chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Felt very nauseous; Low fever; Left arm was painful in large area of bicep for 24 hours; Left armpit lymph node swelled up for 3-4 days; Had 2 inch red area on left arm a few inches from vaccine injection point.; Area was warm and firm, created pain; Area was warm and firm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 16:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medications included ethinylestradiol; norethisterone acetate (JUNEL) for birth control from unknown start date, cetirizine hydrochloride (ZYRTEC) and ibuprofen (ADVIL) for unknown indications from unknown start dates and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. The patient previously 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 16Mar2021 at 11:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks of vaccination. On 08Apr2021 at 08:00, the patient had felt very nauseous, had a low fever for 36 hours, left arm was painful in large area of bicep for 24 hours. Left armpit lymph node swelled up for 3-4 days. Area was warm and firm, created pain. He had a 2-inch red area on left arm a few inches from vaccine injection point. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events low fever was recovered on 09Apr2021 after the duration of 36 hours and left arm painful was recovered on 09Apr2021 after the duration of 24 hours. The clinical outcome of the events felt very nauseous, left armpit lymph node swelled up, area was warm and firm, created pain and 2-inch red area on left arm a few inches from vaccine site was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Muscle spasms, Nerve compression
Clinical narrative: Feels like pinched nerve; Muscle spasms in arm; Lost sense of taste; This is a spontaneous report from a contactable consumer.  A 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the left arm on 09Apr2021 at 14:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was reported that the patient had no allergies to medications, food, or other products. Concomitant medications included B12 and probiotic (unspecified) for an unknown indication, started from unknown date, had taken within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 04:00, the patient woke up with muscle spasms in arm, feels like pinched nerve and lost sense of taste. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events muscle spasms in arm, feels like pinched nerve and lost sense of taste were not resolved 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: Asthma, Paraesthesia oral, Pharyngeal paraesthesia, Pruritus
Clinical narrative: Within a minute or so I noticed my tongue and throat tingling/burning.; Within a minute or so I noticed my tongue and throat tingling/burning.; Within a couple more minutes face started to itch all over.; asthma; 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: unknown) via an unspecified route of administration in the right arm on 05Apr2021 at 10:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma chronic. The patient had known allergies to medications, food or other products (UNSPECIFIED). Concomitant medications included gliclazide (CLARITIN), fluticasone propionate (FLOVENT) and salbutamol (PROVENTIL) from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 10:45 within a minute or so, the patient experienced tongue and throat tingling/burning. Within a couple more minutes her face started to itch all over and this lasted for about 2.5 hours. The patient asthma kicked up for 24 hours. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tongue and throat tingling/burning, face itch all over and asthma was recovered on 06Apr201.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: tongue andlips swelled; n tongue andlips swelled; Broke out in hives; Headache; This is a spontaneous report from a 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: EW0151) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included seafood allergy. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 15:15 (at the age of 61-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 10Apr2021 at 10:45, the patient experienced broke out in hives, then tongue and lips swelled then headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events broke out in hives, then tongue and lips swelled then headache was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Swelling
Clinical narrative: Swelling/discomfort in under arm (armpit, potentially lymph node); Discomfort; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. Concomitant medications were not reported. The patient had no known allergies. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced swelling/discomfort in under arm that is the armpit, potentially lymph node. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events swelling, discomfort in under arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: Severe headache, unable to left head from from pillow or open eyes without increased pain; unable to left head from from pillow or open eyes without increased pain; This is a spontaneous report from a contactable consumer, the parent. A 21-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 right arm on 09Apr2021 at 15:45 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included Tourette's syndrome, anxiety, depression and allergy. The patient received unknown medications within two weeks of vaccination. 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. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 13:00 as a single dose for COVID-19 immunisation. On 10Apr2021 at 00:00, the patient experienced severe headache and was unable to lift head from pillow or open eyes without increased pain. Therapeutic measures were taken as a result of severe headache and open eyes without increased pain and included treatment with Tylenol, rest and hydration. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. The clinical outcome of the events, severe headache and was unable to lift head from pillow or open eyes without increased pain was resolved in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypoaesthesia, Illness, Pyrexia
Clinical narrative: chills/sick; 101 temperature; Chills; Left side of face went numb about 20-30 mins; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 17:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included nocturnal epilepsy, fibromyalgia, asthma, sleep apnea, migraine, COVID-19 and CAT scan dye allergy. Concomitant medications included oxcarbazepine (OXTELLAR XR), omeprazole (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), vitamin B (MANUFACTURER UNKNOWN) and montelukast sodium (MONTELUKAST) all for unknown indication on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 17:30, after vaccination the patient experienced left side of face went numb for about 20-30 mins. On 27Mar2021, 24 hours after vaccination, the patient experienced 101 temperature and chills/sick. Therapeutic measures were not taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the events left side of face went numb, 101 temperature and chills/sick was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Rash
Clinical narrative: fever up to 98.5; Rash on the upper right side of my body; Chills; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731/ZR8731) via an unspecified route of administration in the right arm on 09Apr2021 at 12:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy (thyroid remover) on an unknown date in 2012, heart murmur, blood pressure high, allergy to latex and sulfur. Concomitant medications included nifedipine (PROCARDIA) 60mg and levothyroxine sodium (SYNTHROID) 112mg; all for an unknown indication and from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021, the patient experienced chills. Chills became more intense, the patient slept under two blanks and turned on the heat. On 11Apr2021, the patient had rash on the upper right side of body and at 21:00, the patient had fever up to 98.5 (units unspecified). Therapeutic measures were taken as a result of events and included treatment with two BENADRYL and two TYLENOL, on an unknown date in Apr2021. The clinical outcome of the event fever up to 98.5, chills and rash on the upper right side of my body were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: arm was swollen and very red; arm was swollen and very red; Left arm sore; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER6955) via an unspecified route of administration in the left arm on 11Mar2021 at 09:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient received medication(unspecified) within two weeks of vaccination. The patient had no known allergies. 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 02Apr2021(friday) at 08:00,the patient experienced left arm sore, the arm was swollen and was very red, it was about the size of 1/2 dollar.  On saturday, the same symptoms were present but it was the size of tennis ball and on Sunday same but size was very large about 5 inches long and wrapped about 1/2 of the arm. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events left arm sore, swollen and very red arm were resolved with sequelae on an unknown date in Apr2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 08Apr2021 at 09:30 as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A seventy-two-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of seventy-two-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to intravenous contrast media (reported as intravenous dye). Concomitant medications taken within two weeks of vaccination included phenytoin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and amlodipine (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient previously took 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 12Mar2021 at 09:00 (at the age of 72-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. Next day, on 07Apr2021 at 10:00, the patient experienced numbness in left leg, he could hardly walk, seemed to be dragging left foot. This lasted for 3 days, (almost stroke like). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events next day numbness in left leg, could hardly walk, seemed to be dragging left foot, this lasted for 3 days, (almost stroke like) was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Pain
Clinical narrative: Mild body aches; Fatigue; Headache; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 08:30(at the age of 37-years-old) as a single dose for COVID-19 immunisation. The last menstruation period was on 14Mar2021. The patient had no medical history. The patient was pregnant at the time of vaccination. The last menstruation period was on 14Mar2021. The patient had no allergies to medications, food, or other products. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), paracetamol, diphenhydramine hydrochloride (TYLENOL PM) and caffeine, mepyramine maleate, paracetamol (MIDOL); all for unspecified indication and from an unknown start date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30(at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 07:00, the patient experienced mild body aches, fatigue and headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events mild body aches, fatigue and headache were resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Impaired work ability, Pain in extremity
Clinical narrative: intense shoulder, wrist and elbow pain; intense shoulder, wrist and elbow pain; could not lift either arm, couldn't grab the steering wheel, barely made it home; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Apr2021 at 15:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, fibromyalgia, hyperpituitarism, rosacea and ocular rosacea. The patient was allergic to sulfates and antibiotics. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and hydrocortisone (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously took codeine and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 16:15, 30 minutes after the vaccination, the patient experienced intense shoulder, wrist and elbow pain, he could not lift either arm, could not grab the steering wheel and barely made it home. The events lasted over night and when the patient woke up, the pain had gone. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intense shoulder, wrist and elbow pain and could not lift arm were resolved on 07Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Headache; Fever of 100.2; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 10Apr2021 at 16:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and breast cancer. The patient received unspecified medication within two weeks of vaccination. The patient previously took amoxycillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 12:00, the patient experienced fatigue, headache and fever of 100.2. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of fatigue, headache and fever of 100.2 were recovered on an unknown date Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysgeusia, Fatigue, Headache
Clinical narrative: Metallic taste in the mouth for 45-minutes; Neck muscles felt tight; Headache; Chills; Joint aching; Very cold; Fatigue; Sleeping; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on an unknown date in Apr2021(at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, sleeve gastrectomy, obesity, penicillin allergy, latex allergy, allergy to nuts and peanut allergy. Concomitant medications included calcium (MANUFACTURER UNKNOWN), cyanocobalamin-tannin complex (B12), vitamin d nos (VITAMIN D), zinc (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced metallic taste in the mouth for 45-minutes, neck muscles felt tight, headache, chills, joint aching, very cold, fatigue, slept on and off for 24 hours. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events metallic taste in the mouth for 45-minutes, neck muscles felt tight, headache, chills, joint aching, very cold, fatigue, slept on and off for 24 hours were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Nasopharyngitis, Somnolence
Clinical narrative: Metallic taste in the mouth for 45-minutes; Neck muscles felt tight; Headache; Chills; Joint aching; Very cold; Fatigue; Sleeping; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on an unknown date in Apr2021(at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, sleeve gastrectomy, obesity, penicillin allergy, latex allergy, allergy to nuts and peanut allergy. Concomitant medications included calcium (MANUFACTURER UNKNOWN), cyanocobalamin-tannin complex (B12), vitamin d nos (VITAMIN D), zinc (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced metallic taste in the mouth for 45-minutes, neck muscles felt tight, headache, chills, joint aching, very cold, fatigue, slept on and off for 24 hours. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events metallic taste in the mouth for 45-minutes, neck muscles felt tight, headache, chills, joint aching, very cold, fatigue, slept on and off for 24 hours were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Nausea; Chills; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 79-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 right arm on 08Apr2021 at 09:15, (at the age of 79-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. 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 18Mar2021 at 09:15, (at the age of 79-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 12:00, the patient experienced nausea, chill and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event nausea which included treatment with shot for nausea. The clinical outcome of the events of nausea, chill and exhaustion was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Right hand has been tingling; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no 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. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient had undergone COVID-19 nasal swab test and tested negative. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 25Feb2021 at 12:30. On 18Mar2021 at 12:30, since a few hours after second dose of vaccine, the patient experienced right hand tingling even though the vaccine was administered in left arm. 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 event. The clinical outcome of the event tingling in right hand was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: ringing in ear; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) in the right arm on 13Mar2021 at 17:45 (at the age of 61-year-old) as a dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) in the left arm on 03Apr2021 at 17:45 (at the age of 61-year-old) as a dose for COVID-19 immunisation. Medical history included diabetes. Concomitant medications included metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), esomeprazole sodium (NEXIUM) and ezetimibe (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 17:45 the patient experienced ringing in ear since the first dose and more so on the 2nd dose. Came and went then in varying degrees. Always present. On 15Mar2021, the patient underwent nasal swab test and the result was negative. No therapeutic measures were taken as a result of the adverse event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tinnitus was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle pain everywhere; Fever; Fatigue; Big headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration on 07Apr2021 at 14:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and estradiol gel (ESTROGEN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient previously took erythromycin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 07:00, the patient experienced fever, big headache, muscle pain everywhere and fatigue for 2 and a half days. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, big headache and muscle pain everywhere were resolved on an unknown date in Apr2021 and the clinical outcome of fatigue was resolved on 10Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Odynophagia, Oral pain, Oropharyngeal pain
Clinical narrative: Having a severe sore throat. The worst I've ever had.; Avoiding swallowing because it's so painful; I'm sneezing; my nose is running; I'm super congested.; My mouth ache.; teeth pain; Body chills; sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 10Apr2021 at 13:30 as a single dose for COVID-19 immunisation. The patient previously took Co-Trimoxazole and experienced allergy to it. The patient did not take any concomitant medications within two weeks. The patient did not take any other vaccine in four weeks. Prior to the vaccination, the patient was not tested positive for COVID-19. On 11Apr2021, the patient experienced severe sore throat, the worst she ever had and was avoiding swallowing because it was so painful, sneezing, nose was running, super congested, mouth/teeth ache body chills and sore left arm. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test on 12Apr2021 which included the nasal swab test (rapid antigen test) and the result was negative. The clinical outcome of the events severe sore throat, was avoiding swallowing because it was so painful, sneezing, nose was running, super congested, mouth/teeth ache, body chills and sore left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Toothache
Clinical narrative: Having a severe sore throat. The worst I've ever had.; Avoiding swallowing because it's so painful; I'm sneezing; my nose is running; I'm super congested.; My mouth ache.; teeth pain; Body chills; sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 10Apr2021 at 13:30 as a single dose for COVID-19 immunisation. The patient previously took Co-Trimoxazole and experienced allergy to it. The patient did not take any concomitant medications within two weeks. The patient did not take any other vaccine in four weeks. Prior to the vaccination, the patient was not tested positive for COVID-19. On 11Apr2021, the patient experienced severe sore throat, the worst she ever had and was avoiding swallowing because it was so painful, sneezing, nose was running, super congested, mouth/teeth ache body chills and sore left arm. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test on 12Apr2021 which included the nasal swab test (rapid antigen test) and the result was negative. The clinical outcome of the events severe sore throat, was avoiding swallowing because it was so painful, sneezing, nose was running, super congested, mouth/teeth ache, body chills and sore left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: lymph nodes under left armpit began to swell and generate mild to moderate pain; no swelling anywhere else at this time other than right armpit.; No swelling anywhere else at this time other than right armpit; pain and swelling in left arm; pain and swelling in left arm; This is a spontaneous report from a contactable consumer, the patient. A 28-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 08Apr2021 at 16:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to walnuts and shellfish and COVID-19. Information on other medications taken within two weeks of vaccination was reported as not applicable. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient first had mild pain and swelling in the left arm (where the shot was inserted). On 10Apr2021 at 18:00 within the following 48 hours, lymph nodes under the left armpit began to swell and generate mild to moderate pain. At this time the pain was not alarming, however, the swelling was medium to severe. The other set of lymph nodes in the right arm were completely normal, and there was no swelling anywhere else at the time of this report other than the right armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events first had mild pain and swelling in the left arm, lymph nodes under the left armpit began to swell and generate mild to moderate pain, and swelling of the right armpit were 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: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZER8731) via an unspecified route of administration in the right arm on 11Apr2021 at 16:45 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. 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 12Apr2021 at 08:00, the patient experienced dizziness. No therapeutic measures were taken as a result of the adverse event. 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. The clinical outcome of the event dizziness was resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Fever of 101.6; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), furosemide (MANUFACTURER UNKNOWN) and multi vitamin; 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 COVID-19 vaccination. On 11Apr2021, the patient experienced a fever of 101.6 (unspecified units), chills and headache which lasted for 24 hours. 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, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 101.6, chills and headache were resolved on 12Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Headache; Muscle aches; Fatigue; Swollen lymph nodes under arms; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 08:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, insect bite allergy, allergy to sweet corn and lactose sensitive since an unspecified date. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021, the patient experienced headache, muscle aches, fatigue and swollen lymph nodes under arms. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events headache, muscle aches, fatigue and swollen lymph nodes under arms was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Felt light-headed and woozy; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 17:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19 on an unknown date. The patient did not have any known allergies to food, medications, or other products. The patient's concomitant medications and past drugs were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 17:30, the patient went to stand up about 1 minute after the vaccination, the patient immediately felt light-headed and woozy and had to sit down. If the patient had not sat down, the patient believed she would have fainted. The patient was monitored for 30 minutes and then she was able to leave. The patient did not have low blood sugar or high anxiety about getting the vaccination. The patient's vitals came back clear. It was unknown whether any therapeutic measures were taken as a result  of the event. It was unknown if therapeutic measure were taken as a result of adverse event. The clinical outcome of the event felt light-headed and woozy was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pruritus, Pyrexia, Rash
Clinical narrative: feel itching all over the body; had one quarter size rash on left leg; Feel tired; Warm (99.5 F); This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient 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 05Apr2021 at 16:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, one to two hours after the first dose, the patient felt tired and warm and could not even open eyes. On the same day body temperature was 99.5 Fahrenheit. On 07Apr2021 at 21:00, at night, the patient felt itching all over the body and had one quarter size rash on left leg. 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. The clinical outcome of the events felt tired and warm (99.5 F), could not even open eyes, felt itching all over the body and had one quarter size rash on left leg was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.