chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Polymerase chain reaction, Product use issue, Pulmonary pain
Clinical narrative: minor injection muscle site tightness & pain; minor injection muscle site tightness & pain; fevers; muscle aches; shortness of breath; lung pain; severe swelling; pain in my neck&shoulders; pain in my neck&shoulders; fatigue; On April 6th, I tested positive for Covid; The patient received the Pfizer unspecified vaccine on the same date (28Mar2021).; This is a spontaneous report from a contactable consumer (patient).   This is the 1st of 2 reports, for the 1st dose.   A 59 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 13:00 (Lot Number: ER8737) at age of 59 years old as single dose for covid-19 immunisation.  The patient received the Pfizer unspecified vaccine (lot number=ER8735, dose number 2, vaccine location=Left Arm) on the same date (28Mar2021).  Medical history included restless legs syndrome, poison ivy (severe allergy to poison ivy). Concomitant medication(s) within 2 weeks of vaccination included clonazepam 0.5mg. Reported Event: "I had my first shot in my left arm on March 28th. I only had minor injection muscle site tightness & pain that resonated down my left arm for 2-4 days. On April 6th, I tested positive for Covid (Nasal Swab) and experienced fevers, muscle aches shortness of breath, lung pain, severe swelling & pain in my neck & shoulders which persisted until April 16th. I had a second COVID PCR test on April 16th (Nasal Swab). which was also positive. I also have experienced severe fatigue since the onset of Covid on April 6th with only mild relief coming over the last few days beginning on May 1st." Adverse events result in Emergency room/department or urgent care, patient recovered with lasting effects, and no treatment received for events. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome for events was Recovered/Resolved with Sequel(except for Product use for unapproved combination).  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497277 same patient, same drug, different AE, different dose of vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vaccination site pain
Clinical narrative: minor injection muscle site tightness & pain; minor injection muscle site tightness & pain; fevers; muscle aches; shortness of breath; lung pain; severe swelling; pain in my neck&shoulders; pain in my neck&shoulders; fatigue; On April 6th, I tested positive for Covid; The patient received the Pfizer unspecified vaccine on the same date (28Mar2021).; This is a spontaneous report from a contactable consumer (patient).   This is the 1st of 2 reports, for the 1st dose.   A 59 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 13:00 (Lot Number: ER8737) at age of 59 years old as single dose for covid-19 immunisation.  The patient received the Pfizer unspecified vaccine (lot number=ER8735, dose number 2, vaccine location=Left Arm) on the same date (28Mar2021).  Medical history included restless legs syndrome, poison ivy (severe allergy to poison ivy). Concomitant medication(s) within 2 weeks of vaccination included clonazepam 0.5mg. Reported Event: "I had my first shot in my left arm on March 28th. I only had minor injection muscle site tightness & pain that resonated down my left arm for 2-4 days. On April 6th, I tested positive for Covid (Nasal Swab) and experienced fevers, muscle aches shortness of breath, lung pain, severe swelling & pain in my neck & shoulders which persisted until April 16th. I had a second COVID PCR test on April 16th (Nasal Swab). which was also positive. I also have experienced severe fatigue since the onset of Covid on April 6th with only mild relief coming over the last few days beginning on May 1st." Adverse events result in Emergency room/department or urgent care, patient recovered with lasting effects, and no treatment received for events. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome for events was Recovered/Resolved with Sequel(except for Product use for unapproved combination).  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497277 same patient, same drug, different AE, different dose of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program, COVAX US Support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient received her first dose of the vaccine last 21Apr2021. She tested positive for Covid-19 on unspecified date in May2021 (exact onset date after vaccination was not provided). Patient asked if she can still take her second dose of the vaccine scheduled on 12May2021. She mentioned that it will be more than 10 days after she presented the symptoms of Covid-19 on 12May2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive; This is a spontaneous report from a Pfizer-sponsored program. A ontactable male consumer of 59-years-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 15Apr2021 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Apr2021, the patient experienced covid-19 tested positive. They're currently in quarantine and will be out for quarantine on Wednesday 05May2021. His 2nd dose is scheduled on 06May2021, the day after he will be out for quarantine. He would like to confirm if he can still take the 2nd dose since he got tested positive with the Covid19. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 23Apr2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypoaesthesia, Night sweats, Paraesthesia
Clinical narrative: decreased nerve sensitivity of the skin all over her body; Almost constant tingling pins & needles feeling throughout arms, legs, and face & head; night sweating; hot flashes; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm at age of 29-years, on 24Apr2021 14:15 (Lot Number: ER8735) as single dose for COVID-19 immunisation. Medical history included allergies to an unknown sushi ingredient; she had asthma and Raynaud's. The patient was not pregnant at time of vaccination. Concomitant medications included Montellukast, Advair Inhaler and ProAir Inhaler (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took nifedipine and experienced allergies. The patient experienced almost constant tingling pins & needles feeling throughout arms, legs, and face & head; constant decreased nerve sensitivity of the skin all over her body (her skin was not as sensitive to pain as she used to be before the vaccine, especially her upper bod. She even accidentally cut her finger kind of badly and she didn't feel anything); night sweating; hot flashes. She experienced many other side effects from the vaccine, but the symptoms listed above were the ones that all started the night she received the vaccine and had not improved since, even after 9 days at the time she was submitting this form. Adverse events started at 02:00 on 25Apr2021. There was no treatment. The patient did not diagnose with COVID-19 prior to vaccination and not test it post vaccination. Events outcome was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood test, Chills, Dizziness
Clinical narrative: I felt like I was going to die.; Chills; headache; stomach upset; nausea; fever; fatigue; weakness; dizziness; vomiting; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 16:00 (Batch/Lot number was not reported), at age of 38 years old, as single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient previously took dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 09:00 AM (Batch/Lot Number: 1 as reported) as single dose for covid-19 immunisation.  Medical history was none and no known allergies. Concomitant drugs within 2 weeks of vaccination was not reported. Reported Event as reported: "24 hours after I took my 2nd dose, I felt like I was going to die.  Chills, headache, stomach upset, nausea, vomiting, fever did not go away with Tylenol, fatigue, weakness and I even passed out. I alternated the use of Tylenol and Ibuprofen and it didn't work. Today (03May2021), 10 days after my second dose, i still feel weakness, fatigue, dizziness, stomach upset and nausea and I went to Emergency Room. I did bloodwork today at the and the doctor said that everything is normal in my blood test. They even tested me for the covid, but the test was negative for Covid. I was feeling very well, and healthy before the second dose of the vaccine and now I never felt well again. Terrible and weird side effects." Events onset date reported as 23Apr2021 07:00AM, AEs resulted In: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Zofran used as treatment and still feeling bad Outcome for events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19 with negative result.  The patient did not receive any other vaccines within 2 weeks prior to the COVID vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Near death experience, Pyrexia
Clinical narrative: I felt like I was going to die.; Chills; headache; stomach upset; nausea; fever; fatigue; weakness; dizziness; vomiting; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 16:00 (Batch/Lot number was not reported), at age of 38 years old, as single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient previously took dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 09:00 AM (Batch/Lot Number: 1 as reported) as single dose for covid-19 immunisation.  Medical history was none and no known allergies. Concomitant drugs within 2 weeks of vaccination was not reported. Reported Event as reported: "24 hours after I took my 2nd dose, I felt like I was going to die.  Chills, headache, stomach upset, nausea, vomiting, fever did not go away with Tylenol, fatigue, weakness and I even passed out. I alternated the use of Tylenol and Ibuprofen and it didn't work. Today (03May2021), 10 days after my second dose, i still feel weakness, fatigue, dizziness, stomach upset and nausea and I went to Emergency Room. I did bloodwork today at the and the doctor said that everything is normal in my blood test. They even tested me for the covid, but the test was negative for Covid. I was feeling very well, and healthy before the second dose of the vaccine and now I never felt well again. Terrible and weird side effects." Events onset date reported as 23Apr2021 07:00AM, AEs resulted In: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Zofran used as treatment and still feeling bad Outcome for events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19 with negative result.  The patient did not receive any other vaccines within 2 weeks prior to the COVID vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: I felt like I was going to die.; Chills; headache; stomach upset; nausea; fever; fatigue; weakness; dizziness; vomiting; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 16:00 (Batch/Lot number was not reported), at age of 38 years old, as single dose for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient previously took dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 09:00 AM (Batch/Lot Number: 1 as reported) as single dose for covid-19 immunisation.  Medical history was none and no known allergies. Concomitant drugs within 2 weeks of vaccination was not reported. Reported Event as reported: "24 hours after I took my 2nd dose, I felt like I was going to die.  Chills, headache, stomach upset, nausea, vomiting, fever did not go away with Tylenol, fatigue, weakness and I even passed out. I alternated the use of Tylenol and Ibuprofen and it didn't work. Today (03May2021), 10 days after my second dose, i still feel weakness, fatigue, dizziness, stomach upset and nausea and I went to Emergency Room. I did bloodwork today at the and the doctor said that everything is normal in my blood test. They even tested me for the covid, but the test was negative for Covid. I was feeling very well, and healthy before the second dose of the vaccine and now I never felt well again. Terrible and weird side effects." Events onset date reported as 23Apr2021 07:00AM, AEs resulted In: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Zofran used as treatment and still feeling bad Outcome for events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19 with negative result.  The patient did not receive any other vaccines within 2 weeks prior to the COVID vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, SARS-CoV-2 test
Clinical narrative: Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ER8732, expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history was not reported. There was no other medications in four weeks. It was also reported that there was allergy medicine in two weeks, which was considered concomitant medication. Patient had blood in stool on 01Apr2021 with outcome of not recovered. Patient reported the event as non-serious. Patient had no COVID-19 prior vaccination. Patient performed COVID-19 tested post vaccination by nasal swab with unknown results.  Information on the lot/batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Neuropathy peripheral, SARS-CoV-2 test, Urticaria
Clinical narrative: (I also had aggravation of existing neuropathy in left foot day of.) At day 10 after vaccine I had full-body hives.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; Hives. Minor: I had discomfort, mostly gastro and fatigue for nearly three weeks.; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EN6208), via an unspecified route of administration in left leg on 13Mar2021 at 16:00 as a single dose for COVID-19 immunization. Medical history included mental health, orthopedic, allergies and existing neuropathy in left foot. Concomitant medications included lamotrigine, OTC paracetamol (Tylenol) and Vitamin supplements which was received within 2 weeks of vaccination. 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 tested for COVID-19, where the nasal swab test was performed on 03May2021 and the result was obtained as negative. On 23Mar2021, the patient experienced discomfort, mostly gastro and fatigue for nearly three weeks also had aggravation of existing neuropathy in left foot day of. It was also reported on day 10 after vaccine she had full-body hives and it was very unusual for her and there was no other obvious cause. At the time of this report event outcome was recovered, on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with the Covid virus after receiving the first dose of the Pfizer Covid-19 vaccine; diagnosed with the Covid virus after receiving the first dose of the Pfizer Covid-19 vaccine; This is a spontaneous report via a Pfizer-sponsored program, from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Apr2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with the Covid virus after receiving the first dose of the Pfizer Covid-19 vaccine. He was scheduled to receive the second dose of vaccine on 04May2021 but tested positive for Covid after receiving first dose. He wanted to know if they need to wait to receive second dose. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count, SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: ITP - platelets of 3; severe thrombocytpenia; This is a spontaneous report from a contactable physician. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at single dose for covid-19 immunisation at the age of 44-year-old. The patient medical history and concomitant medications were not reported. No any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Idiopathic thrombocytopenic purpura (ITP) - platelets of 3 and severe thrombocytpenia, both on 30Apr2021. The events were reported as serious with seriousness criteria of hospitalization (from an unspecified date in 2021). The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included platelet count: severe thrombocytpenia/ITP - platelets of 3 on 30Apr2021, Nasal Swab: negative on 30Apr2021. Treatment received for the events that included intravenous immunoglobulin (IVIG), IV steroids. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Idiopathic thrombocytopenic purpura and severe thrombocytopenia and the use of BNT162B2 cannot be fully excluded.  There is limited information available, thus precluding further assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dyspnoea, Ear pain, Fatigue
Clinical narrative: felt like my body was hit by a truck; felt like my head was exploding; exhausted; arm pain; hardness and swollen in my other arm like a blood clot; brain fog; suicidal thoughts; I got sick for ten days; Migraine; severe body aches; chills; shakes; dehydrated; saw weird lights when I closed my eyes; hard to breathe; earache; This is a spontaneous report from a contactable consumer reporting for himself.    A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on Apr2021 (Batch/Lot Number: ER8734; Expiration Date: Apr2021) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced suicidal thoughts on 05Apr2021 04:00 with outcome of recovering , i got sick for ten days  on 05Apr2021 04:00 with outcome of recovering , migraine  on 05Apr2021 04:00 with outcome of recovering , severe body aches  on 05Apr2021 04:00 with outcome of recovering , chills  on 05Apr2021 04:00 with outcome of recovering , shakes  on 05Apr2021 04:00 with outcome of recovering , dehydrated  on 05Apr2021 04:00 with outcome of recovering , saw weird lights when i closed my eyes  on 05Apr2021 04:00 with outcome of recovering , hard to breathe on 05Apr2021 04:00 with outcome of recovering , earache  on 05Apr2021 04:00 with outcome of recovering , felt like my body was hit by a truck  on 05Apr2021 04:00 with outcome of recovering , felt like my head was exploding  on 05Apr2021 04:00 with outcome of recovering , exhausted  on 05Apr2021 04:00 with outcome of recovering , arm pain on 05Apr2021 04:00 with outcome of recovering , hardness and swollen in my other arm like a blood clot  on 05Apr2021 04:00 with outcome of recovering , brain fog  on 05Apr2021 04:00 with outcome of recovering.   Suicidal thoughts was considered an Important Medical Event.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  Follow up information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Illness, Migraine, Pain
Clinical narrative: felt like my body was hit by a truck; felt like my head was exploding; exhausted; arm pain; hardness and swollen in my other arm like a blood clot; brain fog; suicidal thoughts; I got sick for ten days; Migraine; severe body aches; chills; shakes; dehydrated; saw weird lights when I closed my eyes; hard to breathe; earache; This is a spontaneous report from a contactable consumer reporting for himself.    A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on Apr2021 (Batch/Lot Number: ER8734; Expiration Date: Apr2021) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced suicidal thoughts on 05Apr2021 04:00 with outcome of recovering , i got sick for ten days  on 05Apr2021 04:00 with outcome of recovering , migraine  on 05Apr2021 04:00 with outcome of recovering , severe body aches  on 05Apr2021 04:00 with outcome of recovering , chills  on 05Apr2021 04:00 with outcome of recovering , shakes  on 05Apr2021 04:00 with outcome of recovering , dehydrated  on 05Apr2021 04:00 with outcome of recovering , saw weird lights when i closed my eyes  on 05Apr2021 04:00 with outcome of recovering , hard to breathe on 05Apr2021 04:00 with outcome of recovering , earache  on 05Apr2021 04:00 with outcome of recovering , felt like my body was hit by a truck  on 05Apr2021 04:00 with outcome of recovering , felt like my head was exploding  on 05Apr2021 04:00 with outcome of recovering , exhausted  on 05Apr2021 04:00 with outcome of recovering , arm pain on 05Apr2021 04:00 with outcome of recovering , hardness and swollen in my other arm like a blood clot  on 05Apr2021 04:00 with outcome of recovering , brain fog  on 05Apr2021 04:00 with outcome of recovering.   Suicidal thoughts was considered an Important Medical Event.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  Follow up information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Suicidal ideation, Tremor, Visual impairment
Clinical narrative: felt like my body was hit by a truck; felt like my head was exploding; exhausted; arm pain; hardness and swollen in my other arm like a blood clot; brain fog; suicidal thoughts; I got sick for ten days; Migraine; severe body aches; chills; shakes; dehydrated; saw weird lights when I closed my eyes; hard to breathe; earache; This is a spontaneous report from a contactable consumer reporting for himself.    A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on Apr2021 (Batch/Lot Number: ER8734; Expiration Date: Apr2021) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced suicidal thoughts on 05Apr2021 04:00 with outcome of recovering , i got sick for ten days  on 05Apr2021 04:00 with outcome of recovering , migraine  on 05Apr2021 04:00 with outcome of recovering , severe body aches  on 05Apr2021 04:00 with outcome of recovering , chills  on 05Apr2021 04:00 with outcome of recovering , shakes  on 05Apr2021 04:00 with outcome of recovering , dehydrated  on 05Apr2021 04:00 with outcome of recovering , saw weird lights when i closed my eyes  on 05Apr2021 04:00 with outcome of recovering , hard to breathe on 05Apr2021 04:00 with outcome of recovering , earache  on 05Apr2021 04:00 with outcome of recovering , felt like my body was hit by a truck  on 05Apr2021 04:00 with outcome of recovering , felt like my head was exploding  on 05Apr2021 04:00 with outcome of recovering , exhausted  on 05Apr2021 04:00 with outcome of recovering , arm pain on 05Apr2021 04:00 with outcome of recovering , hardness and swollen in my other arm like a blood clot  on 05Apr2021 04:00 with outcome of recovering , brain fog  on 05Apr2021 04:00 with outcome of recovering.   Suicidal thoughts was considered an Important Medical Event.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the second COVID vaccine on 16Mar2021 and was diagnosed with COVID (positive COVID test, had symptoms) on 19Apr2021; received the second COVID vaccine on 16Mar2021 and was diagnosed with COVID (positive COVID test, had symptoms) on 19Apr2021; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient received the second COVID vaccine on 16Mar2021 and was diagnosed with COVID (positive COVID test, had symptoms) on 19Apr2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperthyroidism, Inflammation, Thyroiditis subacute, Ultrasound thyroid
Clinical narrative: severe hyperthyroidism; Ultrasound showed nodules in the thyroid with dysrygulated thyroid hormones, diagnosed as subacute thyroiditis; hyper inflammation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 16:45 at the age of 42 years old (Lot Number: EN6201) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 in left arm (lot number: EL9261) on 08Jan2021 08:00 at the age of 42 years old for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient developed severe hyperthyroidism post 3 weeks of 2nd dose of infection. On 15Mar2021, Ultrasound showed nodules in the thyroid with dysrygulated thyroid hormones, diagnosed as subacute thyroiditis. The patient believed hyper inflammation due to vaccination damaged her thyroid resulting in excess production of thyroid hormones. He had never faced such symptoms before and neither this was in his family history. Date of start of reaction/events was 15Mar2021 20:00. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Prednisone to suppress the symptoms. The reported considered the report as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe hyperthyroidism post 3 weeks of 2nd dose of infection (subacute thyroiditis) and the administration of the suspect, COVID19 vaccine, BNT162B2, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid19 on 18Apr2021, with symptoms starting on 16Apr2021, after receiving her first dose of the Covid Vaccine on 07Apr2021; Cough; Runny nose; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for her 17-year-old daughter (patient). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 09:50 (at the age of 17 years) as 1st dose, single for COVID-19 immunisation. The patient had no medical and familial history. The patient did not take any concomitant medications. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no other additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations within 4 weeks. On 16Apr2021, evening, the patient started with a slight cough and runny nose and thought it was allergies. The reporter stated that the patient's friend tested positive on Thursday and they were also tested Thursday and she was negative and then Sunday, she tested again and was positive. On 18Apr2021, the patient was tested positive for Covid 19 and was clear now. The patient recovered from her symptoms by 23Apr2021 but she was isolated for the full 10 days. The reporter asked whether it was okay to take second dose after testing positive for COVID-19. The patient did not receive any treatment other than rest. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021 and negative on unspecified date in 2021. The outcome of the event Covid-19 was unknown, and outcome of the event cough and runny nose was recovered on 23Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report from a non-contactable other HCP via a Pfizer sales representative. A 28-year-old patient of an unspecified gender received second dose of BNT162B2 (Lot Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Unknown if diagnosed with COVID-19 prior vaccination, and unknown if COVID-19 tested post vaccination. The patient was diagnosed with myocarditis following second dose vaccine on unknown date. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was seen at a Medical Center for treatment and diagnosis. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of Myocarditis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Menstruation irregular, Pain, Pyrexia
Clinical narrative: The patient's medical history and concomitant medications were reported as None. The patient previously received the first dose of BNT162B2 (lot EW0158) on 08Apr2021 at the age in left arm for covid-19 immunization. The patient stated after the 2nd dose she had around 11:00am was mostly related to menstruation and she had her period that was supposed to be coming after 7 days but suddenly after the 2nd dose of the vaccine she began bleeding with clots 1-2 hours after the 2nd dose of the Pfizer COVID Vaccine; Patient stated this was unusual for her to bleed and have blood clots in her menses that started right away and the other thing she had were body aches and fever which are normal, the fever and body aches began in the evening around 9:00pm on 30Apr2021 and then the next day she had fever and body aches the whole day and the fever and body aches are not there now and resolved the third day. Stated the bleeding was still there and is now better. She wanted to report this and got worried that one thing was unusual regarding the menstrual bleeding and will visit the healthcare professional (HCP) to make sure everything was ok in terms of bleeding and because she needs to visit her GYN doctor just to check that this was ok. The outcome of the events fever and body aches 02May2021, the outcome of the other events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: The patient's medical history and concomitant medications were reported as None. The patient previously received the first dose of BNT162B2 (lot EW0158) on 08Apr2021 at the age in left arm for covid-19 immunization. The patient stated after the 2nd dose she had around 11:00am was mostly related to menstruation and she had her period that was supposed to be coming after 7 days but suddenly after the 2nd dose of the vaccine she began bleeding with clots 1-2 hours after the 2nd dose of the Pfizer COVID Vaccine; Patient stated this was unusual for her to bleed and have blood clots in her menses that started right away and the other thing she had were body aches and fever which are normal, the fever and body aches began in the evening around 9:00pm on 30Apr2021 and then the next day she had fever and body aches the whole day and the fever and body aches are not there now and resolved the third day. Stated the bleeding was still there and is now better. She wanted to report this and got worried that one thing was unusual regarding the menstrual bleeding and will visit the healthcare professional (HCP) to make sure everything was ok in terms of bleeding and because she needs to visit her GYN doctor just to check that this was ok. The outcome of the events fever and body aches 02May2021, the outcome of the other events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Menstruation irregular, Pain, Pyrexia
Clinical narrative: After taking this shot her bleeding and blood clots started ideally her period was scheduled to come after 7 days; After taking this shot her bleeding and blood clots started ideally her period was scheduled to come after 7 days; This is a spontaneous report form a contactable consumer (patient). A non-pregnant 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 31 years old, on 30Apr2021 11:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no medication received within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 31 years old on 08Apr2021 11:00 (24hr) in the arm left as single dose for covid-19 immunisation. The patient received the second dose on 30Apr2021 at 11:30 (24hr). After taking this shot her bleeding and blood clots started ideally her period was scheduled to come after 7 days, so she was little worried about it. The outcome of the events was unknown. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: After taking this shot her bleeding and blood clots started ideally her period was scheduled to come after 7 days; After taking this shot her bleeding and blood clots started ideally her period was scheduled to come after 7 days; This is a spontaneous report form a contactable consumer (patient). A non-pregnant 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 31 years old, on 30Apr2021 11:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no medication received within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 31 years old on 08Apr2021 11:00 (24hr) in the arm left as single dose for covid-19 immunisation. The patient received the second dose on 30Apr2021 at 11:30 (24hr). After taking this shot her bleeding and blood clots started ideally her period was scheduled to come after 7 days, so she was little worried about it. The outcome of the events was unknown. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: having Covid 19 after he got both doses of the Covid Vaccine; Diagnosed with Covid 19; This is a spontaneous report from a contactable consumer. A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as 1st dose, single and 2nd dose, single (Batch/Lot number was not reported) for Covid-19 immunization. Medical history included heavy smoker and alcoholic (heavy drinker). The patient's concomitant medications were not reported. It was reported that the patient was hospitalized after having Covid 19 after he got both doses of the Covid vaccine. The patient ended up diagnosed with Covid 19 on an unspecified date and was hospitalized in the Intensive Care Unit on an unspecified date. The patient is currently out of the hospital. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Road traffic accident
Clinical narrative: involved in a fender bender car accident; missed second dose of vaccine; This is a spontaneous report from a contactable consumer, the parent. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular on 02Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The consumer stated she was 88 years old (case 2021495539 )and her daughter was 65 years old and both got their first Pfizer Covid shot in series on 02Mar2021, stated they both ended up being hospitalized and missed second on 23Mar2021. The patient was involved in a fender bender car accident on 21Mar2021 and hospitalized from 21Mar2021 to Apr2021. The consumer stated she read that as long as you get the second dose within 6 weeks, but it has now been 8 weeks since first shot. The consumer wanted to know do they at this point have to start over with the first dose of the vaccine. The outcome of the event car accident was unknown.  The consumer stated the hospitalization/car accident had nothing to do with the vaccine.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, the event Automobile accident is most likely related to an intercurrent condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. Linked Report(s) : PFIZER INC-2021495539 same reporter/drug/events, different patients
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture
Clinical narrative: fell; broke her hip; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 03May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's husband). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 18Mar2021 10:00 (Batch/Lot number: ER2613) at the age of 76-years-old female as single dose for covid-19 immunisation. Medical history included diabetes, pain and manic depression. Concomitant medication included metformin taken for diabetes from an unspecified start date and ongoing; paracetamol (TYLENOL) taken for pain from an unspecified start date and ongoing; valproate semisodium (DIVALPROEX ER) taken for manic depression from an unspecified start date and ongoing; furosemide taken for an unspecified indication from an unspecified start date and ongoing; nitrofurantoin (NITROFURANTOIN MONO) taken for an unspecified indication from an unspecified start date and ongoing; vitamin D taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (EUTHYROX) taken for an unspecified indication from an unspecified start date and ongoing; alendronate sodium (ALENDRONATE) taken for an unspecified indication from an unspecified start date and ongoing; lisinopril taken for an unspecified indication from an unspecified start date and ongoing; potassium chloride taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine taken for an unspecified indication from an unspecified start date and ongoing. The patient fell and broke her hip 05Apr2021 and had to go to the hospital. He said now she is in a rehab center, so she couldn't get her second shot then, a few weeks later got she got her second shot. He said she had surgery for her broken hip and now she is in rehab. He said she left the hospital to go to rehab. She was in the hospital from 05Apr2021 to 10Apr2021. He said she was slowly improving. The outcome of the event fell was unknown, the outcome of the event 'broken hip' was recovering.
Sex: M
Vaccine: PNC13
Symptoms: Death
Clinical narrative: Found obituary through web search. Patient passed away on 25Apr2021.; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer. A 64-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown number dose, single dose for immunisation (Pneumococcal Pneumonia). Medical history included asthma and diabetes. The patient's concomitant medications were not reported. Found obituary through web search. Patient passed away on 25Apr2021. Cause of death is unknown. The patient died on 25Apr2021. It was unknown if an autopsy was performed.  Amendment: This follow-up report is being submitted to amend previously reported information: formulation of product has been changed.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Patient passed away on 25Apr2021.