chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: Severe headache; Blurred vision; Elevated blood pressure; Nausea; Injection site severe swelling; Fever; Body aches; Tiredness; Underarm/breast lymph nodes swelling; Nose bleed only from left nostril; This is a spontaneous report from a contactable healthcare professional, 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 intramuscular route of administration in the left arm on 13Sep2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Sep2021 at 15:00 (reported as Day 01), the patient experienced injection site severe swelling, fever 100.5 (unspecified units), body aches, severe headache, blurred vision, elevated blood pressure, nausea, and tiredness. On an unknown date in Sep2021 (reported as Day 02-04), the patient experienced underarm/breast lymph nodes swelling, severe headache, nausea and tiredness. On an unknown date in Sep2021 the patient experienced nose bleed only from left nostril and continued severe headaches from 15Sep2021 (reported as Day 03) to present (at the time of this report). Therapeutic measures were taken as a result of the events nausea, headache, lymph node swelling and nose bleed. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site severe swelling, fever 100.5, body aches, blurred vision, elevated blood pressure, nausea, tiredness, underarm/breast lymph nodes swelling and nose bleed only from left nostril was recovering while the outcome of severe headaches was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Severe headache; Blurred vision; Elevated blood pressure; Nausea; Injection site severe swelling; Fever; Body aches; Tiredness; Underarm/breast lymph nodes swelling; Nose bleed only from left nostril; This is a spontaneous report from a contactable healthcare professional, 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 intramuscular route of administration in the left arm on 13Sep2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Sep2021 at 15:00 (reported as Day 01), the patient experienced injection site severe swelling, fever 100.5 (unspecified units), body aches, severe headache, blurred vision, elevated blood pressure, nausea, and tiredness. On an unknown date in Sep2021 (reported as Day 02-04), the patient experienced underarm/breast lymph nodes swelling, severe headache, nausea and tiredness. On an unknown date in Sep2021 the patient experienced nose bleed only from left nostril and continued severe headaches from 15Sep2021 (reported as Day 03) to present (at the time of this report). Therapeutic measures were taken as a result of the events nausea, headache, lymph node swelling and nose bleed. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site severe swelling, fever 100.5, body aches, blurred vision, elevated blood pressure, nausea, tiredness, underarm/breast lymph nodes swelling and nose bleed only from left nostril was recovering while the outcome of severe headaches was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FC3180), at the age of 61, via an unspecified route of administration, left arm, on Aug 27, 2021, at 14:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient has no known allergies. 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. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FA6780), at the age of 61, via an unspecified route of administration, left arm, on Jul 31, 2021, at 19:30, single dose, for COVID-19 immunisation. On an unknown date in 2021, patient experienced 3 weeks of diarrhea. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures taken as a result of event included self-treatment with Imodium (loperamide hydrochloride). Since the vaccination, patient has not been tested for COVID-19. The outcome of the event 3 weeks of diarrhea was unknown at the time of the report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chest pain, Cold sweat, Dizziness
Clinical narrative: Chest pain; Increased heart rate; Blurred/dark vision; Light headedness; Weakness; Increased temperature; Cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Sep2021 at 14:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable and the patient's had allergies to oranges, dust, birch, elm, mulberry, ragweed, oak, cats, dogs. 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 fexofenadine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown start date and unknown if ongoing. On 08Sep2021 at 21:30, the patient experienced chest pain, increased heart rate, blurred/dark vision, light headedness, weakness, increased temperature followed by cold sweats. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain, increased heart rate, blurred/dark vision, light headedness, weakness, increased temperature and cold sweats was unknown at the time of reporting.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Vision blurred
Clinical narrative: Chest pain; Increased heart rate; Blurred/dark vision; Light headedness; Weakness; Increased temperature; Cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Sep2021 at 14:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable and the patient's had allergies to oranges, dust, birch, elm, mulberry, ragweed, oak, cats, dogs. 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 fexofenadine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown start date and unknown if ongoing. On 08Sep2021 at 21:30, the patient experienced chest pain, increased heart rate, blurred/dark vision, light headedness, weakness, increased temperature followed by cold sweats. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain, increased heart rate, blurred/dark vision, light headedness, weakness, increased temperature and cold sweats was unknown at the time of reporting.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Headache, Off label use, Pyrexia
Clinical narrative: Patient was administered third dose on 19Sep2021; Patient was administered third dose on 19Sep2021; Vomiting; Fever; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448), via an unspecified route of administration in the left arm on 19Sep2021 at 11:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Medical history included advanced chronic obstructive pulmonary disease (COPD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date; both as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, the patient experienced vomiting, fever, chills and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting, fever, chills and headache was resolving at the time of this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient was administered third dose on 19Sep2021; Patient was administered third dose on 19Sep2021; Vomiting; Fever; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448), via an unspecified route of administration in the left arm on 19Sep2021 at 11:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Medical history included advanced chronic obstructive pulmonary disease (COPD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date; both as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, the patient experienced vomiting, fever, chills and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting, fever, chills and headache was resolving at the time of this report.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pneumonia
Clinical narrative: Pneumonia; Atrial fibrillation; This is a spontaneous report from a contactable consumer.  An 84-year-old patient of an unspecified gender received the 2nd dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm on 26Jan2021 11:00 (Batch/Lot Number: FC3182) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing Crohn's disease, Parkinson's disease from 2021 and ongoing, ongoing diabetes mellitus. Concomitant medications included l-dopa (L-DOPA) taken for Parkinson's disease from 2021 and ongoing; metformin (METFORMIN) taken for diabetes mellitus from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from an unspecified start date and ongoing; oxybutynin (OXYBUTYNIN) taken for an unspecified indication from an unspecified start date and ongoing; carbidopa, levodopa (RYTARY, strength 48.75/195) taken for an unspecified indication from an unspecified start date and ongoing; vedolizumab (ENTYVIO) taken for Crohn's disease from an unspecified start date and ongoing. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (Batch/Lot number: EL3246) on 05Jan2021 at 84 years for COVID-19 immunisation. The patient experienced pneumonia (caused hospitalization, medically significant) on 20Jul2021 with outcome of recovering, atrial fibrillation (caused hospitalization, medically significant) on 20Jul2021 with outcome of recovering. The events required emergency room visit. The patient was hospitalized for 4 days. Therapeutic measures were taken as a result of the events.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Significant pain from should you shoulder abs inability to move neck. Very sore on both sides of top of spine; This is a spontaneous report from a contactable consumer. This 46-year-old female consumer (patient).  A 46-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200, Expiration date: unknown), via unspecified route, administered on 17Feb2021 (at the age of 46-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Systemic lupus erythematosus, Asthma and Hypothyroidism and concomitant medications includes Levothyroxine, Plaquenil [HYDROXYCHLOROQUINE SULFATE], Fluoxetine, Dupilumab (DUPIXENT, Traz [OMEPRAZOLE]. On 18Feb2021, after the vaccination, the patient experienced Significant pain from should you shoulder abs inability to move neck. Very sore on both sides of top of spine. No other vaccine in four weeks, patient was not diagnosed with covid prior vaccination and patient was not tested with covid post vaccination. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Illness
Clinical narrative: hair is falling out; sick; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 78-year-old female patient received bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 08:30 as Dose 2, single (at the age of 78-year-old) for covid-19 immunisation. Patient height (170 cm) and weight (210 pounds) reported. Medical history included cardiac disorder, three years ago from an unknown date and unknown if ongoing. Patient had a heart surgery and valve replacement. Concomitant medication(s) included rosuvastatin calcium, (ROSUVASTATIN CALCIUM, 40 mg, half a tablet a day), metoprolol succinate (METOPROLOL SUCCINATE, 50 mg, twice a day), lisinopril (LISINOPRIL, 5 mg, one tablet every day), acetylsalicylic acid (ASPIRINE, Low dose tablet everyday) all taken for an un-specified indication and spironolactone (SPIRONOLACTONE, 25 mg, one half tablet Mon-day, Wednesday and Friday.) taken for heart trouble, start and stop date were not reported. On 21Feb2021 the patient got sick for two days and her hair is falling out. Patient was okay on Saturday, but Sunday and Monday she was sick. Patient stated she got the shot at 8:30 in the morning in Hospital. Patient had undergone all kind of tests when she had a heart surgery but not recently. Patient was fine now. It took her two days to get rid of it. Patient did not receive any treatment for event. The outcome of the events was recovered on 23Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia, SARS-CoV-2 test negative
Clinical narrative: Severe lymphadenopathy (golf ball size near left clavicle); fatigue; muscle aches; This is a spontaneous report from a contactable consumer. A 59-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN9581), dose 2 via an unspecified route of administration, administered in Arm Right on 10Feb2021 15:15 as DOSE 2, SINGLE, and bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 15:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism and food allergy (allergies Cantaloupe) from an unknown date. Patient previously took bnt162b2 for covid-19 immunisation. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication. The patient experienced severe lymphadenopathy (golf ball size near left clavicle), fatigue, muscle aches on 12Feb2021 06:00. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 16Feb2021. Outcome of the events was not recovered.  No follow-up attempts are needed; no further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Pain of skin, Rash, Sensitive skin
Clinical narrative: Slightly darker in color/ Large dark hyperpigmented patch; Mild burning and stinging; Not able to wear clothing covering that area of skin as it was too sensitive; Mild burning and stinging/ intense burning and stinging; Large red mark 1-2 inches from injection side; Large red mark; Rash appeared overnight; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 15:45 (at the age of 39-year-old) (Lot Number: EJ1685) as dose 1, single for COVID-19 immunization. Medical history included skin sensitivities to detergents. The patient was not pregnant at the time of vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), levonorgestrel (LEVONORGESTREL) both taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04Mar2021 06:30, the patient experienced large dark hyperpigmented patch/rash appeared overnight, large red mark 1-2 inches from injection side, does not burn or itch, and reported that when arm was iced, the mark (skin in that area) felt more rough. The patient reported that it looked similar to COVID arm pictures found on google. On 05Mar2021 07:00, reaction are almost completely disappeared. On 06Mar2021 11:00 (day 3, post vaccine), reaction are reappeared with shape slightly changed. The patient had intense burning and stinging, for which she applied ointment which provided relief. She was not able to wear clothing covering that area of skin as it was too sensitive. On 07Mar2021, 09:45, reaction area and shape was about the same as the day before, and was slightly darker in color. (Morning & Daytime) Mild burning and stinging, applied ointment which provided relief, was able to wear a shirt over the area. (Evening) Burning and stinging amplified around 20:00, ointment did not provide relief, took 800 mg of ibuprofen to dull the pain, not able to wear clothing over the area. The outcome of the events was not recovered. The event large dark hyperpigmented patch/rash appeared overnight, large red mark 1-2 inches from injection side, does not burn or itch was assessed as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Vaccination site erythema
Clinical narrative: Slightly darker in color/ Large dark hyperpigmented patch; Mild burning and stinging; Not able to wear clothing covering that area of skin as it was too sensitive; Mild burning and stinging/ intense burning and stinging; Large red mark 1-2 inches from injection side; Large red mark; Rash appeared overnight; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 15:45 (at the age of 39-year-old) (Lot Number: EJ1685) as dose 1, single for COVID-19 immunization. Medical history included skin sensitivities to detergents. The patient was not pregnant at the time of vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), levonorgestrel (LEVONORGESTREL) both taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04Mar2021 06:30, the patient experienced large dark hyperpigmented patch/rash appeared overnight, large red mark 1-2 inches from injection side, does not burn or itch, and reported that when arm was iced, the mark (skin in that area) felt more rough. The patient reported that it looked similar to COVID arm pictures found on google. On 05Mar2021 07:00, reaction are almost completely disappeared. On 06Mar2021 11:00 (day 3, post vaccine), reaction are reappeared with shape slightly changed. The patient had intense burning and stinging, for which she applied ointment which provided relief. She was not able to wear clothing covering that area of skin as it was too sensitive. On 07Mar2021, 09:45, reaction area and shape was about the same as the day before, and was slightly darker in color. (Morning & Daytime) Mild burning and stinging, applied ointment which provided relief, was able to wear a shirt over the area. (Evening) Burning and stinging amplified around 20:00, ointment did not provide relief, took 800 mg of ibuprofen to dull the pain, not able to wear clothing over the area. The outcome of the events was not recovered. The event large dark hyperpigmented patch/rash appeared overnight, large red mark 1-2 inches from injection side, does not burn or itch was assessed as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Slightly darker in color/ Large dark hyperpigmented patch; Mild burning and stinging; Not able to wear clothing covering that area of skin as it was too sensitive; Mild burning and stinging/ intense burning and stinging; Large red mark 1-2 inches from injection side; Large red mark; Rash appeared overnight; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 15:45 (at the age of 39-year-old) (Lot Number: EJ1685) as dose 1, single for COVID-19 immunization. Medical history included skin sensitivities to detergents. The patient was not pregnant at the time of vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), levonorgestrel (LEVONORGESTREL) both taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04Mar2021 06:30, the patient experienced large dark hyperpigmented patch/rash appeared overnight, large red mark 1-2 inches from injection side, does not burn or itch, and reported that when arm was iced, the mark (skin in that area) felt more rough. The patient reported that it looked similar to COVID arm pictures found on google. On 05Mar2021 07:00, reaction are almost completely disappeared. On 06Mar2021 11:00 (day 3, post vaccine), reaction are reappeared with shape slightly changed. The patient had intense burning and stinging, for which she applied ointment which provided relief. She was not able to wear clothing covering that area of skin as it was too sensitive. On 07Mar2021, 09:45, reaction area and shape was about the same as the day before, and was slightly darker in color. (Morning & Daytime) Mild burning and stinging, applied ointment which provided relief, was able to wear a shirt over the area. (Evening) Burning and stinging amplified around 20:00, ointment did not provide relief, took 800 mg of ibuprofen to dull the pain, not able to wear clothing over the area. The outcome of the events was not recovered. The event large dark hyperpigmented patch/rash appeared overnight, large red mark 1-2 inches from injection side, does not burn or itch was assessed as non-serious.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Limb discomfort, Malaise
Clinical narrative: tiredness; muscle pain; nausea; not feeling well; Joint pain; slight headache; Slight pain in the injection site; On first day after, the patient had discomfort in arm; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-Sponsored program. A female patient of an unspecified age (Age: 94, no unit as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 28Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021, the next day after vaccination, the patient experienced slight pain in the injection site and had discomfort in arm and she took two paracetamol (TYLENOL) for it. On the second day, on 02Mar2021, the patient then experienced slight headache. Then on 03Mar2021, the patient experienced tiredness, muscle pain, nausea, was not feeling well and there was slight joint pain. The patient have had no fever and that's mostly what she had been experiencing. On 06Mar2021, the patient just stayed in bed almost the whole day and was just getting up to do some things. The patient further stated that when she was not moving around she does not have nausea or headache. The patient was wondering if it is normal to still experience the symptoms up until the time of report. The patient was concerned that these symptoms were lasting too long and wanted to know what to expect from the second dose. The patient also asked if she will develop more intense symptoms after receiving the second dose. Treatment was given in response to slight pain in the injection site and discomfort in arm which included paracetamol (TYLENOL). The patient recovered from pain in the injection site and discomfort in arm both on an unspecified date and the outcome for the rest of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: tiredness; muscle pain; nausea; not feeling well; Joint pain; slight headache; Slight pain in the injection site; On first day after, the patient had discomfort in arm; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-Sponsored program. A female patient of an unspecified age (Age: 94, no unit as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 28Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021, the next day after vaccination, the patient experienced slight pain in the injection site and had discomfort in arm and she took two paracetamol (TYLENOL) for it. On the second day, on 02Mar2021, the patient then experienced slight headache. Then on 03Mar2021, the patient experienced tiredness, muscle pain, nausea, was not feeling well and there was slight joint pain. The patient have had no fever and that's mostly what she had been experiencing. On 06Mar2021, the patient just stayed in bed almost the whole day and was just getting up to do some things. The patient further stated that when she was not moving around she does not have nausea or headache. The patient was wondering if it is normal to still experience the symptoms up until the time of report. The patient was concerned that these symptoms were lasting too long and wanted to know what to expect from the second dose. The patient also asked if she will develop more intense symptoms after receiving the second dose. Treatment was given in response to slight pain in the injection site and discomfort in arm which included paracetamol (TYLENOL). The patient recovered from pain in the injection site and discomfort in arm both on an unspecified date and the outcome for the rest of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Woke up on 07Mar with bottom swollen lip. 08Mar woke up with bottom and top lip swollen; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6203 and expiration date: not reported), via an unspecified route of administration, administered in Arm Left, on 06Mar2021 09:00 (at the age of 72-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included arthritis and NSAIDs allergy. Concomitant medication included ezetimibe 10mg. The patient previously took ibuprofen and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9266 and expiration date: not reported), via an unspecified route of administration, administered in Arm Left, on 13Feb2021 09:00 (at the age of 72-year-old), as dose 1, single, for COVID-19 immunisation. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination and was not tested COVID post vaccination. On 07Mar2021, the patient woke up with bottom swollen lip. On 08Mar2021, the patient woke up with bottom and top lip swollen. Patient was treated with antihistamines due to the event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Diarrhoea, Dysgeusia, Erythema, Flushing
Clinical narrative: Face became red and flushed; Face became red and flushed; Bad taste in my mouth; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 05Mar2021 10:00 (Lot number was not reported) (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. Medical history included chronic atrial fibrillation, diabetes, contrast media allergy (CT scan dye) and penicillin allergy. Concomitant medications received within two weeks of vaccination included nuclear stress test medicine taken a day before vaccination. No other vaccine was received within four weeks of vaccination. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination. On 05Mar2021 10:00, immediately after vaccine injection the patient had a bad taste in her mouth, this lasted for about 4 hours. On 05Mar2021 11:30, about 1 and 1/2 hours later after vaccine injection, her face became red and flushed, lasting about 4 hours. Later that evening she had diarrhea. The patient did not receive treatment for the events. The outcome of events dysgeusia was recovered on 05Mar2021 14:00; outcome of red face and flushed face was recovered on 05Mar2021 15:30; outcome of diarrhea was recovered in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain in extremity
Clinical narrative: Headache; Pain in my left arm; Fever (100°F); Chills/shivering; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Mar2021 21:45 (at the age of 65-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 on 02Apr2020 (prior to COVID vaccination), celiac disease and, glaucoma. Concomitant medications included brimonidine tartrate (BRIMONIDINE TARTRATE); estradiol (ESTROGEN), both taken for an unspecified indication, start and stop date were not reported. The patient previously took cetirizine (antihistamine) and experienced allergies. The patient did not receive any other vaccine within 4 weeks. The patient experienced had pain in left arm, fever (100°F), chills, shivering, joint pain, and headache on the same night of vaccination. The patient received paracetamol 500 mg for the events. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Pain in my left arm; Fever (100°F); Chills/shivering; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Mar2021 21:45 (at the age of 65-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 on 02Apr2020 (prior to COVID vaccination), celiac disease and, glaucoma. Concomitant medications included brimonidine tartrate (BRIMONIDINE TARTRATE); estradiol (ESTROGEN), both taken for an unspecified indication, start and stop date were not reported. The patient previously took cetirizine (antihistamine) and experienced allergies. The patient did not receive any other vaccine within 4 weeks. The patient experienced had pain in left arm, fever (100°F), chills, shivering, joint pain, and headache on the same night of vaccination. The patient received paracetamol 500 mg for the events. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Swelling of eyelid
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# and expiration date not reported), at the age of 51, via an unspecified route of administration, right arm, on Mar 7, 2021, at 02:15, single dose, for COVID-19 immunization. Medical history included allergy to gluten, wheat and yeast. There were no concomitant medications. Prior to vaccination, patient was not diagnosed with COVID-19; and did not receive any vaccines within four weeks. Patient was not pregnant. The patient experienced pain in right eye and eyelid became swollen on Mar 7, 2021, 15:00. The events resulted in doctor or other healthcare professional office/clinic visit. It was reported that eyelid became swollen, continued pain in right eye. Eyelid swollen 15 hours following vaccine and pain still in eye. Patient will call ophthalmologist in the morning. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the event. The outcome of events not resolved. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lip swelling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 06Mar2021 at the age of 72-year-old as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient receive vaccine shot on saturday at about 9 or 11 in the morning. On 08Mar2021 this morning, her lip is swollen, and she has never had swelling of the lip before. Patient wanted to know if this is a known side effect of the product, and she is trying to decide if she needs to go to the ER. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pruritus, Urticaria
Clinical narrative: Late afternoon my face, scalp, neck and hands began to itch; Late afternoon my face, scalp, neck and hands began to itch, get red; Late afternoon my face, scalp, neck and hands began to itch, get red - hives; headache; This is a spontaneous report from a contactable consumer (patient). A 71-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 05Mar2021 11:45 (Lot Number: EN6203) (at the age of 71-years-old) as dose 1, single for covid-19 immunisation. Medical history included thyroid, hypertension, heart palpitations, shellfish allergy, sulpha allergy, bee allergy. The patient previously took naproxen sodium and experienced allergy. The patient received other concomitant medications within two weeks of vaccination. No other vaccine was received within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination and was not tested for Covid since the vaccination. On 05Mar2021 14:00, late afternoon patient's face, scalp, neck and hands began to itch, got red, hives and headache. She had a busy afternoon and ignored it until about 5pm. It got worse through 07Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Tiredness; Increased soreness & red around injection site; Increased soreness & red around injection site; Fever 99.8/fever 101.4; Severe chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Mar2021 11:00 (at the age of 76-year-old) (Lot Number: EUA) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included heart disease, COVID-19 (prior to vaccination) and allergy to penicillin, TACE, a pain medicine and, Demerol. Concomitant medication(s) included levothyroxine; lisinopril; sotalol; atorvastatin, all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccine in four weeks. On 05Mar2021 11:00, the patient had vaccine, chills, headache, Next day headache, tiredness, evening fever 99.8. Next day slight headache, tiredness, that evening severe chills, fever 101.4. Next day increased soreness & red around injection site, slight headache so far. It was unknown if treatment was given for the events. The outcome of events was recovering. Since vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Tiredness; Increased soreness & red around injection site; Increased soreness & red around injection site; Fever 99.8/fever 101.4; Severe chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Mar2021 11:00 (at the age of 76-year-old) (Lot Number: EUA) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included heart disease, COVID-19 (prior to vaccination) and allergy to penicillin, TACE, a pain medicine and, Demerol. Concomitant medication(s) included levothyroxine; lisinopril; sotalol; atorvastatin, all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccine in four weeks. On 05Mar2021 11:00, the patient had vaccine, chills, headache, Next day headache, tiredness, evening fever 99.8. Next day slight headache, tiredness, that evening severe chills, fever 101.4. Next day increased soreness & red around injection site, slight headache so far. It was unknown if treatment was given for the events. The outcome of events was recovering. Since vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Insomnia, Myalgia
Clinical narrative: muscle pain in his shoulder, upper quarter or his chest and back sometimes quite large area; muscle pain in his shoulder, upper quarter or his chest and back sometimes quite large area; muscle pain in his shoulder, upper quarter or his chest and back sometimes quite large area; not able to sleep on his left side; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9266), via an unspecified route of administration in left arm on 25Feb2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing pacemaker use. The patient's concomitant medications were not reported. The patient experienced muscle pain in his shoulder, upper quarter or his chest and back sometimes quite large area and not able to sleep on his left side on 26Feb2021. It was reported that first day patient had no problem, second day in the evening developed a muscle pain in shoulder, on chest and back sometimes quite large area, and can't sleep on his left side. It continued right up until those days although it had been subsiding for the past 6 days but still present. Patient asked should he get the next vaccine and if yes then should he get it in his right arm instead of left and can expect same results. Outcome of events was resolving.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Hypoglycaemia
Clinical narrative: Differential Diagnosis: hypoglycemic event; chest tightness; lightheadedness; This is a spontaneous report from a non-contactable other health care professional (patient).   A 77-year-old non pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration on an unspecified date at the age of 77-year-old as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. After the injection, 15 minute later, the patient began to experience chest tightness and lightheadedness. She denied rash, glossal tightness or increased work of breathing This provider was notified of patient reaction and was then assessed in the emergency bay area. Treatment provided in response to the event was oxygen, blood glucose and Vital Sign monitoring, snack. In response to the treatment, complete resolution of symptoms Patient discharge with stable to go home and follow up with primary care physician. Patient's differential diagnosis was hypoglycemic event. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Myalgia, Pain in extremity, Swelling
Clinical narrative: 2 lumps in the right shoulder at clavicle-high that shows swallowing, pain and movement at touch; 2 lumps in the right shoulder at clavicle-high that shows swallowing, pain and movement at touch; pain/she has a severe pain all over the right leg from gluteus to leg.; pain/she has a severe pain all over the right leg from gluteus to leg.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6226), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has 2 lumps in the right shoulder at clavicle-high that shows swallowing, pain and movement at touch. Consumer stated she has a severe pain all over the right leg from gluteus to leg. she wants to know if she can be treated with pain medication such as Ibuprofen. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.