chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain, Vaccination site nodule, Vaccination site pain
Clinical narrative: Headaches began day after and continue to today- 5 days later; Next morning grapefruit size hot tender knot at injection site; Next morning grapefruit size hot tender knot at injection site; Next morning grapefruit size hot tender knot at injection site; Immediate swelling at site; Severe fatigue for 3 days after, moderate today; Muscle, body and neck aches continuing; Muscle, body and neck aches continuing; Muscle, body and neck aches continuing; GI upset with diarrhea x 3 days; GI upset with diarrhea x 3 days; Lymph node swelling underarm on side of injection; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 03Sep2021 at 12:30 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 03Sep2021 at 17:30, the patient experienced immediate swelling at site. On 04Sep2021, the next morning, patient experienced grapefruit size hot tender knot at injection site. On 05Sep201, the patient had headaches which began day after and continued to current day, 5 days later. The patient had severe fatigue for 3 days after, moderate the current day and muscle, body and neck aches which were continuing. The patient also had gastrointestinal upset (GI upset) with diarrhea for three days and lymph node swelling in underarm on side of injection. 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 immediate swelling at site, next morning grapefruit size hot tender knot at injection site, headaches began day after and continue to today- 5 days later, severe fatigue for 3 days after, moderate today, muscle, body and neck aches continuing, lymph node swelling underarm on side of injection was not recovered at the time of this report and of GI upset with diarrhea x 3 days was recovered on an unknown date of Sep2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Headaches began day after and continue to today- 5 days later; Next morning grapefruit size hot tender knot at injection site; Next morning grapefruit size hot tender knot at injection site; Next morning grapefruit size hot tender knot at injection site; Immediate swelling at site; Severe fatigue for 3 days after, moderate today; Muscle, body and neck aches continuing; Muscle, body and neck aches continuing; Muscle, body and neck aches continuing; GI upset with diarrhea x 3 days; GI upset with diarrhea x 3 days; Lymph node swelling underarm on side of injection; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 03Sep2021 at 12:30 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 03Sep2021 at 17:30, the patient experienced immediate swelling at site. On 04Sep2021, the next morning, patient experienced grapefruit size hot tender knot at injection site. On 05Sep201, the patient had headaches which began day after and continued to current day, 5 days later. The patient had severe fatigue for 3 days after, moderate the current day and muscle, body and neck aches which were continuing. The patient also had gastrointestinal upset (GI upset) with diarrhea for three days and lymph node swelling in underarm on side of injection. 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 immediate swelling at site, next morning grapefruit size hot tender knot at injection site, headaches began day after and continue to today- 5 days later, severe fatigue for 3 days after, moderate today, muscle, body and neck aches continuing, lymph node swelling underarm on side of injection was not recovered at the time of this report and of GI upset with diarrhea x 3 days was recovered on an unknown date of Sep2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Hair texture abnormal, SARS-CoV-2 test, Trichorrhexis
Clinical narrative: Hair is breaking; It is dry; Hair has become brittle and is falling out.; Patient is losing her hair like crazy; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD179) via an unspecified route of administration in the left arm on 01Jun2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO196) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and hypothyroid. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included etanercept (ENBREL), ibuprofen (MOTRIN) and levothyroxine (MANUFACTURER UNKNOWN); all for an unknown indications from unknown dates and unknown if ongoing. On 30Jun2021, since receiving the vaccine, the patient's hair was breaking, was dry and had become brittle and was falling out. The patient was not stressed and had no anxiety. It was also reported this had never happened and was not ending and the patient was losing her hair like crazy. 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 reported events. On 02Jul2021, the patient underwent lab test and procedure which included antigen COVID-19 test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events her hair was breaking, it was dry, had become brittle and was falling out and losing her hair like crazy were not recovered at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Oropharyngeal pain, Palpitations, Pyrexia
Clinical narrative: Heart race; Fever; Chills; Shaking; Throat sore; Trouble breathing; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 07Sep2021 at 13:00 (at the age of 41-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. The patient did not receive any concomitant medications. On 08Sep2021 at 03:00, the patient experienced heart race, fever, chills, shaking, throat sore and trouble breathing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart race, fever, chills, shaking, throat sore and trouble breathing were unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Heart race; Fever; Chills; Shaking; Throat sore; Trouble breathing; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 07Sep2021 at 13:00 (at the age of 41-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. The patient did not receive any concomitant medications. On 08Sep2021 at 03:00, the patient experienced heart race, fever, chills, shaking, throat sore and trouble breathing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart race, fever, chills, shaking, throat sore and trouble breathing were unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Hyperhidrosis
Clinical narrative: Nausea; Loss of appetite; Lethargic; Weak; Severe chills; Muscle aches; Sweats; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 20Aug2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney and pancreas transplant on 10Jan2007, allergy to lactose and COVID-19. Prior to the vaccination the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications in two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 21Aug2021 at 16:00, the evening after the injection, the patient experienced severe chills, muscle aches, sweats, vomiting, and diarrhea. On 08Sep2021, the day of the report, the patient experienced muscle ache, nausea, loss of appetite, weak and lethargic. The events did not result in a doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, muscle aches, sweats, vomiting, diarrhea, nausea, loss of appetite, weak and lethargic was resolved with sequelae on an unknown date in 2021.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea; Loss of appetite; Lethargic; Weak; Severe chills; Muscle aches; Sweats; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 20Aug2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney and pancreas transplant on 10Jan2007, allergy to lactose and COVID-19. Prior to the vaccination the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications in two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 21Aug2021 at 16:00, the evening after the injection, the patient experienced severe chills, muscle aches, sweats, vomiting, and diarrhea. On 08Sep2021, the day of the report, the patient experienced muscle ache, nausea, loss of appetite, weak and lethargic. The events did not result in a doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, muscle aches, sweats, vomiting, diarrhea, nausea, loss of appetite, weak and lethargic was resolved with sequelae on an unknown date in 2021.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Runny nose, tired, sore arm after 12 hours; Runny nose, tired, sore arm after 12 hours; Runny nose, tired, sore arm after 12 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Sep2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Sep2021 after 12 hours, the patient experienced runny nose, was tired and had sore arm. It was also reported that this may be common to all vaccines though. 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 been tested for COVID-19. On an unknown date in Sep2021, the patient underwent COVID-19 virus test and the result was unknown. The clinical outcome of the events runny nose, tired, sore arm after 12 hours was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Hypoaesthesia, Muscle spasms, Muscle twitching
Clinical narrative: chills; icy hot feeling all over body; muscle spasms; twitching; numb/tingly sensations; numb/tingly sensations; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Aug2021 at 19:00 (at the age of 25-year-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. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Aug2021 at 00:00, the patient experienced chills, icy hot feeling all over body, muscle spasms, twitching and numb/tingly sensations. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with dexamethasone and antibiotics. On 03Sep2021, the patient underwent PCR (Nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, icy hot feeling all over body, muscle spasms, twitching and numb/tingly sensations 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: chills; icy hot feeling all over body; muscle spasms; twitching; numb/tingly sensations; numb/tingly sensations; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Aug2021 at 19:00 (at the age of 25-year-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. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Aug2021 at 00:00, the patient experienced chills, icy hot feeling all over body, muscle spasms, twitching and numb/tingly sensations. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with dexamethasone and antibiotics. On 03Sep2021, the patient underwent PCR (Nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, icy hot feeling all over body, muscle spasms, twitching and numb/tingly sensations 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: right sided bells palsy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 13Aug2021 (at the age of 60-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypertension and type 2 diabetes mellitus. No known allergies. Concomitant medications included semaglutide (RYBELSUS) and blood pressure medications (unspecified). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19Jul2021 as dose 1, single for COVID-19 immunization. Patient not had Covid prior vaccination. Patient was not tested Covid post vaccination. On 01Sep2021 at 15:00, the patient experienced right sided bells palsy. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated with prednisone as a result of event. The outcome of the event was not resolved.  Follow-up attempts have been completed and no further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Menstrual cycle started day after vaccine and is still ongoing.; This is a spontaneous report from a contactable healthcare professional. A 17-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 19Aug2021 at 13:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included VSD (ventricular septal defect) heart condition, asthma and allergy to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included medroxyprogesterone acetate (DEPO-PROVERA) in the right arm on 21Jul2021 and salbutamol (ALBUTEROL) inhaler from an unknown date; both for an unknown indication and unknown if ongoing. On 20Aug2021, the patient experienced that her menstrual cycle started day after the vaccine and was still ongoing at the time of report. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle started day after vaccine and was still ongoing was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant tinnitus both ears started approximately 30 minutes after vaccination; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 01Sep2021 at 13:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis, postural orthostatic tachycardia syndrome (POTS), hashimotos, migraines and allergy to iodinized contrast dye. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dimethyl fumarate (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Sep2021 at 14:00, approximately 30 minutes after vaccination, the patient experienced constant tinnitus in both ears and continued to present date/time and will be scheduling appointment with physician. The constant tinnitus 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 constant tinnitus. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant tinnitus in both ears started approximately 30 minutes after vaccination was not recovered at the time of this report.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inflammatory pain, Neck pain, Pain in extremity, Rash papular
Clinical narrative: Painful inflammation; Blister like bumps; Blister like bumps; Sore behind neck head area and in fold of right arm.; Sore behind neck head area and in fold of right arm.; Sore behind neck head area and in fold of right arm.; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3183) via an unspecified route of administration in the left arm on 28Aug2021 at 10:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications taken within two weeks of vaccination were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa6780) via an unspecified route of administration in the left arm on 04Aug2021 at 10:00 (at the age of 12-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 31Aug2021, the patient experienced painful inflammation and blister like bumps and sore behind neck head area and in fold of right arm. Those were the areas where the reporters son had eczema. Therapeutic measures taken included treatment with self medication with prescription products. 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 was tested for COVID-19. On 03Sep2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events painful inflammation, blister like bumps, sore behind neck head area and in fold of right arm were not resolved at the time of this report.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular, SARS-CoV-2 test
Clinical narrative: Painful inflammation; Blister like bumps; Blister like bumps; Sore behind neck head area and in fold of right arm.; Sore behind neck head area and in fold of right arm.; Sore behind neck head area and in fold of right arm.; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3183) via an unspecified route of administration in the left arm on 28Aug2021 at 10:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications taken within two weeks of vaccination were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fa6780) via an unspecified route of administration in the left arm on 04Aug2021 at 10:00 (at the age of 12-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 31Aug2021, the patient experienced painful inflammation and blister like bumps and sore behind neck head area and in fold of right arm. Those were the areas where the reporters son had eczema. Therapeutic measures taken included treatment with self medication with prescription products. 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 was tested for COVID-19. On 03Sep2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events painful inflammation, blister like bumps, sore behind neck head area and in fold of right arm were not resolved at the time of this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: Headaches for a week; Lightheaded, duzzy and foggy brain for multiple weeks.; Lightheaded, duzzy and foggy brain for multiple weeks.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 20Aug2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Aug2021, the patient experienced headaches for a week and felt lightheaded, duzzy and had foggy brain for multiple weeks. The patient was now concerned with taking the second dose. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 virus test via nasal swab and the result was unknown. The clinical outcome of the events headaches for a week and lightheaded, duzzy and foggy brain for multiple weeks was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lip swelling
Clinical narrative: Swollen lips; Memory fog; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 04Apr2021 at 12:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 00:00, the patient experienced swollen lips and memory fog. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lips and memory fog was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregular period; Heavy bleeding; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on 29Apr2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nuts, shellfish, soy and bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) for an unknown indication, since an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8437) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19May2021, the patient experienced irregular period. The patient always had a regular cycle prior to the vaccine and also reported heavy bleeding, sometimes occurring twice a month. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular period and heavy bleeding, sometimes twice a month was not resolved at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural
Clinical narrative: When ever I happen to lay down some what fast I get really dizzy, also has happened when I have moved my head fast as well, I have never had this problem before.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181 10121) via an unspecified route of administration in the left arm on 03Sep2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Concomitant medication received within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Sep2021, whenever the patient happened to lay down some what fast, she got really dizzy. This also happened when she had moved her head fast as well and has never had this problem before. It was unknown whether therapeutic measures were taken as a result of the event. 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 whenever happen to lay down some what fast get really dizzy, also had happened when had moved head fast as well, has never had this problem before was not resolved at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles about week after taking second shot; This is a spontaneous report from a non-contactable consumer, the patient. A 61-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 on an unknown date in Jun2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history stated that the patient was a thyroid cancer survivor- removed. The patient had no known allergies. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, the patient developed shingles about week after taking second shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event developed shingles about week after taking second shot was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hot flush
Clinical narrative: Extreme fatigue; Weakness; Tinnitus; Chills/hot flashes; Chills/hot flashes; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 07Sep2021 at 12:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and valaciclovir (VALACYCLOVIR); both 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: FC3180) via an unspecified route of administration in the right arm on 17Aug2021 at 11:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation and received erythromycin (MANUFACTURER UNKNOWN), cefalexin (KEFLEX) and tetracycline (MANUFACTURER UNKNOWN); on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Sep2021, the patient experienced extreme fatigue, weakness, tinnitus, chills/hot flashes and headache. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced extreme fatigue, weakness, tinnitus, chills/hot flashes and headache was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Extreme fatigue; Weakness; Tinnitus; Chills/hot flashes; Chills/hot flashes; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 07Sep2021 at 12:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and valaciclovir (VALACYCLOVIR); both 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: FC3180) via an unspecified route of administration in the right arm on 17Aug2021 at 11:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation and received erythromycin (MANUFACTURER UNKNOWN), cefalexin (KEFLEX) and tetracycline (MANUFACTURER UNKNOWN); on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Sep2021, the patient experienced extreme fatigue, weakness, tinnitus, chills/hot flashes and headache. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced extreme fatigue, weakness, tinnitus, chills/hot flashes and headache was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, SARS-CoV-2 test
Clinical narrative: Whole face pain within 12 hours after vaccine. Hurt to even make any facial expressions for 4 days without relief.; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 03Sep2021 at 19:00 (at the age of 14-year-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. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the right arm on 11Aug2021 at 14:00 (at the age of 14-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 04Sep2021 at 07:00, within 12 hours after vaccination, the patient experienced whole face pain and hurt to even make any facial expressions for 4 days without relief. The present day was day 5 and slowly dissipating. The whole face pain 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 whole face pain. On 27Aug2021, the patient underwent lab tests and procedures, which included Nasal Swab SARS CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event whole face pain within 12 hours after vaccine, hurt to even make any facial expressions for 4 days without relief was recovering at the time of this report.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Joint swelling, Pain, Pain in extremity
Clinical narrative: Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Flu like symptoms; Slight fever; Overall body aches; The initial case was missing the following minimum criteria: specific number of patients. Upon receipt of follow-up information on 23Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient) reported that a 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302, Expiration Date: 30May2021), via an unspecified route of administration in left deltoid, on 20Jan2021 at 10:30 AM (at the age of 76 years), as dose 1, single, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received influenza vaccine between the 1960s and 1970s (unspecified) for immunization and experienced swelling and pain at the site, stiffness in the arm, feeling feverish, and feeling sick. On 20Jan2021 in the morning, the patient experienced soreness, tenderness, swelling, and ache in left shoulder and arm; no treatment was received for these events. It became more painful during the day so that 10 hours later it was very painful to lift the patient's left arm. Also, as day progressed on 20Jan2021 (evening), the patient developed mild flu like symptoms (slight fever and overall body aches) that persisted for approximately 24 hours; the patient self-medicated for this as treatment. These adverse events after COVID-19 first shot was very similar to their reaction the patient used to have to his annual flu shot in the military when they were still using live-virus vaccines. The patient had no reaction to the second shot of this series (COVID-19) 23 days later (12Feb2021; Lot Number: EL9264, Expiration Date: 30May2021). The patient was not admitted to the hospital for these events. The patient recovered from the events in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Soreness, tenderness, swelling, and ache in left shoulder and arm; Flu like symptoms; Slight fever; Overall body aches; The initial case was missing the following minimum criteria: specific number of patients. Upon receipt of follow-up information on 23Feb2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient) reported that a 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302, Expiration Date: 30May2021), via an unspecified route of administration in left deltoid, on 20Jan2021 at 10:30 AM (at the age of 76 years), as dose 1, single, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received influenza vaccine between the 1960s and 1970s (unspecified) for immunization and experienced swelling and pain at the site, stiffness in the arm, feeling feverish, and feeling sick. On 20Jan2021 in the morning, the patient experienced soreness, tenderness, swelling, and ache in left shoulder and arm; no treatment was received for these events. It became more painful during the day so that 10 hours later it was very painful to lift the patient's left arm. Also, as day progressed on 20Jan2021 (evening), the patient developed mild flu like symptoms (slight fever and overall body aches) that persisted for approximately 24 hours; the patient self-medicated for this as treatment. These adverse events after COVID-19 first shot was very similar to their reaction the patient used to have to his annual flu shot in the military when they were still using live-virus vaccines. The patient had no reaction to the second shot of this series (COVID-19) 23 days later (12Feb2021; Lot Number: EL9264, Expiration Date: 30May2021). The patient was not admitted to the hospital for these events. The patient recovered from the events in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Nausea, Sinus congestion
Clinical narrative: sinus congestion; headache; slight nausea; Chills; Swollen lymph gland on left side of neck just above collar bone; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9267), second dose via an unspecified route of administration, administered in left arm on 14Feb2021 at 15:30 (at the age of 67-year-old) as dose 2, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medications in 2 weeks of COVID-19 vaccination included simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; zolmitriptan (ZOMIG) taken for an unspecified indication, start and stop date were not reported; nadolol (NADOLOL) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), first dose via an unspecified route of administration, administered in left arm on 24Jan2021 at 13:30 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 15Feb2021, the patient experienced swollen lymph gland on left side of neck just above collar bone. Chills, slight nausea, headache, sinus congestion. No treatment was received for the events. The outcome of the events was reported as resolving.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This is a spontaneous report from a contactable consumer. This (Age: 71; Unit: Unknown) male consumer (Patient) reported that: Who received (BNT162B2) Pfizer-Biontech Covid-19 Vaccine solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter received the first shot of the Pfizer covid vaccine (where he experienced only some pain in the arm), and his second dose was scheduled on 05Mar. He was scheduled to travel the next day and wants to know if it is okay to proceed with that. Outcome of the events was unknown   Follow-up attempts are completed. No further information is expected.