chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature increased, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; upper back & lower back pain/I have back pain; I have on back I have very sharp pain in my lower back and in my back; I cannot sit for long period, I have to lay down; temperature of 101-102°F/I had high temperature of 101; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 12May2021 (at the age of 35-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Aug2020, to an unknown date. The patient concomitant medications were not reported. On 12May2021, the patient experienced temperature of 101-102 degree Fahrenheit. The patient had high temperature of 101. On 17May2021, nausea, vomiting and back pain on back very sharp pain in lower back and in back; patient cannot sit for long period to lay down. Consumer reported the patient took the Pfizer shot (Pfizer Covid vaccine) a week ago on Wednesday (confirmed as 12 May 2021), 8 days ago, he had this reaction. He took it 8 days ago on the first day on the first he had high temperature of 101 and then he had back pain, nausea and vomiting for the 5th, 6th, 7th, 8th day he had on back and very sharp pain in his lower back and in his back and he cannot sit for long period, he had to lay down so he just, why that was and this is his first shot he took, he had Covid back in august, this way I have same feeling. But the back pain, back sharp pain was just too much, he cannot stand it, he spoke with his regular doctor. The patient underwent lab tests and procedures which included body temperature increased: the first 4 days 101- 102 degree Fahrenheit on 12May2021. The clinical outcome of the events were unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Patient have not had a period since 2nd dose, It was been almost 2 months and still did not have period.; 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: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (Hashimoto's) for which patient received a low daily dose (0.25mg) of Levothyroxine. The patient had no known allergies to medications, food or other products. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 02Mar2021 at 14:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient previously took levothyroxine for hypothyroidism (Hashimoto's), patient take a low daily dose (.25mg). 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 24Mar2021 the patient received the 2nd dose of Pfizer vaccine on the last day of her last menstrual cycle (March 24th), and she not had a period since. Patient used a tracker app to keep track of her cycle, and she never skipped a period before. The patient was not pregnant, and have not started taking any new medication since receiving the 2nd dose of Pfizer vaccine that would affect her period. That has been almost 2 months and patient still did not had her period. Therapeutic measures were not taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events she not had a period since, has been almost 2 months and patient still did not had her period was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain, Pain in extremity
Clinical narrative: Sore left arm -whole arm; Metallic taste in mouth; Body aches especially upper shoulder and back area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 11May2021 at 13:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, dupuytren's contracture, attention deficit-hyperactivity disorder (ADHD) and osteopenia. Concomitant medications included levothyroxine sodium (TIROSINT) 88 mcg, liothyronine (MANUFACTURER UNKNOWN) 5 mcg and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25mg twice daily from an unknown date and unknown if ongoing for unknown indications. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug 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 12May2021 at 09:00, the patient experienced sore left arm -whole arm, metallic taste in mouth and body aches especially upper shoulder and back area. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore left arm -whole arm, metallic taste in mouth and body aches especially upper shoulder and back area was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Flatulence
Clinical narrative: Stomach cramps; Gas pains; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17May2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included adhd and allergy to chicken. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both from unknown start dates and 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 COVID vaccine. On 18May2021, the patient experienced stomach cramps and gas pains. 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 clinical outcome of the events stomach cramps and gas pains were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Large red and raised spot at injection site. Growing hotter and bigger daily; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 17May2021 at 13:30 (at the age of 36-year-old) as a single dose for COVID-19immunisation. Medical history and concomitant medications were not reported. The patient previously took penicillin (MANUFACTURER UNKNOWN), ketorolac tromethamine (TORADOL) and prochlorperazine edisylate (COMPAZINE) for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 the patient experienced large red and raised spot at injection site, growing hotter and bigger daily. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event large red and raised spot at injection site, growing hotter and bigger daily was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: sore arm; left arm pit lymph nodes swollen with pain; left arm pit lymph nodes swollen with pain; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 15May2021 at 10:00 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medication included multivitamins (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 10:15 the patient experienced sore arm. On an unknown date in May2021 the patient experienced left armpit lymph nodes swollen with pain. Therapeutic measures were not taken as a result of the events sore arm and left armpit lymph nodes swollen with pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events sore arm and left armpit lymph nodes swollen with pain was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Parosmia
Clinical narrative: Inappropriate schedule of vaccine administered; After second dose experiencing phantosmia.  Smelling very bad odors that don't exist; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8737) via an unspecified route of administration in the right arm on 13Apr2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication included eszopiclone (LUNESTA) from an unknown date for an unknown indication and unknown if its ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the right arm on 20Feb2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, after second dose, the patient experienced phantosmia. Smelling very bad odors that don't exist. 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.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event phantosmia was not recovered/not resolved/ongoing.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: stabbing pain in right ear/ intermittent ear pain; loud ringing in right ear; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, 7 hours after receiving the vaccine the patient woke up from a deep sleep with a stabbing pain in right ear and loud ringing in right ear and six weeks later, the patient still have ringing in ears, pain in ear was slowly going away and had intermittent ear pain. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with an unspecified medication. The clinical outcome of the events a stabbing pain in right ear/ intermittent ear pain and loud ringing in right ear was recovered with sequelae on an unknown date.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Vaccination site mass
Clinical narrative: large lump at vaccination site on left arm, red, hot, itchy and painful to touch; large lump at vaccination site on left arm, red, hot, itchy and painful to touch; large lump at vaccination site on left arm, red, hot, itchy and painful to touch; large lump at vaccination site on left arm, red, hot, itchy and painful to touch; large lump at vaccination site on left arm, red, hot, itchy and painful to touch; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0167) via an unspecified route of administration in the left arm on 17May2021 at 14:45(at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had no allergy to food, medication or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 15:00(at the age of 54-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 vaccine. On 18May2021 at 00:00, the patient experienced large lump at vaccination site on left arm, red, hot, itchy and painful to touch. 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. The clinical outcome of large lump at vaccination site on left arm, red, hot, itchy and painful to touch were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore upper arm; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 19May2021 at 14:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included zolpidem tartrate (AMBIEN), fluoxetine hydrochloride (PROZAC), cefdinir (MANUFACTURER UNKNOWN) and colecalciferol (5000International Units) (VITAMIN D3), all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 04:30, the patient experienced very sore upper arm. 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 clinical outcome of the event very sore upper arm was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Hypoaesthesia, Joint swelling, Myalgia
Clinical narrative: My right foot also got tendonitis which I have never gotten before; Periodic numbness in leg; Abnormal bruising/entire wrist area bruised; Bump swell up in wrist area and felt a slight burst; Feet just had random pains like muscle pain; I have been having joint pain in my wrists and feet; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to sun flower seeds. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 24Feb2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On an unknown date in Mar2021, the patient had been having joint pain in wrists, and feet, and periodic numbness in leg, as well as abnormal bruising, a few weeks back (unspecified date), in the middle of the night, the patient felt a bump swell up in his wrist area, and felt a slight burst, and the next day his entire wrist area was bruised. The patient felt that he was more easily bruised than normal. The patient wrist still had a pain in it, and his feet just had random pains like muscle pain. The patient right foot also got tendonitis which he had never gotten before, and sometimes if he step wrong, he could feel pain. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events right foot also got tendonitis, periodic numbness in leg, abnormal bruising/entire wrist area bruised, bump swell up in wrist area and felt a slight burst, feet just had random pains like muscle pain and joint pain in wrists and feet was resolved with sequelae, with lasting effects on an unknown date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: My right foot also got tendonitis which I have never gotten before; Periodic numbness in leg; Abnormal bruising/entire wrist area bruised; Bump swell up in wrist area and felt a slight burst; Feet just had random pains like muscle pain; I have been having joint pain in my wrists and feet; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to sun flower seeds. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 24Feb2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On an unknown date in Mar2021, the patient had been having joint pain in wrists, and feet, and periodic numbness in leg, as well as abnormal bruising, a few weeks back (unspecified date), in the middle of the night, the patient felt a bump swell up in his wrist area, and felt a slight burst, and the next day his entire wrist area was bruised. The patient felt that he was more easily bruised than normal. The patient wrist still had a pain in it, and his feet just had random pains like muscle pain. The patient right foot also got tendonitis which he had never gotten before, and sometimes if he step wrong, he could feel pain. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events right foot also got tendonitis, periodic numbness in leg, abnormal bruising/entire wrist area bruised, bump swell up in wrist area and felt a slight burst, feet just had random pains like muscle pain and joint pain in wrists and feet was resolved with sequelae, with lasting effects on an unknown date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 17May2021 at 00:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was having stone fruit allergy. The patient did not receive any concomitant medications in two weeks. 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 17May2021 at 21:00, the patient experienced fever, chills and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events fever, chills and body aches were recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: Left underarm (arm pit) swollen; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN603) via an unspecified route of administration in the left arm on 18May2021 at 09:30 AM (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and penicillin allergy. The patient previously took Tamiflu and experienced allergy to it. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 19May2021 at 13:00, one day after vaccination, the patient experienced left underarm (arm pit) swollen and fatigue. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors 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. The clinical outcome of the events left underarm (arm pit) swollen and fatigue was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Lymphadenopathy, Nasal congestion, Pain in extremity
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 62, via an unspecified route of administration, left arm, on Apr 7, 2021, at 09:45, single dose, for COVID-19 immunisation. Medical history included asthma, hypothyroidism and pseudocholinesterase deficiency. Concomitant medications included levothyroxine from an unknown date and for an unknown indication. The patient previously took tetracycline hydrochloride on an unknown date and experienced allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 7, 2021, at 16:00, patient experienced stuffed nose, fatigue, left arm pain, swelling, swollen lymph nodes (opposite arm), breast rash (opposite-side) and trouble breathing. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of reported events included treatment with topical creams, inhalers and ice from unknown dates. The clinical outcome of the events stuffed nose, fatigue, left arm pain and swelling, swollen lymph nodes (opposite-arm), breast rash (opposite-side) and trouble breathing: unknown (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 62, via an unspecified route of administration, left arm, on Apr 7, 2021, at 09:45, single dose, for COVID-19 immunisation. Medical history included asthma, hypothyroidism and pseudocholinesterase deficiency. Concomitant medications included levothyroxine from an unknown date and for an unknown indication. The patient previously took tetracycline hydrochloride on an unknown date and experienced allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 7, 2021, at 16:00, patient experienced stuffed nose, fatigue, left arm pain, swelling, swollen lymph nodes (opposite arm), breast rash (opposite-side) and trouble breathing. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of reported events included treatment with topical creams, inhalers and ice from unknown dates. The clinical outcome of the events stuffed nose, fatigue, left arm pain and swelling, swollen lymph nodes (opposite-arm), breast rash (opposite-side) and trouble breathing: unknown (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Ultrasound scan
Clinical narrative: I had spotting - like a menstrual cycle. I have been in menopause for 5 years; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 (Lot number was not reported) as dose 2, single at 52-years-old for covid-19 immunization at a hospital. Medical history included menopause from an unknown date for 5 years. The patient's concomitant medications include unspecified vitamins and thyroid medications. The patient previously receive the first dose of bnt162b2 on Feb2021 at 10:00 am Left arm at 52-years-old for covid-19 immunization. No known allergies. Not diagnosed with covid-19 prior and not tested post vaccination. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021 13:00, the patient reported that "I had spotting - like a menstrual cycle. I have been in menopause for 5 years so this was shocking." The event resulted in: doctor or other healthcare professional office/clinic visit. The reporter considered the event as non-serious. The patient underwent lab tests and procedures which included ultrasound scan: result not provided on an unspecified date. The patient received an unspecified treatment. The outcome of the event was recovered on an unspecified date in 2021.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Vision blurred
Clinical narrative: Immediate blurred vision; nausea; sweats; This is a spontaneous report from a non-contactable consumer (patient). A 12-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 20May2021 at 10:00 at the age of 12-years-old as dose number unknown, single for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 10:00, the patient experienced immediate blurred vision, nausea and sweats. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events, immediate blurred vision, nausea and sweats were recovering at the time of this report.   The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Chills, Dyspnoea, Fatigue, Feeding disorder
Clinical narrative: cannot eat; tired; nausea; severe headache; total body aches; shortness of breath; severe pain in lower abdomen; severe chills; sweating; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in right arm on 18May2021 at 14:30 (at the age of 63 years old) as single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had been tested for COVID-19. On 08Apr2021, the patient underwent SARS COV2 by PCR (nasal swab) test and the result was negative. On the same day, the patient underwent SARS-COV-2 by RAPID ANTIGEN (nasal swab) test and the result was negative. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in right arm on 27Apr2021 at 14:30 (at the age of 62 years old) as single dose for COVID-19 immunisation. On 18May2021 at 14:45, within 20 minutes of vaccination, the patient experienced severe pain in lower abdomen. On the same day, in the night, the patient experienced severe chills and sweating. On 19May2021, the patient was tired, had nausea, severe headache, total body aches and shortness of breath. The patient stated she almost went to emergency room (ER) and patient had to sit upright all night. On 20 May2021, the patient finally got out of bed, but cannot eat and only drank ice water. The events were present event at the time of report and the patient missed work for 4 days and was sure even the next day of report she will not be able to work. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event severe pain in lower abdomen, severe chills, sweating, tired, nausea, severe headache, total body aches, shortness of breath and cannot eat were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: cannot eat; tired; nausea; severe headache; total body aches; shortness of breath; severe pain in lower abdomen; severe chills; sweating; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in right arm on 18May2021 at 14:30 (at the age of 63 years old) as single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had been tested for COVID-19. On 08Apr2021, the patient underwent SARS COV2 by PCR (nasal swab) test and the result was negative. On the same day, the patient underwent SARS-COV-2 by RAPID ANTIGEN (nasal swab) test and the result was negative. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0187), via an unspecified route of administration in right arm on 27Apr2021 at 14:30 (at the age of 62 years old) as single dose for COVID-19 immunisation. On 18May2021 at 14:45, within 20 minutes of vaccination, the patient experienced severe pain in lower abdomen. On the same day, in the night, the patient experienced severe chills and sweating. On 19May2021, the patient was tired, had nausea, severe headache, total body aches and shortness of breath. The patient stated she almost went to emergency room (ER) and patient had to sit upright all night. On 20 May2021, the patient finally got out of bed, but cannot eat and only drank ice water. The events were present event at the time of report and the patient missed work for 4 days and was sure even the next day of report she will not be able to work. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event severe pain in lower abdomen, severe chills, sweating, tired, nausea, severe headache, total body aches, shortness of breath and cannot eat were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blisters up and down left and right arms and top of shoulders; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8736), via an unspecified route of administration in the left arm on 30Apr2021 at 10:45 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetic type 2 and the patient had known allergies to medications, food, or other products. Concomitant medications were not reported. 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. On 10May2021, the patient experienced blisters up and down left and right arms and top of shoulders. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of blisters up and down left and right arms and top of shoulders was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 69-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09May2021 10:30 (at the age of 69-years-old) as dose 2, single for COVID-19 immunization. Vaccination facility type was reported as Pharmacy or Drug Store. Patient medical history included high cholesterol and known allergies to chestnuts. The patient previously received simvastatin for high cholesterol from unknown date. The patient previously received varicella zoster vaccine (shingles vaccine) on an unspecified date in 2018. Historical vaccine received the BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EW171) via an unspecified route of administration in left arm on 18r2021 10:30 as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 22:00, 2 days after the second vaccine, the patient experienced a series of red dots appeared in a triangular pattern on 2 parts of upper right thigh. The patient dermatologist diagnosed it as Shingles. The patient had the shingles vaccine in 2018, hence was surprised by this side effect. The patient underwent lab tests and procedures which included Sars-Cov-2 (nasal swab) test for COVID-19 on 17May2021 and tested negative. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with valacyclovir. The clinical outcome of the event shingles was not recovered at the time of this report.   The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 05May2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included oral antibiotics from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 10May2021, the patient experienced insomnia. The event 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 event. The clinical outcome of insomnia was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Feeling abnormal, Migraine, Sinus congestion
Clinical narrative: Fog like feeling; lightheadedness; Decrease in appetite; Vomiting; Severe migraine; Dizziness; Tightness of sinuses; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 18May2021 at 13:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to latex, watermelon and seafood. Concomitant medications included fluoxetine hydrochloride (PROZAC), aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) and gliclazide (CLARITIN), all taken for unspecified indications from unknown dates. The patient previously took bactrim, macrobid, ciprofloxacin and monistat and experienced drug 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 18May2021 at 22:45, the patient experienced severe migraine with dizziness and tightness of sinuses. On 19May2021, the next morning, the patient experienced vomiting twice. On 21May2021, 60 hours after the shot, the patient experienced fog like feeling as well as some lightheadedness and decrease in appetite. 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. The clinical outcome of the events severe migraine with dizziness, tightness of sinuses, vomiting, fog like feeling, lightheadedness and decrease in appetite were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fog like feeling; lightheadedness; Decrease in appetite; Vomiting; Severe migraine; Dizziness; Tightness of sinuses; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 18May2021 at 13:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to latex, watermelon and seafood. Concomitant medications included fluoxetine hydrochloride (PROZAC), aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) and gliclazide (CLARITIN), all taken for unspecified indications from unknown dates. The patient previously took bactrim, macrobid, ciprofloxacin and monistat and experienced drug 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 18May2021 at 22:45, the patient experienced severe migraine with dizziness and tightness of sinuses. On 19May2021, the next morning, the patient experienced vomiting twice. On 21May2021, 60 hours after the shot, the patient experienced fog like feeling as well as some lightheadedness and decrease in appetite. 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. The clinical outcome of the events severe migraine with dizziness, tightness of sinuses, vomiting, fog like feeling, lightheadedness and decrease in appetite were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain
Clinical narrative: Severe lower back and bone pain. Sever Left elbow joint pain.; Severe lower back and bone pain. Sever Left elbow joint pain.; Severe lower back and bone pain. Sever Left elbow joint pain.; This is a spontaneous report from a contactable consumer, the patient. A 36-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 19May2021 at 09:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patients other medical history was reported as no. The patient had no known allergies to medications, food, or other products. The patient received other medication within two weeks prior to vaccination which included Prenatal (unspecified) from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 09:30 (at the age of 36-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 20May2021 at 02:00, the patient experienced severe lower back and bone pain. The patient also experienced severe left elbow joint pain on 20May2021 at 02:00. 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 clinical outcome of the events severe lower back and bone pain, severe left elbow joint pain 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.