chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; severe ringing in my left ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hearing loss and severe ringing in left ear on an unspecified date. Hours after receiving the first Covid vaccine, the patient had severe ringing in left ear, same side the patient had the injection. Now, patient had hearing loss in that ear. Patient had been advised by an ENT and GP medical doctor to not receive second vaccine. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Diagnosed with Covid 19; Diagnosed with Covid 19; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included ongoing Sheehan's syndrome and ongoing hypopituitarism (she was diagnosed about 7 years ago and has no pituitary gland). Concomitant medication included somatropin (GENOTROPIN), she has been on this medication for about a year. On unspecified date in 2021, the patient was diagnosed with COVID 19 and was having difficulty breathing. The patient stated she was diagnosed with Covid 19 about a week ago. She stated that her vaccination card is upstairs, and she has been having difficulty breathing and is taking care of her daughter. She received both doses of the Covid Vaccine in Mar2021. The outcome of the events was not recovered.    The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cognitive disorder, Disturbance in attention, Dizziness, Feeling abnormal
Clinical narrative: scattered thoughts; I had a severe headache; felt terrible all day; I now have neurological symptoms; My symptoms are dizziness; Vertigo; Balance problems; Brain fog; Trouble concentrating; trouble thinking straight; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Oct2021 10:30 (Lot Number: Ff8841) at the age of 46-years-old as single dose for covid-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. No known allergies. No other relevant medical history and concurrent conditions. Patient received concomitant medications within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 18Sep2021 01:00 PM (Lot Number: Fe3592) at the age of 46-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had a severe headache and felt terrible all day. He had neurological symptoms since he had had the second vaccine. Patient symptoms are dizziness/vertigo, balance problems, brain fog, trouble concentrating, scattered thoughts, trouble thinking straight. The date of start of reaction/event: 09Oct2021 at 10:30. No treatment received for the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Mental impairment, Neurological symptom, Vertigo
Clinical narrative: scattered thoughts; I had a severe headache; felt terrible all day; I now have neurological symptoms; My symptoms are dizziness; Vertigo; Balance problems; Brain fog; Trouble concentrating; trouble thinking straight; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Oct2021 10:30 (Lot Number: Ff8841) at the age of 46-years-old as single dose for covid-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. No known allergies. No other relevant medical history and concurrent conditions. Patient received concomitant medications within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 18Sep2021 01:00 PM (Lot Number: Fe3592) at the age of 46-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had a severe headache and felt terrible all day. He had neurological symptoms since he had had the second vaccine. Patient symptoms are dizziness/vertigo, balance problems, brain fog, trouble concentrating, scattered thoughts, trouble thinking straight. The date of start of reaction/event: 09Oct2021 at 10:30. No treatment received for the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Dry skin, Joint swelling, Pain
Clinical narrative: Bullous pemphigoid; Rash; Itchy/ itching; knee and foot got swollen; knee and foot got swollen; dry skin; blisters; red bumps; weight has gone down substantially; stinging; burning and itchy and it feels like the worse sunburn; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bullous pemphigoid, rash, itchy/ itching, knee and foot got swollen, dry skin, blisters, red bumps, weight had gone down substantially, stinging and burning and itchy and it feels like the worse sunburn in 2021 with outcome of unknown. All events caused emergency room visit. Reporter's husband had his first dose and 10 days later broke out in a rash. The rash got worse with blisters. One of the doctors he saw said that this was brought on by the Covid-19 vaccine. His weight had gone down substantially, people thought he was ill and sick. She thinks it was stress with what he was going through with this. He started itching a little bit before 02Mar2021, he asked her if she changed the detergent and they did not know why he was starting to itch. He was wondering why he was feeling itchy and had dry skin and that is where it started. He was diagnosed with Bullous Pemphigoid and they said that it was incurable. It is itchy with bubbles and blisters that grow on his body. They have to be popped and drained. The blisters were a quarter to a half inch big. They grow like a bubble. He had burning and itchy and it felt like the worse sunburn, itchy like bugs were on skin, and stinging. There were red bumps that grew to big red bumps that started connecting and looked like burns with patches of red that grew together. Some of them were raised and others had blisters. They were on his chest, back, they spread to his arms and legs. His knee and foot got swollen. Reporter's husband went to urgent care in emergency room. No one knew what it was or knew what to do with him. No one wanted to say it was related to the vaccine because of liability. They had another patient that had the exact same thing.  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-202101515803 same reporter/drug, different patient, similar AE
Sex: U
Vaccine: COVID19
Symptoms: Pemphigoid, Peripheral swelling, Pruritus, Rash, Rash papular
Clinical narrative: Bullous pemphigoid; Rash; Itchy/ itching; knee and foot got swollen; knee and foot got swollen; dry skin; blisters; red bumps; weight has gone down substantially; stinging; burning and itchy and it feels like the worse sunburn; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bullous pemphigoid, rash, itchy/ itching, knee and foot got swollen, dry skin, blisters, red bumps, weight had gone down substantially, stinging and burning and itchy and it feels like the worse sunburn in 2021 with outcome of unknown. All events caused emergency room visit. Reporter's husband had his first dose and 10 days later broke out in a rash. The rash got worse with blisters. One of the doctors he saw said that this was brought on by the Covid-19 vaccine. His weight had gone down substantially, people thought he was ill and sick. She thinks it was stress with what he was going through with this. He started itching a little bit before 02Mar2021, he asked her if she changed the detergent and they did not know why he was starting to itch. He was wondering why he was feeling itchy and had dry skin and that is where it started. He was diagnosed with Bullous Pemphigoid and they said that it was incurable. It is itchy with bubbles and blisters that grow on his body. They have to be popped and drained. The blisters were a quarter to a half inch big. They grow like a bubble. He had burning and itchy and it felt like the worse sunburn, itchy like bugs were on skin, and stinging. There were red bumps that grew to big red bumps that started connecting and looked like burns with patches of red that grew together. Some of them were raised and others had blisters. They were on his chest, back, they spread to his arms and legs. His knee and foot got swollen. Reporter's husband went to urgent care in emergency room. No one knew what it was or knew what to do with him. No one wanted to say it was related to the vaccine because of liability. They had another patient that had the exact same thing.  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-202101515803 same reporter/drug, different patient, similar AE
Sex: U
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Bullous pemphigoid; Rash; Itchy/ itching; knee and foot got swollen; knee and foot got swollen; dry skin; blisters; red bumps; weight has gone down substantially; stinging; burning and itchy and it feels like the worse sunburn; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bullous pemphigoid, rash, itchy/ itching, knee and foot got swollen, dry skin, blisters, red bumps, weight had gone down substantially, stinging and burning and itchy and it feels like the worse sunburn in 2021 with outcome of unknown. All events caused emergency room visit. Reporter's husband had his first dose and 10 days later broke out in a rash. The rash got worse with blisters. One of the doctors he saw said that this was brought on by the Covid-19 vaccine. His weight had gone down substantially, people thought he was ill and sick. She thinks it was stress with what he was going through with this. He started itching a little bit before 02Mar2021, he asked her if she changed the detergent and they did not know why he was starting to itch. He was wondering why he was feeling itchy and had dry skin and that is where it started. He was diagnosed with Bullous Pemphigoid and they said that it was incurable. It is itchy with bubbles and blisters that grow on his body. They have to be popped and drained. The blisters were a quarter to a half inch big. They grow like a bubble. He had burning and itchy and it felt like the worse sunburn, itchy like bugs were on skin, and stinging. There were red bumps that grew to big red bumps that started connecting and looked like burns with patches of red that grew together. Some of them were raised and others had blisters. They were on his chest, back, they spread to his arms and legs. His knee and foot got swollen. Reporter's husband went to urgent care in emergency room. No one knew what it was or knew what to do with him. No one wanted to say it was related to the vaccine because of liability. They had another patient that had the exact same thing.  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-202101515803 same reporter/drug, different patient, similar AE
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Paternal exposure during pregnancy, Ventricular septal defect
Clinical narrative: Maternal exposure during pregnancy; Paternal exposure during pregnancy; The baby has been diagnosed with Ventricular Septal Defect (VSD); This is a spontaneous report from a contactable consumer (patient's father). This consumer reported information for mother, father (reporter), and fetus/baby. This is the fetus/baby report. Only this case is serious.  A fetus patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), transplacental on an unspecified date (administration time: 12:15AM) (Batch/Lot number was not reported) as DOSE 1, SINGLE and then transplacental on an unspecified date (administration time: 12:15PM) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The mother/father received the vaccine in a pharmacy or drug store facility on unspecified date administered in left arm. The mother/father had no other vaccine in four weeks but had other medications in two weeks (unspecified). The mother/father has no known allergies and no other medical history. The patient's medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy and paternal exposure during pregnancy on an unspecified date. The baby has been diagnosed with ventricular septal defect (VSD) on 29Oct2021. The father reported that they have fathered three healthy children before receiving the vaccine. After his wife and him were both 1 month removed from being fully vaccinated, they conceived a 4th child, who is currently due in Mar2022. The baby has been diagnosed with Ventricular Septal Defect (VSD) and they suspect, but of course can not prove, that the issue results from the vaccine. The events were considered as serious resulting to congenital anomaly or birth defect. No treatment was received for the events. Prior to vaccination, the mother/father was not diagnosed with COVID-19. Since the vaccination, the mother/father has not been tested for COVID-19. The patient had not yet recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101515655 same reporter/drug, different patient/AE (maternal case)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Polymerase chain reaction
Clinical narrative: I have developed shingles on my scalp & face; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0178), dose 2 via an unspecified route of administration, administered in Arm Left on 04Oct2021 16:00 (age at vaccination: 39 year) as dose 2, single for covid-19 immunisation. The patient medical history was not reported and past drug event was none. Concomitant medications included lorazepam (LORAZEPAM), lisdexamfetamine mesilate (VYVANSE), buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF8839), dose 1 via an unspecified route of administration, administered in Arm Left on 13Sep2021 14:30 (age at vaccination: 39 year) as dose 1, single for covid-19 immunisation. Known allergies reported as none. If other vaccine in four weeks reported as No. Covid prior vaccination reported as unknown. Covid tested post vaccination reported as yes. On 02Nov2021 12:00 the patient experienced Shingles outbreak on my face. Patient never had shingles in life however 4 weeks after my 2nd dose of the pfizer vaccine patient have developed shingles on my scalp & face. The patient underwent lab tests and procedures which included PCR: negative, on 27Sep2021 Nasal Swab. Treatment received was valacyclovir 1gm tablet. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous reporter from a contactable Pharmacist via Pfizer Sales Representative.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as single dose (dose # unknown) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stroke on 2021. The event outcome was unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event Cerebrovascular accident. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: 2 COVID tests- both positive; 2 COVID tests- both positive; Booster; This is a spontaneous report from a contactable consumer (patient). This patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as Dose 1, single, dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot Number: Not known) as Dose 2, single and dose 3 via an unspecified route of administration on 28Oct2021 (Batch/Lot Number: Not known) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient took 2 COVID tests on 04Nov2021, both indicated positive. The patient had mild symptoms - incl sore throat and cough. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 20Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 39) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient received the first dose on 30May2021 (at the age of 39), lot# unknown. Medical history was none. No known allergies. There were no concomitant medications.The patient experienced appendicitis on 12Jul2021. The patient was hospitalized for appendicitis for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05Sep2021 Nasal Swab, sars-cov-2 test: negative on 24Sep2021 Nasal Swab. Appendix removed with surgery. The outcome was recovered in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: On 06Nov2021 patient presented with sore throat and tested positive following covid-19 test.; On 06Nov2021 patient presented with sore throat and tested positive following covid-19 test.; Adverse event: On 06Nov2021 patient presented with sore throat and tested positive following covid-19 test.; This is a spontaneous report from a contactable consumer (Pfizer employee). A 12-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, Lot Number: EW0185) via an unspecified route of administration on 02Jun2021 (age at vaccination 12 years-old) as single dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0169) via an unspecified route of administration on 11May2021 (age at vaccination 12 years-old) as single dose for covid-19 immunisation. 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 medical history and concomitant medications were not reported. Since the vaccination, the patient has tested for COVID-19. On 06Nov2021, patient experienced sore throat and tested positive following covid-19 test and vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test and result was positive on 06Nov2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 11-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration (age at vaccination 11-year), administered in left arm on 07Nov2021 at 17:30 as dose 1, single for COVID-19 immunization. The patient medical history and patient's concomitant medications were not reported. Reported facility type vaccine was pharmacy or drug store. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not taken any COVID prior vaccination. Patient had not been tested for COVID-19 since the vaccination. On 07Nov2021 at 17:30, patient experienced COVID. The patient underwent lab tests and procedures on 02Nov2021 which included SARS-CoV-2 test: negative. The clinical outcome of the event was resolved on an unspecified date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: Parkinson; This is a spontaneous report from a contactable consumer (wife) from a Pfizer-sponsored program. A contactable female consumer reported for a patient (husband) that: A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 15Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included fludrocortisone acetate (FLUDROCORTISONE [FLUDROCORTISONE ACETATE]) taken for an unspecified indication from an unspecified date in April. (patient was on fludrocortisone and started in April, wants to know if any drug interaction with steroid and the booster vaccine). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 25Jan2021 as dose 1, single for COVID-19 immunization. On an unspecified date the patient experienced Parkinson. Reporter stated her husband also has Parkinson, wanted to know if it was okay if he gets the booster vaccine (going to have his booster on the 22Nov). The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Feeling abnormal, Hyperpyrexia, Influenza like illness
Clinical narrative: chills; felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side; she had almost 110 temperature; she wasn't feeling good; felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side; fluish; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 31Oct2021 10:00 (Batch/Lot Number: FD0810) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced she had almost 110 temperature, chills, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, she wasn't feeling good, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, fluish on 01Nov2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature decreased:110 temperature on 01Nov2021. Therapeutic measures were taken as a result of she had almost 110 temperature, chills, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side.  No follow-up attempts are possible, no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: chills; felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side; she had almost 110 temperature; she wasn't feeling good; felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side; fluish; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 31Oct2021 10:00 (Batch/Lot Number: FD0810) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced she had almost 110 temperature, chills, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, she wasn't feeling good, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, fluish on 01Nov2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature decreased:110 temperature on 01Nov2021. Therapeutic measures were taken as a result of she had almost 110 temperature, chills, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side, felt very achy/when a new pain come out on her behind part but was not going down to her leg but to the back part where the hip is and the very next day it started also by the neck on the on the right side.  No follow-up attempts are possible, no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid; covid; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program. A 95-years-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced covid and drug ineffective. Events covid and drug ineffective were considered as medically significant. The outcome of the event covid was reported as unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Shortness of breath; experiencing heart propagation and raising heart beat; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) as single dose via an unspecified route of administration on 2021 as DOSE 3 (BOOSTER) for covid-19 immunisation. The concomitant medications and medical history was not reported. The patient received his two Pfizer about ten months ago and than he had COVID and than last since two week after he had COVID they gave him a booster and he was experiencing heart propagation and raising heart beat and shortness of breath and many other different things like this. he did not received treatment after vaccine. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID; I tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route of administration on 04Mar2021 (age at the time of vaccination was 40 years) as DOSE 1, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248) via an unspecified route of administration on 26Mar2021 as DOSE 2, SINGLE both for covid-19 immunisation at Workplace clinic. Medical history included previous diagnosis of asthma and seasonal allergies from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) and fluticasone propionate (FLUTICASONE PROPRIONATE) both taken for an unspecified indication, start and stop date were not reported and birth control. The patient previously took Advil [ibuprofen] and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that, on 04Nov2021, the patient tested positive for COVID after being at a wedding with mostly vaccinated guests. The direct exposure was from someone vaccinated with Moderna COVID vaccine who tested positive for COVID on 03Nov2021. Symptoms of COVID included cough, shortness of breath (have asthma before covid so making worse), sore throat, fever, body aches, and fatigue. On 04Nov2021, the patient underwent lab tests and procedures which included Abbott Binax Now Antigen Test: positive (Nasal Swab). Therapeutic measures were taken as a result of events which included using nebulizer with albuterol and budesonide. Since the vaccination, the patient has been tested for COVID-19. The outcome of the event I tested positive for COVID (Vaccination failure) was unknown and the outcome of rest all the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Dyspnoea, Painful respiration
Clinical narrative: I think shot triggered an attack of pleurisy as those were my exact symptoms; chills; fever; Pains in chest like pins and needles all around chest muscles; breathing became very difficult and painful; breathing became very difficult and painful; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself (patient).  A 73-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 05Nov2021 at 14:15 (at the age of 73-years-old) as dose 3 (booster), single for covid-19 immunization. Patient medical history included migraine and hypothyroidism. No known allergies were reported. Concomitant medications included erenumab aooe (AIMOVIG) on 04Nov2021. Patient was on shot 43 of Aimovig. Patient did not have Covid prior to vaccination and was not tested for it post vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Historical vaccination included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 10:45AM (at the age of 73-years-old) as dose 2, single and bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 10:30AM (at the age of 73-years-old) as dose 1, single for covid-19 immunization and experienced got tired and headache during both doses. Patient got booster shot 215p on Friday. On 06Nov2021 07:00 All day on saturday patient got chills and fever and was laying down. At 7pm fever got at 103 degrees. Pain in chest like pins and needles all around chest muscles and breathing became very difficult and painful. Took Tylenol for fever. Fever started to drop. Took another Tylenol and by 11 pm the severe chest pains eased and I fell asleep. On waking, breathing and chest had returned to normal. Fever gone. I think shot triggered an attack of pleurisy as those were my exact symptoms. I never had pleurisy before but my husband has and he said that is what I had. Therapeutic measures were taken in response to events and Tylenol 500 mg was taken. The patient underwent lab tests and procedures which included body temperature: 103 degrees on 06Nov2021. The outcome of events was recovered on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy, Pyrexia
Clinical narrative: I think shot triggered an attack of pleurisy as those were my exact symptoms; chills; fever; Pains in chest like pins and needles all around chest muscles; breathing became very difficult and painful; breathing became very difficult and painful; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself (patient).  A 73-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 05Nov2021 at 14:15 (at the age of 73-years-old) as dose 3 (booster), single for covid-19 immunization. Patient medical history included migraine and hypothyroidism. No known allergies were reported. Concomitant medications included erenumab aooe (AIMOVIG) on 04Nov2021. Patient was on shot 43 of Aimovig. Patient did not have Covid prior to vaccination and was not tested for it post vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Historical vaccination included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 10:45AM (at the age of 73-years-old) as dose 2, single and bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 10:30AM (at the age of 73-years-old) as dose 1, single for covid-19 immunization and experienced got tired and headache during both doses. Patient got booster shot 215p on Friday. On 06Nov2021 07:00 All day on saturday patient got chills and fever and was laying down. At 7pm fever got at 103 degrees. Pain in chest like pins and needles all around chest muscles and breathing became very difficult and painful. Took Tylenol for fever. Fever started to drop. Took another Tylenol and by 11 pm the severe chest pains eased and I fell asleep. On waking, breathing and chest had returned to normal. Fever gone. I think shot triggered an attack of pleurisy as those were my exact symptoms. I never had pleurisy before but my husband has and he said that is what I had. Therapeutic measures were taken in response to events and Tylenol 500 mg was taken. The patient underwent lab tests and procedures which included body temperature: 103 degrees on 06Nov2021. The outcome of events was recovered on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Hypoaesthesia, Immunisation
Clinical narrative: symptoms of Bell's Palsy / right eye and right facial drooping; weakness; numbness; as dose 3 (booster), 0.3 ml single for covid-19 immunisation; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself that: A 43-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG3527; Expiration Date: 28Feb2022), via an unspecified route of administration, administered in right deltoid on 02Nov2021 (at the age of 43-years-old) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunization. The patient received influenza vaccine (FLU), via an unspecified route of administration on 02Nov2021 (Batch/Lot number was not reported), as dose number unknown, single for immunization.  The patient medical history was not reported. Concomitant medication(s) included liraglutide (SAXENDA) taken one time every evening, 0.6mg subcutaneously in abdomen for weight control, start and stop were not reported. The patient had previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot: EL8982, Expiry date: unknown), via an unspecified route of administration, administered on 05Feb2021 as DOSE 1, SINGLE and second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot: EL8982, Expiry date: unknown), via an unspecified route of administration, administered on 24Feb2021 as dose 1, single both doses for covid-19 immunization (at the age of 42 years old). On 09Nov2021, the patient experienced symptoms of Bell's Palsy / right eye and right facial drooping, weakness and numbness. On 02Nov2021 the patient received as dose 3 (booster), 0.3 ml single for covid-19 immunization. It was reported that, patient a female consumer who stated that she received the booster dose of the Pfizer COVID 19 vaccine about a week ago. She also received the flu shot around the same time. She stated that she started experiencing symptoms of Bell's Palsy on the right side of her face. Starting with her right eyelid drooping and then moving down her face she stated it felt like it was affecting her mouth now. She stated it started yesterday and was just gotten worse today. She stated that she did not think it was a stroke and she was not hypertensive. She would like to know if Bell's Palsy was reported with the vaccine. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: got Covid; got Covid; Covid vaccine booster shot; This is a spontaneous report from a contactable consumer or other non hcp.  A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for Injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. On an unspecified date, the patient had COVID vaccine booster shot (immunization) and afterward the patient got COVID (COVID-19) and drug ineffective even though the patient was vaccinated. The reporter did not want follow-up regarding this matter as she had nothing else to share regarding this event. The outcome of the events was unknown.  No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardiac electrophysiologic study, Cardiac stress test, Chest discomfort, Dyspnoea
Clinical narrative: Patient died / Cause of Death Cardiac Arrest; racing heart rate; started having shortness of breath; heaviness in chest; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a 50-year-old male patient that, A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration on 03May2021 (at the age of 50-years-old), as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included diabetes mellitus and Other medical history: diagnosed with diabetes while in hospital. Patient had no Known allergies.The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) on 12Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 14Jun2021, patient died due to cardiac arrest, shortness of breath, racing heart rate, fatigue, heaviness in chest. Date of death: 09Jul2021. Autopsy was not performed. He was hospitalized for 15 days. Patient received treatment included medication. He did not have covid prior to vaccination. He was not tested for covid post vaccination. He was on other medicines in two weeks which included multivitamins. Patient did not take any other vaccine in four weeks. The patient underwent lab tests and procedures which included angioplasty: no blockage on, cardiac electrophysiologic study: unknown results on, cardiac stress test: unknown results on, echocardiogram: unknown results on.The outcome for the events was fatal.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Fatigue, Heart rate increased
Clinical narrative: Patient died / Cause of Death Cardiac Arrest; racing heart rate; started having shortness of breath; heaviness in chest; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a 50-year-old male patient that, A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration on 03May2021 (at the age of 50-years-old), as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included diabetes mellitus and Other medical history: diagnosed with diabetes while in hospital. Patient had no Known allergies.The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) on 12Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 14Jun2021, patient died due to cardiac arrest, shortness of breath, racing heart rate, fatigue, heaviness in chest. Date of death: 09Jul2021. Autopsy was not performed. He was hospitalized for 15 days. Patient received treatment included medication. He did not have covid prior to vaccination. He was not tested for covid post vaccination. He was on other medicines in two weeks which included multivitamins. Patient did not take any other vaccine in four weeks. The patient underwent lab tests and procedures which included angioplasty: no blockage on, cardiac electrophysiologic study: unknown results on, cardiac stress test: unknown results on, echocardiogram: unknown results on.The outcome for the events was fatal.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest