chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest discomfort, Electrocardiogram, Headache
Clinical narrative: Very sensitive skin; body/joint aches; body/joint aches; Headache; Tightness; Fast heart rate; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6206) via an unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis of neck. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lorazepam (ATIVAN), fluticasone propionate (FLONASE), omeprazole (OMEPRAZOL) and montelukast sodium (SINGULAIR) all for unknown date for unknown indications. The patient received tetracycline (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. 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 01Apr2021, reportedly experienced all after second shot; very sensitive skin, body/joint aches, headache and now almost 2 weeks after shot - patient was having check tightness and fast heart rate--- went to ER to check out and all ok with heart but not sure why had tightness. On an unknown date in Apr2021, the patient underwent blood test, ECG and x-ray and the results were unknown. The events of tightness and fast heart rate resulted in emergency room/department or urgent care. The clinical outcome of the events of sensitive skin, body ache, joint ache, headache, tightness and fast heart rate was recovered with sequelae on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain, Sensitive skin, X-ray
Clinical narrative: Very sensitive skin; body/joint aches; body/joint aches; Headache; Tightness; Fast heart rate; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6206) via an unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis of neck. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lorazepam (ATIVAN), fluticasone propionate (FLONASE), omeprazole (OMEPRAZOL) and montelukast sodium (SINGULAIR) all for unknown date for unknown indications. The patient received tetracycline (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. 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 01Apr2021, reportedly experienced all after second shot; very sensitive skin, body/joint aches, headache and now almost 2 weeks after shot - patient was having check tightness and fast heart rate--- went to ER to check out and all ok with heart but not sure why had tightness. On an unknown date in Apr2021, the patient underwent blood test, ECG and x-ray and the results were unknown. The events of tightness and fast heart rate resulted in emergency room/department or urgent care. The clinical outcome of the events of sensitive skin, body ache, joint ache, headache, tightness and fast heart rate was recovered with sequelae on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Syncope
Clinical narrative: exhausted; stomach ached all day; Had a slight headache; Couple of days later collapsed in bathroom; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2  at vaccination age of 35-year-old via an unspecified route of administration in the left arm on 05Apr2021 17:15 (Lot Number: ER8729) as dose 2, single for covid-19 immunization. Medical history included asthma, high blood pressure, and had known allergies to bees. The patient did not have covid prior vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient's concomitant medications were none. The patient previously took Lisinopril but had Lisinopril allergy. The patient did not receive other vaccine in four weeks. On 06Apr2021 06:00 AM, the patient reported that she was exhausted the next day and her stomach ached all day. She had a slight headache and couple of days later (Apr2021), she collapsed in the bathroom. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Dysphagia, Erythema, Flushing
Clinical narrative: Dizziness; Vomiting; Metallic taste; Tingly mouth; Difficulty swallowing; Rapid heartbeat; Flushed red face; Flushed red face; This is a spontaneous report from a contactable consumer (patient). This 38-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0150) via an unspecified route of administration on 07Apr2021 at 14:00 (at the age of 38-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history penicillin allergy and artificial food dye allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included a multivitamin. The patient previously received vancomycin from an unknown date and experienced allergy. On 07Apr2021 at 14:15 the patient experienced dizziness, vomiting, metallic taste, tingly mouth, difficulty swallowing, rapid heartbeat, and flushed red face. The patient visited an emergency room/department or urgent care as a result of the events. The patient received treatment with diphenhydramine (BENADRYL), famotidine (PEPCID), cetirizine (ZYRTEC), dexamethasone (DECADRON), and albuterol. The outcomes of dizziness, vomiting, metallic taste, tingly mouth, difficulty swallowing, rapid heartbeat, and flushed red face were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Paraesthesia oral, Vomiting
Clinical narrative: Dizziness; Vomiting; Metallic taste; Tingly mouth; Difficulty swallowing; Rapid heartbeat; Flushed red face; Flushed red face; This is a spontaneous report from a contactable consumer (patient). This 38-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0150) via an unspecified route of administration on 07Apr2021 at 14:00 (at the age of 38-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history penicillin allergy and artificial food dye allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included a multivitamin. The patient previously received vancomycin from an unknown date and experienced allergy. On 07Apr2021 at 14:15 the patient experienced dizziness, vomiting, metallic taste, tingly mouth, difficulty swallowing, rapid heartbeat, and flushed red face. The patient visited an emergency room/department or urgent care as a result of the events. The patient received treatment with diphenhydramine (BENADRYL), famotidine (PEPCID), cetirizine (ZYRTEC), dexamethasone (DECADRON), and albuterol. The outcomes of dizziness, vomiting, metallic taste, tingly mouth, difficulty swallowing, rapid heartbeat, and flushed red face were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Body temperature, Hypoaesthesia, Lip erythema, Pharyngeal swelling
Clinical narrative: top of tongue got all chopped like when she had allergic reaction to nicotine; Also start having a little pain in left ovary.; Not a painful, not a shape pain, but it feels like tooth ache; lips are red; I have a fever, 100; injection site hurts; throat was swollen; lower legs got numb/her left side became numb, whole left side became numb; tongue got swollen; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot number was not reported), via an unspecified route of administration, administered in right arm on 08Apr2021 13:30 (at the age of 59-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included asthma, bronchitis and allergy to shellfish, exotic fruit, Dust, Pet Dander, wine. Concomitant medication in which the patient received within 2 weeks of vaccination included loratadine, pseudoephedrine sulfate (CLARITIN D 12 HOUR). The patient previously took nicotine and experienced allergies. After shot (on 08Apr2021) for 20 minutes the patient stayed at the clinic. About 40 minutes later (on 08Apr2021 at 14:30) her lower legs got numb. Her tongue got swollen. By the time she came home around 14:50 her throat was swollen. She can still breath. Then, she administered Epipen. After the epipen, her left side became numb, whole left side became numb. Slowly her tongue, her throat became less swollen. She started to feel her left fingers, toes, left side face.  It took 4 hours for her to feel normal. Then 22:38 her tongue was swollen, her throat felt like when she had bronchitis, her lips were red as if she had a fever, 100, injection site hurts. She can still breath. Then it gets better, tongue get less swollen, throat feels better. Then these symptoms repeated throughout the night. Also, on unspecified date her top of tongue got all chopped like when she had allergic reaction to nicotine. She also started having a little pain in left ovary on unspecified date. Not a painful, not a shape pain, but it feels like tooth ache on unspecified date. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment was received for the reported adverse events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swollen tongue, Tongue disorder, Toothache, Vaccination site pain
Clinical narrative: top of tongue got all chopped like when she had allergic reaction to nicotine; Also start having a little pain in left ovary.; Not a painful, not a shape pain, but it feels like tooth ache; lips are red; I have a fever, 100; injection site hurts; throat was swollen; lower legs got numb/her left side became numb, whole left side became numb; tongue got swollen; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot number was not reported), via an unspecified route of administration, administered in right arm on 08Apr2021 13:30 (at the age of 59-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included asthma, bronchitis and allergy to shellfish, exotic fruit, Dust, Pet Dander, wine. Concomitant medication in which the patient received within 2 weeks of vaccination included loratadine, pseudoephedrine sulfate (CLARITIN D 12 HOUR). The patient previously took nicotine and experienced allergies. After shot (on 08Apr2021) for 20 minutes the patient stayed at the clinic. About 40 minutes later (on 08Apr2021 at 14:30) her lower legs got numb. Her tongue got swollen. By the time she came home around 14:50 her throat was swollen. She can still breath. Then, she administered Epipen. After the epipen, her left side became numb, whole left side became numb. Slowly her tongue, her throat became less swollen. She started to feel her left fingers, toes, left side face.  It took 4 hours for her to feel normal. Then 22:38 her tongue was swollen, her throat felt like when she had bronchitis, her lips were red as if she had a fever, 100, injection site hurts. She can still breath. Then it gets better, tongue get less swollen, throat feels better. Then these symptoms repeated throughout the night. Also, on unspecified date her top of tongue got all chopped like when she had allergic reaction to nicotine. She also started having a little pain in left ovary on unspecified date. Not a painful, not a shape pain, but it feels like tooth ache on unspecified date. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment was received for the reported adverse events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Insomnia, Pain in extremity, Peripheral coldness, Peripheral swelling
Clinical narrative: Moderate pain, pain increased severity to 8/10 (Pain on entire arm and hand); Arm and hand are slightly swollen; Barely able to sleep due to pain; Felt like my entire arm and hand were having an arthritic flare, were blown up; Hand was cold to touch; palm looked red-blue; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0151), via an unspecified route of administration in the left arm on 08Apr2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to latex, intravenous contrast, soft shell crab, various medications, bee stings; as well as seasonal allergies, arthritis, increased blood pressure, lipidemia, chronic pain related to several injuries. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included colecalciferol (VIT D), atorvastatin calcium (ATORVASTIN), buproprion, varenicline tartrate (CHANTIX), mirabegron (MYRBETRIQ). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6199) in the left arm on 17Mar2021 at 10:30 for COVID-19 immunisation. The patient did not receive any other vaccinations within 4 weeks. On 08Apr2021 at 15:00, several hours after injection, the patient experienced moderate pain to the entire arm and hand which increased in severity to 8/10. There was no response to ice, paracetamol (TYLENOL). The pain was so severe that the patient took tramadol to help diminish the pain. The arm and hand were slightly swollen. The patient was barely able to sleep due to the pain. It felt like the entire arm and hand were having an arthritic flare, were blown up. The hand was cold to the touch, the palm looked red-blue. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events was not resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Moderate pain, pain increased severity to 8/10 (Pain on entire arm and hand); Arm and hand are slightly swollen; Barely able to sleep due to pain; Felt like my entire arm and hand were having an arthritic flare, were blown up; Hand was cold to touch; palm looked red-blue; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0151), via an unspecified route of administration in the left arm on 08Apr2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to latex, intravenous contrast, soft shell crab, various medications, bee stings; as well as seasonal allergies, arthritis, increased blood pressure, lipidemia, chronic pain related to several injuries. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included colecalciferol (VIT D), atorvastatin calcium (ATORVASTIN), buproprion, varenicline tartrate (CHANTIX), mirabegron (MYRBETRIQ). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6199) in the left arm on 17Mar2021 at 10:30 for COVID-19 immunisation. The patient did not receive any other vaccinations within 4 weeks. On 08Apr2021 at 15:00, several hours after injection, the patient experienced moderate pain to the entire arm and hand which increased in severity to 8/10. There was no response to ice, paracetamol (TYLENOL). The pain was so severe that the patient took tramadol to help diminish the pain. The arm and hand were slightly swollen. The patient was barely able to sleep due to the pain. It felt like the entire arm and hand were having an arthritic flare, were blown up. The hand was cold to the touch, the palm looked red-blue. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events was not resolved.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 20Mar2021 at 02:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma and allergy. The patient received other medicines (unspecified) within two 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced rash. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rash was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; Moderate fever, joint aches, chills, body aches, headache. all but the fever were severe and i was in bed aprox. 24 hrs.; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patients medical history was reported as no. The patient had no known allergies to food, medicine or other products. The patient had taken other medications (unspecified) within two weeks prior to vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 13:30 (at the age of 72-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 02Apr2021 at 02:30, the patient experienced moderate fever, joint aches, chills, body aches, headache. All but the fever were severe and the patient was in bed approximately 24 hours. No therapeutic measures were taken as a result of the events. The clinical outcome of the events moderate fever, joint aches, chills, body aches, headache, all but the fever were severe and patient was in bed approximately 24 hours was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: pox-like lesion on thigh, observed many more lesions on mainly on midriff, but also behind knee, a couple on the arm and lesions are raised, but not itchy or painful; This is a spontaneous report from a 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: EP6955) in the left arm on 17Mar2021 at 10:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) on 07Apr2021 at 10:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease. The patient did not have allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT) and levothyroxine (MANUFACTURER UNKNOWN) all from unknown date, for unknown indications.  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 05Apr2021 the patient experienced pox-like lesion on thigh and on 08Apr2021 approx. 24 hours after second vaccine dose, the patient observed many more lesions on mainly on midriff, but also behind knee, a couple on the arm and lesions are raised, but not itchy or painful. It was unknown whether therapeutic measures were taken as a result of the event. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pox-like lesion on thigh, observed many more lesions on mainly on midriff, but also behind knee, a couple on the arm and lesions are raised, but not itchy or painful was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Inflammation
Clinical narrative: Shortness of breath about 18 hours alter; Inflammation; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hypogonadism and hypothyroidism. Patient did not report any known allergies to food, medications or other products. Concomitant medications included metformin hydrochloride (METFORM), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ), levothyroxine (MANUFACTURER UNKNOWN) and testosterone (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG204) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 11:00 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 vaccine. On 09Apr2021 at 08:45, the patient experienced shortness of breath about 18 hours alter and at 06:00, experienced inflammation. 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 shortness of breath about 18 hours alter and inflammation were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives and rashes 48 hours after shot. Itching. One Benadryl taken, resolved within 10-15 minutes; Hives and rashes 48 hours after shot. Itching. One Benadryl taken, resolved within 10-15 minutes; Hives and rashes 48 hours after shot. Itching. One Benadryl taken, resolved within 10-15 minutes; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8730) via an unspecified route of administration in the right arm on 01Apr2021 at 15:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis. The patient had no known allergies to food, medicine or other products. The patient had not taken other medications within two weeks prior to 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 03Apr2021 at 17:00, the patient experienced hives and rashes 48 hours after shot and itching. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of hives, rashes and itching which included treatment with one Benadryl and it resolved within 10-15 minutes. The clinical outcome of the events hives and rashes 48 hours after shot and itching was resolved within 10-15 minutes after taking one Benadryl on 03Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Muscle spasms, Nausea
Clinical narrative: Chills; ever (highest noted was 102); nausea; vomiting; severe body aches; muscle cramps; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 06Apr2021 at 11:00(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to melons, certain nuts and seasonal allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE); both for unspecified indication and unknown start date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 16Mar2021 at 08:30 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 vaccine. On 06Apr2021 at 21:00, the patient experienced chills, fever (highest noted was 102), nausea, vomiting, severe body aches & muscle cramps, fatigue. The patient did not receive any treatment for the events. 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. On 06Apr2021, the patient underwent body temperature and the result was 102(unit unknown). The clinical outcome of the event chills, fever (highest noted was 102), nausea, vomiting, severe body aches & muscle cramps, fatigue were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Chills; ever (highest noted was 102); nausea; vomiting; severe body aches; muscle cramps; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 06Apr2021 at 11:00(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to melons, certain nuts and seasonal allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE); both for unspecified indication and unknown start date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 16Mar2021 at 08:30 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 vaccine. On 06Apr2021 at 21:00, the patient experienced chills, fever (highest noted was 102), nausea, vomiting, severe body aches & muscle cramps, fatigue. The patient did not receive any treatment for the events. 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. On 06Apr2021, the patient underwent body temperature and the result was 102(unit unknown). The clinical outcome of the event chills, fever (highest noted was 102), nausea, vomiting, severe body aches & muscle cramps, fatigue were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very tiny bit of a sore arm the next day; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (reported as high blood pressure), hypothyroidism and cholesterol high. The patient had no known allergies to food, medicine or other products. The patient had received other medication (unspecified) within two weeks prior to 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. The patient experienced very tiny bit of a sore arm the next day on 09Apr2021. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event very tiny bit of a sore arm the next day was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, SARS-CoV-2 test, Urticaria
Clinical narrative: The eczema on my upper back and shoulders broke out in hives after two hours of receiving the vaccine. The next morning, my skin had sharp small pains where the hives were.; The eczema on my upper back and shoulders broke out in hives after two hours of receiving the vaccine. The next morning, my skin had sharp small pains where the hives were.; This is a spontaneous report from a contactable consumer, the patient. A 19-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 on 08Apr2021 at 19:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and eczema. The patient did not receive any medication within two weeks prior to vaccination. Prior to the vaccination, the patient was 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. The eczema on the patients upper back and shoulders broke out in hives on 08Apr2021 at 21:00, after two hours of receiving the vaccine. The next morning on 09Apr2021, her skin had sharp small pains where the hives were. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The patient underwent tests and investigations which included COVID-19 test on 05Apr2021, and the result was negative. The clinical outcome of the events the eczema on upper back and shoulders broke out in hives after two hours of receiving the vaccine; the next morning, skin had sharp small pains where the hives were was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Deafness transitory, Dizziness, Dysstasia, Face injury
Clinical narrative: lightheaded; hitting her face against the wall; passed out; losing vision; was not able to sit up without losing vision, hearing; Could not stand up; sweats; nausea; This is a spontaneous report from a contactable physician (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Apr2021 (at the age of 47 years) (Batch/Lot Number: EW0158) as a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included systemic lupus erythematosus and allergies: sulfa. Concomitant medications (other medications in two weeks) included unspecified birth control pills, allergy pills, and joint pills. The patient previously took codeine and experienced allergies. On 08Apr2021 23:00, thirty hours after the vaccination, patient got up to get something from the bathroom. She felt lightheaded - like when standing up too fast. On the way out of the bathroom, she passed out, hitting her face against the wall. When she came around, she could not stand up, had cold sweats and nausea. Symptoms lasted for several hours. She was not able to sit up without losing vision, hearing and feeling lightheaded. Patient is recovering from the events. No treatment was received. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events passed out, temporary vision loss, deafness transitory . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: lightheaded; hitting her face against the wall; passed out; losing vision; was not able to sit up without losing vision, hearing; Could not stand up; sweats; nausea; This is a spontaneous report from a contactable physician (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Apr2021 (at the age of 47 years) (Batch/Lot Number: EW0158) as a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included systemic lupus erythematosus and allergies: sulfa. Concomitant medications (other medications in two weeks) included unspecified birth control pills, allergy pills, and joint pills. The patient previously took codeine and experienced allergies. On 08Apr2021 23:00, thirty hours after the vaccination, patient got up to get something from the bathroom. She felt lightheaded - like when standing up too fast. On the way out of the bathroom, she passed out, hitting her face against the wall. When she came around, she could not stand up, had cold sweats and nausea. Symptoms lasted for several hours. She was not able to sit up without losing vision, hearing and feeling lightheaded. Patient is recovering from the events. No treatment was received. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events passed out, temporary vision loss, deafness transitory . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Wheezing
Clinical narrative: Worst asthma attack in decades.; Difficulty breathing.; Wheeze.; This is a spontaneous report from a contactable consumer (patient). This 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration in the left arm on 05Apr2021 at 08:30 (at 67-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received ibuprofen from an unknown date for an unknown indication and experienced allergy; and previously received the first dose of BNT162B2 (lot number EN6708) in the left arm on 15Mar2021 at 08:00 (at 67-years-old) for COVID-19 immunisation. On 05Apr2021 at 17:00 the patient experienced the worst asthma attack in decades, difficulty breathing, and wheezing. The events required a doctor's appointment and albuterol. The clinical outcomes of the events were not recovered. Since vaccination the patient had not been tested for COVID-19.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: burst blood vessel in my right eye.; This is a spontaneous report received 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: 3248), via an unspecified route of administration in the right arm on 02Mar2021 at 13:45 (at the age of 53-years-old) and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 3248), via an unspecified route of administration in the right arm on 23Mar2021 at 13:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Prior to vaccination, the patient did not test positive for COVID-19. Concomitant medications included atorvastatin, multivitamins, ibuprofen (ADVIL), paracetamol (TYLENOL), melatonin (MELATON). There were no other vaccinations within 4 weeks of the COVID-19 vaccine. On an unspecified date (Mar2021), about 2 weeks after each dose, the patient experienced a burst blood vessel in the right eye. The clinical course was follows: About 2 weeks after each dose, the patient noticed a burst blood vessel in the right eye. He did not associate it with the vaccine after dose 1. It went away within 3-4 days. But it happened again approximately 2 weeks after the second dose, on 07Apr2021. Again, the patient initially did not associate it given the time lag. But today, the patient started wondering and so reported it as a precaution. There was no pain or irritation in the eye but just a red splotch on the eyeball. The patient had never had a burst blood vessel in the eye before. There was no treatment received for the event. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the event was resolving.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Dizziness, Fatigue
Clinical narrative: Extreme dizziness; Extreme chills; Overall muscle pain; Joint pain; Bone pain; Extreme fatigue; Extreme site pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 05Apr2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure that was controlled by meds (medications). The patient had no known allergies to medications, food or other products. Concomitant medications included medications for high blood pressure, amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and estradiol (MANUFACTURER UNKNOWN); from unknown dates for unspecified indications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 14Mar2021 at 15:45 (at the age of 55-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 05Apr2021 at 18:00, with in six hours the patient experienced extreme site pain. On05Apr2021 at 19:00, the patient experienced extreme chills, overall muscle pain, joint pain, bone pain and extreme fatigue. On 09Apr2021, the patient experienced extreme dizziness which set in after 4 days and continued. 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 extreme site pain was resolved by 48 hours on 07Apr2021 at 18:00. The clinical outcome of the event's extreme chills, overall muscle pain, joint pain, bone pain and extreme fatigue was resolved by 48 hours on 07Apr2021 at 19:00. The clinical outcome of the event extreme dizziness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Extreme dizziness; Extreme chills; Overall muscle pain; Joint pain; Bone pain; Extreme fatigue; Extreme site pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 05Apr2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure that was controlled by meds (medications). The patient had no known allergies to medications, food or other products. Concomitant medications included medications for high blood pressure, amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and estradiol (MANUFACTURER UNKNOWN); from unknown dates for unspecified indications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 14Mar2021 at 15:45 (at the age of 55-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 05Apr2021 at 18:00, with in six hours the patient experienced extreme site pain. On05Apr2021 at 19:00, the patient experienced extreme chills, overall muscle pain, joint pain, bone pain and extreme fatigue. On 09Apr2021, the patient experienced extreme dizziness which set in after 4 days and continued. 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 extreme site pain was resolved by 48 hours on 07Apr2021 at 18:00. The clinical outcome of the event's extreme chills, overall muscle pain, joint pain, bone pain and extreme fatigue was resolved by 48 hours on 07Apr2021 at 19:00. The clinical outcome of the event extreme dizziness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Muscle tightness
Clinical narrative: Severe lower back pain; "muscle spasms and tightness"; "muscle spasms and tightness"; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ewo158) via an unspecified route of administration in the right arm on 07Apr2021 at 14:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient received unspecified 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 four weeks prior to the vaccination. On 09Apr2021 at 05:00, the patient experienced severe lower back pain with muscle spasms and tightness. 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 severe lower back pain with "muscle spasms and tightness" were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.