chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriage after receiving both doses of COVID19 vaccine; This is a spontaneous report received from Pfizer sponsored program from a contactable consumer reported for self. A female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient is pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient had a miscarriage after receiving both doses of COVID-19 vaccines. The patient received no treatment. The outcome of event was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in arm where shot was administered; This is a spontaneous report from a contactable consumer. A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in arm where shot was administered on an unspecified date. Outcome of event was unknown.     No follow-up attempts possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal
Clinical narrative: her blood test done and the result is different from her usual results; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 19Feb2021 at single dose for covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced her blood test done and the result is different from her usual results on an unspecified date with outcome of unknown.  No treatment received for the adverse event. The patient underwent lab tests and procedures which included blood test: abnormal. The patient did not receive other medications within 2 weeks of vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: Mild headache; mild upset stomach; tiredness; This is a spontaneous report from a contactable consumer(patient). The 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Feb2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced mild headache, mild upset stomach, and tiredness, all on an unspecified date(Feb2021) with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I am unwell; This is a spontaneous report from a Sponsored Program . A contactable consumer (patient) reported for herself that a female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced I was unwell (non-serious) on an unspecified date with outcome of unknown. Adverse event details: Her 1st Covid-19 Pfizer Vaccine shot on 23Jan, she was suppose to return on 13Feb but I am unwell, when she went to one of a hospital last Saturday they said she had to get the 2nd dose in the previous location.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Protein total, Protein total increased
Clinical narrative: elevated data protein after the vaccine; This is a spontaneous report received from a sponsored program. A contactable Physician reported for patient that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had an elevated data protein after the vaccine on an unspecified date with outcome of unknown and is inquiring if it is normal.  lot/batch number has been requested in follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tongue dry
Clinical narrative: Sore arm; Dryness on tip of tongue; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced Sore arm and dryness on tip of tongue, both on 2021. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Rash
Clinical narrative: Swollen right eye; Rash under the eye; Fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative.  A 33-years-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was administered the Pfizer Covid19 vaccine on 01Mar2021 and experienced a swollen right eye with a rash under the eye. He also said he experienced fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: a little more than a month later, I suspect my HPV has resolved or is resolving; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received second dose bnt162b2 (reported as PFIZER COVID VACCINE -19), intramuscular on 19Jan2021 at single dose for COVID-19 immunisation.  Medical history included Human papilloma virus infection (HPV) and external warts.  The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 on an unspecified date for COVID-19 immunization. The patient got second immunization 19Jan2021, a little more than a month later, the patient suspect his/her HPV has resolved or is resolving (the patient was making an appointment with his/her OBGYN to verify) The patient stated he/she was not saying it cured it but maybe the antiviral properties did help. His/her reason for suspecting was the patient had external warts that had all of a sudden resolved and minimized in size. The outcome of the event was unknown.  No follow-up attempts are needed. Information about to batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: Bones were hurting, but the pain was gone the next morning; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 27Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient received the 1st dose of Pfizer Covid-19 vaccine last Saturday (27Feb2021) during the night on 27Feb2021 after the 1st dose her bones were hurting, but the pain was gone the next morning on 28Feb2021. Her 2nd dose is scheduled on 27Mar2021. The outcome of the event was recovered on 28Feb2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19 positive; Covid-19 positive; This is a spontaneous report received from a Pfizer sponsored program Pfizer from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Feb2021 at single dose for COVID-19 immunization. Medical history included exposure to Covid-19 (her boyfriend was covid positive). Concomitant medications were not reported. The patient got Covid-19 positive as her boyfriend was covid positive. The patient had 1st dose last 18Feb2021 and 2nd dose will be on 11Mar2021. Boyfriend didn't take any vaccine. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid-19 positive; Covid-19 positive; This is a spontaneous report received from a Pfizer sponsored program Pfizer from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Feb2021 at single dose for COVID-19 immunization. Medical history included exposure to Covid-19 (her boyfriend was covid positive). Concomitant medications were not reported. The patient got Covid-19 positive as her boyfriend was covid positive. The patient had 1st dose last 18Feb2021 and 2nd dose will be on 11Mar2021. Boyfriend didn't take any vaccine. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable consumer who reported for himself via a sponsored program. A male patient of an unspecified age received his second single dose of bnt162b2 (Pfzier-BioNTech Covid-19 vaccine) in Feb2021 for Covid-19 immunization. The patient received his first dose of bnt162b2 on an unspecified date. The patient's medical history and concomitant medications were not reported. Since the second injection (Feb2021), the patient had complained that he had dizziness. He went to ENT and doctor and could find nothing wrong. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: still dizzy on and off; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for herself that a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received second dose last Thursday (25Feb2021) and yesterday (28Feb2021) was still dizzy on and off. Wanting to know if that's normal. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Nausea, Sinus headache
Clinical narrative: My neck is bothering; I was nauseas; had a little but of a sinus headache; This is a spontaneous report received from a Pfizer sponsored program Pfizer RXPathways from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the covid vaccine two weeks before and was going for second dose in a week. Patient's neck was bothering at the time of the report and wanted to take ibuprofen(ADVIL) or paracetamol(TYLENOL). The patient's question was number one could she or he take it and number two was it going to change the efficacy of the vaccine. Patient slept the wrong way, patient knew exactly what happened, he or she fell asleep with the TV on. Patient just want to take something to alleviate that, its her or his shoulder somewhere around there. Patient just slept the wrong way, he or she knew it when woke up. As far as the vaccine the patient was good with that. Patient took it with no reaction, second day patient was nauseas and had a little but of a sinus headache, drank a can of soda and a little grits and patient was fine and been fine since. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Presyncope
Clinical narrative: felt like I was ready to collapse; increased effort to breathe; I have been deathly sick for two weeks; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported different events after different doses of vaccine. This is the second of 2 reports. This 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. After the first dose of the BNT162B2 vaccine, given on 28Jan2021, the patient experienced dizziness, dry cough, sneezing, no taste, nausea, tiredness and headache. After the second dose, the patient reported that "it elevated completely". The patient stated that on an unspecified date after the second dose "I have been deathly sick for two weeks". She reported also an increased effort to breathe and "felt like I was ready to collapse". The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021245359 same patient, different dose/AE
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: She died 5 days after her second vaccine; This is a spontaneous report from a contactable consumer.   An 83-year-old female patient (Not pregnant) received the second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not provided), via an unspecified route of administration in the left arm on 12FEB2021 at 03:00 PM (at the age of 83-years-old) at single dose for covid-19 immunisation. The subject had a history of Heart condition and thyroid.  Relevant concomitant medications included calcium, fish oil, multivitamin and potassium. The patient died on 16Feb2021 (12:00 PM), 5 days after her second dose of vaccine (as reported). The cause of patient's death was unknown. She had no adverse effects until her death. It was unknown if autopsy was performed.   Information on batch/lot number was requested.; Reported Cause(s) of Death: She died 5 days after her second vaccine
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death 5 days after 2nd Pfizer vaccine
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Rhinorrhoea
Clinical narrative: watery eyes; runny nose; slight headache; This is a spontaneous report from a contactable consumer.    A 74-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 25Feb2021 for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2) on 01Feb2021 for COVID-19 immunisation and she experienced she passed out and fell to the floor before daylight and dizziness on 01Feb2021.  The patient experienced watery eyes, runny nose and slight headache in 2021. No treatment was received. No admission to hospital due to the events. The outcome of events was recovered in 2021, she was fine now.  Information about lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Rhinorrhoea
Clinical narrative: watery eyes; runny nose; This is a spontaneous report from a contactable consumer.   A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 30Jan2021 for COVID-19 immunisation, administered at hospital.  The patient medical and concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (BNT162B2) on 04Jan2021 (also reported as 07Jan2021) for COVID-19 immunisation, administered at hospital and the reporter did not indicate that he had any side effects.  The patient experienced watery eyes and runny nose in 2021. He did not experience any headache. No treatment was received. No admission to hospital due to the events. The outcome of events was recovered in 2021, he was fine now.    Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Chest pain, Fatigue
Clinical narrative: some kind of back pain, behind her heart; heart pain; pretty strong chest pain; fatigue caused by the vaccine was so profound; This is a spontaneous report received from a contactable consumer(reporting for her daughter) A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 expiry date 31Mar2021 via an unspecified route of administration on 08Jan2021 (at the age of 29-year-old) at single dose for COVID-19 immunisation. The first dose of bnt162b2 was taken on 17Dec2020. The patient's medical history included bipolar disorder. Concomitant medications included quetiapine (QUETIAPINE). The patient experienced some kind of back pain, behind her heart, heart pain and pretty strong chest pain on 08Jan2021 with outcome of recovered. In addition experienced "fatigue caused by the vaccine was so profound that was advised to not take her bipolar medication, quetiapine" on an unspecified date with outcome of recovered. It was reported that "It took 36 hours for the extreme fatigue to stop. This was very frightening because being without the medication could cause auditory hallucinations to return after 36 hours. There should be a warning for people who must take sedative medication regularly so that they can make an informed decision about whether or not to receive the vaccine".
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Muscular weakness, Pain in extremity
Clinical narrative: This case involved a 39-year old female patient who experienced joint pain (arthralgia), weakness in right arm (muscular weakness), Saturday moved to right knee and foot, Saturday evening went to her back (pain in extremity), Saturday evening went to her back (back pain) and Saturday moved to right knee and foot (arthralgia), while patient received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 25-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, injection (lot number: UT7000DA and expiry date: unknown) via an intramuscular route at an unknown administration site for prophylactic vaccination. Suspect vaccine was administered with medical device FLUZONE QUADRIVALENT PRE-FILLED SYRINGE. On 25-Sep-2020, the patient experienced joint pain (arthralgia) and weakness in right arm (muscular weakness), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 26-Sep-2020, the patient on Saturday moved to right knee and foot, Saturday evening went to her back (pain in extremity), Saturday evening went to her back (back pain), 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient on Saturday moved to right knee and foot (arthralgia, (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. The outcome was reported as unknown for all events.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Muscular weakness, Paraesthesia
Clinical narrative: This case involves a 27 year old female patient who experienced injection left hand started to tingle (paraesthesia), left arm weak (muscular weakness) and injection site warm to the touch (vaccination site warmth), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient had no medical history, concomitant disease or risk factor. Medical treatment, vaccination, concomitant medication and family history were not provided. On 06-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7000DA and expiry date: not reported) (Injection) via an intramuscular route in the left deltoid for prophylactic vaccination. On 06-Oct-2020, the patient developed a non-serious injection left hand started to tingle (paraesthesia) and left arm weak (muscular weakness), (also reported that 20 minutes) on same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. In Oct-2020, the patient developed a non-serious injection site warm to the touch (vaccination site warmth) (few day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported that It was unknown if patients physician provided consent to be contacted. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the patient had not recovered from the paraesthesia (also reported that today left hand still tingling) and the outcome of event muscular weakness and vaccination site warmth was reported as unknown.
Age: 9.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: patient received Adacel vaccine at the age of 9 years and 10 months in error which should be administered at 11 years of age/no AE; Initial information regarding an unsolicited valid non-serious case was received on 25-Feb-2021 from a Nurse via Agency (Reference number- 00493530) and transmitted to Sanofi on 25-FEB-2021.  This case involves a 9 years 10 months old female patient who was vaccinated with first dose 0.5 mL DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [Strength- Standard] in error which should be administered at 11 years of age (batch number and expiry date not reported) lot number not reported via unknown route in unknown administration site for prophylactic vaccination on 01-Jul-2016 (Inappropriate schedule of product administration).  At the time of reporting, the patient was 14 year-old and the nurse asked if patient could receive next Adacel vaccine.  The patient's past vaccination(s) included TD and DTAP for prophylactic vaccination. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  No adverse event reported at the time of reporting.  Reporter wanted to know if they need to revaccinate the patient at 11 years old. Nurse was at lunch at the time of the call. Left contact information with the front desk. If the nurse calls back, it was mentioned please provide information from "Catch Up Schedule" standard. It was not sure if it was relevant as it sounded like from the call that the patient may have already had her TD and DTAP vaccines for prophylactic vaccination  Product used: Used; First time product used: Yes; Still using product: No  It was a case of actual medication error due to inappropriate schedule of product administration (latency was on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; PROQUAD that underwent a temperature excursion was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.   On 16-FEB-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027115, expiration date was 07-FEB-2022, dose, strength and route were not provided) for prophylaxis.         Temperature excursion of this vaccine was -10 degrees Celsius to 8 degrees Celsius (-3.7 degrees Celsius) for 22 hours without any previous temperature excursion. The digital data logger was involved. No additional adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebral infarction, Deafness neurosensory, Dizziness, Headache, Hypertension
Clinical narrative: cerebral infarction/Dizziness and Giddiness/blurry vision, altered speech, headache, difficulty with speech; hypertension; Meniere's Disease affecting the left ear/ moderate Sensorineural Hearing Loss in left ear; severe Sensorineural Hearing Loss in right ear; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 14-JAN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered blurry vision, altered speech, headache, difficulty with speech and was diagnosed with dizziness and giddiness, hypertension, cerebral infarction, severe sensorineural hearing loss in right ear and moderate sensorineural hearing loss in left ear and Meniere's Disease affecting the left ear. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was not recovered. The causality assessment was considered as related by the lawyer.  All the aforementioned events were considered to be disabling by the lawyer. Upon internal review, cerebral infarction, severe sensorineural hearing loss in right ear and moderate sensorineural hearing loss in left ear and Meniere's disease were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Meniere's disease, Speech disorder, Vision blurred
Clinical narrative: cerebral infarction/Dizziness and Giddiness/blurry vision, altered speech, headache, difficulty with speech; hypertension; Meniere's Disease affecting the left ear/ moderate Sensorineural Hearing Loss in left ear; severe Sensorineural Hearing Loss in right ear; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 14-JAN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered blurry vision, altered speech, headache, difficulty with speech and was diagnosed with dizziness and giddiness, hypertension, cerebral infarction, severe sensorineural hearing loss in right ear and moderate sensorineural hearing loss in left ear and Meniere's Disease affecting the left ear. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was not recovered. The causality assessment was considered as related by the lawyer.  All the aforementioned events were considered to be disabling by the lawyer. Upon internal review, cerebral infarction, severe sensorineural hearing loss in right ear and moderate sensorineural hearing loss in left ear and Meniere's disease were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Frontal lobe epilepsy
Clinical narrative: Pneumonia Hypoxemia; Pneumonia Hypoxemia; exacerbation of Chronic Obstructive Pulmonary Disease; Metabolic Encephalopathy; frontal lobe seizures; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 03-MAR-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered chest pain, shortness of breath, altered mental status and was diagnosed with pneumonia hypoxemia, exacerbation of chronic obstructive pulmonary disease, metabolic encephalopathy and frontal lobe seizures. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  All the events were considered to be disabling by the lawyer. Upon internal review, pneumonia hypoxemia, metabolic encephalopathy and frontal lobe epilepsy were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoxia, Mental status changes, Metabolic encephalopathy, Pneumonia
Clinical narrative: Pneumonia Hypoxemia; Pneumonia Hypoxemia; exacerbation of Chronic Obstructive Pulmonary Disease; Metabolic Encephalopathy; frontal lobe seizures; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 03-MAR-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered chest pain, shortness of breath, altered mental status and was diagnosed with pneumonia hypoxemia, exacerbation of chronic obstructive pulmonary disease, metabolic encephalopathy and frontal lobe seizures. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  All the events were considered to be disabling by the lawyer. Upon internal review, pneumonia hypoxemia, metabolic encephalopathy and frontal lobe epilepsy were determined to be medically significant.
Age: 50.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Ill-defined disorder, Vaccination site discomfort
Clinical narrative: his arms were "killing him"; having discomfort at the injection sites; This spontaneous report was received from a consumer, referring to her husband, a 50-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 04-MAR-2021, the patient received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) (strengths, vaccination schemes, routes of administration, lot numbers and expiration dates were not reported) vaccines in different arms.  On the same date, the patient's arms were "killing him" (ill-defined disorder) and he was having discomfort at the injection sites (vaccination site discomfort).  The outcome of ill-defined disorder and vaccination site discomfort, and the causal relationship between the aforementioned events and the suspect therapies were not reported.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Erythema, Eye swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: My eyes are a mess / Skin around my eyes became very red; Fever; My eyes are still swollen; 5 days after the shot I got COVID; This case was reported by a consumer via call center representative and described the occurrence of erythema periorbital in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th August 2020, refer case US2021AMR007178).   On 29th November 2020, the patient received the 2nd dose of Shingrix. In December 2020, an unknown time after receiving Shingrix, the patient experienced coronavirus infection. On an unknown date, the patient experienced erythema periorbital, fever and eye swelling. On an unknown date, the outcome of the erythema periorbital, fever and coronavirus infection were unknown and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the erythema periorbital, fever, coronavirus infection and eye swelling to be related to Shingrix.  Additional details were provided as follows: With 1st dose of Shingrix, the patient had an eye reaction and doctor did not think it was due to the vaccine. It lasted on and off about a month or more. The patient stated his/her eyes were a mess. The patient got a fever and the skin around eyes became very red. Five days after vaccination, the patient had COVID and eyes were still swollen. Less than 2 months after vaccination, the patient had erythema periorbital, fever and eye swelling. The patient asked for antidote.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR007178:Same reporter US-GLAXOSMITHKLINE-US2021AMR007178:same reporter
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Lymphadenopathy, Mobility decreased, Nodule
Clinical narrative: swollen lymph node; grape size lump on the back; arm pain / I couldn't even use it.; feel like i was hit by a bus; arm pain / I couldn't even use it.; food like symptoms; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine with an associated reaction of pain in extremity (received shingrix on an unknown date, refer case US2021AMR028925).   On 3rd February 2021 19:30, the patient received the 2nd dose of Shingrix. On 3rd February 2021 21:30, 2 hrs after receiving Shingrix, the patient experienced enlargement of lymph nodes and skin mass. In February 2021, the patient experienced pain in arm, feeling abnormal, mobility decreased and influenza-like symptoms. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the enlargement of lymph nodes, pain in arm, feeling abnormal, mobility decreased, influenza-like symptoms and skin mass were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, feeling abnormal, mobility decreased, influenza-like symptoms and skin mass to be related to Shingrix.  Additional details were provided as follows: The patient received the shingles vaccine the second one last night of reporting at 7:30 pm and experienced flu like symptoms. The patient stated that which was not concern. The patient was curious to know if that vaccine could cause a swollen lymph node and if it was common. The patient had a swollen lymph node on the left side back of my neck between the head and the shoulder started at 9:30 pm. The patient felt like hit by a bus. The patient experienced arm  pain on a scale of 1 to 10 the pain in my arm was a 7. The patient couldn't even use the arm. The patient was very stubborn to take medicine for pain because the patient  believed pain was what keeps you from overdoing things. But in this case the patient actually need furry Tylenol.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028925:same reporter
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin mass
Clinical narrative: swollen lymph node; grape size lump on the back; arm pain / I couldn't even use it.; feel like i was hit by a bus; arm pain / I couldn't even use it.; food like symptoms; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine with an associated reaction of pain in extremity (received shingrix on an unknown date, refer case US2021AMR028925).   On 3rd February 2021 19:30, the patient received the 2nd dose of Shingrix. On 3rd February 2021 21:30, 2 hrs after receiving Shingrix, the patient experienced enlargement of lymph nodes and skin mass. In February 2021, the patient experienced pain in arm, feeling abnormal, mobility decreased and influenza-like symptoms. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the enlargement of lymph nodes, pain in arm, feeling abnormal, mobility decreased, influenza-like symptoms and skin mass were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, feeling abnormal, mobility decreased, influenza-like symptoms and skin mass to be related to Shingrix.  Additional details were provided as follows: The patient received the shingles vaccine the second one last night of reporting at 7:30 pm and experienced flu like symptoms. The patient stated that which was not concern. The patient was curious to know if that vaccine could cause a swollen lymph node and if it was common. The patient had a swollen lymph node on the left side back of my neck between the head and the shoulder started at 9:30 pm. The patient felt like hit by a bus. The patient experienced arm  pain on a scale of 1 to 10 the pain in my arm was a 7. The patient couldn't even use the arm. The patient was very stubborn to take medicine for pain because the patient  believed pain was what keeps you from overdoing things. But in this case the patient actually need furry Tylenol.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028925:same reporter
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: cough; Sore throat; This case was reported by a consumer and described the occurrence of cough in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced cough and sore throat. On an unknown date, the outcome of the cough and sore throat were unknown.   It was unknown if the reporter considered the cough and sore throat to be related to Shingrix.  Additional details were reported as follows: Last week, the patient received Shingrix in the right arm, she was not sure of the dates but stated it was most probably on 22nd February 2021. The reporter did not have lot or expiry date of Shingrix. No other information was available.
Sex: F
Vaccine: MENB
Symptoms: Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: she got cold; has fewer; running nose; This case was reported by a consumer via interactive digital media and described the occurrence of cold in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced cold, fever and runny nose. On an unknown date, the outcome of the cold, fever and runny nose were not recovered/not resolved.   It was unknown if the reporter considered the cold, fever and runny nose to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. This case was reported by the patient's parent. Vaccination date for 1st dose was discrepantly reported as 4th March 2021. The reporter stated that 2nd dose should be given on 4th March 2021 (at least 2 weeks) but the patient got cold now and the patient had fever and running nose for few days. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: "More reactions" than usual / reported-diarrhea; This case was reported by a physician via call center representative and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The reporter stated that the patient received the dose of Shingrix and experienced diarrhea.as opposed to the usual muscle pain and fever The reporter asked information about Shingrix recall and mentioned that they had none to return and was not sure if she had any from the lots that were affected, she also asked what was the risk to the patient. The reporter was not certain though if the reaction was from the Shingrix nor if they were of the same batch of recalled Shingrix. The reporter did not consented to follow up. The reporter did not have any additional information regarding the events or the patients (demographics). This case was linked with US2021057184 and US2021AMR057596 reported by the same reporter. Note- Since the reporter was just inquiring about recall of Shingrix and Hub also added comment about the same, no event about product recall has been coded. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021057184:Same reporter. Patient #1. US-GLAXOSMITHKLINE-US2021AMR057596:Same reporter. Master case "several pts".
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: rash after her first Shingrix dose; hives and rash after her first Shingrix dose; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and hives. The action taken with Shingrix was unknown. On an unknown date, the outcome of the rash and hives were unknown.   It was unknown if the reporter considered the rash and hives to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. The reporter declined to provide patient information. The reporter did not consent to follow up. The case has been  linked with case US2021056506, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021056506:same reporter