chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: After he had the first vaccine he tested positive with the Covid; I was officially diagnosed with corona virus; he got sick, 02Jul; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (mother) and male consumer reported that a 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0176), via an unspecified route of administration on 24Jun2021 (at the age of 26 years old) as single for covid-19 immunisation. There was no medical history. There were no concomitant medications. Reporter stated that her 26-year-old son got his first vaccine and then he tested, after he had the first vaccine he tested positive with the Covid on 02Jul2021. He got sick on 02Jul2021 So, he do not know when can he get the vaccine again. He waited 10 days and he went to go another test and he was supposed to get the second dose on 15Jul2021, thursday. On 02Jul2021, he was officially diagnosed with corona virus and he went just now to get an additional test just because he had not had any symptom in the last few days so he wanted to confirm that he was ok at this point and he was wondering if he could still get the second vaccine on the 15Jul2021. He wanted to know if he should get that second dose now because he tested positive or if he should do both series again? Consumer stated that he went to go get the PCR test today and he was just now waiting for the results that are supposed to be in by Thursday morning but he was just want to confirm whether or not if he come out as negative if he can just proceed to go ahead and just take the second dose of vaccine. The patient underwent lab tests and procedures which included polymerase chain reaction: unknown result on 13Jul2021, sars-cov-2 test: unknown result on 02Jul2021. Consumer was informed that a product complaint was filed. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for COVID-19 in July 2021; Tested positive for COVID-19 in Jul2021; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Dec2020 (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no other vaccine in four weeks. He had no covid prior vaccination. It was reported that the patient tested positive for COVID-19 in July 2021. He had nasal swab and PCR tests on Jul2021 with positive result. He did not receive any treatment for the event. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Jul2021 nasal Swab and PCR.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 in July2021; Tested positive for COVID-19 in July2021; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Jul2021 the patient tested positive for covid-19 in July2021. COVID test type post vaccination: PCR (nasal swab): positive. No treatment was received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event was recovering.   lot/batch number and expiration date not reported
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: arm stay sore; pain where he got the shot; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-years-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 12Jul2021 as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced arm stays sore on an unspecified date, pain where he got the shot on an unspecified date. Upon follow-up on 14Jul2021 spontaneous report from a contactable consumer. This male consumer (patient) reported about characteristics (age, sex, version for reaction or event term LLT was not applicable, Reaction or event in terminology (LLT)was medical information potential AE, drugs information (proprietary medicinal product name, dose details). Patient wanted to know how long does pain in the arm and swelling of the arm usually lasts after getting the Pfizer BioNTech Covid-19Vaccine. Outcome of the event was unknown.   No follow-up attempts are possible. No further information expected. Information on batch/lot num-ber cannot be obtained. Follow-up (14Jul2021): This is a follow-up spontaneous report from a contactable consumer. This male consumer (patient) reported about characteristics (age, sex, version for reaction or event term LLT was not applicable, Reaction or event in terminology (LLT) was medical information potential AE, drugs information (proprietary medicinal product name, dose details). Patient wanted to know how long does pain in the arm and swelling of the arm usually lasts after getting the Pfizer BioNTech Covid-19Vaccine
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: exhaustion; after first and second vaccine; headaches; after first and second vaccine; sore arm; after first vaccine/ Sore arm: she had a sore arm from the first vaccine after 2 days.  This is worse.  Caller confirms the sore arm was only after the first vaccine and lasted 2 days.; This is a spontaneous report from a contactable consumer (Mother). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), Solution for injection, via an unspecified route of administration, administered in Arm Left on 10Jun2021 (at the age of 17-year-old) as single dose for covid-19 immunisation. The patient medical history was reported as none. Family medical history Relevant to AE was reported as none. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced exhaustion; after first and second vaccine, headaches; after first and second vaccine and sore arm; after first vaccine/ sore arm: she had a sore arm from the first vaccine after 2 days, this was worse. It was reported that she had headaches both times the next day when she woke up, for both of them. She had a sore arm from the first vaccine after 2 days. This was worse. Caller confirmed the sore arm was only after the first vaccine and lasted 2 days. Caller confirms the sore arm was only after the first vaccine and lasted 2 days. No test was performed. After the first vaccine, she got her meningitis vaccine. She got it 5 days after the first Pfizer Covid-19 Vaccine. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), Solution for injection, via an unspecified route of administration, administered in Arm right on 12Jul2021 as single dose for covid-19 immunisation. The outcome of events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Dizziness, Gait disturbance, Headache, Laboratory test
Clinical narrative: Neuropathy; tingling in her hands, like neuropathy, up to the forearms; Dizziness/ dizzy 24 hours a day/dizziness makes you feel like you're high or drunk; horrible, extreme migraine; Muscle weakness; Muscle cramps; pain in her legs; headache; couldn't sleep; felt sick; crying; pain; could not even walk up the steps; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 22Mar2021 (Batch/Lot Number: ER8727) (at the age of 69-years-old) as dose 1, single; and via an unspecified route of administration, administered in right arm on 12Apr2021 (Batch/Lot Number: EW0162) (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient explained that 15 days after completing vaccine series (in 27Apr2021), she experienced horrible, extreme migraine, neuropathy, muscle weakness, muscle cramps, dizziness and pain in her legs. She was also having tingling in her hands, like neuropathy, up to the forearms. She confirmed that all of the previously stated side effects occurred at the end of Apr2021. She said the headache is what happened first, and she felt sick and then the other side effects, like the neuropathy and the weakness in her calves and the tingling all slowly crept up on her. She went to the doctor, but they said nothing because they do not know if it is from the COVID vaccine, they just said that she was sick, and they didn't do anything or help. She just came home from seeing a neurologist who was doing tests on her. She stated that the side effects slowly reached a crescendo and it got bad to where she was crying and she couldn't sleep because she was in such pain and then they kind of got a little better but they were all still there. It dropped a level of the pain, she was not at a 9 or a 10 anymore, now she is at a 5. But they are all still there, and she is still very dizzy. She could not even walk up the steps because she felt that sick and dizzy. Patient wanted to know if her side effects have been reported previously. She stated that the pain was life changing, and that she is not dead from COVID, but this is altering her body. She is dizzy 24 hours a day and she is not a drinker, but the dizziness makes you feel like you're high or drunk. The patient stated that all side effects are current, they initially "crescendo" got really bad and have gotten a little bit better. She went to a neurologist on 14Jul2021 to have testing and labs. The outcome of the event migraine was recovered with sequelae, while for the rest of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Muscle spasms, Muscular weakness, Neuropathy peripheral
Clinical narrative: Neuropathy; tingling in her hands, like neuropathy, up to the forearms; Dizziness/ dizzy 24 hours a day/dizziness makes you feel like you're high or drunk; horrible, extreme migraine; Muscle weakness; Muscle cramps; pain in her legs; headache; couldn't sleep; felt sick; crying; pain; could not even walk up the steps; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 22Mar2021 (Batch/Lot Number: ER8727) (at the age of 69-years-old) as dose 1, single; and via an unspecified route of administration, administered in right arm on 12Apr2021 (Batch/Lot Number: EW0162) (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient explained that 15 days after completing vaccine series (in 27Apr2021), she experienced horrible, extreme migraine, neuropathy, muscle weakness, muscle cramps, dizziness and pain in her legs. She was also having tingling in her hands, like neuropathy, up to the forearms. She confirmed that all of the previously stated side effects occurred at the end of Apr2021. She said the headache is what happened first, and she felt sick and then the other side effects, like the neuropathy and the weakness in her calves and the tingling all slowly crept up on her. She went to the doctor, but they said nothing because they do not know if it is from the COVID vaccine, they just said that she was sick, and they didn't do anything or help. She just came home from seeing a neurologist who was doing tests on her. She stated that the side effects slowly reached a crescendo and it got bad to where she was crying and she couldn't sleep because she was in such pain and then they kind of got a little better but they were all still there. It dropped a level of the pain, she was not at a 9 or a 10 anymore, now she is at a 5. But they are all still there, and she is still very dizzy. She could not even walk up the steps because she felt that sick and dizzy. Patient wanted to know if her side effects have been reported previously. She stated that the pain was life changing, and that she is not dead from COVID, but this is altering her body. She is dizzy 24 hours a day and she is not a drinker, but the dizziness makes you feel like you're high or drunk. The patient stated that all side effects are current, they initially "crescendo" got really bad and have gotten a little bit better. She went to a neurologist on 14Jul2021 to have testing and labs. The outcome of the event migraine was recovered with sequelae, while for the rest of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain assessment, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: Neuropathy; tingling in her hands, like neuropathy, up to the forearms; Dizziness/ dizzy 24 hours a day/dizziness makes you feel like you're high or drunk; horrible, extreme migraine; Muscle weakness; Muscle cramps; pain in her legs; headache; couldn't sleep; felt sick; crying; pain; could not even walk up the steps; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 22Mar2021 (Batch/Lot Number: ER8727) (at the age of 69-years-old) as dose 1, single; and via an unspecified route of administration, administered in right arm on 12Apr2021 (Batch/Lot Number: EW0162) (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient explained that 15 days after completing vaccine series (in 27Apr2021), she experienced horrible, extreme migraine, neuropathy, muscle weakness, muscle cramps, dizziness and pain in her legs. She was also having tingling in her hands, like neuropathy, up to the forearms. She confirmed that all of the previously stated side effects occurred at the end of Apr2021. She said the headache is what happened first, and she felt sick and then the other side effects, like the neuropathy and the weakness in her calves and the tingling all slowly crept up on her. She went to the doctor, but they said nothing because they do not know if it is from the COVID vaccine, they just said that she was sick, and they didn't do anything or help. She just came home from seeing a neurologist who was doing tests on her. She stated that the side effects slowly reached a crescendo and it got bad to where she was crying and she couldn't sleep because she was in such pain and then they kind of got a little better but they were all still there. It dropped a level of the pain, she was not at a 9 or a 10 anymore, now she is at a 5. But they are all still there, and she is still very dizzy. She could not even walk up the steps because she felt that sick and dizzy. Patient wanted to know if her side effects have been reported previously. She stated that the pain was life changing, and that she is not dead from COVID, but this is altering her body. She is dizzy 24 hours a day and she is not a drinker, but the dizziness makes you feel like you're high or drunk. The patient stated that all side effects are current, they initially "crescendo" got really bad and have gotten a little bit better. She went to a neurologist on 14Jul2021 to have testing and labs. The outcome of the event migraine was recovered with sequelae, while for the rest of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin swelling, Vaccination site warmth
Clinical narrative: scratchy and also the area feels warm; redness and tiny bit of puffiness and itching below injection site in left arm; redness and tiny bit of puffiness and itching below injection site in left arm; redness and tiny bit of puffiness and itching below injection site in left arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0198, patient was 70-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 09Jul2021 as single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0191), via an unspecified route of administration, administered in Arm right on 18Jun2021 as single dose for covid-19 immunisation. It was reported that patient got the second dose of the Pfizer- BioNTech COVID-19 vaccine on friday, 09Jul2021, states she was looking at her arm today, states it is not at penetration site of the needle, but down below it, there is some redness, itchiness and it is a tiny bit puffy. She said that it is getting better, but it is "scratchy" and also the area feels warm. and it has been very minimal looking at in now and the redness may be due to her scratching. States it is itchy and she has scratched so that could be contributing to the redness, wants to know if this is related to the vaccine or may be a blood clot. She is also asking if these symptoms doesn't go away when will she need to consult her doctor. On 14Jul2021, the patient experienced redness and tiny bit of puffiness and itching below injection site in left arm, on an unspecified date, the patient experienced scratchy and also the area feels warm. The outcomes of events (redness and tiny bit of puffiness and itching below injection site in left arm) were not recovered, and the outcome of event (scratchy and also the area feels warm) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was excruciating painful; This is a spontaneous report from a non-contactable consumer or other non hcp (patient reported for herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in arm on 07Jul2021, dose number unknown, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after receiving the dose of vaccine, on an unspecified date the patient's arm was excruciating painful. The reporter stated that the people she knows who got the shot before her say to expect some soreness after getting the shot as they did after they got the shot. She was thinking afterwards okay, a little soreness. However, after getting the shot her arm was excruciating painful, it was so painful. She declined to continue with safety report and she then questioned if the pfizer covid shot causes nausea. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Pain in extremity
Clinical narrative: upper arm soreness in both arms; it's like muscle strain; upper arm soreness in both arms; it's like muscle strain; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored Program. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration Date: not provided), dose 2 via an unspecified route of administration on 09Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (at the age of 68-year-old) for COVID-19 immunization. Patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 09Mar2021 and since then had been experiencing soreness of both her upper arms, which feels like muscle strain (Mar2021). She would like to know how long this side effect will last. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Nasopharyngitis, Neuralgia, Neurological symptom, Neuropathy peripheral
Clinical narrative: neuropathy; neurological symptoms; cold like symptoms; Small fiber neuropathy; nerve pain; GBS; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 23Mar2021 12:00 (Lot Number: EP 7534) as dose 2, single (at the age of 26 years old) for COVID-19 immunization. Medical history included COVID-19 from an unknown date. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 02Mar2021 at 09:00 AM (Lot number: DOHCBRP) via unspecified route of administration administered in left arm as dose 1 for COVID-19 immunization. The patient had COVID-19 prior vaccination. The patient tested COVID post vaccination, test type post vaccination was rapid, COVID test date was 22Jun2021 and COVID test result was negative. No known allergies. Other medical history was none (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications within 2 weeks of vaccination. Received vaccine on 23Mar2021. Developed neuropathy and neurological symptoms on 15Jun2021 after cold like symptoms. Currently dealing with small fiber neuropathy and nerve pain all over body. PCP believes atypical case of GBS (Guillain-Barre syndrome). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 7 days due to the events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid test: negative on 22Jun2021. The outcome of the events was not recovered.; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient, unrelated 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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: neuropathy; neurological symptoms; cold like symptoms; Small fiber neuropathy; nerve pain; GBS; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 23Mar2021 12:00 (Lot Number: EP 7534) as dose 2, single (at the age of 26 years old) for COVID-19 immunization. Medical history included COVID-19 from an unknown date. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 02Mar2021 at 09:00 AM (Lot number: DOHCBRP) via unspecified route of administration administered in left arm as dose 1 for COVID-19 immunization. The patient had COVID-19 prior vaccination. The patient tested COVID post vaccination, test type post vaccination was rapid, COVID test date was 22Jun2021 and COVID test result was negative. No known allergies. Other medical history was none (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications within 2 weeks of vaccination. Received vaccine on 23Mar2021. Developed neuropathy and neurological symptoms on 15Jun2021 after cold like symptoms. Currently dealing with small fiber neuropathy and nerve pain all over body. PCP believes atypical case of GBS (Guillain-Barre syndrome). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 7 days due to the events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid test: negative on 22Jun2021. The outcome of the events was not recovered.; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient, unrelated 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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: Small balls on feet; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN0164, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 07Jun2021 as dose 1, single (at the age of 80-years-old) for COVID-19 immunisation. Medical history included deep vein thrombosis (DVT), thrombosis right leg (had this twice when she was 50-55 years of age) from an unknown date and unknown if ongoing. The patient had not received any other products/concomitant medications. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient's family medical history relevant to adverse event was not reported. On 07Jun2021, patient had a reaction to it and stated that she doesn't know how to explain it, but it was like small balls on her feet. Duration of the event was 6 days and then symptom passed. Patient denied any medications, labs, testing, or treatments relevant to event. Patient had no emergency room and physician office visit for the event. The outcome of the event was recovered on 13Jun2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Diarrhoea, Dysstasia, Feeling abnormal, Gait disturbance
Clinical narrative: Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown.  Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown.  Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: nerve issues in her left arm, which include pain and constant tingling from shoulder to hand; nerve issues in her left arm, which include pain and constant tingling from shoulder to hand/fingertips feel spikey, for lack of a better term, like maybe needle pricks; her hands itch; nerve issues in her left arm, which include pain and constant tingling from shoulder to hand; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date of 2021 (earlier this year) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, patient experienced nerve issues in her left arm, which include pain and constant tingling from shoulder to hand, her hands itch, and her fingertips feel spikey, for lack of a better term, like maybe needle pricks. Patient was wondering if this was reported before in anyone who took the COVID vaccine and was there anything she can do for relief. The outcome of all the events was unknown.  Information on the Lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Parosmia, Taste disorder
Clinical narrative: I am a 3 year cancer survivor that has neuropathy from chemo. My neuropathy was getting much better until I had the second dose of the Pfizer vaccine.  The pain has intensified in my feet and hands ho; I also have only 50% of my taste and smell since the last vaccine that I was given; I also have only 50% of my taste and smell since the last vaccine; This is a spontaneous report from a contactable consumer (patient).   A 53-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (at the age of 53-years-old) ,  via an unspecified route of administration, administered in the Left arm on 25Feb2021 16:15 (Batch/Lot Number: EN6203) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included COVID-19 from an unknown date and unknown if ongoing (patient diagnosed with COVID-19:Yes), cancer survivor  from an unknown date and unknown if ongoing (3 year cancer survivor) and had ongoing neuropathy from chemo. Patient had no known allergies and past drug history. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no any other medications the patient received within 2 weeks of vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2  via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (04:15 PM) (lot number: EN5318) (at the age of 53-years-old) as DOSE 1, SINGLE for COVID-19 immunisation.  The patient reported that she was a 3-year cancer survivor that had ongoing neuropathy from chemo. Her neuropathy was getting much better until she had the second dose of the Pfizer vaccine.  The pain had intensified in her feet and hands horribly (medically significant) on 26Feb2021 06:30. The patient also had only 50% of her  taste and smell since the last vaccine that she was given on 26Feb2021 06:30.  The events did not require treatment.  Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Migraine, Vertigo
Clinical narrative: Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 09Apr2021 13:00 (at the age of 56-year-old) (Batch/Lot Number: EW0158) as dose 2, single for covid-19 immunisation. Medical history included migraines, Seizure Disorder, and Penicillin Allergy. The patient was not pregnant. Concomitant medications were not reported but patient had other medications in two weeks. The patient had no other vaccine in four weeks. The patient received first dose of bnt162b2 for covid-19 immunisation on 19Mar2021 (at the age of 56-year-old). On 23Apr2021, the patient experienced massive increase in migraines from 6 a year to 3-6 a week and also was dizzy all the time and struggling with vertigo (neither were present before). The events resulted in doctor or other healthcare professional office/clinic visit, and disability or permanent damage. There were no therapy for the events. The patient had no covid prior vaccination and patient was not covid tested post vaccination. Outcome of events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Blood test, Condition aggravated, Deafness unilateral, Electroencephalogram
Clinical narrative: Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 09Apr2021 13:00 (at the age of 56-year-old) (Batch/Lot Number: EW0158) as dose 2, single for covid-19 immunisation. Medical history included migraines, Seizure Disorder, and Penicillin Allergy. The patient was not pregnant. Concomitant medications were not reported but patient had other medications in two weeks. The patient had no other vaccine in four weeks. The patient received first dose of bnt162b2 for covid-19 immunisation on 19Mar2021 (at the age of 56-year-old). On 23Apr2021, the patient experienced massive increase in migraines from 6 a year to 3-6 a week and also was dizzy all the time and struggling with vertigo (neither were present before). The events resulted in doctor or other healthcare professional office/clinic visit, and disability or permanent damage. There were no therapy for the events. The patient had no covid prior vaccination and patient was not covid tested post vaccination. Outcome of events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Migraine, Vertigo
Clinical narrative: Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); Massive increase in migraines from 6 a year to 3-6 a week. Also dizzy all the time and struggling with vertigo (neither were present before); This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 09Apr2021 13:00 (at the age of 56-year-old) (Batch/Lot Number: EW0158) as dose 2, single for covid-19 immunisation. Medical history included migraines, Seizure Disorder, and Penicillin Allergy. The patient was not pregnant. Concomitant medications were not reported but patient had other medications in two weeks. The patient had no other vaccine in four weeks. The patient received first dose of bnt162b2 for covid-19 immunisation on 19Mar2021 (at the age of 56-year-old). On 23Apr2021, the patient experienced massive increase in migraines from 6 a year to 3-6 a week and also was dizzy all the time and struggling with vertigo (neither were present before). The events resulted in doctor or other healthcare professional office/clinic visit, and disability or permanent damage. There were no therapy for the events. The patient had no covid prior vaccination and patient was not covid tested post vaccination. Outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: sweating and having to change clothes 3-4 times a night, she was concerned. Subsequently, they put off getting his second dose; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (son) that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 13May2021 as single for covid-19 immunisation. Medical history included history of allergy problems. The patient's concomitant medications were not reported. Reporter stated regarding her 17-year old son, who got his first shot of the Pfizer BioNTech Covid-19 vaccine on 13May2021. She reports that he had a history of allergy problems and when he was telling her his problems with sweating and having to change clothes 3-4 times a night, she was concerned. Subsequently, they put off getting his second dose. She was wondering, was it too late to get the second dose? Reporter stated that while she understands that this was all new, that it was frustrating that she gets different information from different places and that was the reason a lot of people don't get vaccinated. Reporter was asking about use in patients like herself and several people she knows that are immunocompromised and/or taking immunosuppressants. Reporter was asking for information regarding immunocompromised people who are vaccinated and walking around without masks thinking that they're protected. Reporter asks how effective/ what was the protection level after one dose. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sunburn
Clinical narrative: Sunburn; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (sister).  A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified age as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced sunburn. It's been 2 weeks and 3 weeks and not much colour change. The outcome of the events was Not recovered.  No follow-up attempts possible. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: Received second dose Vaccine and developed, can't walk on legs anymore; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 16Jun2021 (Batch/Lot Number: EW0180) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There was nothing wrong with the patient. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in left arm on 17May2021 (lot number: EW0177) for COVID-19 immunisation. On 16Jun2021, the patient received the second dose Pfizer Covid 19 Vaccine and she developed, can't walk on legs anymore. The patient could not walk properly within 5 minutes of receiving the second dose Pfizer Covid 19 Vaccine. The reporter thought the not walking properly would subside but it was getting worse. The reporter stated that he needed to get the patient near the phone to answer the questions. The patient does not have a primary care physician. The reporter stated that the patient was too young for this. The patient can't even walk. There was no Investigation Assessment. Reporter wanted to know if anybody else called Pfizer regarding something similar to this walking problem. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast discolouration
Clinical narrative: Breast nipple is a different color; This is a spontaneous report from a non-contactable female consumer (patient).  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced different colour in her breast nipple. She came back and was so surprised and shocked. She got the Pfizer vaccine and her breast nipples each have a different colour. It is something she has never experienced. Caller is wondering if it is okay for her to get the second Pfizer Covid-19 vaccine if she had a side effect to the first one. she is concerned it will be heavy and worse than the first. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.