chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fowler's position
Clinical narrative: Intense lower back pain; could only sleep sitting up; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), via an unspecified route of administration on the left arm on 16Mar2021 at 10:00 (at the age of 76-year-old), as a single dose for COVID-19 immunisation. The patient reported that no medical history. Concomitant medications included simvastatin (ZOCOR), Vitamin D (MANUFACTURER UNKNOWN) (not specified), 81 mg aspirin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE) for unknown indication. 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. On 16Mar2021 at 15:00 (about 4 hours after shot), the patient experienced intense lower back pain which began. She could not stand up straight, walk at 45-degree angle for 3 days and could only sleep be sitting up. The patient did not take any treatment 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 the events intense lower back pain and sleep sitting up were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Sunburn
Clinical narrative: sun sensitivity; skin burned beyond a normal sunburn on chest and arms; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533), via unspecified route of administration in the right arm on 25Mar2021 at 09:30 (at an age of 51-year-old) as a single dose for COVID-19 immunisation. The patient medical history included rheumatoid arthritis, psoriatic arthritis and thyroid disease. The patient was allergic to penicillin, codeine, morphine and latex. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 150 mcg daily from an unknown date and for an unknown indication. 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 26Mar2021 at 16:00, the day after COVID-19 vaccine, the patient became severely sun sensitive as the patient works outside and wear sunblock regularly, skin was burned beyond a normal sunburn on chest and arms, but strangely not on face and neck. The patient did not receive any treatment for the events experienced. 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 sun sensitive and skin burned beyond a normal sunburn on chest and arms was resolving at the time of report.    No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 61-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 25Mar2021 at 11:00 as a single dose (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was not reported. The patient had known allergies to morphine. The patient received unspecified medication within 2 weeks of vaccination. 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 25Mar2021 at 12:15, the patient experienced injection site soreness. No therapeutic measures were taken as a result of the event. The 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 injection site soreness was recovering, at the time of this report.   No follow up attempts are needed; Information on lot/ batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old-non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7553), via an unspecified route of administration in the left arm on 26Mar2021 at 14:30 (at the age of 43-years-old) as a single dose for COVID-19 Immunisation. Medical history included paroxysmal supraventricular tachycardia. Concomitant medication included propranolol (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. 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. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.  On 26Mar2021 at 16:00 (within one and half hour after receiving the vaccination), the patient experienced nausea and headache. The patient reported that the events nausea and headache and It had been just over five hours and these symptoms persist. The patient did not receive any treatment for the reported event. 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 nausea and a headache was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Skin disorder, Skin exfoliation
Clinical narrative: Dry skin on hands; flaky skin on hands; Skin issues on my hands : picks on everything; Skin issues on my hands: dry, flaky, picks on everything, covering tips of fingers.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic headaches, some seasonal allergies, tree nuts allergy and adhesive allergy; all from unknown dates. The patient previously took amoxicillin for unknown indication from unknown date and experienced drug allergy. Four weeks prior to the COVID vaccine, the patient received hepatitis A (MANUFACTURER UNKNOWN) administered in the right arm on 23Feb2021. The medications received within 2 weeks of vaccination included doxycycline (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D), desvenlafaxine fumarate (MANUFACTURER UNKNOWN), ubrogepant (UBRELVY), ibuprofen (IBUPROFEN); all started on unknown date for unknown indication. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient developed skin issues on hands: it was dry, flaky and picked on everything, tried lotions, covering tips of fingers. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient tried lotions as treatment for the reported events. The clinical outcome of the dry skin, flaking skin, skin disorder and exfoliation on fingertips were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Bone pain, Decreased appetite, Diarrhoea
Clinical narrative: high fever; trembling; pain when breathing; bone pain; severe sweating; nausea; diarrhea; weakness; loss of appetite; back pain; stabbing pains in my lungs; headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep6955), via an unspecified route of administration in the right arm on 23Mar2021 at 11:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Medical history included scleroderma and crest syndrome. Concomitant medications included losartan (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and isosorbide (MANUFACTURER UNKNOWN); all for unspecified indications from unknown date. The patient did not receive any other vaccines within the 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 24Mar2021 at 03:00, the patient experienced high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Painful respiration, Pulmonary pain
Clinical narrative: high fever; trembling; pain when breathing; bone pain; severe sweating; nausea; diarrhea; weakness; loss of appetite; back pain; stabbing pains in my lungs; headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep6955), via an unspecified route of administration in the right arm on 23Mar2021 at 11:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Medical history included scleroderma and crest syndrome. Concomitant medications included losartan (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and isosorbide (MANUFACTURER UNKNOWN); all for unspecified indications from unknown date. The patient did not receive any other vaccines within the 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 24Mar2021 at 03:00, the patient experienced high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: high fever; trembling; pain when breathing; bone pain; severe sweating; nausea; diarrhea; weakness; loss of appetite; back pain; stabbing pains in my lungs; headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep6955), via an unspecified route of administration in the right arm on 23Mar2021 at 11:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Medical history included scleroderma and crest syndrome. Concomitant medications included losartan (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and isosorbide (MANUFACTURER UNKNOWN); all for unspecified indications from unknown date. The patient did not receive any other vaccines within the 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 24Mar2021 at 03:00, the patient experienced high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Steady headache; arm only slightly sore around injection site; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via an unspecified route of administration on left arm on 25Mar2021 at 09:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to compazine and codeine. The patient had received concomitant medications within two weeks of vaccination. The patient did not receive any other vaccination within four 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 for COVID-19. On 25Mar2021 at 10:00, the patient experienced sore arm and on 26Mar2021, the patient experienced steady headache that did not respond to ibuprofen but not debilitating, and arm only slightly sore around injection site. The patient was treated with ibuprofen (MANUFACTURER UNKNOWN) for steady headache. The patient did not receive any treatment for the events sore arm and arm only slightly sore around injection site. The 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 the events sore arm, steady headache that does not respond to ibuprofen but not debilitating and arm only slightly sore around injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear pain, Fatigue, Headache
Clinical narrative: extremely tired; super lathargic,; sore throat started; Fever was ranging between 101-102 degrees; chills; headache; nausea; glands in neck on left side swollen; Day 1 (day after getting vaccine) woke up with severe pain next to the left ear Day 2: same pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) in the left arm 21Mar2021 at 13:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Patient medical history included high cholesterol and eczema. Concomitant medications included norethindrone (NORTREL) and sertraline (MANUFACTURER UNKNOWN) both for unknown indications from unknown dates received within 2 weeks of vaccination. The patient did not receive any other vaccines within four 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 undergone a COVID-19 nasal swab test and the result is pending. The patient reported no known allergies to medications, food, or other products. On 22Mar2021 at 06:00 am, the patient had severe ear pain next to the left ear, on 24Mar2021, the patient had glands in neck on left side swollen and hurt to touch, sore throat, fever at 101-102 degrees, chills, headache and nausea, on 25Mar2021, the patient was not able to get out of bed, the patient also had fever at 102 degrees, sore throat and was super lethargic and on 26Mar201, the patient woke up with throat on fire and extremely tired. The events resulted in emergency room visit/ doctor or other healthcare professional office visit. Therapeutic measures taken as a result of the events ear pain, painful lymphadenopathy, sore throat, fever, chills, headache, nausea, lethargy and tiredness included treatment with TYLENOL extra strength. The patient underwent lab tests and procedures, which included COVID nasal swab test on 26Mar2021 and the report was pending, on 26Mar2021, the patient had strep test and the result was negative. The clinical outcome of the event severe ear pain was resolved on 24Mar2021, the clinical outcome of events headache and nausea was resolved on 25Mar2021. The clinical outcome of the events painful lymphadenopathy, sore throat, chills, lethargic, tiredness and fever was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: extremely tired; super lathargic,; sore throat started; Fever was ranging between 101-102 degrees; chills; headache; nausea; glands in neck on left side swollen; Day 1 (day after getting vaccine) woke up with severe pain next to the left ear Day 2: same pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) in the left arm 21Mar2021 at 13:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Patient medical history included high cholesterol and eczema. Concomitant medications included norethindrone (NORTREL) and sertraline (MANUFACTURER UNKNOWN) both for unknown indications from unknown dates received within 2 weeks of vaccination. The patient did not receive any other vaccines within four 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 undergone a COVID-19 nasal swab test and the result is pending. The patient reported no known allergies to medications, food, or other products. On 22Mar2021 at 06:00 am, the patient had severe ear pain next to the left ear, on 24Mar2021, the patient had glands in neck on left side swollen and hurt to touch, sore throat, fever at 101-102 degrees, chills, headache and nausea, on 25Mar2021, the patient was not able to get out of bed, the patient also had fever at 102 degrees, sore throat and was super lethargic and on 26Mar201, the patient woke up with throat on fire and extremely tired. The events resulted in emergency room visit/ doctor or other healthcare professional office visit. Therapeutic measures taken as a result of the events ear pain, painful lymphadenopathy, sore throat, fever, chills, headache, nausea, lethargy and tiredness included treatment with TYLENOL extra strength. The patient underwent lab tests and procedures, which included COVID nasal swab test on 26Mar2021 and the report was pending, on 26Mar2021, the patient had strep test and the result was negative. The clinical outcome of the event severe ear pain was resolved on 24Mar2021, the clinical outcome of events headache and nausea was resolved on 25Mar2021. The clinical outcome of the events painful lymphadenopathy, sore throat, chills, lethargic, tiredness and fever was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Streptococcus test
Clinical narrative: extremely tired; super lathargic,; sore throat started; Fever was ranging between 101-102 degrees; chills; headache; nausea; glands in neck on left side swollen; Day 1 (day after getting vaccine) woke up with severe pain next to the left ear Day 2: same pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) in the left arm 21Mar2021 at 13:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Patient medical history included high cholesterol and eczema. Concomitant medications included norethindrone (NORTREL) and sertraline (MANUFACTURER UNKNOWN) both for unknown indications from unknown dates received within 2 weeks of vaccination. The patient did not receive any other vaccines within four 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 undergone a COVID-19 nasal swab test and the result is pending. The patient reported no known allergies to medications, food, or other products. On 22Mar2021 at 06:00 am, the patient had severe ear pain next to the left ear, on 24Mar2021, the patient had glands in neck on left side swollen and hurt to touch, sore throat, fever at 101-102 degrees, chills, headache and nausea, on 25Mar2021, the patient was not able to get out of bed, the patient also had fever at 102 degrees, sore throat and was super lethargic and on 26Mar201, the patient woke up with throat on fire and extremely tired. The events resulted in emergency room visit/ doctor or other healthcare professional office visit. Therapeutic measures taken as a result of the events ear pain, painful lymphadenopathy, sore throat, fever, chills, headache, nausea, lethargy and tiredness included treatment with TYLENOL extra strength. The patient underwent lab tests and procedures, which included COVID nasal swab test on 26Mar2021 and the report was pending, on 26Mar2021, the patient had strep test and the result was negative. The clinical outcome of the event severe ear pain was resolved on 24Mar2021, the clinical outcome of events headache and nausea was resolved on 25Mar2021. The clinical outcome of the events painful lymphadenopathy, sore throat, chills, lethargic, tiredness and fever was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Itchy bump at injection site; Small, round bump atinjection site; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 18Mar2021 at 13:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported. Concomitant medications included fluconazole (MANUFACTURER UNKNOWN), ibuprofen sodium (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE) and cyclobenzaprine hydrochloride (FLEXERIL) taken for unknown indications from unspecified dates. 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-19 vaccine. On 25Mar2021, the patient experienced slight headache on the seventh- and eighth-day post vaccine. On 26Mar2021 at 22:00, the patient experienced a small, round bump at injection site (vaccination site lump) and itchy bump at injection site (vaccination site pruritus) approximately half an inch in diameter which appeared on the eighth day post vaccine. The patient did not receive any therapeutic measures 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 event slight headache and small, round, itchy bump at injection site was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: debilitating; continuous headache; intermittent chills; Body aches; fatigue; malaise; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain and compromised immune system due to liver transplant. Concomitant medications included entecavir monohydrate (ENTECAVIR), tacrolimus (MANUFACTURER UNKNOWN), oxycodone (MANUFACTURER UNKNOWN) and morphine sulphate (MANUFACTURER UNKNOWN) for unknown indications. The patient had a history of allergy to bee stings. 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. The patient had not been tested for COVID-19 since having the vaccine. On 20Mar2021 at 07:00, the patient experienced debilitating, continuous headache for 7 straight days, intermittent chills/sweats, body aches, fatigue and malaise. Adverse events had resulted in doctor or other healthcare professional office/clinic visit. The patient had not received any therapeutic measures for the adverse events. The clinical outcome of the events debilitating, continuous headache for 7 straight days, intermittent chills/sweats, body aches, fatigue and malaise was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: debilitating; continuous headache; intermittent chills; Body aches; fatigue; malaise; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain and compromised immune system due to liver transplant. Concomitant medications included entecavir monohydrate (ENTECAVIR), tacrolimus (MANUFACTURER UNKNOWN), oxycodone (MANUFACTURER UNKNOWN) and morphine sulphate (MANUFACTURER UNKNOWN) for unknown indications. The patient had a history of allergy to bee stings. 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. The patient had not been tested for COVID-19 since having the vaccine. On 20Mar2021 at 07:00, the patient experienced debilitating, continuous headache for 7 straight days, intermittent chills/sweats, body aches, fatigue and malaise. Adverse events had resulted in doctor or other healthcare professional office/clinic visit. The patient had not received any therapeutic measures for the adverse events. The clinical outcome of the events debilitating, continuous headache for 7 straight days, intermittent chills/sweats, body aches, fatigue and malaise was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Headache, Hordeolum, Lymphadenopathy
Clinical narrative: stabbing pain in eye; stye forming; ulceration under eyelid; pinky toe; Headache; Earache; Swollen gland in neck; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received the first dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: EN6203) via an unspecified route of administration in the left arm on 06Mar2021 at 06:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Mar2021 at 18:00 the patient had experienced headache, earache, glands swollen and on 14Mar2021, she had pinky toe, stabbing pain in eye, stye forming which followed by ulceration under eyelid. It was reported that all events occurred on left side of body and lasted for 2 days moving from a different area each time. Adverse events resulted in the doctor or other healthcare professional office/clinic visit. The patient was treated with gentamicin for the reported events. The patient underwent COVID-19 virus test post vaccination, which included SARS-CoV-2 RT PCR (Nasal swab) test on 15Mar2021 and the result was found to be negative. The clinical outcome of the events headache, earache, swollen gland in neck, pinky toe, stabbing pain in eye, stye forming and ulceration under eyelid was resolved in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin discolouration, Ulcer
Clinical narrative: stabbing pain in eye; stye forming; ulceration under eyelid; pinky toe; Headache; Earache; Swollen gland in neck; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non pregnant female patient received the first dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: EN6203) via an unspecified route of administration in the left arm on 06Mar2021 at 06:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Mar2021 at 18:00 the patient had experienced headache, earache, glands swollen and on 14Mar2021, she had pinky toe, stabbing pain in eye, stye forming which followed by ulceration under eyelid. It was reported that all events occurred on left side of body and lasted for 2 days moving from a different area each time. Adverse events resulted in the doctor or other healthcare professional office/clinic visit. The patient was treated with gentamicin for the reported events. The patient underwent COVID-19 virus test post vaccination, which included SARS-CoV-2 RT PCR (Nasal swab) test on 15Mar2021 and the result was found to be negative. The clinical outcome of the events headache, earache, swollen gland in neck, pinky toe, stabbing pain in eye, stye forming and ulceration under eyelid was resolved in Mar2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Couldnt lift my right arm where Ireceived my shot. It is swollen andsore and hurts to move at all; Couldnt lift my right arm where Ireceived my shot. It is swollen andsore and hurts to move at all; Couldnt lift my right arm where Ireceived my shot. It is swollen andsore and hurts to move at all; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Pfizerer8727), via an unspecified route of administration in the right arm on 26Mar2021 at 18:30, as a single dose for COVID-19 immunisation. Medical history included grass allergy, allergy to cats and penicillin allergy (some penicillin-based medicines). Concomitant medications included isotretinoin (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN) and probiotic NOS (PROBIOTIC). The patient previously received doxycycline for an unknown indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 07:30, the patient woke up in the morning after her shot, and she could not lift her right arm where she received her shot. It was swollen and sore and hurts to move at all. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes of the events pain in right arm, swollen arm and pain upon movement were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Pain
Clinical narrative: Cough; Chills; Fatigue; Body aches; Joint pain / joints below waist ache; Low grade fever; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) as solution for injection on the left arm, on 25Mar2021 at 14:00 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient had no past medical history as the patient was very healthy middle-aged man. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) as solution for injection on the left arm, on 04Mar2021 at 14:00 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 (within 12 hours of vaccination), the patient experienced chills, fatigue, body aches, joints below waist ache and low-grade fever. On 27Mar2021 (36 hours of vaccination), the patient experienced slight cough. The patient did not receive any treatment for the reported adverse events. The clinical outcome for events chills, fatigue, general body pain, joint pain, low grade fever and cough were resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cough; Chills; Fatigue; Body aches; Joint pain / joints below waist ache; Low grade fever; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) as solution for injection on the left arm, on 25Mar2021 at 14:00 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient had no past medical history as the patient was very healthy middle-aged man. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) as solution for injection on the left arm, on 04Mar2021 at 14:00 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 (within 12 hours of vaccination), the patient experienced chills, fatigue, body aches, joints below waist ache and low-grade fever. On 27Mar2021 (36 hours of vaccination), the patient experienced slight cough. The patient did not receive any treatment for the reported adverse events. The clinical outcome for events chills, fatigue, general body pain, joint pain, low grade fever and cough were resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle spasms in legs, moved to ribs, hands, feet, forehead, back, and arms.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 15.45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included alprazolam (XANAX) and sulfasalazine (MANUFACTURER UNKNOWN); both from unknown date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 , the day after the received the first shot, the patient experienced muscle spasms on his legs which had moved to his ribs, hands, feet, forehead, back, and arms and it was reported that there had not been a day since the initial shot that the patient had not experienced the event. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event muscle spasms was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful lymph node left armpit; Swollen, painful lymph node left armpit; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male 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 13:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, moderate sleep apnoea and seasonal pollen allergies. 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 for COVID-19. Concomitant medications included meloxicam 15mg (MANUFACTURER UNKNOWN) and pravastatin 50mg (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. 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 04Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 at 21:00, the patient had swollen, painful lymph node left armpit and this had persisted longer than other symptoms. 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 swollen, painful lymph node left armpit. The clinical outcomes of the events swollen, painful lymph node left armpit were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Occipital neuralgia, Pain in extremity, Spinal pain
Clinical narrative: occipital neuralgia; body heat; Aches in my legs; Spinal pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), in left arm on 11Mar2021 at 05:15 (at the age of 75-year-old), as single dose for COVID-19 immunisation. Medical history of the patient included lyme disease, trigeminal neuralgia and meningioma. The patient was allergic to some unspecified antibiotics. The concomitant medications were not reported. 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 vaccination, the patient was not tested for COVID-19. On an unspecified date in Mar2021, the patient experienced occipital neuralgia, body heat, aches in legs, spinal pain and fatigue. No treatment was received 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 occipital neuralgia, body heat, aches in legs, spinal pain and fatigue was not recovered at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspepsia, Fatigue, Headache
Clinical narrative: severe heartburn; Headache; Chills; joint pain; muscle aches and pains; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, breast cancer in 2010, hearing impairment. The patient was allergic to NSAID. Concomitant medications included ibandronate (MANUFACTURER UNKNOWN), niacinamide (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. 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 left arm on 13Jan2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 03Feb2021 at 22:00, the patient experienced severe heartburn, headache, chills, joint pain, muscle aches and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events heartburn, headache, chills, joint pain, muscle aches and fatigue were recovered with sequelae on an unknown date.   No follow-up attempts are needed; Information about lot number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe heartburn; Headache; Chills; joint pain; muscle aches and pains; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, breast cancer in 2010, hearing impairment. The patient was allergic to NSAID. Concomitant medications included ibandronate (MANUFACTURER UNKNOWN), niacinamide (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. 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 left arm on 13Jan2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 03Feb2021 at 22:00, the patient experienced severe heartburn, headache, chills, joint pain, muscle aches and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events heartburn, headache, chills, joint pain, muscle aches and fatigue were recovered with sequelae on an unknown date.   No follow-up attempts are needed; Information about lot number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Feverish; headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the right arm on 25Mar2021 at 14:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, fatty liver disease and COVID-19. The patient took unspecified medication within two weeks. 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 the vaccination, the patient was diagnosed with COVID-19.Since the vaccination, the Patient had not tested for COVID-19. On 26Mar2021 at 14:00, the patient experienced body aches, feverish and headache. The patient did not receive treatment for the reported events. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events body aches, feverish and headache were recovering.   No follow-up attempts are needed. No further information is expected.