chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Rotator cuff syndrome
Clinical narrative: Pt reports that the same day after she had her vaccines on her last visit on 10-14-2022 she started having strong shoulder pain and could not elevate her arm above her head. Since that time she has been trying stretching and topical pain creams and has noticed it has gotten a little bit better, but still to this day she cannot elevate her arm and still has significant pain.   It is difficult for her to do anything with that arm that involves elevation of her arm. She has never had problems with this shoulder in the past and she has not had any injuries
Sex: F
Vaccine: PPV
Symptoms: Antibody test abnormal
Clinical narrative: antibody test negative; Literature Report.  This literature marketed report has been received from the authors of a published literature article, titled as stated above, and refers to a 34-year-old female patient.  The patient's medical history included multilobar pneumonia, respiratory failure, bronchiectasis, purpura, and bruising. The patient's concurrent conditions included hair thinning with alopecia, skin depigmentation, leukopenia, lymphopenia, asthma chronic, upper respiratory tract infection, alopecia areata, vitiligo, infertility. The patient was a lifetime nonsmoker. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with polysaccharide pneumococcal vaccine, (manufacturer unknown) injection, administered for prophylaxis (exact dose, lot #, expiry date, and route of administration were not provided).   Before vaccine booster (pre-allogenic HCT), the patient's Streptococcal pneumoniae antibodytest was 3 of 14 serotypes. After vaccine booster (post-allogenic HCT; 1 year) the result of test was reported as off IgRT postimmunizations). Therefore,the patient displayed poor antibody response to polysaccharide pneumococcal vaccine (manufacturer unknown) despite receiving a booster. The outcome of the event was not reported.  The event was considered as to be related to polysaccharide pneumococcal vaccine (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Bacterial test negative, Blister, Erythema, Swelling
Clinical narrative: patient experiencing a localized erythema, swelling, and blistering; patient experiencing a localized erythema, swelling, and blistering; patient experiencing a localized erythema, swelling, and blistering; This spontaneous report was received from a physician and refers to a 4-year-old female patient. The patient's concomitant medications and pertinent medical history were not reported. The patient had no known drug allergies.  On 12-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #X011112 has been verified to be valid, expiration date: 18-JUL-2024, albumin status has been verified as recombinant human albumin (rHA), administered intramuscularly on right thigh for vaccination against measles, mumps, rubella, and varicella (strength and exact dose were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), at other body site (strength, formulation, dose, exact anatomical location, lot #, expiry date, route of administration, and indication were not provided).  On 13-JUN-2023, the patient experienced a localized erythema, swelling, and blistering after receiving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient had prescribed cefalexinum (KEFLEX) as treatment. At the time of report, events seemed to be improving. On 15-JUN-2023, polymerase chain reaction (PCR) test was ordered and bacterial cultures were negative.  The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not provided.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong patient received product
Clinical narrative: No adverse event; the medical assistant made a miistake and gave it to the wrong patient; Indicate in which point in the process the medication error ocurred: dispending; Medical assistant calls tor report VAQTA dose given twice in 2 weeks. 2nd dose given today; This spontaneous report was received from a physician concerning to a 12-month-old female patient with otitis media. The patient{s medical history was not provided and her concomitant medications included ceftriaxone sodium (ROCEPHIN).  On 19-JUN-2023, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated(VAQTA) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided). On 26-JUN-2023, due a dispensing issue, the patient was accidentally vaccinated with a second dose of hepatitis a vaccine, inactivated (VAQTA) (inappropriate schedule of product administration) which was supposed to be given to another patient (wrong patient received product). No adverse effect were reported.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: cold symptoms; Extra dose administered; This spontaneous report was received from  a pharmacist who is also the male patient of unspecified age. The patient's medical history included 2 previous doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient's concurrent conditions and concomitant therapies were not reported.  On 08-JUN-2023, the patient was vaccinated with a third dose (extra dose administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 01-JUL-2023, the patient experienced cold symptoms. At the time of reporting, the outcome of cold symptoms was not known.   The reporter considered cold symptoms to be not related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Vaccination failure
Clinical narrative: admitted to hospital within days of receiving Gardasll 9; they only had a 48 hour window for a Bone Marrow Transplant; the bone marrow donor was a sibling; breast tumor; Gardasll HPV vaccine was found to INCREASE the risk of Cancer by 44.6% In pooplo who had alroady boon oxposod to tho HPV virus.; elevated interferon; Is returning for more surgery for additional tumors; This spontaneous report was received from unspecified reporter and refers to an unknown number of patients (included 17 year old female and male of unknown age).  The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  It was reported that the Gardasll HPV vaccine was found to increase the risk of cancer by 44.6% In people who had already been exposed to the HPV virus (vaccination failure). Ono vaccinated 17 yr old teen developed a breast tumor after receiving the GARDASIL HPV Vaccine, and had It removed at age 16. She Is now 17, and was returning for more surgery for additional tumors. A male Gardasil HPV Vaccine recipient was recently admitted to hospital within days of receiving Gardasll 9. After a week of observation, doctors at a notified his parents that they only had a 48 hour window for a Bone Marrow Transplant. It appears that the Gardasll9 caused elevated Interferon, and severely elevated Interferon can affect bone marrow and Interfere with platelet production. Because the bone marrow donor was a sibling with active CMV, the survival of the patient was questionable because CMV can thrive if transplant anti-rejection suppressants are administered. Onset date of the events and outcome were unknown.   The reporter considered elevated interferon to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The causal relationship between additional tumors, hospitalization, breast tumor and bone marrow disorder and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  The reporter considered elevated interferon to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The causal relationship between additional tumors, hospitalization, breast tumor and bone marrow disorder and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). was unknown.  Causality between vaccination failure and suspect therapies was assessed as related.  Upon internal review, the event bone marrow disorder was determined to be medically significant.
Sex: M
Vaccine: HPV4
Symptoms: Blood 25-hydroxycholecalciferol decreased, Spinal fracture
Clinical narrative: Gardasll victim's 25(0H)vitD to decllno so badly that his spinal column began to fracture; Gardasll victim's 25(0H)vitD to decllno so badly that his spinal column began to fracture; This spontaneous report was received from an unspecified and refers to an 18-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced 25(OH)vitamin D decrease so bad that his spinal column began to fracture. At the time of reporting, the outcome of the event s was not known.  The causal relationship between the events and suspect therapies was unknown  Upon internal review, the event spinal fracture was determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported; TE for vaccines, which was also administered to a patient on 06/01/2023; This spontaneous report was received from a medical assistant referring to 9-week-old female patient. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 01-JUN-2023, the patient was vaccinated with improperly stored doses of: pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (0.5 mL in right thigh, formulation pre-filled syringe, lot#W039033, expiration date 01-OCT-2024, route of administration was not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2 mL, orally, lot #1968385, expiration date 22-MAY-2024) for prophylaxis (Product storage error).  On unknown days, the suspect vaccines experienced a temperature excursion of 49.1 degrees Fahrenheit (F) for 34 minutes, 35.9 F for 2 minutes and again 35.9 F for 2 minutes. No adverse side effects were reported with the administration of the vaccines. No additional adverse event (AE) or product quality complaint (PQC) information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report AE for supported VARIVAX TE administered to patient.; No additional AE.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, and concomitant medications was not provided.  On unknown day, the patient was vaccinated with improperly stored dose varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot #W034708, expiration date 01-NOV-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown days, the suspect vaccine experienced a temperature excursion of 6 up to 14 degrees Fahrenheit for 597 hours. No additional adverse event (AE) or product quality complaint (PQC) (No adverse event). No previous excursions.
Sex: M
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a TE; This spontaneous report was received from a medical assistance and refers to a 6-month-old male. patient  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #W039033, expiration date: 01-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered orally for prophylaxis (strength was not provided). Pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excurion three times: in 35.9 Farenheit (F) for 2 minutes, 35.9 Farenheit (F) for 2 minutes and in 49.1 Farenhet (F) for 34 minutes (product storage error). No additional adverse event were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report AE for supported VARIVAX TE administered to patient.; No additional AE; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On an unknown date the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W039697 and expiration date 13-DEC-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event. Temperature excursion was 6°F up to 14°F (7.5) for 597 Hours 0 Minutes 0 Seconds. No previous excursions reported.
Age: 0.92
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) which was also administered to a patie; This spontaneous report was received from a medical assistant referring to a 11-month-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 16-JUN-2023, the patient was vaccinated with improperly stored pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL once via injection in right thigh, lot # W039033 with expiration date 01-OCT-2024, for prophylaxis (strength and route of administration were not reported). It was stated that the vaccines was exposed to a temperature of 49.1 °F for 34 minutes, with two previous excursions at (35.9 °F) for 2 minutes and again at (35.9 °F) for 2 minutes). No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; Nurse called to inquire about the need for VAQTA revaccination for a 5 year-old female patient. According to Nurse, Patient is coming to HCP office today, 10JUL2023 for vaccinations, and their EMR alerted them that the patient requires a second dose; This spontaneous report was received from a nurse and refers to a 5-year-old female patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 24-SEP-2018 at age of 1 year old, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and anatomical site of injection were not provided) and received the second dose of hepatitis a vaccine, inactivated (VAQTA) on 13-MAR-2019 as prophylaxis (strength, dose, lot #, expiry date, and anatomical site of injection were not provided) (11 days earlier than recommended dosage interval of 6 months between first and second dose) (inappropriate schedule of product administered). The nurse was inquired if the patient needed a re-vaccination. No additional adverse events.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Product expiration date issue, Product storage error
Clinical narrative: they had a temperature excursion 3/31/2023/ Date of administration: 7/7/2023; The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally administered after the new short dated expiration date; The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally administered after the new short dated expiration date; This spontaneous report was received from an office manager and refers to a patient of no reported age or gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-JUL-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliters, lot #W035470, expiration date: 06-MAY-2024, administered as prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) following a temperature excursion of 6 degree Fahrenheit (F) up to 14 F 4 hours 0 minutes; 14 F up to 46 F 4 hours 0 minutes; 47 F to 77 F (50 F) 3 hours 57 minutes (TOTAL: 11 hours 57 minutes)  (Improper storage of product in use). The vaccine was short-dated, and a new expiration date of 30-JUN-2023 was given, it was mentioned that the vaccine was labeled but still accidentally administered after the new short-dated expiration date (Expired product administered, Product expiration date issue).  This is one of several cases from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-Jul-2023 This case was reported the patient via interactive digital media. The patient got the shots over a ago and on the recent time had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/ I got 2 vaccines and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ I got 2 vaccines and still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 09-Jul-2023 This case was reported the patient via interactive digital media. The patient got the 2 vaccines and still got it. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Endoscopy upper gastrointestinal tract normal, Gastrooesophageal reflux disease, Pain
Clinical narrative: I stay in severe pain; Two days after vaccine severe reflux; This non-serious case was reported by a consumer and described the occurrence of gastroesophageal reflux in a 63-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-JUN-2023, the patient received Shingles vaccine. On 16-JUN-2023, 2 days after receiving Shingles vaccine, the patient experienced gastroesophageal reflux (Verbatim: Two days after vaccine severe reflux). On an unknown date, the patient experienced pain (Verbatim: I stay in severe pain). The outcome of the gastroesophageal reflux was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the gastroesophageal reflux and pain to be related to Shingles vaccine.     It was unknown if the company considered the gastroesophageal reflux and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:08-JUL-2023 This report was submitted via the online direct entry reporting system by site: Public Reporting.  Two days after vaccine the patient had severe reflux that gastroenterologist could not find reason. The gastroenterologist doctor did an upper endoscopy and could not find reason for the severity of the issue.  She went to emergency room once thinking she was having a heart attack and later to a cardiologist. It was not her heart, she stayed in severe pain and even water could set it off. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Nausea; Chills; This non-serious case was reported by a consumer and described the occurrence of nausea in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, chronic obstructive pulmonary disease, depression and back pain. Concomitant products included fluticasone furoate + umeclidinium bromide + vilanterol trifenatate (Trelegy Ellipta), amlodipine besilate, pregabalin, buspirone and sertraline.   On 10-MAR-2023, the patient received the 1st dose of Shingrix. On 11-MAR-2023, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea) and chills (Verbatim: Chills). The outcome of the nausea and chills were not resolved.   It was unknown if the reporter considered the nausea and chills to be related to Shingrix.     It was unknown if the company considered the nausea and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2023 The reporter was a caregiver. The symptoms were not treated. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was pretty sore; This non-serious 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.   The patient's past medical history included shingles, feeling abnormal (feeling like someone held something over a flame and stuck it to patient back), pain and crying.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm was pretty sore). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUL-2023. This case was reported by a patient via interactive digital media. The patient had them once it felt like someone held something over a flame and stuck it to patient back. The patient could handle guite a bit of pain, but the shingles had patient crying in agony, never hurt that bad before but never again.  The patient got the two vaccines. The patient arm was pretty sore for a couple of days but it was worth it to prevent getting shingles again. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female 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, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got the first shingles vaccine shot (1st of 2) and immediately got shingles before she ever could get the second shot. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: break out all over the place with a bad rash for two months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of generalized rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced generalized rash (Verbatim: break out all over the place with a bad rash for two months). The patient was treated with steroids nos (Steroids). The outcome of the generalized rash was resolved (duration 2 months).   It was unknown if the reporter considered the generalized rash to be related to Shingles vaccine.     It was unknown if the company considered the generalized rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-jul-2023, 10-jul-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she took the shingles shot and the second shot made him/her break out all over the place with a bad rash for two months and he/she had to take steroids shot and a medication that was toxic came to find out and she/he might have kidney disease from that so he/she suggested not to take the shot and take chance with shingles. On follow up patient asked what was Shingles. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I developed shingles within 2 days of getting the shingrix vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: I developed shingles within 2 days of getting the shingrix vaccine). The outcome of the shingles was not reported.   The reporter considered the shingles to be possibly related to Shingrix.     The company considered the shingles to be possibly related to Shingrix.   Additional Information: GSK receipt date: 08-JUL-2023 This case was reported by a patient via interactive digital media. The reporter reported that within 2 days of receiving Shingrix vaccine, she developed Shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Knee arthroplasty
Clinical narrative: total knee replacement; This non-serious case was reported by a consumer and described the occurrence of knee replacement in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-JAN-2023, the patient received the 1st dose of Shingrix. On 17-MAY-2023, 107 days after receiving Shingrix, the patient experienced knee replacement (Verbatim: total knee replacement). The outcome of the knee replacement was not reported.   It was unknown if the reporter considered the knee replacement to be related to Shingrix.     It was unknown if the company considered the knee replacement to be related to Shingrix.   Additional Information: GSK receipt date: 08-Jul-2023 The patient had 1st dose of Shingrix and had total knee replacement. The patient wanted to know if there any contraindications with a total knee replacement 8 weeks post operation. The reporter was requested for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: It hurt for about four days; This non-serious 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.   In JUL-2023, the patient received Shingles vaccine. In JUL-2023, less than a week after receiving Shingles vaccine, the patient experienced pain (Verbatim: It hurt for about four days). The outcome of the pain was resolved (duration 4 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Jul-2023 This case was reported the patient via interactive digital media. The patient got the follow up shot last week. The vaccine hurt for about 4 days. The reporter asked if the vaccine will be worth if the patient actually did  get shingles. Follow-up not possible as no contact details provided.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: product she used may have been recalled / Possibly received recalled vaccine; product she used may have been recalled / Possibly received recalled vaccine; product she used may have been recalled / Possibly received recalled vaccine; product she used may have been recalled / Possibly received recalled vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of recalled drug administered in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced recalled drug administered (Verbatim: product she used may have been recalled / Possibly received recalled vaccine), recalled drug administered (Verbatim: product she used may have been recalled / Possibly received recalled vaccine), product dispensing error (Verbatim: product she used may have been recalled / Possibly received recalled vaccine) and product dispensing error (Verbatim: product she used may have been recalled / Possibly received recalled vaccine). The outcome of the recalled drug administered, recalled drug administered, product dispensing error and product dispensing error were unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The patient self-reported this case. The reporter asked if her Flovent was on recall. No recall found in content. The reporter stated she received a call stating a GSK product she used might had been recalled. She did receive 2 doses of Shingrix around 6 months ago from reporting (did not know lot number), which led to recalled drug administered and product dispensing error. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not get her second dose until 8th June 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd September 2018).   On 08-JUN-2023, the patient received the 2nd dose of Shingrix. On 08-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: did not get her second dose until 8th June 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: One week later the patient received a third dose of Menveo in error; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included MENVEO and MENVEO.   In MAY-2023, the patient received the 3rd dose of Menveo. In MAY-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: One week later the patient received a third dose of Menveo in error). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023 The Medical Director of a research study reported a patient was given two doses of Menveo 8 weeks apart per guidelines. One week later the patient received a third dose of Menveo in error. The healthcare professional did not have any details about lot's expiry dates etc. (it was a blind study) and he said follow up was ok with him and he could get some details about the patient such as sex and age. The reporter consented to follow up. The patient received a third dose of Menveo in error, which led to extra dose administered.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: He felt like a bus hit him; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: He felt like a bus hit him). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.     It was unknown if the company considered the feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR095588   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter was a patient. The reporter commented on the Shingrix page about his ordeal with the Shingrix vaccine. The reporter reported that after receiving Shingrix vaccine he felt like a bus hit him. No other information was provided. The reporter did consent to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: male patient received the 1st dose of Engerix on 27Mar2023 and is late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 24-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 27th March 2023 and batch number:9255P).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: male patient received the 1st dose of Engerix on 27Mar2023 and is late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2023 The reporter reported that a patient was late for the 2nd dose of Engerix B. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional did not have the expiration date. The reporter consented to follow up via postal mail. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 9 month old patient who received Havrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 9 month old patient who received Havrix.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2023 The healthcare professional asked if it was a valid dose or if the patient still needed 2 doses. The reporter did not provide any information about the patient nor the Havrix dose administered, since she mentioned that this event happened at a different office. The reporter called to ask for information regarding a 9-month-old patient who received Havrix, which led to inappropriate age at vaccine admisnitration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: but he have never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020). Additional patient notes included The patient was not immunocompromised.  On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: but he have never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt Date: 11-JUL-2023 The reporter was a pharmacist technician. The reporter reported that patient had never received second dose of Shingrix.  The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix ,which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Impaired quality of life, Lung disorder, Respiratory distress
Clinical narrative: EXTREME PULMONARY PROBLEMS; LOST ENTIRE QUALITY OF LIFE; RESPIRATORY DISTRESS; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 10-JUL-2023. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was avid hiker and rode horses. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient reported she took the Vaccine little over 2 years ago and had severe adverse events. She was still having trouble with it. She was angry and upset that the company pushed the vaccine on her and now cannot help her. She reported she had extreme pulmonary problems. She was upset. She stated she had been to 4 pulmonologist and her primary care doctor was an internist. She stated that she had lost her entire quality of life. She was am avid hiker and rode horses. She could not do anything of those now because 3 days after she took it, she had respiratory distress where she thought she was going to die. She could not get a test tube amount of air. She had to be on a breathing machine, on rescue inhalers, on disks and pills. She wanted her quality of life back.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme pulmonary problems, lost entire quality of life, and respiratory distress. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: The suspected product quality complaint has been confirmed to be voided (this record describes (multiples adverse events), which does not meet the definition of a product quality complaint or explicitly allege a potency issue. This record will be voided as no) based on the evaluation/investigation performed.; Sender's Comments: V0: 20230713906- Respiratory distress. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Occlusive deep vein thrombosis; This literature-non-study case was reported in a literature article and describes the occurrence of DEEP VEIN THROMBOSIS (Occlusive deep vein thrombosis) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE: No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Occlusive deep vein thrombosis) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Occlusive deep vein thrombosis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Author stated that there has been limited information regarding thrombosis development after receiving a messenger RNA (mRNA)-based vaccine. This case series highlights four different patients who received an mRNA-based COVID-19 vaccine and subsequently developed venous thromboembolism. Therefore, author hope that after reviewing this article, physicians will be more aware of thrombosis-related developments following mRNA vaccine administration for COVID-19. Fortunately, with early diagnosis and prompt treatment, patients can still expect full recovery from any vaccine thrombosis-associated complications, and the benefits of receiving an mRNA-based COVID-19 vaccine still outweigh the risks of post-vaccination complications.  Company comment: This is a literature non-study case concerning a 58-year-old male patient with No Medical History reported, who experienced the serious unexpected medically significant AESI deep vein thrombosis (reported as Occlusive deep vein thrombosis). The event occurred after receiving the booster dose of mRNA-1273 vaccine (event and vaccine date were not provided). No treatment or concomitant medication was provided. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-732783 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732783:31-Y-F
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired Moderna Bivalent vaccine no other adverse events were reported.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine no other adverse events were reported.) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine no other adverse events were reported.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine no other adverse events were reported.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine no other adverse events were reported.).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732810 (E2B Linked Report). This case was linked to MOD-2023-732790 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732810:same reporter