chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Body temperature, Chills, Electroencephalogram, Feeling abnormal
Clinical narrative: Running a 101 plus fever.; Chills; Body aches; Influenza like illness; She started feeling bad yesterday.; She had really bad tremors; This is spontaneous report received from contactable other consumer (Patient mother) report for her daughter reported. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm right on 11Mar2021 at 11:30 as dose 1 single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2 single for COVID-19 immunization. Medical history included anxiety, depression, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Verbatim: ADHD, cardiac operation from an unknown date and unknown if ongoing (had open heart surgery when she was child, a baby, abdominal pain lower from an unknown date and unknown if ongoing monitoring her heart all time but her lower abdomen hurt too). Concomitant medications included valproate semisodium (DEPAKOTE), fluoxetine hydrochloride (PROZAC), zolpidem (ZOLPIDEM), ibuprofen (ADVIL 12 HOUR) and ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for anxiety, start and stop date were not reported; diazepam (DIAZEM [DIAZEPAM]) taken for attention deficit hyperactivity disorder, start and stop date were not reported. On an unspecified date, the reporter reported about the events "My Daughter and I both got the shot yesterday. She got the flu like symptoms, was running a 101 plus fever and chills and body ache." Post the second shot it was reported that the patient had body ache and it felt like flu like symptoms. The patient also experienced "She started feeling bad yesterday yes and then that morning probably last this got kind of little worse and she had really bad tremors". The patient underwent lab tests and procedures which included bacterial test: with results unknown on an unspecified date, body temperature: 101 on an unspecified date, electroencephalogram: unknown on 24Feb2021 (She had a what's the brain's scan EEG where they put the 'lobes' on your head"). Outcome of the events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, Tremor
Clinical narrative: Running a 101 plus fever.; Chills; Body aches; Influenza like illness; She started feeling bad yesterday.; She had really bad tremors; This is spontaneous report received from contactable other consumer (Patient mother) report for her daughter reported. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm right on 11Mar2021 at 11:30 as dose 1 single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2 single for COVID-19 immunization. Medical history included anxiety, depression, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Verbatim: ADHD, cardiac operation from an unknown date and unknown if ongoing (had open heart surgery when she was child, a baby, abdominal pain lower from an unknown date and unknown if ongoing monitoring her heart all time but her lower abdomen hurt too). Concomitant medications included valproate semisodium (DEPAKOTE), fluoxetine hydrochloride (PROZAC), zolpidem (ZOLPIDEM), ibuprofen (ADVIL 12 HOUR) and ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for anxiety, start and stop date were not reported; diazepam (DIAZEM [DIAZEPAM]) taken for attention deficit hyperactivity disorder, start and stop date were not reported. On an unspecified date, the reporter reported about the events "My Daughter and I both got the shot yesterday. She got the flu like symptoms, was running a 101 plus fever and chills and body ache." Post the second shot it was reported that the patient had body ache and it felt like flu like symptoms. The patient also experienced "She started feeling bad yesterday yes and then that morning probably last this got kind of little worse and she had really bad tremors". The patient underwent lab tests and procedures which included bacterial test: with results unknown on an unspecified date, body temperature: 101 on an unspecified date, electroencephalogram: unknown on 24Feb2021 (She had a what's the brain's scan EEG where they put the 'lobes' on your head"). Outcome of the events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity
Clinical narrative: I felt like I had the flu; hands don't hurt all the time; This is a spontaneous report received from a Pfizer-sponsored program, XELSOURCE. A contactable consumer (patient) reported that a 64-year-old female patient received the first dose of BNT162B2 via an unspecified route on an unspecified date as single dose for COVID-19 immunization; and tofacitinib citrate (XELJANZ XR 11 mg prolonged-release tablet) via an unspecified route of administration from an unspecified date at 11 mg of unspecified frequency for an unspecified indication. Medical history and concomitant medications were not reported. The patient stated that her hands didn't hurt all the time. She hasn't felt this good in years. She can walk down the stairs. She reacted to her first Pfizer vaccine, but not the second. She felt like she had the flu. The action taken in response to the event for tofacitinib citrate and the outcome of the events were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Yeast infection; This is a spontaneous report from a Pfizer-sponsored program. The contactable nurse and consumer (patient) reported that a 44-year-old female patient (unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 29Mar2021 (at the age of 44 years), as dose 2, single, for COVID-19 immunization; and tofacitinib citrate (XELJANZ XR Tablet; Strength: 11 mg, Expiration Date: 30Jan2023), oral, from Apr2016 to 2021, at 11 mg, once daily, for rheumatoid arthritis. The patient's medical history was not reported. The patient's concomitant medication included methotrexate. The patient previously took codeine/ paracetamol (ACETAMINOPHEN;CODEINE Elixir) and experienced allergies. The patient got her second COVID-19 vaccine on 29Mar2021 and was told to hold her tofacitinib citrate for a week when getting the vaccine. While off of tofacitinib citrate for the week, the patient was also treated for a yeast infection (2021). The patient was started back on tofacitinib citrate a week after getting COVID-19 vaccine (Apr2021). The physician was aware. The action taken in response to the event for tofacitinib citrate was post-therapy. The outcome of the event was unknown.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Sinusitis
Clinical narrative: tested positive after receiving the first dose of the pfizer vaccine/ she took an antigen test and was positive; sinus infection; This is a spontaneous report from a patient.   A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunisation. The patient medical history included auto-immune disorder and Rheumatoid arthritis. Concomitant medications were not reported. On an unspecified date after the first dose, the patient tested positive for Covid-19. On the same day of getting the first dose Pfizer vaccine, they took covid tests and were both negative. They have been taking the precautions. A few weeks later, on an unspecified date, she had a sinus infection, and she took an antigen test and was positive. She has been doing her research and when she got the first dose of the covid, she developed antibodies so, she could test positive. She tested positive for Covid and had the symptoms for five days. Her doctor told her to take it after 10 days. She was scheduled for her second dose on 19Apr2021 and asked if she can get the second dose of the vaccine on 19Apr2021. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms
Clinical narrative: having issues with her fingers cramping; numbness in her left leg and foot/her left leg and left foot went numb/Both feet went numb; This is a spontaneous report from a contactable other hcp (patient). A 67-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), intramuscularly, administered in Arm Left on 05Apr2021 13:15 as DOSE 1, SINGLE (at the age of 67-year-old) for covid-19 immunization. Medical history included patient had Covid virus on an unknown date in Jan2021 to an unknown date for 12 days along with it the patient experienced high fevers for 12 days, body aches, and headaches, ongoing thyroiditis Since 18 years ago. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) 88 ug daily taken for thyroiditis, from an unknown start date (18 year ago as reported). The patient previously took flu and experienced Sore arm and feel muscle aches. The patient also reported of having allergy (unspecified). The patient had significant exposure with an AIDS patient years ago, they put her on two AIDS drugs and was supposed to be on them 6 weeks. The medications were Combivar and Sustiva. All of a sudden, her throat closed off and she had severe hives, and she had an anaphylactic reaction. She had to go to the ER. She had to stop taking both of them. On the same 05Apr2021 13:35, the patient experienced numbness in her left leg and foot/her left leg and left foot went numb/both feet went numb. This lasted 5-10 minutes. She walks 4-5 miles 4-5 times a week and it is not like she is not on her feet. Plus, she was having issues with her fingers cramping. Plus, she was having issues with her fingers cramping. The patient had the same numbness in feet again on 06Apr2021. The patient did not visit any emergency room due to the events. The outcome of the event numbness in feet was reported as recovered in APR2021, while for the event fingers cramping outcome was unknown at the time of report.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Chest discomfort, Chest pain, Gait disturbance, Movement disorder
Clinical narrative: body felt like it was sleepy and sore; body felt like it was sleepy and sore; chest pain; heavy and putting pressure on her chest; difficulty in her movement and walking coordination and her brain was "not working; difficulty in her movement and walking coordination and her brain was "not working; difficulty in her movement and walking coordination and her brain was "not working; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. This 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 14Apr2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. On 14Apr2021, about after 12 hours, half of her body felt like it was sleepy and sore. She also had chest pain, which felt like there was something heavy and putting pressure on her chest. She also mentioned that she had difficulty in her movement and walking coordination and her brain was "not working". She was asking if this is common or something that she needs to go to the doctor to. She mentioned that her friends who got the vaccines had fevers but no chest pain. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body felt like it was sleepy and sore; body felt like it was sleepy and sore; chest pain; heavy and putting pressure on her chest; difficulty in her movement and walking coordination and her brain was "not working; difficulty in her movement and walking coordination and her brain was "not working; difficulty in her movement and walking coordination and her brain was "not working; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. This 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 14Apr2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. On 14Apr2021, about after 12 hours, half of her body felt like it was sleepy and sore. She also had chest pain, which felt like there was something heavy and putting pressure on her chest. She also mentioned that she had difficulty in her movement and walking coordination and her brain was "not working". She was asking if this is common or something that she needs to go to the doctor to. She mentioned that her friends who got the vaccines had fevers but no chest pain. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Headache, Pain in extremity, Pruritus
Clinical narrative: sore left arm; severe itch whole body; headache; slightly elevated temperature; low energy; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route in the left arm on 03Mar2021, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 20:00, the patient experienced sore left arm, severe itch whole body, headache, slightly elevated temperature, and low energy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took ibuprofen as a treatment for the reported events. The clinical outcomes of the events sore left arm, severe itch whole body, headache, slightly elevated temperature, and low energy were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Pfizer Covid-19 vaccine that was administered to her has been ineffective; Pfizer Covid-19 vaccine that was administered to her has been ineffective; This is a spontaneous report from a non-contactable pharmacist.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 17Mar2021 as dose 1, single, and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date, as dose 2, single for Covid-19 immunization. Medical history was not reported. Concomitant medications included methotrexate taken for an unspecified indication, start and stop date were not reported; and rituximab (RITUXAN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, Pfizer covid-19 vaccine that was administered to her has been ineffective. Patient said that she was under the medication of methotrex-ate and rituxan (rituximab) before and after the Covid-19vaccine shots. She said that her doctor advised her to take another shot of Covid-19 vaccine either Johnson and Johnson or Pfizer Covid-19 vaccine because her doctor told her that the Pfizer Covid-19 vaccine that was administered to her has been ineffective due to the medications that she was currently taking. The outcome of the event was unknown.  Information about lot/batch number could not be obtained. Additional information had been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Suspected Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Pericarditis, Sinusitis
Clinical narrative: He has developed a pericarditis.; It was a sinus infection; This is a Spontaneous report from a non-contactable consumer or other non-HCP. This consumer reported for a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, NDC number, Batch/Lot number was EK4176, Expiry Date: unknown) via an unspecified route of administration, administered in left arm on 29Jan2021 morning as dose 1, single and received second dose of BNT162B2 via an unspecified route of administration, administered in left arm on 19Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient age at time of vaccination was 66 years. The medical history, family history and concomitant medications were not reported. The patient was on an unspecified medication. The prior vaccinations were reported as none. On an unspecified date in 2021, the patient has developed a pericarditis and some sinus infection after COVID Vaccine. The reporter reported that, he just had that X-ray, a few days ago, where he was diagnosed with it. The doctor said that, he had the pericarditis at his heart right away. It was a sinus infection. Chest x-ray, that was told to him have that. The lab data included chest x-ray on an unspecified date in 2021 which confirmed that pericarditis at his heart right away. No treatment medication received for the events. The outcome for the events was unknown.  Follow-up attempts are needed; Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test, Vaccination site movement impairment
Clinical narrative: symptoms of myocarditis include chest pains, heart palpitations and shortness of breath; Difficulty lifting my left arm higher than my shoulder.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 11Feb2021 at 15:00 (at the age of 65-year-old), as dose 2, single in left arm for COVID-19 immunisation in other facility. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medications within 2 weeks of vaccination included acyclovir taken for an unspecified indication, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9263), via an unspecified route of administration on 21Jan2021 (at the age of 65-year-old) as single dose in left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021, 12 days after the administration of second dose of vaccine, the patient experienced difficulty in lifting her left arm higher than her shoulder; which lasted over a week and got worse before she went to the hospital. On 23Mar2021, 1 month and 12 days after the administration of the second dose of vaccine, the patient experienced symptoms of myocarditis include chest pains, heart palpitations and shortness of breath. The adverse events resulted in visit of emergency room. Treatment medications included anti-inflammatory and muscle relaxer. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): negative; on 04Jun2021. The patient had no COVID prior vaccination and was tested COVID post vaccination. The clinical outcome of all the events was resolved on unspecified dates in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Diabetes mellitus, Fall, Gait disturbance
Clinical narrative: Diabetes; Osteoarthritis knee; trouble sleeping at night/sleeplessness; injured right wrist; fallen twice; Back pain; Neck pain; shoulders pain; Difficulty in walking; Pain; This is a solicited report from a marketing program received from a non-contactable consumer (patient) based on information received by Pfizer, (manufacturer control number: 21K-163-3786549-00). A 55-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular first dose in Mar2021 second dose in Mar2021 both at the 55 years old at single dose for COVID-19 immunization; adalimumab(HUMIRA) Subcutaneous from 2019 and ongoing at 40 mg, cyclic(1 in 2 wk) for Moderate to severe Rheumatoid arthritis.  The medical history included Non-smoker, Abstains from alcohol, Diabetes, Right knee replaced, Hysterectomy, Left foot ganglion cyst surgery. It was unknown if patient was enrolled in a covid-19 vaccine trial. The concomitant medications were not reported. The patient previously took Farxiga and experienced allergy manifested by Dehydrated dizzy and weak to get out from bed; Amlodipine and experienced allergy manifested by Broke out in rash all over the body. The patient experienced Osteoarthritis knee, fallen twice, injured right wrist, back pain, neck pain, shoulders pain, difficulty in walking, diabetes, pain and trouble sleeping at night, sleeplessness, all in 2021. The patient underwent lab tests and procedures, which included X-RAY on 03JUN2021: Needs Knee surgery. The action taken in response to the event for adalimumab was dose not changed. The outcome of the events was not recovered.  Causality for adalimumab: The reporter causality for the events of left knee was bone on bone/osteoarthritis, fallen twice/injured right wrist unknown onset, pain and sleeplessness was no reasonable possibility. The reporter's causality for the events of trouble sleeping at night, back pain, neck pain, shoulders pain, difficulty walking and diabetes was not provided.  The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: The reported events are most likely intercurrent conditions or related to underlying medical conditions and unrelated to BNT162B2.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Insomnia, Joint injury, Neck pain, Osteoarthritis, Pain
Clinical narrative: Diabetes; Osteoarthritis knee; trouble sleeping at night/sleeplessness; injured right wrist; fallen twice; Back pain; Neck pain; shoulders pain; Difficulty in walking; Pain; This is a solicited report from a marketing program received from a non-contactable consumer (patient) based on information received by Pfizer, (manufacturer control number: 21K-163-3786549-00). A 55-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular first dose in Mar2021 second dose in Mar2021 both at the 55 years old at single dose for COVID-19 immunization; adalimumab(HUMIRA) Subcutaneous from 2019 and ongoing at 40 mg, cyclic(1 in 2 wk) for Moderate to severe Rheumatoid arthritis.  The medical history included Non-smoker, Abstains from alcohol, Diabetes, Right knee replaced, Hysterectomy, Left foot ganglion cyst surgery. It was unknown if patient was enrolled in a covid-19 vaccine trial. The concomitant medications were not reported. The patient previously took Farxiga and experienced allergy manifested by Dehydrated dizzy and weak to get out from bed; Amlodipine and experienced allergy manifested by Broke out in rash all over the body. The patient experienced Osteoarthritis knee, fallen twice, injured right wrist, back pain, neck pain, shoulders pain, difficulty in walking, diabetes, pain and trouble sleeping at night, sleeplessness, all in 2021. The patient underwent lab tests and procedures, which included X-RAY on 03JUN2021: Needs Knee surgery. The action taken in response to the event for adalimumab was dose not changed. The outcome of the events was not recovered.  Causality for adalimumab: The reporter causality for the events of left knee was bone on bone/osteoarthritis, fallen twice/injured right wrist unknown onset, pain and sleeplessness was no reasonable possibility. The reporter's causality for the events of trouble sleeping at night, back pain, neck pain, shoulders pain, difficulty walking and diabetes was not provided.  The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: The reported events are most likely intercurrent conditions or related to underlying medical conditions and unrelated to BNT162B2.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: X-ray
Clinical narrative: Diabetes; Osteoarthritis knee; trouble sleeping at night/sleeplessness; injured right wrist; fallen twice; Back pain; Neck pain; shoulders pain; Difficulty in walking; Pain; This is a solicited report from a marketing program received from a non-contactable consumer (patient) based on information received by Pfizer, (manufacturer control number: 21K-163-3786549-00). A 55-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular first dose in Mar2021 second dose in Mar2021 both at the 55 years old at single dose for COVID-19 immunization; adalimumab(HUMIRA) Subcutaneous from 2019 and ongoing at 40 mg, cyclic(1 in 2 wk) for Moderate to severe Rheumatoid arthritis.  The medical history included Non-smoker, Abstains from alcohol, Diabetes, Right knee replaced, Hysterectomy, Left foot ganglion cyst surgery. It was unknown if patient was enrolled in a covid-19 vaccine trial. The concomitant medications were not reported. The patient previously took Farxiga and experienced allergy manifested by Dehydrated dizzy and weak to get out from bed; Amlodipine and experienced allergy manifested by Broke out in rash all over the body. The patient experienced Osteoarthritis knee, fallen twice, injured right wrist, back pain, neck pain, shoulders pain, difficulty in walking, diabetes, pain and trouble sleeping at night, sleeplessness, all in 2021. The patient underwent lab tests and procedures, which included X-RAY on 03JUN2021: Needs Knee surgery. The action taken in response to the event for adalimumab was dose not changed. The outcome of the events was not recovered.  Causality for adalimumab: The reporter causality for the events of left knee was bone on bone/osteoarthritis, fallen twice/injured right wrist unknown onset, pain and sleeplessness was no reasonable possibility. The reporter's causality for the events of trouble sleeping at night, back pain, neck pain, shoulders pain, difficulty walking and diabetes was not provided.  The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: The reported events are most likely intercurrent conditions or related to underlying medical conditions and unrelated to BNT162B2.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration, Menstrual disorder, Migraine
Clinical narrative: Massive hair loss; migraines came back; menstrual cycle all messed up; vaccine is administered on the same date; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: WG10190, Expiration date: Not reported), via unspecified route, administered in left arm on 31Mar2021 (at the age of 45-year-old) as dose 2, single; and first dose of BNT162B2  (Lot Number: WG10190) via an unspecified route of administration, administered in  left arm on 31Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Chronic migraines. And patient had known allergies to Sulfur. No other vaccine 4 weeks prior to covid vaccine. Concomitant medications were not reported but Patient received few mediations within 2 weeks of vaccination and details unknown. Prior and post vaccination, patient was not diagnosed and tested with covid 19. On 15Apr2021, after the vaccination, the patient experienced Massive hair loss, migraines came back, and menstrual cycle all messed up. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the events is not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Inappropriate schedule of product administration, Overdose
Clinical narrative: two bouts of Bell's palsy; patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2; A 48-years-old male patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWO151) via an unspecified route of administration on 29Apr2021 on left arm as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWO170) via an unspecified route of administration on 29Apr2021 (at age 48-year-old) on left arm as dose 2, single for COVID-19 immunization. Medical history included several previous incidents of Bell's palsy and allergy to penicillin (start data and ongoing status unknown). The patient's concomitant medications were not reported. It was mentioned that patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. It was reported that, a 48-year-old male patient received the first dose on 29Apr2021 on left arm as dose 1, single and second on 29Apr2021 on left arm as dose 2 (inappropriate schedule of vaccine administered, overdose) and the patient experienced two bouts of bell's palsy on 25May2021. One 4 weeks after vaccination on the right side and now a second one on the left about four weeks after the first incident. Therapeutic measures were taken with valtrex and prednisone as a result of two bouts of bell's palsy. The outcome of event two bouts of Bell's palsy was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: chest inflammation (heart); fatigue; chills; fever; sweats; large got hot spot on arm (for one week); chest tension; This is a spontaneous report from a contactable consumer (patient). A 32 years old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Ew0191), via an unspecified route, administered in Left Arm on 25May2021 (at the age of 32-year-old at vaccination) as Dose 2, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included high blood pressure, known penicillin allergy. The patient's concomitant medications included norethindrone acetate and hydrochlorothiazide, triamterene within two weeks of Covid-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient had not received any other vaccine within four weeks of Covid-19 vaccination. The patient was not diagnosed with Covid infection prior to vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Ew0179), via an unspecified route, administered in Left Arm on 04May2021 (at the age of 32-year-old at vaccination) as Dose 1, single for COVID-19 immunization. After first shot, experienced two weeks of extreme brain fog and fatigue. On 25May2021 (after the second shot), the patient had experienced fatigue, chills, fever, sweats, large got hot spot on arm (for one week) and chest tension. Diagnosed with chest inflammation (heart) and prescribed Prednisone after one month of symptoms. These adverse events resulted the patient to Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not been tested for COVID-19. The patient received Prednisone as treatment medication for the resulted events. The outcome of the events was recovering.  Follow-up attempts are possible. Further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pyrexia
Clinical narrative: chest inflammation (heart); fatigue; chills; fever; sweats; large got hot spot on arm (for one week); chest tension; This is a spontaneous report from a contactable consumer (patient). A 32 years old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Ew0191), via an unspecified route, administered in Left Arm on 25May2021 (at the age of 32-year-old at vaccination) as Dose 2, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included high blood pressure, known penicillin allergy. The patient's concomitant medications included norethindrone acetate and hydrochlorothiazide, triamterene within two weeks of Covid-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient had not received any other vaccine within four weeks of Covid-19 vaccination. The patient was not diagnosed with Covid infection prior to vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Ew0179), via an unspecified route, administered in Left Arm on 04May2021 (at the age of 32-year-old at vaccination) as Dose 1, single for COVID-19 immunization. After first shot, experienced two weeks of extreme brain fog and fatigue. On 25May2021 (after the second shot), the patient had experienced fatigue, chills, fever, sweats, large got hot spot on arm (for one week) and chest tension. Diagnosed with chest inflammation (heart) and prescribed Prednisone after one month of symptoms. These adverse events resulted the patient to Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not been tested for COVID-19. The patient received Prednisone as treatment medication for the resulted events. The outcome of the events was recovering.  Follow-up attempts are possible. Further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Oxygen saturation decreased, SARS-CoV-2 test, Thrombosis
Clinical narrative: She was admitted to the hospital 6/21/21 with lethargy and was intubated due to low oxygen levels.  She developed a blood clot in her left arm around 4 am 6/24/21.; She was admitted to the hospital 6/21/21 with lethargy and was intubated due to low oxygen levels.  She developed a blood clot in her left arm around 4 am 6/24/21.; She was admitted to the hospital 6/21/21 with lethargy and was intubated due to low oxygen levels.  She developed a blood clot in her left arm around 4 am 6/24/21.; This is a spontaneous report received from a contactable male consumer. A 70-year-old female patient (non-pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0180), via an unspecified route of administration on arm left on 17Jun2021 (Age at Vaccination: 70 years) at single dose for COVID-19 immunization. The patient medical history included Alpha-1 Antitrypsin deficiency, emphysema, depression/anxiety, chronic kidney disease and known allergies to Medication-Paxil. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The device date was reported as 25Jun2021. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient Concomitant medications were not reported. On 21Jun2021 15:00 PM, the patient was admitted to the hospital with lethargy and was intubated due to low oxygen levels. On 24Jun2021, around 4 am, the patient experienced blood clot in her left arm.  The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The relevant lab tests included Test: Covid test, result: Negative on 21-JUN-2021. Therapeutic measures were taken and treatment included Heparin IV medication. The outcome of the events was Not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Thrombosis, Ultrasound Doppler
Clinical narrative: Developed a blood clot in her leg after receiving the first dose of vaccine on 23Jan2021; High blood pressure/ Blood pressure up; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 23Jan2021 11:00 (age at vaccination was 86 years) (Batch/Lot Number: EL9261) as dose 1, single for covid-19 immunization. Medical history included ongoing Difficulty sleeping since 10 to 20 years, osteoarthritis and osteoporosis probably since 20 years or more, hip arthroplasty or replacement when she was 64 years old, Hip revision when she was 83 or 84 years old, she wore out the ball in her hip. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included trazodone (TRAZODONE) taken for insomnia. The patient experienced developed a blood clot in her leg after receiving the first dose of vaccine on 23Jan2021 on an unspecified date in 2021 and taking Eliquis, she took it for 90 days. She said she was doing better, she now had high blood pressure. They first noticed the high blood pressure when she had her ultrasound for her blood clot. It was in the 170s, but now she was on blood pressure medication taking Losartan 100mg, Metoprolol 25mg. Her blood pressure reading this morning (25Jun2021) was 152/83. Her blood pressure reading in 08Sep2020 was 126/84. The events led to the emergency room. She had been seeing her doctor as well. The patient underwent lab tests and procedures which included blood pressure measurement: 126/84 on 08Sep2020, blood pressure measurement: 170s on unspecified date in 2021, blood pressure measurement: 152/83 on 25Jun2021, ultrasound doppler: blood clot in vein on an unspecified date in 2021. The patient received treatment for the events. The event blood clot in her leg was always serious and medically significant. The outcome of the event blood clot in her leg was unknown and other events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Pain in extremity
Clinical narrative: vaccine paralyzed his left leg; extreme leg pain; This is a spontaneous report from a non-contactable consumer or other non hcp via Pfizer sponsored program. A male patient of an unspecified age received the second dose of bnt162b2 (Pfizer Covid-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was unknown if the reporter was a health care professional. It was unknown if the reporter was the prescribing HCP. The patient previously took BNT162B2 as the 1st dose for COVID 19 immunization. On an unspecified date, the patient experienced vaccine paralyzed his left leg and extreme leg pain. The patient took 2nd dose of Covid vaccine 7 weeks ago tomorrow and said the vaccine paralyzed his left leg and caused extreme leg pain. The patient would like to know if there are tests people are supposed to get prior to receiving the vaccine as he says he did not sign up to be a human Guinea pig. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Lymphoedema, Near death experience
Clinical narrative: My dad is going to die; has developed lymphedema on his legs; they are extremely swollen and sore; they are extremely swollen and sore; This is a spontaneous report from a contactable consumer (patient's daughter). An 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; pemetrexed disodium (ALIMTA) and pegfilgrastim (NEULASTA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included mesothelioma (Her father was diagnosed with Mesothelioma 6 months ago and has been on chemo for 5 months). The concomitant medications were not reported. Caller stated that the day his father got his vaccine, he also received his chemotherapy and now has developed lymphedema on his legs. Caller is asking if this is advisable. Patient (reporter's father) had the COVID vaccine, and he was on Alimta and Neulasta which was a patch that they put on them that injects so many hours after chemotherapy stops. It was a time release patch (filgristam). He had developed lymphedema in his legs and they were extremely swollen and sore. Reported that Alimta does not caused lymphedema and he was been on it for several cycles on Alimta and had no problems. Reporter had a feeling that giving these drugs together with the COVID vaccine caused lymphedema. Reporter's dad was going to die. Mesothelioma had no cure. Lymphedema only happens when there was an injury to the lymph nodes. Now her dad who had these drugs that he was getting for several months, never had any problems, now had lymphedema. The doctors were lying (as reported). Now he can't have his chemo because of the lymphedema. 100 percent reporter believe that the vaccine caused this. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: 28 days after receiving 1st dose, had a small menstrual period (I'm 65 and have been in menopause since I was 48).; This is a spontaneous report from a non-contactable consumer or other non hcp. A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 28Feb2021 16:30 (Batch/Lot Number: EN6202) as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 07Feb2021 15:30 (Batch/Lot Number: EN9581) as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history included high blood pressure from an unknown date. The patient is in her menopause since she was 48-year-old. Concomitant medication included candesartan (CANDESARTAN) 8mg taken for an unspecified indication, from an unknown start date. The patient is allergic to aspirin and amoxicillin. On 07Mar2021, the patient experienced 28 days after receiving 1st dose, had a small menstrual period (I'm 65 and have been in menopause since I was 48). Had a second smaller incident on 20Jun. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the event. The outcome of the event was reported as unknown at the time of report.  No follow-up attempts are possible. No further information is expected.