chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Body aches; Skin soreness; Joint pain; Chills; Headache; 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: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included spring allergies (seasonal allergy) and soy 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. Concomitant medications included ascorbic acid (VITAMIN C), rainbow lite multi-vitamin (MANUFACTURER UNKNOWN), asthma inhaler (MANUFACTURER UNKNOWN); all for unknown indications 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: ER8734) via an unspecified route of administration in the right arm on 27Mar2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.  On 18Apr2021 at 04:00, the patient experienced body aches, skin soreness, joint pain, chills and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (TYLENOL) Since the vaccination, the patient had been tested for COVID-19. On an unknown date (also reported as 13Jan2021), the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events body aches, skin soreness, joint pain, chills and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Erythema, Fatigue, Nausea
Clinical narrative: Injection site swelling; Redness; Fatigue extreme; Nausea; Vomiting; Low grade fever; Cough; Appetite lost; This is a spontaneous report from a contactable consumer, the patient. A 60-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 15Apr2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes, and hypertension. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 00:00, the patient experienced injection site swelling, redness, fatigue extreme, nausea, vomiting, low grade fever, cough and appetite lost. The event 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 injection site swelling, redness, fatigue extreme, nausea, vomiting, low grade fever, cough and appetite lost was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: Injection site swelling; Redness; Fatigue extreme; Nausea; Vomiting; Low grade fever; Cough; Appetite lost; This is a spontaneous report from a contactable consumer, the patient. A 60-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 15Apr2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes, and hypertension. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 00:00, the patient experienced injection site swelling, redness, fatigue extreme, nausea, vomiting, low grade fever, cough and appetite lost. The event 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 injection site swelling, redness, fatigue extreme, nausea, vomiting, low grade fever, cough and appetite lost was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, in the left arm, on Apr 8, 2021, at 08:45, single dose, for COVID-19 immunisation. No medical history or allergies reported. Prior to the vaccination, 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 metoprolol, for an unknown indication from an unknown date and unknown if ongoing. On Apr 8, 2021, patient experienced fever onset at 12 hours. On Apr 10, 2021 (after 48 hours), patient experienced loose bowels/diarrhea. On Apr 15, 2021, at 16:30, patient experienced headache fairly consistent for 3 days. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the reported events. The patient recovered from the fever on an unknown date in Apr 2021. The headache and loose bowels/diarrhea: not recovered (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Pain
Clinical narrative: Chills; Body aches; Diarrhea; Headache; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 16Mar2021 at 18:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. On 18Apr2021, the patient experienced chills, body aches, diarrhea, headache and joint pain. 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 chills, body aches, diarrhea, headache and joint pain was not recovered at the time pf this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Malaise
Clinical narrative: Sore arm; warm to touch; Chills; Fever for five days; Muscle aches; Sore throat; Headache; Fatigue; Feeling unwell; Nausea; A fast heartbeat the first night; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included seizure disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified known allergies to medications, food or other products. Concomitant medications included levetiracetam (KEPPRA), diazepam (VALIUM), fluticasone propionate (FLONASE) and cetirizine hydrochloride (ZYRTEC); all for unknown indication from unknown date and unknown if ongoing. 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 17Mar2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 18:00, the patient experienced sore arm, warm to touch, chills, fever for five days, muscle aches, sore throat,  headache, fatigue, feeling unwell, nausea and a fast heartbeat the first night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever for five days was recovered on 12Apr2021 and of the events sore arm, warm to touch, chills, muscle aches, sore throat, headache, fatigue, feeling unwell, nausea and a fast heartbeat the first night was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; warm to touch; Chills; Fever for five days; Muscle aches; Sore throat; Headache; Fatigue; Feeling unwell; Nausea; A fast heartbeat the first night; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included seizure disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified known allergies to medications, food or other products. Concomitant medications included levetiracetam (KEPPRA), diazepam (VALIUM), fluticasone propionate (FLONASE) and cetirizine hydrochloride (ZYRTEC); all for unknown indication from unknown date and unknown if ongoing. 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 17Mar2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 18:00, the patient experienced sore arm, warm to touch, chills, fever for five days, muscle aches, sore throat,  headache, fatigue, feeling unwell, nausea and a fast heartbeat the first night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever for five days was recovered on 12Apr2021 and of the events sore arm, warm to touch, chills, muscle aches, sore throat, headache, fatigue, feeling unwell, nausea and a fast heartbeat the first night was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Sore arm; warm to touch; Chills; Fever for five days; Muscle aches; Sore throat; Headache; Fatigue; Feeling unwell; Nausea; A fast heartbeat the first night; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included seizure disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified known allergies to medications, food or other products. Concomitant medications included levetiracetam (KEPPRA), diazepam (VALIUM), fluticasone propionate (FLONASE) and cetirizine hydrochloride (ZYRTEC); all for unknown indication from unknown date and unknown if ongoing. 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 17Mar2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 18:00, the patient experienced sore arm, warm to touch, chills, fever for five days, muscle aches, sore throat,  headache, fatigue, feeling unwell, nausea and a fast heartbeat the first night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever for five days was recovered on 12Apr2021 and of the events sore arm, warm to touch, chills, muscle aches, sore throat, headache, fatigue, feeling unwell, nausea and a fast heartbeat the first night was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 07Apr2021 at 08:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies to medications, food, or other products. 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 unspecified medications within two weeks of vaccination. On 07Apr2021 at 12:00, approximately 4 hours after vaccination, the patient experienced sore arm that lasted for less than 24 hours. On same day, approximately 14 hours after vaccination, the patient experienced severe headache which was lasted for approximately 36 hours. 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 sore arm and severe headache were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oropharyngeal pain, Pruritus, Rash, Swelling face
Clinical narrative: Itching; tongue had become swelled; swelling started in face; throat itching and pain; throat itching and pain; rash/had become worst day by day by rash spreading a whole body/again the rash started coming on face, hand, leg, knees; realized it is adverse impact and acutely allergies/allergies continued to speak whole body including head; This is a spontaneous report from a contactable consumer (patient) via . This 42-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 03Apr2021 at 13:00 (at 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19, had no allergies, and had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included phyllanthus emblica, terminalia bellirica, terminalia chebula (TRIPHALA) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S), both from unknown dates for unknown indications. The patient reported events started 06Apr2021 at 12:00. The patient reported that kind of rash started from second day from the vaccination time. It had become worst day by day by rash spreading throughout the whole body, and on 08Apr2021 throat itching and pain started. The patient visited her primary physician and she realized it was adverse impact and acutely allergies. She prescribed a steroid, "be ADDA do" esomeprazole (NEXIUM) and a course of the steroid for 8 days. The issue was not resolved, and the allergies continued to spread whole body including head. On 12Apr2021 the tongue had become swollen, and swelling started in face. The patient went to doctor again, she checked and suggested to go to an allergy specialist and emergency room if there was no progress. On 15Apr2021 the patient went to emergency room as the itching, pain and allergy had become un-manageable. The doctor treated the patient with a steroid and other medicines intravenously (IV) and she was there for 7 hours. After the IV it felt good, itching reduced and she got discharged back to home. On 17Apr2021, again the rash started coming on face, hand, leg, knees and itching also started. The clinical outcome of itching was unknown; the outcomes of the other events were not recovered. Since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: Itching; tongue had become swelled; swelling started in face; throat itching and pain; throat itching and pain; rash/had become worst day by day by rash spreading a whole body/again the rash started coming on face, hand, leg, knees; realized it is adverse impact and acutely allergies/allergies continued to speak whole body including head; This is a spontaneous report from a contactable consumer (patient) via . This 42-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 03Apr2021 at 13:00 (at 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19, had no allergies, and had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included phyllanthus emblica, terminalia bellirica, terminalia chebula (TRIPHALA) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S), both from unknown dates for unknown indications. The patient reported events started 06Apr2021 at 12:00. The patient reported that kind of rash started from second day from the vaccination time. It had become worst day by day by rash spreading throughout the whole body, and on 08Apr2021 throat itching and pain started. The patient visited her primary physician and she realized it was adverse impact and acutely allergies. She prescribed a steroid, "be ADDA do" esomeprazole (NEXIUM) and a course of the steroid for 8 days. The issue was not resolved, and the allergies continued to spread whole body including head. On 12Apr2021 the tongue had become swollen, and swelling started in face. The patient went to doctor again, she checked and suggested to go to an allergy specialist and emergency room if there was no progress. On 15Apr2021 the patient went to emergency room as the itching, pain and allergy had become un-manageable. The doctor treated the patient with a steroid and other medicines intravenously (IV) and she was there for 7 hours. After the IV it felt good, itching reduced and she got discharged back to home. On 17Apr2021, again the rash started coming on face, hand, leg, knees and itching also started. The clinical outcome of itching was unknown; the outcomes of the other events were not recovered. Since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 22-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 22, via an unspecified route of administration, in the left arm, on Apr 12, 2021, at 08:30, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included Loestrin (ethinyl-estradiol/norethisterone acetate) for birth control from an unknown date and unknown if ongoing. Prior to the vaccination, patient was not diagnosed with COVID-19. On Apr 14, 2021 (1 week since she got the shot), patient reported two, 24-hour periods. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of two, 24-hour periods (in 1 week since she got the shot): unknown (at the time of this report). No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Noninfective gingivitis, Oral pain, Pyrexia, Rash
Clinical narrative: Fever for two days after receiving second vaccine; Developed rash from point of vaccine down arm to atuberculosis vaccine scar received at infancy in birthplace,; Developed sores all over my gums, roof of mouth; Developed sores all over my gums, roof of mouth; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8734, Expiration date: 31Jul2021) via an unspecified route of administration in the right arm on 06Apr2021 at 15:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. The patient had known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), unspecified probiotics and calcium (BONE BUILDER); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534, Expiration date: 31Jul2021) via an unspecified route of administration in the right arm on 16Mar2021 at 15:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient previously took cefuroxime axetil (CEFTIN) and experienced drug allergy. On 07Apr2021 at 01:00, the patient experienced fever for two days after receiving second vaccine, developed rash from point of vaccine down arm to a tuberculosis vaccine scar received at infancy in birthplace. Few days later developed sores all over her gums and roof of mouth. The rash on arm lasted until Apr15, almost a week and half after receiving second vaccination. Therapeutic measures were not taken as a result of the events reported. The events 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. The clinical outcome of the event fever for two days after receiving second vaccine was recovered on 09Apr2021. The clinical outcome of the event developed rash from point of vaccine down arm to a tuberculosis vaccine scar received at infancy in birthplace, was recovered on 15Apr2021. The clinical outcome of the events developed sores all over my gums, roof of mouth was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Pruritus, Rash macular, Vaccination site erythema, Vaccination site macule
Clinical narrative: Still have a light red circle, now the entire diameter is red (rather then just ring); Still slight discomfort; discomfort and itch.; noticed arm itchy, earlier in night; large, red circle that looked like a ringworm circle; circle was around the injection site. The circle was about 4-6 inches in diameter; "covid arm"; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder(ADHD) and chronic unspecified migraines. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone (TULANA), methylphenidate (MANUFACTURER UNKNOWN) and topiramate (MANUFACTURER UNKNOWN); all taken 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. On 17Apr2021, the patient noticed arm itchy, earlier that night and she ignored, showered that evening, noticed a large, red circle that looked like a ringworm circle, the circle was around the injection site, the circle was about 4-6 inches in diameter, looked up as "covid arm", found comfort and she went to bed. On 18Apr2021 she still had a light red circle and the entire diameter was red (rather then just ring). On that day also slight discomfort and itch. She reported that she was on hold for 4 hours with the pfizer vaccine hotline, she had documented on her phone as she was filling this report. 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 the patient noticed arm itchy, earlier that night and she ignored, showered that evening, noticed a large, red circle that looked like a ringworm circle, the circle was around the injection site, the circle was about 4-6 inches in diameter, looked up as "covid arm", found comfort and she went to bed. On 18Apr2021 she still had a light red circle and the entire diameter was red (rather then just ring), on that day also slight discomfort and itch was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Still have a light red circle, now the entire diameter is red (rather then just ring); Still slight discomfort; discomfort and itch.; noticed arm itchy, earlier in night; large, red circle that looked like a ringworm circle; circle was around the injection site. The circle was about 4-6 inches in diameter; "covid arm"; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder(ADHD) and chronic unspecified migraines. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone (TULANA), methylphenidate (MANUFACTURER UNKNOWN) and topiramate (MANUFACTURER UNKNOWN); all taken 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. On 17Apr2021, the patient noticed arm itchy, earlier that night and she ignored, showered that evening, noticed a large, red circle that looked like a ringworm circle, the circle was around the injection site, the circle was about 4-6 inches in diameter, looked up as "covid arm", found comfort and she went to bed. On 18Apr2021 she still had a light red circle and the entire diameter was red (rather then just ring). On that day also slight discomfort and itch. She reported that she was on hold for 4 hours with the pfizer vaccine hotline, she had documented on her phone as she was filling this report. 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 the patient noticed arm itchy, earlier that night and she ignored, showered that evening, noticed a large, red circle that looked like a ringworm circle, the circle was around the injection site, the circle was about 4-6 inches in diameter, looked up as "covid arm", found comfort and she went to bed. On 18Apr2021 she still had a light red circle and the entire diameter was red (rather then just ring), on that day also slight discomfort and itch was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pruritus, SARS-CoV-2 test
Clinical narrative: Within 30 minutes of vaccination itchiness of the scalp and neck; Within 24 hours of vaccination metallic taste in mouth that resolved 4 days after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was allergic to latex and peanuts. 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.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and prenatal vitamins (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received doxycycline (MANUFACTURER UNKNOWN), hydrocodone (MANUFACTURER UNKNOWN) and vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy with all these medications. On an unknown date in Apr2021, within 30 minutes of vaccination, the patient experienced itchiness of the scalp and neck and within 24 hours of vaccination, the patient experienced metallic taste in mouth that resolved 4 days after the vaccination. 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 been tested for COVID-19. On 18Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was unknown. The clinical outcome of the events itchiness of the scalp and neck and metallic taste in mouth were resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: lost the sense of smell and taste; lost the sense of smell and taste; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 09:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose 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. On 17Mar2021, the patient experienced lost the sense of smell and taste, since second shot of vaccination. 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 events. Since the vaccination, the patient had been tested for COVID-19; on 31Mar2021, the patient underwent Nasal Swab test (SARS- Cov2-test) and the result was negative. The clinical outcome of the events sense of smell and taste 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: VERY MILD rash of petechia blood spots on inner calves and arms 48 hr after shot. (Rash looks like tiny freckles or razor burn, maybe 3 doz small spots the size of a pin head to pen mark); This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder, HLA-B27 tested, ocular iritis, not in flare, not on steroids this year, history of borderline iron deficiency anemia and low Vitamin D. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included plantago ovata (PSYLLIUM), multivitamin (MANUFACTURER UNKNOWN) and vitamin d nos (VIT D); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received lidocaine hydrochloride (LIDOCAINE) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 16:00, 48 hours after shot, the patient experienced very mild rash of petechia blood spots on inner calves and arms. Rash looked like tiny freckles or razor burn, maybe 3 dots, small spots the size of a pin head to pen mark. The patient's pulse/breathing/temperature seemed okay. The patient had put in call to consult regular doctor and would go to ER if needed. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very mild rash of petechia blood spots on inner calves and arms 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: Arthralgia, Chills, Headache, Migraine, Pain
Clinical narrative: joint pain; Severe body ache/pain; itchiness; chills; migraine; fever; headache; This is a spontaneous report from a contactable consumer(patient). A 22-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on 17Apr2021 14:00 (Age at Vaccination 22-years-old) as DOSE 2, SINGLE for COVID-19 immunization at Pharmacy or Drug Store. Medical history included epilepsy from an unknown date and unknown if ongoing, allergies Cats. Concomitant medication was not provided. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ep6955) via an unspecified route of administration, administered in Arm Left on 27Mar2021 14:00 (Age at Vaccination 22-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, has the patient did not test for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination. On 18Apr2021 17:00 the patient experienced joint pain, severe body ache/pain, itchiness, chills, migraine and fever. Patient experienced headache on 18Apr2021. Patient did not received treatment for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: joint pain; Severe body ache/pain; itchiness; chills; migraine; fever; headache; This is a spontaneous report from a contactable consumer(patient). A 22-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151) via an unspecified route of administration, administered in Arm Left on 17Apr2021 14:00 (Age at Vaccination 22-years-old) as DOSE 2, SINGLE for COVID-19 immunization at Pharmacy or Drug Store. Medical history included epilepsy from an unknown date and unknown if ongoing, allergies Cats. Concomitant medication was not provided. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ep6955) via an unspecified route of administration, administered in Arm Left on 27Mar2021 14:00 (Age at Vaccination 22-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, has the patient did not test for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination. On 18Apr2021 17:00 the patient experienced joint pain, severe body ache/pain, itchiness, chills, migraine and fever. Patient experienced headache on 18Apr2021. Patient did not received treatment for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm right on 11Apr2021 at 12:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm right on 14Mar2021 at 12:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the day after second vaccination, the patient experienced diarrhea. The patient was currently on her third day of diarrhea. 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 diarrhea was not recovered at the time of the 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: Rash pruritic
Clinical narrative: Dry itchy rash under both arms; 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: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 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: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, the patient experienced dry itchy rash under both arms, left arm was worse than right and similar to razor burn. The event 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 taken as a result of the event and included treatment with hydrocortisone (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dry itchy rash under both arms, similar to razor burn was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Pain
Clinical narrative: Cold sweats; Severe body ache; Headache; Started feeling extremely tired; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW051) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 17:00, the patient started feeling extremely tired. On the same day at 23:00, the patient experienced cold sweats, severe body ache and headache. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started feeling extremely tired, cold sweats, severe body ache and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia
Clinical narrative: Severe fatigue; Myalgia; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 17:15 (at the age of 38-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO), both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received nystatin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 13Apr2021 at 05:00, the patient experienced severe fatigue, myalgia and diarrhea. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or 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 events severe fatigue, myalgia and diarrhea were 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.