chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# 1045), at the age of 64, via an unspecified route of administration, in the left arm, on May 4, 2021, single dose, for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, patient diagnosed with COVID-19). The patient has no known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On May 5, 2021, at 03:00, patient experienced left arm swelling/itch (dark red, almost black). The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of reported events. The outcome of left arm swelling/itch (dark red, almost black): not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Somnolence
Clinical narrative: Tired; Sleepy; Sore; This is a spontaneous report from a contactable consumer, the patient. A 50-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 05May2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05May2021 at 13:00, the patient experienced tired, sleepy and sore. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tired, sleepy and sore was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Headache, Hypertension
Clinical narrative: Body aches; Hypertension; Chest tightness; Shortness of breath; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 28Apr2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome and possibly lupus. The patient was allergic to amoxicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), hydroxychloroquine (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unspecified indication since an unknown date and unknown if ongoing.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 07Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 06:00, the patient experienced body aches (day 2 only), headache, hypertension, chest tightness, shortness of breath and chills. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events body aches (day 2 only), headache, hypertension, chest tightness, shortness of breath and chills. On 06May2021, the patient underwent PCR (polymerase chain reaction) test (saliva) and the result was negative. The clinical outcome of the events body aches was resolved on 29Apr2021 while the clinical outcome of the events headache, hypertension, chest tightness, shortness of breath and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Body aches; Hypertension; Chest tightness; Shortness of breath; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 28Apr2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome and possibly lupus. The patient was allergic to amoxicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), hydroxychloroquine (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unspecified indication since an unknown date and unknown if ongoing.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 07Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 06:00, the patient experienced body aches (day 2 only), headache, hypertension, chest tightness, shortness of breath and chills. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events body aches (day 2 only), headache, hypertension, chest tightness, shortness of breath and chills. On 06May2021, the patient underwent PCR (polymerase chain reaction) test (saliva) and the result was negative. The clinical outcome of the events body aches was resolved on 29Apr2021 while the clinical outcome of the events headache, hypertension, chest tightness, shortness of breath and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; Swelling  redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles.; This is a spontaneous report from a contactable consumer, the patient. An 86-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 left arm on 06May2021 at 14:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included lung cancer, diabetic, arthritis, diverticulosis and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), diclofenac (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) four more (unspecified medications) & supplement (supplie) (unspecified) from an unknown start date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 17:00, the patient experienced itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles and included self-treatment with lavender, ice packs and antihistamine (unspecified) from an unknown start date to an unknown stop date. The clinical outcome of the event itching, swelling, redness in a wide "stripe" formation on the lower inside of each leg beginning above the ankles was recovered at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, SARS-CoV-2 test
Clinical narrative: Having a headache/migraine almost every day since around the time; Having a headache/migraine almost every day since around the time; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021. Medical history included ADHD (attention deficit-hyperactivity disorder), depression, hyperhidrosis and allergy to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexmethylphenidate (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) for unspecified indications, from an unknown date and unknown if ongoing. The patient previously received cefalexin (KEFLEX) and amoxicillin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. From 28Mar2021, the patient has been having headache and migraine almost every day since around the time, the patient received first vaccination (24Mar2021) . The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events headache and migraine almost every day was not recovered at the time of report.  The patient received second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 12:45  (at the age of 21-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival bleeding, Mouth ulceration
Clinical narrative: Mouth ulcers & minor gum bleeding. It happened after the first dose as well / ulcers appeared after the second dose and they went away faster; however one has come up again, 2 weeks later; Mouth ulcers & minor gum bleeding. It happened after the first dose as well; 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: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration on 21Apr2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included common variable immunodeficiency (CVID) - hypogammaglobulinemia. The patient was allergic to fluoroquinolone antibiotics. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medication within two weeks of vaccination. On 22Apr2021 at 12:00, the patient experienced mouth ulcers and minor gum bleeding. On an unknown date, the events happened after the first dose as well. She took ZICAM tablets when the ulcers appeared after the second dose and they went away faster, however one had come up again, 2 weeks later. Therapeutic measures were taken as a result of the events which included treatment with piroxicam (ZICAM) tablets. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth ulcers and minor gum bleeding which happened after the first dose as well and ulcers appeared after the second dose and they went away faster, however one had come up again, 2 weeks later was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Migraine, Pain, Pain in extremity
Clinical narrative: Migraine; intermittent pain in my head that goes from one ear to the other, like a string is inside my head and it connects to my ears or the place above your jaw.; intermittent pain in my head that goes from one ear to the other, like a string is inside my head and it connects to my ears or the place above your jaw.; pain in left arm for about a day 1/2,; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol, osteoporosis, migraines, allergies and known allergy to latex and a long list of foods. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included rosuvastatin calcium (CRESTOR), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), vitamin d nos (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received ibuprofen (ADVIL) and cefaclor (CECLOR); both for unspecified indication from unknown date and experienced drug allergy. On an unknown date in 2021, originally after shot, the patient had pain in left arm for about a day and half and a slight headache. On 05May2021 at 23:00, two weeks after shot, the patient experienced migraine but for the last 2 days, the patient had this intermittent pain in head that went from one ear to the other, like a string was inside head and it connected to ears or the place above your jaw. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in left arm was resolved on unknown date in 2021, after a day and half. The clinical outcome of the events slight headache, migraine and intermittent pain in head that went from one ear to the other, like a string was inside head and it connected to ears or the place above your jaw was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Tongue coated, Tongue discomfort, Tongue disorder
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included malignant melanoma, diverticulitis, high blood pressure and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) and medicines for high blood pressure (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6205) via an unspecified route of administration in the right arm on 17Mar2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 09:00, three weeks after the second dose of the vaccine the patient's tongue started to hurt/burn and there were little red bumps on it and a yellowish/whitish coating. It was very painful and sore; the patient was not able to brush it off or remove the coating. It was bad for 2 days and then started to slowly resolve. On the day of reporting, it was day 6 and the coating had finally gone but it still felt as if the patient had burned the tongue on hot food. It was noted that, the patient had recently been to the dentist for a full check-up so aware that oral health was totally fine. The patient had not eaten or drank anything that would have contributed to this. Hence, the patient, was convinced it was reaction to the vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tongue started to hurt/burn, was very painful and sore, there were little red bumps on it and a yellowish/whitish coating were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis flare in upper mid back and neck; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0173) via an unspecified route of administration in the left arm on 05May2021 at 08:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, polycystic ovarian syndrome (PCOS) and allergy to sulfa. The patient previously received fluconazole (MANUFACTURER UNKNOWN) and ciprofloxacin (CIPRO) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included too many supplements (unspecified) for unknown indications, from unknown start dates and unknown if on going. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 07Apr2021 at 08:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. On 07May2021 at 10:00, on the third day after COVID shot, the patient experienced arthritis flare in upper mid back and neck. The patient was not on any immunosuppressive therapy or particular treatment plan for arthritis, but she suffered from flares for nearly 10 years for unknown reasons despite thorough testing. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event arthritis flare in upper mid back and neck was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Headache; Nausea; Severe pain in arms/legs (feels like arm was being broken in half); Severe pain in arms & legs (feels like my arm was being broken in half, could not walk on legs without shooting pain going up & down my legs),; Tiredness; Injection sight was burning; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 19:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS), asthma, penicillin allergy and adhesive allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included norethisterone acetate (NORETHINDRONE) and metoprolol (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN); amoxicillin, clavulanic acid (AUGMENTIN) and morphine (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 16Apr2021 at 20:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 10:00, the patient experienced headache, nausea, severe pain in arms and legs (felt like her arm was being broken in half, could not walk on legs without shooting pain going up and down legs), tiredness and injection site was burning. 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. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, severe pain in arms and legs (felt like arm was being broken in half, could not walk on legs without shooting pain going up and down legs), tiredness and injection site was burning was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; Nausea; Severe pain in arms/legs (feels like arm was being broken in half); Severe pain in arms & legs (feels like my arm was being broken in half, could not walk on legs without shooting pain going up & down my legs),; Tiredness; Injection sight was burning; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 19:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS), asthma, penicillin allergy and adhesive allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included norethisterone acetate (NORETHINDRONE) and metoprolol (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN); amoxicillin, clavulanic acid (AUGMENTIN) and morphine (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 16Apr2021 at 20:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 10:00, the patient experienced headache, nausea, severe pain in arms and legs (felt like her arm was being broken in half, could not walk on legs without shooting pain going up and down legs), tiredness and injection site was burning. 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. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, severe pain in arms and legs (felt like arm was being broken in half, could not walk on legs without shooting pain going up and down legs), tiredness and injection site was burning was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Nausea, Pain
Clinical narrative: Insomnia; Body aches; Fever; Chills; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW976) via an unspecified route of administration in the left arm on 05May2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 10:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 06May2021 at 03:30, the patient experienced insomnia, body aches, fever, chills, headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events insomnia, body aches, fever, chills, headache and nausea were recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Insomnia; Body aches; Fever; Chills; Headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW976) via an unspecified route of administration in the left arm on 05May2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 10:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 06May2021 at 03:30, the patient experienced insomnia, body aches, fever, chills, headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events insomnia, body aches, fever, chills, headache and nausea were recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: After second dose, pain at site injection administration; Muscle and joint aches; Muscle and joint aches; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05May2021 at 12:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history included allergy to lysol and bleach. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included loratadine (MANUFACTURER UNKNOWN), mometasone (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN) and an unspecified medication; all for unknown indications from unknown dates and unknown if ongoing. 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 14Apr2021 at 12:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 18:30, after second dose, the patient experienced pain at site injection administration, muscle and joint aches, chills and headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at site injection administration, muscle and joint aches, chills and headache were resolved on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Had a very bad headache mostly front of head (eyes and forehead area); Slight discomfort in the abdominal area; Slight discomfort in the abdominal area and lower back; Had a mild fever; Had a mild fever with chills / chills again / continued having chills; Would feel very hot and start sweating / feeling hot seconds after; Would feel very hot and start sweating; Felt pain in the injection site (left arm); Felt pain in the injection site (left arm) with limited mobility in the arm; 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: ER2613) via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 23:00, after the second dose of Pfizer, on the same night after vaccination, the patient experienced mild fever with chills all over and seconds later she felt very hot, started sweating and then got the chills again. She also felt pain in the injection site (left arm) with limited mobility in the arm. On 07May2021, in the morning, she had a very bad headache, mostly front of her head (eyes and forehead area) and continued having chills and felt hot seconds after. She also felt slight discomfort in the abdominal area and lower back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild fever with chills all over / chills again / continued having chills, would feel very hot and started sweating / feeling hot, felt pain in the injection site (left arm) with limited mobility in the arm, very bad headache mostly front of head (eyes and forehead area) and slight discomfort in the abdominal area and lower back was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Musculoskeletal discomfort, Pyrexia, Vaccination site pain
Clinical narrative: Had a very bad headache mostly front of head (eyes and forehead area); Slight discomfort in the abdominal area; Slight discomfort in the abdominal area and lower back; Had a mild fever; Had a mild fever with chills / chills again / continued having chills; Would feel very hot and start sweating / feeling hot seconds after; Would feel very hot and start sweating; Felt pain in the injection site (left arm); Felt pain in the injection site (left arm) with limited mobility in the arm; 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: ER2613) via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 23:00, after the second dose of Pfizer, on the same night after vaccination, the patient experienced mild fever with chills all over and seconds later she felt very hot, started sweating and then got the chills again. She also felt pain in the injection site (left arm) with limited mobility in the arm. On 07May2021, in the morning, she had a very bad headache, mostly front of her head (eyes and forehead area) and continued having chills and felt hot seconds after. She also felt slight discomfort in the abdominal area and lower back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild fever with chills all over / chills again / continued having chills, would feel very hot and started sweating / feeling hot, felt pain in the injection site (left arm) with limited mobility in the arm, very bad headache mostly front of head (eyes and forehead area) and slight discomfort in the abdominal area and lower back was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Dizziness, Dry mouth
Clinical narrative: Muscle aches; Joint aches; Malaise; Headache and earache on left side of head; Headache and earache on left side of head; Nausea; Lightheadedness; Fatigue; Alternating between the chills and feeling feverish; Feverish; Chest pain; Dry mouth; Brain fog; 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: EWO179) via an unspecified route of administration in the left arm on 06May2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included raynaud's phenomenon and polycystic ovarian syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and bupropion hydrochloride (WELLBUTRIN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 03:00, the patient experienced muscle/joint aches, malaise, headache and earache on left side of head, nausea, lightheadedness, fatigue, alternating between the chills and feeling feverish, chest pain, dry mouth and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle/joint aches, malaise, headache and earache on left side of head, nausea, lightheadedness, fatigue, alternating between the chills and feeling feverish, chest pain, dry mouth and brain fog was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: Muscle aches; Joint aches; Malaise; Headache and earache on left side of head; Headache and earache on left side of head; Nausea; Lightheadedness; Fatigue; Alternating between the chills and feeling feverish; Feverish; Chest pain; Dry mouth; Brain fog; 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: EWO179) via an unspecified route of administration in the left arm on 06May2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included raynaud's phenomenon and polycystic ovarian syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and bupropion hydrochloride (WELLBUTRIN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 03:00, the patient experienced muscle/joint aches, malaise, headache and earache on left side of head, nausea, lightheadedness, fatigue, alternating between the chills and feeling feverish, chest pain, dry mouth and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle/joint aches, malaise, headache and earache on left side of head, nausea, lightheadedness, fatigue, alternating between the chills and feeling feverish, chest pain, dry mouth and brain fog was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle aches; Joint aches; Malaise; Headache and earache on left side of head; Headache and earache on left side of head; Nausea; Lightheadedness; Fatigue; Alternating between the chills and feeling feverish; Feverish; Chest pain; Dry mouth; Brain fog; 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: EWO179) via an unspecified route of administration in the left arm on 06May2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included raynaud's phenomenon and polycystic ovarian syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and bupropion hydrochloride (WELLBUTRIN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 15Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 03:00, the patient experienced muscle/joint aches, malaise, headache and earache on left side of head, nausea, lightheadedness, fatigue, alternating between the chills and feeling feverish, chest pain, dry mouth and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle/joint aches, malaise, headache and earache on left side of head, nausea, lightheadedness, fatigue, alternating between the chills and feeling feverish, chest pain, dry mouth and brain fog was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: ''My'' left arm has been tingling/pins and needles from ''my'' shoulder down to ''my'' fingers for the past few days. It has been almost a week since ''my'' second injection; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 left arm on unknown date as a single dose for COVID-19 immunisation. On 03May2021 at 11:00, the patient experienced her left arm had been tingling/pins and needles from her shoulder down to her fingers for the past few days. It had been almost a week since her second injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of event. The clinical outcome of the event left arm had been tingling/pins and needles from her shoulder down to her fingers for the past few days was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Inflammation, Migraine, Paraesthesia
Clinical narrative: Chills; migraine; inflammation throughout entire body; tingling and numbness in hands and feet.; tingling and numbness in hands and feet.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8736) via an unspecified route of administration in the right arm on 03May2021 at 13:15 at the age of 37-years-old as a single dose for COVID-19 immunisation. The medical history included fibromyalgia, lupus, and allergic to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included IBUPROFEN for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8731) via an unspecified route of administration in the right arm on 12Apr2021 at 13:15 at the age of 37-years-old as a single dose for COVID-19 immunisation. On 04May2021 at 01:00, the patient experienced chills, migraine, inflammation throughout entire body, and tingling and numbness in hands and feet. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events which included treatment with unspecified pain medication and anti-depressant. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, migraine, inflammation throughout entire body, and tingling and numbness in hands and feet were resolved with sequelae on an unknown date in May2021.    No follow-up attempts are needed. No further information is expected.