chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears started ringing; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 09:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks of vaccination. On 20Apr2021 at 15:00, around day seventeen after the vaccination, the patient's ears started ringing which continues to a really loud level for the last 24 hours from the day of this report. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or 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 event ears started ringing was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash papular, SARS-CoV-2 test
Clinical narrative: Seems to be lymphadenopathy.; Raised red spots along under the armpit (both sides), on the chest (left), in the crook of the arm (left), and groin (left); This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 14:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) from unknown date and for unspecified indication. On 16Apr2021 at 07:30, the patient experienced raised red spots along under the armpit (both sides), on the chest (left), in the crook of the arm (left), and groin (left). The patient reported as seemed to be lymphadenopathy. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 15Apr2021, the patient underwent polymerase chain reaction (PCR test) and the result was negative. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the raised red spots along under the armpit (both sides), on the chest (left), in the crook of the arm (left), and groin (left) and seems to be lymphadenopathy were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Muscle spasms, Pain
Clinical narrative: Brain fog; Calf muscles cramps; foot cramps; Fatigue; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8713) via an unspecified route of administration in the arm right on 20Apr2021 at 15:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 30Mar2021 at 15:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 10:00, the patient experienced calf muscles cramps, foot cramps, fatigue, headache, body ache and brain fog. Therapeutic measures were not taken as a result of the events. 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 events calf muscles cramps, foot cramps, fatigue, headache, body ache and brain fog was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Developed pain, numbness, and paresthesia in right leg; Developed pain, numbness, and paresthesia in right leg; Developed pain, numbness, and paresthesia in right leg; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 26-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), OTC antihistamines and multivitamins all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 27Mar2021, 72 hours after first vaccination, the patient experienced pain, numbness, and paresthesia in right leg. The symptoms improved but did not resolve over time period until next vaccination. Symptoms recurred significantly within 24 hours after second vaccination and had yet to improve or resolve 7 days post second vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with physical therapy and unspecified medications and awaiting neuro appt. The clinical outcomes of the events pain in right leg, numbness in right leg and paresthesia in right leg were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen armpit on arm of injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-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 05Apr2021 at 13:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, asthma, high cholesterol and seasonal allergies. The patient had known allergies to cefaclor (CECLOR) and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), montelukast sodium (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced swollen armpit on arm of injection site. The event resulted in doctor or other healthcare professional office/clinic visit. 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 event swollen armpit on arm of injection site was not resolved 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear; This is a spontaneous report from a contactable consumer, the patient. A 24-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 14Apr2021 at 11:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient 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 COVID-19 vaccine. The patient did not receive any medication within two weeks of the COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Since the vaccination, the patient had not been tested for COVID-19. Four days after vaccination on 18Apr2021, the patient experienced tinnitus in left ear, the same side as she was vaccinated on. She had no other side effects. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event tinnitus in left ear, the same side as she was vaccinated on was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness and lightheartedness/ Mild dizziness; This is a spontaneous report from a contactable pharmacist. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an intramuscular route of administration in the left arm on 27Feb2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, diabetes and obstructed sleep apnoea. The patient previously took ciprofloxacin (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021,  the patient experienced dizziness and light heartedness that was not treated with medications. 20 minutes later patient reported mild dizziness. Patient drank 2 bottles of water. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included drinking 2 bottles of water. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.The clinical outcome of dizziness, light heartedness and 20 minutes later mild dizziness was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Vertigo
Clinical narrative: Mild vertigo and still occurring 24 hours later; Metallic taste in mouth during first day; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 60-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 arm left on 20Apr2021 at 10:15 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 20Apr2021, the patient experienced mild vertigo, metallic taste in mouth during first day and mild headache. The mild vertigo was occurring 24 hours later at the time of report. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild vertigo, metallic taste in mouth and mild headache 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: gland under that armpit is swollen and very sore; gland under that armpit is swollen and very sore; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Apr2021 at 17:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, obesity and high cholesterol. The patient had no allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 09:30, a day after the shot on her right arm, the patient experienced that the gland under the right armpit was swollen and very sore. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event gland under the right armpit was swollen and very sore was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast atrophy, Suppressed lactation
Clinical narrative: stopped lactating; Breast size decreased; This is a spontaneous report from a contactable pharmacist. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153) via an intramuscular route of administration in the left arm on 20Apr2021 at 15:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient had any allergies to medications, food, or other products. Prior to vaccination, it was unknown whether the patient was 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 within two weeks of vaccination. On 20Apr2021 at 15:00, after the first dose of vaccination, the patient stopped lactating and breast size decreased to a full cup size in less than 24 hours and the patient was no longer able to breastfeed her infant. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events stopped lactating and breast size decreased were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypoaesthesia, Hypoaesthesia oral, Respiratory rate
Clinical narrative: Feel slight numbness in left arm to fingertips and left side of face, in the temple, cheek and mouth area; Feel slight numbness in left arm to fingertips and left side of face, in the temple, cheek and mouth area; 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: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included vitamins nos, minerals nos, nutrients nos (OLLY WOMENS MULTIVITAMIN). On 21Apr2021 at 15:45, 15 minutes after the first dose, the patient felt slight numbness in left arm to fingertips and left side of face, in the temple, cheek and mouth area. It was reported that two hours after the injection the symptoms were only improved slightly and the patient did not experience any other symptoms. 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 patient's breathing and blood pressure were normal. The clinical outcome of the events feel slight numbness in left arm to fingertips and left side of face, in the temple, cheek and mouth area was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Experience heavy hot flashes 24/7 since vaccination.  Never before and have regular monthly cycle; can't be coincidental; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 10:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa. Prior to vaccination, it was unknown whether the patient was 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 other medication within two weeks of vaccination. On 28Mar2021, the patient experienced experience heavy hot flashes 24/7 since vaccination. The patient stated that never ever before and had regular monthly cycle and it could not be coincidental. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event hot flashes was not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 15Apr2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Nausea
Clinical narrative: 13 hours after injection woke with sore arm; Intense chills; Shaking; Nausea; Vomiting; Mild headache; Tired; Dehydrated; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 10:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hemophilia, gastroesophageal reflux disease (gerd), irritable bowel syndrome (ibs), Barrett's esophagus, incontinentia pigmenti, ehlers-danlos syndrome (hEds) and sulfonamide allergy (sulfa). Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included celecoxib (CELEBREX), octocog alfa (KOVALTRY), pantoprazole (MANUFACTURER UNKNOWN) and thyroid (MANUFACTURER UNKNOWN), all taken 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: ER8732), via an unspecified route of administration in the left arm on 20Mar2021, at 10:00, (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 20Apr2021 at 00:15, 13 hours after injection the patient woke with sore arm followed by intense chills, shaking, nausea, vomiting, mild headache. Next morning on 21Apr2021, the patient was super tired and unable to keep down liquids or medicines (including TYLENOL) and became dehydrated. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported events. The clinical outcome of the event 13 hours after injection woke with sore arm, intense chills, shaking, nausea, vomiting, mild headache, tired and dehydrated were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor, Vomiting
Clinical narrative: 13 hours after injection woke with sore arm; Intense chills; Shaking; Nausea; Vomiting; Mild headache; Tired; Dehydrated; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 10:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hemophilia, gastroesophageal reflux disease (gerd), irritable bowel syndrome (ibs), Barrett's esophagus, incontinentia pigmenti, ehlers-danlos syndrome (hEds) and sulfonamide allergy (sulfa). Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included celecoxib (CELEBREX), octocog alfa (KOVALTRY), pantoprazole (MANUFACTURER UNKNOWN) and thyroid (MANUFACTURER UNKNOWN), all taken 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: ER8732), via an unspecified route of administration in the left arm on 20Mar2021, at 10:00, (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 20Apr2021 at 00:15, 13 hours after injection the patient woke with sore arm followed by intense chills, shaking, nausea, vomiting, mild headache. Next morning on 21Apr2021, the patient was super tired and unable to keep down liquids or medicines (including TYLENOL) and became dehydrated. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported events. The clinical outcome of the event 13 hours after injection woke with sore arm, intense chills, shaking, nausea, vomiting, mild headache, tired and dehydrated were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Paraesthesia, Skin burning sensation
Clinical narrative: Night sweats; Skin burning and tingling like it is burning from the inside out.; Skin burning and tingling like it is burning from the inside out.; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. On 17Mar2021, the patient experienced night sweats, skin burning and tingling like it was burning from the inside out. The patient had severe reaction that would not subside with treatment. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Acyclovir and Benadryl and Aleve. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events night sweats, skin burning and tingling like it was burning from the inside out was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Neuralgia, Pain
Clinical narrative: With in hours of the vaccine experienced nerve pain; exacerbate an old nerve condition/ continued to get worse with the second dose; experienced serious insomnia; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 09Mar2021 at 04:00 (at the age of 65-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN28730) via an unspecified route of administration in the left arm on 28Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included steroid sensitivity, tumour excision and nerve pain (it appeared to exacerbate an old nerve condition that occurred after having a large tumour removed from a nerve in back). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 10Mar2021 at 17:00, within hours of the vaccine, patient experienced nerve pain. It appeared to exacerbate an old nerve condition that occurred after having a large tumour removed from a nerve in her back. With the second dose on an unknown date in Mar2021, the patient experienced it continued to get worse. Three weeks later, still had pain and also experienced serious insomnia. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with temporary pain medications (meds). The clinical outcome of the events with in hours of the vaccine experienced nerve pain, exacerbate an old nerve condition/ continued to get worse with the second dose and experienced serious insomnia were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful lymph nodes under R armpit.; Painful lymph nodes under R armpit.; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 12Apr2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient reported no known drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 COVID vaccine. On 17Apr2021 at 00:00, the patient experienced swollen and painful lymph nodes under R armpit. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event swollen and painful lymph nodes under R armpit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red, itchy rash around injection site; Red, itchy rash around injection site; Red, itchy rash around injection site; 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: EK8729) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levocetirizine dihydrochloride (XYZAL ALLERGY 24HR) and ibuprofen (ADVIL); both taken for unknown indications from an unknown date and unknown if ongoing. On 10Apr2021 at 13:00, 2 days after administration of second dose red, itchy rash was appeared around injection site. Rash lasted about 6-7 days. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events red, itchy rash around injection site were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Swelling face, Vaccination site pain
Clinical narrative: mild pain at the injection site; mild pain at two locations on face; swelling at two locations on face; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 19Apr2021 at 18:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included factor v Leiden. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), phentermine (MANUFACTURER UNKNOWN) and vitamins nos (VITAMINS) on an unknown date for unknown indication. The patient previously took hyaluronic acid (JUVEDERM), 4 syringes of JUVEDERM injections near both cheekbones and chin on 30 July 2020.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 18:30 (at the age of 46-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 an unknown date Apr2021, 36 hours after vaccination the patient experienced two potential adverse events following the second dose of the COVID-19 vaccine. First, she experienced mild pain and swelling at two locations on her face. This occurred approximately 36-hours after her vaccination. Both are areas where she previously received facial fillers. She received 4 syringes of JUVEDERM injections near both cheekbones and her chin on 30 July 2020. The current pain/swelling was on her chin and right cheekbone close to those injection sites. It was now 12 hours after from the onset of facial pain/swelling and the issue persisted. The patient planned to follow-up with her physician the next day if the issue continued. Second, she also experienced mild pain at the injection site on her left arm. It began shortly after injection. She managed it successfully by taking the indicated dose of acetaminophen for 24 hours. The pain had largely gone. Therapeutic measures were taken as a result of the event and included treatment with acetaminophen for 24 hours.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild pain at two locations on face and swelling at two locations on face was not resolved. The clinical outcome of the event mild pain at the injection site was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: A month after the second Pfizer vaccine came down with shingles.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG198) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included norethisterone acetate, ethinylestradiol, ferrous fumarate (LARIN FE) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 24Feb2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, a month after the second Pfizer vaccine, the patient came down with shingles. This was the first time the patient had shingles. The patient was not sure if they're connected, but thought it was best to report it. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with unspecified medication. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site swelling
Clinical narrative: Swelling of lymph nodes in size of injection; Swelling of lymph nodes in size ofinjection- painful shoulder nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date  as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 16Apr2021, the patient experienced swelling of lymph nodes in size of injection along with painful shoulder nodes. No therapeutic measures were taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swelling of lymph nodes in size of injection along with painful shoulder nodes was recovering at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; Bodyache; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 16:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VITAMIN D) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021 (at the age of 35-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 21Apr2021, the patient experienced headache and body ache. 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 headache and body ache was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles sl; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included food allergy (soy, tomatoes and wheat), allergy to nuts (peanuts) and allergy to metals. The patient checked with her allergist and said that she was not allergic to anything in vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and loteprednol etabonate (LOTEMAX) 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 08Apr2021 the patient experienced Shingles. Therapeutic measures were taken as a result of shingles and included treatment with Valacyclovir. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in emergency room/department or urgent care. The clinical outcome of the event Shingles was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dehydration, Feeding disorder, Migraine, Visual impairment
Clinical narrative: Throwing up for hours; Struggling to stay hydrated and eat anything; Struggling to stay hydrated and eat anything; Terrible migraine; Terrible migraine; Terrible migraine that is limiting vision; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and ubidecarenone (COENZYME Q10); both were taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 16:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 03:00, the patient had been throwing up for hours and she was struggling to stay hydrated and eat anything. The patient also had a terrible migraine that was limiting her vision. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events throwing up for hours, struggling to stay hydrated and eat anything, terrible migraine and terrible migraine that is limiting vision 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up for hours; Struggling to stay hydrated and eat anything; Struggling to stay hydrated and eat anything; Terrible migraine; Terrible migraine; Terrible migraine that is limiting vision; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and ubidecarenone (COENZYME Q10); both were taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 16:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 03:00, the patient had been throwing up for hours and she was struggling to stay hydrated and eat anything. The patient also had a terrible migraine that was limiting her vision. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events throwing up for hours, struggling to stay hydrated and eat anything, terrible migraine and terrible migraine that is limiting vision 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Quarter sized rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 19Apr2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 10:00, the patient had a quarter sized rash at injection site. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measure was not taken as a result of the events. The clinical outcome of the event quarter sized rash at injection site was resolved on 21Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included vasodepressor syncope and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin d nos (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole; trimethoprim(BACTRIM) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 21:00, within 12 hours of the vaccination, the patient experienced vertigo. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included treatment with unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.