chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fluid overload, Headache, Mobility decreased
Clinical narrative: Could barely move arms; Stomach ache; Loss of appetite; Severe hydration; Loss of sense of taste and smell; Loss of sense of taste and smell; Chills; Headache; Exhausted; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 74-year-old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; Batch/Lot Number was not reported) via an unspecified route of administration on 05Mar2021 as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 25Jan2021 for COVID-19 immunization and experienced sneeze, lost sense of taste and smell for ten days on 01Feb2021, she had tested positive for Covid-19, felt dizziness, extreme fatigue, stomach ache, really horrific headache on the frontal area, had diarrhea for two days, had checked her temperature and oximeter (92, 91, 09) for ten days. Her appointment for her second dose was put off and she was told to not get the shot until symptoms subside. On 10Feb2021, all COVID-19 signs and symptoms went away except for constant loss of taste and smell. She experienced the events till then. On 05Mar2021, nine hours later after receiving the second dose the patient reported that she could barely move her arms (mobility decreased) and had chills for hours all night. She had headache and she felt that COVID-19 came back. She also had stomach ache, loss of appetite and severe hydration. She mentioned she had no temperature and was so exhausted that she slept all day. She reported all events went away except for loss of sense of taste and smell. She called in to Pfizer because she thought these data could help. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome for the event ageusia and anosmia was not recovered and for all other events was recovered on Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269114 Same patient, different dose
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Lymphadenopathy, Malaise
Clinical narrative: Overwhelming lethargy; Swollen lymph nodes; Diarrhea; General unwellness; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EN6203) via an unspecified route of administration on 25Feb2021 as 2nd dose, single dose for Covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3247) via unspecified route of administration on 02Feb2021 as 1st dose single for Covid-19 immunization. Medical history and concomitant medications were not reported. It was unknown, if COVID prior vaccination. It was reported that patient experienced overwhelming lethargy, swollen lymph nodes, diarrhea and general unwellness that lasted for around 4 days after second dose. After first dose mention of nausea for one week afterwards. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown, patient received treatment or not. It was unknown, if COVID tested post vaccination. Patient was not pregnant. It was queried, the Pfizer US Drug safety unit recently received the attached report submitted by you via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. In Response, I overhead her casually telling another friend about having a bad reaction to the vaccine at dinner on 07Mar. As this was a group setting I waited until the following day, Monday 08Mar - at which point I had a solo phone conversation with her. At this point she provided the details I put in the event description and I communicated that it would be reported at work the following day, Tuesday 09Mar. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disease recurrence, Fatigue, Feeling abnormal, Fibromyalgia
Clinical narrative: fibromyalgia and it caused a flare up; fibromyalgia and it caused a flare up; Vertigo; Joint pain; Joint swelling; Hot flashes; Brain Fog; Headache; Fatigue extreme; severe nausea; full body itching; This is a spontaneous report received from contactable Health Care professionals (included patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration on the left arm on 13Mar2021 at 03:30 PM (at the age of 33-year-old) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD), major depression disorder (MDD). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included dextroamphetamine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), loratil (MANUFACTURER UNKNOWN). The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 13Mar2021 at 04:30 PM, the patient had fibromyalgia and it caused a flare up, vertigo, joint pain and swelling, hot flashes, brain fog, headache (feels like an ice pick hitting the top of head) and extreme fatigue. Initially, the patient had severe nausea, but it resolved itself in less than 24 hours. She also had been experiencing full body itching that only goes away if she take allergy medicine. Therapeutic measures were taken as a result of full body itching and included treatment with allergy medicine, no treatment for the other events. On an unknown date in Mar2021 patient was recovered from the event nausea. The clinical outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Joint swelling, Nausea, Pruritus
Clinical narrative: fibromyalgia and it caused a flare up; fibromyalgia and it caused a flare up; Vertigo; Joint pain; Joint swelling; Hot flashes; Brain Fog; Headache; Fatigue extreme; severe nausea; full body itching; This is a spontaneous report received from contactable Health Care professionals (included patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration on the left arm on 13Mar2021 at 03:30 PM (at the age of 33-year-old) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD), major depression disorder (MDD). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included dextroamphetamine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), loratil (MANUFACTURER UNKNOWN). The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 13Mar2021 at 04:30 PM, the patient had fibromyalgia and it caused a flare up, vertigo, joint pain and swelling, hot flashes, brain fog, headache (feels like an ice pick hitting the top of head) and extreme fatigue. Initially, the patient had severe nausea, but it resolved itself in less than 24 hours. She also had been experiencing full body itching that only goes away if she take allergy medicine. Therapeutic measures were taken as a result of full body itching and included treatment with allergy medicine, no treatment for the other events. On an unknown date in Mar2021 patient was recovered from the event nausea. The clinical outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: fibromyalgia and it caused a flare up; fibromyalgia and it caused a flare up; Vertigo; Joint pain; Joint swelling; Hot flashes; Brain Fog; Headache; Fatigue extreme; severe nausea; full body itching; This is a spontaneous report received from contactable Health Care professionals (included patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration on the left arm on 13Mar2021 at 03:30 PM (at the age of 33-year-old) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD), major depression disorder (MDD). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included dextroamphetamine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), loratil (MANUFACTURER UNKNOWN). The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 13Mar2021 at 04:30 PM, the patient had fibromyalgia and it caused a flare up, vertigo, joint pain and swelling, hot flashes, brain fog, headache (feels like an ice pick hitting the top of head) and extreme fatigue. Initially, the patient had severe nausea, but it resolved itself in less than 24 hours. She also had been experiencing full body itching that only goes away if she take allergy medicine. Therapeutic measures were taken as a result of full body itching and included treatment with allergy medicine, no treatment for the other events. On an unknown date in Mar2021 patient was recovered from the event nausea. The clinical outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: Pain in some muscles in leg; Itching throughout body; Headaches; Chills; Dizzy at times; Pain in joints; This is a spontaneous report received from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a single dose via unspecified route of 1st dose on 26Feb2021 at 8 AM for COVID-19 immunization. The patient's medical history included prostate cancer low grade, penicillin allergy and sulpha allergy. He was allergic to Gadolinium when he had it for an MRI or Cat Scan. He broke out into a rash for a few days. Concurrent medical condition and concomitant medication were not reported. Patient did not test positive before vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient believe he had COVID in Mar2020 on and off until Aug2020 but did not had any trouble breathing or fever. On 27Feb2021 20:00, the patient experienced chills, dizzy at times, pain in joints, runs, headaches and so on. Actually his normal temperature dropped from 98.4 to 96.4. When he had BNT162B2, 8 days later (06Mar2021) he had pain in some muscles in his legs and then had major itching throughout his body for about 36 hours. He took strong doses of B12, B, C, D3, Zinc, olive leaf extract, baby aspirin, Dandelion root tea. Clinical outcome of all the events were reported as recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pruritus
Clinical narrative: Pain in some muscles in leg; Itching throughout body; Headaches; Chills; Dizzy at times; Pain in joints; This is a spontaneous report received from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a single dose via unspecified route of 1st dose on 26Feb2021 at 8 AM for COVID-19 immunization. The patient's medical history included prostate cancer low grade, penicillin allergy and sulpha allergy. He was allergic to Gadolinium when he had it for an MRI or Cat Scan. He broke out into a rash for a few days. Concurrent medical condition and concomitant medication were not reported. Patient did not test positive before vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient believe he had COVID in Mar2020 on and off until Aug2020 but did not had any trouble breathing or fever. On 27Feb2021 20:00, the patient experienced chills, dizzy at times, pain in joints, runs, headaches and so on. Actually his normal temperature dropped from 98.4 to 96.4. When he had BNT162B2, 8 days later (06Mar2021) he had pain in some muscles in his legs and then had major itching throughout his body for about 36 hours. He took strong doses of B12, B, C, D3, Zinc, olive leaf extract, baby aspirin, Dandelion root tea. Clinical outcome of all the events were reported as recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first vaccine was on March 2nd and I tested positive for Covid on March 12.; This is a spontaneous report from a contactable consumer (patient) or other non-Health Care Professional. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number EN6198 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 38-years-old) as single dose for Covid-19 immunization. Medical history included ongoing hypertension and started around age 16 years. The patient's concomitant medications were not reported.  The patient was not taking other products. She received her first dose of the Pfizer Covid vaccine 02Mar2021 and this past Friday 12Mar2021 she tested positive for Covid19. It was stated that her question was that she had her second dose 23Mar2021 through the county, the county approved that she could come in and get it because she would be out of quarantine by then, does Pfizer recommend getting the second vaccine on that date or waiting ninety days and starting over with the first dose again. She was experiencing fever, cough, congestion, chills, body aches, and headaches. She stated they all started on 11Mar2021 and were ongoing except the fever was gone away 14Mar2021. The rest have persisted but the body aches had improved. The patient received treatment of prescribed with Zinc and taking Mucinex and Motrin. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Mar2021 Rapid and Send Out. The outcome of event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness on neck, upper chest, sides of belly, lower back, left arm; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 29Jan2021 at 13:45 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration on 21Feb2021 as a 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 4 weeks prior to the COVID vaccine. The patient had experienced itchiness on neck, upper chest, sides of belly, lower back (not at vaccination site - left arm) which began mildly about two weeks after first shot (on an unknown date in Feb2021) and increased markedly after 2nd shot, over three weeks after 2nd shot with no relief. The treatment received for the event included benadryl. The clinical outcome of the event itchiness on neck, upper chest, sides of belly, lower back was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Full body chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 40 -year-old non-pregnant female patient, received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN,) solution for injection in the left arm, on 15Mar2021 at 13:15 (at the age of 40-years-old) for COVID-19 immunisation. The patient's medical history and drug history included penicillin allergy. concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not undergone COVID-19 test. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 15Mar2021, at 19:00 hours the patient experienced full body chills. No therapeutic measure was taken for the adverse event. At the time of report in Mar2021, the patient had recovered from full body chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Decreased appetite, Headache, Insomnia, Malaise
Clinical narrative: Lost voice; Lose of appetite; Feet and legs very swollen; Muscle aches; Headache behind right eye; Fever for one day(temp unknown); Not sleeping at night; Tight vocal cords; Feel lousy; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199 Dose number: unknown) as a single dose via unspecified route of administration in the left arm on 05Mar2021 at 16:30 PM for COVID-19 immunisation. The patient's medical history included high blood pressure and high cholesterol. Concomitant medications included venlafaxine, lisinopril and atorvastatin all for unknown indications from unknown dates. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient had no symptoms associated with COVID-19 and not had a COVID-19 test. 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 08Mar2021, the patient had headache behind right eye, lost voice, tight vocal cords, feet and legs very swollen, felt lousy, fever for one day (temp unknown), lost appetite, muscle aches, could not sleep at night. Therapeutic treatments included ProAir Inhaler and advised to drink lots of fluids. Events lead to doctor or other healthcare professional office/clinic visit. Clinical outcome of  the events headache behind right eye, lost voice, tight vocal cords, feet and legs very swollen, felt lousy, fever for one day (temp unknown), lost appetite, muscle aches, could not sleep at night were reported as recovering/resolving. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Pyrexia, Vocal cord disorder
Clinical narrative: Lost voice; Lose of appetite; Feet and legs very swollen; Muscle aches; Headache behind right eye; Fever for one day(temp unknown); Not sleeping at night; Tight vocal cords; Feel lousy; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199 Dose number: unknown) as a single dose via unspecified route of administration in the left arm on 05Mar2021 at 16:30 PM for COVID-19 immunisation. The patient's medical history included high blood pressure and high cholesterol. Concomitant medications included venlafaxine, lisinopril and atorvastatin all for unknown indications from unknown dates. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient had no symptoms associated with COVID-19 and not had a COVID-19 test. 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 08Mar2021, the patient had headache behind right eye, lost voice, tight vocal cords, feet and legs very swollen, felt lousy, fever for one day (temp unknown), lost appetite, muscle aches, could not sleep at night. Therapeutic treatments included ProAir Inhaler and advised to drink lots of fluids. Events lead to doctor or other healthcare professional office/clinic visit. Clinical outcome of  the events headache behind right eye, lost voice, tight vocal cords, feet and legs very swollen, felt lousy, fever for one day (temp unknown), lost appetite, muscle aches, could not sleep at night were reported as recovering/resolving. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: hurt all over; numbness in shot arm; headache; nauseous; shortness of breath that was scary; pouring sweat/excessive sweating; itching; eye twitching; sick; really tired; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine) (Lot/batch number: unknown) dose number 1 via unspecified route of administration on left arm as a single dose on 13Mar2021 at 12:00 (at the age of 55-year-old) for COVID-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included high blood pressure (BP) and fibromyalgia. No history of allergy to any medication or food or other products. Concomitant medications included the patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 14Mar2021, patient experienced scary shortness of breath, hurting all over, eye twitching, headache, excessive sweating/pouring sweat, numbness in shot arm, itching, really really tired, nauseous and was feeling sick for consecutive three days after vaccination. There was no treatment received for the adverse event. The clinical outcome of all the events was recovered with sequelae on an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscle twitching, Nausea, Pain, Pruritus
Clinical narrative: hurt all over; numbness in shot arm; headache; nauseous; shortness of breath that was scary; pouring sweat/excessive sweating; itching; eye twitching; sick; really tired; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine) (Lot/batch number: unknown) dose number 1 via unspecified route of administration on left arm as a single dose on 13Mar2021 at 12:00 (at the age of 55-year-old) for COVID-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included high blood pressure (BP) and fibromyalgia. No history of allergy to any medication or food or other products. Concomitant medications included the patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 14Mar2021, patient experienced scary shortness of breath, hurting all over, eye twitching, headache, excessive sweating/pouring sweat, numbness in shot arm, itching, really really tired, nauseous and was feeling sick for consecutive three days after vaccination. There was no treatment received for the adverse event. The clinical outcome of all the events was recovered with sequelae on an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphagia, Fatigue, Muscular weakness, Myalgia
Clinical narrative: patient cannot swallow pills; Muscle weakness/weakness and a collapse; shooting pains/severe pain in the arm muscle where the shot was given; Nausea; fatigue; sore to the touch and all muscles that are noted below; Knee joint pain; shooting pains progressed to lower arm, then to thighs/pains still in upper left calf; This is a spontaneous report from contactable consumer (patient). A 73-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration in the right arm on 06Mar2021 at 13:45 as a single dose for COVID-19 immunisation. The patient's medical history was non-significant. Prior to the vaccination. The patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products. Concomitant medications included blood pressure medication, triamcinolone acetonide (NASACORT), clarithromycin (CLARITIN) (within two weeks of vaccination as reported) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:00, the patient experienced severe pain in the arm muscle where the shot was given and sore to the touch and all muscles that are noted below. Had shooting pains progressed to lower arm, then to thighs, then to knee joints which had a weakness and a collapse. Experienced fatigue and some nausea. Pains are now in the 12th. day and pains still in upper left calf and knee. Pain levels are 6-7 and limiting most all normal daily activities. On 18Mar2021, the patient cannot swallow pills to take Ibuprofen or Tylenol. Since they are time release, patient cannot cut or crush. The patient took acetylsalicylic acid (ASPIRIN) with little relief. The patient read the second symptoms are greater and patient cannot take another two weeks more pain. It seems these issues are lasting more than 12 days and am concerned with them. The patient contacted her doctor. The clinical outcomes of all the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: patient cannot swallow pills; Muscle weakness/weakness and a collapse; shooting pains/severe pain in the arm muscle where the shot was given; Nausea; fatigue; sore to the touch and all muscles that are noted below; Knee joint pain; shooting pains progressed to lower arm, then to thighs/pains still in upper left calf; This is a spontaneous report from contactable consumer (patient). A 73-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration in the right arm on 06Mar2021 at 13:45 as a single dose for COVID-19 immunisation. The patient's medical history was non-significant. Prior to the vaccination. The patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No allergies to medications, food, or other products. Concomitant medications included blood pressure medication, triamcinolone acetonide (NASACORT), clarithromycin (CLARITIN) (within two weeks of vaccination as reported) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:00, the patient experienced severe pain in the arm muscle where the shot was given and sore to the touch and all muscles that are noted below. Had shooting pains progressed to lower arm, then to thighs, then to knee joints which had a weakness and a collapse. Experienced fatigue and some nausea. Pains are now in the 12th. day and pains still in upper left calf and knee. Pain levels are 6-7 and limiting most all normal daily activities. On 18Mar2021, the patient cannot swallow pills to take Ibuprofen or Tylenol. Since they are time release, patient cannot cut or crush. The patient took acetylsalicylic acid (ASPIRIN) with little relief. The patient read the second symptoms are greater and patient cannot take another two weeks more pain. It seems these issues are lasting more than 12 days and am concerned with them. The patient contacted her doctor. The clinical outcomes of all the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Dizziness, Vomiting
Clinical narrative: 5 days after 1st dose dizzy and violet vomiting; 5 days after 1st dose dizzy and violet vomiting; This is a spontaneous report from a contactable patient. A 69-year-old elderly non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL8982) via unspecified route of administration on the right arm on 29Jan2021 at 10:00 AM and second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9265) on right arm on 26Feb2021 at 10:00 AM (age at vaccination was 69-year-old) for COVID-19 immunisation. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested for COVID-19. She did not receive any other vaccines within 4 weeks prior to the vaccine. She has no known allergies. Concomitant medication was not reported. On 03Feb2021 at 20:00 PM (five (5) days after the first dose), she experienced dizzy and violet vomiting. On an unspecified date in Mar2021, eleven (11) days after the second dose, she experienced dizzy and violet vomiting and dizzy and light-headed which was continuing for 12 days (at the time of this report). The patient received treatment with nasal spray and had brain CT scan (result was unknown). The clinical outcome of the events dizzy and violet vomiting was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021300512 Same patient, same dug, different event (split)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever; chills; Body aches; Muscle aches; Nausea; 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 her left arm on 12Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications included iron (MANUFACTURER UNKNOWN), vitamin-D (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) at a dose of 20 mg and mirtazapine (MANUFACTURER UNKNOWN) at a dose of 20 mg. The patient was allergic to medications penicillin, codeine, erythromycin and prednisone. Since the vaccination, the patient had not tested for COVID-19.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 12Mar2021, at 12:30, the patient experienced fever, chills, body aches, muscle aches and nausea. The patient did not receive any treatment for the events. The clinical outcome of fever, chills, body aches, muscle aches and nausea were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue the following day after second shot; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution.  A 59-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eng205), via an unspecified route of administration, administered in left arm on 15Mar2021, at 15:30 as single dose for covid-19 immunization at the age of 59 years.  Medical history included allergy from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included Pris, methylphenidate hydrochloride (RITALIN), taken for an unspecified indication, start and stop date were not reported; meloxicam (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; simvastatin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; triamterene (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took BNT162B2 for covid-19 immunization as dose 1.  Past product experience included drug allergy to Bactrim.  The patient experienced fatigue the following day after second shot on 16Mar2021.  No  treatment  was received for the adverse event. The outcome of event was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I started to have ringing in my ear on left side. It started about 30 after i got the shot; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event.   A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration, administered in left arm on 16Mar2021, at 09:00 as single dose for covid-19 immunization.  Medical history included blood pressure high from an unknown date, type 2 diabetes mellitus from an unknown date. Patient was not pregnant at the time of vaccination. 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. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; metformin, metformin hydrochloride, sitagliptin (JANUMET) taken for an unspecified indication, start and stop date were not reported. The patient previously took lisinopril and experienced drug allergy.  The  patient reported  "I started to have ringing in my ear on left side. It started about 30 after I got the shot " on 16Mar2021, at 09:00 with outcome of not recovered.  No treatment was given for the event.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Peripheral coldness, SARS-CoV-2 test, Swelling face
Clinical narrative: headache; Hands were cold; Nauseous; Swollen face; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution.  A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eke199), via an unspecified route of administration, administered in right arm on 12Mar2021 as single dose for covid-19 immunization at the age of 61-years old.  Medical history included drug allergy to salidine from an unknown date and thyroid removal 2008/cancer from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 (Sofia 2) on an unspecified date with unknown results. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), route of administration, start and stop date, were not reported for an unspecified indication taken within two weeks of vaccination.  The patient experienced headache, hands were cold, nauseous and swollen face on 12Mar2021, at 16:15.  The events were reported as after receiving the vaccine, headache for 2 days, swollen face 1 day; hands were cold for 2 days, and she was nauseous 3 days.  No treatment was received for the adverse events. The patient underwent lab tests and procedures which included negative nasal swab on 02Feb2021. The outcome of events were as follow: headache recovered on 13Mar2021, hands were cold recovered on 14Mar2021, nauseous recovered on 15Mar2021 and swollen face recovered on 13Mar2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: headache; Hands were cold; Nauseous; Swollen face; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution.  A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eke199), via an unspecified route of administration, administered in right arm on 12Mar2021 as single dose for covid-19 immunization at the age of 61-years old.  Medical history included drug allergy to salidine from an unknown date and thyroid removal 2008/cancer from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 (Sofia 2) on an unspecified date with unknown results. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), route of administration, start and stop date, were not reported for an unspecified indication taken within two weeks of vaccination.  The patient experienced headache, hands were cold, nauseous and swollen face on 12Mar2021, at 16:15.  The events were reported as after receiving the vaccine, headache for 2 days, swollen face 1 day; hands were cold for 2 days, and she was nauseous 3 days.  No treatment was received for the adverse events. The patient underwent lab tests and procedures which included negative nasal swab on 02Feb2021. The outcome of events were as follow: headache recovered on 13Mar2021, hands were cold recovered on 14Mar2021, nauseous recovered on 15Mar2021 and swollen face recovered on 13Mar2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Arm has itched at the vaccination site; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9263) via an unspecified route of administration in the left arm on 30Jan2021 at 13:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis. The patient was allergic to penicillin and demerol. Concomitant medications included EFFEXOR and centrum silver (MANUFACTURER UNKNOWN), TYLENOL, vitamin D (MANUFACTURER UNKNOWN) and Gingko biloba (MANUFACTURER UNKNOWN) for an unknown indication from unknown dates. 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. The patient experienced  itch at the vaccination site since she had the first shot on 01Feb2021. The patient had her second shot on the other arm on an unspecified date. The patient did not received any treatment for the events. At the time of report, the clinical outcome of the event arm had itched at the vaccination site was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; vomiting multiple times; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration on the left arm on 16Mar2021 at 16:45 (at the age of 20-years-old) for COVID-19 immunisation. Medical history included gluten allergy, depression and celiac disease. Concomitant medications (within 2 weeks of vaccination) included Sertraline (MANUFACTURER UNKNOWN) and etonogestrel (NEXPLANON). She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine neither was not diagnosed with COVID-19 prior to vaccination and since the vaccination, she had not tested positive for COVID-19. On 16Mar2021 at 23.00, she experienced nausea and almost vomiting multiple times. No therapeutic measures were taken to treat these events. The outcome of nausea and vomiting are not recovered/not resolved. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Right arm sore; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the right arm on 16Mar2021 at 08:30 (at the age 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included simvastatin (ZOCOR) from an unknown date. On 17Mar2021, 22 hours post vaccination the patient experienced sore in right arm and had slight headache. The patient did not receive any treatment for the events. The clinical outcome of events sore in arm and headache were resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy bumpy rash on mid torso; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 14Mar2021 at 09:15 (at the age of 52-year-old) as a 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 been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced itchy bumpy rash on mid torso. The treatment received for the event itchy bumpy rash included BENADRYL. The clinical outcome of the event itchy bumpy rash was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Epicondylitis
Clinical narrative: Medial Epicondylitis; This is a spontaneous report from a non-contactable physician, the patient. A patient of an unspecified age and gender received second dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot number: El3842) via an unspecified route of administration on 08Jan2021 as a single dose for COVID-19 Immunisation. Medical history was reported as none. The patient had previously taken trimethoprim/sulfamethoxazole (BACTRIM) on an unknown date for an unknown indication and had experienced allergy. The patient had previously received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot number: unknown) as a single dose on an unknown date for covid-19 immunisation, The patient was not diagnosed with covid-19 prior to vaccination. The patient was not tested positive since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 15Jan2021, the patient had developed medial epicondylitis one week after the vaccination. There was no change in patients activity, no stress on arm, no trauma. Even after two months it was not resolved. The patient had received NSAIDS (unspecified), compression bands, physical therapy and was taken rest as a part of therapeutic measure for the reported event medial epicondylitis. The clinical outcome of the event medial epicondylitis was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Headache, Oropharyngeal pain, Pain
Clinical narrative: Painful eye; Swollen eye; Body ache; Sore throat; Injection site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration on left arm on 16Mar2021 at 18:30 hours (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient medical history included possible lupus and allergies (Zithromax, Spirolactin, sulfa and wool allergy). The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and BENADRYL, taken within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 07:30 hours, the patient experienced painful, swollen eye, headache, body ache, sore throat and injection site pain (vaccination site pain). No treatment was received for the events. The clinical outcome of the all the events was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.