chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor
Clinical narrative: she experienced nausea and shakiness; she experienced nausea and shakiness; This is a spontaneous report from a contactable pharmacist. A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: unknown), dose 2 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation. On an unspecified date, the patient experienced nausea and shakiness. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort
Clinical narrative: stomach issue; This is a spontaneous report from a Pfizer sponsored program. A contactable other HCP and a contactable consumer (patient) reported that a 52-years-old female patient 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; palbociclib (IBRANCE), via an unspecified route of administration from 07Jun2021 to an unspecified date, at 125 mg for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stomach issue on an unspecified date (reported as Tuesday). Patient thinks that it was related to the COVID shot she got that Sunday. The outcome was recovered after 1 day.  The action taken in response to the event for palbociclib was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: both shoulders ached; This is a spontaneous report from a contactable consumer (patient's friend). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) on an unspecified date as dose 2, single for COVID-19 immunisation. The vaccine was administered in a clinic. The patient's medical history included COVID-19 (tested positive for COVID in Dec2020) and asthmatic. The patient has no concomitant medications. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and experienced compromised breathing, lethargy, general achiness, and heart thing (as reported)(recovered). On an unspecified date, after receiving the second dose, the patient experienced "both shoulders ached" and described like it was bursitis which persisted to this day (on the day of the report). The outcome of the event was not recovered.  Information on batch/lot number has been requested.
Sex: M
Vaccine: UNK
Symptoms: Drug interaction
Clinical narrative: taking RITUXAN during his dose 2 series rendered the vaccine ineffective; This is a spontaneous report from a contactable consumer (patient), via medical information team). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as Dose 2, single for COVID-19 immunization; and received rituximab (RITUXAN), via an unspecified route of administration on an unspecified date (taking during his Pfizer dose 2 series), for an unknown indication. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as Dose 1, single for COVID-19 immunization. The patient asked if there was any information in taking a second 2 dose series of the Pfizer COVID vaccine and he was taking RITUXAN during his dose 2 series, which rendered the vaccine ineffective (encoded as potentiating drug interaction). He was wondering if the medication was out of his system now if he would take the 2 dose vaccine series a second time. The outcome of the event of drug interaction was unknown.  Information on the lot/batch number has been requested.  Follow-up (28Jun2021): New follow up spontaneous report received from a contactable consumer included: Reporter contact details updated.  Amendment: This follow-up report is being submitted to amend previously reported information: updated RITUXAN as suspect product, and re-coded event as drug interaction for VT "taking RITUXAN during his dose 2 series rendered the vaccine ineffective".
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: joint pain; pain at night; This is a spontaneous report from a contactable other healthcare professional via Pfizer-sponsored program. A 55-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation and oral tofacitinib citrate (XELJANZ XR) on 21Apr2021 and ongoing at 11mg, daily for Rheumatoid arthritis. Medical history and concomitant medications were unknown. The patient reported after start of therapy XELJANZ XR has helped. Medical doctor aware. The patient reported after start of therapy she got her second covid vaccine 2 weeks before the report and currently has joint pain and pain at night. Medical doctor aware. The patient did not report any missed doses or side effect. XELJANZ XR was continued. The outcome of the events was unknown. No follow-up attempts are needed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: she has experienced  massive headaches nonstop; she experienced is a blinding headache; This is a spontaneous report received from a contactable Pharmacist (patient). A 62-year- old pharmacist received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Batch/Lot Number: EW0181), via an unspecified route of administration in the left arm on 29Jun2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Time the vaccination was given as sometime in the evening, about 19:00 or maybe a little earlier, 18:30. Medical history was reported as none. Concomitant medications were not reported. The patient stated she was in a clinical trial last year, 2020, for the Astra Zeneca Vaccine and received the active Astra Zeneca Vaccine. The patient stated no one recognizes the Astra Zeneca Vaccine here. An Airline told the caller they would not fly her and she was considered not vaccinated. In order to secure a CDC Card, the caller had to go and have the Pfizer Covid 19 Vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Had first dose of the Pfizer COVID-19 vaccine on 29Jun2021. Since then she had experienced massive headaches nonstop. She had read from the internet that there had been reports of headaches but what she experienced was a blinding headache. For two or three days the patient had been running a blinding headache. The patient's headache was not subsiding. The patient had taken Aspirin and Tylenol. The patient stated, today is Friday, 02Jul2021, on Wednesday, 30Jun2021 and Thursday 01Jul2021, the patient was incapacitated sitting at home and trying to put an ice pack. The patient rotated warm packs and ice packs. The patient could not function. When asked if the headache had improved, persisted or worsened the patient replied the headache was just as it is, its blinding. The headache had not improved even after taking the over the counter pain pills. The outcome of events was not resolved.  Additional Information: Description of Product Complaint: Tylenol (Lot: P108696, NDC: 0363-0519-12, Expiration: Jan2020, Additional lot numbers: P108696) The patient reported a blinding headache after receiving the first dose Pfizer Covid 19 Vaccine. The patient stated the headache has continued even after taking over the counter pain medication. The patient stated the headache had continued and the patient has taken Tylenol. The patient stated she needed to put on glasses to read the information on the Tylenol bottle.   Description of Product Complaint: Aspirin (Lot: P121168, expiration: Jul2022, NDC: 0363-0563-32, Additional lot numbers: P121168) The patient reported a blinding headache after receiving the first dose Pfizer Covid 19 Vaccine. The patient stated the headache had continued even after taking over the counter pain medication. The patient stated the headache had continued and the patient had taken Aspirin.  Follow up needed, further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Inflammation, Peripheral swelling
Clinical narrative: ankles along with feet swelled up; inflammation; chest pain; difficult breathing; This is a spontaneous report received from a contactable other healthcare professional (patient). A 38-year-old female patient (also the age at vaccination time) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06May2021 12:00 (Batch/Lot Number: Ew0175) as dose 1, single; dose 2 via an unspecified route of administration, administered in Arm Left on 27May2021 12:00 (Batch/Lot Number: Ew0177) as dose 2, single for Covid-19 immunization. Medical history included Covid-19 (Prior to vaccination, was the patient diagnosed with COVID-19? - Yes). There were no concomitant medications. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her ankles along with feet swelled up after 4 days of receiving Pfizer Covid 19 vaccine and continued to swell and inflammation occurred with chest pain and difficult breathing. Side effect continued for two months. Blood work was drawn, and inflammation marker were very high. Adverse event start date was 10May2021 (12:00 PM). The patient was treated with Prednisone 10 mg tab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) (as reported). The patient has not been tested for COVID-19 since the vaccination. The patient recovered with lasting effects on an unspecified date in 2021. The events were reported as serious with seriousness criteria of life threatening.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: ankles along with feet swelled up; inflammation; chest pain; difficult breathing; This is a spontaneous report received from a contactable other healthcare professional (patient). A 38-year-old female patient (also the age at vaccination time) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06May2021 12:00 (Batch/Lot Number: Ew0175) as dose 1, single; dose 2 via an unspecified route of administration, administered in Arm Left on 27May2021 12:00 (Batch/Lot Number: Ew0177) as dose 2, single for Covid-19 immunization. Medical history included Covid-19 (Prior to vaccination, was the patient diagnosed with COVID-19? - Yes). There were no concomitant medications. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her ankles along with feet swelled up after 4 days of receiving Pfizer Covid 19 vaccine and continued to swell and inflammation occurred with chest pain and difficult breathing. Side effect continued for two months. Blood work was drawn, and inflammation marker were very high. Adverse event start date was 10May2021 (12:00 PM). The patient was treated with Prednisone 10 mg tab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) (as reported). The patient has not been tested for COVID-19 since the vaccination. The patient recovered with lasting effects on an unspecified date in 2021. The events were reported as serious with seriousness criteria of life threatening.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza A virus test, Therapeutic response unexpected
Clinical narrative: specific symptoms she had been experiencing because of her tick bite had either resolved all together or lessened in severity; This is a spontaneous report from a contactable Nurse reported for herself. A 77-year-old female patient received first dose of bnt162b2 (BNT162B2) on 30Mar2021 (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included patient was bitten by a tick on 06 or 07Jul2019 and was hospitalized because of it on 29Jul2019.  She stated 3 parasites were found in her labs because of the tick bite: Lymes, Babesia, and Ehrlickia. The patient had since been ill and her immune system hadn't been so hot for the last few years and she had been sick because of the tick bite.  "lung" side effects of chest tightness- which felt like her chest had been "wrapped with saran wrap" and what her physicians call it "air hunger". Heat intolerance and sweating. She was in (withheld) for 5 months and then when she went back to (withheld)  in Nov2019 they said that in Babesia world that they call it air hunger, she never felt right with that. When she went in Nov2019 she had a bruise about 2.5 inches wide around the front of her chest and that's how she felt. The Babesia affect her red blood cells, like malaria, and the Ehrlickia only eats plasma. She was in her 30's and she cut her finger. She said to them that she felt like she had the flu and they did a nasal swab and she was positive for influenza A, this occurred in Jul2019. She told them at the urgent care that it was Jul 2019 and you don't usually have the flu in July, and they just said well it is hot and she is old.  Concomitant medications included doxycycline, azithromycin (ZITHROMAX), ceftriaxone (CEFTIN), metronidazole (FLAGYL).  Patient received the first dose of the vaccine on 30Mar2021 and 3 days later, specific symptoms she had been experiencing because of her tick bite had either resolved all together or lessened in severity.  Her "lung" side effects of chest tightness- which felt like her chest had been "wrapped with wrap" were gone.  Her heat intolerance and sweating have lessened in severity. She can't give an exact date for when it stopped she just noticed that it was gone. It was not a drastic elimination but she said then it has taken a while for it go away completely. She was probably the only one who can't wait to get a booster. She confirmed that for both that sometime in Apr2021 her conditions were slowly lessened. Events resulted in physician office visit.  The outcome of events was unknown.  Seriousness: She thought it was medically significant but maybe that was because it only applied to her.  The reporter considered the causality between COVID vaccine and event all of her lung side effects of the tick bite were gone/the heat intolerance and sweating have lessened in severity was Related.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: ITP; platelet count has dropped 20 points every two days; tired; This is a spontaneous report from a contactable consumer reporting for spouse.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  dose 1 via an unspecified route of administration on an unspecified date in Jun2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter states the patient has ITP. He received the first dose of the Pfizer BioNTech Covid-19 vaccine three weeks ago (as of report date 06Jul2021) and was scheduled to get his second dose at the pharmacy today or tomorrow. After the last dose, the pharmacy required him to wait for one hour after the dose was administered to monitor for adverse reactions. Since then, his platelet count has dropped 20 points every two days, and he got more and more tired. The outcome of the events was unknown. The reporter was asking where should her husband be for the second dose since his blood disorder puts him at risk for bleeding.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased, Systemic lupus erythematosus, White blood cell count decreased
Clinical narrative: The doctor is thinking Lupus; ANA was elevated; My white blood count is low; This is a spontaneous report from a contactable registered nurse (patient). A female patient of an unspecified age received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), dose 2 via an unspecified route of administration in Apr2021 as a single dose for COVID-19 immunisation. The patient medical history included she didn't have an efficient immune system. Concomitant medications were not reported. The patient previously took "Hatrzam" for 4 years which mainly gave her IGG and another osteo treatment for 7 years and she and received dose 1 of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in Mar2021 as a single dose for COVID-19 immunization. The patient previously took Pneumovax and never builds immunity against Pneumovax, pneumonia or pneumococcal. The patient had her blood drawn prior to COVID-19 vaccination back in Dec or maybe Feb for an antinuclear antibody (ANA) test and it was negative.  The doctor re-did the ANA test and it came out the same. She received the first dose of the vaccine at the end of Mar2021 and the second dose at the end of Apr2021. Six weeks post vaccination, in Jun2021, ANA numbers were high The doctor believed she had lupus. She had a very high response which was not usual for her. She usually never builds immunity against Pneumovax, pneumonia or pneumococcal. She was surprised with the high response to the vaccine. The ANA test was positive with titers between 1-320 (normal range is 1-40 or 1-80 at most).  It was very elevated. The patient was wondering if the BNT162b2 vaccine could cause this. The doctor also said she had a low white count the second time around. Her ANA was normal and then after receiving the BNT162b2 Vaccine her ANA was elevated as well as she had a low white count. She reported that she also didn't have an efficient immune system. The outcome of white blood count low, ANA was elevated and lupus was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dysuria, Fatigue, Pain in extremity
Clinical narrative: Dark and painful urination; dark and painful urination; Pain in back of left thigh; Fatigue; This is a spontaneous report from a contactable consumer. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at age of 33-years-old on 05Jul2021 10:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included depression, anxiety, post-traumatic stress disorder, scoliosis. Pregnant: No. The patient previously received first dose of bnt162b2 at age of 33 years old on 14Jun2021 for COVID-19 immunization. Concomitant medications included paracetamol (TYLENOL); ibuprofen; duloxetine hydrochloride (CYMBALTA); trazodone; hydroxyzine taken for an unspecified indication, start and stop date were not reported.  Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dark and painful urination, pain in back of left thigh, fatigue on 06Jul2021 15:30. No treatment was received for the events. Outcome of events was not recovered.  The patient was not  tested covid post vaccination.   Information on the lot/ batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Dizziness, Eye pain
Clinical narrative: achey eyeballs; tiredness; low grade headache; chills; bone pain; muscle pain; mild swelling at injection site; mild occasional nausea; welts; light headedness; joint point; Possible fever; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191, Expiration date was not reported), via an unspecified route of administration on 01Jul2021 13:15 (age at vaccination 58 years) as dose number unknown, single for covid-19 immunisation. Medical history not reported. Concomitant medication(s) included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. COVID-19 vaccine was administered at workplace clinic. On 02Jul2021 06:00 the patient experienced achey eyeballs, tiredness, low grade headache, chills, bone pain, muscle pain, mild swelling at injection site, mild occasional nausea, welts, light headedness, joint point, possible fever, persisting 5 days as of report submission. The patient had not received any treatment for events. The outcome of events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: achey eyeballs; tiredness; low grade headache; chills; bone pain; muscle pain; mild swelling at injection site; mild occasional nausea; welts; light headedness; joint point; Possible fever; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191, Expiration date was not reported), via an unspecified route of administration on 01Jul2021 13:15 (age at vaccination 58 years) as dose number unknown, single for covid-19 immunisation. Medical history not reported. Concomitant medication(s) included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. COVID-19 vaccine was administered at workplace clinic. On 02Jul2021 06:00 the patient experienced achey eyeballs, tiredness, low grade headache, chills, bone pain, muscle pain, mild swelling at injection site, mild occasional nausea, welts, light headedness, joint point, possible fever, persisting 5 days as of report submission. The patient had not received any treatment for events. The outcome of events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site swelling
Clinical narrative: achey eyeballs; tiredness; low grade headache; chills; bone pain; muscle pain; mild swelling at injection site; mild occasional nausea; welts; light headedness; joint point; Possible fever; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191, Expiration date was not reported), via an unspecified route of administration on 01Jul2021 13:15 (age at vaccination 58 years) as dose number unknown, single for covid-19 immunisation. Medical history not reported. Concomitant medication(s) included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. COVID-19 vaccine was administered at workplace clinic. On 02Jul2021 06:00 the patient experienced achey eyeballs, tiredness, low grade headache, chills, bone pain, muscle pain, mild swelling at injection site, mild occasional nausea, welts, light headedness, joint point, possible fever, persisting 5 days as of report submission. The patient had not received any treatment for events. The outcome of events was recovering.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin exfoliation
Clinical narrative: scales and itching on head and both arms; scales and itching on head and both arms; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old female patient received second 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 12May2021 (Age at vaccination 59 years), as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2, solution for injection via an unspecified route of administration on unspecified date as single dose for covid-19 immunization. In May2021, the patient experienced scales and itching on head and both arms, scales and itching on head and both arms. Flare began approximately 2 weeks after injection and still has scaling. The outcome of event scales on head and both arms was not recovered, itching on head and both arms was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Expired product administered, Fatigue, Pain in extremity
Clinical narrative: the dose she received yesterday had expired by 30 minutes; moderate fatigue; diarrhea; lot of pain in her arm, moderate pain in her arm; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a 50-year-old female patient (reporter's wife).  A 50-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 05Jul2021 (50-years-at the time of vaccination), (Batch/Lot Number: EWB171) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "My wife got the Pfizer BioNTech Covid 19 vaccination yesterday, she had moderate fatigue, diarrhea and a lot of pain in her arm, moderate pain in her arm, now today was the day at pharmacy where was get her vaccination at, said that the vaccine that she got yesterday was expired 30 minutes, it was 30 minutes then she was given a next shot and she was and it was like that after the pharmacy tonight to get another shot and what I am concerned about is before her reaction been worse after giving the 2nd shot." Reporter was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday as per EST. The clinical outcome of the events was unknown.   Further probing could not be done as reporter don't want to share further information. Hence, limited information available over the call.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Vision blurred
Clinical narrative: Presented dizziness; tight chest; blurry vision; This is a spontaneous report received from a non-contactable consumer. An 18-year-old female patient (unknown if pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jul2021 at 12:00 PM (Lot number: EW0172) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Unknown if covid prior vaccination; unknown if covid tested post vaccination. On 06Jul2021 at 12:00 PM, patient presented dizziness, tight chest, blurry vision; refused EMS. Treatment received for events including first aid, vitals. Outcome of events was unknown.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hallucination, auditory, Paraesthesia, Psychiatric evaluation
Clinical narrative: Hears voices in her stomach and head; Feels like her body has been taken over/Feels like things are running through her body; Feels like her skin is tingling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration on an unspecified date 2 months ago (May2021) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned she went to the ER and the doctor. She received the vaccine two months ago. She felt like her body had been taken over. She hears voices in her stomach and head. It is just not like sounds, but actual people voices. She feels like her skin is tingling. She feels like things are running through her body. The ER gave her a mental assessment and could not find anything wrong with her. The patient mentioned she had issues in the past and the doctor gave her a pill with a camera in it. She was informed the pill would leave her body after 24 hours. She believed this was in the past and not related ot the COVID-19 vaccine. The outcome of hears voices in her stomach and head, feels like her body has been taken over/feels like things are running through her body and feels like her skin is tingling was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, SARS-CoV-2 antibody test
Clinical narrative: 2 weeks of low grade flu symptoms; including 2 days of being so bad that I couldn't get out of bed.; I couldn't get out of bed; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8736) via an unspecified route of administration in left arm on 01Jun2021 as dose 2 single (at the age of 54-year-old) for COVID-19 immunization at Pharmacy or Drug Store. Medical history included Covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm as dose 1 single (at the age of 54-year-old) for COVID-19 immunization and It was awful after the first vaccine, including a day of vomiting and being in bed. On 23Jun2021, patient experienced 2 weeks of low grade flu symptoms, including 2 days of being so bad that patient could not get out of bed. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: covid positive prior to vaccination. Device Date: 06Jul2021. The reported assessed the case as non-serious. The outcome of events was recovered.  Additional information is requested. Further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dysstasia, Fear, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: My extremities were numb and tingling and I could not stand without falling over.; I was unable to shower or work; I lost balance to the point of feeling like vertigo for 9 days; I lost balance to the point of feeling like vertigo for 9 days; My extremities were numb and tingling and I could not stand without falling over.; My extremities were numb and tingling and I could not stand without falling over.; scared; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received first dose of bnt162B2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302) via unspecified route of administration on Left arm on May2021 (at 52-years of age) as Dose 1, single for COVID-19 immunization. Medical history included allergies to tomatoes, allergies to many antibiotics (unspecified) and Possibly Covid in autumn of 2020, hair fell out in chunks & had a skin rash, had a terrible time sleeping because of nervousness. She didn't have respiratory issues but in hindsight think it may have been Covid. The patient has not received any other vaccine in four weeks. The patient has not received other medications in two weeks. Device timestamp was reported as 06Jul2021. Concomitant medications were not reported. Known allergies included many antibiotics, tomatoes. No Covid prior vaccination nor post vaccination reported. No other vaccine administered in four weeks and other medications in two weeks. It was reported that "I lost balance to the point of feeling like vertigo for 9 days. My extremities were numb and tingling and I could not stand without falling over. This was after the 1st dose and I am too scared to take the 2nd dose. I was unable to shower or work and want to know what to do about a 2nd vaccination". No treatment received for AE's. Outcome of the event was recovered on 2021.  Information about lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vertigo
Clinical narrative: My extremities were numb and tingling and I could not stand without falling over.; I was unable to shower or work; I lost balance to the point of feeling like vertigo for 9 days; I lost balance to the point of feeling like vertigo for 9 days; My extremities were numb and tingling and I could not stand without falling over.; My extremities were numb and tingling and I could not stand without falling over.; scared; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received first dose of bnt162B2(PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302) via unspecified route of administration on Left arm on May2021 (at 52-years of age) as Dose 1, single for COVID-19 immunization. Medical history included allergies to tomatoes, allergies to many antibiotics (unspecified) and Possibly Covid in autumn of 2020, hair fell out in chunks & had a skin rash, had a terrible time sleeping because of nervousness. She didn't have respiratory issues but in hindsight think it may have been Covid. The patient has not received any other vaccine in four weeks. The patient has not received other medications in two weeks. Device timestamp was reported as 06Jul2021. Concomitant medications were not reported. Known allergies included many antibiotics, tomatoes. No Covid prior vaccination nor post vaccination reported. No other vaccine administered in four weeks and other medications in two weeks. It was reported that "I lost balance to the point of feeling like vertigo for 9 days. My extremities were numb and tingling and I could not stand without falling over. This was after the 1st dose and I am too scared to take the 2nd dose. I was unable to shower or work and want to know what to do about a 2nd vaccination". No treatment received for AE's. Outcome of the event was recovered on 2021.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Condition aggravated, Dizziness, Headache, Nausea
Clinical narrative: Symptoms got worse; Abdominal pain/ Abdominal pain on his left and right side that is still going on; Headache; Rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too; dizziness; Nausea/ Nauseous; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient previously received first dose of bnt162b2 on 21May2021 for Covid-19 Immunization and experienced abdominal pain, headache, dizziness, nausea and rash on both legs/left side of the leg. On an unspecified date in 2021, the patient experienced abdominal pain/ abdominal pain on his left and right side that is still going on, headache, rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too, dizziness, nausea/ nauseous. On 11Jun2021, the symptoms got worse. It was reported that patient received the vaccine on 21May2021 and the second dose on 11Jun2021 and basically his symptoms were severe abdominal pain, rashes on legs, dizziness, nausea, and headaches that were severe and still going on. Then, he got the second dose 11Jun2021 and his symptoms got worse. They were still going on. Patient added it was his left side of leg and severe headache and nauseous and it was his left side of leg but then on his right side on 11Jun2021 and then the rash on the right too. Outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Symptoms got worse; Abdominal pain/ Abdominal pain on his left and right side that is still going on; Headache; Rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too; dizziness; Nausea/ Nauseous; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient previously received first dose of bnt162b2 on 21May2021 for Covid-19 Immunization and experienced abdominal pain, headache, dizziness, nausea and rash on both legs/left side of the leg. On an unspecified date in 2021, the patient experienced abdominal pain/ abdominal pain on his left and right side that is still going on, headache, rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too, dizziness, nausea/ nauseous. On 11Jun2021, the symptoms got worse. It was reported that patient received the vaccine on 21May2021 and the second dose on 11Jun2021 and basically his symptoms were severe abdominal pain, rashes on legs, dizziness, nausea, and headaches that were severe and still going on. Then, he got the second dose 11Jun2021 and his symptoms got worse. They were still going on. Patient added it was his left side of leg and severe headache and nauseous and it was his left side of leg but then on his right side on 11Jun2021 and then the rash on the right too. Outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Alopecia, Blood glucose increased, Blood pressure increased, Blood pressure measurement
Clinical narrative: Symptoms got worse; Abdominal pain/ Abdominal pain on his left and right side that is still going on; Headache; Rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too; dizziness; Nausea/ Nauseous; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient previously received first dose of bnt162b2 on 21May2021 for Covid-19 Immunization and experienced abdominal pain, headache, dizziness, nausea and rash on both legs/left side of the leg. On an unspecified date in 2021, the patient experienced abdominal pain/ abdominal pain on his left and right side that is still going on, headache, rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too, dizziness, nausea/ nauseous. On 11Jun2021, the symptoms got worse. It was reported that patient received the vaccine on 21May2021 and the second dose on 11Jun2021 and basically his symptoms were severe abdominal pain, rashes on legs, dizziness, nausea, and headaches that were severe and still going on. Then, he got the second dose 11Jun2021 and his symptoms got worse. They were still going on. Patient added it was his left side of leg and severe headache and nauseous and it was his left side of leg but then on his right side on 11Jun2021 and then the rash on the right too. Outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cluster headache, Dizziness, Insomnia, Investigation
Clinical narrative: Symptoms got worse; Abdominal pain/ Abdominal pain on his left and right side that is still going on; Headache; Rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too; dizziness; Nausea/ Nauseous; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient previously received first dose of bnt162b2 on 21May2021 for Covid-19 Immunization and experienced abdominal pain, headache, dizziness, nausea and rash on both legs/left side of the leg. On an unspecified date in 2021, the patient experienced abdominal pain/ abdominal pain on his left and right side that is still going on, headache, rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too, dizziness, nausea/ nauseous. On 11Jun2021, the symptoms got worse. It was reported that patient received the vaccine on 21May2021 and the second dose on 11Jun2021 and basically his symptoms were severe abdominal pain, rashes on legs, dizziness, nausea, and headaches that were severe and still going on. Then, he got the second dose 11Jun2021 and his symptoms got worse. They were still going on. Patient added it was his left side of leg and severe headache and nauseous and it was his left side of leg but then on his right side on 11Jun2021 and then the rash on the right too. Outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Rash, Thrombosis
Clinical narrative: Symptoms got worse; Abdominal pain/ Abdominal pain on his left and right side that is still going on; Headache; Rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too; dizziness; Nausea/ Nauseous; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient previously received first dose of bnt162b2 on 21May2021 for Covid-19 Immunization and experienced abdominal pain, headache, dizziness, nausea and rash on both legs/left side of the leg. On an unspecified date in 2021, the patient experienced abdominal pain/ abdominal pain on his left and right side that is still going on, headache, rash on both legs/then on his right side on 11Jun2021 and then the rash on the right too, dizziness, nausea/ nauseous. On 11Jun2021, the symptoms got worse. It was reported that patient received the vaccine on 21May2021 and the second dose on 11Jun2021 and basically his symptoms were severe abdominal pain, rashes on legs, dizziness, nausea, and headaches that were severe and still going on. Then, he got the second dose 11Jun2021 and his symptoms got worse. They were still going on. Patient added it was his left side of leg and severe headache and nauseous and it was his left side of leg but then on his right side on 11Jun2021 and then the rash on the right too. Outcome of the events was not recovered.  Information related to batch/Lot no. was requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Mass, Skin disorder
Clinical narrative: bruising to all areas injected; dents and rock bubbles/bumps inside her mouth beneath the upper and lower lips; dents and rock bubbles/bumps inside her mouth beneath the upper and lower lips; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported that.  A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; hyaluronic acid (RESTYLANE), sublingual from 17Jun2021 (Batch/Lot number was not reported) to an unspecified date, at 2 mL for an unspecified indication. Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported. As per reporter it was reported that Reference is made to the Guidelines for Post-marketing Re-porting of Adverse Drug Experiences (Docket No.-#) dated Mar1992, requires Reports in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant. In accordance with the guideline, we are forwarding the be-low information related to an adverse drug experience received by withheld. Should you require further information concerning this report, please contact the reporter. It was reported that Reported Adverse Event: Patient was injected with 2mL Restylane withheld to the chin/between my chin and bottom lip, upper lip, and both the top and bottom lips 17Jun2021. Patient developed bruising to all areas injected and dents and rock bubbles/bumps inside her mouth beneath the upper and lower lips 17Jun2021. Patient contacted HCP and was advised not to apply ice, saying that ice would not be necessary. No further treatment information was provided by HCP. In the past patient has been injected with Restylane withheld as well as about 20 different fillers (patient did not wish to specify names of other fillers from the past). It was reported that Patient has not had any toxins in the past. It was reported that She had her COVID-19 vaccine (Pfizer; 1st dose Jan2021 and 2nd dose Feb2021). Patient has not had any other vaccines and dental procedures in the past 6-12 months, and she has not had any illness the month prior to her treatment. The outcome of events was unknown.  Information on batch/lot number has been requested.