chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It is unknown if the doses are first, second or third doses for the  patients. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions. No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported   This case was linked to MOD21-152032, MOD-2021-351062 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Heart rate, Heart rate increased, Influenza
Clinical narrative: Fatigue; He has rapid heart rate and blood pooling from Covid but it got worse after the vaccine; He has rapid heart rate and blood pooling from Covid but it got worse after the vaccine; Fever; This is a spontaneous report received from a contactable consumer or other non hcp. A 21-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FA7485; Expiration Date: 31Oct2021) via an unspecified route of administration on 07Aug2021 12:45 (age at vaccination 21years old) as single dose for covid-19 immunisation. Medical history included heart rate increased from an unknown date and unknown if ongoing He has rapid heart rate and blood pooling from Covid, covid-19 from an unknown date and unknown if ongoing He has had covid for 13 months. He still has antibodies, blood pressure abnormal from an unknown date and unknown if ongoing he is on medication for his blood pressure and heart rate already. The patient experienced fever on unspecified date in Aug2021, fatigue, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine on an unspecified date. Additional information reported as her son had adverse effect also. He was vaccinated on 07Aug, 12:45 in the afternoon. He has had covid for 13 months. He still has antibodies when he got the vaccine. We got it pulled out 1 day before the vaccine. When he got the vaccine, he felt okay for the first 3 days, then he started with a fever on day 4 and it continued for 8 days. We tested him for Covid and influenza. He was negative for everything it was the vaccine. Then he started to feel fatigue. It is almost 3 weeks, and he still feels fatigued, does not feel normal and he has had problems with very rapid heart rate and blood pooling. He has rapid heart rate and blood pooling from Covid, but it got worse after the vaccine. He also has low fever and fatigue from the vaccine and is not going away. Consumer stated, He is 6 feet 1 inches and weighs approximately 150 pounds. Treatment: Reporter stated, He hydrated, he took Tylenol and Advil for the fever, and he is on Medication for his blood pressure and heart rate already. No, he can't take anything for the fatigue. I don't think there's anything to give for fatigue. The patient underwent lab tests and procedures which included heart rate: rapid on unspecified date, influenza: negative on unspecified date, sars-cov-2 test negative on unspecified date. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of fever, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fatigue; He has rapid heart rate and blood pooling from Covid but it got worse after the vaccine; He has rapid heart rate and blood pooling from Covid but it got worse after the vaccine; Fever; This is a spontaneous report received from a contactable consumer or other non hcp. A 21-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FA7485; Expiration Date: 31Oct2021) via an unspecified route of administration on 07Aug2021 12:45 (age at vaccination 21years old) as single dose for covid-19 immunisation. Medical history included heart rate increased from an unknown date and unknown if ongoing He has rapid heart rate and blood pooling from Covid, covid-19 from an unknown date and unknown if ongoing He has had covid for 13 months. He still has antibodies, blood pressure abnormal from an unknown date and unknown if ongoing he is on medication for his blood pressure and heart rate already. The patient experienced fever on unspecified date in Aug2021, fatigue, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine on an unspecified date. Additional information reported as her son had adverse effect also. He was vaccinated on 07Aug, 12:45 in the afternoon. He has had covid for 13 months. He still has antibodies when he got the vaccine. We got it pulled out 1 day before the vaccine. When he got the vaccine, he felt okay for the first 3 days, then he started with a fever on day 4 and it continued for 8 days. We tested him for Covid and influenza. He was negative for everything it was the vaccine. Then he started to feel fatigue. It is almost 3 weeks, and he still feels fatigued, does not feel normal and he has had problems with very rapid heart rate and blood pooling. He has rapid heart rate and blood pooling from Covid, but it got worse after the vaccine. He also has low fever and fatigue from the vaccine and is not going away. Consumer stated, He is 6 feet 1 inches and weighs approximately 150 pounds. Treatment: Reporter stated, He hydrated, he took Tylenol and Advil for the fever, and he is on Medication for his blood pressure and heart rate already. No, he can't take anything for the fatigue. I don't think there's anything to give for fatigue. The patient underwent lab tests and procedures which included heart rate: rapid on unspecified date, influenza: negative on unspecified date, sars-cov-2 test negative on unspecified date. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of fever, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine, he has rapid heart rate and blood pooling from covid, but it got worse after the vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Angioscopy, Arthralgia, Back pain, Central vision loss
Clinical narrative: Left eye central vision loss; Back pain; Hip/Knees pain; Blurred vision; Limping R leg; This is a spontaneous report from a contactable nurse (patient).  A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly administered in Deltoid Left on 21May2021 11:52, at 50-year-old, as single dose (Lot Number: EW0183) for covid-19 immunisation.  Medical history included eye surgeries stagBlue for over 12 years until after the COVID shot. Concomitant medication included influenza vaccine inact split 3v (FLUARIX) taken for an unspecified indication, via intramuscular in right deltoid, at 50-year-old, as single dose (Lot number: 59HN3) on 01Apr2021. The patient had not got covid prior vaccination and had not been tested covid post vaccination. No Known allergies. On 21May2021, the patient experienced blurred vision and limping right leg. On 22May2021(reported as "22May - 24May"), the patient had left eye central vision loss (medically significant and disability), back pain (disability), hip and knees pain(disability). The patient underwent lab tests and procedures which included angiogram: retinal surgeon did angiogram and confirmed revascularization on 2021; Fluorescent Angioscopy: left subretinal revascularization on 27Aug2021; CT (Computerised tomogram) Scan Head Brain: normal and No mass. No stroke on 28Jun2021; Eye pressure: 24 (patient's normal was 10-14) on 27Aug2021; Rheumatoid lab tests: normal on Jul2021; magnetic resonance imaging (MRI) spinal: bulges spondylosis, subcentimeter csf cyst and facet degeneration Disc bulge. Foramen narrowing on 12Sep2021; Hip and Knees X-rays: normal on 28Jun2021. The patient had an emergency room visit for events left eye central vision loss, back pain, hip and knees pain. Therapeutic measures were taken as a result of all events, included: Avastin 1.25mg Eye injection for left eye central vision loss; CT, MRI Physical medicines, ortho referral, oral medicines for pain. The outcome of events left eye central vision loss, Back pain, Hip and Knees pain and limping right leg were not recovered. The outcome of event blurred vision was unknown. The case was reported as serious due to medically significant and disability condition.  Follow-up attempts completed. No further information expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of central tunnel vision , arthralgia and back pain cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202101252495 same patient/drug, different dose/AE
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, X-ray, X-ray of pelvis and hip
Clinical narrative: Left eye central vision loss; Back pain; Hip/Knees pain; Blurred vision; Limping R leg; This is a spontaneous report from a contactable nurse (patient).  A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly administered in Deltoid Left on 21May2021 11:52, at 50-year-old, as single dose (Lot Number: EW0183) for covid-19 immunisation.  Medical history included eye surgeries stagBlue for over 12 years until after the COVID shot. Concomitant medication included influenza vaccine inact split 3v (FLUARIX) taken for an unspecified indication, via intramuscular in right deltoid, at 50-year-old, as single dose (Lot number: 59HN3) on 01Apr2021. The patient had not got covid prior vaccination and had not been tested covid post vaccination. No Known allergies. On 21May2021, the patient experienced blurred vision and limping right leg. On 22May2021(reported as "22May - 24May"), the patient had left eye central vision loss (medically significant and disability), back pain (disability), hip and knees pain(disability). The patient underwent lab tests and procedures which included angiogram: retinal surgeon did angiogram and confirmed revascularization on 2021; Fluorescent Angioscopy: left subretinal revascularization on 27Aug2021; CT (Computerised tomogram) Scan Head Brain: normal and No mass. No stroke on 28Jun2021; Eye pressure: 24 (patient's normal was 10-14) on 27Aug2021; Rheumatoid lab tests: normal on Jul2021; magnetic resonance imaging (MRI) spinal: bulges spondylosis, subcentimeter csf cyst and facet degeneration Disc bulge. Foramen narrowing on 12Sep2021; Hip and Knees X-rays: normal on 28Jun2021. The patient had an emergency room visit for events left eye central vision loss, back pain, hip and knees pain. Therapeutic measures were taken as a result of all events, included: Avastin 1.25mg Eye injection for left eye central vision loss; CT, MRI Physical medicines, ortho referral, oral medicines for pain. The outcome of events left eye central vision loss, Back pain, Hip and Knees pain and limping right leg were not recovered. The outcome of event blurred vision was unknown. The case was reported as serious due to medically significant and disability condition.  Follow-up attempts completed. No further information expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of central tunnel vision , arthralgia and back pain cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202101252495 same patient/drug, different dose/AE
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: develop a rash between receiving the two doses of the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable physician. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 19Feb2021 as DOSE 1, SINGLE (at the age of 48-years-old) for COVID-19 immunisation. The patient's medical history included diabetic and osteomyelitis from an unknown date and unknown if ongoing. The patient had no prior vaccinations (within 4 weeks) of COVID-19 vaccination. On an unspecified date in 2021, the patient experienced develop a rash between receiving the two doses of the Pfizer COVID 19 vaccine. The patient was also on IV antibiotics for osteomyelitis of her toe at the time. The rash was treated with steroids and resolved when the antibiotics were stopped and changed. It was, therefore, the consensus, that the reaction was more likely than not due to the antibiotics, not the vaccine. And the patient has since received a third dose as a booster (being a high-risk insulin diabetic patient) without any incident. Therapeutic measures were taken as a result of the event. The patient had recovered from the event on an unspecified date in 2021.  The reporter did not consider that the Pfizer product had a causal effect to the adverse events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Oct2021) This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure abnormal, Blood pressure measurement, Bone pain, Chest discomfort
Clinical narrative: constipated throat; did not allow him to swallow; swelling in the heel and foot of the right leg; stronger rush" in the chest; severe headache; body aches; stomach pain,; bone pain; his sciatica "was activated"; also affected his blood pressure; This is a spontaneous report from a contactable consumer (patient himself).  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation, he mentioned that when he received the first dose, he manifested a small rush and fatigue for two days. On an unspecified date, the patient suffered from a constipated throat that did not allow him to swallow and swelling in the heel and foot of the right leg. The patient received both doses of the vaccine (he does not remember when). He mentioned that when he received the first dose, he manifested a small rush and fatigue for two days, when he received the second dose he presented a stronger rush in the chest, he had to take Benadryl, he had a severe headache, body aches similar to when he has flu, he presented stomach pain, bone pain, his sciatica was activated and the vaccine also affected his blood pressure. The reporter consider the seriousness as non-serious. The patient underwent lab tests and procedures which included blood pressure measurement: affected, the vaccine also affected his blood pressure on an unspecified date. The clinical outcome for the events was unknown.  No follow-up attempts needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Oropharyngeal discomfort, Pain, Peripheral swelling
Clinical narrative: constipated throat; did not allow him to swallow; swelling in the heel and foot of the right leg; stronger rush" in the chest; severe headache; body aches; stomach pain,; bone pain; his sciatica "was activated"; also affected his blood pressure; This is a spontaneous report from a contactable consumer (patient himself).  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation, he mentioned that when he received the first dose, he manifested a small rush and fatigue for two days. On an unspecified date, the patient suffered from a constipated throat that did not allow him to swallow and swelling in the heel and foot of the right leg. The patient received both doses of the vaccine (he does not remember when). He mentioned that when he received the first dose, he manifested a small rush and fatigue for two days, when he received the second dose he presented a stronger rush in the chest, he had to take Benadryl, he had a severe headache, body aches similar to when he has flu, he presented stomach pain, bone pain, his sciatica was activated and the vaccine also affected his blood pressure. The reporter consider the seriousness as non-serious. The patient underwent lab tests and procedures which included blood pressure measurement: affected, the vaccine also affected his blood pressure on an unspecified date. The clinical outcome for the events was unknown.  No follow-up attempts needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: constipated throat; did not allow him to swallow; swelling in the heel and foot of the right leg; stronger rush" in the chest; severe headache; body aches; stomach pain,; bone pain; his sciatica "was activated"; also affected his blood pressure; This is a spontaneous report from a contactable consumer (patient himself).  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation, he mentioned that when he received the first dose, he manifested a small rush and fatigue for two days. On an unspecified date, the patient suffered from a constipated throat that did not allow him to swallow and swelling in the heel and foot of the right leg. The patient received both doses of the vaccine (he does not remember when). He mentioned that when he received the first dose, he manifested a small rush and fatigue for two days, when he received the second dose he presented a stronger rush in the chest, he had to take Benadryl, he had a severe headache, body aches similar to when he has flu, he presented stomach pain, bone pain, his sciatica was activated and the vaccine also affected his blood pressure. The reporter consider the seriousness as non-serious. The patient underwent lab tests and procedures which included blood pressure measurement: affected, the vaccine also affected his blood pressure on an unspecified date. The clinical outcome for the events was unknown.  No follow-up attempts needed. No further information expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: chills; vomiting; diaharrea; fever; dizziness; aches and pain; intense fatigue/Complete exhaustion; no energy for days; headache; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Oct2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the third dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) an unspecified route of administration, administered in Arm Right on 20Aug2021 14:30 (at the age of 86 years old) (Lot Number: FC3180) as dose 3 (booster), single for COVID-19 immunisation. Medical history included nasal polyp in Feb2021. No COVID prior vaccination. No known allergies. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No other medications in two weeks. There were no concomitant medications. The patient took the first dose of BNT162B2 (Batch/Lot number: FL0142) Intramuscular administered to Arm on 06Jan2021 (at the age of 85 years old) for COVID-19 immunization. The patient took the second dose of BNT162B2 (Batch/Lot number: FL8982) Intramuscular administered to Arm on 27Jan2021 (at the age of 85 years old) for COVID-19 immunization. On 20Aug2021 16:00 (also reported as 4 hours after vaccination), patient experienced chills, vomiting, diarrhea, fever, dizziness, aches and pain, intense fatigue/ complete exhaustion, no energy for days, headache. Patient could not move for three days-just slept. On the 4th day, patient had some ginger-ale and husband had to help her get into shower and dress. Patient still lacked energy. No treatment was given for the events. Patient was not Covid tested post vaccination. The events required visit to Physician Office.  The events were reported as Serious, Important Medical event, Persistent/Significant disability/ incapacity. The last reported outcome of the events was recovering.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: chills; vomiting; diaharrea; fever; dizziness; aches and pain; intense fatigue/Complete exhaustion; no energy for days; headache; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Oct2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the third dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) an unspecified route of administration, administered in Arm Right on 20Aug2021 14:30 (at the age of 86 years old) (Lot Number: FC3180) as dose 3 (booster), single for COVID-19 immunisation. Medical history included nasal polyp in Feb2021. No COVID prior vaccination. No known allergies. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No other medications in two weeks. There were no concomitant medications. The patient took the first dose of BNT162B2 (Batch/Lot number: FL0142) Intramuscular administered to Arm on 06Jan2021 (at the age of 85 years old) for COVID-19 immunization. The patient took the second dose of BNT162B2 (Batch/Lot number: FL8982) Intramuscular administered to Arm on 27Jan2021 (at the age of 85 years old) for COVID-19 immunization. On 20Aug2021 16:00 (also reported as 4 hours after vaccination), patient experienced chills, vomiting, diarrhea, fever, dizziness, aches and pain, intense fatigue/ complete exhaustion, no energy for days, headache. Patient could not move for three days-just slept. On the 4th day, patient had some ginger-ale and husband had to help her get into shower and dress. Patient still lacked energy. No treatment was given for the events. Patient was not Covid tested post vaccination. The events required visit to Physician Office.  The events were reported as Serious, Important Medical event, Persistent/Significant disability/ incapacity. The last reported outcome of the events was recovering.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sneezing, Urine analysis
Clinical narrative: The second time, it start bringing cold; you know like I was having a lot of sneezing; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 81-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 20Aug2021 (at the age of 81-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma, and prostate surgery where the patient described that "I had prostate surgery all this '28'/2012".  Patient previously took first dose of BNT162B2 (at the age of 81-year-old) (lot number: FA7485) on 30Jul2021 for covid-19 immunisation. The patient reported event described as "the second time, it start bringing cold" and "you know like I was having a lot of sneezing". Where the patient had cold and also experienced lot of sneezing back to back after the second dose of vaccination. But patient's voice was not clear at the time of reporting for the other information. The patient underwent lab tests and procedures which included urine analysis: unknown (And then I had urinalysis (further clarification unknown hence not checked in LAB)). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of all the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nervousness, Off label use, Pain in extremity, Panic attack
Clinical narrative: breastfeeding; breastfeeding; Soreness towards her arm and shoulder; I couldn't move my arm; It was from the shoulder all the way down to the wrist; I got little nervous; I panicked; Soreness towards her arm and shoulder; I couldn't move my arm; It was from the shoulder all the way down to the wrist; I got little nervous; I panicked; This is a spontaneous report from a Pfizer-sponsored program Support and from a contactable 38-Year-Old female consumer (Patient). A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an unspecified route on 30Jul2021 (at the age of 38-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced Soreness towards her arm and shoulder and couldn't move her arm. It was from the shoulder all the way down to the wrist and patient got little nervous and panicked. After she received her first dose, she was breastfeeding and the mother experienced after the first dose some soreness towards her arm and shoulder and she said that her baby also had a reaction from the breastfeeding and had some projectile vomiting. Consumer stated, "So on the first shot that I got, my baby, he just, he did not take nothing all day, he was vomiting all day and I had my arm was you know, I couldn't move my arm for the first day. It was from the shoulder all the way down to the wrist. The second shot it was just like just at the injection site, like a normal shot (further clarification unknown), nothing out of ordinary and then it is fine with the 'second shot'." Patient did not receive treatment for the events. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101192776 EDP (baby 's 2nd dose);US-PFIZER INC-202101192586 EDP (baby 's 1st dose)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: breastfeeding; breastfeeding; Soreness towards her arm and shoulder; I couldn't move my arm; It was from the shoulder all the way down to the wrist; I got little nervous; I panicked; Soreness towards her arm and shoulder; I couldn't move my arm; It was from the shoulder all the way down to the wrist; I got little nervous; I panicked; This is a spontaneous report from a Pfizer-sponsored program Support and from a contactable 38-Year-Old female consumer (Patient). A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an unspecified route on 30Jul2021 (at the age of 38-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced Soreness towards her arm and shoulder and couldn't move her arm. It was from the shoulder all the way down to the wrist and patient got little nervous and panicked. After she received her first dose, she was breastfeeding and the mother experienced after the first dose some soreness towards her arm and shoulder and she said that her baby also had a reaction from the breastfeeding and had some projectile vomiting. Consumer stated, "So on the first shot that I got, my baby, he just, he did not take nothing all day, he was vomiting all day and I had my arm was you know, I couldn't move my arm for the first day. It was from the shoulder all the way down to the wrist. The second shot it was just like just at the injection site, like a normal shot (further clarification unknown), nothing out of ordinary and then it is fine with the 'second shot'." Patient did not receive treatment for the events. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101192776 EDP (baby 's 2nd dose);US-PFIZER INC-202101192586 EDP (baby 's 1st dose)
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: she knows 3 other people with the same symptoms/ all over body pain; shoulders were really painful; hardly lift arms up; legs were like lost mobility; inflammation; This is a spontaneous report from a contactable consumer, reporting same events under the same suspect product for 4 patients. This is second of the 4 reports. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: not provided, expiry date: not provided), via an unknown route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Reporter stated that she knew 3 other people (patient) with the same symptom, all over body pain, shoulders were really painful, hardly lift arms up, legs were like lost mobility and inflammation on an unspecified date. The clinical outcome for events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182532 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: she knows 3 other people with the same symptoms/body pain; shoulders are really painful; she can hardly lift her arms up; legs are like she lost mobility; inflammation; This is a spontaneous report from a contactable consumer or other non-healthcare professional reporting same events under the same suspect product for 4 patients. This is one of 4 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that she knew 3 other people (patient) with the same symptoms, body pain, shoulders are really painful, she can hardly lift her arms up, legs are like she lost mobility and inflammation on an unspecified date. She would like to know is there a way if Pfizer knows of this side effect is there something that can help. The outcome of the events was unknown.  Follow-up attempts have been completed. Batch/lot number is not available for [BNT162B2]. No further Information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182532 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Paraesthesia
Clinical narrative: Dizziness; Pain in chest; Tingling in my hands; 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, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 07Sep2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took patient shot last Tuesday and on Sep2021 patient got side effects which is like dizziness and like tingling in patient hands as well. Having like pain in chest. That is all patient feeling, no blood clot. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaginal infection, Vulvovaginal pain
Clinical narrative: 2 days after my second covid shot, I had painful vaginal sores appear on my vagina.; 2 days after my second covid shot, I had painful vaginal sores appear on my vagina.; This is a spontaneous report from a contactable nurse reported for herself. A 35-years-old non-pregnant female patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an intramuscular route of administration in Left arm on 12Sep2021 at 11:30 AM (Batch/Lot number: FC3183) (at the age of 35-year-old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patients medical history included Hx of these sores, Cold sore (illness). The patient past drug event included Omnicef with known allergies. The patient received other vaccines within four weeks prior to the COVID-19 vaccine tetanus (Batch/Lot number: unknown).The patient received other medications within 2 weeks of vaccination included Super B Complex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Historical vaccine included the patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) ) via an intramuscular route of administration in Right arm on 16Augr2021 at 04:00 PM (at the age of 35-year-old) (Batch/Lot no: FA7485). On 14Sep2021 07:00 PM, the patient experienced 2 days after her second covid shot, the patient had painful vaginal sores appear on her vagina. The patient underwent laboratory tests Nasal Swab (Binax NOW) as a resulted as negative On 13sep2021. The oucome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Heart rate, Hyperhidrosis, Maternal exposure during pregnancy
Clinical narrative: multiple bouts of tachycardia reaching a resting HR of up to 138.; profuse sweating; Gestational period at time of initial exposure was 7 Months 2nd trimester; fever; chills; muscle spasms in the legs/muscle cramping throughout my body; nausea; diarrhea; This is a spontaneous report from a contactable female consumer. This consumer reported information for both mother and fetus/baby. This is a maternal report.    A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 38-years-old, via an unspecified route of administration, administered in arm Left on 17Sep2021 13:00 (Batch/Lot Number: FF2587, expiration date: 30Dec2021) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm Left on 27Aug2021 13:00 (Batch/Lot Number: FD8448) as dose 1, single for COVID-19 immunization. Medical history included one previous pregnancy, Breech c-section delivery. The patient had no known allergies, no history of smoking, drinking and use of illicit drugs during pregnancy. Concomitant medications included ascorbic acid, calcium, folic acid, iron, nicotinamide, pyridoxine, retinol, riboflavin, thiamine, tocopherol, vitamin B12 NOS, vitamin D NOS, zinc (PRENATAL); and ferrous sulfate (IRON) both from 01Mar2021. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Gestational period at time of initial exposure was 7 Months 2nd trimester. The first night on 18Sep2021, the patient experienced fever, chills, muscle spasms in the legs, muscle cramping throughout her body. Her baby thrashed violently in her stomach most of the night. She woke with nausea and diarrhea multiple times. The second day on 19Sep2021, she had nausea and multiple bouts of tachycardia reaching a resting HR of up to 138. The second night she experienced another fever and profuse sweating. Her ob-gyn recommended fluids, rest and Tylenol. The patient has not received treatment. The outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101228216 baby case
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pyrexia, Tachycardia
Clinical narrative: multiple bouts of tachycardia reaching a resting HR of up to 138.; profuse sweating; Gestational period at time of initial exposure was 7 Months 2nd trimester; fever; chills; muscle spasms in the legs/muscle cramping throughout my body; nausea; diarrhea; This is a spontaneous report from a contactable female consumer. This consumer reported information for both mother and fetus/baby. This is a maternal report.    A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 38-years-old, via an unspecified route of administration, administered in arm Left on 17Sep2021 13:00 (Batch/Lot Number: FF2587, expiration date: 30Dec2021) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm Left on 27Aug2021 13:00 (Batch/Lot Number: FD8448) as dose 1, single for COVID-19 immunization. Medical history included one previous pregnancy, Breech c-section delivery. The patient had no known allergies, no history of smoking, drinking and use of illicit drugs during pregnancy. Concomitant medications included ascorbic acid, calcium, folic acid, iron, nicotinamide, pyridoxine, retinol, riboflavin, thiamine, tocopherol, vitamin B12 NOS, vitamin D NOS, zinc (PRENATAL); and ferrous sulfate (IRON) both from 01Mar2021. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Gestational period at time of initial exposure was 7 Months 2nd trimester. The first night on 18Sep2021, the patient experienced fever, chills, muscle spasms in the legs, muscle cramping throughout her body. Her baby thrashed violently in her stomach most of the night. She woke with nausea and diarrhea multiple times. The second day on 19Sep2021, she had nausea and multiple bouts of tachycardia reaching a resting HR of up to 138. The second night she experienced another fever and profuse sweating. Her ob-gyn recommended fluids, rest and Tylenol. The patient has not received treatment. The outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101228216 baby case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Within three (3) hrs of recirving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful.; Within three (3) hrs of recirving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful.; Within three (3) hrs of recirving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful.; Within three (3) hrs of recirving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful.; This is a spontaneous report received from a contactable consumer or other non hcp. A 48-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration in Arm Right on 25Aug2021 at 16:30 (age at vaccination 48years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks prior to the COVID vaccine reported as none. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Medical history included congenital cystic kidney disease from an unknown date and unknown if ongoing Polycystic Kidney Disease, drug hypersensitivity from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing Very mild nut allergy. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced within three (3) hrs of receiving 1st dose of Pfizer vaccine i had an extensive rash and hives from my knees down on both legs that was itching and painful on 25Aug2021 at 19:30. Clinical course was reported as Within three (3) hrs of receiving 1st dose of Pfizer vaccine I had an extensive rash and hives from my knees down on both legs that was itching and painful. This lasted two (2) weeks then started to recede for a week. Rash came back with a vengeance on the evening of 9/14/2021 from midthigh down, as well as on my neck, ears and face. Initiated a walk-in clinic visit for treatment on 9/16/2021. The patient received treatment with Prednisone & hydroxyzine for the adverse events. The clinical outcome of the events was recovering. Therapeutic measures were taken as a result of within three (3) hrs of receiving 1st dose of Pfizer vaccine i had an extensive rash and hives from my knees down on both legs that was itching and painful.  No follow-up attempts are needed. No further information is expected.