chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Peripheral swelling, Vaccination site mass
Clinical narrative: Neck Pain; Arm Pain; Shoulder Pain; Swelling of Arm and Underarm; Lump at vaccine site; Headache; Nausea; Feeling Cold; Exhaustion; Cough; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: ER8730) via an unspecified route of administration in the left arm on 22Mar2021 at 19.00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included Osteoporosis. Concomitant medications were not provided. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 17.00 as a single dose for COVID-19 immunisation. The patient was not allergic to any medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if the patient received any other medications within 2 weeks prior to vaccination. On 23Mar2021, the patient experienced severe neck pain, severe arm pain, severe shoulder pain, moderate swelling of arm and underarm, moderate lump at vaccine site, severe headache, moderate nausea, severe cold feeling, severe exhaustion and moderate cough. Therapeutic measures were taken as a result of neck pain, pain in arm, shoulder pain, swelling arm, vaccination site lump, headache, nausea, feeling cold, exhaustion and cough and included ibuprofen.  The clinical outcome of neck pain, pain in arm, shoulder pain, swelling arm, vaccination site lump, headache, nausea, feeling cold, exhaustion and cough was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: The next day i began to get a rash on my body. Each day it got worse & all over my body. Itchier every day.Itd been 9 dys & i still have it.; This is a spontaneous report from a contactable consumer, the patient. A 72-Year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot Number: En6205), via an unspecified route of administration in the arm left on 15Mar2021 at 12:30 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), strontium (MANUFACTURER UNKNOWN), b12 (MANUFACTURER UNKNOWN) and D3 (MANUFACTURER UNKNOWN) given for an unknown indication from an unknown 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 vaccination. After the vaccination, on 16Mar2021 at 09:30 the patient began to experience rash on the body. Each day it got worse & experienced all over the body. It had been 9 days & still it is continuing. The events did not result in doctor or other healthcare professional office/clinic visit. The patient received prednisone for 5 days, BENADRYL and hydrocortisone (MANUFACTURER UNKNOWN) for the event rash. The clinical outcome of the event rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information was expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills
Clinical narrative: Chills at 75 degrees; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 24Mar2021 at 07:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. There were no known allergies. The concomitant medications included sitagliptin phosphate (JANUVIA), metformin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 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 not received any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since receiving the vaccine. On 24Mar2021 at 18:00, the patient experienced chills at 75 degrees. The patient had not received any treatment for the event chills. 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 event chills was unknown at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Tinnitus and partial loss of hearing.; Tinnitus and partial loss of hearing.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206, Expiry date was not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 11:15 (at the age of at 61-year-old), as single dose, for covid-19 immunization at other facility. The patient's medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), oxybutynin, and rosuvastatin calcium (CRESTOR). On 11Mar2021 at 14:00, the patient experienced tinnitus and partial loss of hearing. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with steroid injection and oral steroids. The outcome of the events tinnitus and partial loss of hearing was not resolved.  No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Headache, Night sweats, Pain, Pyrexia
Clinical narrative: Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This is a spontaneous report from a contactable consumer, the patient. A 58-years old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose on left arm via unspecified route on 22Mar2021 at 03:00 PM (at the age of 58-years old) for COVID-19 immunisation. The patient medical history included major cirrhosis of the liver needs a liver transplant. The patient was allergic to morphine cipro and motto patch.Concomitant medications was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, at 20:00 the patient experienced major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again. The patient did not receive treatment for the reported events. The clinical outcome of major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again was not recovered.                  No follow-up attempts needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Verbatim of Relevant Med History updated as same as source document, note added, "Concomitant medications were not reported" updated as "Concomitant medications was reported as none", "on left arm", "The patient did not receive treatment for the reported events " added in narrative and Reference No. added.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This is a spontaneous report from a contactable consumer, the patient. A 58-years old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose on left arm via unspecified route on 22Mar2021 at 03:00 PM (at the age of 58-years old) for COVID-19 immunisation. The patient medical history included major cirrhosis of the liver needs a liver transplant. The patient was allergic to morphine cipro and motto patch.Concomitant medications was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, at 20:00 the patient experienced major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again. The patient did not receive treatment for the reported events. The clinical outcome of major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again was not recovered.                  No follow-up attempts needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Verbatim of Relevant Med History updated as same as source document, note added, "Concomitant medications were not reported" updated as "Concomitant medications was reported as none", "on left arm", "The patient did not receive treatment for the reported events " added in narrative and Reference No. added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Fatigue, Irritability, Malaise
Clinical narrative: a bit more depressed/more nonproductive; Feel run down/ Sluggish; irritated; Injection site tender; Very fatigued; very slight chills; Feverish; Subpar/under the weather; This is a spontaneous report from a non-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: EP 7534), via an unspecified route of administration in the right arm on 23Mar2021 at 14:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included life was ruining, depression, chronic anxiety, OCD, insomnia, chronic adverse effects from accutane poisoning and severe neck discs injuries. The patient was allergic to unspecified medications, food, or other products. 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 received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23March2021 at 16:00, the patient experienced injection site tender, was irritated, felt very fatigued especially the next day and night. The patient felt feverish, had very slight chills, felt run down and sluggish, tired, subpar/under the weather, a bit more depressed and more non-productive. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events injection site tender, irritated, very fatigued, feverish, very slight chills, feel run down/sluggish, subpar//under the weather and a bit more depressed/more nonproductive. The clinical outcomes of the events injection site tender, irritated, very fatigued, feverish, very slight chills, feel run down/sluggish, subpar//under the weather and a bit more depressed/more nonproductive were not recovered at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness, Vaccination site pain
Clinical narrative: a bit more depressed/more nonproductive; Feel run down/ Sluggish; irritated; Injection site tender; Very fatigued; very slight chills; Feverish; Subpar/under the weather; This is a spontaneous report from a non-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: EP 7534), via an unspecified route of administration in the right arm on 23Mar2021 at 14:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included life was ruining, depression, chronic anxiety, OCD, insomnia, chronic adverse effects from accutane poisoning and severe neck discs injuries. The patient was allergic to unspecified medications, food, or other products. 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 received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23March2021 at 16:00, the patient experienced injection site tender, was irritated, felt very fatigued especially the next day and night. The patient felt feverish, had very slight chills, felt run down and sluggish, tired, subpar/under the weather, a bit more depressed and more non-productive. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events injection site tender, irritated, very fatigued, feverish, very slight chills, feel run down/sluggish, subpar//under the weather and a bit more depressed/more nonproductive. The clinical outcomes of the events injection site tender, irritated, very fatigued, feverish, very slight chills, feel run down/sluggish, subpar//under the weather and a bit more depressed/more nonproductive were not recovered at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: fatigues; Chill; This is a spontaneous report from a non-contactable consumer, patient. A 42-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration on 23Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021, patient had experienced chills and fatigue. The clinical outcome of the event chills and fatigue were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Mild headache; Mild nausea; Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal hay fever. The patient was allergic to tree nuts. Concomitant medication included cetirizine hydrochloride (ZYRTEC) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the right arm on 02Mar2021 at 11:30 (at the age of 43-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 tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 06:00, approximately 24 hours after second shot, the patient woke up with mild headache, mild nausea and sore arm at injection site. 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 headache, nausea and sore arm at injection site was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pyrexia, Vomiting
Clinical narrative: low grade fever; severe diarrhea for 3 days; intermittent vomiting; headache; This is a spontaneous report received from a contactable consumer, the patient. A 17-Year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FP7534) as a single dose via an unspecified route of administration in her left arm on 20Mar2021 at 10:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 21Mar2021, the patient experienced severe diarrhea for 3 days with intermittent vomiting, low grade fever and headache. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes for the events severe diarrhea, intermittent vomiting, low grade fever and headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Periorbital swelling, Swelling of eyelid
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 23Mar2021 at 08:30 (at the age of 69-year-old) as a single dose, for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient was allergic to penicillin. Concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 04:30, the patient experienced eyelids swollen, increasingly puffy, and itching. The patient was concerned about the impact on vision. It was unknown whether the patient received therapeutic measures for the events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events eyelids swollen, eyelids increasingly puffy, eyelids increasingly puffy were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Mild pain at injection site; fever of 99.9; chills (mild); Achy all over(moderate); Feeling worn down; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown) via unspecified route of administration in left arm on 23Mar2021 at 13:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high triglycerides. No allergies to medications, food, or other products were reported. Concomitant medication included amlodipine(NORVASC), fenofibrate (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) all taken for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown) via unspecified route of administration in left arm on 02Mar2021 at 13:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 10:00, the patient experienced vaccination site pain, fever, chills, general body pain and was worn out. The patient had mild pain at injection site, fever of 99.9, chills (mild), achy all over (moderate) and was feeling worn down. No treatment was received for the adverse 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 all the events vaccination site pain, fever, chills, general body pain, worn out were resolved on an unknown date.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild pain at injection site; fever of 99.9; chills (mild); Achy all over(moderate); Feeling worn down; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown) via unspecified route of administration in left arm on 23Mar2021 at 13:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high triglycerides. No allergies to medications, food, or other products were reported. Concomitant medication included amlodipine(NORVASC), fenofibrate (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) all taken for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown) via unspecified route of administration in left arm on 02Mar2021 at 13:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 10:00, the patient experienced vaccination site pain, fever, chills, general body pain and was worn out. The patient had mild pain at injection site, fever of 99.9, chills (mild), achy all over (moderate) and was feeling worn down. No treatment was received for the adverse 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 all the events vaccination site pain, fever, chills, general body pain, worn out were resolved on an unknown date.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Petechiae
Clinical narrative: Shortness of breath; Petechiae on top of both hands, more prominently on Left hand; Tiredness; This is a spontaneous report from a contactable nurse. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6200) via an unspecified route of administration in the right arm on 11Mar2021 at 12:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) since an unknown date. The patient did not have any allergies to medications, food or other products. Prior to 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 4 weeks prior to the COVID vaccine. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and isotretinoin (MANUFACTURER UNKNOWN), both for unknown indications received on unknown dates. On 11Mar2021 at 13:30, the patient experienced petechiae on top of both hands, more prominently on left hand, tiredness and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of petechiae, tiredness and shortness of breath were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Headache; Throbbing pain in my left arm near injection site.; I felt a fever coming on and when measured had a 99.8 degree fever; Body chills; Sweats; Nauseous stomach; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 08:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. No known relevant medical history was reported. Concomitant medications included birth control. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 03Mar2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. 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 not been tested for COVID-19. On 24Mar2021 at 13:00, the patient experienced throbbing pain in the left arm near injection site within a few hours. By the evening the patient experienced fever and when measured it was observed to be a 99.8-degree fever (unspecified unit), body chills, sweats, and a nauseous stomach. On 25Mar2021, the patient had a splitting headache and no fever. The patient did not receive any treatment for the events. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events throbbing pain in the left arm near injection site, fever, body chills, sweats, nauseous stomach and splitting headache were resolving. No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache; Throbbing pain in my left arm near injection site.; I felt a fever coming on and when measured had a 99.8 degree fever; Body chills; Sweats; Nauseous stomach; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 08:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. No known relevant medical history was reported. Concomitant medications included birth control. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 03Mar2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. 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 not been tested for COVID-19. On 24Mar2021 at 13:00, the patient experienced throbbing pain in the left arm near injection site within a few hours. By the evening the patient experienced fever and when measured it was observed to be a 99.8-degree fever (unspecified unit), body chills, sweats, and a nauseous stomach. On 25Mar2021, the patient had a splitting headache and no fever. The patient did not receive any treatment for the events. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events throbbing pain in the left arm near injection site, fever, body chills, sweats, nauseous stomach and splitting headache were resolving. No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Lethargy, Musculoskeletal stiffness, Myalgia, Vaccination site pain
Clinical narrative: blistering (herpes simplex); Muscle aches; stiffness; lethargy; soreness; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in left arm on 16Mar2021 at 16:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had allergies to NSAIDs and anti-inflammatory medications, morphine - ivory soap. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included paracetamol (TYLENOL) 500 mg for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in left arm on 23Feb2021 at 16:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 (day after second dose), the patient experienced lethargy and soreness at injection site (vaccination site pain). On 19Mar2021 (three days post injection), the patient experienced muscle aches and stiffness. On 21Mar2021 (five-seven days post injection), the patient experienced severe blistering (herpes simplex) covering top lip under nose. The events did result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included antiviral ointment and oral medication. The clinical outcome of the events lethargy, soreness at injection site (vaccination site pain), muscle aches and stiffness and severe blistering (herpes simplex) were resolving at the time of this report.   No follow-up attempts possible. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Change in smell; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 19Mar2021 at 10:30 (at the age of 56-years-old), as single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, fibromyalgia, carpal tunnel, cervical disc replacement lower back. The patient was allergic to morphine and hydrocodone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within 2 weeks of vaccination. On 20Mar2021, the patient experienced change in smell. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event change in smell was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Muscle fatigue, Nausea
Clinical narrative: Muscle fatigue; Vomiting; Diarrhea; Headache; Nausea; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 10:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included pantoprazole DR (MANUFACTURER UNKNOWN) 40 mg for an unknown indication from an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 24Mar2021 at 15:00, the patient experienced headache, nausea, vomiting, diarrhea, joint pain, and muscle fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the headache, nausea, vomiting, diarrhea, joint pain, and muscle fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Muscle fatigue; Vomiting; Diarrhea; Headache; Nausea; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 10:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included pantoprazole DR (MANUFACTURER UNKNOWN) 40 mg for an unknown indication from an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 24Mar2021 at 15:00, the patient experienced headache, nausea, vomiting, diarrhea, joint pain, and muscle fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the headache, nausea, vomiting, diarrhea, joint pain, and muscle fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over arms, legs, and trunk.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via unspecified route in the right arm on 11Mar2021 at 13:15 (at the age of 56-year-old) for COVID-19 immunisation. Medical history included GERD (gastroesophageal reflux disease). The patient was allergic to sulfas (sulfonamide drug) and gluten (might be as reported) allergy. Concomitant medications included naltrexone hydrochloride, bupropion hydrochloride (CONTRAVE), omeprazole (MANUFACTURER UNKNOWN), valacyclovir (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date. Prior to 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 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced itching all over arms, legs, and trunk. It was reported that the patient was not experienced rash. Therapeutic measures were taken as a result of event itching included treatment with over the counter (OTC) skin calming cream and OTC BENADRYL gel. The adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event itching all over arms, legs, and trunk 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: Tuberculin test, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red itchy rash at injection site; Red itchy rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8727), via an unspecified route of administration in left arm on 22Mar2021 at 15:00 (at the age of 48 years) as a single dose for COVID-19 immunisation. Medical history included cerebral palsy, seizures, oral pharyngeal dysphagia, depression, anxiety, sleep apnea and sulfonamide allergy. The patient reported allergies to PPD skin test, ampicillin (MANUFACTURER UNKNOWN), amoxicillin and clavulanic acid (AUGMENTIN) and high-protein medical nutritional supplement with fiber (JEVITY). Concomitant medications included loratadine (CLARITIN), buspirone (MANUFACTURER UNKNOWN), carbamazepine (TEGRETOL), medroxyprogesterone acetate (DEPOPROVERA), Ibuprofen (IBUPRO). Prior to 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-19 vaccination. On 24Mar2021, after the vaccination, the patient experienced red itchy rash at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken for the adverse events. The clinical outcome of vaccination site rash and vaccination site pruritus was not recovered at the time of this report.   No follow-up attempts possible. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Excruciating headache for 12 hours starting 3 hours after the vaccine.; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown), via unspecified route of administration in right arm on 15Mar2021 at 09:45 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was reported as a cancer survivor. The concomitant medication included unspecified female hormones, thyroid medicine and vitamins. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since having the vaccine, the patient was not tested for COVID-19. On 15Mar2021 at 13:00, the patient experienced excruciating headache for 12 hours starting 3 hours after the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The patient did not receive treatment for the adverse event. The clinical outcome of the event headache was recovered on 16Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pollakiuria, Urinary tract infection bacterial
Clinical narrative: Have pelvic, bladder spasms after I pee; Peeing frequently; bacterial uti; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) dose 1, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bacterial uti on 24Mar2021, experienced pelvic, bladder spasms after she peed and peed frequently on an unspecified date. No fever. It was reported that, patient due for second Pfizer vaccine tomorrow. Patient enquired if she could still get her 2nd vaccine tomorrow. The patient was treated with nitrofurantoin mono. MCR 100 MG (MACROBID) as a result of bacterial uti. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Intense left arm pain; Intense left arm pain resulting in aninability to move it; Body aches; Upset stomach; This is a spontaneous report received from a contactable consumer, the patient. A 17-year-old male 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 24Mar2021 at 15:45 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to the vaccination. The patient was only allergic to Hazelnuts. Concomitant medication included sarecycline hydrochloride (SEYSARA) for unknown indication from unknown date. 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 25Mar2021 at 08:00, the patient experienced intense left arm pain resulting in an inability to move it or else there was excruciating pain. The patient also experienced full body aches and upset stomach. 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 intense left arm pain, intense left arm pain resulting in an inability to move it, body aches and upset stomach were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Chills (to the point of shaking); Nausea; Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 as a single dose (at the age of 49-year-old) for COVID-19 immunisation. Relevant past drug history included received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248), via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 49-year-old) as a first single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within two weeks of vaccination included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), all for unknown indication and from unknown date. On 25Mar2021 at 01:30, the patient experienced chills (to the point of shaking) for 3 hours, nausea, headache and body aches. The patient did not receive any treatment for the reported 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 chills (to the point of shaking), nausea, headache and body aches were resolving.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills; Aches; 100 degree fever; Tired; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at an age of 58-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 03Mar2021 at 17:30 (at an age of 58-years-old), as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 08:00, the patient experienced chills, aches, 100-degree fever, tired and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of chills, aches, 100-degree fever, tired and headaches were not resolved.   No follow-up attempts are needed. No further information is expected.