chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cataract, Eye haemorrhage
Clinical narrative: Cataract surgery; had a massive blood vessel burst in his right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 11May2021 as dose 2, single (Lot number: EW0165) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FOCUS FORMULA [AVENA SATIVA;CENTELLA ASIATICA;GINKGO BILOBA;MATRICARIA RECUTITA;SCUTELLARIA LATERIFLORA;URTICA DIOICA]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; VITAMIN E [TOCOPHEROL]. Vaccination history included: BNT162b2 (1st dose was administered on 20Apr2021 with lot ER8731.), administration date: 20Apr2021, when the patient was 64-year-old, for Covid-19 immunization.  The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 11May2021, outcome "unknown", described as "had a massive blood vessel burst in his right eye"; CATARACT (medically significant) with onset 14May2022, outcome "unknown", described as "Cataract surgery". Therapeutic measures were not taken as a result of eye haemorrhage. Therapeutic measures were taken as a result of cataract.  Clinical information: The reporter stated that the cataract surgery was done first on 14May2022 and the last one was he thinks the week before that on 07May2022. Patient mentioned he experienced a major blood vessel burst in his right eye within hours of getting the vaccine. stated nothing else in terms of his medications has changed and for his covid, he might be upped his Vitamin C to 1500mg a day, takes Vitamin D and Vitamin E and was already taking those and did not change anything and was taking the same regimen of supplements and takes very limited vitamins D and E supplements and takes a support focus formula that does not have a lot of blood thinner in it and the doctor looked it up before he had surgery done and that had not been an issue and states for the support focus formula, it has Vitamin C, E, b12 folic acetate and B12 and a DHA complex in it and alphalopoic acid in it and had lot 0212E5A, expiry date Dec2025 and UPC 3504606866. Stated he was taking all those supplements for more than 10 years. Stated that he has had no testing or treatment for the reported event and is still waiting to hear from his doctor who is the retinal surgeon.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Change in sustained attention, Chest discomfort, Dissociation, Heart rate increased
Clinical narrative: Day after vaccination I have intense anxiety about nothing. My heart rate feels much higher and more intense. My chest feels incredibly tight and when I let my thoughts wander I become increasingly worried about nothing and hyperfocus on the tight feeling in my chest. I can end up feeling disassociated from myself not really knowing what's going on. Never had any history of anxiety before this. I only feel relief when I distract myself, so I lose a lot of sleep because of it. I end up feeling restless and can't sit still if I end up in one of these cycles.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Restlessness
Clinical narrative: Day after vaccination I have intense anxiety about nothing. My heart rate feels much higher and more intense. My chest feels incredibly tight and when I let my thoughts wander I become increasingly worried about nothing and hyperfocus on the tight feeling in my chest. I can end up feeling disassociated from myself not really knowing what's going on. Never had any history of anxiety before this. I only feel relief when I distract myself, so I lose a lot of sleep because of it. I end up feeling restless and can't sit still if I end up in one of these cycles.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Crying, Decreased appetite, Discomfort, Dizziness
Clinical narrative: I've lost 13 pounds in the last 23 days. I lost 6 of those pounds within the first 5 days. It is hard to keep food down because I projectile vomit 20 minutes after eating and I am never hungry anymore. I only know I need to eat if I feel like I am going to faint. A couple days after the first dose and the night of the second dose I had severe pain, the worst I've experienced in my life, and it lasted for about 8 hours each time. I felt like all my nerves and all my bones were on fire.  It was terrifying. My vision gets grey and splotchy and there is a swollen lump in my armpit that is half the size of a baseball. I have not been able to sleep a full 8 hours a night since I received this vaccine due to pain and discomfort.  I take vitamin C & D, got a vitamin C IV, aspirin, my mom had to massage me for hours so I could stop screaming and crying. I am still not ok and I am scared.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Insomnia, Pain, Screaming, Visual impairment
Clinical narrative: I've lost 13 pounds in the last 23 days. I lost 6 of those pounds within the first 5 days. It is hard to keep food down because I projectile vomit 20 minutes after eating and I am never hungry anymore. I only know I need to eat if I feel like I am going to faint. A couple days after the first dose and the night of the second dose I had severe pain, the worst I've experienced in my life, and it lasted for about 8 hours each time. I felt like all my nerves and all my bones were on fire.  It was terrifying. My vision gets grey and splotchy and there is a swollen lump in my armpit that is half the size of a baseball. I have not been able to sleep a full 8 hours a night since I received this vaccine due to pain and discomfort.  I take vitamin C & D, got a vitamin C IV, aspirin, my mom had to massage me for hours so I could stop screaming and crying. I am still not ok and I am scared.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting projectile, Weight decreased
Clinical narrative: I've lost 13 pounds in the last 23 days. I lost 6 of those pounds within the first 5 days. It is hard to keep food down because I projectile vomit 20 minutes after eating and I am never hungry anymore. I only know I need to eat if I feel like I am going to faint. A couple days after the first dose and the night of the second dose I had severe pain, the worst I've experienced in my life, and it lasted for about 8 hours each time. I felt like all my nerves and all my bones were on fire.  It was terrifying. My vision gets grey and splotchy and there is a swollen lump in my armpit that is half the size of a baseball. I have not been able to sleep a full 8 hours a night since I received this vaccine due to pain and discomfort.  I take vitamin C & D, got a vitamin C IV, aspirin, my mom had to massage me for hours so I could stop screaming and crying. I am still not ok and I am scared.
Sex: F
Vaccine: MMR
Symptoms: Blood test, Expired product administered, No adverse event
Clinical narrative: No additional AE; Consumer reporting her daughter was given an expired vaccine. No additional AE. No PQC.; This spontaneous report was received from the patient's mother and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant human albumin) subcutaneous injection, 0.5 milliliter, lot #S014429, expiration date: 09-MAY-2021, administered for prophylaxis (strength, route and site of administration were not provided) (expired vaccine used). The mother of the patient thought that it was pediatricians office fault that gave to daughter an expired vaccine. She stated that she received a call from the pediatrician and they said the site has wrong records; there has been cases where the lab has the wrong expiration date. The mother requested another immunization but the pediatrician refused. She wanted to make sure her daughter was covered but the pediatrician said he cannot give her another shot. The pediatrician said it is impossible to give her shot that was expired and it was a problem at lab and the site that did not have records. Mother stated she never checked records at all and always trusts the pediatrician but recently had a problem with a nurse and that was why she checked the records. The mother finally moved the patient to another pediatrician's office and they would perform a blood test and find out if her daughter is covered with vaccine and if not they will give another shot. Caller stated the pediatrician that gave the expired vaccine did not offer this at all and was in denial and acted like he could not make mistakes. She just wanted this to be documented so this did not happen again to another child. No additional adverse event was reported.  During follow-up process the contact with pediatrician office was performed. The nurse reported no adverse event occurred and the vaccine administered to the patient was not expired (conflicting information). The office used a system which recorded the vaccine that was administered to the patient and that she could fax in the report from the system if needed. The patients electronic medical record was not updated correctly and that is why the consumer believed the vaccine was expired.
Sex: U
Vaccine: VARCEL
Symptoms: Product preparation issue
Clinical narrative: No additional adverse event were reported; Office manager reported that a patient received an improperly stored VARIVAX that was reconstituted with properly stored sterile diluent; This spontaneous report has been received from office manager, regarding a patient of unknown gender and age.   The patient's concurrent conditions, medical history and concomitant therapies were not reported   On 11-APR-2022, the patient was vaccinated with first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U025791 has been verified to be valid, expiration date 19-AUG-2023) (dose regimen, route of administration and anatomical location were not reported), reconstituted with properly stored Merck sterile diluent (lot# and expiration date were not provided) administered for prophylaxis.   It was reported that the varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 6 Fahrenheit (°F) up to 14 °F for 15 minutes and 14 °F up to 46 °F (average temperature 34.93 °F) for 1 hours and 15 minutes (product storage error). There was no previous temperature excursion. Not adverse events (AE) were reported, and no further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time.; This spontaneous report was received from a costumer referring to an unknown age and gender patient.  The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U039949 has been verified to be valid, expiration date 16-DEC-2023) (dose regimen, route of administration and anatomical location were not reported), for prophylaxis that underwent a temperature excursion (TE) (Product storage error). The time frame of the temperature excursion was -14 degree Celsius (C) up to -10C for 2 hours 5 minutes 0 seconds; -10C up to 8C (-0.4C) for 1 hour 25 minutes 0 seconds. A previous temperature excursion occurred with temperatures of -14C up to -10C (-12C) for 0 hours 50 minutes 0 seconds. No adverse event occurred.   This is one of 13 reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX has been administered with an inappropriate storage; No adverse event; This spontaneous report was received from a customer and referring to a patient of unknown age and gender.  The patient's medical history, drug reactions, allergies, concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).   On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039949 with expiration date: 16-DEC-2023, for prophylaxis (strength, dose and route of administration were not provided) (product storage error). The vaccine underwent temperature excursion of -14 Celsius degree up to-10 Celsius degree for 2 hours 5 minutes; -10 Celsius degree up to 8 Celsius degree (-0.4C) for 1 hour 25 minutes. Previous temperature excursion was -14 Celsius degree up to-10 Celsius degree (-12C) for 50 minutes; 8.1 degrees Fahrenheit for 17 minutes and 9.5 degrees Fahrenheit for 21 minutes. No additional adverse event details was reported.  This is one of 13 reports received from the same reporter.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: E evaluation states vaccines have been administered to multiple patients. Customer has a list of patients but states it would take too long to read each patient name. States 39 patients total received vaccines.; No additional AE details; This spontaneous report has been received from a medical assistant, concerning a 1-years-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 22-APR-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) first dose, subcutaneously (valid lot number U025790 [expiration date 19-AUG-2023]) for prophylaxis, after a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec. The time frame of 3 h, 0 min, 0 sec; 1 h, 30, min 0 sec (product storage error) and a device component malfunction was reported (dose, vaccination scheme frequency, and anatomical location of vaccination were not provided). No previous temperature excursion was reported.  No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.  As recorded by data digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA007821: US-009507513-2205USA007852:
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs were reported; The patient received the first dose of VARIVAX on 11/13/2008. The patient was supposed received second VARIVAX  on 5/31/2022 but instead received SHINGRIX.; The patient received the first dose of VARIVAX on 11/13/2008. The patient was supposed received second VARIVAX  on 5/31/2022 but instead received SHINGRIX.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 13-NOV-2008, the patient received the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route of administration, lot#, and expiration date were not reported), for prophylaxis. The patient was supposed to receive the second varicella virus vaccine live (Oka/Merck) (VARIVAX) dose on 31-MAY-2022, but instead received varicella zoster vaccine rge (CHO) (SHINGRIX) (, dose, route of administration, lot#, expiration date, and indication were not reported). No additional adverse events (AEs) were reported. No further information provided.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Patient missed his second dose; No additional AE reported; This spontaneous report has been received from a pharmacist referring to a 12-years-old male patient. The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided.   On an unspecified date in Jun 2021 (reported as a year ago), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was reported that the patient misses his second dose  of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product dose omission issue). No additional adverse events were reported.
Age: 0.58
Sex: M
Vaccine: DTAPIPV, MMRV, RV5
Symptoms: Diarrhoea, Drug ineffective, Product administered to patient of inappropriate age, Pyrexia, Wrong product administered
Clinical narrative: lack of drug effect; diarrhea; fever; Inappropriate age at vaccine administration; wrong vaccine administered; This spontaneous report was received from a consumer, concerning a 7-month-old male patient. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 23-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), once in the left thigh by subcutaneous route (lot number, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 29-MAR-2023) (product administered to patient of inappropriate age) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form orally (lot number 1863317 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). Lot number 1863317 does not match any Company product as confirmed by Lot Verification team. Furthermore, it was reported the patient was supposed to be vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS), but he received diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL), at a dose of 0.5 ml, once in the left vastus lateralis by intramuscular route (lot number: C5970AA, expiration date not reported) instead (wrong product administered). All the vaccines were administered as prophylaxis.  On an unknown date, the patient experienced mild fever (pyrexia), diarrhea and lack of drug effect.  At the time of the report, the outcome of the events was unknown.  The causality between the events and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) was not related. The causal relationship between events and the remaining suspect vaccines was related, further described as "expected side effects of given vaccines".  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA006736:
Sex: F
Vaccine: HPV9
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: She states that a patient's mother experienced an unspecified allergic reaction and she wants to see if there's an alternate available for her daughter.; This spontaneous report has been received from a medical assistant, concerning to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date, the patient was administered vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, vaccination scheme, frequency, lot number, and expiration date were not provided) for prophylaxis.   On an unknown date, the patient experienced an unspecified allergic reaction (allergy to vaccine). Additionally, it was unknown by reporter, if the patient sought medical attention, if she received any treatment or if any laboratory diagnostics or studies were performed.The outcome of the event allergy to vaccine was not provided.  The causality assessment between the event allergy to vaccine with the suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Antibody test, Antibody test negative, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: negative titers; VZV Ab IgG V negative; Negative titer pneumococcal serotypes; This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 10-year-old male patient.  The patient's concurrent conditions included cough and asthma. Medical history included pneumococcal bacteremia. Concomitant therapies included salbutamol sulfate; montelukast sodium (manufacturer unknown); amoxicillin (+) clavulanate potassium; pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and Hemophilus influenza B vaccine (manufacturer unknown).  On 27-JUL-2018, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). On 19-OCT-2021, he was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and a dose of varicella virus vaccine live (oka/merck) (manufacturer unknown).   12-month post-pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (repeat) pneumococcal titers were unchanged or decreased (3/24 > 1.0 micrograms/mL). Varicella titers were all non-detectable (vaccination failure, antibody test negative).  The outcome of vaccination failure and antibody test negative was unknown.  The authors considered the events of vaccination failure and antibody test negative to be related to the suspect vaccines.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report
Sex: U
Vaccine: MMRV, RV5
Symptoms: Diarrhoea, Drug ineffective, Pyrexia
Clinical narrative: lack of drug effect; diarrhea; fever; This spontaneous report was received from a consumer, concerning a 4-year-old patient of unknown gender. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 23-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), once in the left thigh by subcutaneous route (lot number, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 29-MAR-2023) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form orally (lot number 1863317 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). Lot number 1863317 does not match any Company product as confirmed by Lot Verification team. The vaccines were administered as prophylaxis.  On an unknown date, the patient experienced mild fever (pyrexia), diarrhea and lack of drug effect.  At the time of the report, the outcome of the events was unknown.   The causal relationship between events and the suspect vaccines was related, further described as "expected side effects of given vaccines".  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA003956:
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed a dose of Vivotif; A spontaneous report was received from a nurse practitioner on 23MAY2022. It described a patient (unknown age and gender) who "missed a dose of Vivotif" (PT: Product dose omission issue). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization.  It was reported that the patient missed a dose of Vivotif (dose: unknown) on an unknown date.  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a consumer missed a dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is not applicable to Vivotif.; Sender's Comments: It was reported that a consumer missed a dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is not applicable to Vivotif.
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Hypersensitivity, Lethargy, Swelling
Clinical narrative: Swelling; Lethargy; Joint pain; Allergic reaction/bad reaction to the second shot; A spontaneous report was received from a patient on 24MAY2022.  The male patient (unknown age) developed "allergic reaction/bad reaction to the second shot" (PT: Hypersensitivity) which included joint pain (PT: Arthralgia), swelling (PT: Swelling) and lethargy (PT: Lethargy) following immunisation with BioThrax (anthrax vaccine adsorbed). It was reported that around 1999 to 2000, the patient received 2 shots of Anthrax vaccine (lot number: FAV037 and FAV44). It was reported that the patient did not have a reaction to the first shot however he had a bad reaction to the second shot. He developed allergic reactions. The reactions he had to the product included joint pain, swelling, and lethargy which were persisted for months. Thus, he was given pain management medications for treatment, and it was confirmed that these issues were no longer existed.  Action taken with BioThrax with respect to the reported events was not applicable.  The patient had recovered from the reported events at the time of this report.  It was reported that the patient believed that he was allergic to polyethylene glycol and or polysorbate 80 and he believed that Anthrax vaccine may have either of these components.  Additionally, the patient stated that after receiving the Anthrax vaccine, he believed that his allergies were started but he was trying to establish that.  No additional information was reported.  Company comment: A consumer received BioThrax and developed allergic reaction/bad reaction (hypersensitivity) which included joint pain (arthralgia), swelling, and lethargy. This patient had recovered from these events at the time of reporting. Considering the case information, the role of BioThrax cannot be ruled out and the causality of hypersensitivity, arthralgia, swelling, and lethargy is assessed as possible with BioThrax.; Sender's Comments: A consumer received BioThrax and developed allergic reaction/bad reaction (hypersensitivity) which included joint pain (arthralgia), swelling, and lethargy. This patient had recovered from these events at the time of reporting. Considering the case information, the role of BioThrax cannot be ruled out and the causality of hypersensitivity, arthralgia, swelling, and lethargy is assessed as possible with BioThrax.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: first dose on April 14th, shingles outbreak several days later Five weeks later I had a second, VERY minor outbreak in a different location of my body; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Jun-2022 Reporters comment: The patient self reported the case.  The patient received a dose of Shingrix and experienced severe shingles outbreak several days later. The patient experienced second very minor outbreak five weeks later in a different location of body. The patient had never had an outbreak prior to this vaccination. The patient had been discussing with primary physician and pharmacist whether or not to have the second dose, and what did the manufacturer recommended to which they disagreed. Consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick, in hospital for 5 days; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2.5 years ago still had numbness, severe pain and sometimes burning sensation all the time on Right side). Concurrent medical conditions included pain, numbness and burning sensation.   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 sickness (serious criteria hospitalization). On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media and described the hospitalization for 5 days. The patient received dose of Shingles vaccine and it made him/her sick. The patient was in hospital for 5 days.  The patient stated that doller 100.00 decided not get 2nd one.  The patient wouldn't wish this on worst enemy. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurts; 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 14th June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received the first dose Shingles vaccine on Tuesday before the reporting time and only side effects was arm hurts so bad. The patient wished to get shot in his/her left arm.  Wednesday night arm started to feel better. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Skin exfoliation, Skin fissures
Clinical narrative: hands and feet to itch; hands and feet peel; hands and feet crack open; This case was reported by a consumer via interactive digital media and described the occurrence of localized itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 20 years before the date of reporting and it was horrible).   In December 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 6 and 7 months after receiving Shingles vaccine, the patient experienced localized itching, skin peeling and skin cracked. On an unknown date, the outcome of the localized itching, skin peeling and skin cracked were not recovered/not resolved.   It was unknown if the reporter considered the localized itching, skin peeling and skin cracked to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient was recently told that patient need the Shingles vaccine. The patient received the first dose of Shingles vaccine and had bad reaction that caused hands and feet to itch, peal and crack open. The patient had been suffering ever since. The patient was on several medications now just to contain the problem and it was not fully under control. The patient reported that not everyone did well with the vaccine. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Feeling abnormal, Headache
Clinical narrative: fever; headache; nausea; chills; body aches and extremely sore arm/arm hurts less/soreness; fatigue; horizontal red rash; felt so awful; sick and went to bed; felt "dopey"; not feel comfortable; sore arm; This case was reported by a consumer and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (got the chickenpox as a young child).   In June 2022, the patient received the 1st dose of Shingrix. In June 2022, 1 day after receiving Shingrix, the patient experienced fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm. On an unknown date, the outcome of the fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient self reported the case. The patient received Shingrix on left arm. The patient received a dose of Shingrix and experienced headache, nausea, fever, chills, body aches, fatigue, an extremely sore arm and about 2 inches beneath the injection site about 6 inches long horizontal red rash. The patient felt so awful the morning after the shot that they called in sick from work, and went to bed and slept for hours. They took the following day off as well as they felt dopey when they woke up and slightly dopey the following day and did not feel comfortable driving to the office or doing her job. The patient got the chickenpox as a young child along with my other siblings On the day of reporting her arm hurted less but still hurted. The red rash had slightly lessened but was still there. Her personal care physician told her it was probably a good idea to skip the second shot. The patient wanted to know if others still have soreness this far out after the injection and they was fatigued but didn't knew if it was because they had been working hard or if it was connected in any way to the shot.  Consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Impaired driving ability, Impaired work ability, Nausea, Pain
Clinical narrative: fever; headache; nausea; chills; body aches and extremely sore arm/arm hurts less/soreness; fatigue; horizontal red rash; felt so awful; sick and went to bed; felt "dopey"; not feel comfortable; sore arm; This case was reported by a consumer and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (got the chickenpox as a young child).   In June 2022, the patient received the 1st dose of Shingrix. In June 2022, 1 day after receiving Shingrix, the patient experienced fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm. On an unknown date, the outcome of the fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient self reported the case. The patient received Shingrix on left arm. The patient received a dose of Shingrix and experienced headache, nausea, fever, chills, body aches, fatigue, an extremely sore arm and about 2 inches beneath the injection site about 6 inches long horizontal red rash. The patient felt so awful the morning after the shot that they called in sick from work, and went to bed and slept for hours. They took the following day off as well as they felt dopey when they woke up and slightly dopey the following day and did not feel comfortable driving to the office or doing her job. The patient got the chickenpox as a young child along with my other siblings On the day of reporting her arm hurted less but still hurted. The red rash had slightly lessened but was still there. Her personal care physician told her it was probably a good idea to skip the second shot. The patient wanted to know if others still have soreness this far out after the injection and they was fatigued but didn't knew if it was because they had been working hard or if it was connected in any way to the shot.  Consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Sedation
Clinical narrative: fever; headache; nausea; chills; body aches and extremely sore arm/arm hurts less/soreness; fatigue; horizontal red rash; felt so awful; sick and went to bed; felt "dopey"; not feel comfortable; sore arm; This case was reported by a consumer and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (got the chickenpox as a young child).   In June 2022, the patient received the 1st dose of Shingrix. In June 2022, 1 day after receiving Shingrix, the patient experienced fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm. On an unknown date, the outcome of the fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient self reported the case. The patient received Shingrix on left arm. The patient received a dose of Shingrix and experienced headache, nausea, fever, chills, body aches, fatigue, an extremely sore arm and about 2 inches beneath the injection site about 6 inches long horizontal red rash. The patient felt so awful the morning after the shot that they called in sick from work, and went to bed and slept for hours. They took the following day off as well as they felt dopey when they woke up and slightly dopey the following day and did not feel comfortable driving to the office or doing her job. The patient got the chickenpox as a young child along with my other siblings On the day of reporting her arm hurted less but still hurted. The red rash had slightly lessened but was still there. Her personal care physician told her it was probably a good idea to skip the second shot. The patient wanted to know if others still have soreness this far out after the injection and they was fatigued but didn't knew if it was because they had been working hard or if it was connected in any way to the shot.  Consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; headache; body aches thru the night; arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, chills, headache, general body pain and pain in arm. On an unknown date, the outcome of the fever, chills, headache, general body pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, general body pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just got his/her shingles shot. The patient had fever, chills, headache, body aches throughout the night and arm hurt for 3 days.  The patient stated that he/she would take it compared to the horror stories of getting shingles. Additional Supportive information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; 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.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2022AMR094578).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR094578   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had arm hurt both times much worse and longer than the Covid shots. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094578:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the Shingrix vaccines, developed shingles/ suspected vaccination failure; shingles; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The patient was healthy. She received the Shingrix vaccine both doses correctly about 2 years ago and developed shingles last month. The patient asked if she/he need to repeat the vaccine series because the first series did not work. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The reporter stated that the patient received first dose of Shingrix and experienced headache and fatigue.   The reporter denied to follow up from GlaxoSmithKline. For tolerance to the 2nd dose refer case US2022AMR094668.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094668:Same patient, different dose
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Vaccine positive rechallenge
Clinical narrative: headache; fatigue; This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on an unknown date and experienced headache and fatigue, refer case US2022AMR094661).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache and fatigue were unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR094661   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The physician reported that patient received second dose of Shingrix and experienced headache and fatigue.   The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094661:Same patient, different dose
Sex: U
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: temperature excursion for GSK vaccines; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and HAV (Havrix) for prophylaxis.   In November 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Havrix. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The reporter stated that a previous temperature excursion for GlaxoSmithKline vaccines(Kinrix, Pediarix, Engerix-B and Havrix) and that those products had been administered to patients since that excursion in November of 2021. The reporter also stated that multiple patients had received multiple vaccines and that the vaccines had been evaluated by GlaxoSmithKline and determined to be supported by GlaxoSmithKline's stability data. The reporter provided the names of the vaccines involved.  The reporter unable to provided additional details. The reporter consented to follow-up. Additional supportive information: The patients received doses of Kinrix, Pediarix, Engerix-B and Havrix vaccines which were previously temperature excursion, which led to Incorrect storage of drug.