chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: could not move their arms/hands; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional This case involves three patients of unknown age and gender, who could not move their arms/hands (mobility decreased), while they received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to the patient.  On 01-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7041MA and expiration date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  On 02-Oct-2020, the patients who could not move their arms/hands (mobility decreased) (non-serious), 1 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event mobility decreased.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: Chills, headache, aches, sore throat
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Headache, Myalgia, Pyrexia
Clinical narrative: Average fever of 101.5, headache, muscle aches, weakness and diarrhea. A time period of a day and a half.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: felt pretty bad in head all night....next morning feel a little better...minor headache......I took some Excedrin migraine  1 tab every 4 hrs  Are really sore
Age: 7.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local site, erythema, redness, swelling
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Allergy to vaccine, Paraesthesia, Rash
Clinical narrative: Developed rash and paresthesia of arm/upper chest, lasted for almost 3 weeks.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Nausea, Vertigo
Clinical narrative: severe vertigo along with lethargy and nausea. Patient rested and drank fluids.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Felt chills (first 24 hours), itchy at injection site (first 24 hours),  Continuous muscle aches, fatigue,  headaches, neck aches, sore at injection site.  Took acetaminophen 500 mg, 2 tablets every 4-6 hours for at least 2 days. Took Benadryl 2 tablets once first night.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain
Clinical narrative: Felt chills (first 24 hours), itchy at injection site (first 24 hours),  Continuous muscle aches, fatigue,  headaches, neck aches, sore at injection site.  Took acetaminophen 500 mg, 2 tablets every 4-6 hours for at least 2 days. Took Benadryl 2 tablets once first night.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain, Peripheral swelling, Urticaria
Clinical narrative: Flu vaccine was given at pharmacy, I received a notice of administration date, but don't have lot number or site of administration.  Mom called my office the next day.  He developed hives on his face and swollen hands about an hour after administration.  That resolved, but the next day he had significant abdominal pain that lasted 2 days.  All symptoms have resolved now.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient who is now 14 years-old received MMR II & VARIVAX at age 1 and has not received their second dose.; This spontaneous report was received from a medical assistant referring to a currently 14 years old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, batch/lot# and expiration date were unknown, strength and route were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, batch/lot# and expiration date were unknown, strength and route were not provided) for prophylaxis at 1 years old. The patient was now 14 years old and had not received their second dose (inappropriate schedule of vaccine administered).
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: only time I ever got the flu was the one time a got the damn shot / Suspected vaccination failure; flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 75-year-old patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.  Additional case details were reported as follows: The patient reported case for our self. The age at vaccination was not reported. The patient received flu shot and got the flu. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Infection
Clinical narrative: made me sick hospital for 2 days; Secondary infection; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness (serious criteria hospitalization) and secondary infection. On an unknown date, the outcome of the sickness and secondary infection were unknown.   It was unknown if the reporter considered the sickness and secondary infection to be related to Flu vaccine.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. The patient was sick and in hospital for 2 days. The patient also experienced secondary infection due to shot. The follow up was not required.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: patient experienced Shingles after the administration of 1st and 2nd dose / suspected vaccination failure; patient experienced Shingles after the administration of 1st and 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter enquired if a patient who experienced Shingles after the administration of 1st and 2nd dose, needs to repeat the series, did we have clinical studies on this. The healthcare professional declined to provided any details (Name, phone) from him and patient. No further clarifications provided. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The permission to follow up was denied.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199108:same patient (1st dose)
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Pain, Rash
Clinical narrative: cellulitis left arm; rashes; not severe pain; This case was reported by a pharmacist via other manufacturer and described the occurrence of cellulitis in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple myeloma. Concomitant products included ciprofloxacin and cetirizine (Zytrec).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting ciprofloxacin, the patient experienced cellulitis (serious criteria GSK medically significant), rash and pain. On an unknown date, the outcome of the cellulitis was not recovered/not resolved and the outcome of the rash and pain were unknown.   It was unknown if the reporter considered the cellulitis, rash and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had cellulitis left arm and might be a reaction to the vaccine. The patient also stated that he had common to get rashes but not with severe pain. The reporter stated that patient was not hospitalized due to the event cellulitis and no other seriousness criteria was reported. The lab data, corrective treatment if any was not provided. The permission to follow up denied.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Monoplegia, Muscular weakness, Myelitis transverse, Myelopathy
Clinical narrative: thoracic myelopathy; neural impingement; Neuropathy; pain in her back and legs; weakness in her legs; Transverse Myelitis; paralyzed in her left leg; This case was reported by a lawyer and described the occurrence of myelitis transverse in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received Shingrix (intramuscular). On 6th September 2019, 1 days after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant), paralysis (serious criteria GSK medically significant), pain and lower extremities weakness of. On 23rd October 2019, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the patient experienced thoracic myelopathy (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse, paralysis, neuropathy, thoracic myelopathy, pain and lower extremities weakness of were unknown.   It was unknown if the reporter considered the myelitis transverse, paralysis, neuropathy, thoracic myelopathy, pain and lower extremities weakness of to be related to Shingrix.  Additional information: On 05 September 2019, a pharmacist telephonically prescribed a Shingrix vaccination to be administered to the patient by an unsupervised intern. As a direct and proximate consequence, she suffered from Transverse Myelitis, was permanently paralyzed in her left leg, and forced to take medication for severe and chronic pain that interferes with sleep. On awakening the morning of 06 September 2019, she had sharp pain in her back and legs. She went to doctors and was prescribed a muscle relaxant. Over the next few weeks, the condition worsened into weakness in her legs. She did not connect the condition to the vaccination she had received the day earlier. On 23 October 2019, she had a nerve conduction study done. The study showed severe peripheral neuropathy. She consulted with her acupuncturist determined that the cause of the problem was most likely the Shingrix vaccination. As per records dated 21 September 2020, she had shingles and/or been previously vaccinated with Zostavax. She received a Zostavax vaccination in October 2017, only two years prior to being vaccinated with Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Nerve conduction studies abnormal, Neuropathy peripheral, Pain, Pain in extremity, Sleep disorder
Clinical narrative: thoracic myelopathy; neural impingement; Neuropathy; pain in her back and legs; weakness in her legs; Transverse Myelitis; paralyzed in her left leg; This case was reported by a lawyer and described the occurrence of myelitis transverse in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received Shingrix (intramuscular). On 6th September 2019, 1 days after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant), paralysis (serious criteria GSK medically significant), pain and lower extremities weakness of. On 23rd October 2019, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the patient experienced thoracic myelopathy (serious criteria GSK medically significant). On an unknown date, the outcome of the myelitis transverse, paralysis, neuropathy, thoracic myelopathy, pain and lower extremities weakness of were unknown.   It was unknown if the reporter considered the myelitis transverse, paralysis, neuropathy, thoracic myelopathy, pain and lower extremities weakness of to be related to Shingrix.  Additional information: On 05 September 2019, a pharmacist telephonically prescribed a Shingrix vaccination to be administered to the patient by an unsupervised intern. As a direct and proximate consequence, she suffered from Transverse Myelitis, was permanently paralyzed in her left leg, and forced to take medication for severe and chronic pain that interferes with sleep. On awakening the morning of 06 September 2019, she had sharp pain in her back and legs. She went to doctors and was prescribed a muscle relaxant. Over the next few weeks, the condition worsened into weakness in her legs. She did not connect the condition to the vaccination she had received the day earlier. On 23 October 2019, she had a nerve conduction study done. The study showed severe peripheral neuropathy. She consulted with her acupuncturist determined that the cause of the problem was most likely the Shingrix vaccination. As per records dated 21 September 2020, she had shingles and/or been previously vaccinated with Zostavax. She received a Zostavax vaccination in October 2017, only two years prior to being vaccinated with Shingrix.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed mood, Diarrhoea, Fatigue, Feelings of worthlessness, Hangover
Clinical narrative: headache; feeling tired; first dose 7/30/2020 and her second dose on 9/24/2020; feeling of melancholy was described as a feeling of rejection / escalated following both injections.; stomach issues / as a feeling of / being hungover / though she didn't drink alcohol; stomach issues / described as a feeling of motion sickness; loose stool; feeling of rejection; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of headache (1st dose received on 30th July 2020, experienced adverse events-blood in stool, tiredness, feeling blue, hangover effect, motion sickness, loose stools and feelings of worthlessness. refer link case- US2020AMR194807).   On 24th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced feeling sad, hangover effect, motion sickness, loose stools and feelings of worthlessness. On 24th September 2020, the patient experienced drug dose administration interval too short. On 25th September 2020, the patient experienced headache and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, tiredness, feelings of worthlessness and drug dose administration interval too short were unknown and the outcome of the feeling sad was recovering/resolving and the outcome of the hangover effect, motion sickness and loose stools were recovered/resolved.   It was unknown if the reporter considered the headache, tiredness, feeling sad, hangover effect, motion sickness, loose stools and feelings of worthlessness to be related to Shingrix.  Additional details were provided as follows:  The patient received shingrix in the left arm. The patient received 2nd dose delayed than the recommended schedule, which lead to shortening of vaccination schedule. The day after the vaccination, the patient experienced headache and feeling tired. In less than a week, the patient was feeling of melancholy it was described as a feeling of rejection.  She was supposed to see her physician for a physical and then was told she would not see her physician but would receive the vaccine by a nurse.  It left her feeling rejected and that feeling escalated following both injections (1st and 2nd). In less than a week, the patient had stomach issues were described as a feeling of motion sickness or being hungover even though she did not drink alcohol. The patient experienced loose stool. The stomach issues presented 2 to 3 days following vaccine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR194807:same patient
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Motion sickness, Vaccine positive rechallenge
Clinical narrative: headache; feeling tired; first dose 7/30/2020 and her second dose on 9/24/2020; feeling of melancholy was described as a feeling of rejection / escalated following both injections.; stomach issues / as a feeling of / being hungover / though she didn't drink alcohol; stomach issues / described as a feeling of motion sickness; loose stool; feeling of rejection; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of headache (1st dose received on 30th July 2020, experienced adverse events-blood in stool, tiredness, feeling blue, hangover effect, motion sickness, loose stools and feelings of worthlessness. refer link case- US2020AMR194807).   On 24th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced feeling sad, hangover effect, motion sickness, loose stools and feelings of worthlessness. On 24th September 2020, the patient experienced drug dose administration interval too short. On 25th September 2020, the patient experienced headache and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, tiredness, feelings of worthlessness and drug dose administration interval too short were unknown and the outcome of the feeling sad was recovering/resolving and the outcome of the hangover effect, motion sickness and loose stools were recovered/resolved.   It was unknown if the reporter considered the headache, tiredness, feeling sad, hangover effect, motion sickness, loose stools and feelings of worthlessness to be related to Shingrix.  Additional details were provided as follows:  The patient received shingrix in the left arm. The patient received 2nd dose delayed than the recommended schedule, which lead to shortening of vaccination schedule. The day after the vaccination, the patient experienced headache and feeling tired. In less than a week, the patient was feeling of melancholy it was described as a feeling of rejection.  She was supposed to see her physician for a physical and then was told she would not see her physician but would receive the vaccine by a nurse.  It left her feeling rejected and that feeling escalated following both injections (1st and 2nd). In less than a week, the patient had stomach issues were described as a feeling of motion sickness or being hungover even though she did not drink alcohol. The patient experienced loose stool. The stomach issues presented 2 to 3 days following vaccine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR194807:same patient
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received both doses / Herpes zoster outbreaks/  suspected vaccination failure; Herpes zoster outbreaks on her buttocks; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the vaccination failure and herpes zoster were recovering/resolving.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received both doses of what she believed was Shingrix, four years before time of reporting. She could not remember the date.  She stated that she started having herpes zoster outbreaks on her buttocks at that time.  The patient did not have them as frequently and that she had not had an outbreak for two weeks.  She wanted to know a remedy for it. She stated she would talk with her doctor. The reporter did not consent to follow up. No information given. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Oedema peripheral
Clinical narrative: Swollen lymph nodes in armpit.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: Case describes having immediate pain from the injection and felt shot was given high up in arm.  After injection case applied ice and took Motrin. Pain continued and case reports reports pain as 5/10. Case reports inability to lift arm along with difficulty removing shirt and limited range of motion.  Case reports being woken up from sleep on Oct 7/8 and as of this report pain was 7/10, case took Motrin and pain currently 2/10. Case went to Urgent Care on 10/7/20 and was instructed to follow up with an orthopedic person.  Case reports not having a PCP. Case denies numbness/tingling and reports pain as a sharp pain.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Muscle discomfort, Pain, Product administered at inappropriate site
Clinical narrative: After injection was given, there was no immediate pain.  In the afternoon, approximately 3pm, I began to feel muscle discomfort in my left shoulder/arm area where the injection was given.  In my opinion, the injection was given to far back on my shoulder near my joint and not properly given.  It was an achy kind of muscle pain, although when I rotated my shoulder, it hurt also.  I just thought it would go away.  The pain never went away and got a bit worse, in that it began to hurt down in the muscle and the joint rotation hurt more.  Flu clinic was open on Thursday, 9/24/2020, so I went to enquire as to the pain I was having and was told that was not normal and was sent to the emergency room/employee health to have it looked at. I was told that I had a "Shoulder Injury Related to Vaccination Injection".  To ice the shoulder and take Tylenol.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder injury related to vaccine administration, X-ray limb
Clinical narrative: After injection was given, there was no immediate pain.  In the afternoon, approximately 3pm, I began to feel muscle discomfort in my left shoulder/arm area where the injection was given.  In my opinion, the injection was given to far back on my shoulder near my joint and not properly given.  It was an achy kind of muscle pain, although when I rotated my shoulder, it hurt also.  I just thought it would go away.  The pain never went away and got a bit worse, in that it began to hurt down in the muscle and the joint rotation hurt more.  Flu clinic was open on Thursday, 9/24/2020, so I went to enquire as to the pain I was having and was told that was not normal and was sent to the emergency room/employee health to have it looked at. I was told that I had a "Shoulder Injury Related to Vaccination Injection".  To ice the shoulder and take Tylenol.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: soreness at sight of injection, muscle pain throughout body for about 24 hours (enough to require reduction in normal daily activity)
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Child is 11 years 10 months of age. MD ordered DTaP and nurse gave DTaP instead of the TDaP.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: From initial Shingrix dose, I develpoed Verigo. Doctor perscribed chropractic exercises and vertigo went away after 5 days
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Pt presented on 10/06/2020 for evaluation of left arm pain to deltoid and bicep s/p IM injection received 09/20/20 in same clinic.  Pt with full range of motion and no neurological or peripheral vascular deficits.  No redness or swelling and injection site, no evidence of infection or trauma.  Pt reports frequent carrying toddler in left arm,  Encouraged rest to extremity with applications of cold/heat for comfort, compression, and NSAIDs as needed. With plan to follow up.  Unable to reach patient at present time.
Age: 66.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain, redness and swelling in the left arm at injection site(s).  A mild fever that lasted about 36 hours after the vaccinations
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash erythematous, Swelling
Clinical narrative: red rash, swelling, hot touch in area of injection site
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Angioedema
Clinical narrative: Severe angioedema of tongue, upper lip and face, primarily on the right side. Required ER admission. Treated with IV Benadryl and Dexamethasone, and nebulized Epinephrine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Sleep disorder
Clinical narrative: 10/7 2:45 PM had shot, went for 25 mile bike ride at 5:30 PM, home by 8 PM, by 8:30 PM unbelievably tired,  went to bed,  feeling soar, took Ibuprofen 200 mg,  had trouble sleeping, headache,  got up this morning and have taken another ibuprofen 200 mg.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: Pt had glass of Mescal. Body aches, headache, no chills, started when he went to bed, just felt terrible. Very sore arm. No medical treatment needed.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Complex regional pain syndrome, Injection site pain, Magnetic resonance imaging abnormal, Pain in extremity, Periarthritis
Clinical narrative: Pain in left arm started later that day. Have had almost constant pain in the left arm/shoulder since the injection. A few months later it developed into frozen shoulder, along with bouts of Complex Regional Pain Syndrome (CRPS), in my left wrist and hand. I have had an X-ray, an MRI, along with many sessions of physical therapy. The MRI confirmed the frozen shoulder.  It has been extremely painful, and has limited a great amount of activities, along with daily life and being able to sleep.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Sleep disorder, X-ray
Clinical narrative: Pain in left arm started later that day. Have had almost constant pain in the left arm/shoulder since the injection. A few months later it developed into frozen shoulder, along with bouts of Complex Regional Pain Syndrome (CRPS), in my left wrist and hand. I have had an X-ray, an MRI, along with many sessions of physical therapy. The MRI confirmed the frozen shoulder.  It has been extremely painful, and has limited a great amount of activities, along with daily life and being able to sleep.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Nurse gave expired vaccine. Vaccine expired 9/24/20
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain upper, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Low grade fever,  sore arm where shingrix shot given, body aches, nausea, stomach ache 1 day after shot and still continuing
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: It has been a month, and I can barely raise my right arm.  And that with a lot of pain.
Age: 60.0
Sex: M
Vaccine: RAB
Symptoms: Hallucination, Headache, Muscle twitching
Clinical narrative: Client came into clinic today to report that he has been experiencing side effects of rabies vaccines staring 2 weeks ago: headaches, hallucinations, "jumping muscles", no fever. He spoke with his PMD and made an appointment for next week, but PMD recommended to go to urgent care if needed. Last COVID test was negative 2 months  ago.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Supraclavicular lymphadenopathy 1 day after vaccination with tenderness. Treat with supportive care, potential antibiotic, ultraound/CT with persistent symptoms
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swelling, redness, warm to touch, painful at the injection site
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Dysphagia, Pruritus
Clinical narrative: approximately 20 minutes after patient received the vaccine and had left our clinic, she called me stating she had a hard time swallowing, felt a tightness in her chest , and also felt itchy all over asking what to do. I told her to get to the Emergency Dept right away.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: Symptoms:  Fever 101.5, severe chills, night sweats. Treatment:  Ibuprofen (3) Outcome:  Symptoms were gone by the following morning.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pallor, Rash macular
Clinical narrative: Pale pink blanching  macular rash to abdomen and chest, Calamine lotion 2-3 times a day
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no other adverse events; temperature excursion; This spontaneous report was received from a consumer and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-OCT-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S031494 (also reported as: 5031494 but upon internal investigation established as a valid # S031494) with an expiration date of 07-OCT-2021 (formulation, strength, dose and route of administration were not reported) for prophylaxis. It was reported that the door to the freezer was left open overnight from 6 PM last night to 7:30 AM this morning. The temperature excursion was also reported as: temperature -1.0 Celsius, time frame 13 hours and 20 minutes. There was no information available on previous temperature excursions. A data logger was not used to capture the temperatures. No other adverse events reported. The outcome was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis). On an unspecified date (reported as subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 23-JAN-2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis). On an unspecified date (reported as subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a physician for hearing loss. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, hearing loss was determined to be medically significant.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: received a pediatric dose of VAQTA instead of the adult dose; received a pediatric dose of VAQTA instead of the adult dose; This spontaneous report was received from a registered nurse and refers to a 45-year-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 05-OCT-2020, the patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) injection, vial, 0.5 ml, lot # T001419 was confirmed to be valid, expiration date was 06-JAN-2021 (route of administration, anatomical location were not reported) for prophylaxis instead of the an adult dose.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a currently approximately 65-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 18-DEC-2014, the patient was administered zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and zoster-related conditions, by a healthcare provider at physician's office. Subsequently, on an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis.   On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 6 months after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The age was not provided but captured an adult as per vaccine indication. The patient was vaccinated with dose of SHINGRIX a few months ago. After vaccination patient experienced arm pain. This case was linked with case US2020AMR199031 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199031:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; got a flu shot, I got the flu / got the shot one time , 2 months later got the flu; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 months after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that only time the patient got a flu shot, 2 months later the patient experienced the flu. The physician stated that it was a coincidence. The patient would take chances. This case was considered as suspected vaccination failure since the details regarding laboratory test was not provided.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Felt little sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt little sick after receiving flu shot. Apparently it was normal. It was reported as day after, the patient felt ok.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient had first Shingrix shot and had a sore arm for about a week.  The patient asked if the second shot had worse effects.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: rash; itching; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 56-year-old male patient who received SHINGRIX (batch number 5JT9C, expiry date 28th August 2021) and (batch number 7L355, expiry date 28th August 2021) for prophylaxis.   On 11th September 2020, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. In September 2020, less than 3 weeks after receiving SHINGRIX, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were recovered/resolved.   It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX.  Additional details were provided as follows: The patient on 11th September 2020 received first dose of SHINGRIX intramuscularly. The patient experienced rash and itching that lasted 2 to 3 days. The patient had completely recovered. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Burning sensation, Fatigue, Headache, Herpes zoster
Clinical narrative: Light case of shingles; Sore arm; Flu-like symptoms; a rash (under her left breast; a rash (under her left breast) that was painful, itchy; Tiredness / Fatigue; Headache; Nausea; Abdominal pain; Body aches / a rash that was painful; itchiness all over (mainly back and head)\Itch burning; a rash that was burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bronchitis. Concomitant products included calamine lotion (Calamine) and topical antibiotic (nos) (Antibiotic Ointment (Trade Name Unknown)).   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 23rd September 2020, 1 days after receiving Shingrix, the patient experienced shingles, pain in arm, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain, generalized pruritus and burning sensation. On an unknown date, the outcome of the shingles, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain and generalized pruritus were recovering/resolving and the outcome of the pain in arm was recovered/resolved and the outcome of the burning sensation was unknown.   It was unknown if the reporter considered the shingles, pain in arm, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain, generalized pruritus and burning sensation to be related to Shingrix.  Additional details were provided as follows:  The patient experienced light case of shingles. The patient has been healthy most of her life and has only really been sick twice in her life. The day after receiving the vaccine, the patient experienced a sore arm (but nothing around the injection site) for a few days, flu-like symptoms, a rash (under her left breast) that was painful, itchy, and burning; tiredness, fatigue, headache, nausea, abdominal pain, body aches, and itchiness all over (mainly back and head).  The rash has gotten better and was clearing up. The patient was feeling much better compared to a week before reporting.  The patient might have contracted the shingles from her sister who recently recovered from it.  Not all information was available. The reporter did not consent to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain, Pain in extremity, Pruritus
Clinical narrative: Light case of shingles; Sore arm; Flu-like symptoms; a rash (under her left breast; a rash (under her left breast) that was painful, itchy; Tiredness / Fatigue; Headache; Nausea; Abdominal pain; Body aches / a rash that was painful; itchiness all over (mainly back and head)\Itch burning; a rash that was burning; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bronchitis. Concomitant products included calamine lotion (Calamine) and topical antibiotic (nos) (Antibiotic Ointment (Trade Name Unknown)).   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 23rd September 2020, 1 days after receiving Shingrix, the patient experienced shingles, pain in arm, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain, generalized pruritus and burning sensation. On an unknown date, the outcome of the shingles, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain and generalized pruritus were recovering/resolving and the outcome of the pain in arm was recovered/resolved and the outcome of the burning sensation was unknown.   It was unknown if the reporter considered the shingles, pain in arm, influenza-like symptoms, painful rash, itchy rash, tiredness, headache, nausea, abdominal pain, general body pain, generalized pruritus and burning sensation to be related to Shingrix.  Additional details were provided as follows:  The patient experienced light case of shingles. The patient has been healthy most of her life and has only really been sick twice in her life. The day after receiving the vaccine, the patient experienced a sore arm (but nothing around the injection site) for a few days, flu-like symptoms, a rash (under her left breast) that was painful, itchy, and burning; tiredness, fatigue, headache, nausea, abdominal pain, body aches, and itchiness all over (mainly back and head).  The rash has gotten better and was clearing up. The patient was feeling much better compared to a week before reporting.  The patient might have contracted the shingles from her sister who recently recovered from it.  Not all information was available. The reporter did not consent to follow-up.