chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test
Clinical narrative: Previously reported increase in muscle spasms.; This is a spontaneous report from a non-contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) from unspecified date at single dose for COVID-19 immunisation. Medical history included irritable bowel and quadriplegia. Concomitant medication included take multiple meds in two weeks. Previously reported increase in muscle spasms. AE resulted in Hospitalization. No COVID prior vaccination. COVID tested post vaccination with covid test result of Negative. Outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Guillain-Barre syndrome
Clinical narrative: she did not know if the patient's inability to walk was due to Guillain-Barre; Unable to walk; This is a spontaneous report from a contactable Pharmacist. A female patient in her 20's received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Apr2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The pharmacist reported that she did not have a lot of information but the incident prompted her to reach out to Pfizer. There was a situation with a young female that received her first dose of the Covid-19 vaccine last week that was unable to walk on 19Apr2021. She was unsure of where the patient received her Covid-19 vaccine. She was unsure if there were any co-factors that could have contributed to the patient's inability to walk. She reported that she did not know if the patient's inability to walk was due to Guillain-Barre. Her number one concern was that the patient was not walking. The pharmacist inquired if there was any help that Pfizer could provide. She reported that she did not know if IViG, intravenous immunoglobin, had a place in therapy for the patient. The patient was going to be admitted to the hospital at the time of the report on 19Apr2021. Clarified that the patient was not hospitalized yet and that she believed that the patient was en route to the caller's facility at time of call on 19Apr2021. The event unable to walk was reported as serious due to Medically significant. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on limited information provided, a possible relation for BNT162B2 injection and serious Guillain-Barre syndrome with secondary walking inability cannot be completely excluded, only supported by plausible drug/event chronological sequence. Other evidence or argument, indicating a contributory role in development of reported events cannot be established. 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 05Mar2021 09:30 (Batch/Lot number was not reported) as single dose at the age of 60-year-old for COVID-19 immunisation.  The patient medical history included known allergies not specified. No COVID prior vaccination. The patient was taking concomitant medication but they were not specified as "to many to list". No other vaccine in fourweeks.  The patient experienced fatigue in Mar2021. It was unknown if the patient received treatment for the event. COVID was not tested post vaccination. The outcome of event was unknown.    Information on the Lot/Batch number has been requested.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: He has had blood in his stool, since yesterday, three separate times; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of the covid vaccine yesterday (18Apr2021). He has had blood in his stool, since yesterday (18Apr2021), three separate times. He was asking if this is normal. He has been waiting for a long time already. The outcome of the event was unknown.    Information about lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate irregular
Clinical narrative: had an arrhythmia; now she has an irregular heartbeat that sent her to the emergency room; This is a spontaneous report from a contactable consumer (patient). The reporter reported two reports for different dose for the same patient. This is the second of two reports.      A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 44-year-old via an unspecified route of administration on an unspecified date (Lot Number: EN6003; Expiration Date: Jun2021) as single dose for covid-19 immunisation.  The patient medical history was not reported.  There were no concomitant medications. The patient previously took first dose of BNT162B2 for covid-19 immunisation and experienced a cough, she was tired and she had body chills; then she was struggling for 2 weeks maybe; then she went to the doctor and she had some kind of upper respiratory infection. The patient experienced an arrhythmia, and she had an irregular heartbeat that sent her to the emergency room. The events start date was 11Apr2021. She was admitted from the emergency room and was sent to be monitored for 24 hours and since then she has had episodes that happen once a week or so. It depends. She was just thinking maybe it was from the COVID vaccine because she has never had problems with her heart. Caller was admitted on 11Apr2021 and was discharged on 12Apr2021.  The outcome was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Loss of consciousness, Migraine
Clinical narrative: passed out at home; Migraine; chills; aches; tired; slight temp; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in right arm on 12Apr2021 (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included High cholesterol, hypothyroidism. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, at the age of 63-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 18:30 (Lot Number: ER8727) as single dose for covid-19 immunisation. The patient was not pregnant. The patient experienced migraine, chills, aches, slight temp and tired on 13Apr2021 10:00; passed out at home 22:30 13Apr2021. No treatment received. The outcome of the events was recovered in Apr2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: passed out at home; Migraine; chills; aches; tired; slight temp; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in right arm on 12Apr2021 (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included High cholesterol, hypothyroidism. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2, at the age of 63-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 18:30 (Lot Number: ER8727) as single dose for covid-19 immunisation. The patient was not pregnant. The patient experienced migraine, chills, aches, slight temp and tired on 13Apr2021 10:00; passed out at home 22:30 13Apr2021. No treatment received. The outcome of the events was recovered in Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Hypertension, Osteoporosis
Clinical narrative: Hashimoto's disease; high blood pressure; osteoporosis; This is a spontaneous report from a contactable consumer.   A 77-year-old female patient received the first dose of  BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced Hashimoto's disease, high blood pressure, and osteoporosis on an unspecified date. The outcome of events was unknown.   The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  The information about lot number and expiration date has been requested
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Pelvic pain, Thrombosis, Vaginal haemorrhage
Clinical narrative: more than usual vaginal bleeding/with very dark blood with clots.; menstrual cramps; sharp pelvic pain; more than usual vaginal bleeding; more than usual vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Facility type Vaccine: Other. Medical history included known allergies: Sulfa and Folate deficiency. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206) on 15Mar2021 10:30 AM in left arm for covid-19 immunisation and experienced vaginal bleeding/blood clots at mid-cycle on 15Mar2021 08:00 PM. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient experienced more than usual vaginal bleeding/with very dark blood with clots, menstrual cramps, sharp pelvic pain, all on Apr2021 with outcome of not recovered. Clinical course: After the first dose, the patient had vaginal bleeding/blood clots at mid-cycle. The same day after the 2nd dose, she started feeling menstrual cramps and sharp pelvic pain. After taking paracetamol (TYLENOL) and feeling a bit of relief, she stood up and started having more than usual vaginal bleeding at the level that it reached the floor as if it was a hemorrhage with very dark blood with clots. This lasted for 1 minute. This lasted for 5 days and 7 days later, she started bleeding again with dark blood clots for a period of 3 days. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for events more than usual vaginal bleeding/with very dark blood with clots.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Pyrexia, Vertigo
Clinical narrative: Every time she bends over, if her head gets below her shoulders to pick something up she will black out; fever; everything in her body ached; vertigo; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 26Mar2021 10:00 (Batch/Lot Number: ER8733; Expiration Date: Jul2021) as single dose at age of 61-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medications included methotrexate; hydroxychloroquine. Adverse event following prior vaccinations violently ill from flu shot, ended up in urgent care, 20 years. The patient experienced every time she bends over, if her head gets below her shoulders to pick something up she will black out, fever, everything in her body ached, vertigo on an unspecified date in 2021. Clinical course: The first Covid 19 vaccine she ran a fever and everything in her body ached. Every time she bends over, if her head gets below her shoulders to pick something up she will black out. She reports she has blacked out in the shower and blacked out from leaning off the sofa to pet her dog. She almost went into her coffee table trying to pet her dog. This lasted for about 5 days after she received her first Covid 19 vaccine. After about 5 days it cleared up and went away. She called the facility that gave her the Covid 19 vaccine, a drive thru facility and they told her she had vertigo. She knows she didn't have vertigo because she didn't have these problems until after she received the Covid 19 vaccines. Outcome of event black out was recovered in 2021, and outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Incorrect route of product administration, SARS-CoV-2 test
Clinical narrative: hospital due to Sars-COV-2.; hospital due to Sars-COV-2.; first doe on 20Mar2021 and was inadvertently administered subcutaneously or intradermally; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on 20Mar2021 and was inadvertently administered subcutaneously or intradermally. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that patient was in the hospital due to Sars-COV-2. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on unknown date. Outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, there is not a reasonable possibility that the reported event SARS-CoV-2 infection is related to the suspect product bnt162b2. The event is an intercurrent condition.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Covid shot made her sick; This is a spontaneous report from a contactable consumer via Pfizer from (manufacturer control number. This case was split from master case 2021435665 for BNT162B2. A 56-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated covid shot made her sick on an unspecified date. The outcome was unknown.  Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Bone scan, Burning sensation, Chest X-ray
Clinical narrative: heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer.  Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Magnetic resonance imaging head, Muscle tightness, Myalgia
Clinical narrative: heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer.  Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Paraesthesia
Clinical narrative: heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer.  Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Intervertebral disc disorder, Magnetic resonance imaging abnormal, Pain, Paraesthesia
Clinical narrative: heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer.  Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Bone scan, Burning sensation, Chest X-ray
Clinical narrative: Patient presented to ER on 4/12/21 with after developing a numbness/tingling sensation in both of her shoulders that radiated down both of her arms.  Patient then developed tingling in both of her lower extremities. MRI demonstrated a non-specific C7 lesion and neurosurgery was consulted who did not recommend any intervention. Ultimately the patient was discharged on 4/15/21 with no definitive diagnosis or rationale for the numbness and patient wondered if it could be related to the vaccine. Patient is scheduled to follow up with outpatient neurology.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Magnetic resonance imaging head, Muscle tightness, Myalgia
Clinical narrative: Patient presented to ER on 4/12/21 with after developing a numbness/tingling sensation in both of her shoulders that radiated down both of her arms.  Patient then developed tingling in both of her lower extremities. MRI demonstrated a non-specific C7 lesion and neurosurgery was consulted who did not recommend any intervention. Ultimately the patient was discharged on 4/15/21 with no definitive diagnosis or rationale for the numbness and patient wondered if it could be related to the vaccine. Patient is scheduled to follow up with outpatient neurology.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Paraesthesia
Clinical narrative: Patient presented to ER on 4/12/21 with after developing a numbness/tingling sensation in both of her shoulders that radiated down both of her arms.  Patient then developed tingling in both of her lower extremities. MRI demonstrated a non-specific C7 lesion and neurosurgery was consulted who did not recommend any intervention. Ultimately the patient was discharged on 4/15/21 with no definitive diagnosis or rationale for the numbness and patient wondered if it could be related to the vaccine. Patient is scheduled to follow up with outpatient neurology.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Intervertebral disc disorder, Magnetic resonance imaging abnormal, Pain, Paraesthesia
Clinical narrative: Patient presented to ER on 4/12/21 with after developing a numbness/tingling sensation in both of her shoulders that radiated down both of her arms.  Patient then developed tingling in both of her lower extremities. MRI demonstrated a non-specific C7 lesion and neurosurgery was consulted who did not recommend any intervention. Ultimately the patient was discharged on 4/15/21 with no definitive diagnosis or rationale for the numbness and patient wondered if it could be related to the vaccine. Patient is scheduled to follow up with outpatient neurology.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bacterial vaginosis, Fatigue, Feeling abnormal, Herpes zoster
Clinical narrative: been a weird 2 months; shingles symptoms/it's been mild; swollen lymph nodes; yeast or bacterial vaginosis; yeast or bacterial vaginosis; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (the patient).  A  44 year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6208), intramuscularly, on 13Mar2021 at 12:00 (at the age of 44 years old) as a single dose in the right arm for COVID-19 immunization. Medical history included ongoing hypertension and ongoing decreased appetite. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number:EL9269) in the right arm on 13Feb2021. Concomitant medication included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; metoprolol (METOPROLOL) taken for hypertension from an unspecified start date and ongoing; phentermine (PHENTERMINE) taken for decreased appetite from an unspecified start date and ongoing. The patient experienced shingles symptoms/it's been mild on 03Apr2021 with outcome of recovering. The event shingles required a physician office visit and it was considered medically significant. The patient also experienced joint pain on 16Mar2021 with outcome of recovered with sequelae,  fatigue on 16Mar2021 with outcome of recovered with sequelae , swollen lymph nodes on 20Mar2021 with outcome of recovered, yeast or bacterial vaginosis on 20Mar2021 with outcome of recovered, yeast or bacterial vaginosis on 20Mar2021 with outcome of recovered, been a weird 2 months on an unspecified date with outcome of unknown. Shingles was considered medically significant.  Therapeutic measures were taken as a result of shingles, joint pain, fatigue, swollen lymph nodes, yeast or bacterial vaginosis and included, ibuprofen, Epsom salts, ointment and Valtrex; Sender's Comments: Linked Report(s) :PFIZER INC-2021218674 Same reporter, same patient same product, different event (Dose # 1 )
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vulvovaginal mycotic infection
Clinical narrative: been a weird 2 months; shingles symptoms/it's been mild; swollen lymph nodes; yeast or bacterial vaginosis; yeast or bacterial vaginosis; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (the patient).  A  44 year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6208), intramuscularly, on 13Mar2021 at 12:00 (at the age of 44 years old) as a single dose in the right arm for COVID-19 immunization. Medical history included ongoing hypertension and ongoing decreased appetite. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number:EL9269) in the right arm on 13Feb2021. Concomitant medication included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; metoprolol (METOPROLOL) taken for hypertension from an unspecified start date and ongoing; phentermine (PHENTERMINE) taken for decreased appetite from an unspecified start date and ongoing. The patient experienced shingles symptoms/it's been mild on 03Apr2021 with outcome of recovering. The event shingles required a physician office visit and it was considered medically significant. The patient also experienced joint pain on 16Mar2021 with outcome of recovered with sequelae,  fatigue on 16Mar2021 with outcome of recovered with sequelae , swollen lymph nodes on 20Mar2021 with outcome of recovered, yeast or bacterial vaginosis on 20Mar2021 with outcome of recovered, yeast or bacterial vaginosis on 20Mar2021 with outcome of recovered, been a weird 2 months on an unspecified date with outcome of unknown. Shingles was considered medically significant.  Therapeutic measures were taken as a result of shingles, joint pain, fatigue, swollen lymph nodes, yeast or bacterial vaginosis and included, ibuprofen, Epsom salts, ointment and Valtrex; Sender's Comments: Linked Report(s) :PFIZER INC-2021218674 Same reporter, same patient same product, different event (Dose # 1 )
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had both shots and still came down with COVID; had both shots and still came down with COVID; This is a spontaneous report from a contactable consumer reporting for a friend.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The reporter stated that  her friend had both shots and still came down with COVID.The events outcome was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had the Pfizer Covid Vaccine than got Covid; had the Pfizer Covid Vaccine than got Covid; This is a spontaneous report from a contactable consumer(patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reported that she had the Covid Vaccine then got Covid.The Physicians said wait ninety days after for the Booster and she wanted to know whether it was okay.The event outcome was unknown.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Atrial fibrillation, Pain, Pain in extremity
Clinical narrative: Afib; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: EN6198) (age at vaccination: 55-year-old) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included nebivolol nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication from 2013 and ongoing; doxycycline (ORACEA) taken for an unspecified indication from Jul2020 and ongoing. Historical vaccine included first dose of bnt162b2 (Batch/Lot number: EC9269) on 02Feb2021 as single dose in Left arm for covid-19 immunisation.  The patient had been experiencing pains on and off for about5-6 days after his first slot. Then he read an article (he swear, he was not researching anything online) about a 56 year old man who developed ITP days after receiving Pfizer vaccine. since he had Afib this article worried him. He had no idea what blood clots felt like, but he was having sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach. The doppal came back negative. The doctor suggested symptoms finally disappeared for good about two days after his second dose. The outcome of the events was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes simplex
Clinical narrative: herpes outbreak; This is a spontaneous report received from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 04Mar2021 at age of 80-years-old as single dose for covid-19 immunization. Patient's medical history (including any illness at time of vaccination) was none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 09Feb2021 in arm for covid-19 immunization, and approximately 7-10 days after vaccination 1 had outbreak of herpes. No other prior vaccination (within 4 weeks). The patient experienced herpes outbreak on 14Mar2021 with outcome of recovered. Seriousness criteria: important medical event. Treatment included resume use of Valtrex.   No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: herpes outbreak; This is a spontaneous report received from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 04Mar2021 at age of 80-years-old as single dose for covid-19 immunization. Patient's medical history (including any illness at time of vaccination) was none. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 09Feb2021 in arm for covid-19 immunization, and approximately 7-10 days after vaccination 1 had outbreak of herpes. No other prior vaccination (within 4 weeks). The patient experienced herpes outbreak on 14Mar2021 with outcome of recovered. Seriousness criteria: important medical event. Treatment included resume use of Valtrex.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: suffered from a TIA post covid shot; This is a spontaneous report from a contactable consumer (reporter's family member). A male patient of an unspecified age (reported as 65 +) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient suffered from a transient ischemic attack (TIA) post COVID shot this morning on 19Apr2021 with outcome of unknown. He was doing well, but was warned her could suffer from another stroke up to 4 months after his vaccination. The outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Deafness bilateral, Meniere's disease
Clinical narrative: bilateral hearing loss 10 days after; This is a spontaneous report from a contactable consumer (the patient is reporter's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bilateral hearing loss 10 days after receiving the Pfizer vaccine. Hearing returned in one ear. Hearing remained intermittent in the other ear. Patient did not have inflamed auditory nerve. Patient is currently undergoing testing for Meniere's disease. The outcome of event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: turned out to be Covid; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program .   A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in right arm on 28Jan2021 at 15:00 (at the age of 70-years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included unspecified blood pressure medications. There was no history of previous immunization with the Pfizer vaccine that was considered suspect. The patient did not take any other vaccine four weeks prior Covid-19 vaccination. On an unspecified date (3-4 days of vaccination), patient had sore throat and fever which he thought was strep and needed to visit physician office. Patient stated that they were sent to the hospital for treatment. The patient received treatment that included infusion with monoclonal antibody. On 02Feb2021 at 11:00, doctor checked and found out that patient was COVID Positive. Patient and his wife both were tested Positive. The patient underwent lab test which included SARS-CoV-2 test: Positive on 02Feb2021. They were informed to wait to get his 2nd dose. Stated that they were fine and relieved. Nurse informed that they shall not have shot until about 90 days. Patient wants to know when he should get the second dose. The patient stated that he was taking vaccine because government scared him and told him he would get sick and die without it. The symptom sore throat was resolved in 3-4 days. The outcome of the COVID-19 was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Panic attack
Clinical narrative: severe panic attacks; Neither him or I have been able to sleep for days.; This is a spontaneous report from a contactable consumer (patient). This is one of the 2 report from same reporter. A patient of an unknown age and gender received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unknown date in Apr2021, the patient reported neither reporter's son nor reporter have been able to sleep for days. They have seen a doctor twice. Reporter stated that they ended up calling (emergency number) twice and other two times to urgent care with severe panic attacks. The reporter has been trying to find psychological therapy without any luck and that was not a normal reaction, reported as please help them. The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: received her 1st vaccine and now tested positive for covid.; received her 1st vaccine and now tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (daughter).   A female patient (mother) of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received her 1st vaccine and now tested positive for covid. The reporter wanted to know how to make another appointment and also know would her mother be able to get the 2nd dose. Outcome of event was unknown.  Information about lot/batch number requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Vision blurred
Clinical narrative: A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot# EP7533), via unspecified route of administration in left arm on 6Apr2021 at 2:40PM at single dose for COVID-19 immunization. The patient was not administered with prior vaccine within four weeks. Patient had a history of ongoing high blood pressure. The patient's concomitant medication included ongoing Amlodipine Besylate at 5mg one tablet one time a day for high blood pressure and ongoing. On 14Apr2021, patient experienced her left eye got blurry. She doesn't know if her eye getting blurry is coming from the Covid-19 vaccine. She hasn't taken the second Covid-19 vaccine yet. She reports her eye might be blurry because of the Covid-19 vaccine. She reports the left eye blurriness started about 4 or 5 days ago on 14Apr2021. Her eye was getting blurry a little bit then it seemed to get worse, now it's staying about the same. It seems like there is something in her eye, just her left eye. When she tries to read, the letters are blurry but if she puts what she's reading up close to her face she can make the letters out. She reports her husband got his Covid 19 vaccine first and she was skeptical about getting the vaccine for herself. On 25Nov2020, when she went to the doctor on for a regular checkup, he changed one of her medications and she didn't notice the change. She doesn't know if she needs glasses. She doesn't wear glasses not even to read. She tried reading glasses but they gave her a headache. She has made an appointment to see an eye doctor. She reports it seems like there is something in her left eye. She might have cataracts. She has an eye appointment in about 3 weeks on 04May2021 or 05May2021. She can see fine out of her right eye and she can see out of her left eye she just has to put what she's reading close to her left eye to see it. No emergency Room/ Physician Office due to AE. Outcome of the events was not resolved.