chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Neutrophil count, Neutrophil count increased, Overdose
Clinical narrative: WBH high at 12.1; neutrophils (high 9.2); Received an undiluted, entire vial dose of the Pfizer Covid-19 Vaccine; Instead of doing a single dose the patient got the multiple dose vial; This is a spontaneous report from a contactable nurse via medical information team. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot Number: unknown, Expire Date: unknown), via an unspecified route of administration in arm, on 05Oct2021 (age at vaccination: 17 years), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No history of all pervious immunization with Pfizer vaccine considered as suspect. Family medical history was not provided. Patients receive any other vaccines within 4 weeks prior to the COVID vaccine: unknown. Adverse event prior vaccination was not provided. On 05Oct2021 patient received an undiluted, entire vial dose of the Pfizer Covid-19 Vaccine as her first dose/she got the whole vial. The patient said it was six doses. A vial holds ten doses, so the patient got between six and ten doses/ she got 6 to 10 doses, whatever is in the vial. It was given in the arm. Instead of doing a single dose the patient got the multiple dose vial. The patient was concerned of side effects from that and asked if she should get a second dose. The doctor has never heard of this happening. Patient did not go to the Emergency Room. Patient was seen by physician's office today, 11Oct2021. Patient investigation assessment was not reported. It could have been another medication and that could have been her last breath. She was not hospitalized. It was reporter stated that they did not see the patient until 6 days after the overdose event, and that is when they found out about it, so they cannot provide information on the cause of the overdose. Patient had a chest x-ray on 18Oct2021 that showed something but was unclear. Patient was sent for CT scan on the 19Oct2021 which came back all clear so determined no issue. Patient also had lab work done on 18Oct2021 which included TSH, WBH high at 12.1, neutrophils (high 9.2), glucose (121), BUN creatinine (125), SARS antibodies (96.6). The outcome of blood test abnormal and neutrophils increased was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (21Oct2021): This is a Follow up spontaneous report from contactable nurse. This nurse reported in response to HCP telephonic follow up activity. Updated information included: lab data (chest x-ray, TSH, WBH, Neutrophils, Glucose, BUN creatinine, SARS antibodies).  Amendment: This follow up is being submitted to amend previously reported information: added the event 'blood test abnormal and neutrophils increased' with description 'WBH high at 12.1' and 'neutrophils (high 9.2)'.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error, SARS-CoV-2 antibody test
Clinical narrative: WBH high at 12.1; neutrophils (high 9.2); Received an undiluted, entire vial dose of the Pfizer Covid-19 Vaccine; Instead of doing a single dose the patient got the multiple dose vial; This is a spontaneous report from a contactable nurse via medical information team. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot Number: unknown, Expire Date: unknown), via an unspecified route of administration in arm, on 05Oct2021 (age at vaccination: 17 years), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No history of all pervious immunization with Pfizer vaccine considered as suspect. Family medical history was not provided. Patients receive any other vaccines within 4 weeks prior to the COVID vaccine: unknown. Adverse event prior vaccination was not provided. On 05Oct2021 patient received an undiluted, entire vial dose of the Pfizer Covid-19 Vaccine as her first dose/she got the whole vial. The patient said it was six doses. A vial holds ten doses, so the patient got between six and ten doses/ she got 6 to 10 doses, whatever is in the vial. It was given in the arm. Instead of doing a single dose the patient got the multiple dose vial. The patient was concerned of side effects from that and asked if she should get a second dose. The doctor has never heard of this happening. Patient did not go to the Emergency Room. Patient was seen by physician's office today, 11Oct2021. Patient investigation assessment was not reported. It could have been another medication and that could have been her last breath. She was not hospitalized. It was reporter stated that they did not see the patient until 6 days after the overdose event, and that is when they found out about it, so they cannot provide information on the cause of the overdose. Patient had a chest x-ray on 18Oct2021 that showed something but was unclear. Patient was sent for CT scan on the 19Oct2021 which came back all clear so determined no issue. Patient also had lab work done on 18Oct2021 which included TSH, WBH high at 12.1, neutrophils (high 9.2), glucose (121), BUN creatinine (125), SARS antibodies (96.6). The outcome of blood test abnormal and neutrophils increased was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (21Oct2021): This is a Follow up spontaneous report from contactable nurse. This nurse reported in response to HCP telephonic follow up activity. Updated information included: lab data (chest x-ray, TSH, WBH, Neutrophils, Glucose, BUN creatinine, SARS antibodies).  Amendment: This follow up is being submitted to amend previously reported information: added the event 'blood test abnormal and neutrophils increased' with description 'WBH high at 12.1' and 'neutrophils (high 9.2)'.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A Moderna Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, SARS-CoV-2 test
Clinical narrative: With both shots I was almost immediately lightheaded; With both shots I was almost immediately got a headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Apr2021 10:30 (Lot number: EW0173) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo", start date: 2019 (unspecified if ongoing), notes: I have never had Migraines in my life, but I did have a short episode of Vertigo in 2019. Concomitant medication(s) included: ALLOPURINOL; LOSARTAN + HIDROCLOROTIAZIDA; SILDENAFIL taken for erectile dysfunction, start date: Jun2021 (ongoing); TOPAMAX taken for migraine, start date: Jun2021 (ongoing).  The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "With both shots I was almost immediately lightheaded"; HEADACHE (non-serious), outcome "recovered", described as "With both shots I was almost immediately got a headache". The events "with both shots i was almost immediately lightheaded" and "with both shots i was almost immediately got a headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Computerised tomogram head abnormal, Laboratory test, Loss of consciousness
Clinical narrative: She got her vaccine, she did not have any issues.  But about 3 weeks later her dogs wanting to go outside and she passed out in her living room.  She tried to get herself up and again passed out.  Her boss called her and then called her mom and sister who finally answered the phone and she called her, did not answer and she went over to her house.  She was going to meet with her boss and coworkers and she did not show up for the zoom meeting.  About 2-3 hours her sister came, as well as the police, and the sister kicked in the door and they found her on the floor.  Her arm was impacted, her legs were too, and she was not able to let her dogs out.  They took her to the hospital and did CAT scans and found that she had had a stroke.  She went to surgery to remove the clots in her brain.  Since she is now recovering. It was tough for her to deal with the stroke due to her age, and she was in the hospital for about 3 weeks, and then at the rehab facility for 5 weeks, and then at her sisters house for a month recovering from the stroke.   She was finally able to go to her own home, and told what her limitations were.  She only had one hand that would work, and now she can use both of them, has difficulties with her fingers.  Her leg improved, she can now run, walk, and use it and can now use a bicycle.  Her speech is coming along, and can read some stuff, and can right and can type a little bit, but it has been a long process, and 9 1/2 months, but she has made steady progress, and her doctors tell her that she has done this fast.    Her doctors feel that the vaccine and the stress she was under attributed to the stroke.  She was in Hospital for 3 weeks.  Rehab center for 5 weeks,  She also knows of three other people that had the vaccine and suffered a stroke as well.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Monoplegia, Muscular weakness, Reading disorder, Speech disorder
Clinical narrative: She got her vaccine, she did not have any issues.  But about 3 weeks later her dogs wanting to go outside and she passed out in her living room.  She tried to get herself up and again passed out.  Her boss called her and then called her mom and sister who finally answered the phone and she called her, did not answer and she went over to her house.  She was going to meet with her boss and coworkers and she did not show up for the zoom meeting.  About 2-3 hours her sister came, as well as the police, and the sister kicked in the door and they found her on the floor.  Her arm was impacted, her legs were too, and she was not able to let her dogs out.  They took her to the hospital and did CAT scans and found that she had had a stroke.  She went to surgery to remove the clots in her brain.  Since she is now recovering. It was tough for her to deal with the stroke due to her age, and she was in the hospital for about 3 weeks, and then at the rehab facility for 5 weeks, and then at her sisters house for a month recovering from the stroke.   She was finally able to go to her own home, and told what her limitations were.  She only had one hand that would work, and now she can use both of them, has difficulties with her fingers.  Her leg improved, she can now run, walk, and use it and can now use a bicycle.  Her speech is coming along, and can read some stuff, and can right and can type a little bit, but it has been a long process, and 9 1/2 months, but she has made steady progress, and her doctors tell her that she has done this fast.    Her doctors feel that the vaccine and the stress she was under attributed to the stroke.  She was in Hospital for 3 weeks.  Rehab center for 5 weeks,  She also knows of three other people that had the vaccine and suffered a stroke as well.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Thrombectomy
Clinical narrative: She got her vaccine, she did not have any issues.  But about 3 weeks later her dogs wanting to go outside and she passed out in her living room.  She tried to get herself up and again passed out.  Her boss called her and then called her mom and sister who finally answered the phone and she called her, did not answer and she went over to her house.  She was going to meet with her boss and coworkers and she did not show up for the zoom meeting.  About 2-3 hours her sister came, as well as the police, and the sister kicked in the door and they found her on the floor.  Her arm was impacted, her legs were too, and she was not able to let her dogs out.  They took her to the hospital and did CAT scans and found that she had had a stroke.  She went to surgery to remove the clots in her brain.  Since she is now recovering. It was tough for her to deal with the stroke due to her age, and she was in the hospital for about 3 weeks, and then at the rehab facility for 5 weeks, and then at her sisters house for a month recovering from the stroke.   She was finally able to go to her own home, and told what her limitations were.  She only had one hand that would work, and now she can use both of them, has difficulties with her fingers.  Her leg improved, she can now run, walk, and use it and can now use a bicycle.  Her speech is coming along, and can read some stuff, and can right and can type a little bit, but it has been a long process, and 9 1/2 months, but she has made steady progress, and her doctors tell her that she has done this fast.    Her doctors feel that the vaccine and the stress she was under attributed to the stroke.  She was in Hospital for 3 weeks.  Rehab center for 5 weeks,  She also knows of three other people that had the vaccine and suffered a stroke as well.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Illness, Lethargy
Clinical narrative: doctor took her temperature, and it was 100.2; pain; she just felt awful; she was so sick; tired and lethargic; tired and lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Lot number: FF2587) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Metastatic breast cancer" (ongoing); "she has cancer in her lower spine hips, pelvis, ribs and other places." (unspecified if ongoing), notes: she has cancer in her lower spine hips, pelvis, ribs and other places. Concomitant medication(s) included: ANASTROZOLE taken for breast cancer metastatic (ongoing). The following information was reported: ILLNESS (non-serious) with onset 04Oct2021, outcome "unknown", described as "she was so sick"; FATIGUE (non-serious), LETHARGY (non-serious) all with onset 2021, outcome "unknown" and all described as "tired and lethargic"; PYREXIA (non-serious), outcome "unknown", described as "doctor took her temperature, and it was 100.2"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "pain"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "she just felt awful". The event "doctor took her temperature, and it was 100.2" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was stated she got the Covid 19 Vaccine and it sent her down hill. States she was so sick from her first dose on 04Oct2021. States that afternoon she tanked, she was tired and lethargic. States she was supposed to leave on a trip, and she couldn't leave until 5 days later. States she went to her mom's and she was there for 3 weeks and she was so lethargic. States she went to see (with held) her Naturopath and she told her it was a bad reaction to the vaccine. States her Oncologist didn't think so but she knew. States her doctor took her temperature, and it was 100.2 and she didn't know she had a fever, she just felt awful, and her pain amped up around mid November. States she only got one dose of the vaccine, it made her so sick.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Scan
Clinical narrative: doctor took her temperature, and it was 100.2; pain; she just felt awful; she was so sick; tired and lethargic; tired and lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Lot number: FF2587) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Metastatic breast cancer" (ongoing); "she has cancer in her lower spine hips, pelvis, ribs and other places." (unspecified if ongoing), notes: she has cancer in her lower spine hips, pelvis, ribs and other places. Concomitant medication(s) included: ANASTROZOLE taken for breast cancer metastatic (ongoing). The following information was reported: ILLNESS (non-serious) with onset 04Oct2021, outcome "unknown", described as "she was so sick"; FATIGUE (non-serious), LETHARGY (non-serious) all with onset 2021, outcome "unknown" and all described as "tired and lethargic"; PYREXIA (non-serious), outcome "unknown", described as "doctor took her temperature, and it was 100.2"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "pain"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "she just felt awful". The event "doctor took her temperature, and it was 100.2" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was stated she got the Covid 19 Vaccine and it sent her down hill. States she was so sick from her first dose on 04Oct2021. States that afternoon she tanked, she was tired and lethargic. States she was supposed to leave on a trip, and she couldn't leave until 5 days later. States she went to her mom's and she was there for 3 weeks and she was so lethargic. States she went to see (with held) her Naturopath and she told her it was a bad reaction to the vaccine. States her Oncologist didn't think so but she knew. States her doctor took her temperature, and it was 100.2 and she didn't know she had a fever, she just felt awful, and her pain amped up around mid November. States she only got one dose of the vaccine, it made her so sick.   No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Gave adult dose instead of pediatric dose
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase, Blood thyroid stimulating hormone, Burning sensation
Clinical narrative: Neuropathy type of issues; Constant muscle twitches; Pins and needles in arms and legs; Burning pains; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing); "gerd" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Bactrim, reaction(s): "known allergies: bactrim"; Cipro, reaction(s): "known allergies: Cipro"; Macrobid, reaction(s): "known allergies: Macrobid" and multivitamins. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 27Sep2021, outcome "not recovered", described as "Neuropathy type of issues"; MUSCLE TWITCHING (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Constant muscle twitches"; PARAESTHESIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Pins and needles in arms and legs"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Burning pains"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Tinnitus". The events "neuropathy type of issues", "constant muscle twitches", "pins and needles in arms and legs", "burning pains" and "tinnitus" were evaluated at the physician office visit and emergency room visit.  Clinical course: Neuropathy type of issues, constant muscle twitches, pins and needles in arms and legs, burning pains and tinnitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: C-reactive protein, Chest X-ray normal, Chest pain, Costochondritis, Differential white blood cell count normal
Clinical narrative: Neuropathy type of issues; Constant muscle twitches; Pins and needles in arms and legs; Burning pains; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing); "gerd" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Bactrim, reaction(s): "known allergies: bactrim"; Cipro, reaction(s): "known allergies: Cipro"; Macrobid, reaction(s): "known allergies: Macrobid" and multivitamins. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 27Sep2021, outcome "not recovered", described as "Neuropathy type of issues"; MUSCLE TWITCHING (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Constant muscle twitches"; PARAESTHESIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Pins and needles in arms and legs"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Burning pains"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Tinnitus". The events "neuropathy type of issues", "constant muscle twitches", "pins and needles in arms and legs", "burning pains" and "tinnitus" were evaluated at the physician office visit and emergency room visit.  Clinical course: Neuropathy type of issues, constant muscle twitches, pins and needles in arms and legs, burning pains and tinnitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Dyskinesia, Dyspnoea, Feeling abnormal, Full blood count normal, Glycosylated haemoglobin
Clinical narrative: Neuropathy type of issues; Constant muscle twitches; Pins and needles in arms and legs; Burning pains; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing); "gerd" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Bactrim, reaction(s): "known allergies: bactrim"; Cipro, reaction(s): "known allergies: Cipro"; Macrobid, reaction(s): "known allergies: Macrobid" and multivitamins. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 27Sep2021, outcome "not recovered", described as "Neuropathy type of issues"; MUSCLE TWITCHING (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Constant muscle twitches"; PARAESTHESIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Pins and needles in arms and legs"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Burning pains"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Tinnitus". The events "neuropathy type of issues", "constant muscle twitches", "pins and needles in arms and legs", "burning pains" and "tinnitus" were evaluated at the physician office visit and emergency room visit.  Clinical course: Neuropathy type of issues, constant muscle twitches, pins and needles in arms and legs, burning pains and tinnitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: HIV test negative, Headache, Heart rate increased, Hepatitis A virus test, Metabolic function test
Clinical narrative: Neuropathy type of issues; Constant muscle twitches; Pins and needles in arms and legs; Burning pains; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing); "gerd" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Bactrim, reaction(s): "known allergies: bactrim"; Cipro, reaction(s): "known allergies: Cipro"; Macrobid, reaction(s): "known allergies: Macrobid" and multivitamins. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 27Sep2021, outcome "not recovered", described as "Neuropathy type of issues"; MUSCLE TWITCHING (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Constant muscle twitches"; PARAESTHESIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Pins and needles in arms and legs"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Burning pains"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Tinnitus". The events "neuropathy type of issues", "constant muscle twitches", "pins and needles in arms and legs", "burning pains" and "tinnitus" were evaluated at the physician office visit and emergency room visit.  Clinical course: Neuropathy type of issues, constant muscle twitches, pins and needles in arms and legs, burning pains and tinnitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Muscle spasms, Myalgia, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Neuropathy type of issues; Constant muscle twitches; Pins and needles in arms and legs; Burning pains; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing); "gerd" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Bactrim, reaction(s): "known allergies: bactrim"; Cipro, reaction(s): "known allergies: Cipro"; Macrobid, reaction(s): "known allergies: Macrobid" and multivitamins. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 27Sep2021, outcome "not recovered", described as "Neuropathy type of issues"; MUSCLE TWITCHING (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Constant muscle twitches"; PARAESTHESIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Pins and needles in arms and legs"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Burning pains"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Tinnitus". The events "neuropathy type of issues", "constant muscle twitches", "pins and needles in arms and legs", "burning pains" and "tinnitus" were evaluated at the physician office visit and emergency room visit.  Clinical course: Neuropathy type of issues, constant muscle twitches, pins and needles in arms and legs, burning pains and tinnitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Red blood cell sedimentation rate normal, Spinal X-ray normal, Tinnitus, Treponema test negative, Vitamin B12 normal
Clinical narrative: Neuropathy type of issues; Constant muscle twitches; Pins and needles in arms and legs; Burning pains; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing); "gerd" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Bactrim, reaction(s): "known allergies: bactrim"; Cipro, reaction(s): "known allergies: Cipro"; Macrobid, reaction(s): "known allergies: Macrobid" and multivitamins. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 27Sep2021, outcome "not recovered", described as "Neuropathy type of issues"; MUSCLE TWITCHING (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Constant muscle twitches"; PARAESTHESIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Pins and needles in arms and legs"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Burning pains"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Tinnitus". The events "neuropathy type of issues", "constant muscle twitches", "pins and needles in arms and legs", "burning pains" and "tinnitus" were evaluated at the physician office visit and emergency room visit.  Clinical course: Neuropathy type of issues, constant muscle twitches, pins and needles in arms and legs, burning pains and tinnitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: X-ray limb normal
Clinical narrative: Neuropathy type of issues; Constant muscle twitches; Pins and needles in arms and legs; Burning pains; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing); "gerd" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Bactrim, reaction(s): "known allergies: bactrim"; Cipro, reaction(s): "known allergies: Cipro"; Macrobid, reaction(s): "known allergies: Macrobid" and multivitamins. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 27Sep2021, outcome "not recovered", described as "Neuropathy type of issues"; MUSCLE TWITCHING (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Constant muscle twitches"; PARAESTHESIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Pins and needles in arms and legs"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Burning pains"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Tinnitus". The events "neuropathy type of issues", "constant muscle twitches", "pins and needles in arms and legs", "burning pains" and "tinnitus" were evaluated at the physician office visit and emergency room visit.  Clinical course: Neuropathy type of issues, constant muscle twitches, pins and needles in arms and legs, burning pains and tinnitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Muscle twitching, Neuropathy peripheral, Pain, Paraesthesia, Tinnitus
Clinical narrative: Neuropathy type of issues; Constant muscle twitches; Pins and needles in arms and legs; Burning pains; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing); "gerd" (unspecified if ongoing); "gastritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; PROTONIX [OMEPRAZOLE]. Past drug history included: Bactrim, reaction(s): "known allergies: bactrim"; Cipro, reaction(s): "known allergies: Cipro"; Macrobid, reaction(s): "known allergies: Macrobid" and multivitamins. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 27Sep2021, outcome "not recovered", described as "Neuropathy type of issues"; MUSCLE TWITCHING (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Constant muscle twitches"; PARAESTHESIA (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Pins and needles in arms and legs"; PAIN (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Burning pains"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "Tinnitus". The events "neuropathy type of issues", "constant muscle twitches", "pins and needles in arms and legs", "burning pains" and "tinnitus" were evaluated at the physician office visit and emergency room visit.  Clinical course: Neuropathy type of issues, constant muscle twitches, pins and needles in arms and legs, burning pains and tinnitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Pain
Clinical narrative: PSORIATIC ARTHRITIS WORSENED; This spontaneous report received from a patient concerned an adult female of an unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown, expiry: unknown) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis worsened. The patient was treated with prazitone.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of psoriatic arthritis worsened was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments 20220334820-COVID-19 VACCINE AD26.COV2.S-Psoriatic arthritis worsened. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE. Therefore, this event(s) is considered not related.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Psoriatic arthropathy
Clinical narrative: PSORIATIC ARTHRITIS WORSENED; This spontaneous report received from a patient concerned an adult female of an unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown, expiry: unknown) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced psoriatic arthritis worsened. The patient was treated with prazitone.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of psoriatic arthritis worsened was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments 20220334820-COVID-19 VACCINE AD26.COV2.S-Psoriatic arthritis worsened. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE. Therefore, this event(s) is considered not related.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Pt has a syncopal event and associated dizziness. Vitals: 12:30 86/96, 67, 18, 99% on RA -- > 12:36 103/60, 72, 18, 99% on RA -- > 100/65, 69 Pt did not eat breakfast.  Pt given water, orange juice, cookies.  Pt felt better.  Pt stable and released from the vaccination site @12:46.
Age: 87.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, UNK
Symptoms: Acute kidney injury, Dehydration, Hypophagia, Urinary tract infection
Clinical narrative: Urinary tract infection; Dehydration; This spontaneous case from the was retrieved on 09-Mar-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2129154-1) reported by other healthcare professional and concerned an 87-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 08-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as '1', route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 312845.  On the same day, the patient was vaccinated with a non-company co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as '3', indication, route of administration and anatomical location: not reported). The batch number was not reported.  On 28-Oct-2021, 20 days after receiving Fluad Quadrivalent and  Pfizer BioNTech COVID-19 vaccine, the patient was admitted to emergency room for dehydration. The patient was found to have a urinary tract infection and received first dose of nitrofurantoin in the emergency department. The patent with remaining prescription was sent to the pharmacy.  On an unspecified date in 2021, the patient experienced acute kidney injury (AKI).  On 09-Nov-2021, the patient was admitted to hospital for 23 days.   On unspecified date in 2021, the patient recovered from AKI. AKI was resolved with hydration. The patient was stable off intravenous (IV) fluids although per oral (PO) intake was poor.  On 02-Dec-2021, the patient was discharged from the hospital.  The outcome of other events was not reported.  The reporter did not provide a causality assessment.  The events were assessed as serious due to hospitalization. Additionally, the events 'acute kidney injury' and urinary tract infection were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: An 87-year-old female patient experienced dehydration, urinary tract infection and acute kidney injury (AKI) approximately 3 weeks after vaccination with Fluad Quadrivalent and Pfizer BioNTech COVID-19 vaccines. Causality for the reported events is assessed as not related due to biological implausibility.; Sender's Comments: An 87-year-old female patient experienced dehydration, urinary tract infection and acute kidney injury (AKI) approximately 3 weeks after vaccination with Fluad Quadrivalent and Pfizer BioNTech COVID-19 vaccines. Causality for the reported events is assessed as not related due to biological implausibility.
Age: 87.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, UNK
Symptoms: Acute kidney injury, Dehydration, Urinary tract infection
Clinical narrative: Urinary tract infection; Dehydration; This spontaneous case from the was retrieved on 09-Mar-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2129154-1) reported by other healthcare professional and concerned an 87-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 08-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as '1', route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 312845.  On the same day, the patient was vaccinated with a non-company co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as '3', indication, route of administration and anatomical location: not reported). The batch number was not reported.  On 28-Oct-2021, 20 days after receiving Fluad Quadrivalent and  Pfizer BioNTech COVID-19 vaccine, the patient was admitted to emergency room for dehydration. The patient was found to have a urinary tract infection and received first dose of nitrofurantoin in the emergency department. The patent with remaining prescription was sent to the pharmacy.  On an unspecified date in 2021, the patient experienced acute kidney injury (AKI).  On 09-Nov-2021, the patient was admitted to hospital for 23 days.   On unspecified date in 2021, the patient recovered from AKI. AKI was resolved with hydration. The patient was stable off intravenous (IV) fluids although per oral (PO) intake was poor.  On 02-Dec-2021, the patient was discharged from the hospital.  The outcome of other events was not reported.  The reporter did not provide a causality assessment.  The events were assessed as serious due to hospitalization. Additionally, the events 'acute kidney injury' and urinary tract infection were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: An 87-year-old female patient experienced dehydration, urinary tract infection and acute kidney injury (AKI) approximately 3 weeks after vaccination with Fluad Quadrivalent and Pfizer BioNTech COVID-19 vaccines. Causality for the reported events is assessed as not related due to biological implausibility.; Sender's Comments: An 87-year-old female patient experienced dehydration, urinary tract infection and acute kidney injury (AKI) approximately 3 weeks after vaccination with Fluad Quadrivalent and Pfizer BioNTech COVID-19 vaccines. Causality for the reported events is assessed as not related due to biological implausibility.
Age: 3.0
Sex: F
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; administration of vaccines involved in a temperature excursion; This spontaneous report was received from a medical assistant referring to a 3-year-old female patient.  Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 16-FEB-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U024090, expiration date reported as 28-OCT-2022 but upon internal validation established as 28-OCT-2023, intramuscular in the left arm for prophylaxis (dose and vaccination scheme frequency were reported as "1") (product storage error). The patient had received 2 previous doses of the vaccine.         The vaccine was stored in a temperature of 1.35 degree Celsius for 1 hour as recorded by a data logger. There was no previous temperature excursion reported.  This is one of three reports received from the same reporter.