chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Nausea, Vomiting
Clinical narrative: Patient came into vaccination site on 1/03/21 for COVID-19 Pfizer second dose. Patient received first dose on 12/13/21. Patient reported to the RN that 10 hours after her first dose she experienced dizziness, nausea, vomiting, and diarrhea for 7 hours and SOB for approximately 30 minutes. Patient did not go to ED or see PCP. Patients mother gave her paracetamol. Patient stated that within 7 hours her symptoms had subsided. The RN submitted a medical consult via text message to vaccine operations Leads, requesting to proceed with the COVID vaccine Pfizer second dose. Per regulatory authority guidance, approval to proceed with COVID vaccine Pfizer second dose was obtained from medical consult team, vaccine operations Lead registered nurse, via doctor approval. Patient received COVID vaccine Pfizer second dose LOT#: FL3198 at 1632. Patient was educated on adverse reactions of COVID vaccine and when to seek EMS. Patient and patients mother verbalized understanding. Patient left vaccination site with her mom at 1647 unassisted and with a steady gait.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: AFTER ADMINISTERING MODERNA 1ST DOSE @ 1747, ABOUT 5 MINUTES LATER PT'S FELT DIZZY, SWEATING, HAD SOME WATER, PT'S WAS WITH MOTHER, PT'S SAID HE FAINT , OR FEEL THIS WAY EVERY TIME HE GETS VACCINE BECAUSE PT'S IS AFRAID OF NEEDLE. PT'S JUST WANTED SOME WATER AND SAID HE IS GETTING BETTER. @ 1810 PT'S TOOK TYLENOL 500MG (2 TABLETS). PT'S FELT ALRIGHT TO LEAVE ~@1815; MOTHER SAID SHE WILL DROP OFF HER SON AND BE WITH HIM. PT;S FEELING FINE TO LEAVE PHARMACY WITH MOTHER. DP 01/03/2022
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: patient want to get Pfizer and we typed pfizer and gave her moderna.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Condition aggravated, Deafness, Dizziness, Pallor
Clinical narrative: Vaccinated: 10AM Reaction: 10:01AM Pt experienced dizziness and light headedness after receiving her Pfizer booster. PT noted also to be clammy and pale. PT taken to hospital to lay down and was given juice and crackers. PT later reported she briefly lost her hearing until she sat in wheelchair to be taken to hospital and her hearing came back. Patient noted to have significant history of dizziness with needlesticks. Father says she gets this from him.  Vitals: 109/48, 65, 14 -> @10:31: 108/72, 56, 14, O2 100% Pt reported feeling better after laying down and after sitting up and eating crackers and juice. Her adverse symptoms resolved and she left facility ambulating independently with steady gate, accompanied by her parents, and in NAD at 10:34AM. Patient educated to stay well hydrated before and after needlestick injections in future and to have future needlestick injections given at facility where she can receive injection while laying down, i.e. doctor's office, vaccine center.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 4TH BOOSTER SHOT WAS GIVEN TO THE PATIENT.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 days after receiving vaccine, patient developed red area around injection site left upper arm.  Area has slowly spread over past 2 days.  Red, warm, firm.  No drainage.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Migraine, Muscle twitching, Ophthalmological examination normal, Specialist consultation
Clinical narrative: Starting the morning of 10/14/2021, or 5 days from the shot, I woke up with tunnel vision in both eyes, although much more pronounced in my left eye.  My upper left lip was also twitching.  I've never experienced anything like this before.  Both of these symptoms lasted for nearly 1.5 days until subsiding.  I went to a urgent care facility the evening of 10/15/2021, but by the time I got there the sumptoms were gone.  I was examined by a doctor on site, and he consulted with an opthamologist and they believed everything seemed to be back to normal.  I then saw an opthamologist, Dr., on 10/18/21.  He conducted an exam and everything appeared normal and he thought I was experiencing probably migraine equivalent.  An MRI was ordered and completed on 11/21/2021 and the results were negative for anything neurological.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tunnel vision
Clinical narrative: Starting the morning of 10/14/2021, or 5 days from the shot, I woke up with tunnel vision in both eyes, although much more pronounced in my left eye.  My upper left lip was also twitching.  I've never experienced anything like this before.  Both of these symptoms lasted for nearly 1.5 days until subsiding.  I went to a urgent care facility the evening of 10/15/2021, but by the time I got there the sumptoms were gone.  I was examined by a doctor on site, and he consulted with an opthamologist and they believed everything seemed to be back to normal.  I then saw an opthamologist, Dr., on 10/18/21.  He conducted an exam and everything appeared normal and he thought I was experiencing probably migraine equivalent.  An MRI was ordered and completed on 11/21/2021 and the results were negative for anything neurological.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: No symptoms
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: During a review of the local Department of Health?s internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Ultrasound scan, Uterine dilation and curettage
Clinical narrative: Had Pfizer dose #1 on 12-18-2020 and Pfizer dose #2 on 1-8-2021.  Experienced a miscarriage at 9 weeks in June 2021 (first miscarriage) and had a D&C on 6-10-2021.  received 3rd dose of Pfizer vaccine (booster) on 9-28-2021.  Experienced a second miscarriage on 12-20-2021 and took cytotec medication twice and did three doses of methergine for treatment.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: About 13 hours after vaccine had uncontrollable shaking of all limbs, hands and feet for about 4 hours. For 42 hours I could not be upright due to feeling like I would pass out. Was flat out in bed for 42 hours starting 13 hours after vaccination. Other symptoms:fever, body aches, headache, exhausted.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: About 13 hours after vaccine had uncontrollable shaking of all limbs, hands and feet for about 4 hours. For 42 hours I could not be upright due to feeling like I would pass out. Was flat out in bed for 42 hours starting 13 hours after vaccination. Other symptoms:fever, body aches, headache, exhausted.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Fatigue, Headache, Irritability, Migraine
Clinical narrative: Fever up to 102 and migraine for 2 days. Headache and fatigue for a week. Irritability and depression for 2 weeks.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever up to 102 and migraine for 2 days. Headache and fatigue for a week. Irritability and depression for 2 weeks.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient brought in vaccine card with one dose of J&J in June of 2021- gave her booster 1-3-2022. After I finished she informed me she had one dose of Moderna in march or April 2021 ( ended up being March 10, 2021) but it caused her hearing issues.  She did not complete that series and instead was told by her md to get a J&J dose - she went to a pharmacy for that
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Gynaecological examination, Intermenstrual bleeding, Menstrual disorder, Ultrasound scan
Clinical narrative: -Menstruating at time of ovulation in August 2021 (one-time occurrence) -Increase in menstruation pain since June 2021 (has continued until today)
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Computerised tomogram, Cough
Clinical narrative: On both my 2nd dose in March 2021 and now my booster (this vaccine) in Dec, I have suffered a persistent dry cough, chest tightness and some shortness of breath which continues 3 weeks so far after the booster shot. On my 2nd dose, the cough lasted 16 weeks. In both cases, these symptoms were exactly the same and started immediately after the vaccine. I am by all measures, a very healthy, fit individual and the symptoms have inhibited my ability to exercise fully.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Exercise tolerance decreased, Specialist consultation
Clinical narrative: On both my 2nd dose in March 2021 and now my booster (this vaccine) in Dec, I have suffered a persistent dry cough, chest tightness and some shortness of breath which continues 3 weeks so far after the booster shot. On my 2nd dose, the cough lasted 16 weeks. In both cases, these symptoms were exactly the same and started immediately after the vaccine. I am by all measures, a very healthy, fit individual and the symptoms have inhibited my ability to exercise fully.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Computerised tomogram head, Condition aggravated, Electromyogram
Clinical narrative: Post vaccine day 5, started feeling tingling in legs; 2 days later had twitching and fatigue after walking 1 mile - was admitted and dx'd with recurrent Guillain- Barre syndrome and treated with IVIG. EMG pending to verify GBS (sensory only) vs small fiber neuropathy. Incidentally found B12 deficient and Vitamin D insufficient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test, Muscle twitching
Clinical narrative: Post vaccine day 5, started feeling tingling in legs; 2 days later had twitching and fatigue after walking 1 mile - was admitted and dx'd with recurrent Guillain- Barre syndrome and treated with IVIG. EMG pending to verify GBS (sensory only) vs small fiber neuropathy. Incidentally found B12 deficient and Vitamin D insufficient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Small fibre neuropathy, Vitamin B12 deficiency, Vitamin D deficiency
Clinical narrative: Post vaccine day 5, started feeling tingling in legs; 2 days later had twitching and fatigue after walking 1 mile - was admitted and dx'd with recurrent Guillain- Barre syndrome and treated with IVIG. EMG pending to verify GBS (sensory only) vs small fiber neuropathy. Incidentally found B12 deficient and Vitamin D insufficient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate decreased, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Mild injection site pain within a couple hours, moderate injection site pain and swollen lymph node next day - swollen lymph node was moderately to very painful, radiating from left armpit (injection was in left arm). Fatigue and lower than normal heart rate variability since vaccine.  Lymphoma has  80% resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: Mild injection site pain within a couple hours, moderate injection site pain and swollen lymph node next day - swollen lymph node was moderately to very painful, radiating from left armpit (injection was in left arm). Fatigue and lower than normal heart rate variability since vaccine.  Lymphoma has  80% resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Physical examination, Pyrexia
Clinical narrative: 12/28 In the morning felt feverish and chills, shortness of breath. Went to PCP and after a physical advised to alternate between Tylenol and other pain relief/fever reducers. Fever got worse but only to 99.8 and kept fluctuating. Did not start feeling better until 12/31. On Sunday 01/01 only felt short of breath while walking. No more feverish chills. As of 01/3/2022 no fever, chill or headache, but still short of breath.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: people are getting breakthrough cases; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (people are getting breakthrough cases) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (people are getting breakthrough cases). At the time of the report, VACCINATION COMPLICATION (people are getting breakthrough cases) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter. No treatment details were added.  Patient mentioned that people were getting breakthrough cases despite administration of 2 doses and booster dose of Moderna COVID-19 Vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pain
Clinical narrative: left chest on my heart had sharp pain / stabbing then stopping then stabbing then stopping/Heart sharpness; She was thinking what she ate last night caused her pain; headache that wasn't bad; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (left chest on my heart had sharp pain / stabbing then stopping then stabbing then stopping/Heart sharpness), PAIN (She was thinking what she ate last night caused her pain) and HEADACHE (headache that wasn't bad) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 013L20A and 039K20A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 NOS for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, the patient experienced CHEST PAIN (left chest on my heart had sharp pain / stabbing then stopping then stabbing then stopping/Heart sharpness), PAIN (She was thinking what she ate last night caused her pain) and HEADACHE (headache that wasn't bad). At the time of the report, CHEST PAIN (left chest on my heart had sharp pain / stabbing then stopping then stabbing then stopping/Heart sharpness) and PAIN (She was thinking what she ate last night caused her pain) had resolved and HEADACHE (headache that wasn't bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include another vitamin.  No treatment medications were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Expired dose of M-M-R II was administered to a patient today (06-DEC-2021); This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.       On 06-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot number S031483, expiration date 07-OCT-2021, (strength, dose, dose number, frequency, route, and anatomical location), for prophylaxis (expired product administered). the reporter stated that the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was stored properly through the time of vaccination. No adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: no adverse event; one dose of PNEUMOVAX 23 was improperly stored and administered to a patient; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 10-DEC-2021, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (lot number T039322, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 09-SEP-2022) (frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis (product storage error). The administered vaccine experienced a temperature excursion of 48.5 Fahrenheit (°F) during a time frame of 4 hours 0 minutes and 0 seconds. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA005883:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from an office manager and refers to a female patient of unknown age. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2021, the patient became pregnant. The last menstrual period (LMP) was on an unknown date in 2021, the estimated delivery date (EDD) was not known. The pregnancy outcome was pending. On 14-DEC-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, (exposure during pregnancy). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided. No additional adverse event reported.; measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered to a patient after experiencing a temperature excursion; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter lot # T035393, expiration date 14-APR-2022 (route of administration and anatomical location not reported) for prophylaxis. measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered to a patient after experiencing a temperature excursion on 27-DEC-2021 (product storage error), temperature was -9.6C and time frame unknown by reporter. No additional information provided. No additional adverse event reported (no adverse event).
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Malaise, Nausea, Pain in extremity
Clinical narrative: severe pain done her arm; arm felt heavy; nausea; not feeling good; This spontaneous report was received from a medical assistant and refers to a 57-year-old female. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-DEC-2021, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe injection, lot #U018309, expiration date: 08-JAN-2023, administered intramuscularly into the right arm for immunisation (strength was not provided).   On 17-DEC-2021, the patient experienced severe pain done her arm (pain in extremity), her arm felt heavy (limb discomfort ), nausea (nausea) and not feeling good (malaise). The patient did not seek medical attention.  No treatment was given for the events.  The outcome of aforementioned events was unknown.   The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional adverse events reported; Improperly stored dose administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T031202, expiration date 14-JUN-2022) 0.5 milliliter (frequency and route not reported) for prophylaxis (product storage error). The vaccine was stored at 50.5 fahrenheit (F) for 57 minutes. No previous temperature excursions were reported and it was not reported if a digital data logger was involved. No additional adverse events were reported.
Age: 0.17
Sex: M
Vaccine: HEP, UNK, UNK
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no adverse symptoms were reported; Wrong Drug Administered/inadvertently administered VAXELIS; extra dose simultaneously of Hepatitis B; HepB was not deleted from orders and was administered along with Vaxelis; This spontaneous report as received from a nurse practitioner and medical assistant via company representative concerning a 2-month-old patient, gender unspecified with no illness at the time of vaccination. There was no information about the patient's medical history or concurrent conditions.  Concomitant medication include: First dose of : rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and pneumococcal vaccine conj 13v (crm197)(PREVENAR 13),administered on the same date.   Medical assistant reported that the patient was inadvertently vaccinated with a first  dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), lot number: U7124AA, expiration date: 13-JUL-2024, intramuscularly, in the right deltoid (dose  was not reported)for prophylaxis in combination with a second dose of  hepatitis b vaccine rhbsag (yeast)(ENGERIX), in the left deltoid (lot number: FB9RH, expiration date: 21-JAN-2024) (dose was not reported) for prophylaxis instead of the originally reported Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, route of administration, lot number and expiration date were not reported), on 20-DEC-2021 in separately locations. No additional information provided. No additional adverse events reported. No product quality complaints reported. No further details provided. No digital data logger was reporter.  The medical assistant mentioned that while ordering new vaccines for the well visit , and the Hepatitis B was not deleted from the orders (product prescribing error) and the vaccines were administered along with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (wrong product administered, extra dose administered), on 20-DEC-2021. The medical assistant immediately reported to provider after vaccines were administered.  The nurse practitioner reported that poison control and the company was notified: the Toxicologist and the physician with the poison control alone with the company representative reported that hepatitis B to be a very safety vaccine with no expected adverse events, for receiving an extra dose simultaneously. The nurse practitioner spoke with the paternal grandmother and the mom regarding with the information received. It was stated that the patient was that the patient to be sleeping comfortably. No reports of fever or significant changes behaviors reported by the mother and maternal grad mother. The mother was advised to monitor and call if changes in behaviors, redness to injection site and fever would be presented.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Condition aggravated, Pain, Vaccine positive rechallenge
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 (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and experienced burning in arm, refer case- US2021AMR231061). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and burning sensation. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the pain and burning sensation 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 got the shot and was still feeling burning in arm from having them, was very painful. The reporter stated that, he/she had been down that road and did not ever wanted to again. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR231061:1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Stress, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain burning in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles 6 years ago). Previously administered products included Shingles vaccine with an associated reaction of pain (received on an unknown date, refer case US2021AMR242504). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain burning, pruritus and stress. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain burning, pruritus and stress were not recovered/not resolved. It was unknown if the reporter considered the pain burning, pruritus and stress to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced burning pain and itch on areas on his/her back, no rash. It came and went. The patient thought stress brings it on. The follow-up would not possible as no contact details were available; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR242504:Same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Heart rate increased, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox at 3 years of age) and shingles (had shingles at 50 years of age). Previously administered products included Shingrix (received 1st dose in September 2021, refer case US2021248411). Concurrent medical conditions included reaction to drug preservatives. On 1st December 2021, the patient received the 2nd dose of Shingrix. On 1st December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, general body pain, chills, heart rate increased, headache, weakness, tiredness, dizziness and vaccine administered at inappropriate site. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, general body pain and dizziness were not recovered/not resolved and the outcome of the chills, heart rate increased, headache, weakness, tiredness and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the pain in arm, general body pain, chills, heart rate increased, headache, weakness, tiredness and dizziness to be related to Shingrix. Additional details were provided are as follows: The patient received 2nd dose of Shingrix in left upper arm and she felt pain after the injection was administered and then in 3 to 4 hours she experienced the pain spread throughout her body and had body pain, chills, weak and tired. Three hours after receiving the vaccine, the patient had racing heart and headache. The patient received 2nd dose of Shingrix too high on the arm near the shoulder, which led to vaccine administered at inappropriate site. The reporter called to inquire how long was Shingrix effective in patients 50 years and older, regarding approval date of Shingrix, placement of Shingrix in arm and ingredients of Shingrix. The reporter reported that she had many allergies including allergy to preservatives and would like to know the ingredients in the vaccine. The reporter was given medical disclaimer and referred to health care professional. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021248411:Same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox at 3 years of age) and shingles (had shingles at 50 years of age). Previously administered products included Shingrix (received 1st dose in September 2021, refer case US2021248411). Concurrent medical conditions included reaction to drug preservatives. On 1st December 2021, the patient received the 2nd dose of Shingrix. On 1st December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, general body pain, chills, heart rate increased, headache, weakness, tiredness, dizziness and vaccine administered at inappropriate site. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, general body pain and dizziness were not recovered/not resolved and the outcome of the chills, heart rate increased, headache, weakness, tiredness and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the pain in arm, general body pain, chills, heart rate increased, headache, weakness, tiredness and dizziness to be related to Shingrix. Additional details were provided are as follows: The patient received 2nd dose of Shingrix in left upper arm and she felt pain after the injection was administered and then in 3 to 4 hours she experienced the pain spread throughout her body and had body pain, chills, weak and tired. Three hours after receiving the vaccine, the patient had racing heart and headache. The patient received 2nd dose of Shingrix too high on the arm near the shoulder, which led to vaccine administered at inappropriate site. The reporter called to inquire how long was Shingrix effective in patients 50 years and older, regarding approval date of Shingrix, placement of Shingrix in arm and ingredients of Shingrix. The reporter reported that she had many allergies including allergy to preservatives and would like to know the ingredients in the vaccine. The reporter was given medical disclaimer and referred to health care professional. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021248411:Same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included guillain barre syndrome (had Guillain-Barre syndrome about 15 years ago). Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 22nd April 2021 and also experienced injection site pain, sluggishness and pain in arm, refer case US2021250234). Concurrent medical conditions included lower extremities weakness of (has some slight weakness in her left leg). On 21st June 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st June 2021, immediately after receiving Shingrix, the patient experienced injection site pain and injection site swelling. In July 2021, the patient experienced stiff joint, muscle tightness, decrease in coordination, ataxia, weakness of limbs, leg pain and pain ankle. On an unknown date, the patient experienced condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/ resolved and the outcome of the stiff joint, muscle tightness, ataxia, weakness of limbs, leg pain and pain ankle were not recovered/not resolved and the outcome of the decrease in coordination and condition aggravated were unknown. The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, stiff joint, muscle tightness, decrease in coordination, ataxia, weakness of limbs, leg pain, pain ankle and condition aggravated to be related to Shingrix. Additional details were provided are as follows: The patient self-reported this case. The patient had a history of Guillian Barr Syndrome (about 15 years ago) and was recovered other than some slight weakness in her left leg. The patient received a dose of Shingrix in left deltoid and immediately had soreness at injection site that lasted several days. Less than a day after receiving the vaccination, the patient had swollen upper left arm. About a month ago, after receiving the vaccination, the patient had experienced weakness of the legs and arms, tightness in her ankles and legs, stiffness of her joints, ataxia, pain in her ankles and legs and a loss of coordination. In 2021, less than 6 months after receiving vaccination, the patient got increased weakness in her left leg and the weakness spread to her right leg and both arms. The reporter stated that these side effects felt exactly the same as the effects of Guillian Barr Syndrome when she had previously been diagnosed. The reporter called to ask if the Shingrix vaccine could reactive Guillian Barr Syndrome. The reporter did not have any further healthcare professional's contact information. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021250234:Same patient, different dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Influenza like illness, Injection site erythema, Pain in extremity
Clinical narrative: warm spot below site of injection; red spot below site of the injection; fever; chills; flu-like symptoms; arm is still sore; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received in 21st September 2021, experienced a red, swollen arm, and cellulitis refer case US2021252050).   On 6th December 2021 11:00, the patient received the 2nd dose of Shingrix. On 7th December 2021, 1 days after receiving Shingrix, the patient experienced injection site warmth and injection site erythema. In December 2021, the patient experienced fever, chills, influenza-like symptoms and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills and influenza-like symptoms were recovered/resolved and the outcome of the pain in arm, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, influenza-like symptoms, pain in arm, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The patient received the 2nd dose of Shingrix in her right arm at around 11 am on Monday from the day of reporting. 14 hours after received Shingrix around 1 am on 7th December 2021, the patient developed a fever, chills, and flu-like symptoms that lasted a few hours and then resolved. The patient reported on the day of reporting that her arm was still sore and that there was a warm, red spot that appeared below the site of the injection (currently unresolved). She could not provide the lot or expiration date of either dose of Shingrix vaccine. The reporter consented to follow up by phone. The reporter gave consent to contact her HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252050:Same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: warm spot below site of injection; red spot below site of the injection; fever; chills; flu-like symptoms; arm is still sore; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received in 21st September 2021, experienced a red, swollen arm, and cellulitis refer case US2021252050).   On 6th December 2021 11:00, the patient received the 2nd dose of Shingrix. On 7th December 2021, 1 days after receiving Shingrix, the patient experienced injection site warmth and injection site erythema. In December 2021, the patient experienced fever, chills, influenza-like symptoms and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills and influenza-like symptoms were recovered/resolved and the outcome of the pain in arm, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, influenza-like symptoms, pain in arm, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The patient received the 2nd dose of Shingrix in her right arm at around 11 am on Monday from the day of reporting. 14 hours after received Shingrix around 1 am on 7th December 2021, the patient developed a fever, chills, and flu-like symptoms that lasted a few hours and then resolved. The patient reported on the day of reporting that her arm was still sore and that there was a warm, red spot that appeared below the site of the injection (currently unresolved). She could not provide the lot or expiration date of either dose of Shingrix vaccine. The reporter consented to follow up by phone. The reporter gave consent to contact her HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252050:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: Pain all over; Joint pain; This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on 20th July 2020, for tolerance of 1st dose refer case US2021252028).   On 19th October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and joint pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the pain and joint pain to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and in 2020, less than 2 years after receiving vaccine, the patient had experienced pain all over and joint pain. It was unknown if the adverse events occurred after the first dose of Shingrix or the second dose of Shingrix. The pain all over and joint pain have lasted for months after the Shingrix was administered.  The physician had ruled out rheumatoid arthritis and other auto-immune diseases.  As of 8th December 2021, the patient continued to experience pain all over and joint pain. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252028:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Illness, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: 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. Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date and also experienced influenza-like symptoms, refer case US2021AMR254584). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness and influenza-like symptoms. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just had the 2nd dose of newest Shingles shot. The day after 2nd dose, the patient was very sick with flu like symptoms that lasts 24 hours. The patient stated that they did not warn the person about that when you get it. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR254584:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of injection site warmth (1st dose received on an unknown date, refer case US2021AMR263517). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site warmth and sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site warmth and sickness were unknown. It was unknown if the reporter considered the injection site warmth and sickness to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The shots were not so hot, either. Especially the second one was sick as a dog. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR263485:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling around injection area; red around injection area; injection area hurts/ it hearts a lot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than a month after receiving Shingles vaccine, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain 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 got his/her first shot before the holiday and the next shot was due on 30th Jaunuary 2022. The reporter stated that, it hurt a lot some swelling red around the injection area hurt for a few days but the thought of shingles was more painful that he/she could not stand. The reporter adviced to get the Shingles shots and it would be glad. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 and shingles were unknown. 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 age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter.