chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: she tested positive for Covid-19; she tested positive for Covid-19; This is a spontaneous report from a contactable consumer(patient husband). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on unspecified date. The patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. Then a few days later, patient tested positive for Covid-19. Patient wanted to know when should receive the 2nd dose. Patient received the monoclonal antibody infusion as a treatment. The outcome of the events resolved.  Description of complaint: Incoming attempted transfer from regulatory authority: INT-00412862. His wife received the first dose of the Pfizer Covid BioNtech Vaccine. His wife, a few days later she tested positive for covid 19. She has now already recovered from the virus. He wants to know when she can get the second dose. Caller is being transferred to share his wife's side effects. His wife also had a monoclonal antibody infusion as a treatment. Caller disconnected prior to completion of transfer. No Additional information provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dry throat, Dyspnoea, Fatigue
Clinical narrative: not feeling well; tiredness; short of breath; chills; mild body aches; chest pain; that she experience draining and scratchiness in the back of her throat; draining in throat; scratchy throat; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FC3183) via an unspecified route of administration in Arm Right on 02Sep2021 17:00 (age at vaccination 54years old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included sinusitis from an unknown date and unknown if ongoing had sinus infection 2 1/2 -3 weeks prior COVID vaccine. There were no concomitant medications. The patient experienced that she experiences draining and scratchiness in the back of her throat, draining in throat, scratchy throat on 02Sep2021, chest pain on 13Sep2021, and not feeling well, tiredness, short of breath, chills, mild body aches on an unspecified date. She has a question about an adverse event she may have experienced after having the first dose Pfizer COVID 19, 02Sep2021. 15-20 minutes after having vaccine she experienced draining in throat and scratchy throat. She Has been having this ever since that first dose. Yesterday, she was experiencing some chest pain and just not feeling well and some tiredness. Not having the drainage so much now, but still has the scratchiness. It was immediately and it was worse right after. It is less frequent now, but just wants to be sure before she gets the next one and doesn't want to have issues. The chest pains started yesterday and is staying about the same, but it's not severe, but continuous. Just felt really tired and has been really tired ever since she got the vaccine and a little short of breath. Had the other things that happen and common, had a few chills and mild body aches and that went away 2 days afterwards and she has not had a problem with it since. No further details provided. Unable to provide the NDC, expiry, or dose for first dose, but provides a lot number. States it didn't really hurt. No other vaccines the same day or 4 weeks prior. She Has had issues with the flu shots before, but unable to provide dates, NDC, Lot, or expiries. No further details provided. Say about 2 1/2 to 3 weeks prior she intended on getting the COVID vaccine soon but ended up with a sinus infection and so she waited until it all cleared before getting it. Was feeling some what about 2 1/2 to 3 weeks prior. Attempt made to clarify statement, unsuccessful. No further details provided. The clinical outcome of the events chills, mild body aches were recovered, draining and scratchiness in the back of her throat, draining in throat were recovering, short of breath was unknown and other events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal discomfort, Pain, Throat irritation
Clinical narrative: not feeling well; tiredness; short of breath; chills; mild body aches; chest pain; that she experience draining and scratchiness in the back of her throat; draining in throat; scratchy throat; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FC3183) via an unspecified route of administration in Arm Right on 02Sep2021 17:00 (age at vaccination 54years old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included sinusitis from an unknown date and unknown if ongoing had sinus infection 2 1/2 -3 weeks prior COVID vaccine. There were no concomitant medications. The patient experienced that she experiences draining and scratchiness in the back of her throat, draining in throat, scratchy throat on 02Sep2021, chest pain on 13Sep2021, and not feeling well, tiredness, short of breath, chills, mild body aches on an unspecified date. She has a question about an adverse event she may have experienced after having the first dose Pfizer COVID 19, 02Sep2021. 15-20 minutes after having vaccine she experienced draining in throat and scratchy throat. She Has been having this ever since that first dose. Yesterday, she was experiencing some chest pain and just not feeling well and some tiredness. Not having the drainage so much now, but still has the scratchiness. It was immediately and it was worse right after. It is less frequent now, but just wants to be sure before she gets the next one and doesn't want to have issues. The chest pains started yesterday and is staying about the same, but it's not severe, but continuous. Just felt really tired and has been really tired ever since she got the vaccine and a little short of breath. Had the other things that happen and common, had a few chills and mild body aches and that went away 2 days afterwards and she has not had a problem with it since. No further details provided. Unable to provide the NDC, expiry, or dose for first dose, but provides a lot number. States it didn't really hurt. No other vaccines the same day or 4 weeks prior. She Has had issues with the flu shots before, but unable to provide dates, NDC, Lot, or expiries. No further details provided. Say about 2 1/2 to 3 weeks prior she intended on getting the COVID vaccine soon but ended up with a sinus infection and so she waited until it all cleared before getting it. Was feeling some what about 2 1/2 to 3 weeks prior. Attempt made to clarify statement, unsuccessful. No further details provided. The clinical outcome of the events chills, mild body aches were recovered, draining and scratchiness in the back of her throat, draining in throat were recovering, short of breath was unknown and other events were not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: she now has blood clots and received the first dose in July and second in August, on the 14th; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional via Medical Information Team. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route, on an unspecified date in Jul2021 as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient has blood clots and received the first dose in july and second in august, on the 14th, she didn't know if it was related or not but she thought she would report it. She wanted to know if any study on things that happened or not to people after the vaccines. The event was medically significant. Outcome of the event was unknown.  The Lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient
Clinical narrative: his vision in one eye went blind and came back, then had partial vision and came back again; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, caller stated that after getting the shot, his vision in one eye went blind and came back, then had partial vision and came back again. Caller stated it happened to him 3 times. The patient had visited physician office. Caller wanted to know if between the EUA and FDA approval, there had been case reports of vision loss. Outcome of event was recovered on an unspecified date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: PL3183, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 20Aug2021 at 05:00 PM as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included myasthenia gravis, rheumatoid arthritis, Known Allergies with Gluten and Celiac disease. No other vaccine received in four weeks, no covid prior vaccination, not tested covid post vaccination. Concomitant medication(s) included tofacitinib citrate (XELJANZ) taken within two weeks. The patient experienced shingles. Ae resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles with Valacyclovir HCL. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, SARS-CoV-2 test, Umbilical cord abnormality
Clinical narrative: Dose 1/Dose 2/The day after my pregnant wife received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord); The day after my pregnant wife received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord); This is a spontaneous report from a contactable consumer (husband). This consumer reported for reported information for both mother and fetus. This is the maternal report.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 23Aug2021 as dose 2, single; and via an unspecified route of administration on an unknown date as dose 1, single; for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no known allergies. The day after the patient received the second dose of the vaccine, on 24Aug2021, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord). These concerns ultimately to patient had delivered at 29 weeks and baby ultimately passing away on the same day. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization from 24Aug2021, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient was tested for covid post vaccination on an unknown date which included nasal swab (unknown results). The outcome of the events was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101210524 fetal case
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain after the first dose/ left arm is the affected arm; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route in the arm on an unspecified date as a single dose for covid-19 immunization. Medical history included illness. The patient concomitant medications were not reported. On an unknown date, patient experienced pain after the first dose/ left arm is the affected arm. The clinical outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Speech disorder
Clinical narrative: Feels sick; She cant even talk right; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 35-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177) via an unspecified route of administration in left arm on 13Sep2021 at around 10:30 - 11:00 as dose 2, single (at the age of 35-years-old) for COVID-19 immunization. Patient medical history (including any illness at time of vaccination) was reported as none. Vaccine was not administered at military facility. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- FC3180) via an unspecified route of administration in left arm on 23Aug2021 15:00 as dose 1, single for COVID-19 immunization and experienced change in her menstrual cycle as it was longer and heavy than normal. On 13Sep2021 she took her second shot for Covid and was tell the person that helped when she got her second shot, that after the first shot she experienced a changed in her menstrual cycle. After the first vaccine it came early. She went to the bathroom and was like there it is. Then it was 1.5 days with no blood. After that, it came really strong and heavy, lasting for another 6 days. So it was longer and heavy than normal, from the first signs of blood it was 9 days total instead of the 4-5 days it normally lasts. Her normal period was 4-5 days and started low with a small amount in the first day, then on the second and third day was heavy, then the last days was just a small portion of blood. She was also very regular it comes every 27-28 days. She marked her calendar as it started on 30Aug2021 but it was the 28Aug2021 when she had the first sign and nothing until the 30Aug2021, she did not have accidents anymore, she was too regular. This time there was no sign and she was surprised. The patient experienced feels sick, she could not even talk right, she woke up today feeling that way on 14Sep2021. The adverse events did not result in emergency room or physician office visit. She felt fine yesterday. The outcome of the event was unknown.  Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Foetal distress syndrome, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Dose 1/Dose 2/The day after my pregnant wife received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord).; The day after my pregnant wife received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord).; These concerns ultimately to my son being delivered at 29 weeks and ultimately passing away on the same day; This is a spontaneous report from a contactable consumer (parent).   This consumer reported for reported information for both mother and fetus. This is the fetal report.   A male fetal patient (reported as son) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported) transplacental on 23Aug2021 as dose 2, single for covid-19 immunisation. The mother received dose 1, single of BNT162B2, transplacental for Covid-19 immunization on an unspecified date. The patient's mother of unspecified age received BNT162B2 via an unspecified route of administration. The patient's and mother's medical history and concomitant medications were not reported. The mother had no other vaccine in four weeks. The patient's mother had no covid prior vaccination. The patient's mother had no known allergies. The day after the patient received the second dose of the vaccine, on 24Aug2021, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord). These concerns ultimately to patient being delivered at 29 weeks and ultimately passing away on the same day. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization from 24Aug2021, life threatening illness (immediate risk of death from the event), disability or permanent damage, congenital anomaly or birth defect and death. The patient's mother was tested for covid post vaccination which included nasal swab (unknown results). The patient died on 24Aug2021. The causes of death were "the mother received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord))" and "patient being delivered at 29 weeks".  It was unknown if an autopsy was performed.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101206741 mother case; Reported Cause(s) of Death: The day after my pregnant wife received the vaccine, the doctors identified concerns with the pregnancy (related to blood flow in the umbilical cord).; The day after my pregnant wife received the vaccine, the doctors identified concerns with the preg
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Feeling abnormal, Off label use, Pyrexia
Clinical narrative: Feeling awful; Fever; Third dose administered/Booster dose; Third dose administered/Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 04Sep2021 at 13:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN) and cyanocobalamin (VITAMIN B12); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 04Sep2021 at 16:00, the patient experienced fever. The patient reported that she had a fever daily in the sundown hours since the vaccine. It was her booster third dose. It was reported that she felt awful every evening. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever and feeling awful was not resolved at the time of this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Developed blood clots in lung; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient (not pregnant) received second dose of BNT162B2 (Pfizer) on 05Apr2021 08:30 AM (at age of 72-year-old) on Left arm at single dose for Covid-19 Immunization. Medical history included Thyroid, cholesterol and high blood pressure. No Known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR), nebivolol hydrochloride (MAXINEB), metoprolol, d-mannose. No other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (Pfizer) on 15Mar2021 08:30 AM (at age of 72-year-old) on Left arm for Covid-19 Immunization. Facility type vaccine was Hospital. Patient developed blood clots in lung on 06Aug2021 11:00 AM. Ae resulted in: Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). The outcome of the event was recovering. Heparin received as treatment. No covid prior vaccination. No covid tested post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Bradyphrenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: When he bent over at the waist he had sharp pain across his forehead.; severe brain fog; inability to think clearly; Exhaustion; headache; This is a spontaneous report from a contactable consumer (mother) reported for male patient (son) that:  A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 (Batch/Lot Number: FC3180; Expiration Date: Oct2021) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included attention deficit hyperactivity disorder from 2018 and ongoing (ADHD), diagnosed at the end of sixth grade and he is sophomore in high school, so about 3.5 years ago. The Historical Vaccine include Comirnaty (1st dose) on 23Jul2021(lot number: EW0179/expiry date: Aug2021) for covid-19 immunization. The patient's concomitant medications were not reported. The Family Medical History Relevant to AE(s): caller suffers from migraines, but she is not sure if it is relevant. Migraines are more sudden and don't last days on end. His maternal grandfather had Meniere's Disease and died of a heart attack at age 45. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. She is not sure if that is relevant. She is calling to report a possible side effect the first day when he went to the school nurse for the sharp headache. When he bent over at the waist, he had sharp pain across his forehead. Severe brain fog, inability to think clearly, and Exhaustion: around Labor Day weekend about on 05Sep2021. when he told her that it was getting worse, and he wanted to see a doctor. He went to the doctor on 07Sep2021. Went to ER on 08Sep2021 and again to ER on 12Sep2021. He was not admitted to the hospital and was only treated in the emergency room and they were unable to find anything wrong. The patient underwent lab tests and procedures which included Investigations: Tested for Mono, Meningitis, blood clots, and stroke. He has had CAT scan and urinalysis to check for diabetes. All have been negative. The event outcome was unknown.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pain
Clinical narrative: When he bent over at the waist he had sharp pain across his forehead.; severe brain fog; inability to think clearly; Exhaustion; headache; This is a spontaneous report from a contactable consumer (mother) reported for male patient (son) that:  A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 (Batch/Lot Number: FC3180; Expiration Date: Oct2021) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included attention deficit hyperactivity disorder from 2018 and ongoing (ADHD), diagnosed at the end of sixth grade and he is sophomore in high school, so about 3.5 years ago. The Historical Vaccine include Comirnaty (1st dose) on 23Jul2021(lot number: EW0179/expiry date: Aug2021) for covid-19 immunization. The patient's concomitant medications were not reported. The Family Medical History Relevant to AE(s): caller suffers from migraines, but she is not sure if it is relevant. Migraines are more sudden and don't last days on end. His maternal grandfather had Meniere's Disease and died of a heart attack at age 45. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. She is not sure if that is relevant. She is calling to report a possible side effect the first day when he went to the school nurse for the sharp headache. When he bent over at the waist, he had sharp pain across his forehead. Severe brain fog, inability to think clearly, and Exhaustion: around Labor Day weekend about on 05Sep2021. when he told her that it was getting worse, and he wanted to see a doctor. He went to the doctor on 07Sep2021. Went to ER on 08Sep2021 and again to ER on 12Sep2021. He was not admitted to the hospital and was only treated in the emergency room and they were unable to find anything wrong. The patient underwent lab tests and procedures which included Investigations: Tested for Mono, Meningitis, blood clots, and stroke. He has had CAT scan and urinalysis to check for diabetes. All have been negative. The event outcome was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Headache, Migraine, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Migraine; Stiff neck; Brain zaps on the back right side of head; Pain in injection arm; Headache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969) via an unspecified route of administration in the right arm on 14Sep2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included heart palpitations, high cholesterol, thrombophilia, and allergy to paper tape. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 15Sep2021 at 01:00, the patient experienced migraine, stiff neck, pain in injection arm, and the patient had been experiencing brain zaps on the back right side of the head, especially when the patient started to drift off to sleep, it jolted the patient back awake. It felt like an electrical zap inside the patient's brain shocking him every about 5 to 10 minutes. It had subsided but still had it once or twice every hour. The patient's headache also did not go away with medicine (unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the events migraine, stiff neck, pain in injection arm, and brain zaps on the back right side of head. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, stiff neck, pain in injection arm, headache, and brain zaps on the back right side of head was not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Hypokinesia
Clinical narrative: needing support to move from one place to another; dizziness and light-headedness for 2 weeks already and is still experiencing it; the patient can not concentrate; This is a spontaneous report from a contactable pharmacist reported for a male patient. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 01Sep2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2021, the patient experienced dizziness and light-headedness for 2 weeks already and is still experiencing it, needing support to move from one place to another, and the patient cannot concentrate. The clinical details of the events as follows: Caller had a patient who received the first dose of the Pfizer COVID-19 vaccine on 01Sep2021 and experienced dizziness and light-headedness for 2 weeks already and is still experiencing it. Caller stated that the patient wasdesperately trying to find a solution for that. Caller wanted more information on the side effects experienced by the patient and how to help the patient. The caller stated that it was the next morning that the side effects experienced by the patient started and that the patient could not concentrate and was needing support to move from one place to another. Caller also stated that the patient was a little bit better but not improving. The case was reported as non-serious. The patient outcome of the events was not resolved at the time of this report.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: I was paralyzed; the vaccine gave me guillain-barre; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration on 03Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient was paralyzed and hospitalised for 11 days and then in rehab for 5 days. The patient also experienced medically significant Guillain-Barre syndrome. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Throat lesion
Clinical narrative: lesions at the back of her throat; she is not feeling well; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, mRNA, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Sep2021, the patient experienced lesions at the back of her throat, she is not feeling well. Caller wanted to know if what she is experiencing is a reported side effect with the Pfizer COVID-19 vaccine. Caller also asked if it was okay for her not to see her doctor now because she called her doctor, and the doctor can't see her now. The outcomes of events were unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He contracted Covid-19 in August; He contracted Covid-19 in August; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Mar2021 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on 22Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was a consumer calling to report a breakthrough case of the Pfizer vaccine. Caller stated that he received the first dose in March and second dose in 22March2021. Caller stated that on Aug2019 he contracted Covid-19 in August. The events assessed as serious (medically significant). The outcome of the events was reported as unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: muscle spasms and tingling in her feet for a month and a half; muscle spasms and tingling in her feet for a month and a half; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), 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 immunisation. The patient medical history and concomitant medications were not reported. Pharmacist stated she was calling to report an adverse event that occurred in a 43-year-old female patient after she received her second dose of the Pfizer BioNTech Covid-19 Vaccine. The patient has been experiencing muscle spasms and tingling in her feet for a month and a half. Pharmacist denies any questions for Pfizer. Pharmacist requested transfer. The clinical outcome of the event was unknown at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report from a contactable consumer or other non hcp.   A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 15Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Caller states her daughter received the second dose of the Comirnaty Vaccine today and is vomiting. Caller asking if there are any contraindications to administering any particular medications to treat her nausea and vomiting after receiving the Comirnaty Vaccine. Outcome of the event was not recovered.    The Lot number for BNT162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient got covid-19 disease 5 months after he received his Pfizer Covid vaccines; Patient got covid-19 disease 5 months after he received his Pfizer BT Covid vaccines.; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 66-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: not reported) via unspecified route of administration on unspecified date in 2021 as dose 2, single and on 03Mar2021 as dose1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that patient got covid-19 disease 5 months after he received his Pfizer Covid vaccines. He had his 1st vaccine dose on 03Mar2021. 2nd dose after that. Reporter querying if the efficacy of the Pfizer covid vaccine was 80% up to 6 months after receiving the vaccine series and queried for why he got COVID-19 disease. Patient queried for what are the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine. In response to patient query provided information as on 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of COVID-19 Vaccine Study. on analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC) and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration (FDA) on vaccine was 100% effective in preventing COVID-19 cases. where the B.1.351 lineage is prevalent vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon. The press release is available at:(mail) Please note that the Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity, has been updated to include the Press Release information. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Diplopia, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: The hospital thought I had a stroke; My entire right side of my face went numb including my throat, tongue and behind my right eye into my head,; causing the vision in my eye to become distorted and double vision.; causing the vision in my eye to become distorted and double vision.; This is a spontaneous report from a contactable consumer reporting for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Sep2021 17:00 (at the age of 53-year-old) (Lot Number: FC3182) as DOSE2, SINGLE for covid-19 immunization. The patient was nonpregnant. Medical history included high blood pressure. The patient was allergy to Penicillin, nuts, seafood and egg yolks. Historical vaccine included BNT162B2(first dose, lot number:FC8448) administered in Arm Left on 13Aug2021 14:30. The patient's concomitant medications included lisinopril (LISINOPRIL) 10 mg. Clinical course: her entire right side of her face went numb, including throat, tongue and behind right eye into the head on 10Sep2021 18:30, and that cause the vision in her eye to become distorted and double vision on 10Sep2021 18:30. Then she visited an Emergency room/department or urgent care and the hospital thought she had a stroke on 10Sep2021 18:30. Adverse event resulted in hospitalization for 1 day. Outcome of all the events was recovering and therapeutic drug was administrated. The patient underwent lab tests included computerized tomogram (CT) scan and magnetic resonance imaging (MRI) on an unspecified date with unknown result and Nasal Swab (SARS-CoV-2 test) showed negative on 13Sep2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Metamorphopsia, SARS-CoV-2 test
Clinical narrative: The hospital thought I had a stroke; My entire right side of my face went numb including my throat, tongue and behind my right eye into my head,; causing the vision in my eye to become distorted and double vision.; causing the vision in my eye to become distorted and double vision.; This is a spontaneous report from a contactable consumer reporting for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Sep2021 17:00 (at the age of 53-year-old) (Lot Number: FC3182) as DOSE2, SINGLE for covid-19 immunization. The patient was nonpregnant. Medical history included high blood pressure. The patient was allergy to Penicillin, nuts, seafood and egg yolks. Historical vaccine included BNT162B2(first dose, lot number:FC8448) administered in Arm Left on 13Aug2021 14:30. The patient's concomitant medications included lisinopril (LISINOPRIL) 10 mg. Clinical course: her entire right side of her face went numb, including throat, tongue and behind right eye into the head on 10Sep2021 18:30, and that cause the vision in her eye to become distorted and double vision on 10Sep2021 18:30. Then she visited an Emergency room/department or urgent care and the hospital thought she had a stroke on 10Sep2021 18:30. Adverse event resulted in hospitalization for 1 day. Outcome of all the events was recovering and therapeutic drug was administrated. The patient underwent lab tests included computerized tomogram (CT) scan and magnetic resonance imaging (MRI) on an unspecified date with unknown result and Nasal Swab (SARS-CoV-2 test) showed negative on 13Sep2021.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (BNT162B2 Solution for injection), 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.  Medical history included covid-19 from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient experienced caller states they still have aches and pains, fever, chills/shivers  on an unspecified date.  The patient underwent lab tests and procedures which included body temperature: fever on unspecified date day and a half. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101212266 same reporter/drug, different patients.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac Arrest; This is a spontaneous report from a contactable consumer. A 21-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Sep2021 at age of 21-years-old as dose number unknown, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced cardiac arrest (hospitalization, disability, life threatening) on 12Sep2021. The event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage.  Therapeutic measures were taken as a result of cardiac arrest. The outcome of the event was not recovered. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Numbness/tingling she describes as "spider-web" like sensations down both arms and legs.; Numbness/tingling she describes as "spider-web" like sensations down both arms and legs.; Soreness in arm; This is a spontaneous report from a non-contactable healthcare professional. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via intramuscular route of administration in the right arm on 11Sep2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Sep2021, the patient experienced normal soreness in arm for a couple days that went away but, on 15Sep2021, the patient was having numbness/tingling described as "spider-web" like sensations down both arms and legs. The clinical outcome of the event soreness in arm was resolved on an unknown date in Sep2021. The clinical outcome of the events numbness/tingling described as "spider-web" like sensations was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: had a rash all over her body; developed full blown shingles on the right side of her body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 03Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had a reaction to her first dose that she received on 03Jul2021 and stated that on an unspecified date in 2021 the patient had a rash all over her body and after a week developed full blown shingles on the right side of her body and 8 weeks later today, she was still recovering. The doctor told her not to get a second dose until she is well, and she does not consider herself well, so she asks for any information on getting a second dose after these events. The patient was recovering from the events at the time of report.   The lot number for BNT162b2 was not provided and will be requested during follow up.