chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Sore throat on Sunday, 1/9/22 evening at 1:00AM Started fever on Sunday, 1/9/22 morning at 99 degrees. Low grade fever until Tuesday, 1/11/22 evening. Body rash on the back started evening on Wednesday 1/12. No fever on 1/12/22 Saw doctor and was negative strep throat.  Slight red in the ear but not major.  COVID test negative as of 1/12/22
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Sore throat on Sunday, 1/9/22 evening at 1:00AM Started fever on Sunday, 1/9/22 morning at 99 degrees. Low grade fever until Tuesday, 1/11/22 evening. Body rash on the back started evening on Wednesday 1/12. No fever on 1/12/22 Saw doctor and was negative strep throat.  Slight red in the ear but not major.  COVID test negative as of 1/12/22
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast tenderness, Lymphadenopathy
Clinical narrative: Breast/armpit tenderness, lymph node swelling moderate side effect 5 out of ten.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: 101.3 fever aches in joints
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expiration date 12/31/2021
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, left underarm lymph swelling, chest pain
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Lip swelling, Mechanical urticaria, Rash, Rash pruritic
Clinical narrative: Member received Moderna vaccine x2 as well as a Moderna Booster 6 Dec 2021.  Noted dermatographic, intensely pruritic rash throughout the body starting 10 days after vaccination.  Also noted occasional angioedema of L hand.   Patient states he has had two separate reactions to the Moderna Covid-19 Vaccination.  The first occurring after his second dose and the next occurring after his booster.    Patient was seen 22 Dec 2021 in clinc  and later that night, after eating chili at home, he noticed swelling of the lips and cheeks.  Patient visiting the ER again where a new set of steroids was prescribed and a EPI Pen was prescribed as well. Patient denies ever having dyspnea or problems swallowing, never used epi pen.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Vaccine positive rechallenge
Clinical narrative: Member received Moderna vaccine x2 as well as a Moderna Booster 6 Dec 2021.  Noted dermatographic, intensely pruritic rash throughout the body starting 10 days after vaccination.  Also noted occasional angioedema of L hand.   Patient states he has had two separate reactions to the Moderna Covid-19 Vaccination.  The first occurring after his second dose and the next occurring after his booster.    Patient was seen 22 Dec 2021 in clinc  and later that night, after eating chili at home, he noticed swelling of the lips and cheeks.  Patient visiting the ER again where a new set of steroids was prescribed and a EPI Pen was prescribed as well. Patient denies ever having dyspnea or problems swallowing, never used epi pen.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after expiration date. Expiration date confusion due to Pfizer BUD extension.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Palpitations
Clinical narrative: Heart racing and increased blood pressure 2-3months after second shot. Had to be put on medication for both. Otherwise was healthy and in good physical condition.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Blood thyroid stimulating hormone normal, C-reactive protein normal, Chronic spontaneous urticaria, Differential white blood cell count normal
Clinical narrative: Chronic spontaneous urticaria beginning on October 20th, 2021. Outbreaks of hives/itching/swelling occur on various areas of the body with the most prevalent sites being the lower legs, eyes/lips/ears, wrists, and upper back. Episodes usually resolve within 20 minutes of taking an allergy medication such as Zyrtec. No triggers have been identified.  Dermatology visit 1: November 5th, 2021; recommendation to switch to sensitive skin products (lotions, detergents, etc..) and begin taking over the counter Claritin 3x/day, Benadryl as needed Primary Care Provider Visit: November 11th, 2021; switch from Claritin to Zyrtec, add hydroxyzine 10mg as needed Dermatology visit 2: January 5th, 2022; continue Zyrtec/hydroxyzine/benadryl, labs ordered, refer to allergist
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Metabolic function test normal, Platelet count normal, Pruritus, Red blood cell sedimentation rate normal
Clinical narrative: Chronic spontaneous urticaria beginning on October 20th, 2021. Outbreaks of hives/itching/swelling occur on various areas of the body with the most prevalent sites being the lower legs, eyes/lips/ears, wrists, and upper back. Episodes usually resolve within 20 minutes of taking an allergy medication such as Zyrtec. No triggers have been identified.  Dermatology visit 1: November 5th, 2021; recommendation to switch to sensitive skin products (lotions, detergents, etc..) and begin taking over the counter Claritin 3x/day, Benadryl as needed Primary Care Provider Visit: November 11th, 2021; switch from Claritin to Zyrtec, add hydroxyzine 10mg as needed Dermatology visit 2: January 5th, 2022; continue Zyrtec/hydroxyzine/benadryl, labs ordered, refer to allergist
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Thyroxine free normal
Clinical narrative: Chronic spontaneous urticaria beginning on October 20th, 2021. Outbreaks of hives/itching/swelling occur on various areas of the body with the most prevalent sites being the lower legs, eyes/lips/ears, wrists, and upper back. Episodes usually resolve within 20 minutes of taking an allergy medication such as Zyrtec. No triggers have been identified.  Dermatology visit 1: November 5th, 2021; recommendation to switch to sensitive skin products (lotions, detergents, etc..) and begin taking over the counter Claritin 3x/day, Benadryl as needed Primary Care Provider Visit: November 11th, 2021; switch from Claritin to Zyrtec, add hydroxyzine 10mg as needed Dermatology visit 2: January 5th, 2022; continue Zyrtec/hydroxyzine/benadryl, labs ordered, refer to allergist
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired. Vaccine expiration mislabeled due to confusion over Pfizer BUD extension.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Severe pain to left upper bicep and arm since I got the shot.  It's hard to left my arm sometimes and painful to move after I take alleve.  When I work (I work as a nurse) it's painful with all movement. I'm home resting and doing this and it hurts and is throbbed and I have uses massage, capsaicin cream, icy hot, ice and heat, aleve...it's constant pain.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Severe pain to left upper bicep and arm since I got the shot.  It's hard to left my arm sometimes and painful to move after I take alleve.  When I work (I work as a nurse) it's painful with all movement. I'm home resting and doing this and it hurts and is throbbed and I have uses massage, capsaicin cream, icy hot, ice and heat, aleve...it's constant pain.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Lymphadenopathy, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Swelling on left side of body along the lymph nodes. Left neck (minor swelling), left underarm (armpit/pec area) severe swelling painful to the touch. Pain and arm stiffness shooting down the left arm. Pain gravitating up the left part of the head that feels like pressure leading to the crown of my head. (Vaccine info for booster reads ?Moderna 059H21A?- this is self-reported)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Swelling, Tenderness
Clinical narrative: Swelling on left side of body along the lymph nodes. Left neck (minor swelling), left underarm (armpit/pec area) severe swelling painful to the touch. Pain and arm stiffness shooting down the left arm. Pain gravitating up the left part of the head that feels like pressure leading to the crown of my head. (Vaccine info for booster reads ?Moderna 059H21A?- this is self-reported)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram normal, Myocardial infarction, Troponin increased
Clinical narrative: Heart attack on 12/25/2021,  Admitted to ER at 9:30 AM,  Troponin levels high.  Angiogram was clear, no narrowing, no blockages, no stent required.  No myocardial injury.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired. Vaccine expiration mislabeled due to confusion over Pfizer BUD extension. Labeled 01/21/2022 31 days from movement from ULT. Per county public health department and Pfizer, expiration is 12/31/2021.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head normal, Facial paralysis, Lacrimation increased, Magnetic resonance imaging head normal
Clinical narrative: Pt received Moderna Boost 12/27/2021. He did not report any flu/viral like symptoms previous to or after vaccination. On 01/08/2022 he noticed lacrimation of his right eye and on 01/11/2022 noticed right sided facial droop and presented to the ED. Initially a stroke was suspected but an MRI was negative for any acute stroke or infarction and was ruled out. Pt was diagnosed to have bell's palsy with persistent lacrimation of right eye and right sided facial droop, no other symptoms.  Upon history the only inciting factor was the moderna booster shot 1.5 weeks before onset of symptoms.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Rash, Urticaria
Clinical narrative: Full body generalized rash starting about 12 days from receiving third moderna dose. Rash produces occasional hives/welts and does not improve with prednisone or medrol. Intensely itchy.  Also has produced  dermatographia  as an effect.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Chills, Dizziness, Fatigue
Clinical narrative: Vaccine 1&2: Day 1:  Sore arm, tired for rest of day; Day 2:  flu-like symptoms- low grade fever, chills, body aches for 3/4 of the day; Day 3:  no symptoms  Booster: Day 1:  sore arm, little dizziness, mild pressure at sternum within 20 mins; dizziness subsided, still had anxious feeling in chest area Day 2:  flu-like symptoms throughout the day - low grade fever, chills, body aches for the day; Day 3: tired throughout the day, mild flu symptoms intermittently  Day 12 to current:   Hives and rashes - sporadically all over body, hot ears, pressure in sternum
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Vaccine 1&2: Day 1:  Sore arm, tired for rest of day; Day 2:  flu-like symptoms- low grade fever, chills, body aches for 3/4 of the day; Day 3:  no symptoms  Booster: Day 1:  sore arm, little dizziness, mild pressure at sternum within 20 mins; dizziness subsided, still had anxious feeling in chest area Day 2:  flu-like symptoms throughout the day - low grade fever, chills, body aches for the day; Day 3: tired throughout the day, mild flu symptoms intermittently  Day 12 to current:   Hives and rashes - sporadically all over body, hot ears, pressure in sternum
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Urticaria
Clinical narrative: Vaccine 1&2: Day 1:  Sore arm, tired for rest of day; Day 2:  flu-like symptoms- low grade fever, chills, body aches for 3/4 of the day; Day 3:  no symptoms  Booster: Day 1:  sore arm, little dizziness, mild pressure at sternum within 20 mins; dizziness subsided, still had anxious feeling in chest area Day 2:  flu-like symptoms throughout the day - low grade fever, chills, body aches for the day; Day 3: tired throughout the day, mild flu symptoms intermittently  Day 12 to current:   Hives and rashes - sporadically all over body, hot ears, pressure in sternum
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Gait inability, Magnetic resonance imaging normal
Clinical narrative: She was fine until she started taking the Moderma vaccines. The she started with numbness in her legs and after she took the booster shot she wasnt able to walk at all.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Muscle spasms
Clinical narrative: Slight dizziness but started getting cramping..labor breathing when walking long distance.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Same side Lymph Nodes swelling under left arm and left side of groin area
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Swollen tongue
Clinical narrative: She reports that approximately one hour after receiving her second Moderna COVID19 mRNA vaccine she developed itching over her chest, abdomen, and anterior thighs associated with subjective tongue swelling. Her symptoms lasted for approximately 6-7 hours and resolved without treatment. She reports that approximately 30 minutes after she received her Moderna COVID19 mRNA vaccine booster dose she developed itching and redness of her arms that resolved spontaneously without treatment. She denies generalized cutaneous, laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes.
Sex: U
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and concerned a patient of unknown age. No information regarding patient's medical history, concurrent conditions or concomitant medications were provided. On 13-AUG-2018, the patient was administered with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N021571, expiry date: 29-APR-2020 (dose, site and route of administration were not provided) for prophylaxis. On 16-APR-2019, patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1586749, expiry date: 13-FEB-2021 (dose, site and route of administration were not provided). The third dose of the vaccine (lot# R020949, expiry date: 04-MAY-2021; dose, site and route of administration were not provided) was administered on 15-AUG-2019 (inappropriate schedule of vaccine administered). On 13-DEC-2021, the patient received fourth dose (extra dose administered) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiry date: 20-MAY-2023 (dose, site and route of administration were not provided). On unknown date, an unspecified adverse event was experienced by the patient. The outcome was unknown. Causality was not provided.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Interval between the first and second dose more than one year; no other reported AE; This spontaneous report was received from a nurse referring to a 14 year old female patient.  Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.      On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 milliliter for prophylaxis, and over a year later she return for her second dose (inappropriate schedule of product administration). No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-NOV-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), lot number T033814, expiration date: 05-OCT-2022, administered as prophylaxis (strength, dose and route of administration were not provided). The vaccine had the following temperature excursions: at 8.5 degrees celsius (C) for 9 minutes, at 9.5 C for 23 minutes, at 9.6 C for 34 minutes and at 12.4 C for 53 minutes; no previous temperature excursions and no additional adverse events were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2112USA007442: US-009507513-2112USA006870: US-009507513-2112USA007443:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient did not experience any other AE; patient received after it experienced a temperature excursion; This spontaneous report was received from a medical assistant, and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2021, the patient was vaccinated with one dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot number T037648, expiration date: 20-JUL-2023, administered as prophylaxis (strength, exact dose and route of administration were not provided). That vaccine dose had experienced a temperature excursion (product storage error), at 8.5 degrees Celsius (C) for 30 minutes, no previous temperature excursions were reported. No other adverse events were reported. The outcome of the event was unknown.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2112USA008421:02080041 US-009507513-2112USA008430:02080039
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Ae's reported; Temperature excursion involving administered PROQUAD vaccines; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's medical history and concomitant medications were not provided.  On 21-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(Reported Lot # U022726 and reported expiration date was : 16-JAN-2023) for prophylaxis after involving in temperature excursion (Product storage error). No additional Ae's and no PQC's were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional Ae's reported; Temperature excursion involving administered PROQUAD vaccines; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's medical history and concomitant medications were not provided.  On 14-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (reported Lot # U022726 and expiry date : 16-JAN-2023) for prophylaxis after involving in temperature excursion (Product storage error). No additional Ae's and no PQC's were reported.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling cold, Hypoaesthesia, Muscular weakness, Nausea
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 62-year-old female patient. The patient's current conditions included drug reactions/allergies to cephalexin (KEFLEX) and nitrofurantoin (MACROBID). Her pertinent medical history and concomitant medications were not reported. On 20-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, lot # U018309, expiry date 08-JAN-2023, 0.5 milliliter, intramuscularly in the left arm for prophylaxis (reported as immunization). On 20-DEC-2021, the night of the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced pain and weakness in her left arm, numbness, nausea, vomiting, lightheadedness, and "her arm had got cold". On 28-DEC-2021, the patient came to the physician's office and reported that she was still experiencing the adverse events that she initially had and the only change was the pain was only at the top half of her arm. No treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-2112USA010039: US-009507513-2112USA010311: US-009507513-2112USA010181.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 62-year-old female patient. The patient's current conditions included drug reactions/allergies to cephalexin (KEFLEX) and nitrofurantoin (MACROBID). Her pertinent medical history and concomitant medications were not reported. On 20-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, lot # U018309, expiry date 08-JAN-2023, 0.5 milliliter, intramuscularly in the left arm for prophylaxis (reported as immunization). On 20-DEC-2021, the night of the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced pain and weakness in her left arm, numbness, nausea, vomiting, lightheadedness, and "her arm had got cold". On 28-DEC-2021, the patient came to the physician's office and reported that she was still experiencing the adverse events that she initially had and the only change was the pain was only at the top half of her arm. No treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-2112USA010039: US-009507513-2112USA010311: US-009507513-2112USA010181.
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: broke out in hives; This spontaneous report was received from a 64-year-old male patient, referring to himself. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (dose, strength, lot# and expiration date were not provided) intramuscularly for prevention of hepatits b infection.  On an unknown date (also reported occurred sometime in the 1990"s), the patient broke out in hives after receiving the second dose of the three dose series. The outcome of the event was reported as recovered.  The reporter considered the event to be related to Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB).
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: His left arm where Pneumovax 23 shot was given felt like it was on fire; It was hot to touch, it was red and was hurting; It was hot to touch, it was red and was hurting; It was hot to touch, it was red and was hurting; This spontaneous report has been received from a 70-year-old male patient, reporting on himself. The patient's concurrent conditions, and concomitant therapies were not reported. His medical history included "some reactions" to paracetamol (TYLENOL) with codeine 4, and aspirin with codeine 4.  He said he never had any reactions to any other medications.   On 05-AUG-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, and route of administration were not provided) in his left arm for prevention of pneumococcal.  On 07-AUG-2017, his left arm where pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shot was given felt like it was on fire (Burning sensation), It was hot to touch, it was red, and was hurting (Vaccination site warmth/erythema/pain). He saw his health care professional (HCP) on the same date, and they give him  diphenhydramine (BENADRYL), orally, and some other "shot" (name unknown) that helped him the side effects he was experiencing. No additional adverse events (AE) were reported. It was unknown wether laboratories were performed.   At the reporting time, the outcome for the adverse events was unknown.    The causal relationship between the patient's burning sensation in his left arm, vaccination site warmth, erythema, pain and vaccination with polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event, Pneumonia
Clinical narrative: pneumonia date of vaccination (yearly); No adverse event; This spontaneous report was received from lawyer an elderly male patient, concerning to himself via a plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 2108USA002039). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On and unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). It was reported that another doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") was administered yearly (inappropriate schedule of product administration). No adverse reaction or side effects experienced.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2108USA002039:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 20-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot # U015681 and expiration date of 18-MAY-2023, at a dose of 0.5 milliliter, administered subcutaneously for prophylaxis (strength was not provided). The vaccine was exposed to a temperature excursion of 6.8°F with a time frame 8 hours and 5 minutes. There was no previous temperature excursion. No additional adverse events or product quality complaint (PQC) were reported.  .
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored dose of PROQUAD administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-DEC-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U019286, expiration date 15-DEC-2022 (therapy type rHA), 0.5 milliliter, subcutaneously, for prophylaxis.     The vaccine was stored at a temperature of 6.8 fahrenheit degrees during 8 hours and 5 minutes. There were no previous temperature excursions. No adverse events were reported.
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: the product leaked from the needle while it was being administrated; patient reported that they felt like they did not get the vaccine; no additional AEs; This spontaneous report was received from  a nurse and refers to a 55-year-old female. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-JAN-2022, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered subcutaneously for prophylaxis (strength, lot #, and expiry date were not provided). When the vaccine was being administrated, they sawit leaking from  the needle. The patient felt like she did not get the vaccine, receiving less than the recommended dose. No other adverse events were reported.   A causality assessment was not provided.
Sex: F
Vaccine: ANTH
Symptoms: Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: Spontaneous report received on 10DEC2021. A healthcare professional reported that the patient had a "reaction to the BioThrax (anthrax vaccine)" (PT: Vaccination complication). On 29MAR1999, the patient received BioThrax (lot number: FAV038) and in the same year, the patient had a reaction (not specified) to the anthrax vaccine. Outcome of the reported event was unknown. No additional information was reported. Company comment: It was reported that a patient received BioThrax and had a reaction (vaccination complication). Further information regarding the event, medical history or concomitant medication is limited. Considering the limited information, the causality of vaccination complication is assessed as possible with BioThrax (its role cannot be ruled out). On 20DEC2021, significant follow up information received from the healthcare professional. The follow up information included patient information (date of birth, name, gender, age), vaccine information, and event details. It was updated that the patient was 34-year-old female. Earlier, it was reported that the patient had reaction to Biothrax vaccine, now the specific details had been received from the reporter and it was updated that she had "severe whole arm swelling which turned purple with pruritis" (PT: Peripheral swelling, PT: Skin discolouration and PT: Pruritus). The reporter was not sure about the treatment for the events. Additionally, it was reported that the patient did not have any idea about the administration of the BioThrax vaccine but assumed that it might be intramuscular (IM), and the information provided was about the second shot of the vaccine. Outcome of reported events "severe whole arm swelling which turned purple with pruritis" was unknown. Company comment: It was reported that a patient received BioThrax and developed severe whole arm swelling which turned purple with pruritis (peripheral swelling, skin discolouration, and pruritus). Further information regarding the events, medical history or concomitant medication is limited. Considering the case information, the causality of peripheral swelling, skin discolouration, and pruritus is assessed as possible with BioThrax (its role cannot be ruled out).; Sender's Comments: It was reported that a patient received BioThrax and developed severe whole arm swelling which turned purple with pruritis (peripheral swelling, skin discolouration, and pruritus). Further information regarding the events, medical history or concomitant medication is limited. Considering the case information, the causality of peripheral swelling, skin discolouration, and pruritus is assessed as possible with BioThrax (its role cannot be ruled out).
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Gastrointestinal disorder, Nausea, Oral herpes, Vomiting
Clinical narrative: cold sore on her lip; gastrointestinal symptoms; nausea; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) tablet for uveitis.   Concurrent medical conditions included uveitis.   On an unknown date, the patient received Shingrix and Valtrex at an unknown dose and frequency. On 6th January 2022, unknown after receiving Shingrix and Valtrex, the patient experienced nausea, vomiting and diarrhea. On an unknown date, the patient experienced cold sores lip and gastrointestinal disorder. Valtrex was continued with no change. On an unknown date, the outcome of the nausea, vomiting, diarrhea, cold sores lip and gastrointestinal disorder were not recovered/not resolved.   It was unknown if the reporter considered the nausea, vomiting, diarrhea, cold sores lip and gastrointestinal disorder to be related to Shingrix and Valtrex.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient got the Shingrix vaccine while on Valtrex.  She asked the physician who ordered the Valtrex whether it was contraindicated and he said it was ok.  The patient had nausea, vomiting and diarrhea this am. She indicated that her gastrointestinal symptoms had not yet resolved. She indicated she was still taking Valtrex.  She said it was prescribed for uveitis and that she also had a cold sore on her lip.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccinated two years ago, shingles now/ Suspected vaccination failure; Horrible case of shingles on back and chest and down the inside of his arm.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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: This case was reported for reporter's husband. The age at vaccination was not reported. The reporter stated he got vaccinated Shingles shot two years before reporting time and the patient was dealing with a horrible case of shingles on part of his back, chest and down the inside of his arm. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sore on my lip; This case was reported by a consumer via interactive digital media and described the occurrence of cold sores lip in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown.   It was unknown if the reporter considered the cold sores lip to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient asked if having Shingrix shot could cause a cold sore on lip. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Sinus headache, Vaccine positive rechallenge
Clinical narrative: occasional sinus headache; This case was reported by a consumer via interactive digital media and described the occurrence of sinus headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included herpes zoster (had shingles in forehead) and ophthalmic herpes zoster (had shingles in eye). Previously administered products included Shingles (1st dose received on an unknown date).   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 sinus headache. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sinus headache was unknown.   It was unknown if the reporter considered the sinus headache to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR003422  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient never wanted to get shingles as it was very painful.  The patient received Shingles vaccine and had side effect of occasional sinus headache.  The patient asked that how long the shots last and if it was one and need to repeat both shots ever X years. The follow up was not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR003422:Different dose
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hypoaesthesia, Vaccination failure
Clinical narrative: had it when he was 35 years old.\ had the breakout for months \ suspected vaccination failure; had it when he was 35 years old.\ had the breakout for months; blisters; numbness; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 35-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and numbness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the blister was recovered/resolved and the outcome of the numbness was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and numbness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's son. The age at vaccination was not reported. The reporter stated he had Shingles vaccine and set him on his behind.  The reporter stated even after the blisters cleared up, he still experienced numbness where he had the breakout for months. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Got the shots still got shingles/ Suspected vaccination failure; shingles; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shots and still got the shingles, miserable. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Looked like I had some bruising; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced swelling arm and contusion. On an unknown date, the outcome of the swelling arm and contusion were recovered/resolved.   It was unknown if the reporter considered the swelling arm and contusion to be related to Shingles vaccine and Shingles vaccine.     Additional details were reported as follows: Age at vaccination was not reported. The reporter received both dose of Shingles vaccines and reported to look bruised and the bruising took 3 months to go away. Consent to follow up was not possible as no contact details available.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 2 adult doses to patient 19 yo; 2 adult doses to patient 19 yo; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) for an unknown indication.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022003549  Additional details were reported as follows: This case was reported by the manager. A 19 years old patient, received first dose of Engerix B adult instead of pediatric dose, which led to overdose and inappropriate age at vaccine administration. Second dose was administered on 16th September 2021, for tolerance refer case US2022003549. Consent to follow up was not granted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022003549:Same patient, same reporter, 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills; slight fever; aches; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, fever and pain. On an unknown date, the outcome of the chills, fever and pain were unknown.   The reporter considered the chills, fever and pain 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 stated the first dose gave him/her a slight fever, chills and aches. The patient stated the second dose had no side effects and he/she would take the side effects compared to actually getting shingles, though. The patient stated he knew someone who got shingles in their eyes and it ruined their eyesight. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Took 4 shots and still got them/suspected vaccination failure; still got them bad; pain; Took 4 shots; Took 4 shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine, the 3rd dose of Shingles vaccine and the 4th dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, extra dose administered and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain, extra dose administered and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient took 4 shots, which led to extra dose administered. The patient still experienced shingles bad. The patient hate the pain. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: couldn't raise my left arm. It scared me.; vaccine is so painful, arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased 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 stated that the vaccine for shingle was so painful. The patient received dose of Shingles vaccine and experienced arm soreness for a week and he/she could not raise left arm. The patient scared. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: i got them, i cant get the 2nd dose they suck; they hurt; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced Shingles after that which hurt a lot. The patient could not receive the second dose due to shingles experience. Consent to follow up was not possible as no contact details were available.