chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Inappropriate schedule of product administration, Injection site pain, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: I received the J & J vaccine on 4/11/21 and on 12/30/21 when I had COVID-19 I got a very intense pain in my left arm where the vaccine was administered. It became tingly and like pins and needles were going down my arm, into my elbow, forearm, and up into my neck only on my left side. It was worse at night and felt like my entire arm was asleep and would not wake up. Very painful and uncomfortable. Also extreme fatigue in left arm, and a tingling cold sensation in my brachial plexus. When a dull ache moved into my left chest, I went to the ER on 1/23/22. No cause was found but the nerve pain continues. I am suspicious it could be Parsonage Turner Syndrome or another syndrome related to Guillain - Barre Syndrome.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Neuralgic amyotrophy, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I received the J & J vaccine on 4/11/21 and on 12/30/21 when I had COVID-19 I got a very intense pain in my left arm where the vaccine was administered. It became tingly and like pins and needles were going down my arm, into my elbow, forearm, and up into my neck only on my left side. It was worse at night and felt like my entire arm was asleep and would not wake up. Very painful and uncomfortable. Also extreme fatigue in left arm, and a tingling cold sensation in my brachial plexus. When a dull ache moved into my left chest, I went to the ER on 1/23/22. No cause was found but the nerve pain continues. I am suspicious it could be Parsonage Turner Syndrome or another syndrome related to Guillain - Barre Syndrome.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb
Clinical narrative: I received the J & J vaccine on 4/11/21 and on 12/30/21 when I had COVID-19 I got a very intense pain in my left arm where the vaccine was administered. It became tingly and like pins and needles were going down my arm, into my elbow, forearm, and up into my neck only on my left side. It was worse at night and felt like my entire arm was asleep and would not wake up. Very painful and uncomfortable. Also extreme fatigue in left arm, and a tingling cold sensation in my brachial plexus. When a dull ache moved into my left chest, I went to the ER on 1/23/22. No cause was found but the nerve pain continues. I am suspicious it could be Parsonage Turner Syndrome or another syndrome related to Guillain - Barre Syndrome.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head normal, Memory impairment
Clinical narrative: Menstrual changes, memory impairment, migraines, numbness. Tingling. Vision changes, diarrhea
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Migraine, Paraesthesia, Visual impairment, Vitamin D decreased
Clinical narrative: Menstrual changes, memory impairment, migraines, numbness. Tingling. Vision changes, diarrhea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Pruritus, Rash, Rash macular
Clinical narrative: I started getting a hives/ rash 11 days after vaccine. Still suffering from itchy skin, hives, red blotches of flushed skin, histamines etc. went to my doctor and they couldn't figure it out. Went to an allergist and he suggest Allegra.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I started getting a hives/ rash 11 days after vaccine. Still suffering from itchy skin, hives, red blotches of flushed skin, histamines etc. went to my doctor and they couldn't figure it out. Went to an allergist and he suggest Allegra.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood culture negative, Blood immunoglobulin G, Blood immunoglobulin M, C-reactive protein increased
Clinical narrative: Patient began having severe right upper extremity swelling extending to his right chest. Right shoulder pain. Nausea, vomiting, and diarrhea. He was admitted to the hospital on January 14th, the day after his symptoms started. He was found to be hypotensive but despite aggressive IVF hydration progressed into shock and transferred to the ICU on the evening of 1/15/21 for vasopressor administration.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiolipin antibody negative, Culture stool negative, Culture urine negative, Diarrhoea, Hypotension
Clinical narrative: Patient began having severe right upper extremity swelling extending to his right chest. Right shoulder pain. Nausea, vomiting, and diarrhea. He was admitted to the hospital on January 14th, the day after his symptoms started. He was found to be hypotensive but despite aggressive IVF hydration progressed into shock and transferred to the ICU on the evening of 1/15/21 for vasopressor administration.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Intensive care, Nausea, Procalcitonin
Clinical narrative: Patient began having severe right upper extremity swelling extending to his right chest. Right shoulder pain. Nausea, vomiting, and diarrhea. He was admitted to the hospital on January 14th, the day after his symptoms started. He was found to be hypotensive but despite aggressive IVF hydration progressed into shock and transferred to the ICU on the evening of 1/15/21 for vasopressor administration.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Shock, Swelling, Vomiting, White blood cell count increased
Clinical narrative: Patient began having severe right upper extremity swelling extending to his right chest. Right shoulder pain. Nausea, vomiting, and diarrhea. He was admitted to the hospital on January 14th, the day after his symptoms started. He was found to be hypotensive but despite aggressive IVF hydration progressed into shock and transferred to the ICU on the evening of 1/15/21 for vasopressor administration.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pain, Injection site rash, Pruritus, Urticaria
Clinical narrative: Had a small rash near injection site along with pain. Went away after day 8, but night 9 developed hives and still persisting on day 15. Hives appear all over body. Itchy and burning.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID-19 infection. Patient hospitalized with positive COVID-19 result on 1/22/22.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Eye injury
Clinical narrative: Ocular damage,
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic cheek biting, Depressed mood, Ear pain, Facial paresis, Feeding disorder
Clinical narrative: Half of my face stopped working. Couldn't open my right eye without it watering and tearing up profusely. Sharp pain behind the ear. Couldn't eat or drink and kept biting the inside of my cheek. The right nostril was always runny. Felt restless and depressed when looking at myself in the mirror.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Restlessness, Rhinorrhoea
Clinical narrative: Half of my face stopped working. Couldn't open my right eye without it watering and tearing up profusely. Sharp pain behind the ear. Couldn't eat or drink and kept biting the inside of my cheek. The right nostril was always runny. Felt restless and depressed when looking at myself in the mirror.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Delayed periods since vaccination.  Month of November period was two days late. Month of December was three days late. Month of January it is five days late and I have not had it yet. Three pregnancy tests have been negative the past three days. Have been trying to conceive since October but with the delayed periods and negative ovulations tests since November, It has not happened obviously.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Rash
Clinical narrative: 1. First appearance of rash - 12/30/2021 2. Description of rash: Very itcy. Red leisions. Burns and stings. Occurs anywhere on the body. Occurs anytime of the day. First dose of antihistamine - 12/31/2021 Still persists till date since Dec 30. Stopped taking antihistamines as it causes only temporary relief. Last dose was on 1/5/2022 2.  Have scheduled an appointment with allergy doctor on 1/25/2022.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: 1. First appearance of rash - 12/30/2021 2. Description of rash: Very itcy. Red leisions. Burns and stings. Occurs anywhere on the body. Occurs anytime of the day. First dose of antihistamine - 12/31/2021 Still persists till date since Dec 30. Stopped taking antihistamines as it causes only temporary relief. Last dose was on 1/5/2022 2.  Have scheduled an appointment with allergy doctor on 1/25/2022.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Lymphadenopathy
Clinical narrative: noticably dryer skin; Swollen lymph nodes and noticably dryer skin; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (noticably dryer skin) and LYMPHADENOPATHY (Swollen lymph nodes and noticably dryer skin) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 25-Dec-2021, the patient experienced DRY SKIN (noticably dryer skin) and LYMPHADENOPATHY (Swollen lymph nodes and noticably dryer skin). On 17-Jan-2022, DRY SKIN (noticably dryer skin) and LYMPHADENOPATHY (Swollen lymph nodes and noticably dryer skin) had resolved.            No concomitant and treatment medications were reported. It was reported that patient's armpit was swollen and touched it. It was super sensitive and very hard like a ball patient noticed that had to be a swollen lymph node.
Sex: U
Vaccine: RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Vaccines were administered after a temperature excursion; Information has been received from a vaccine coordinator, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 11-JAN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally (lot number and expiration date were not reported) or was vaccinated with an improperly dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U008181, expiration date 08-FEB-2023 (anatomical location and administration route were not reported) both vaccines for prophylaxis. No adverse effects were reported.  The vaccines had temperature excursions of 14 Fahrenheit degrees (F) 39,6 F, during a time frame of 30 hours 15 minutes and 0 hours 45 minutes.
Age: 1.17
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information reported; Expired MMR II was administered to a patient; This spontaneous report was received from a medical assistant referring to a currently 14-month-old patient of unknown gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 21-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter (Lot # not provided but expiration date reported as 08-JAN-2022) for prophylaxis (expired product administered). There was no current temperature excursion or any previous excursion. No additional AE information reported. No PQC reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No known side effect; Dose of unknown lot of ROTATEQ was administered to a patient after undergoing temperature excursion; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  03-JAN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot# and expiration date were not reported) for prophylaxis after undergoing temperature excursions (product storage error).    On 03-JAN-2022, the agent reported a temperature excursion for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) but did not know the lot number or expiration date therefore this agent was unable to perform a temperature evaluation. Vaccine reached (34.3F) and was out of range for 4 hours 23 minutes and 0 seconds and had no previous excursions. Other rotavirus vaccine, live, oral, pentavalent (ROTATEQ) which she had lot information for were evaluated and supported. Agent reported that a dose of unknown lot rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to a patient. Patient had no known side effects. No PQC reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: blistered rash on my rib cage; looks like Shingles but not as painful; This case was reported by a consumer via interactive digital media and described the occurrence of vesicular rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had in 2016).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vesicular rash and pain. On an unknown date, the outcome of the vesicular rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient stated he/she had the shingles vaccine in 2018 and presently had a blistered rash on his/her rib cage that looked like Shingles but not as painful. The patient enquired if it was possible. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 2 years between Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient reported, more than 2 years between shingrix, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd shot about 2.5 years after the first; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 2.5 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional detaails were provided as follows: The reporter was the patient's relative (son or daughter). The age at vaccination was not reported. The patient received 2nd dose of Shingrix about 2.5 years after 1st dose, whicvh led to lengthening of vaccination schedule. The reporter asked if the patient start the series over.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: may have been given 3 doses of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient. The patient received 3rd dose of Shingrix, which led to extra dose administered. The patient had usual side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via (Shingrix GSK) 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 suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient wanted to know who to report about getting shingles after taking GlaxoSmithKline vaccine. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 2.0
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old Bexsero; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 2-year-old 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 inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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 reporter was the patients parent. The patient received dose of Bexsero at the age of 2 years old, which led to inappropriate age at vaccine administration. The reporter stated that, forgot to give 2nd dose of Bexsero to the patient. The reporter asked if start again with 2 doses.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Dizziness, Feeling abnormal, Hypertension, Loss of consciousness
Clinical narrative: felt like hit by a moped; enormously dizzy; fainted and blacked out; fainted and blacked out; blood pressure high,149 over 98; This case was reported by a consumer via call center representative and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2022 09:15, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced blood pressure high. On 19th January 2022, the patient experienced faint (serious criteria GSK medically significant), blackout (serious criteria GSK medically significant) and dizziness. On 19th January 2022 17:30, the patient experienced discomfort. In January 2022, the outcome of the faint, blackout and dizziness were recovered/resolved. On an unknown date, the outcome of the discomfort was unknown and the outcome of the blood pressure high was not recovered/not resolved.   It was unknown if the reporter considered the faint, blackout, discomfort, dizziness and blood pressure high to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. One day before reporting at 9:15 am, patient received 1st dose of Shingrix vaccine and at 5:30 pm 8 hours 15 minutes after vaccination, the patient was all of the sudden felt like he/she was hit by a moped.  The patient reported that he/she understood that this was normal.  However, less than a day after vaccination, within 5 minutes of that happening patient then became enormously dizzy to the point where he/she fainted and blacked out completely and came to almost an hour later. Since this happened, patient's blood pressure had been extremely high about 149 over 98 (unit unspecified). The patient was concerned about getting the second dose in March 2022 due to the side effects. The patient enquired of how much immunity did one get after one shot of the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: felt like hit by a moped; enormously dizzy; fainted and blacked out; fainted and blacked out; blood pressure high,149 over 98; This case was reported by a consumer via call center representative and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2022 09:15, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced blood pressure high. On 19th January 2022, the patient experienced faint (serious criteria GSK medically significant), blackout (serious criteria GSK medically significant) and dizziness. On 19th January 2022 17:30, the patient experienced discomfort. In January 2022, the outcome of the faint, blackout and dizziness were recovered/resolved. On an unknown date, the outcome of the discomfort was unknown and the outcome of the blood pressure high was not recovered/not resolved.   It was unknown if the reporter considered the faint, blackout, discomfort, dizziness and blood pressure high to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. One day before reporting at 9:15 am, patient received 1st dose of Shingrix vaccine and at 5:30 pm 8 hours 15 minutes after vaccination, the patient was all of the sudden felt like he/she was hit by a moped.  The patient reported that he/she understood that this was normal.  However, less than a day after vaccination, within 5 minutes of that happening patient then became enormously dizzy to the point where he/she fainted and blacked out completely and came to almost an hour later. Since this happened, patient's blood pressure had been extremely high about 149 over 98 (unit unspecified). The patient was concerned about getting the second dose in March 2022 due to the side effects. The patient enquired of how much immunity did one get after one shot of the vaccine.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administrated a 2nd dose 24 days after 1st; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 8-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 9339n, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLULAVAL QUADRIVALENT).   On 17th January 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was 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 patient was administrated a second dose of FluLaval QIV, 24 days after the first dose of the vaccine, which led to drug dose administration interval too short. No further events were reported.  Agreed to be contacted for follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: stored in the freezer by mistake, No patients received; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a 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 intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stored the Shingrix in the freezer by mistake however the patients did not receive a dose of the frozen vaccines which led to intercepted product storage error. The pharmacist cut off the communication after receiving the information about Shingrix stability information. So, consent to follow up was not asked and callback to ask was not successful.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Brain fog; Low grade fever; Feels very weak; Electrical pain headache/his head is still sore; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2022, the patient received the 1st dose of Shingrix (intramuscular). On 5th January 2022, 1 hr after receiving Shingrix, the patient experienced headache and weakness. On 8th January 2022, the patient experienced low grade fever. On 18th January 2022, the patient experienced foggy feeling in head. The action taken with Shingrix was unknown. On 11th January 2022, the outcome of the low grade fever was recovered/resolved. On 17th January 2022, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the weakness and foggy feeling in head were not recovered/not resolved.   It was unknown if the reporter considered the headache, low grade fever, weakness and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: The reporter was the wife of the patient. The patient received Shingrix vaccine in the left arm. About 1 hour after receiving the Shingrix vaccine, the patient experienced an electrical pain headache which lasted about 12 days. Less than a day after vaccination, the patient felt very weak since getting the Shingrix vaccine which was not recovered. Three days after vaccination, the patient experienced a low-grade fever. The patient went to the emergency room on 12th January 2022 and they said, he was fine and sent him home. On the day of reporting, the patient stated his headache was gone but his head was still sore and he had some brain fog. The reporter did not consent to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 18th January 2022, the patient received the 2nd dose of Shingrix. On 18th January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered with an expired dose of Shingrix on the reporting day and the reporter asked if she should be re vaccinated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: inadvertently got some of the product in her eye; inadvertently got some of the product in her eye; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) (batch number 52LX4, expiry date 23rd April 2023) for prophylaxis.   On 19th January 2022, the patient received Shingrix. On 19th January 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter mentioned that, while she was preparing a Shingrix vaccine for injection, inadvertently got some of the product in her eye, which led to occupational exposure while preparing product for administration and exposure via eye contact. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired Engerix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received HBV (Engerix B adult) (batch number P7294, expiry date 3rd January 2022) for prophylaxis.   On 18th January 2022, the patient received Engerix B adult. On 18th January 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient inadvertently administered an expired Engerix B, which led to expired vaccine used. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Menveo reconstituted by using sterile water; Menveo reconstituted by using sterile water; patient has received on Jan 3rd 2022 Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 62-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 31st October 2022) for prophylaxis.   On 3rd January 2022, the patient received Menveo. On 3rd January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received Menveo vaccination but they reconstituted by using sterile water, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered. The patient received dose of Menveo at the age of 62 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Palpitations, Tremor
Clinical narrative: Shaking; Headache; Palpitations; Body ache; This case was reported by a other health professional via call center representative and described the occurrence of tremor in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2022, the patient received the 1st dose of Shingrix (intramuscular). In January 2022, less than a day after receiving Shingrix, the patient experienced tremor, headache, palpitation and general body pain. On an unknown date, the outcome of the tremor, headache, palpitation and general body pain were recovered/resolved.   It was unknown if the reporter considered the tremor, headache, palpitation and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was unknown, however could be 64 years or 65 years at the time of vaccination. The reporter was the health care professional who stated that a patient received Shingrix and experienced symptoms of shaking, headache, palpitations and body ache which started within 24 hours of the dose.  All symptoms resolved after a few days.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot October 2020, never got 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No more information was currently available. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old 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 fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter stated that with her first dose of Shingrix patient had a fever.  The reporter could not provide any details as to when she had the first dose. The reporter consented to follow up. For tolerance of 2nd dose refer case US2022AMR012131.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR012131:Same reporter, same product, same patient, different dose
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race, ethnic origin. Initial information received was processed along with the additional information received on 20-JAN-2022. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cough, sneezing, cold and scratchy throat (coded as suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series 1). On 11-JAN-2022, patient tested positive for covid with Binax Now antigen test.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. The patient received Pfizer vaccine (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 04-JAN-2022 for prophylactic vaccination. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000213233.; Sender's Comments: V0 - 20220126312- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Confusional state, Electrocardiogram, Electroencephalogram, Magnetic resonance imaging head
Clinical narrative: This spontaneous report received from a consumer concerned an 18 year old male. The patient's weight was not reported and height was 179.07 centimeters. The patient's past medical history included: Attention deficit hyperactivity disorder, speech delay, motor delay, and marijuana user, and concurrent conditions included: alcohol user, non-smoker, seasonal allergies (tree, pollen, and grasses), and shellfish allergy, and other pre-existing medical conditions included: At the time of report, the patient's weight was 140 (unit was not provided). The patient had allergies, and had drug abuse or illicit drug usage, had no illness at the time of vaccination, had no past history of similar event, had no adverse event after any previous vaccination(s), had history of allergy to vaccine, drug, or food, had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, no family history of any disease (relevant to vaccination) or allergy. He does not had COVID-19 infection event, and it was not confirmed by test. He had used marijuana 4 years ago but he has been clean since then and have been tested. He was on multivitamin medication at the time the adverse event started. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood test (NR: not provided) no abnormalities. On MAY-2021, the patient experienced motion disorder, ritualistic like hopping over a line, juggling water bottles and dishes around his body, and they seem Tourette's like ticks, had vocal ticks, blinking, vocalizations not previously exhibited. On AUG-2021, Laboratory data included: Blood test (NR: not provided) Unknown. On SEP-2021, Laboratory data included: Blood test (NR: not provided) no abnormalities. On an unspecified date, the patient experienced tensing his body, and he was baffled. Laboratory data (dates unspecified) included: Electrocardiogram (NR: not provided) no abnormalities, Electroencephalogram (NR: not provided) no abnormalities, and MRI brain (NR: not provided) no abnormalities. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from motion disorder, ritualistic like hopping over a line, juggling water bottles and dishes around his body, and they seem Tourette's like ticks, had vocal ticks, blinking, vocalizations not previously exhibited, and the outcome of tensing his body and he was baffled was not reported. This report was non-serious. This case, from the same reporter is linked to 20220126642 and 20220126655.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Tension, Tic
Clinical narrative: This spontaneous report received from a consumer concerned an 18 year old male. The patient's weight was not reported and height was 179.07 centimeters. The patient's past medical history included: Attention deficit hyperactivity disorder, speech delay, motor delay, and marijuana user, and concurrent conditions included: alcohol user, non-smoker, seasonal allergies (tree, pollen, and grasses), and shellfish allergy, and other pre-existing medical conditions included: At the time of report, the patient's weight was 140 (unit was not provided). The patient had allergies, and had drug abuse or illicit drug usage, had no illness at the time of vaccination, had no past history of similar event, had no adverse event after any previous vaccination(s), had history of allergy to vaccine, drug, or food, had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, no family history of any disease (relevant to vaccination) or allergy. He does not had COVID-19 infection event, and it was not confirmed by test. He had used marijuana 4 years ago but he has been clean since then and have been tested. He was on multivitamin medication at the time the adverse event started. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood test (NR: not provided) no abnormalities. On MAY-2021, the patient experienced motion disorder, ritualistic like hopping over a line, juggling water bottles and dishes around his body, and they seem Tourette's like ticks, had vocal ticks, blinking, vocalizations not previously exhibited. On AUG-2021, Laboratory data included: Blood test (NR: not provided) Unknown. On SEP-2021, Laboratory data included: Blood test (NR: not provided) no abnormalities. On an unspecified date, the patient experienced tensing his body, and he was baffled. Laboratory data (dates unspecified) included: Electrocardiogram (NR: not provided) no abnormalities, Electroencephalogram (NR: not provided) no abnormalities, and MRI brain (NR: not provided) no abnormalities. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from motion disorder, ritualistic like hopping over a line, juggling water bottles and dishes around his body, and they seem Tourette's like ticks, had vocal ticks, blinking, vocalizations not previously exhibited, and the outcome of tensing his body and he was baffled was not reported. This report was non-serious. This case, from the same reporter is linked to 20220126642 and 20220126655.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a company representative via social media concerned over 300 multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On an unspecified date, reporter stated "over 300 dead athletes perhaps" . On an unspecified date, the patients died from unknown cause of death. It was unknown if an autopsy was performed (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220126450, 20220126177, 20220126708, 20220126614, 20220126211, 20220126174 and 20220126701.; Sender's Comments: V0: 20220126582 -Covid-19 vaccine ad26.cov2.s- Dead. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus disorder, Suspected COVID-19, Vaccination failure
Clinical narrative: FELT LIKE SINUS PROBLEM; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported), (dose number series 1) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-DEC-2021, the patient experienced cough and felt lethargic. On an unspecified date, the patient felt like he had sinus problem. On 24-DEC-2021, the patient had, at home covid-19 test done which showed positive results twice (suspected clinical vaccination failure, and suspected covid-19 infection) (dose number series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and felt like sinus problem was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211265893. This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220131710-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS