chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Feeling cold, Gait disturbance, Hepatic pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration in the left arm on 19Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 27Feb2021 at 16:30 as a single dose for COVID-19 immunisation. On 19Mar2021 at 23:00, the patient had little soreness in the injection spot. She went to bed around 21:30, but she was awoken around 23:00 because she was feeling extremely cold, even after putting on layers, her electric heating blanket at the highest temperature, and She was under a down comforter. Then the scary part was her organs started to feel heavy and sore. Her lungs, liver, heart, kidneys were weighing down inside. It was difficult for her to get up and walk because she felt like she would damage an organ(s). On 20Mar2021, the patient had a fever for most of the day, and her kidneys were in so much pain. The patient tried stretching, and sleeping it off. Did not work. She drank turmeric tea and a tall glass of water with sodium chloride, himalayan pink salt, and baking soda. The pain started to subside by evening. On 21Mar2021, the patient felt much better, but had a migraine all day and felt very weak. Her kidneys were sore. The patient did not receive any treatment for events. The clinical outcome of the events Feeling extremely cold, Organs started to feel heavy and sore, Liver pain, Organs started to feel heavy and sore, Lungs pain, Organs started to feel heavy and sore, Heart pain, Difficult to get up and walk, Kidneys pain, Migraine all day, felt very weak, Soreness in the injection spot and Fever were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pulmonary pain, Pyrexia, Renal pain, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration in the left arm on 19Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 27Feb2021 at 16:30 as a single dose for COVID-19 immunisation. On 19Mar2021 at 23:00, the patient had little soreness in the injection spot. She went to bed around 21:30, but she was awoken around 23:00 because she was feeling extremely cold, even after putting on layers, her electric heating blanket at the highest temperature, and She was under a down comforter. Then the scary part was her organs started to feel heavy and sore. Her lungs, liver, heart, kidneys were weighing down inside. It was difficult for her to get up and walk because she felt like she would damage an organ(s). On 20Mar2021, the patient had a fever for most of the day, and her kidneys were in so much pain. The patient tried stretching, and sleeping it off. Did not work. She drank turmeric tea and a tall glass of water with sodium chloride, himalayan pink salt, and baking soda. The pain started to subside by evening. On 21Mar2021, the patient felt much better, but had a migraine all day and felt very weak. Her kidneys were sore. The patient did not receive any treatment for events. The clinical outcome of the events Feeling extremely cold, Organs started to feel heavy and sore, Liver pain, Organs started to feel heavy and sore, Lungs pain, Organs started to feel heavy and sore, Heart pain, Difficult to get up and walk, Kidneys pain, Migraine all day, felt very weak, Soreness in the injection spot and Fever were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Hypoaesthesia, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in hands; Tingling lips,; Lips felt swollen but it was not noticeable.; Forehead felt numb; Disorientation; 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: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 20:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included recurring Epstein Barr virus, burning mouth syndrome, anxiety, osteoarthritis and COVID-19. The patient was allergic to mercury, pollen and penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), cetirizine (ZYRTEC), folic Acid (MANUFACTURER UNKNOWN), and alpha lipoic acid (MANUFACTURER UNKNOWN); all for unknown indications from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 20:45, the patient experienced tingling in hands, tingling lips, lips felt swollen but it was not noticeable, forehead felt numb and disorientation. The patient was advised to take BENADRYL for treatment of the adverse 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 tingling in hands, tingling lips, lips felt swollen but it was not noticeable, forehead felt numb and disorientation were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 0.17
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite
Clinical narrative: loss of appetite lasting 36 hours; chills; complete loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: Unknown), via an unknown route of administration in the left arm 19Mar2021 at 11:30 (at the age of 66 years-old) as a single dose for COVID-19 immunisation. Medical history included progressive multiple sclerosis, radical prostatectomy and basal cell carcinoma. The concomitant medication included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), tolterodine (MANUFACTURER UNKNOWN), donepezil (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN), all for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food or other products. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On, 20Mar2021, the patient experienced chills, loss of energy and loss of appetite. 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 event, chills, loss of energy and loss of appetite was recovered on an unknown date in Mar2021.    Information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: Facial numbness in cheeks, chin and around eyes; Facial numbness in cheeks, chin and around eyes; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old adult non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EP6955) via an unspecified route of administration on 20Mar2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included birth control on an unknown date. It was unknown whether the patient had any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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. On 20Mar2021, patient experienced facial numbness in cheeks, chin and around eyes. Lasted 2-3 hours. Felt like face does after dentist numbing wears off. 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 outcome of the event's facial numbness in cheeks, chin and around eyes was recovered on 20Mar2021.   No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Muscle aches; chills; Fever; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8730), via an unspecified route of administration in the right arm on 20Mar2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included stomach issues, arthritis, asthma and penicillin allergy. Concomitant medications included Omeprazole (MANUFACTURER: UNKNOWN) received within 2 weeks of medication as acid reducer from an unknown date. The Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730) via an unspecified route of administration in the right arm on 27Feb2021 at 14:00 as a single dose for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 On 21Mar2021 at 14:00, the patient experienced Muscle aches, chills, headache, fatigue and fever (101.8) started about 12 hours after the shot (during the night), fever went down with tylenol followed by next day 99.9 on second night slept all day. Therapeutic measures were taken as a result of fever and included treatment with tylenol. The clinical outcome of the Muscle aches, chills, headache, fatigue and fever was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle aches; chills; Fever; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8730), via an unspecified route of administration in the right arm on 20Mar2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included stomach issues, arthritis, asthma and penicillin allergy. Concomitant medications included Omeprazole (MANUFACTURER: UNKNOWN) received within 2 weeks of medication as acid reducer from an unknown date. The Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730) via an unspecified route of administration in the right arm on 27Feb2021 at 14:00 as a single dose for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 On 21Mar2021 at 14:00, the patient experienced Muscle aches, chills, headache, fatigue and fever (101.8) started about 12 hours after the shot (during the night), fever went down with tylenol followed by next day 99.9 on second night slept all day. Therapeutic measures were taken as a result of fever and included treatment with tylenol. The clinical outcome of the Muscle aches, chills, headache, fatigue and fever was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Clogged; Right hear started ringing; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248) via an unspecified route of administration on the left arm on 13Jan2021 at 12:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high cholesterol. The patient had a known allergy to penicillin. The concomitant medication included metformin 500mg (MANUFACTURER UNKNOWN) taken for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 15Jan2021, the patient experienced right ear started ringing and was clogged. The patient checked with a physician but nothing was found, there was no wax or infections. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events and included treatment with antibiotics and sinus medication, but nothing worked. The clinical outcome of the events right ear ringing and clogged ear was not recovered 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: Pyrexia
Clinical narrative: Low fever 100.5 F; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Mar2021 at 12:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history reported as not applicable. Concomitant medications were not reported. Th patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL-3247), via an unspecified route of administration in the left arm on 24Feb2021 at 12:00 (at the age of 48-years-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 was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Mar2021 at 13:00, the patient had low fever 100.5 F. Therapeutic measures were taken as a result of event low grade fever and included treatment with two ADVIL tablets. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of event low fever 100.5 F was resolved on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously 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 25Feb2021 at 14:30 (at the age of 22-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. On 20Mar2021 at 03:00, the patient experienced sore throat, fever, chills and body aches. Therapeutic measures were taken as a result of events and included treatment with Advil. 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 sore throat, fever, chills and body aches was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears, not extremely loud, aggravating.; This is a spontaneous report from a contactable consumer. A 71-year-old female non-pregnant patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/Batch No.EN5318) via the left arm on 18Feb2021 at 1200 as a single dose for COVID-19 immunisation. The patients medical history includes hypertension, cholesterol. concomitant medications included biotin, vitamin B 12, D3 for an unknown indication and allergies to medications, food, or other products include bactum. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/Batch No.EN5318) via the left arm on 28Jan2021 at 1200 as a single dose for COVID-19 immunisation.. The patient was not diagnosed with  COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested positive for COVID-19 since having the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. The adverse event was treated with B12.  On 18Feb2021 at 0600, the patient experienced ringing in both ears, not extremely loud, aggravating. The clinical outcome of the reaction was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, SARS-CoV-2 test
Clinical narrative: I have always had minor psoriasis, about 5 days after the first Pfizer vaccine I had a full scalp psoriasis issue. Had to shampoo with coal tar shampoo to get it to go away; This is a spontaneous report from a contactable consumer. A 61-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 61-years-old) at 15:00 as a single dose for COVID-19 immunisation. Medical history includes psoriasis and ovarian cysts. Concomitant medications included ramipril 2.5 mg once daily (MANUFACTUERER UNKNOWN), folic acid 1mg once daily (MANUFACTURER UNKNOWN), calcium magnesium citrate 10 ml twice daily (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN) 2000 units twice daily, CoQ10 200 mg once daily (MANUFACTURER UNKNOWN), MSM 1000mg once daily (MANUFACTURER UNKNOWN), EFA twice daily (MANUFACTURER UNKNOWN), multivitamin once daily, (MANUFACTURER UNKNOWN) claritin once daily (MANUFACTURER UNKNOWN), budesonide (MANUFACTURER UNKNOWN), albuterol (MANUFACTURER UNKNOWN), azestiline (MANUFACTURER UNKNOWN). Patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent nasal swab test (for COVID-19) on 12Mar2021 and the result was positive. On 07Mar2021, the patient experienced minor psoriasis and approximately after five days of vaccination, the patient had a full scalp psoriasis issue. Therapeutic measure for the adverse event included the use of a coal tar shampoo. 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 psoriasis was recovered on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Tinnitus
Clinical narrative: Small bouts of diarrhea; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 33 year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Eh6705) via an unknown route of administration in the left arm on 11Mar2021(at an age of 33 year-old) at 12:15 as a single dose for COVID-19 immunisation.  Medical history of the patient was not reported. The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN), daily multivitamin (MANUFACTURER UNKNOWN) all for unknown indication. The patient did not receive any other vaccine within 4 weeks, prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Mar2021, the patient experienced diarrhea and on an unknown date in Mar2021 the patient experienced tinnitus. The patient reported mid tinnitus was not constant; which came and went. The patient did not receive any treatment for the events. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of mild tinnitus  resolved with sequelae on an unknown date in Mar2021 while the clinical outcome of the event diarrhoea was resolved with sequelae on 12Mar2021 .    No follow-up attempts are needed. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site erythema
Clinical narrative: Reddness at injection site from shoulder and down to elbow.; Itchy; Periodically painful; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 13Mar2021, (at the age of 92-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer and lumpectomy. The patient was allergic to codeine and penicillin. Concomitant medications included levothyroxine (SYNTHROID), calcium carbonate (CALTRATE), biotin (MANUFACTURER UNKNOWN), vit D (MANUFACTURER UNKNOWN), fibre (MANUFACTURERE UNKNOWN), docusate (COLASA) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced redness at injection site from shoulder and down to elbow, itchy and periodically painful. A polysporin ointment on arm was taken as therapeutic measure for event redness at injection site from shoulder and down to elbow, itchy and periodically painful. 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 redness at injection site from shoulder and down to elbow, itchy and period painful were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea, Somnolence, Vomiting
Clinical narrative: Vomited 4 times; nausea; severe abdominal pain; diarrhea; extremely drowsy; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 20Mar2021 at 8:00 (at the age of 33-years) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. The patient did not receive any other vaccines within four weeks. On 20Mar2021 at 12:00, the patient was extremely drowsy. On 21Mar2021, the patient experienced abdominal pain and diarrhea. On 22Mar2021, the patient vomited 4 times overnight and continued to have sharp abdominal pain, diarrhea and nausea. The adverse events resulted in doctor or other healthcare professional office/clinic visit/ emergency visit. It was unknown if therapeutic measures were taken as a result of the events. The clinical outcome of the events extremely drowsy, abdominal pain, diarrhea, vomiting and nausea was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Injection site bruising, Neck pain, Pain
Clinical narrative: Severe headache; Pain in neck; Burning and pain; Sore arm; Bruised at injection site; Back ache; Leg ache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via unknown route in the right arm on 19Mar2021 at 11:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included NEXPLANON implanted birth control, ibuprofen (MANUFACTURER UNKNOWN). The patient did not report any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient had allergy to penicillin and any medications based, flagyl. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 19Mar2021 at 11:15, the patient experienced burning and pain in the injected arm, shooting sharp pain down to wrist, sore and bruised injection site, severe headache, other body aches; both arms, neck, back and legs. The patient reported burning and pain in the injected arm during injection and up to 45 mins after until 800mg of ibuprofen (MANUFACTURER UNKNOWN) was administered. The patient also reported shooting sharp pain down to wrist in the injected arm which lasted for 15 mins. 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 burning and pain in the injected arm, shooting sharp pain down to wrist, sore and bruised injection site, severe headache, other body aches; both arms, neck, back and legs was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe headache; Pain in neck; Burning and pain; Sore arm; Bruised at injection site; Back ache; Leg ache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via unknown route in the right arm on 19Mar2021 at 11:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included NEXPLANON implanted birth control, ibuprofen (MANUFACTURER UNKNOWN). The patient did not report any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient had allergy to penicillin and any medications based, flagyl. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 19Mar2021 at 11:15, the patient experienced burning and pain in the injected arm, shooting sharp pain down to wrist, sore and bruised injection site, severe headache, other body aches; both arms, neck, back and legs. The patient reported burning and pain in the injected arm during injection and up to 45 mins after until 800mg of ibuprofen (MANUFACTURER UNKNOWN) was administered. The patient also reported shooting sharp pain down to wrist in the injected arm which lasted for 15 mins. 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 burning and pain in the injected arm, shooting sharp pain down to wrist, sore and bruised injection site, severe headache, other body aches; both arms, neck, back and legs was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Soreness and pain in lymph node under right armpit; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration in the left arm on 26Feb2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. 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 20Mar2021, the patient experienced soreness and pain in lymph node under right armpit. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event was unknown. The clinical outcome of the event lymph node pain was not resolved 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: Myalgia
Clinical narrative: Muscle soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The concomitant medication included TYLENOL and unspecified medications for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021 at 19:00, the patient experienced muscle soreness in left arm for approximately 24 hours and cleared up the next day. The patient did not receive any treatment for the reported 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 muscle soreness was resolved on 11Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Acute onset of Raynaud's syndrome; This is a spontaneous report received from a contactable physician, the patient. A 73-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 16Jan2021 (age at vaccination 73-year-old), as single dose for COVID-19 immunisation. Medical history included parkinson's, congestive heart failure, pacemaker insertion. The patient had no allergies to medications, food, or other products. Concomitant medication included Metoprolol (MANUFACTURER UNKNOWN), Entresto, Flomax, Sinimet, Finasteride (MANUFACTURER UNKNOWN), Amantadine (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date.   The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route in left arm of administration on 26Dec2020 (age at vaccination 73-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 been tested for COVID-19. On 19Feb2021 at 19:00, the patient experienced acute onset of Raynaud's syndrome with severe cold sensitivity in both hands. Therapeutic measures were taken with respect to Raynauds syndrome that included Tadalafil, Topical Nirol paste on an unknown date. The patient reported that he consulted a rheumatologist and evaluation for underlying CTD (Connective Tissue Diseases) was normal. The patient reported that he had no personal or family history of rash, arthritis, etc. and that there were no changes in medications. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of Raynaud's syndrome was not resolved at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Vaccination site pain
Clinical narrative: Knot formed at injection site; Redness around injection site, bigger than a quarter; Injection site is itchy; Injection site mild soreness; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the right arm on 13Mar2021 at 12:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and type 2 diabetes. The patient was allergic to the drug flagyl. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN), synjardy (MANUFACTURER UNKNOWN) and black cohosh, all for unknown indications and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021, 7 to 8 days after injection, the patient developed knot at the injection site. The patient also developed redness around injection site, bigger than a quarter and was itchy with mild soreness. It was reported that this reaction occurred after the patient started exercising and was exposed to sun. 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 injection site lump, injection site redness, injection site itchy and injection site mild soreness was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Gait inability, Vertigo
Clinical narrative: fell; balance problem; Extreme Vertigo; Unable to walk; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration at right arm as a single dose on 18Mar2021 at 14:30 (at the age of 72-year-old) for COVID-19 immunisation. Relevant medical history of patient includes pancreatic cancer and received active chemo treatment and the patient had no known allergies. Concomitant medication of patient includes gabapentin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), sertraline (ZOLOFT) and unspecified chemo drugs all for an unknown indication. 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. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 08:30 after first dose of vaccination patient experienced extreme vertigo, unable to walk and on 22Mar2021 patient experienced balance problem, fell. It was reported that extreme vertigo started the next morning of vaccination. Patient was unable to walk without assistance. These lasted about 48 hours. It was now been 4 days since the vaccine and still had balance problems. Patient fell today when bending over. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Patient did not received treatment for events. The clinical outcome of extreme vertigo, unable to walk and balance problem was recovering at the time of report, fell was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache
Clinical narrative: Difficult time trying to focus; Low energy; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration to left arm on 17Mar2021 at 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 vaccination. On 18Mar2021 at 07:00, the patient experienced extreme headache, very low energy and he had a difficult time trying to focus currently (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The clinical outcome of extreme headache, very low energy and difficult time trying to focus were not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: extreme dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 19Mar2021 at 10:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and past drug history included aspirin, sulphur, ibuprofen codeine and theophylline. The patient was not diagnosed with COVID-19prior and since the vaccination was not tested for COVID-19. Concomitant medications included brio(MANUFACTURER UNKNOWN), VENTOLIN, singular(MANUFACTURER UNKNOWN), ZYRTEK. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme dizziness on 20Mar2021 at 14.00 about 24 hours after first shot. The patient had not received any treatment for the reported event. The clinical outcome of event extreme dizziness was not recovered. Information about lot number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diaphragmalgia, Pain, Vomiting
Clinical narrative: pain in stomach; Vomited once; extreme pain from diaphragm to waist.; extreme pain in torso area, from diaphragm to waist,front to back, all areas including stomach; This is a spontaneous report received from a contactable consumer, the patient. A 69-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the left arm on 15Mar2021 at 09:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. 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. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN). The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route in the left arm on 22Feb2021 at 09:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 16Mar2021 at 00:30, the patient experienced extreme pain in torso area, from diaphragm to waist, front to back all areas including stomach and vomited once. The patient felt pain and discomfort mostly at night. It was painful to lay down and to sit. The pain continued for one week. On 29Mar2021, the patient started to feel like the pain and discomfort was beginning to subside. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of events pain in torso area, from diaphragm to waist, front to back, all areas including stomach and vomiting were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Peripheral swelling
Clinical narrative: swollen underarm/armpit lymph node area left sided only; swollen underarm/ armpit lymph node area left sided only; Headache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8727), via an unspecified route of administration in the arm left on 19Mar2021 at 10:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergies to strawberries, cats, horses, hay and intolerance to Vicodin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: Unknown), via an unspecified route of administration in the arm left on 26Feb2021 at 12:00 (at the age of 30-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. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) was taken for an unknown indication from an unknown date and levonorgestrel; ethinyl estradiol (AVIANE) was taken for an unknown indication from an unknown date. The patient experienced swollen underarm/ armpit lymph node area left sided only, noticed 24 hours later but still swelling was present. On19Mar2021, headache started around 12 hours, after the vaccine and it lasted for 24 hours (reported as improved with repeated Advil use). It was reported as no longer active. It was reported that the patient did not receive any treatment for the events. The clinical outcome of headache was resolving while that of lymphadenopathy and peripheral swelling was not resolved at the time of this report. No follow-up attempts are needed. No further information was expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metal taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: er8727] via an unspecified route of administration in the right arm on 22Mar2021 at 08:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. 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. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Mar2021 at 09:00, the patient had experienced metal taste in mouth. The patient did not receive any treatment for the reported events. Adverse event 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 metal taste in mouth was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Flushing
Clinical narrative: Injection site pain; Extreme fatigue; Mild headache; Muscle pain; Chills; Flushed; Dizzy; Loss of appetite; Feel unwell; This is a spontaneous report from a consumer, the patient. A 64-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration on left arm on 13Mar2021 at 11:00, (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included epstein barre virus and high blood pressure. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), LIVALO and metoprolol (MANUFACTURER UNKNOWN) and hydroc (MANUFACTURER UNKNOWN) for unknown indication. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 13Mar2021 at 11:30, the patient experienced injection site pain, extreme fatigue, mild headache, muscle pain, chills, flushed, dizzy, loss of appetite (colon cleanse at 3rd night) and the patient felt unwell until 6th day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatments were taken for any events. The clinical outcome of the events injection site pain, extreme fatigue, mild headache, muscle pain, chills, flushed, dizzy, loss of appetite was resolved on an unknown date in Mar2021 and for event feeling unwell was resolved on 19Mar2021 (day 6).   No follow-up attempts are needed. No further information is expected.