chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Nausea, Sleep disorder, Syncope
Clinical narrative: Approximately 12 hours after the shot at around 8pm, the injection site started to hurt. At around 1am on Tuesday, December 7th, I woke up and couldn't get warm or stop shaking. About an hour later, I woke up again in a sweat and fainted on my way to the bathroom. After coming to, I threw up. I was nauseous and exhausted for the next five days. At 2am on December 13th, I woke up again and felt extremely nauseous. I had diarrhea during the night and again during the day of December 13th. For the next five days, I remained nauseous, had no appetite, and was exhausted and constipated.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Approximately 12 hours after the shot at around 8pm, the injection site started to hurt. At around 1am on Tuesday, December 7th, I woke up and couldn't get warm or stop shaking. About an hour later, I woke up again in a sweat and fainted on my way to the bathroom. After coming to, I threw up. I was nauseous and exhausted for the next five days. At 2am on December 13th, I woke up again and felt extremely nauseous. I had diarrhea during the night and again during the day of December 13th. For the next five days, I remained nauseous, had no appetite, and was exhausted and constipated.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Rash, Sensitive skin
Clinical narrative: Rash on left side of face, numbness or sensitivities on left side of face. Patient is assuming allergic reaction on left side of face.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Recurring mild headache, nausea and diarrhea. At least three days per week.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin irritation, Urticaria
Clinical narrative: Starting on the evening of 12/17, I woke up around 11pm with intense itching around my neck, arm pits and groin area. I applied hydrocortisone cream and went back to sleep. In the days that followed, including today (12/20), I continue to experience waves of skin itching and hives all over my body. My skin has become incredibly reactive, where gently rubbing or scratching any part of my body flares up and turns red, with continued irritation and itching.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Mobility decreased, Pain in extremity
Clinical narrative: Severe arm and join pain all over. Chills, and very bad pain in all joins. Can hardly move
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Ongoing diarrhea, 2-3 times a day (specially after a meal); preceded with stomach cramps onset 4th day after vaccination. Imodium and Pepto-Bismol both on 12/10/2021.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Troponin increased
Clinical narrative: CP with elevated troponin >37,000  being admitted to cardiology team at  a local HCF troponin 37,315
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching/Hives that last for a few minutes to an hour and move around. Antihistamines generally help but they're very annoying.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenitis
Clinical narrative: My son got his 2nd Covid shot in his left arm and within 24 hrs developed a large grape sized lump in his neck. The doctor examined and determined it to be a significant inflammation of the supraclavicular lymph nodes on the left side. It pains if it is pressed. For now doctor has suggested we wait for 1-2 weeks to see if the swelling goes away. There was no fever or any other typical symptoms.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Lethargy, Nausea, Pyrexia
Clinical narrative: Nausea, vomitting, diarrhea, fever, lethargy, pain at injection  site
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea, vomitting, diarrhea, fever, lethargy, pain at injection  site
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: I?ve been struggling with chronic nausea, moderate nausea all the time, severe nausea a couple of times per day.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Back pain, Blood test normal, Computerised tomogram head normal
Clinical narrative: Thursday: day of vaccine began to feel a knot/ball in the middle of my stomach underneath my belly button. Took a Tylenol to relieve the pain and took a nap, the stomach cramp pain woke me up and I once again took a Tylenol and went to bed because I felt sick, tired and week. On Friday and Saturday, I still had the stomach cramp, difficulty time breathing, I had a hard time getting out of bed because my waist was hurting, my legs felt heavy and I had a hard time walking. The stomach cramping, leg heaviness, tingling, inflammation, numbing, and back pain got more intense and I had a difficult time moving and breathing. I would get winded walking from one room to another. I spent most of my afternoon sitting down or laying down to rest because I felt sick, tired and very weak, I took Tylenols during the day to see if the pain would go away. By the end of the day, I was having more cramping, difficulty breathing, my legs felt very heavy, numbed, tingling, inflammation and my feet felt as if I was walking on jelly. I had to get help to stand up and walking. On Sunday, the stomach cramp went away, I still would loose my breath when I would walk from one room to another, the tingling, numbness, inflammation, leg and feet heaviness was worse. On Monday, I called clinic and talked to an advice nurse and told her my symptoms and she urged my to go to the nearest ER. I went to the closest ER, where the nurses had to come out to help me walk inside the hospital, because they had no available wheelchairs and I was not able to walk in. I was admitted and they did blood tests (all came out normal, an CT Scan of my head and the ER doctor tried to do a Spinal tap. I was in the ER for a day and then transferred by ambulance to another hospital. Once at hospital they did a MRI of my spine, Ultra Sound to check for any blood clots, blood tests (all came out normal), was in the hospital for a week
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: Thursday: day of vaccine began to feel a knot/ball in the middle of my stomach underneath my belly button. Took a Tylenol to relieve the pain and took a nap, the stomach cramp pain woke me up and I once again took a Tylenol and went to bed because I felt sick, tired and week. On Friday and Saturday, I still had the stomach cramp, difficulty time breathing, I had a hard time getting out of bed because my waist was hurting, my legs felt heavy and I had a hard time walking. The stomach cramping, leg heaviness, tingling, inflammation, numbing, and back pain got more intense and I had a difficult time moving and breathing. I would get winded walking from one room to another. I spent most of my afternoon sitting down or laying down to rest because I felt sick, tired and very weak, I took Tylenols during the day to see if the pain would go away. By the end of the day, I was having more cramping, difficulty breathing, my legs felt very heavy, numbed, tingling, inflammation and my feet felt as if I was walking on jelly. I had to get help to stand up and walking. On Sunday, the stomach cramp went away, I still would loose my breath when I would walk from one room to another, the tingling, numbness, inflammation, leg and feet heaviness was worse. On Monday, I called clinic and talked to an advice nurse and told her my symptoms and she urged my to go to the nearest ER. I went to the closest ER, where the nurses had to come out to help me walk inside the hospital, because they had no available wheelchairs and I was not able to walk in. I was admitted and they did blood tests (all came out normal, an CT Scan of my head and the ER doctor tried to do a Spinal tap. I was in the ER for a day and then transferred by ambulance to another hospital. Once at hospital they did a MRI of my spine, Ultra Sound to check for any blood clots, blood tests (all came out normal), was in the hospital for a week
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inflammation, Limb discomfort, Lumbar puncture normal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Thursday: day of vaccine began to feel a knot/ball in the middle of my stomach underneath my belly button. Took a Tylenol to relieve the pain and took a nap, the stomach cramp pain woke me up and I once again took a Tylenol and went to bed because I felt sick, tired and week. On Friday and Saturday, I still had the stomach cramp, difficulty time breathing, I had a hard time getting out of bed because my waist was hurting, my legs felt heavy and I had a hard time walking. The stomach cramping, leg heaviness, tingling, inflammation, numbing, and back pain got more intense and I had a difficult time moving and breathing. I would get winded walking from one room to another. I spent most of my afternoon sitting down or laying down to rest because I felt sick, tired and very weak, I took Tylenols during the day to see if the pain would go away. By the end of the day, I was having more cramping, difficulty breathing, my legs felt very heavy, numbed, tingling, inflammation and my feet felt as if I was walking on jelly. I had to get help to stand up and walking. On Sunday, the stomach cramp went away, I still would loose my breath when I would walk from one room to another, the tingling, numbness, inflammation, leg and feet heaviness was worse. On Monday, I called clinic and talked to an advice nurse and told her my symptoms and she urged my to go to the nearest ER. I went to the closest ER, where the nurses had to come out to help me walk inside the hospital, because they had no available wheelchairs and I was not able to walk in. I was admitted and they did blood tests (all came out normal, an CT Scan of my head and the ER doctor tried to do a Spinal tap. I was in the ER for a day and then transferred by ambulance to another hospital. Once at hospital they did a MRI of my spine, Ultra Sound to check for any blood clots, blood tests (all came out normal), was in the hospital for a week
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Movement disorder, Myelitis transverse, Nodule
Clinical narrative: Thursday: day of vaccine began to feel a knot/ball in the middle of my stomach underneath my belly button. Took a Tylenol to relieve the pain and took a nap, the stomach cramp pain woke me up and I once again took a Tylenol and went to bed because I felt sick, tired and week. On Friday and Saturday, I still had the stomach cramp, difficulty time breathing, I had a hard time getting out of bed because my waist was hurting, my legs felt heavy and I had a hard time walking. The stomach cramping, leg heaviness, tingling, inflammation, numbing, and back pain got more intense and I had a difficult time moving and breathing. I would get winded walking from one room to another. I spent most of my afternoon sitting down or laying down to rest because I felt sick, tired and very weak, I took Tylenols during the day to see if the pain would go away. By the end of the day, I was having more cramping, difficulty breathing, my legs felt very heavy, numbed, tingling, inflammation and my feet felt as if I was walking on jelly. I had to get help to stand up and walking. On Sunday, the stomach cramp went away, I still would loose my breath when I would walk from one room to another, the tingling, numbness, inflammation, leg and feet heaviness was worse. On Monday, I called clinic and talked to an advice nurse and told her my symptoms and she urged my to go to the nearest ER. I went to the closest ER, where the nurses had to come out to help me walk inside the hospital, because they had no available wheelchairs and I was not able to walk in. I was admitted and they did blood tests (all came out normal, an CT Scan of my head and the ER doctor tried to do a Spinal tap. I was in the ER for a day and then transferred by ambulance to another hospital. Once at hospital they did a MRI of my spine, Ultra Sound to check for any blood clots, blood tests (all came out normal), was in the hospital for a week
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder, Ultrasound Doppler normal
Clinical narrative: Thursday: day of vaccine began to feel a knot/ball in the middle of my stomach underneath my belly button. Took a Tylenol to relieve the pain and took a nap, the stomach cramp pain woke me up and I once again took a Tylenol and went to bed because I felt sick, tired and week. On Friday and Saturday, I still had the stomach cramp, difficulty time breathing, I had a hard time getting out of bed because my waist was hurting, my legs felt heavy and I had a hard time walking. The stomach cramping, leg heaviness, tingling, inflammation, numbing, and back pain got more intense and I had a difficult time moving and breathing. I would get winded walking from one room to another. I spent most of my afternoon sitting down or laying down to rest because I felt sick, tired and very weak, I took Tylenols during the day to see if the pain would go away. By the end of the day, I was having more cramping, difficulty breathing, my legs felt very heavy, numbed, tingling, inflammation and my feet felt as if I was walking on jelly. I had to get help to stand up and walking. On Sunday, the stomach cramp went away, I still would loose my breath when I would walk from one room to another, the tingling, numbness, inflammation, leg and feet heaviness was worse. On Monday, I called clinic and talked to an advice nurse and told her my symptoms and she urged my to go to the nearest ER. I went to the closest ER, where the nurses had to come out to help me walk inside the hospital, because they had no available wheelchairs and I was not able to walk in. I was admitted and they did blood tests (all came out normal, an CT Scan of my head and the ER doctor tried to do a Spinal tap. I was in the ER for a day and then transferred by ambulance to another hospital. Once at hospital they did a MRI of my spine, Ultra Sound to check for any blood clots, blood tests (all came out normal), was in the hospital for a week
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthma, Dyspnoea, Fatigue, Headache
Clinical narrative: Felt tired first on 12/08/2021. Next day tired, needles sensations around heart, fever, breathing issues, (asthma) body aches, headaches and nausea. Today (12 days later) abdominal pain and nausea, strong headaches and great tiredness.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Felt tired first on 12/08/2021. Next day tired, needles sensations around heart, fever, breathing issues, (asthma) body aches, headaches and nausea. Today (12 days later) abdominal pain and nausea, strong headaches and great tiredness.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspiration pleural cavity, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Chest pain, fatigue, shortness of breath, night sweats, coughing, fever. After I went to the doctor, I was diagnosed with pericarditis, and I was prescribed NSAIDs for 2 weeks, but my symptoms got worse after 14 days. Then I went to the ER, and was admitted to cardiology for pericardiocentesis. I exited the hospital after 4 days, but then went back to the ER because I had a persistent cough. I was admitted again for thoracocentesis, to have a tap and get rid of my detected pleural effusion. I exited the hospital after 3 days.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture, Night sweats, Pericardial drainage, Pericarditis, Pleural effusion
Clinical narrative: Chest pain, fatigue, shortness of breath, night sweats, coughing, fever. After I went to the doctor, I was diagnosed with pericarditis, and I was prescribed NSAIDs for 2 weeks, but my symptoms got worse after 14 days. Then I went to the ER, and was admitted to cardiology for pericardiocentesis. I exited the hospital after 4 days, but then went back to the ER because I had a persistent cough. I was admitted again for thoracocentesis, to have a tap and get rid of my detected pleural effusion. I exited the hospital after 3 days.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Chest pain, fatigue, shortness of breath, night sweats, coughing, fever. After I went to the doctor, I was diagnosed with pericarditis, and I was prescribed NSAIDs for 2 weeks, but my symptoms got worse after 14 days. Then I went to the ER, and was admitted to cardiology for pericardiocentesis. I exited the hospital after 4 days, but then went back to the ER because I had a persistent cough. I was admitted again for thoracocentesis, to have a tap and get rid of my detected pleural effusion. I exited the hospital after 3 days.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Eyelid disorder, Facial paralysis
Clinical narrative: Onset of Bell's Palsy starting on Friday 12-17-2021, seen by 911 Emergency around 9pm to rule out Stroke. Over 48 hrs full paralysis of right side of face, to include movement of Eye lid.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Onset of Bell's Palsy starting on Friday 12-17-2021, seen by 911 Emergency around 9pm to rule out Stroke. Over 48 hrs full paralysis of right side of face, to include movement of Eye lid.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Eyelid disorder, Facial paralysis
Clinical narrative: As per patient, patient was diagnosed with Bell's palsy on 12/17/21. Not too much detailed information provided by patient.  Patient has received vaccine on 12/12/2021
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: As per patient, patient was diagnosed with Bell's palsy on 12/17/21. Not too much detailed information provided by patient.  Patient has received vaccine on 12/12/2021
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient in prolonged (4 hours) period of unresponsiveness, awake but unable to communicate.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Ear pain, Headache, Pyrexia
Clinical narrative: feeling of fever; Diarrhea; headache like pulling pain on the left side behind the ear; headache like pulling pain on the left side behind the ear; feeling of weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: 30130BA) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination= Yes. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "feeling of fever"; DIARRHOEA (non-serious) with onset Sep2021, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious), EAR PAIN (non-serious) all with onset Sep2021, outcome "unknown" and all described as "headache like pulling pain on the left side behind the ear"; ASTHENIA (non-serious) with onset Sep2021, outcome "unknown", described as "feeling of weakness". Therapeutic measures were not taken as a result of pyrexia, diarrhoea, headache, ear pain, asthenia.  Additional information: Drug administration time 06:00 PM, adverse event start time: 06:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After the expiration date/ All doses were administered by intramuscular injection and expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date/ All doses were administered by intramuscular injection and expired doses) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date/ All doses were administered by intramuscular injection and expired doses). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date/ All doses were administered by intramuscular injection and expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  None of the patients experienced any reported symptoms.   This case was linked to MOD-2021-413535, MOD-2021-413554, MOD-2021-413598 (Patient Link).
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered GARDASIL 9 while undergoing a temperature excursion; The medical assistant did not report any other adverse events with the patient; This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 0.5 ml, lot # T027789, expiry date 27-FEB-2023 (route and location of administration were not reported) for prophylaxis, which was undergoing a temperature excursion (product storage error). The medical assistant did not report any other adverse events with the patient (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA002604:
Age: 21.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AEs were reported; 21 years old patient received a dose of PROQUAD on 28-SEP-2021; This spontaneous report was received from a medical assistance and refers to a 21-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 28-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) lot # U009262, 19-SEP-2022, 1 dose for prophylaxis (exact dose, dose #, route and anatomical location were not reported) (inappropriate age at vaccine administration). No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No other AE; received a dose on 02-DEC-2021 and the product expired on 05-NOV-2021; This spontaneous report was received from a pharmacist and refers to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 02-DEC-2021, the patient was vaccinated with the expired 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot # S035355, expiration date was provided and also validated as 05-NOV-2021 (exact dose, strength, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). The product did not have any known temperature excursions. No other adverse event (AE) occurred.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient was administered ROT ATEQ after a temperature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were no reported.   On an 18-NOV-2021, the patient was vaccinated with an importer stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot # T033510, expiration date: 28-DEC-2021) 2 milliliters (strength, route of administration, frequency was not reported) for prophylaxis (product storage error). The vaccine underwent a temperature excursion of 47.29-degree Fahrenheit for a period of 3 hours 22 minutes. There was no previous temperature excursion. The patient did not experience any adverse event. At the time of the event, the outcome of the event was not reported.  The causal relationship between the event and the suspect vaccine were no reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE was reported; Administration of an expired dose of VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On 09-DEC-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter one time (Lot # S038175 and expiration date 26-NOV-2021) for prophylaxis (expired product administered).  The vaccine had not undergone a temperature excursion. No other adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no adverse event; expired vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about medical history, concomitant therapy and concurrent condition was not provided.   On 07-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # s039316 was evaluated and changed to the valid Lot # S039316, expiration date 04-DEC-2021; strength, dose detail and route was not reported) for prophylaxis (expired vaccine used). The product did not have any temperature excursions prior to administration. No other adverse event (AE). The outcome of expired vaccine used was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; administration of expired vaccine; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-DEC-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA (recombinant human albumin)) (M-M-R II) lot # S039309, expiration date 04-DEC-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis (Expired product administrated).  There was no additional adverse event (AE) details reported (No adverse event).
Age: 73.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: This spontaneous report was received from a physician, via a medical record, from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs # 1810USA002328), concerning an elderly male patient. His medical history, concurrent conditions and concomitant therapies were not reported. On approximately February 2016 (reported as "about one year ago", on a medical visit on 15-FEB-2017), at approximately 73 years old, the patient was vaccinated with an unspecified human papilloma virus (HPV) vaccine (manufacturer unknown, unclear if the vaccine was hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)) as prophylaxis (product administered to patient of inappropriate age and product origin unknown) (dose, route of administration, lot number and expiration date were not provided). Afterwards, on an unspecified date in 2016 (noted on a dermatology note on 10-AUG-2016), he experienced skin rash (rash) and was treated with different unspecified creams. At the reporting time, the outcome of the events was unknown. The causality assessment between the event rash and the unspecified HPV vaccine was not provided; however, due to temporal association it was considered as related. This is one of several reports concerning the same patient.; Sender's Comments: US-009507513-1810USA002328.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Shoulder feels separated, sore, pain; Very limited arm movement; Unable to bath, dress, get in-out of bed & chairs without help; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 8th December 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced shoulder pain, mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the shoulder pain, mobility decreased and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided are as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine on Wednesday and he/she felt like his/her shoulder was been separated. The word sore did not begin to describe the pain. No outer swelling or bruise but he/she had very limited arm movement. The patient did not expect to be unable to bath, dress or get in and out of bed and chairs without help.  The patient hopes it did not last much longer.  The patient asked that pharmacist might be hit a nerve, and nothing takes away the pain. The patient was not sure for getting the 2nd shot and already had shingles so he/she knew what the pain was like. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Sensitive skin
Clinical narrative: At injection site, whole upper arm became red; At injection site, whole upper arm became swollen; hypersensitive; This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and hypersensitive skin. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site swelling and hypersensitive skin were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and hypersensitive skin to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received dose of Shingrix injection site patients whole upper arm became red and swollen, which lasted until Saturday 11th December 2021. Patient was hypersensitive and took Benadryl. Benadryl was administered as treatment as a result of the hypersensitivity of the patient and, if it was administered 4 days after on Saturday as the injection site erythema and swelling was still present.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Given 3 doses of vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for an unknown indication.   Previously administered products included Shingrix (received 2 dose of shingrix 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 age at vaccination was not reported. The reporter stated that a person was given 3 doses of shingles vaccine, which led to extra dose administered. The reporter asked if it was something to be panicked or should remain calm. The follow-up would not be possible as no contact details were available.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Suspected vaccination failure/1st and 2nd doses in 2019 / had Shingles in 2021; Shingles; received Shingrix when she was 48 / prior to approval of Shingrixfor patients under 50; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had first outbreak of Shingles in 2020, refer case US2021254962).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided are as follows: The case was reported by patient's husband. The patient received both doses of Shingrix on an unknown arm in summer of 2019 (exact dates were unknown) when she was 48 years old prior to the FDA approval Shingrix for immunocompromised patients under 50 years of age which led inappropriate age at vaccine administration and had second outbreak of shingles in 2021. The caller did not ask for lot, expiration date and arm administered. The reporter did not have specific information on his wife's vaccine. Did not ask for consent because caller was not the patient. This case was considered as suspected vaccination failure since the detail regarding and laboratory test confirming shingles was unknown at the time of reporting.; Sender's Comments:  US-GSKCCFUS-Case-01242845_AE-72822: US-GLAXOSMITHKLINE-US2021254962:Same reporter, same product, same patient, case created for event that happened in another point in time
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Myalgia, Pain
Clinical narrative: sore muscle; This case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles at the age of 48 years), pain (It was the most painful thing) and feeling hot (burning from the inside out).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was recovered/resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got shingles. It was not just the elderly that get it. It was the most painful thing he/she ever experienced. The patient experinced shingles over his/her ribcage and every breath he/she took was excruciating.It was like burning from the inside out. The patient received a dose of Shingles vaccine and the only side effect he/she had was a sore muscle for a couple of days.  The patient stated that it was worth getting vaccine. When the vaccine came out, he/she received and it was expensive but all he/she paid was $4.00. Insurance covered the rest. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and skin red. On an unknown date, the outcome of the pain and skin red were unknown. It was unknown if the reporter considered the pain and skin red 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 patient received dose of Shingrix vaccine and experienced wide sore red patch 4 inches below the vaccine. The reporter asked GlaxoSmithKline was it normal to. The follow-up would not possible as no contact details were available.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: The patient inadvertently received a third; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st and 2nd dose received on an unknown date).   On 3rd September 2021, the patient received the 3rd dose of Shingrix. On 3rd September 2021, 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 provided were as follows: Age at vaccination was not reported. The patient received a 3rd dose of Shingrix which led to extra dose administered. The reporter denied to follow-up.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Vx administered after a temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 70-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 29th November 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided are as follows: The reporter reported that a patient received a dose of Boostrix had suffered a previous temperature excursion and was later administrated, which led to incorrect storage of drug. No further events were reported. The reporter agreed to be contacted for follow-up. This case has been linked with case US2021AMR257658, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR257658:Same reporter
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was administered Infanrix; was administered Infanrix instead of the Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 62-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Nurse reported a patient was administered the Infanrix vaccine instead of the Boostrix vaccine inadvertently, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021258434:same reporter
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Vx administered after a temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect product storage in a 59-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 29th November 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.  Additional details were reported as follows: The patient received a dose of Boostrix where the vaccine suffered previous temperature excursion, which led to Product storage error. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR257611:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got my shot and got shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got his/her shot and got shingles but was gone in a few weeks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th December 2021, the patient received the 2nd dose of Shingles vaccine. On 14th December 2021, 1 days after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reported reported that he/she had second shot and he/she was very sick at the time of reporting.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only diluent / The Conjugate was administered a week ago / administered only the liquid component; received only diluent / The Conjugate was administered a week ago / administered only the liquid component; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA602A, expiry date 31st August 2022) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Menveo. On 15th November 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The primary reporter was the father of the patient. The patient received Menveo in the left arm. The reporter stated that, the patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021253723, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021253723:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of shingrix 3 yrs past their first dose; This case was reported by a pharmacist via call center representative 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 0.5 ml 1st dose of Shingrix 3 years ago).   On 10th December 2021, the patient received the 2nd dose of Shingrix .5 ml. On 10th December 2021, 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 provided were as follows: Age at vaccination was not reported. The reporter asked if the patient needed a third dose of shingrix if they were past the 6 months for getting the second dose. He stated that he just gave a patient their second dose of shingrix 3 yrs past their first dose, which led to lengthening of vaccination schedule. The reporter had limited information on the patient's demographics and vaccine. The reporter did not consent to follow-up.