chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure). At the time of the report, HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure) outcome was unknown.            Patient was on three ongoing concomitant medications (unknown name). Treatment information was not reported.  Patient stated that she had lab test high blood pressure but result were not reported. Patient received the booster dose of the Moderna COVID19 vaccine on 9 Dec 2021 and 13 minutes after she started with a high blood pressure reaction and she had to go to the hospital for this situation.  This is a regulatory authority case concerning  a  61-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Hypertension. The event occurred on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as runknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning  a  61-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Hypertension. The events occurred on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as runknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Malaise, Nasopharyngitis
Clinical narrative: Cannot make his appointment for today, because he is sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 01Mar2021 (Lot number: EN6200) at the age of 68 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Cannot make his appointment for today, because he is sick".  Additional information: The reporter was calling to reschedule as her husband could not make his appointment because he was sick.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: Cannot make his appointment for today, because he is sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 01Mar2021 (Lot number: EN6200) at the age of 68 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Cannot make his appointment for today, because he is sick".  Additional information: The reporter was calling to reschedule as her husband could not make his appointment because he was sick.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory symptom, Syncope
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Confusional state, Dizziness, Dysphagia
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Hyperhidrosis, Hyperventilation, Syncope
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Pain in extremity, Peripheral swelling, Ultrasound scan normal
Clinical narrative: Patient developed right arm pain and swelling. Started about 24 hours after vaccine. Recieved medrol dose pack, antihistamine. Pain and swelling improving.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red patch below injection site of shot. Feels slightly warm to touch and painful when touched.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Rash, Tenderness
Clinical narrative: Rash in certain spots around my body, that are red and painful to the touch just like the shot area pain and redness, the spots that are red hurts a lot.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Fall, Head injury, Syncope
Clinical narrative: Passed out while walking back to bed. Made it a few steps then fell and hit head on floor. Went to ER, diagnosed with head injury and syncope with negative head and neck CT.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Following morning, woke up and felt lightheaded, and fainted twice. Lost consciousness.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood prolactin increased, Cystitis interstitial, Cystitis noninfective, Menstrual disorder, Walking aid user
Clinical narrative: My menstrual cycle stopped after vaccine for Covid. We did find my prolactin level is high. Then in June, Previous diagnosis, I begin having inflammation in my bladder and  Interstitial Cystitis. I'm reduced to using a cane and have disposable diapers.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Lymphadenopathy, Malaise, Pain
Clinical narrative: I received my booster shot on December 15. 2021. That same night, the site of the vaccine which was my left arm got swollen like a lymphatic node. Body aches and just some unwell feelings. That kept me off work for about 4 days, and 6 days later, I started to feel numbness and tingling feeling beneath my left breast coming down to my left side stomach and back. It feels like you had placed ice on my skin for a while and took it off. All just on my left side.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site swelling
Clinical narrative: I received my booster shot on December 15. 2021. That same night, the site of the vaccine which was my left arm got swollen like a lymphatic node. Body aches and just some unwell feelings. That kept me off work for about 4 days, and 6 days later, I started to feel numbness and tingling feeling beneath my left breast coming down to my left side stomach and back. It feels like you had placed ice on my skin for a while and took it off. All just on my left side.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time normal, Antibody test, Coagulation time, Double stranded DNA antibody, Lupus nephritis
Clinical narrative: systemic lupus erythematosis nephritis
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: systemic lupus erythematosis nephritis
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Balance disorder, Blood test, Computerised tomogram, Dizziness
Clinical narrative: Neurological Disorder(s); Prior to the second inoculation of the Pfizer COVID-19 vaccination, the recipient was a healthy 44yo female, with an unremarkable medical history. Seven days following the inoculation, the recipient sustained severe headache, neck pains, body aches, fever, blurred vision, dizziness, unsteadiness, and the inability to walk due to initial onset of inoculation side effects. The recipient continues to now suffer chronic blurred vision, unsteadiness, and other vestibular system problems due to the Pfizer COVID-19 vaccine. Continued medical treatment is still being conducted, all while the recipient has been unable to work due to disabling side effects.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Impaired work ability, Laboratory test, Magnetic resonance imaging
Clinical narrative: Neurological Disorder(s); Prior to the second inoculation of the Pfizer COVID-19 vaccination, the recipient was a healthy 44yo female, with an unremarkable medical history. Seven days following the inoculation, the recipient sustained severe headache, neck pains, body aches, fever, blurred vision, dizziness, unsteadiness, and the inability to walk due to initial onset of inoculation side effects. The recipient continues to now suffer chronic blurred vision, unsteadiness, and other vestibular system problems due to the Pfizer COVID-19 vaccine. Continued medical treatment is still being conducted, all while the recipient has been unable to work due to disabling side effects.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Nervous system disorder, Pain, Pyrexia, Vestibular disorder
Clinical narrative: Neurological Disorder(s); Prior to the second inoculation of the Pfizer COVID-19 vaccination, the recipient was a healthy 44yo female, with an unremarkable medical history. Seven days following the inoculation, the recipient sustained severe headache, neck pains, body aches, fever, blurred vision, dizziness, unsteadiness, and the inability to walk due to initial onset of inoculation side effects. The recipient continues to now suffer chronic blurred vision, unsteadiness, and other vestibular system problems due to the Pfizer COVID-19 vaccine. Continued medical treatment is still being conducted, all while the recipient has been unable to work due to disabling side effects.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Neurological Disorder(s); Prior to the second inoculation of the Pfizer COVID-19 vaccination, the recipient was a healthy 44yo female, with an unremarkable medical history. Seven days following the inoculation, the recipient sustained severe headache, neck pains, body aches, fever, blurred vision, dizziness, unsteadiness, and the inability to walk due to initial onset of inoculation side effects. The recipient continues to now suffer chronic blurred vision, unsteadiness, and other vestibular system problems due to the Pfizer COVID-19 vaccine. Continued medical treatment is still being conducted, all while the recipient has been unable to work due to disabling side effects.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemorrhage, Menopause, Menstrual disorder, Migraine
Clinical narrative: I have been menopausal for 2.5 years, and two weeks and six weeks after the booster I started bleeding again.  I have had two menstrual cycles that have lasted 10-12 days each, which is long for even before I was menopausal. All the usual issues with menstruation that I used to have accompanied these menstrual cycles: moodiness, ocular migraine, exhaustion, sleep disturbance, nausea, cravings, etc.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Nausea, Oligomenorrhoea, Sleep disorder
Clinical narrative: I have been menopausal for 2.5 years, and two weeks and six weeks after the booster I started bleeding again.  I have had two menstrual cycles that have lasted 10-12 days each, which is long for even before I was menopausal. All the usual issues with menstruation that I used to have accompanied these menstrual cycles: moodiness, ocular migraine, exhaustion, sleep disturbance, nausea, cravings, etc.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Heart rate increased, Hyperhidrosis, Palpitations, Syncope
Clinical narrative: After I received the shot, I was told to wait 15 minutes to be monitored.  A short time later, everything was getting dark.  I blacked out for a unknow amount of time.  I just remember waking up to the pharmacist and a technician asking me if I was ok and rubbing my arm.  I was given a bottle of water and a mint.  I was weak, dark vision, and sweaty.  I was walked to a recliner chair where I was monitored again.  I stayed there until my weakness left and my vision was normal, maybe 10-15 minutes longer.  My heart rate seemed to be elevated and beating harder, even 6 hours after the shot.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: After I received the shot, I was told to wait 15 minutes to be monitored.  A short time later, everything was getting dark.  I blacked out for a unknow amount of time.  I just remember waking up to the pharmacist and a technician asking me if I was ok and rubbing my arm.  I was given a bottle of water and a mint.  I was weak, dark vision, and sweaty.  I was walked to a recliner chair where I was monitored again.  I stayed there until my weakness left and my vision was normal, maybe 10-15 minutes longer.  My heart rate seemed to be elevated and beating harder, even 6 hours after the shot.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Heart rate increased, Heart rate irregular
Clinical narrative: After I received the shot, I was told to wait 15 minutes to be monitored.  A short time later, everything was getting dark.  I blacked out for a unknow amount of time.  I just remember waking up to the pharmacist and a technician asking me if I was ok and rubbing my arm.  I was given a bottle of water and a mint.  I was weak, dark vision, and sweaty.  I was walked to a recliner chair where I was monitored again.  I stayed there until my weakness left and my vision was normal, maybe 10-15 minutes longer.  My heart rate seemed to be elevated and beating harder, even 6 hours after the shot.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Pain, Pain in extremity
Clinical narrative: After I received the shot, I was told to wait 15 minutes to be monitored.  A short time later, everything was getting dark.  I blacked out for a unknow amount of time.  I just remember waking up to the pharmacist and a technician asking me if I was ok and rubbing my arm.  I was given a bottle of water and a mint.  I was weak, dark vision, and sweaty.  I was walked to a recliner chair where I was monitored again.  I stayed there until my weakness left and my vision was normal, maybe 10-15 minutes longer.  My heart rate seemed to be elevated and beating harder, even 6 hours after the shot.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: After I received the shot, I was told to wait 15 minutes to be monitored.  A short time later, everything was getting dark.  I blacked out for a unknow amount of time.  I just remember waking up to the pharmacist and a technician asking me if I was ok and rubbing my arm.  I was given a bottle of water and a mint.  I was weak, dark vision, and sweaty.  I was walked to a recliner chair where I was monitored again.  I stayed there until my weakness left and my vision was normal, maybe 10-15 minutes longer.  My heart rate seemed to be elevated and beating harder, even 6 hours after the shot.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Skin test positive, Urticaria
Clinical narrative: Allergy- Welts, hives, itching
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Developed hives and dermatographia exactly 10 days after moderna booster. Both are now considered chronic since they have lasted more than 6 weeks. On daily antihistamines to be able to function and sleep through the itch and discomfort.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bone marrow oedema, Cervical spinal stenosis, Demyelination, Hypoaesthesia, Magnetic resonance imaging head abnormal
Clinical narrative: Numbing and tingling in head and face. Started on 8/1/21, 4 months after receiving vaccine. Sensation was primary on left side of head and face, but now is entire head and face. Symptoms have not stopped at all. They vary in intensity all throughout the day.  Seen my p.c.p. who referred me to a neurologist. Had a brain and cervical spine mri with and without dye. Appts with neurologist are still on going to rule out other possibilities. Also seen eye physician to rule out optic neuritis. I don't know for sure that it's vaccine related, but I am trying to get to the bottom of what is causing this.  I need help.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Migraine, Nervous system disorder, Neurological examination, Paraesthesia
Clinical narrative: Numbing and tingling in head and face. Started on 8/1/21, 4 months after receiving vaccine. Sensation was primary on left side of head and face, but now is entire head and face. Symptoms have not stopped at all. They vary in intensity all throughout the day.  Seen my p.c.p. who referred me to a neurologist. Had a brain and cervical spine mri with and without dye. Appts with neurologist are still on going to rule out other possibilities. Also seen eye physician to rule out optic neuritis. I don't know for sure that it's vaccine related, but I am trying to get to the bottom of what is causing this.  I need help.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal stenosis, Spinal osteoarthritis, Vasculitis, Vertebral osteophyte
Clinical narrative: Numbing and tingling in head and face. Started on 8/1/21, 4 months after receiving vaccine. Sensation was primary on left side of head and face, but now is entire head and face. Symptoms have not stopped at all. They vary in intensity all throughout the day.  Seen my p.c.p. who referred me to a neurologist. Had a brain and cervical spine mri with and without dye. Appts with neurologist are still on going to rule out other possibilities. Also seen eye physician to rule out optic neuritis. I don't know for sure that it's vaccine related, but I am trying to get to the bottom of what is causing this.  I need help.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Weight decreased
Clinical narrative: I have had nausea and severe diarrhea since receiving the shot almost a week ago, resulting in stomach pain and weight loss.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Pain in the arm; Headache; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm right, administration date 25Mar2021 09:15 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Mar2021 16:00, outcome "recovered" (Mar2021), described as "Pain in the arm"; HEADACHE (non-serious) with onset 25Mar2021 16:00, outcome "recovered" (Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 25Mar2021 16:00, outcome "recovered" (Mar2021), described as "Tiredness". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue. Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination.  No follow-up attempts are possible, information on the batch/lot number could not be obtained. No further information is expected.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided about AE; Caller was unsure if the PROQUAD that was involved in the temperature excursion was administered; This spontaneous report has been received from a registered nurse referring to an unspecified patient of unreported age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the reporter was unsure if the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), 0.5 milliliters (ml) was possibly administered after a temperature excursion (product storage error) (lot# U019288 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 15-DEC-2022) (vaccination schemes, frequencies, routes of administration and anatomical site of vaccination were not reported) for prophylaxis. The excursion occurred on 15-NOV-2021. No additional information provided about adverse event (AE) or about patient demographics was reported.   This case was considered non-valid due the lack of patient's identifiers.  On 25-JAN-2022, an inbound call was received from the reporter. It was confirmed the company fax number and also provided a Company mailing address.  Follow up information has been received from the reporter on 25-JAN-2022. The case was changed to a valid case (previously reported as non-valid). It was confirmed on 01-DEC-2021, the vaccine was administered to a 5 years old female patient: 0.5 milliliter, subcutaneously. The vaccine administration information was added. The vaccine was used according to the instruction leaflet. The temperature in freezer out of range for less than 3 hours. The reported was advised not to use this vaccine and repointed any additional temperature excursion immediately to Company. There was no other temperature excursion.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events; Administration of expired dose of MMR Il; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 20-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (expired product administered) (lot number# S036663 has been verified to be a valid lot number, expiration date was reported and established as 14-NOV-2021, therapy type: rHA; dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis. The nurse inquired viability information.   No additional adverse events were reported.  This case was considered non-valid due the lack of patient's identifiers.  Follow up information was received from the nurse on 19-JAN-2022. The patient was a 44 years old male. Concurrent conditions included adult-onset Huntington disease (AOHD), bipolar, cervical disc disease, gastrooesophageal reflux disease (GERD), depression, Cannabis use (disorder) and erection disorder. Historical condition included anxiety. Concomitant therapies included pantoprazole and epoprostenol sodium (FLOLAN). There were no other vaccines within 4 weeks prior to administration of the expired vaccine. The medical assistant misread the expiration date on the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) vaccine, and the expired vaccine was given to the patient as first dose subcutaneously on the left upper arm (product administered to patient of inappropriate age). No illness at time of vaccination. No digital data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-DEC-2021, the patient received 1 dose of incorrectly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot #t042014 with expiration date on 23-JUL-2023, administered for prophylaxis (site and route of administration were not provided).   The vaccine underwent temperature excursion of 35.4 Fahrenheit degrees for 5 hours, 34.5 Fahrenheit degrees for 17 hours, 34.3 Fahrenheit degrees for 10 hours and 34.8 Fahrenheit degrees for 2 hours. No adverse event was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA010220:
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 71-year-old patient (pt) of unknown gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 07-JUL-2016, the pt was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist at the pharmacy. Subsequently, on an unknown date, the pt was treated by a physician at the clinic for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): shingles and other zoster-related conditions. The outcome of the shingles and other zoster- related conditions was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 46.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She is currently 46 years old and states that she was advised to get GARDASIL 9; No additional information; This spontaneous report was received from a 46-year-old female patient, who was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On an unknown date, after the patient's husband was diagnosed with head/neck cancer, she was advised to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (it was not specified who advised it). Therefore, on unknown dates, the patient was vaccinated with the first and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route and anatomical location of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). The patient reported that the first 2 doses of vaccine were covered by insurance but the third dose was not covered and the insurance company was requiring documentation supporting its necessity in this situation. No additional information was provided (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Frustration tolerance decreased, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; painful; frustrating; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and frustration. On an unknown date, the outcome of the vaccination failure, shingles, pain and frustration were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and frustration to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was vaccinated and had shingles for third time at the time of reporting.  The patient stated that, it was so frustrating and painful.  This time the patient had shingles beside eye. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided. Note: From the narrative it was not clear if the patient had shingles three times after taking vaccine or not, hence shingle was coded only once.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles twice; shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Couple of months after receiving Shingles vaccine, the patient got shingles and he/she had them once again since. The patient would have them worse without it, but he/she was not convinced. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had shingles and had shingles shots years ago from the date of reporting. After receiving Shingles vaccine, the patient got shingles while in the hospital and lasted for weeks. The patient thought he/she would never get shingles again and stated that, they drive you crazy. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; burning  left side of back; stinging pain on the left side of back; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In January 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and back pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and back pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles, 2 weeks ago from the date of reporting. The patient never got the rash but experienced the burning, stinging pain on the left side of back. The patient was told this was internal shingles.  The patient enquired, if there was anything to help with the pain, had anyone else had shingles with no rash and anything they took to reduce the pain. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had planned to get the Shingles vaccine and waited too long. The patient received Shingles vaccine and recommended everyone to did so, as soon as possible. After receiving Shingles vaccine, the patient got shingles in July or August 2020 and it was the worst pain he/she ever experienced. The patient advised his/her sister to get the vaccine and 5 months later she got shingles, again, because she delayed getting the vaccine. The patient stated that, never let this be the way anyone got it. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This case had been linked with case US2021AMR199640, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199640:Replied comment case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Has shingles 3 times since; Has shingles 3 times since; Has shingles 3 times since; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, shingles and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles 3 times. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: received a dose of Boostrix at a pharmacy and is pregnant; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. The patient's last menstrual period was on an unknown date and estimated date of delivery was 25th January 2021. The patient received Boostrix at an unknown time during the pregnancy. On an unknown date, unknown after receiving Boostrix, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   Additional details were provided as follows: The pregnant patient received Boostrix, which led to vaccine exposure during pregnancy. The reporter did not had lot number. The reporter consented to follow up.   Follow up information received from consumer on 24th January 2022: This pregnancy is now considered as lost to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 3 years ago first dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received 3 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional from a doctor´s office called to report that the patient received 3 years ago Engerix-B first dose and did not completed rest doses, which led to incomplete course of vaccination. The reporter was in a rush ate the moment of the call so she requested a Follow-Up by postal. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose on 2019, never got 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th December 2019, batch number JNKR, expiry date 29th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional reported that, the patient received first dose of Shingrix and never had 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. This is one of the two cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 2019, never got 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd August 2019, batch number AC79X, expiry date 17th October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional reported that, the patient received 1st dose of Shingrix and never got the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. This is one of 2 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for 2nd dose,  1st dose administrated on  2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was late for the second dose of Shingrix and till the reporting time did not receive it, which led to incomplete course of vaccination. The first dose was administrated and no adverse event was reported . No patient's identifiers provided and no lot number and expiration date provided. The reporter did not consent to follow-up.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: adult patient received pediatric instead of adult dose; adult patient received pediatric instead of adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 44-year-old female patient who received HAV (Havrix pediatric) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received in June 2021).   On 17th December 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 17th December 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   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 provided as follows: The registered nurse reported that, the adult patient received pediatric dose of Havrix in error, which led to accidental underdose and adult use of a child product. This dose was given as a booster. The reporter consented to follow up. The case is one of four cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021247333:Same reporter US-GLAXOSMITHKLINE-US2018GSK027335:Same reporter US-GLAXOSMITHKLINE-US2018014434:Same reporter