chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Neurological examination
Clinical narrative: Central venous sinus thrombosis; This is a Spontaneous case report from a contactable nurse reporting for himself/herself, received from Pfizer Sponsored Program. A 20-years-old patient of an unspecified gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, via intramuscular route on 14May2021, at 20 years of age, (Batch/Lot Number: EW0167) as single dose for COVID-19 immunization. The patient had no relevant medical history, except for diagnosis of COVID-19 on an unknown date prior to vaccination and didn't receive any concomitant medication. It is unknown if the patient has been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. On 20May2021 the patient experienced "central" venous sinus thrombosis which resulted in Emergency room/department or urgent care and required the patient's hospitalization. The patient was hospitalized for 4 days. The patient underwent neuro imaging on an unknown date and was treated with enoxaparin (LOVENOX). At the time of the report the event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Cerebral venous sinus thrombosis due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and angiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out 12 hours after receiving the vaccine.; This is a spontaneous report from a contactable consumer(patient). This 16-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0175) at single dose via an unknown route in left arm on 04Jun2021 08:30 at 16-year-old for Covid-19 immunization. Medical history included Paramyotonia-congenita. Prior to vaccination, was the patient diagnosed with COVID-19. Patient had no known allergies. Concomitant drug included fluticasone propionate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 08:00 PM, patient passed out "12 hours" (as reported) after receiving the vaccine. No treatment was received.  Outcome of the event was resolved. Since the vaccination, the had not patient been tested for COVID-19.   The report was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Drug ineffective, Fatigue
Clinical narrative: This is a spontaneous report from a contactable physician.  This physician reported that a 64-year-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown) on an unknown date at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on an unknown date. Medical history and concomitant drugs were not provided. After the 2nd dose of vaccine shortly within 1 week the patient is developed an awful taste and food was awful did not go much into smell (the reporting physician thought smell was off as well). He also reported fatigue, tiredness and dizziness and continued (hasn't gotten over it yet) reports good days and bad days. He waited a month to let the physician know. He did a home test and nasal test which were negative this was 4-5 weeks out. He stated that the vaccine did that to him. The physician told the patient to think had the covid in between, but he says it was the vaccine. Caller added the patient was pretty adamant that after the second dose the patient lost his taste. The caller suggested maybe the patient picked up the virus. Caller wanted to know if loss of taste was a possible side effect of the vaccine. Caller was not too sure this was a vaccine issue, and that he thinks it seemed like the patient contracted the Covid infection while going through the vaccination process.  Patient was tested for Covid but the caller does not have the results.  No identified positive test for Covid, but the caller believes the patient was experiencing Covid and not a side effect of the vaccine.  The outcome of the events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported  COVID-19 cannot be ruled out
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report from a contactable physician.  This physician reported that a 64-year-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown) on an unknown date at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on an unknown date. Medical history and concomitant drugs were not provided. After the 2nd dose of vaccine shortly within 1 week the patient is developed an awful taste and food was awful did not go much into smell (the reporting physician thought smell was off as well). He also reported fatigue, tiredness and dizziness and continued (hasn't gotten over it yet) reports good days and bad days. He waited a month to let the physician know. He did a home test and nasal test which were negative this was 4-5 weeks out. He stated that the vaccine did that to him. The physician told the patient to think had the covid in between, but he says it was the vaccine. Caller added the patient was pretty adamant that after the second dose the patient lost his taste. The caller suggested maybe the patient picked up the virus. Caller wanted to know if loss of taste was a possible side effect of the vaccine. Caller was not too sure this was a vaccine issue, and that he thinks it seemed like the patient contracted the Covid infection while going through the vaccination process.  Patient was tested for Covid but the caller does not have the results.  No identified positive test for Covid, but the caller believes the patient was experiencing Covid and not a side effect of the vaccine.  The outcome of the events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported  COVID-19 cannot be ruled out
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report  from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right.  The patient had lab tests and procedures which included blood pressure measurement: 190/80.  The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks".  He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day.  He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine.    Information about Lot Batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report  from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right.  The patient had lab tests and procedures which included blood pressure measurement: 190/80.  The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks".  He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day.  He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine.    Information about Lot Batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Menstrual disorder, Muscle spasms, Pain, Rash
Clinical narrative: This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 at the age of 41-years-old (Lot Number: ER8731) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took amoxicillin and experienced Known allergies: Amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported: "I broke out in a rash on 17Apr2021. It started on my face in a straight line down my left cheek and neck. Then it appeared in patches on my trunk (both stomach and back). It eventually spread to my legs. I got new patches for 2 weeks following the shot. I went to the doctor and they couldn't prescribe steroids as it was stated that it would lesson the effects of the second shot. When I started my menstrual cycle 3 weeks following the 1st dose of my Pfizer shot I had severe cramping and clotting for 3 days during my period. It was the most pain that I have had from a period. The flow was stronger from the beginning of the cycle than is typical." The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in 2021.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that th event rash is related to 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient was young and healthy. On an unspecified date, after the vaccination, the patient developed COVID-19. The patient tested positive via SARS-CoV-2 test on an unspecified date. The reporter was concerned that certain retail outlets where vaccines were kept were not adhering to proper storage mechanisms. The reporter did not know of any specific locations and did not know that product incorrect storage was being performed, but wanted Pfizer to be aware of the potential issue. The clinical outcome of "developed COVID" was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional information is available. 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Penile pain, Penile swelling, Phlebitis superficial
Clinical narrative: Mondor's disease penile; Peripheral penile vein swelling appeared, with little uncomfort and pain; Peripheral penile vein swelling appeared, with little uncomfort and pain; This is a spontaneous report from a contactable pharmacist (patient).  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 16May2021 at 15:15 (Batch/Lot Number: EW0177) as single dose 2 for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypercholesterolemia, and hypothyroidism. The patient has no known allergies. Concomitant medications included metformin; atorvastatin calcium; levothyroxine sodium (SYNTHROID); all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included BNT162B2 given on 18Apr2021 for COVID-19 immunization at the age of 60 years old (brand: Pfizer, lot number: EW0169, administration time: 3:15 PM, dose number: 1, vaccine location: left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 20 days after receiving the second dose, peripheral penile vein swelling appeared with little uncomfort and pain. Ibuprofen helped when taken. Event was ongoing. The patient believed it was Mondor's disease penile. The reporter was curious if COVID19 vaccine causes this disease. All events occurred on 01Jun2021 with outcome of not recovered. Treatment received for the events was ibuprofen. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the limited in formation provided and due to an unsuitable temporal association, the company, at the present time, deems there is not a reasonable possibility that the reported Mondor's disease, with associated signs and symptoms, are related to BNT162B2 administration. The impacts 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Herpes zoster, Hypoaesthesia, Pruritus
Clinical narrative: Couldn't feel some of her toes; Toes she couldn't feel were totally white; Raynauds; Shingles; burning; itching and blisters on back; itching and blisters on back; This is a spontaneous report from a contactable other hcp.     A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 07:30 (Batch/Lot Number: EL3248) as single  dose for covid-19 immunisation.  Medical history included ongoing allergies, ongoing anaphylactic reaction, raynaud's phenomenon from 2021. Patient informed she was MTHFRA1298 positive. it's kind of like a mutation, says when you're homozygous you usually don't have any issues with clotting or bleeding. The trouble was with heterozygous, says some family is heterozygous and have had bleeding and clotting. Her twin sister and brothers are all homozygous. Patient also informed her father has had autoimmune issues like ITP, so his platelets weren't forming, and if there was bleeding he had to be careful. She reported also her platelets have been fine and both hemoglobin and hematocrit were fine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin d deficiency, start and stop date were not reported.  The patient experienced couldn't feel some of her toes (medically significant) on an unspecified date with outcome of unknown , toes she couldn't feel were totally white (medically significant) on an unspecified date with outcome of unknown , raynaud's phenomenon (medically significant) on an unspecified date with outcome of unknown , shingles (non-serious) on Feb2021 with outcome of recovered  on 2021, burning (non-serious) on Feb2021 with outcome of recovered on 2021 , itching and blisters on back (non-serious) on Feb2021 with outcome of recovered on 2021, itching and blisters on back (non-serious) on Feb2021 with outcome of recovered on 2021.; Sender's Comments: Based on the current available information, the events Numbness in toes and Skin discolouration, and Raynauds are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.  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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon, Skin discolouration
Clinical narrative: Couldn't feel some of her toes; Toes she couldn't feel were totally white; Raynauds; Shingles; burning; itching and blisters on back; itching and blisters on back; This is a spontaneous report from a contactable other hcp.     A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 07:30 (Batch/Lot Number: EL3248) as single  dose for covid-19 immunisation.  Medical history included ongoing allergies, ongoing anaphylactic reaction, raynaud's phenomenon from 2021. Patient informed she was MTHFRA1298 positive. it's kind of like a mutation, says when you're homozygous you usually don't have any issues with clotting or bleeding. The trouble was with heterozygous, says some family is heterozygous and have had bleeding and clotting. Her twin sister and brothers are all homozygous. Patient also informed her father has had autoimmune issues like ITP, so his platelets weren't forming, and if there was bleeding he had to be careful. She reported also her platelets have been fine and both hemoglobin and hematocrit were fine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin d deficiency, start and stop date were not reported.  The patient experienced couldn't feel some of her toes (medically significant) on an unspecified date with outcome of unknown , toes she couldn't feel were totally white (medically significant) on an unspecified date with outcome of unknown , raynaud's phenomenon (medically significant) on an unspecified date with outcome of unknown , shingles (non-serious) on Feb2021 with outcome of recovered  on 2021, burning (non-serious) on Feb2021 with outcome of recovered on 2021 , itching and blisters on back (non-serious) on Feb2021 with outcome of recovered on 2021, itching and blisters on back (non-serious) on Feb2021 with outcome of recovered on 2021.; Sender's Comments: Based on the current available information, the events Numbness in toes and Skin discolouration, and Raynauds are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: My mom has the stroke after the vaccine (Unspecified Vaccine); My mom has a stroke for about 3-4 weeks ago and suffering pretty much on the death bed because of the virus vaccination shot; This is a spontaneous report from a contactable consumer reported for mother. A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. The patient had a stroke after the vaccine for about 3-4 weeks ago (May2021) and suffering pretty much on the death bed because of the virus vaccination shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a non-contactable consumer (reported for her mother).  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The consumer reported her mother got the first Pfizer vaccine dose in late January but had a stroke unrelated to the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported event stroke was most likely an intercurrent disease, and unrelated to dose 1 of the vaccine of bnt162b2.
Sex: F
Vaccine: COVID19
Symptoms: Mycobacterium tuberculosis complex test, Tuberculosis
Clinical narrative: HCP stated that her TB positive test may be related to her recent COVID-19; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. (Reference ID: NUS2021US085589_NC). A 59-year-old female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that HCP stated that her TB (tuberculosis) positive test may be related to her recent COVID-19 on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Drug ineffective, Erythema, Feeling hot
Clinical narrative: SARS-COV-2; drug ineffective; Hurt to pick it up; Redness and heat; Swelling in the arm with a little knot; lost appetite; sick; itching off the arm/Itchy and wanted to scratch it/Really Itchy; arm pain/Arm got really sore; arms getting stiff and could barely move it/it got stiff; arm swelled up like a baseball and was really itchy and hot to the touch; arm swelled up like a baseball and was really itchy and hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 18May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included immune system disorder. Patient was a kidney transplant recipient, being an immunocompromised patient would be a contraindication in getting the second dose of the vaccine. There were no concomitant medications. On 28May2021, the patient experienced itching off the arm and wanted to scratch it, arm pain got really sore, arms getting stiff and could barely move, pain, arm swelled up like a baseball and was really itchy and hot to the touch, redness and swelling in the arm with a little knot or mass, sickness and loss of appetite.The patient underwent SARS-COV-2 test which was positive on an unspecified date in the past. As the patient was immunocompromised wanted to know whether she could take the second dose.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Mass, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: SARS-COV-2; drug ineffective; Hurt to pick it up; Redness and heat; Swelling in the arm with a little knot; lost appetite; sick; itching off the arm/Itchy and wanted to scratch it/Really Itchy; arm pain/Arm got really sore; arms getting stiff and could barely move it/it got stiff; arm swelled up like a baseball and was really itchy and hot to the touch; arm swelled up like a baseball and was really itchy and hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 18May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included immune system disorder. Patient was a kidney transplant recipient, being an immunocompromised patient would be a contraindication in getting the second dose of the vaccine. There were no concomitant medications. On 28May2021, the patient experienced itching off the arm and wanted to scratch it, arm pain got really sore, arms getting stiff and could barely move, pain, arm swelled up like a baseball and was really itchy and hot to the touch, redness and swelling in the arm with a little knot or mass, sickness and loss of appetite.The patient underwent SARS-COV-2 test which was positive on an unspecified date in the past. As the patient was immunocompromised wanted to know whether she could take the second dose.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, SARS-CoV-2 test
Clinical narrative: SARS-COV-2; drug ineffective; Hurt to pick it up; Redness and heat; Swelling in the arm with a little knot; lost appetite; sick; itching off the arm/Itchy and wanted to scratch it/Really Itchy; arm pain/Arm got really sore; arms getting stiff and could barely move it/it got stiff; arm swelled up like a baseball and was really itchy and hot to the touch; arm swelled up like a baseball and was really itchy and hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 18May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included immune system disorder. Patient was a kidney transplant recipient, being an immunocompromised patient would be a contraindication in getting the second dose of the vaccine. There were no concomitant medications. On 28May2021, the patient experienced itching off the arm and wanted to scratch it, arm pain got really sore, arms getting stiff and could barely move, pain, arm swelled up like a baseball and was really itchy and hot to the touch, redness and swelling in the arm with a little knot or mass, sickness and loss of appetite.The patient underwent SARS-COV-2 test which was positive on an unspecified date in the past. As the patient was immunocompromised wanted to know whether she could take the second dose.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pallor, Thrombosis, Tracheal disorder
Clinical narrative: looking for blood clots on her lungs/Suspected blood clot; she is having trouble breathing; caller's wife turned pale, trachea was closing; caller's wife turned pale, trachea was closing; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband) through medical Information. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date, for COVID-19 immunization. The caller's wife (patient) turned pale, and trachea was closing on 10Jun2021 while she is having trouble breathing and looking for blood clots on her lungs/Suspected blood clot on an unspecified date. Caller asked million-dollar question that who was going to pay for all of these bills? his wife has had two ambulance bills, one admission to ER, his wife right now was at the hospital. 45 minutes after receiving the second dose, caller's wife turned pale, trachea was closing. Caller contacted EMS, EMS gave Epi Pen and more medications. After 6-7 hours, his wife needed to be rushed again to hospital, but the fire station was closer. Caller knocked on their door for help and they transported wife to hospital. This happened yesterday 10Jun2021. Callers Wife had two Benadryl within the last two hours today (11Jun2021). She was admitted again today to the hospital. She does not have any medical conditions. She was 36 years. They were looking for blood clots on her lungs because she was having trouble breathing. Caller asked for us to contact her back in one hour (1757 11Jun) to continue the report. She was at the hospital. The seriousness for events was hospitalization. Therapeutic measures were taken as a result events which includes EPI PEN and BENADRYL. The clinical outcome for all events was unknown.  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dry mouth, SARS-CoV-2 test, Vaccination failure
Clinical narrative: began to present strong flu symptoms, so I decided to take the test where I came out positive for COVID-19, I lost my sense of smell, I have a lot of nasal congestion, dry mouth, general malaise.; Covid-19; began to present strong flu symptoms, so I decided to take the test where I came out positive for COVID-19, I lost my sense of smell, I have a lot of nasal congestion, dry mouth, general malaise.; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 22Apr2021 as 2nd dose, single, dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 10Jun2021, patient began to present strong flu symptoms, so he decided to take the test where patient came out positive for COVID-19, he lost his sense of smell, had a lot of nasal congestion, dry mouth, general malaise. The outcome of the event was unknown.  Follow-up attempts are needed. Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Muscular weakness
Clinical narrative: Numbness and weakness Left Leg; Numbness and weakness Left Leg; diagnosis Guillain Barre; This is a spontaneous report from a contactable consumer (patient). A non-pregnancy 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 24Mar2021 at 13:15 (at age of 55 years old, no pregnancy, Lot Number: EP6955) as a single dose for covid-19 immunization. No medical history and concomitant medications. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21May2021, the patient experienced numbness and weakness left leg. On 29May2021 Emergency room misdiagnosed Sciatica couldn't bear weight used wheelchair. Went to primary 02Jun2021, followed by Neurologist diagnosis Guillain Barre. Confirmed by spinal tap at hospital after ER visit and 5 day stay at hospital with immunoglobulin treatments. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Since the vaccination, the patient was not had been tested for COVID-19. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient died recently after getting the vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died recently after getting the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: patient died recently after getting the vaccine
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Condition aggravated, Urticaria chronic
Clinical narrative: I developed chronic urticaria/the hives got significantly worse.; I developed chronic urticaria/the hives got significantly worse.; I have also developed angioedema; This is a spontaneous report from a contactable consumer. This 31-year old female (no pregnant) consumer (patient) received 2nd dose of BNT162B2 (at the age of 31 years old) on an unspecific date at single dose for COVID-19 immunization. Medical history was Hypothyroid. No known allergies. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. Historical vaccine was 1st dose of BNT162B2 (Lot number=En6204), on 10Mar2021 04:00 AM in Left arm for covid-19 immunization. She developed chronic urticaria after first shot. It started appearing after 1 week (17Mar2021 02:00 PM) and after 10 days was there every single day (AER# 2021702659). By the time of the second shot I was on prednisone to control the hives, but stopped the day before to get the second shot. After the second shot, the hives got significantly worse. It has been 3 months and nothing is helping to stop the hives. She had also developed angioedema and now need to carry an epinephrine (EPIPEN). She had never had hives in her life and have never had any allergies. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). She had been on many medications to try and reduce. Outcome of the event was Not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: who received their first Pfizer Covid vaccine dose and then tested positive for Covid after; who received their first Pfizer Covid vaccine dose and then tested positive for Covid after; This is a spontaneous report from a Pfizer sponsored program. A contactable reporter (Physician) reporting on behalf of 57-year-old female consumer (patient) reported that. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter states she has a patient (57 y/o female) who received their first Pfizer Covid vaccine dose and then tested positive for Covid after. The patient received monoclonal antibodies for treatment of the Covid infection. Reporter wants to know more information on administering the second vaccine dose. She mentioned that she wanted the patient to wait 90 days after the antibody treatment, but she is looking for any guidance that Pfizer has regarding this scenario. Dose of covid-19 vaccine or restart due to contracting the Covid-19 virus after her first dose of Pfizer covid-19 vaccine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid 19. 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Pain in extremity, Rash, Vaccination site pain
Clinical narrative: shingles; rash spread down my arm; and was very painful on the surface and extended to deep tissue/ joints; and was very painful on the surface and extended to deep tissue/ joints; arm was sore at the injection site; This is a spontaneous report from a contactable consumer. This contactable Consumer reported events for both doses of Comirnaty for this patient. This is regarding the 2nd dose. A 53-year-old male patient received (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7533) dose 2, administered intramuscular in left deltoid on 08Apr2021 as 2nd dose, single dose for covid-19 immunization. Medical history was not available. Concomitant medications included valacyclovir and gabapentin. Historical vaccine received first dose BNT162B2 (COMIRNATY, Pfizer vaccine, Lot number: EN6204) on 18Mar2021 via intramuscular in right arm/deltoid for Covid-19 immunization and had vaccination site pain. It was reported that, arm was sore at the injection site from the date of the vaccination until the onset of the AE. A rush started forming at the injection site on an unspecified date in 2021. The rash spread down of his Right arm on 12May2021 and was very painful on the surface and extended to deep tissue /joints on an unspecified date in 2021. His physician diagnose shingles on 12May2021 and prescribe antiviral and pain medications. This could be unrelated to the vaccine but he thought they might find it interesting. The outcome of event arm was sore at the injection site was unknown, while with other events was recovering.  No follow ups attempt needed. No further information was available.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Herpes zoster
Clinical narrative: Mild relapse of shingles; Mild to mid level confusion that is from the cognitive damage; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 10Apr2021 08:00 (at the age of 56-years-old) (Batch/Lot Number: ER) as single dose for covid-19 immunisation. Medical history included, multiple sclerosis, herpes zoster (she received the shingles vaccine in 2019 after contracting it at a nursing home she worked at), hypersensitivity and cognitive disorder from an unknown date and unknown if ongoing cognitive damage. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 administered in Arm Right on 20Mar2021 08:00 AM at the age of 55-years-old) (Batch/Lot Number: ER) for covid-19 immunisation. It was reported that 3 weeks after receiving her second dose of the vaccine she began experiencing a mild relapse of shingles. She received the shingles vaccine in 2019 after contracting it at a nursing home. Her primary was aware. She did not take anything for the shingles flare up as she also began to experience mild to mid level confusion that was from the cognitive damage she has from multiple sclerosis. By the third week in May she started feeling fine. The seriousness of the events was reported as non-serious. The patient did not receive treatment for the events. Outcome of the events were reported as recovered on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Fatigue, Headache, Menstrual disorder, Nausea
Clinical narrative: She also had the bleeding under control; She also reported having a period for a week when she has been in menopause for 10 years; She has been having on and off fatigue; Nausea; Headache; Bloating; This is a spontaneous report from a contactable consumer (reported for herself). A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25May2021 (at the age of 59-years-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 04May2021 (at the age of 59-years-old) as 1st dose, single dose for covid-19 immunisation. On an unspecified date, the patient reported that when it started to go downhill. She had been having on and off fatigue, nausea, headache and bloating. She experiences these for 3-4 days out of every week. She has self-medicated with Aspirin and Tylenol. She also reported having a period for a week when she had been in menopause for 10 years. She also had the bleeding under control as she also self-medicated as she cannot get a hold of her gynecologist and it has been frustrating. it has been 6 weeks. The patient is asking whether if this is normal and how long will she experience these. She also added that she doesn't have a primary health care physician and only a gynecologist. Therapeutic measures were taken as a result of events with Aspirin and Tylenol. The event the She also had the bleeding under control was assessed as serious (medically significant). The outcome of the events was not resolved.  Information on the lot/batch number has been requested.