chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Hypoaesthesia, Malaise, Nasopharyngitis, Pain
Clinical narrative: made her arm sore; symptoms of covid -19/tested positive for covid-19; I believe the Pfizer vaccine got me and my 12 year old daughter sick.; This is a spontaneous report from a contactable consumer reported for herself and her daughter, this case is for herself. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Aug2021 14:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at age of 41 years old. Medical history was none. Concomitant medication included semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient reported that that prior to her first covid Pfizer shot on 26Aug2021, she had a negative covid test. Prior to vaccination, the patient was not diagnosed with COVID-19. The shot made her arm sore on 06Sep2021 at 12: 00, and on 06Sep2021 she started to get symptoms of covid -19. She tested positive for covid-19 on 09Sep2021. She believed the Pfizer vaccine got her and her 12 years old daughter sick. The events were serious per life threatening and required physician office visit. No treatment received for the events. The patient underwent lab tests and procedures which included Covid 19 test (Nasal Swab): negative on 17Sep2021. The outcome of the events was resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: made her arm sore; symptoms of covid -19/tested positive for covid-19; I believe the Pfizer vaccine got me and my 12 year old daughter sick.; This is a spontaneous report from a contactable consumer reported for herself and her daughter, this case is for herself. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Aug2021 14:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at age of 41 years old. Medical history was none. Concomitant medication included semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient reported that that prior to her first covid Pfizer shot on 26Aug2021, she had a negative covid test. Prior to vaccination, the patient was not diagnosed with COVID-19. The shot made her arm sore on 06Sep2021 at 12: 00, and on 06Sep2021 she started to get symptoms of covid -19. She tested positive for covid-19 on 09Sep2021. She believed the Pfizer vaccine got her and her 12 years old daughter sick. The events were serious per life threatening and required physician office visit. No treatment received for the events. The patient underwent lab tests and procedures which included Covid 19 test (Nasal Swab): negative on 17Sep2021. The outcome of the events was resolving.  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, SARS-CoV-2 test
Clinical narrative: Caller states she got sick with Covid-19 around that time and recovered and tested negative after one week on 09MAY2021; Caller states she got sick with Covid-19 around that time while she and recovered and tested negative after one week on 09MAY2021; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Apr2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated she was supposed to get her second dose on 01May2021, but she missed the dose as she got sick with Covid-19 around that time while and recovered and tested negative after one week on 09May2021. Now she wishes to get her second dose of the Pfizer BioNTech Covid-19 Vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test which resulted negative on 09May2021. Outcome of the event Covid-19 was recovered on 09May2021.  Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blindness, Dizziness, Feeling abnormal, Movement disorder
Clinical narrative: When he stands up the dizziness worsens,dizziness; His left leg or balance is affected; he is scared to be left alone,He was afraid; having trouble getting to the bathroom; he is totally blind; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on 20Sep2021 morning at 10:05 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Sep2021, the caller was on the line with his caregiver as the patient was legally blind. About 20 minutes after patient received the shot, he experienced dizziness. The Pharmacist advised them that this is natural and can happen after the shot. The caregiver also read it on the information sheet that was provided to the caller prior to the vaccination. It continues now and patient was afraid to be left alone. When he stands up the dizziness worsens, he was totally blind, and he was having trouble using the bathroom. He was fine sitting up and does not complain of nausea, he was drinking coffee at this time. He was afraid because he cannot get around as he usually does. They spoke with someone the first time they called and reported his experience. The caregiver added it was his left side that was affected and now she understood that this could be an allergic reaction because of how soon it happened after he got the shot. Caller stated the patient had a bad reaction to the first Pfizer Covid vaccine received today. His left leg or balance was affected and he was scared to be left alone. He was having trouble getting to the bathroom and that is not cool. Outcome of event was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: When he stands up the dizziness worsens,dizziness; His left leg or balance is affected; he is scared to be left alone,He was afraid; having trouble getting to the bathroom; he is totally blind; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on 20Sep2021 morning at 10:05 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Sep2021, the caller was on the line with his caregiver as the patient was legally blind. About 20 minutes after patient received the shot, he experienced dizziness. The Pharmacist advised them that this is natural and can happen after the shot. The caregiver also read it on the information sheet that was provided to the caller prior to the vaccination. It continues now and patient was afraid to be left alone. When he stands up the dizziness worsens, he was totally blind, and he was having trouble using the bathroom. He was fine sitting up and does not complain of nausea, he was drinking coffee at this time. He was afraid because he cannot get around as he usually does. They spoke with someone the first time they called and reported his experience. The caregiver added it was his left side that was affected and now she understood that this could be an allergic reaction because of how soon it happened after he got the shot. Caller stated the patient had a bad reaction to the first Pfizer Covid vaccine received today. His left leg or balance was affected and he was scared to be left alone. He was having trouble getting to the bathroom and that is not cool. Outcome of event was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke and passes away; This is a spontaneous report from a contactable consumer. A 37-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is inquiring about the Pfizer COVID-19 vaccine. He wants to know if the booster shot is required in the US for the general population or only for immunocompromised patients? The 37-year-old had a stroke and passes away." The virus is not messing around". Caller was not able to confirm if reported cases were vaccinated or not. Caller stated "Pfizer is better than Moderna. They have done more research." Caller also pleased about the results on the use of the Pfizer COVID-19 vaccine in a younger population. The patient died on an unspecified date. 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.; Reported Cause(s) of Death: had a stroke and passes away
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: he would die; paralysis; severe chest pain; could not move or walk; felt very bad; Itching; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,), dose 1 via an unspecified route of administration on 31Aug2021 as 0.3 mL single dose for covid-19 immunisation. Patient stated his patient card was handwritten and the lot was FC3182 or FG3182 and he cannot see the handwriting clearly. The patient's medical history and concomitant medications were not reported. Caller (patient) received first dose of the Pfizer Covid 19 vaccine on 31Aug2021 and second dose was scheduled for 21Sep2021. The first day he was ok and on day two he had such severe chest pain that lasted 24 hours and he paralysis while lying on the floor as he could not move or walk and thought he would die that day on 02Sep2021. He asked his wife to watch over him and to check on him from time to time to make sure he was not dead yet. He explained that 24 hours after the onset it resolved. He could walk, breathe and everything was normal. He was healthy at baseline. He had not experienced that kind of pain and heard about myocarditis regarding the vaccine but could not go that day to his doctor and he felt very bad in Sep2021 and 24 hours later the symptoms resolved. He stated the chest pain and itching in Sep2021, he told his wife to look into that and he may die that day. He was supposed to get the 2nd dose at 11:00am tomorrow.  Caller stated he was concerned and heard reports that after the 2nd dose people get very bad myocarditis. But he did not know what the symptoms were and thought he was going to die that day and asked his wife to come check on him often and he was lying flat. He stated 24 hours later his symptoms resolved and he was able to function again. He did not go to the doctor and did not know what this was and still can go check his EKG and all that and can do that still. Caller stated on his patient card for the Pfizer Covid vaccine has numbers. As a physician he was aware of the reports of myocarditis. While he has not been evaluated by his HCP for a formal diagnosis he would like to know if it was safe to get his second dose of the vaccine. Outcome of itching was unknown, of severe chest pain was recovered on 03Sep2021, of other events was recovered in Sep2021.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Near death experience (Life threatening) and Paralysis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: just test positive for COVID. She previously received the Pfizer-BioNTech COVID vaccine; just test positive for COVID. She previously received the Pfizer-BioNTech COVID vaccine; This is a spontaneous report from a contactable Pfizer colleague (consumer) reported for a friend. A non-pregnant 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACINNE) on an unspecified date at the age of 40-year-old (lot unknown) as single dose for covid-19 immunisation. No covid prior vaccination. It was unknown if the patient has known allergies. Medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wasn't feeling well (sore throat, fever, headache) and just test positive for COVID post vaccination. She previously received the Pfizer-BioNTech COVID vaccine. This case was reported as non-serious. It was unknown if treatment for the event received. The outcome of the event was Recovering.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attacks; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart attacks on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. Autopsy was done.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart attacks
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 through a Rapid test; tested positive for COVID-19 through a Rapid test; This is a spontaneous report from a contactable non-healthcare professional reported that: A 16-year-old male patient received bnt162b2 (BNT162B2) (at the age of 16-year-old), via an unspecified route of administration on 08Apr2021 (Lot Number: EP6955) as DOSE 2, SINGLE and First dose was administrated on 20Mar2021(Lot Number: EP6955) via an unspecified route as single dose, for covid-19 immunization. Patient experienced tested positive for COVID-19 through a Rapid test on 20Sep2021, the patient was currently asymptotic. Outcome of the events was unknown. Therapeutic medication was not administrated. The patient underwent lab test included SARS-CoV-2 test (rapid test) showed positive on unknown date. It was reported that the patient did not diagnose with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-Up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/ Raised welts; General itch; This is a spontaneous report from a contactable consumer. This consumer reported for a 77-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, on 27Feb2021 (age at vaccination: 77 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9263 and expiry date was not reported), via an unspecified route of administration, on 01Feb2021, as a single dose for COVID-19 immunization. This patient encountered hives on the second injection (intermittent with raised welts at random locations with a general itch for 3-4 days) on an unspecified date in 2021 which she treated with Benadryl. The question was she able to receive the booster vaccine since she reacted on the second injection. Outcome of the events was recovered on an unspecified date in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This consumer reported information on additional patient. Caller reported that person in her county just had someone die from heart attack right while they had The Vaccine in the office-he was 56 and healthy. Caller mentioned they've had people who had autopsies who were administered the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. This is serious report for results in death.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Heart attack
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Right arm warm and tender after 1st shot; Right arm warm and tender after 1st shot; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 64-Year-old female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201, Expiry Date, NDC Number: not reported), via intramuscular on right arm (Unable to confirm if given in the muscle) on 10Feb2021 (at the age of 64 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes from 1995 to an unknown date (diagnosed 25 years ago), allergies. She had heart disease regarding that her cardiologist told her that everyone over the age of 50 had a little bit of heart disease. She had kidney disease (diagnosed 2 years ago. It was in the early or beginning stages). Other conditions: diagnosis date not provided. Her son was tested positive for COVID prior to her. AE(s) following prior vaccinations was none. Investigation assessment was done. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA 24 HOUR) taken for allergies from 2020 (took it on a regular basis since end of 2020). She took Allegra and spoke to her Allergists, and she said to continue taking it when she got the vaccine. She was on something else before Allegra, and it made her too drowsy. That medication was Zyrtec. Her allergist said that some medications did not work well with everyone and it was a 24 hour one. She switched her over to Allegra. She threw the Zyrtec out and did not have a lot or expiration for it. She had very bad allergies. When she did not take it, she got sneeze. When she did, it works. She tried not to take it every day to see how long before she starts to sneeze. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Last vaccines, she received before this were in the fall of 2020. She received vaccination at US clinic and not at military facility. The patient experienced right arm warm and tender after 1st shot on 11Feb2021. She was highly allergic and was afraid she was going to have a reaction but did not. She just had normal reactions. Her arm was warm and tender after first shot. It was reported that vaccination site for both doses were given in two different places. One gave it lower and one higher. She did not think they got muscle on first shot and it did not feel the same on the first shot. With first shot, she got to sit down, and they already had the shots in the hand. So, she did not know if it was sealed or not. Both shots in same arm were not in the same place. She knew that for a fact. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pericarditis, Tremor
Clinical narrative: inflammation of the pericardium; Chest pain; she could barely catch her breath; her heart rate was 128 resting; Shaking; Sweating; This is a spontaneous report from a contactable consumer (Parent). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 18Sep2021 11:30 (at the age of 18-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date (at the age of 18-years-old) as dose 1, single for COVID-19 immunization. On 19Sep2021, the patient experienced, inflammation of the pericardium, Chest pain, she could barely catch her breath, her heart rate was 128 resting (these were serious, medically significant), Shaking and Sweating. Reporter stated, she was calling to report an adverse side effect to the vaccine for her daughter. Sure, she got her 2nd dose Saturday morning around 11:30 and 12 am Sunday 19Sep2021 she woke up she had severe chest pain, shaking, sweating, she could barely catch her breath to call me. We ended up in ER, they did EKG her heart rate was 128 resting. They did blood work, they released her about 6 hours later, told me to follow up with doctor, went to doctor yesterday he said that she has inflammation of the pericardium and referred me to the cardiologist. When confirmed vaccine as Pfizer Covid-19 Vaccine she stated, Ofcourse it is Pfizer that's why she calling you. She wouldn't calling you if it was Moderna it was Pfizer. When asked to file a safety report she stated Sure, but she was having a hard time understanding you. Well she may have to put you on hold because she was at work so, go ahead. She stated, She was a girl Height and Weight she stated, "5 foot 9(Confirmed as 5 foot 9 inches), 150(Confirmed as pounds) she guess. Why do you need this for this is ridiculous. She stated, You want to know she was doctor or nurse. No, she was her mother. Email address she stated, email(withheld) she think so she can't really understand you but okay. LOT number: she stated, How would she know that, she don't have that with me so she guess she will be doing this online. Thank you for wasting my time. Product details and pharmacy details could not be probed as the reporter hung up abruptly. Hence limited information available over the call. The patient underwent lab tests and procedures which included blood test: unknown results on 19Sep2021 electrocardiogram: heart rate was 128 resting on 19Sep2021. The outcome for the events inflammation of the pericardium, chest pain, she could barely catch her breath, shaking, sweating, her heart rate was 128 resting was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pemphigus
Clinical narrative: Pemphigus vulgaris; she developed blisters on her mouth that would come and ago.; This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable reporter (patient's daughter) via medical information team. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection Batch/Lot Number: Not Provided) via an unspecified route of administration on 14Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. After her second dose on an unspecified date in 2021 patient developed blisters on her mouth that would come and go. A few months later it came back and it covered her head to toe in blisters. She was diagnosed with Pemphigus vulgaris on an unspecified date in Sep2021. On an unspecified date in Sep2021, patient underwent a lab test in which she was diagnosed with Pemphigus vulgaris. Reporter also added that their other family members also developing blisters. 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-202101246991 same reporter/product, different patient / event.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Hypersensitivity, Pruritus, Rash
Clinical narrative: allergic reactions; rashes all over the body; itching; burning sensation starting in the hands and gradually spread to neck,upper chest, upper extremity, scalp,abdomen, and the rest of all over the body; burning sensation starting in the hands and gradually spread to neck,upper chest, upper extremity, scalp,abdomen, and the rest of all over the body; condition worsened; This is a spontaneous report from a contactable Nurse (patient). A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1, administered in Arm Left on 10Sep2021 14:45 (Batch/Lot number was not reported) at age of 27-year-old as DOSE 1, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included known allergies: Shell fish and Iodine, asthma, caesarean section, preeclampsia.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since receiving the vaccine just before 3 PM, on 10Sep2021 19:15 she have experienced allergic reactions in the form of rashes all over the body that has been itching, and burning sensation starting in the hands and gradually spread to neck, upper chest, upper extremity, scalp, abdomen, and the rest of all over the body. Went to ER, was sent home with steroids, but the condition worsened. Had to go back to ER and got admitted in the hospital in a very severe condition. AE resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Lifethreatening illness (immediate risk of death from the event)]. Events were assessed serious as Life threatening and Caused/prolonged hospitalization (days hospitalization: 3). The patient received Ampicillin, Solumedrol, Benadryl, Methotrexate as treatment. The outcome was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination was Nasal Swab, name RTPCR on 16Sep2021 with result of Negative. The outcome was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the life threatening events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: allergic reactions; rashes all over the body; itching; burning sensation starting in the hands and gradually spread to neck,upper chest, upper extremity, scalp,abdomen, and the rest of all over the body; burning sensation starting in the hands and gradually spread to neck,upper chest, upper extremity, scalp,abdomen, and the rest of all over the body; condition worsened; This is a spontaneous report from a contactable Nurse (patient). A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1, administered in Arm Left on 10Sep2021 14:45 (Batch/Lot number was not reported) at age of 27-year-old as DOSE 1, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included known allergies: Shell fish and Iodine, asthma, caesarean section, preeclampsia.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since receiving the vaccine just before 3 PM, on 10Sep2021 19:15 she have experienced allergic reactions in the form of rashes all over the body that has been itching, and burning sensation starting in the hands and gradually spread to neck, upper chest, upper extremity, scalp, abdomen, and the rest of all over the body. Went to ER, was sent home with steroids, but the condition worsened. Had to go back to ER and got admitted in the hospital in a very severe condition. AE resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Lifethreatening illness (immediate risk of death from the event)]. Events were assessed serious as Life threatening and Caused/prolonged hospitalization (days hospitalization: 3). The patient received Ampicillin, Solumedrol, Benadryl, Methotrexate as treatment. The outcome was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination was Nasal Swab, name RTPCR on 16Sep2021 with result of Negative. The outcome was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the life threatening events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Intermenstrual bleeding, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 35-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0584), at the age of 35, via an unspecified route of administration, left arm, on Jul 25, 2021, at 13:00, single dose, for COVID-19 immunisation. The patient also received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FA7485), at the age of 35, via an unspecified route of administration, left arm, on Aug 15, 2021, at 11:00, single dose, for COVID-19 immunisation. Medical history included BRCA2 positive. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Jul 26, 2021, at 00:00, patient experienced continuous menstrual bleeding from Jul 26, 2021 to current from spotting to heavy bleeding coupled with severe cramps and exhaustion. On an unspecified date in 2021, patient underwent nasal swab test and the test result was negative. Since the vaccination, patient has been tested for COVID-19. It was unknown whether therapeutic measures were taken as a result of reported events. The outcome of continuous menstrual bleeding, spotting to heavy bleeding: not recovered; whereas severe cramps and exhaustion unknown, at the time of this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Body temperature, Body temperature increased, Chest pain
Clinical narrative: Increased body temperature; Sweating; Headaches; GERD/acid reflux; Throat irritation/ burning in throat; Fatigue; Body aches; Pain in injection arm; Nausea; Burping; Cotton mouth; Chest pain; Underarm pain; Ear pain; Back pain; Pityriasis rosea on front and back abdomen; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 27Aug2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome with idiopathic anaphylaxis. The patient had too many allergies to name all but mainly to latex, corn, egg yolk, mold, wheat and dog. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), cromoglicate sodium (NASALCROM) and guaifenesin (MUCINEX); all for unknown indications from an unknown date and unknown if ongoing. The patient previously received pertussis vaccine (MANUFACTURER UNKNOWN) for immunisation and experienced allergy. On 27Aug2021 at 16:15, the patient experienced increased body temperature, sweating, headaches, gastroesophageal reflux disease (GERD)/ acid reflux, throat irritation, fatigue, body aches, pain in injection arm, nausea, burping, burning in throat, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event pityriasis rosea on front and back abdomen and included treatment with unspecified steroid cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events increased body temperature, sweating, headaches, GERD/ acid reflux, throat irritation, burning in throat, fatigue, body aches, pain in injection arm, nausea, burping, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen was unknown at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 17Sep2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Ear pain, Eructation, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Increased body temperature; Sweating; Headaches; GERD/acid reflux; Throat irritation/ burning in throat; Fatigue; Body aches; Pain in injection arm; Nausea; Burping; Cotton mouth; Chest pain; Underarm pain; Ear pain; Back pain; Pityriasis rosea on front and back abdomen; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 27Aug2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome with idiopathic anaphylaxis. The patient had too many allergies to name all but mainly to latex, corn, egg yolk, mold, wheat and dog. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), cromoglicate sodium (NASALCROM) and guaifenesin (MUCINEX); all for unknown indications from an unknown date and unknown if ongoing. The patient previously received pertussis vaccine (MANUFACTURER UNKNOWN) for immunisation and experienced allergy. On 27Aug2021 at 16:15, the patient experienced increased body temperature, sweating, headaches, gastroesophageal reflux disease (GERD)/ acid reflux, throat irritation, fatigue, body aches, pain in injection arm, nausea, burping, burning in throat, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event pityriasis rosea on front and back abdomen and included treatment with unspecified steroid cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events increased body temperature, sweating, headaches, GERD/ acid reflux, throat irritation, burning in throat, fatigue, body aches, pain in injection arm, nausea, burping, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen was unknown at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 17Sep2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pain, Pain in extremity
Clinical narrative: Increased body temperature; Sweating; Headaches; GERD/acid reflux; Throat irritation/ burning in throat; Fatigue; Body aches; Pain in injection arm; Nausea; Burping; Cotton mouth; Chest pain; Underarm pain; Ear pain; Back pain; Pityriasis rosea on front and back abdomen; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 27Aug2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome with idiopathic anaphylaxis. The patient had too many allergies to name all but mainly to latex, corn, egg yolk, mold, wheat and dog. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), cromoglicate sodium (NASALCROM) and guaifenesin (MUCINEX); all for unknown indications from an unknown date and unknown if ongoing. The patient previously received pertussis vaccine (MANUFACTURER UNKNOWN) for immunisation and experienced allergy. On 27Aug2021 at 16:15, the patient experienced increased body temperature, sweating, headaches, gastroesophageal reflux disease (GERD)/ acid reflux, throat irritation, fatigue, body aches, pain in injection arm, nausea, burping, burning in throat, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event pityriasis rosea on front and back abdomen and included treatment with unspecified steroid cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events increased body temperature, sweating, headaches, GERD/ acid reflux, throat irritation, burning in throat, fatigue, body aches, pain in injection arm, nausea, burping, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen was unknown at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 17Sep2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Throat irritation
Clinical narrative: Increased body temperature; Sweating; Headaches; GERD/acid reflux; Throat irritation/ burning in throat; Fatigue; Body aches; Pain in injection arm; Nausea; Burping; Cotton mouth; Chest pain; Underarm pain; Ear pain; Back pain; Pityriasis rosea on front and back abdomen; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 27Aug2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome with idiopathic anaphylaxis. The patient had too many allergies to name all but mainly to latex, corn, egg yolk, mold, wheat and dog. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), cromoglicate sodium (NASALCROM) and guaifenesin (MUCINEX); all for unknown indications from an unknown date and unknown if ongoing. The patient previously received pertussis vaccine (MANUFACTURER UNKNOWN) for immunisation and experienced allergy. On 27Aug2021 at 16:15, the patient experienced increased body temperature, sweating, headaches, gastroesophageal reflux disease (GERD)/ acid reflux, throat irritation, fatigue, body aches, pain in injection arm, nausea, burping, burning in throat, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event pityriasis rosea on front and back abdomen and included treatment with unspecified steroid cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events increased body temperature, sweating, headaches, GERD/ acid reflux, throat irritation, burning in throat, fatigue, body aches, pain in injection arm, nausea, burping, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen was unknown at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 17Sep2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; Body aches; Chills; Extremely sore arm could not lift arm; Swollen lymph node in armpit of arm of injection site; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 20Sep2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and 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. The patient did not have any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3183) via an unspecified route of administration in the left arm on 30Aug2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 21Sep2021 at 10:00, approximately 18 hours after the second dose, the patient experienced low grade fever, body aches, chills, extremely sore arm that she could not lift the arm and swollen lymph node in armpit of arm of injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department visit or urgent care. Therapeutic measures were not 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 low grade fever, body aches, chills, extremely sore arm could not lift arm and swollen lymph node in armpit of arm of injection site was resolving at the time of this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysgeusia, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat; Nausea; Stomach cramps; Metallic taste; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Sep2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included bowel obstruction (BO). 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. The patient did not receive any concomitant medications. On 16Sep2021 at 14:00, the patient experienced sore throat, nausea, stomach cramps, metallic taste, and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 21Sep2021, the patient underwent COVID-19 test via nasal swab and the result was pending. Therapeutic measures were taken as a result of the events which included unspecified treatment. The clinical outcome of the events sore throat, nausea, stomach cramps, metallic taste, and headache were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.