient was recommended follow up with PCP (primary care physician) and he went to urgent care where was given amoxicillin and a topical ointment for the irritation and also refilled Zoloft prescription after initial presentation. On 24May2021 phone follow up with the patient revealed pain was gone and rash had subsided. The event rash on trunk of body that was tingly and painful resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of rash on trunk of body that was tingly and painful and included treatment with amoxicillin (MANUFACTURER UNKNOWN) and topical cream (MANUFACTURER UNKNOWN). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events rash on trunk of body that was tingly and painful was recovered on an unknown date in May2021; while that of nose bleeds and swollen gums was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Cough, Electrocardiogram
Clinical narrative: Chest pains; coughing; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 08:00 as dose 1, single (age at vaccination 22-year-old) for covid-19 immunisation. Medical history included allergy to metals (gold known allergy). The patient's concomitant medications were not reported. Prior to 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. No other medications in two weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient experienced chest pains and coughing on 26May2021 09:30. The patient underwent lab tests and procedures which included chest x-ray: unknown result and electrocardiogram: unknown result on an unknown date. Therapeutic measures were taken as a result of events includes Chest x-ray and EKG. The outcome for event was recovered on an unknown date in 2021.   Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I haven't had a menstrual cycle  in over 2 years. I had a full week heavy menstrual cycle 2 weeks after receiving the 2nd vaccination. I had read that this has been a side ef; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration in Left Arm on 29Apr2021 at 13:45 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8729) via an unspecified route of administration in Left Arm on 06Apr2021 at 12:30 for COVID-19 immunization. It was reported that, patient was in menopause age at time of vaccination and haven't had a menstrual cycle in over 2 years. No known allergies. within 2 weeks of vaccination and patient had not received any other vaccines 4 weeks prior to the COVID vaccine. On 16May2021, she had experienced full week heavy menstrual cycle, 2 weeks after receiving the 2nd vaccination. It was stated that, she read that this was a side effect for many women and wanted to report it so it can be investigated as being a side effect from the vaccine. Unspecified treatment was taken for the adverse event. It was reported that the event was non-serious. Patient visited physician office for the event. The outcome of the events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Jun2021 at 08:30 (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 other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021, the patient experienced injection site pain. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event injection site pain was not recovered at the time of this report.   Information on lot/batch number has been requested.