chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Red rash at point of injection; Red rash at point of injection; This is a spontaneous report from a contactable consumer, the patient. A 64-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 05Apr2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications 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 08Apr2021, the patient experienced red rash at point of injection( vaccination site rash; vaccination site erythema). Therapeutic measures were not reported. The clinical outcome of the event red rash at point of injection was resolved on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Constipation, Fatigue, Headache, Myalgia
Clinical narrative: Ear ringing/sensitivity; Constipation; Ear ringing/sensitivity; Headache across forehead; Joint pain (especially knees); Fatigue; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EW0175) via an unspecified route of administration in the left arm on 30Apr2021 at 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to Shrimp. The patient did not take any concomitant medications. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021 at 22:00, the patient experienced ear ringing/sensitivity, constipation, headache across forehead, joint pain (especially knees). fatigue and muscle soreness. The clinical outcomes of ear ringing/sensitivity, constipation, headache across forehead, joint pain (especially knees), fatigue and muscle soreness were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitisation, Tinnitus
Clinical narrative: Ear ringing/sensitivity; Constipation; Ear ringing/sensitivity; Headache across forehead; Joint pain (especially knees); Fatigue; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EW0175) via an unspecified route of administration in the left arm on 30Apr2021 at 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to Shrimp. The patient did not take any concomitant medications. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021 at 22:00, the patient experienced ear ringing/sensitivity, constipation, headache across forehead, joint pain (especially knees). fatigue and muscle soreness. The clinical outcomes of ear ringing/sensitivity, constipation, headache across forehead, joint pain (especially knees), fatigue and muscle soreness were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Headache, Hypokinesia, Pain, Pyrexia
Clinical narrative: Violent uncontrollable shaking; Loss of motor control; Sensations of electricity shooting; Shooting through my body; High fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 30Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 09Apr2021 at (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient 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 01May2021 at 02:45, the patient experienced violent uncontrollable shaking that occurred in waves and patterns for approximately 1 hour, loss of motor control and sensations of electricity shooting through his body, high fever and headache for the next two days. The clinical outcomes of violent uncontrollable shaking, loss of motor control and sensations of electricity shooting through his body, high fever and headache were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Violent uncontrollable shaking; Loss of motor control; Sensations of electricity shooting; Shooting through my body; High fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 30Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 09Apr2021 at (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient 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 01May2021 at 02:45, the patient experienced violent uncontrollable shaking that occurred in waves and patterns for approximately 1 hour, loss of motor control and sensations of electricity shooting through his body, high fever and headache for the next two days. The clinical outcomes of violent uncontrollable shaking, loss of motor control and sensations of electricity shooting through his body, high fever and headache were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Headache; Muscle ache; Chills; Joint pain; Injection site pain; Tiredness; Fever as high as 104.8; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the upper right arm on 08Apr2021 at 15:15 (at the age of 46-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the upper right arm on 30Apr2021 at 15:00 (at the age of 46-year-old), both as a single dose for COVID-19 immunisation. Medical history included HPV (human papillomavirus) related to cancer. The patient received other unspecified medications within two weeks of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously took Penicillin and sulfa-based medications. 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 08Apr2021, within hours of vaccination, the patient had tiredness. On an unknown date in Apr2021, after 36 hours of vaccination, the patient experienced fever as high as 104.8 unspecified units. On 29Apr2021 at 21:00, the patient experienced injection site pain for five days, headache, muscle ache, chills and joint pain. The clinical outcome of the events injection site pain was recovered on 03May2021. The clinical outcome of the events headache, muscle ache, chills and joint pain, fever as high as 104.8 and tiredness were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Muscle ache; Chills; Joint pain; Injection site pain; Tiredness; Fever as high as 104.8; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the upper right arm on 08Apr2021 at 15:15 (at the age of 46-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the upper right arm on 30Apr2021 at 15:00 (at the age of 46-year-old), both as a single dose for COVID-19 immunisation. Medical history included HPV (human papillomavirus) related to cancer. The patient received other unspecified medications within two weeks of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously took Penicillin and sulfa-based medications. 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 08Apr2021, within hours of vaccination, the patient had tiredness. On an unknown date in Apr2021, after 36 hours of vaccination, the patient experienced fever as high as 104.8 unspecified units. On 29Apr2021 at 21:00, the patient experienced injection site pain for five days, headache, muscle ache, chills and joint pain. The clinical outcome of the events injection site pain was recovered on 03May2021. The clinical outcome of the events headache, muscle ache, chills and joint pain, fever as high as 104.8 and tiredness were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Shingles on the left side of chest; Few itchy spots on left side back; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications blood pressure med and cholesterol (both unspecified) for unknown indication and from an unknown date. Past drug history included NYQUIL for unknown indication and on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 27Apr2021 at 07:00, the patient experienced shingles on the left side of chest and few itchy spots on left side back. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with Herpes pill 3x a day for 5 days. The clinical outcome of the event shingles on the left side of chest and few itchy spots on left side back were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 27Apr2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified 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 01May2021 at 09:00, the patient experienced injections site pain, tiredness, headache, muscle pain, chills, nausea and feeling unwell. The clinical outcomes of the events injections site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell were recovering.  No follow-up attempts are needed; No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 27Apr2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified 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 01May2021 at 09:00, the patient experienced injections site pain, tiredness, headache, muscle pain, chills, nausea and feeling unwell. The clinical outcomes of the events injections site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell were recovering.  No follow-up attempts are needed; No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives over much of both the arms and legs as well as on the waist.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. Concomitant medication included simvastatin (SIMVASTATIN) taken for high cholesterol from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 61-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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 17Apr2021 at 22:00, approximately two and a half days (60 hours) after the second shot, the patient experienced hives over much of both his arms and legs as well as his waist. The patient reported that these continued until the patient took medication to treat the hives. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives and included treatment with a 6-day prescription of methylprednisolone 4mg. The clinical outcome of the event hives was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Aching like arthritis in my knees and legs; Aching like arthritis in my knees and legs; This is a spontaneous report from a contactable physician, the patient. A 46-year-old non-pregnant 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 11Mar2021 at 08:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID), taken from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, approximately one week after vaccination, the patient experienced aching like arthritis in the knees and legs which had lasted approximately two weeks. It was reported that the patient never had arthritis before. The clinical outcome of the event aching like arthritis in the knees and legs was resolved on 01Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Eye swelling, Feeling hot, Headache, Hypersensitivity
Clinical narrative: Headache; became very warm; started to breakout in a rash on arms, face, back of neck; Swelling occurred in the eye; Swelling occurred in the eye and lip area; became very anxious; Has a peanut allergy and felt that she was having a reaction.; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Apr2021 at 08:00, as a single dose for COVID-19 immunisation. Medical history included mild asthma and COVID-19 on unknown dates and peanut allergy. It was unknown if the patient received any medication within two weeks of vaccination and also unknown if received 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 on an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, unknown if the patient had been tested for COVID-19. On 04Apr2021 at 08:00, 48 hours after receipt of the second vaccine, the patient woke up with a headache. Drank water, ate salmon and rice made at home and felt better. Then on 04Apr2021, approximately 55 hours after vaccine, the patient went to play tennis indoors where she became very warm and started to breakout in a rash on arms, face and back of neck. On an unknown date in Apr2021, the patient experienced swelling in the eye and lip area and became very anxious. The patient has a peanut allergy and felt that she was having a reaction. However, she didn't see where she would have been in contact with peanuts and therefore thought it was due to the vaccine. Within an hour, as rash continued, the patient took Benadryl liquid form that reduced the rash. An hour later, the patient took a shower that also reduced the rash. No further action was taken. Therapeutic measures were taken as a result of the events and included treatment with benadryl liquid form. The clinical outcome of events headache, became very warm, rash on arms, face and back of neck, swelling in the eye and lip area, became very anxious and felt that she was having a reaction were recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: Headache; became very warm; started to breakout in a rash on arms, face, back of neck; Swelling occurred in the eye; Swelling occurred in the eye and lip area; became very anxious; Has a peanut allergy and felt that she was having a reaction.; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Apr2021 at 08:00, as a single dose for COVID-19 immunisation. Medical history included mild asthma and COVID-19 on unknown dates and peanut allergy. It was unknown if the patient received any medication within two weeks of vaccination and also unknown if received 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 on an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, unknown if the patient had been tested for COVID-19. On 04Apr2021 at 08:00, 48 hours after receipt of the second vaccine, the patient woke up with a headache. Drank water, ate salmon and rice made at home and felt better. Then on 04Apr2021, approximately 55 hours after vaccine, the patient went to play tennis indoors where she became very warm and started to breakout in a rash on arms, face and back of neck. On an unknown date in Apr2021, the patient experienced swelling in the eye and lip area and became very anxious. The patient has a peanut allergy and felt that she was having a reaction. However, she didn't see where she would have been in contact with peanuts and therefore thought it was due to the vaccine. Within an hour, as rash continued, the patient took Benadryl liquid form that reduced the rash. An hour later, the patient took a shower that also reduced the rash. No further action was taken. Therapeutic measures were taken as a result of the events and included treatment with benadryl liquid form. The clinical outcome of events headache, became very warm, rash on arms, face and back of neck, swelling in the eye and lip area, became very anxious and felt that she was having a reaction were recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: high pitched ringing in  ears; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant adult female patient of unspecified age received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0164) via an unspecified route of administration in the right arm on 21Apr2021 at 08:45 as a single dose for COVID-19 immunisation. Patient had no medical history and past drug history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 08:45 as a single dose for COVID-19 immunisation. 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 COVID vaccine. On an unknown date in 2021, the patient experienced a high-pitched ringing in ears for large parts of the day. The 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 high-pitched ringing in ears was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anal rash, Bone pain, Cough, Fatigue, Lacrimation increased
Clinical narrative: extreme lower-body aches as if the patient had restless leg syndrome for 2 days; collarbone top chest area hurt so bad it felt like it was punched in the collarbone; cold-like symptoms; runny nose; watery eyes; sore throat; cough; rash in anus and perineum that simulated a child's diaper rash; rash in anus and perineum that simulated a child's diaper rash; extreme fatigue where the patient could barely keep eyes open for 12 days; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 15Apr2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, sciatica, scoliosis, eczema, multiple allergies (year-round allergies), sensitive skin and allergy to topical drugs (sensitive to topicals). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), probiotics (MANUFACTURER UNKNOWN), multi-Vitamin (MANUFACTURER UNKNOWN) from an unknown date for unknown indications. The patient previously took sulfa (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 15:00 the patient experienced extreme lower-body aches as if the patient had restless leg syndrome for 2 days, collarbone top chest area hurt so bad it felt like it was punched in the collarbone, cold-like symptoms which included a runny nose, watery eyes, sore throat and cough for 12 days and also the patient experienced rash in anus and perineum that simulated a child's diaper rash (anal rash and perineal rash) and also the patient experienced extreme fatigue where the patient could barely keep eyes open for 12 days. The clinical outcome of the event extreme lower-body aches as if the patient had restless leg syndrome for 2 days was recovered with sequelae on 17Apr2021. The clinical outcome of the event cold-like symptoms which included a runny nose, watery eyes, sore throat and cough for 12 days and extreme fatigue where the patient could barely keep eyes open for 12 days were recovered with sequelae on 27Apr2021. The clinical outcome of the event collarbone top chest area hurt so bad it felt like it was punched in the collarbone, rash in the anus and perineum that simulated a child's diaper rash (anal rash and perineal rash) were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Perineal rash, Rhinorrhoea
Clinical narrative: extreme lower-body aches as if the patient had restless leg syndrome for 2 days; collarbone top chest area hurt so bad it felt like it was punched in the collarbone; cold-like symptoms; runny nose; watery eyes; sore throat; cough; rash in anus and perineum that simulated a child's diaper rash; rash in anus and perineum that simulated a child's diaper rash; extreme fatigue where the patient could barely keep eyes open for 12 days; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 15Apr2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, sciatica, scoliosis, eczema, multiple allergies (year-round allergies), sensitive skin and allergy to topical drugs (sensitive to topicals). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), probiotics (MANUFACTURER UNKNOWN), multi-Vitamin (MANUFACTURER UNKNOWN) from an unknown date for unknown indications. The patient previously took sulfa (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 15:00 the patient experienced extreme lower-body aches as if the patient had restless leg syndrome for 2 days, collarbone top chest area hurt so bad it felt like it was punched in the collarbone, cold-like symptoms which included a runny nose, watery eyes, sore throat and cough for 12 days and also the patient experienced rash in anus and perineum that simulated a child's diaper rash (anal rash and perineal rash) and also the patient experienced extreme fatigue where the patient could barely keep eyes open for 12 days. The clinical outcome of the event extreme lower-body aches as if the patient had restless leg syndrome for 2 days was recovered with sequelae on 17Apr2021. The clinical outcome of the event cold-like symptoms which included a runny nose, watery eyes, sore throat and cough for 12 days and extreme fatigue where the patient could barely keep eyes open for 12 days were recovered with sequelae on 27Apr2021. The clinical outcome of the event collarbone top chest area hurt so bad it felt like it was punched in the collarbone, rash in the anus and perineum that simulated a child's diaper rash (anal rash and perineal rash) were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria; This is a spontaneous report from a contactable physician. A 21-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medications were not reported. Patient had no past drug history.  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 an unknown date in 2021, the patient experienced urticaria. Therapeutic measures were taken as a result of the adverse event and included treatment with steroids. The clinical outcome of the event of urticaria was not recovered at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Myocarditis, Tachycardia, Troponin increased
Clinical narrative: Tachycardia in the 170s, chest pressure, elevated troponin. Diagnosed with myocarditis.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Heart rate increased, Tachycardia
Clinical narrative: Tachycardia in the 170s, chest pressure, elevated troponin. Diagnosed with myocarditis.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Tachycardia in the 170s, chest pressure, elevated troponin. Diagnosed with myocarditis.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Full blood count abnormal, Headache, Myocarditis, Pancytopenia
Clinical narrative: Tachycardia in the 170s, chest pressure, elevated troponin. Diagnosed with myocarditis.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, Troponin increased
Clinical narrative: Tachycardia in the 170s, chest pressure, elevated troponin. Diagnosed with myocarditis.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Myocarditis, Tachycardia, Troponin increased
Clinical narrative: Pt began having chest pressure after the vaccine.  She was also having tachycardia of 140's per her apple watch.  Her heartrate went as high as 170's but would come down to 80-90's.  She also complained of HA and SOB.  At time of admission to hospital, patient symptoms had resolved.  Her troponin was also elevated.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Heart rate increased, Tachycardia
Clinical narrative: Pt began having chest pressure after the vaccine.  She was also having tachycardia of 140's per her apple watch.  Her heartrate went as high as 170's but would come down to 80-90's.  She also complained of HA and SOB.  At time of admission to hospital, patient symptoms had resolved.  Her troponin was also elevated.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Pt began having chest pressure after the vaccine.  She was also having tachycardia of 140's per her apple watch.  Her heartrate went as high as 170's but would come down to 80-90's.  She also complained of HA and SOB.  At time of admission to hospital, patient symptoms had resolved.  Her troponin was also elevated.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Full blood count abnormal, Headache, Myocarditis, Pancytopenia
Clinical narrative: Pt began having chest pressure after the vaccine.  She was also having tachycardia of 140's per her apple watch.  Her heartrate went as high as 170's but would come down to 80-90's.  She also complained of HA and SOB.  At time of admission to hospital, patient symptoms had resolved.  Her troponin was also elevated.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, Troponin increased
Clinical narrative: Pt began having chest pressure after the vaccine.  She was also having tachycardia of 140's per her apple watch.  Her heartrate went as high as 170's but would come down to 80-90's.  She also complained of HA and SOB.  At time of admission to hospital, patient symptoms had resolved.  Her troponin was also elevated.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Polymenorrhoea
Clinical narrative: Early period by 12 days; Was brown from old blood and came on very lightly.; This is a spontaneous report from a contactable consumer, the patient. A 27-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 arm right on 30Apr2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Apr2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient previously took latex (MANUFACTURER UNKNOWN). 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 02May2021 at 13:00 the patient experienced early period by 12 days and was brown from old blood and came on very lightly. It was stated that the patient had no cramps for the first 42 hours. The clinical outcome of the event early period by 12 days and was brown from old blood and came on very lightly was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Palpitations
Clinical narrative: Started having pain in lungs; Having palpitations; Shortness of breath; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration and an unspecified anatomical location on 10Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 31Mar2021 at 13:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient previously received BACTRIM for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced palpitations and shortness of breath. The patient reported that the palpitations and shortness of breath started since she was vaccinated. On 02May2021, the patient experienced pain in lungs. The patient reported that she had no symptoms or issues until after she received the COVID 19 vaccination. On an unspecified date in 2021, the patient underwent tests and blood works which were all found to be normal. The patient reported that she was scheduled for further tests. The events resulted in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events palpitations, shortness of breath and pain in lungs was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: Muscle spasms; Body pain in my back and legs; This is a spontaneous report from a contactable consumer, the patient. A 35-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 arm left on 01May2021 at 18:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic acid reflux disease, esophagitis, non-alcoholic fatty liver disease, asthma and microcytic anemia. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) from unknown date for unknown indication. The patient previously took Codeine, Vicodin, triptan, steriods and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 07:00, the patient experienced muscle spasms and body pain in back and legs. The clinical outcome of the events muscle spasms and body pain in back and legs was unknown at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia, Skin burning sensation, Urticaria
Clinical narrative: Flushing of skin; Full body burning; Tingling; Hives (no itch); This is a spontaneous report from a contactable consumer, the patient. A 24-years-old-non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8733) via unspecified route of administration in the left arm on 17Apr2021 at 10:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient medical history included depression and anxiety. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and magnesium aspartate (MANUFACTURER UNKNOWN)all for unknown indications, from an unknown dates. The patient had no known allergies to medications, food or other products was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. 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 vaccine. On 02May2021 at 11:15, after receiving medications and supplements for several months i.e. approximately 15 minutes later experienced flushing of skin, full body burning, tingling, hives (no itch), appearance similar to sunburn. Resolved on its own 15 minutes later. No breathing problems or nausea. Asked to report these symptoms by local nurse. No therapeutic measures were taken as a result of reported events. The clinical outcome of flushing of skin, full body burning, tingling, hives (no itch), appearance similar to sunburn was recovered on 02May2021 at 11:30 i.e. after the duration of 15 mins.    No follow-up attempts are needed. No further information is expected
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Throat tightness
Clinical narrative: Strong headache; Feeling like throat was closing; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an Intramuscular route of administration in the right arm on 30Apr2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications were not reported. The patient's past drug history included DK (MANUFACTURER UNKNOWN), since unknown date for an unknown indication. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021, the patient initially experienced a strong headache but then progressed to feeling like the throat was closing. It was reported that the patient went to urgent care for tx. The events resulted in emergency room or department or urgent care. The clinical outcome of the events strong headache and feeling like the throat was closing was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Stomach began churning; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm right on 21Apr2021 at 09:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included naproxen sodium (ALEVE) and clonazepam (MANUFACTURER UNKNOWN) for unknown indications. The patient previously received penicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. 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 within hours of getting the shot, the patient experienced stomach began churning. It was reported that this was followed by 3-4 days of what the patient can only describe as having drunk a colon test prep kit. The patient stools had returned to normal, but his stomach reaction to ingesting anything including water has been continual. At that point the patient did not even know if he should get his 2nd dose. The patient called the Centers for Disease Control and Prevention (CDC) and they were unable to tell if this was a normal side effect or an allergic one. The clinical outcome of the event stomach began churning was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Feeling abnormal
Clinical narrative: Mental fog; Acid reflux; Chest pain; Diaphoretic; Exhaustion; Muscle pain; Joint pain; Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 01May2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks of vaccination. The patient previously took Keflex and had received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 25-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 11:00, the patient had experienced mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain. The clinical outcome of the events mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Hyperhidrosis, Myalgia, Nausea, Pyrexia
Clinical narrative: Mental fog; Acid reflux; Chest pain; Diaphoretic; Exhaustion; Muscle pain; Joint pain; Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 01May2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks of vaccination. The patient previously took Keflex and had received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 25-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 11:00, the patient had experienced mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain. The clinical outcome of the events mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.