chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Unevaluable event
Clinical narrative: After receiving the vaccine approximately 30 minutes I developed a rash on my neck and scalp. The rash is worsening overtime has not resolved even with topical medication.; After receiving the vaccine approximately 30 minutes I developed a rash on my neck and scalp. The rash is worsening overtime has not resolved even with topical medication.; developed a very bad case of gout; This is a spontaneous report from a contactable Physician. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 19Mar2021 at 13:30 (59 years age at the time of vaccination) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included thyroid (ARMOUR THYROID), fish oil, and multi vitamin. Historical vaccine included first dose of BNT162B2 for Covid-19 Immunization. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported on 19Mar2021 at 14:30, the patient developed a rash on her neck and scalp. The rash was worsening overtime has not resolved even with topical medication. Within a few weeks' patient developed a very bad case of gout without family or personal medical history of gout. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken because of the events experienced. The outcome of events was not recovered.  Information about lot/batch number has been requested. ; Sender's Comments: Based on temporal association, there is a strong relationship between the suspected drug BNT162b2 and the reported event rash but the other reported event Gout cannot be fully assessed or excluded. 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: 59.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Gout, Rash
Clinical narrative: After receiving the vaccine approximately 30 minutes I developed a rash on my neck and scalp. The rash is worsening overtime has not resolved even with topical medication.; After receiving the vaccine approximately 30 minutes I developed a rash on my neck and scalp. The rash is worsening overtime has not resolved even with topical medication.; developed a very bad case of gout; This is a spontaneous report from a contactable Physician. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 19Mar2021 at 13:30 (59 years age at the time of vaccination) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included thyroid (ARMOUR THYROID), fish oil, and multi vitamin. Historical vaccine included first dose of BNT162B2 for Covid-19 Immunization. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. It was reported on 19Mar2021 at 14:30, the patient developed a rash on her neck and scalp. The rash was worsening overtime has not resolved even with topical medication. Within a few weeks' patient developed a very bad case of gout without family or personal medical history of gout. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken because of the events experienced. The outcome of events was not recovered.  Information about lot/batch number has been requested. ; Sender's Comments: Based on temporal association, there is a strong relationship between the suspected drug BNT162b2 and the reported event rash but the other reported event Gout cannot be fully assessed or excluded. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: extremely high blood pressure; rash on upper body; rapid heartbeat; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 13:30 (at the age of 53 year old) as 1st dose, single for covid-19 immunisation. Medical history within two weeks of vaccination included high blood pressure, cholesterol and prediabetic. Patient had no known allergies. The Patient did not receive any other vaccine in four weeks. Occupation of the patient was not provided. Patient was not covid positive prior to vaccination. Concomitant medications included losartan and rosuvastatin. On 06Mar2021 at 13:30, the patient experienced rash on upper body, rapid heartbeat, shortness of breath, extremely high blood pressure. The adverse event led to doctor or other healthcare professional office/clinic visit. The patient developed the events immediately after the 1st dose of the injection. The patient did not test for covid post vaccination. The patient underwent lab tests and procedures on 06Mar2021 which included blood pressure measurement: extremely high and heart rate: rapid. The patient received treatment with benadryl and was monitored by medical staff. Outcome of the events were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Heart rate increased, Hypertension
Clinical narrative: extremely high blood pressure; rash on upper body; rapid heartbeat; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 13:30 (at the age of 53 year old) as 1st dose, single for covid-19 immunisation. Medical history within two weeks of vaccination included high blood pressure, cholesterol and prediabetic. Patient had no known allergies. The Patient did not receive any other vaccine in four weeks. Occupation of the patient was not provided. Patient was not covid positive prior to vaccination. Concomitant medications included losartan and rosuvastatin. On 06Mar2021 at 13:30, the patient experienced rash on upper body, rapid heartbeat, shortness of breath, extremely high blood pressure. The adverse event led to doctor or other healthcare professional office/clinic visit. The patient developed the events immediately after the 1st dose of the injection. The patient did not test for covid post vaccination. The patient underwent lab tests and procedures on 06Mar2021 which included blood pressure measurement: extremely high and heart rate: rapid. The patient received treatment with benadryl and was monitored by medical staff. Outcome of the events were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: extremely high blood pressure; rash on upper body; rapid heartbeat; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 13:30 (at the age of 53 year old) as 1st dose, single for covid-19 immunisation. Medical history within two weeks of vaccination included high blood pressure, cholesterol and prediabetic. Patient had no known allergies. The Patient did not receive any other vaccine in four weeks. Occupation of the patient was not provided. Patient was not covid positive prior to vaccination. Concomitant medications included losartan and rosuvastatin. On 06Mar2021 at 13:30, the patient experienced rash on upper body, rapid heartbeat, shortness of breath, extremely high blood pressure. The adverse event led to doctor or other healthcare professional office/clinic visit. The patient developed the events immediately after the 1st dose of the injection. The patient did not test for covid post vaccination. The patient underwent lab tests and procedures on 06Mar2021 which included blood pressure measurement: extremely high and heart rate: rapid. The patient received treatment with benadryl and was monitored by medical staff. Outcome of the events were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: Patient was hospitalized multiple times within 60 days of receiving a COVID vaccine and later passed away
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient was hospitalized multiple times within 60 days of receiving a COVID vaccine and later passed away
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Aphonia, Chills, Cough, Nausea
Clinical narrative: horrible cough which resulted in hoarseness and loss of voice; horrible cough which resulted in hoarseness and Loss of voice; aches; abdominal pain; horrible cough; Chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: er8734) via an unspecified route of administration on 01Apr2021 at 02:30 PM (at the age of 70-years-old) in left arm as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Allergies to medications, food or other products was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en6206) via an unspecified route of administration on 11Mar2021 at 03:00 PM in left arm for COVID-19 immunization. On 02Apr2021, the patient experienced chills, nausea, aches, abdominal pain, horrible cough which resulted in hoarseness and loss of voice. The patient did not receive any treatment for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The outcome of the events was not resolved.   Follow-up actions are needed. Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: horrible cough which resulted in hoarseness and loss of voice; horrible cough which resulted in hoarseness and Loss of voice; aches; abdominal pain; horrible cough; Chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: er8734) via an unspecified route of administration on 01Apr2021 at 02:30 PM (at the age of 70-years-old) in left arm as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Allergies to medications, food or other products was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en6206) via an unspecified route of administration on 11Mar2021 at 03:00 PM in left arm for COVID-19 immunization. On 02Apr2021, the patient experienced chills, nausea, aches, abdominal pain, horrible cough which resulted in hoarseness and loss of voice. The patient did not receive any treatment for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The outcome of the events was not resolved.   Follow-up actions are needed. Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Aphonia, Chills, Cough, Dysphonia
Clinical narrative: horrible cough which resulted in hoarseness and loss of voice; horrible cough which resulted in hoarseness and Loss of voice; aches; abdominal pain; horrible cough; Chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: er8734) via an unspecified route of administration on 01Apr2021 at 02:30 PM (at the age of 70-years-old) in left arm as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Allergies to medications, food or other products was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en6206) via an unspecified route of administration on 11Mar2021 at 03:00 PM in left arm for COVID-19 immunization. On 02Apr2021, the patient experienced chills, nausea, aches, abdominal pain, horrible cough which resulted in hoarseness and loss of voice. The patient did not receive any treatment for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The outcome of the events was not resolved.   Follow-up actions are needed. Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain
Clinical narrative: horrible cough which resulted in hoarseness and loss of voice; horrible cough which resulted in hoarseness and Loss of voice; aches; abdominal pain; horrible cough; Chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: er8734) via an unspecified route of administration on 01Apr2021 at 02:30 PM (at the age of 70-years-old) in left arm as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Allergies to medications, food or other products was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: en6206) via an unspecified route of administration on 11Mar2021 at 03:00 PM in left arm for COVID-19 immunization. On 02Apr2021, the patient experienced chills, nausea, aches, abdominal pain, horrible cough which resulted in hoarseness and loss of voice. The patient did not receive any treatment for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The outcome of the events was not resolved.   Follow-up actions are needed. Further information has been requested.
Age: 54.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Electrocardiogram normal, Hyperhidrosis, Hypertension
Clinical narrative: I got very warm; Started sweating profusely; I felt like my heart rate was increasing; I was numb dizzy; I was numb dizzy; Stumbled a bit; I was having trouble breathing; I was also breaking out in hives on my R arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received first dose of (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 21Mar2021 at 13:45 (at the age of 54-years-old) (Batch/Lot Number: ER8727) as single for covid-19 immunization. Vaccination Facility Type was hospital. Medical history included diabetes, HBP (high blood pressure), degenerative Disc Disease, post-Herpatic Neralgia, chronic pain all from an unknown date and unknown if ongoing. Allergic to drugs included morphine, cobalt, adhesives, codeine, oxycodone hydrochloride, paracetamol (Percocet), linaclotide (Linzess), zoledronic acid (Reclast) and tramadol also, allergic to IV Contrast Dye. Concomitant medications included denosumab (PROLIA), amitriptyline, aspirin (ACETYLSALICYLIC ACID), atorvastatin all taken for an unspecified indication and for all start and stop date were not reported. Historical vaccines included first dose of hepatitis B vaccine on left arm and tetanus vaccine on right arm for immunization on 05Mar2021. Patient was not diagnosed with COVID post or prior vaccination. Patient stated on the same day of vaccine first dose (21Mar2021), about 7 mins after injection, I got very warm and started sweating profusely. A nurse noticed I was fanning myself and asked if I was ok. I felt like my heart rate was increasing, and told her I was not ok. She had me stand and walk to a chair at the back of the room. I was numb dizzy, and stumbled a bit. She checked my vitals, which were elevated. I was given Benedryl and also a dose from an eppi pen, as I was having trouble breathing. I was taken to the ER for monitoring, and given steroids and Pepcid via IV. I was also breaking out in hives on my R arm. The treatment also included Prednisone via IV. The events resulted in Emergency room/department or urgent care visit. The outcome of all the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat tightness, Urticaria
Clinical narrative: I got very warm; Started sweating profusely; I felt like my heart rate was increasing; I was numb dizzy; I was numb dizzy; Stumbled a bit; I was having trouble breathing; I was also breaking out in hives on my R arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received first dose of (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 21Mar2021 at 13:45 (at the age of 54-years-old) (Batch/Lot Number: ER8727) as single for covid-19 immunization. Vaccination Facility Type was hospital. Medical history included diabetes, HBP (high blood pressure), degenerative Disc Disease, post-Herpatic Neralgia, chronic pain all from an unknown date and unknown if ongoing. Allergic to drugs included morphine, cobalt, adhesives, codeine, oxycodone hydrochloride, paracetamol (Percocet), linaclotide (Linzess), zoledronic acid (Reclast) and tramadol also, allergic to IV Contrast Dye. Concomitant medications included denosumab (PROLIA), amitriptyline, aspirin (ACETYLSALICYLIC ACID), atorvastatin all taken for an unspecified indication and for all start and stop date were not reported. Historical vaccines included first dose of hepatitis B vaccine on left arm and tetanus vaccine on right arm for immunization on 05Mar2021. Patient was not diagnosed with COVID post or prior vaccination. Patient stated on the same day of vaccine first dose (21Mar2021), about 7 mins after injection, I got very warm and started sweating profusely. A nurse noticed I was fanning myself and asked if I was ok. I felt like my heart rate was increasing, and told her I was not ok. She had me stand and walk to a chair at the back of the room. I was numb dizzy, and stumbled a bit. She checked my vitals, which were elevated. I was given Benedryl and also a dose from an eppi pen, as I was having trouble breathing. I was taken to the ER for monitoring, and given steroids and Pepcid via IV. I was also breaking out in hives on my R arm. The treatment also included Prednisone via IV. The events resulted in Emergency room/department or urgent care visit. The outcome of all the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Feeling hot, Gait disturbance, Heart rate increased
Clinical narrative: I got very warm; Started sweating profusely; I felt like my heart rate was increasing; I was numb dizzy; I was numb dizzy; Stumbled a bit; I was having trouble breathing; I was also breaking out in hives on my R arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received first dose of (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 21Mar2021 at 13:45 (at the age of 54-years-old) (Batch/Lot Number: ER8727) as single for covid-19 immunization. Vaccination Facility Type was hospital. Medical history included diabetes, HBP (high blood pressure), degenerative Disc Disease, post-Herpatic Neralgia, chronic pain all from an unknown date and unknown if ongoing. Allergic to drugs included morphine, cobalt, adhesives, codeine, oxycodone hydrochloride, paracetamol (Percocet), linaclotide (Linzess), zoledronic acid (Reclast) and tramadol also, allergic to IV Contrast Dye. Concomitant medications included denosumab (PROLIA), amitriptyline, aspirin (ACETYLSALICYLIC ACID), atorvastatin all taken for an unspecified indication and for all start and stop date were not reported. Historical vaccines included first dose of hepatitis B vaccine on left arm and tetanus vaccine on right arm for immunization on 05Mar2021. Patient was not diagnosed with COVID post or prior vaccination. Patient stated on the same day of vaccine first dose (21Mar2021), about 7 mins after injection, I got very warm and started sweating profusely. A nurse noticed I was fanning myself and asked if I was ok. I felt like my heart rate was increasing, and told her I was not ok. She had me stand and walk to a chair at the back of the room. I was numb dizzy, and stumbled a bit. She checked my vitals, which were elevated. I was given Benedryl and also a dose from an eppi pen, as I was having trouble breathing. I was taken to the ER for monitoring, and given steroids and Pepcid via IV. I was also breaking out in hives on my R arm. The treatment also included Prednisone via IV. The events resulted in Emergency room/department or urgent care visit. The outcome of all the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Urticaria, Vital signs measurement
Clinical narrative: I got very warm; Started sweating profusely; I felt like my heart rate was increasing; I was numb dizzy; I was numb dizzy; Stumbled a bit; I was having trouble breathing; I was also breaking out in hives on my R arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received first dose of (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 21Mar2021 at 13:45 (at the age of 54-years-old) (Batch/Lot Number: ER8727) as single for covid-19 immunization. Vaccination Facility Type was hospital. Medical history included diabetes, HBP (high blood pressure), degenerative Disc Disease, post-Herpatic Neralgia, chronic pain all from an unknown date and unknown if ongoing. Allergic to drugs included morphine, cobalt, adhesives, codeine, oxycodone hydrochloride, paracetamol (Percocet), linaclotide (Linzess), zoledronic acid (Reclast) and tramadol also, allergic to IV Contrast Dye. Concomitant medications included denosumab (PROLIA), amitriptyline, aspirin (ACETYLSALICYLIC ACID), atorvastatin all taken for an unspecified indication and for all start and stop date were not reported. Historical vaccines included first dose of hepatitis B vaccine on left arm and tetanus vaccine on right arm for immunization on 05Mar2021. Patient was not diagnosed with COVID post or prior vaccination. Patient stated on the same day of vaccine first dose (21Mar2021), about 7 mins after injection, I got very warm and started sweating profusely. A nurse noticed I was fanning myself and asked if I was ok. I felt like my heart rate was increasing, and told her I was not ok. She had me stand and walk to a chair at the back of the room. I was numb dizzy, and stumbled a bit. She checked my vitals, which were elevated. I was given Benedryl and also a dose from an eppi pen, as I was having trouble breathing. I was taken to the ER for monitoring, and given steroids and Pepcid via IV. I was also breaking out in hives on my R arm. The treatment also included Prednisone via IV. The events resulted in Emergency room/department or urgent care visit. The outcome of all the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: His peripheral neuropathy has always been spongy on the back of the heel but it has moved further down a week after the vaccine; Big balance problem on the right side/throwing my balance off quite a bit; More numbness in his knees to the bottom of his foot; This is a spontaneous report from a contactable consumer (the patient). A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Mar2021 as a single dose for COVID-19 immunization. Medical history included neuropathy peripheral from an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced his peripheral neuropathy has always been spongy on the back of the heel but it has moved further down a week after the vaccine, big balance problem on the right side/throwing my balance off quite a bit, more numbness in his knees to the bottom of his foot. The patient reported that "he had peripheral neuropathy and it has been in check, it holds and it gets worse because it was a progressive disease. He also had a big balance problem on the right side. He enquired that has there been any peripheral neuropathy input after the vaccine. His peripheral neuropathy has always been spongy on the back of the heel, but it has moved further down a week after the vaccine. He has a second dose coming up on 30Mar2021 but he also cut his yard and he has a big yard and doesn't know if that's what it is? The patient saying this was not from the vaccine so he declined a safety report. The patient was unsure of the vaccine made a difference, has it made it worse? Things can change in the caller's body, he's on top of it. It could have been from the yard work because he usually hires people to do that. He further stated that a week and a half later noticed more numbness in his knees to the bottom of his foot to where it was "throwing my balance off quite a bit." The patient stated that this happens sometimes after he exercises and reports that before this instance, he was cutting the lawn. The patient stated that "He does not feel that it may be a side effect of the vaccine because it didn't happen immediately after". The outcome of events was unknown.  No follow-up attempts are possible. No information about lot/batch number has been requested. No further information is expected.; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported events of Neuropathy peripheral, Balance disorder and Hypoaesthesia more likely represent intercurrent illness and not related to BNT162B2.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: His peripheral neuropathy has always been spongy on the back of the heel but it has moved further down a week after the vaccine; Big balance problem on the right side/throwing my balance off quite a bit; More numbness in his knees to the bottom of his foot; This is a spontaneous report from a contactable consumer (the patient). A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Mar2021 as a single dose for COVID-19 immunization. Medical history included neuropathy peripheral from an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced his peripheral neuropathy has always been spongy on the back of the heel but it has moved further down a week after the vaccine, big balance problem on the right side/throwing my balance off quite a bit, more numbness in his knees to the bottom of his foot. The patient reported that "he had peripheral neuropathy and it has been in check, it holds and it gets worse because it was a progressive disease. He also had a big balance problem on the right side. He enquired that has there been any peripheral neuropathy input after the vaccine. His peripheral neuropathy has always been spongy on the back of the heel, but it has moved further down a week after the vaccine. He has a second dose coming up on 30Mar2021 but he also cut his yard and he has a big yard and doesn't know if that's what it is? The patient saying this was not from the vaccine so he declined a safety report. The patient was unsure of the vaccine made a difference, has it made it worse? Things can change in the caller's body, he's on top of it. It could have been from the yard work because he usually hires people to do that. He further stated that a week and a half later noticed more numbness in his knees to the bottom of his foot to where it was "throwing my balance off quite a bit." The patient stated that this happens sometimes after he exercises and reports that before this instance, he was cutting the lawn. The patient stated that "He does not feel that it may be a side effect of the vaccine because it didn't happen immediately after". The outcome of events was unknown.  No follow-up attempts are possible. No information about lot/batch number has been requested. No further information is expected.; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported events of Neuropathy peripheral, Balance disorder and Hypoaesthesia more likely represent intercurrent illness and not related to BNT162B2.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Rash
Clinical narrative: LOW PLATELET COUNT; BRUISING; RASH; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and sulfa allergy, and other pre-existing medical conditions included patient was born with whole in the heart. The patient experienced drug allergy when treated with loratadine, and atorvastatin calcium for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, one total administered in Left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, three weeks later the vaccination, patient started getting bruising and rash. On June-2021, patient went to doctor who put patient on steroids. Patient had blood work done which showed platelets were down to 7. The patient was given steroids in hospital and the platelets was 39 after patient got off the hospital. Patient was off of them too fast and platelets started to drop down, as of Wednesday  23-JUN-2021 platelet count was 304, week before that was 321 and lowered the dose of steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelet count was not reported. This report was serious (Other Medically Important Condition).  ,; Sender's Comments: V0: 20210660892-covid-19 vaccine ad26.cov2.s-low platelet count. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Contusion, Platelet count, Platelet count decreased, Rash
Clinical narrative: LOW PLATELET COUNT; BRUISING; RASH; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and sulfa allergy, and other pre-existing medical conditions included patient was born with whole in the heart. The patient experienced drug allergy when treated with loratadine, and atorvastatin calcium for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, one total administered in Left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, three weeks later the vaccination, patient started getting bruising and rash. On June-2021, patient went to doctor who put patient on steroids. Patient had blood work done which showed platelets were down to 7. The patient was given steroids in hospital and the platelets was 39 after patient got off the hospital. Patient was off of them too fast and platelets started to drop down, as of Wednesday  23-JUN-2021 platelet count was 304, week before that was 321 and lowered the dose of steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelet count was not reported. This report was serious (Other Medically Important Condition).  ,; Sender's Comments: V0: 20210660892-covid-19 vaccine ad26.cov2.s-low platelet count. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Contusion, Platelet count decreased, Rash, Thrombocytopenia
Clinical narrative: LOW PLATELET COUNT; BRUISING; RASH; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and sulfa allergy, and other pre-existing medical conditions included patient was born with whole in the heart. The patient experienced drug allergy when treated with loratadine, and atorvastatin calcium for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, one total administered in Left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, three weeks later the vaccination, patient started getting bruising and rash. On June-2021, patient went to doctor who put patient on steroids. Patient had blood work done which showed platelets were down to 7. The patient was given steroids in hospital and the platelets was 39 after patient got off the hospital. Patient was off of them too fast and platelets started to drop down, as of Wednesday  23-JUN-2021 platelet count was 304, week before that was 321 and lowered the dose of steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelet count was not reported. This report was serious (Other Medically Important Condition).  ,; Sender's Comments: V0: 20210660892-covid-19 vaccine ad26.cov2.s-low platelet count. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: injection site reaction (redness, swelling and pain) that progressed to secondary bacterial infection at injection site that was treated with oral cephalexin and resolved within 10 days
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: injection site reaction (redness, swelling and pain) that progressed to secondary bacterial infection at injection site that was treated with oral cephalexin and resolved within 10 days
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, COVID-19, Frustration tolerance decreased, Malaise
Clinical narrative: Caller had first vaccine on 01Mar2021 and got Covid on 08Mar2021; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A female patient of an unspecified age 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 01Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated with first short of vaccine on 01Mar2020 and got covid on 08Mar2021. The patient to known if she could continue to have the second dose of pfizer vaccine on 31Mar2021. Medical information were any unaddressed medical questions referred or forwarded to medical Information was yes. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Caller had first vaccine on 01Mar2021 and got Covid on 08Mar2021; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A female patient of an unspecified age 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 01Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated with first short of vaccine on 01Mar2020 and got covid on 08Mar2021. The patient to known if she could continue to have the second dose of pfizer vaccine on 31Mar2021. Medical information were any unaddressed medical questions referred or forwarded to medical Information was yes. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Hepatic pain, Lethargy
Clinical narrative: felt out of breath; whole breathing experience was easier and stronger/usually have more mucus excretion in the morning, it has gone away/used to feel more stressed and being worked and I don't feel that anymore; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 19Mar2021 (Batch/Lot Number: EN8727) (at the age of 69-years-old) as dose 2, single for COVID-19 immunization. Medical history included patient had hepatitis A in the year 1975, mucus excretion in the morning, stressed and worked, and exercise (normally exercised, would do leg exercises, martial arts exercises, and upper boy exercises; done some weight for years). Concomitant medications included L-arginine; azithromycin (ZMAX); lepidium meyenii root (MACA 2H); all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly in left arm on 23Feb2021 (lot number: EN6201) (at the age of 69-years-old) for COVID-19 immunization and experienced fatigue, little achy, dizzy, lethargic, liver ache, ang drug interaction; and previously took ginseng and experienced liver ache and drug interaction (ginseng interacting with first dose of the vaccine). The patient reported that after the second vaccination, he felt that his whole breathing experience was easier and stronger. He usually had more mucus excretion in the morning, and it has gone away. He didn't have that any longer. His lungs felt stronger, like they accommodate (as reported). He used to feel more stressed and being worked and he didn't feel that anymore. He normally exercised, would do leg exercises, martial arts exercises, and upper boy exercises. He has done some weight for years. He hasn't really walked a lot, but he never had any stresses, he was very athletic. He never had any stress with walking. However, for the past few days with a few slight stairs, the patient felt out of breath. He went up a slight hill, and he felt out of breath and his legs needed to work a little bit more. The patient thought that maybe he needs to exercise a little bit more. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain
Clinical narrative: felt out of breath; whole breathing experience was easier and stronger/usually have more mucus excretion in the morning, it has gone away/used to feel more stressed and being worked and I don't feel that anymore; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 19Mar2021 (Batch/Lot Number: EN8727) (at the age of 69-years-old) as dose 2, single for COVID-19 immunization. Medical history included patient had hepatitis A in the year 1975, mucus excretion in the morning, stressed and worked, and exercise (normally exercised, would do leg exercises, martial arts exercises, and upper boy exercises; done some weight for years). Concomitant medications included L-arginine; azithromycin (ZMAX); lepidium meyenii root (MACA 2H); all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly in left arm on 23Feb2021 (lot number: EN6201) (at the age of 69-years-old) for COVID-19 immunization and experienced fatigue, little achy, dizzy, lethargic, liver ache, ang drug interaction; and previously took ginseng and experienced liver ache and drug interaction (ginseng interacting with first dose of the vaccine). The patient reported that after the second vaccination, he felt that his whole breathing experience was easier and stronger. He usually had more mucus excretion in the morning, and it has gone away. He didn't have that any longer. His lungs felt stronger, like they accommodate (as reported). He used to feel more stressed and being worked and he didn't feel that anymore. He normally exercised, would do leg exercises, martial arts exercises, and upper boy exercises. He has done some weight for years. He hasn't really walked a lot, but he never had any stresses, he was very athletic. He never had any stress with walking. However, for the past few days with a few slight stairs, the patient felt out of breath. He went up a slight hill, and he felt out of breath and his legs needed to work a little bit more. The patient thought that maybe he needs to exercise a little bit more. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.