chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE/PQC reported; a temperature excursion on ROTATEQ, the product had been administered; This spontaneous report was received from an office manager referring to a 10 weeks old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 16-JUN-2021, a temperature excursion occurred on rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1684151 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 23-JUN-2021) as the vaccine was stored under 47.8 degrees Fahrenheit (F) for 5 minutes, recorded by digital data logger. There was no previous temperature excursion. On 22-JUN-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and route were not reported) for prophylaxis. No other adverse event (AE)/product quality complaint (PQC) was reported other than improperly stored administered vaccine.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA007466:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: TCustomer said they had a 1 year old patient who was scheduled to receive VARlVAX and MMRlI, but the patient received VARlVAX and PROQUAD concomitantly.Confirmed with the customer no other AE occurred/patient received each vaccine in different arms; Customer said they had a 1 year old patient who was scheduled to receive VARlVAX and MMRlI, but the patient received VARlVAX and PROQUAD concomitantly.Confirmed with the customer no other AE occurred/patient received each vaccine in different arms; Customer said they had a 1 year old patient who was scheduled to receive VARlVAX and MMRlI, but the patient received VARlVAX and PROQUAD concomitantly.Confirmed with the customer no other AE occurred/patient received each vaccine in different arms; This spontaneous report was received from a Medical Assistant and refers to a 1-year-old patient of unspecified gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 12-JUL-2021, the patient was vaccinated with 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T037643, that was verified to be valid, with an expiration date reported and verified as 06-NOV-2022) and 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (lot number T036565, that was verified to be valid, with an expiration date reported and verified as 26-APR-2022) concomitantly in different arms for prophylaxis (concentrations, dose numbers, vaccination scheme frequencies, routes and exact arm  of  each administration were not provided). It was stated that the patient was scheduled to received varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (concentration, dose number, vaccination scheme frequency, lot number and expiration date were not provided) (wrong product administered) (product prescribing issue). No additional adverse events were reported.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; muscle ache; tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced headache, muscle pain and tiredness. On an unknown date, the outcome of the headache, muscle pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The patient reported that after dose of Shingrix he/she experienced headache, muscle ache and tiredness. The patient inquired how long the side effects would last. No other information was provided.
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / in 2019 / its been over a year and they haven't yet received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAV (Havrix 1440) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 (receive 1st dose on an unknown date in 2019, batch number 2AD47, expiry date 31th January 2020).   On an unknown date, the patient received the 2nd dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Havrix 1440 as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up. This case had been linked with the case US2021151594, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151594:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: hospitalized 1 month after my 1st / vaccine in 2019; This case was reported by a nurse via call center representative and described the occurrence of hospitalization in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On 16th July 2019, 1 month after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On 16th July 2021, the outcome of the hospitalization was recovered/resolved.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional details were provided as follows: The patient had reported for herself. The age at vaccination was not reported. One month after receiving Shingrix, the patient was hospitalized. The patient did not give specifics about the hospitalization. She received 2nd dose of Shingrix on 10th July 2021. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2021153990 and for the tolerance of Valtrex, refer linked case US2021AMR155432.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR155432:Same reporter US-GLAXOSMITHKLINE-US2021153990:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: That vax hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received Shingles vaccine and that vaccine(vax) hurt. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: was so sick like if I had the covid same symptoms or worse; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient had a shot and on 2nd dose was sick like if he/she had the covid symptoms or worsen. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pain
Clinical narrative: cold; suck for a couple of days/ achey; chill; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, cold and pain. On an unknown date, the outcome of the chills, cold and pain were recovered/resolved.   It was unknown if the reporter considered the chills, cold and pain to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient reported that, the shots are good but also suck for a couple of days when first get them. The patient received 1st shot of Shingles vaccine and was achy and had a cold chills for about 3 days. The patient reported that before 1st shot the pharmacist asked that if he/she had anything important to do for the next 3 days. The case was linked with case US2021AMR156032 (2nd dose) reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156032:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pain, Vaccine positive rechallenge
Clinical narrative: Chills; suck for a couple of days/ achey/ had the same reaction.; Cold; This case was reported by a consumer interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of nasopharyngitis (along with cough and aches after receiving1st dose on an unknown date, for tolerance refer case US2021AMR156018).   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 chills, pain and cold. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the chills, pain and cold were unknown.   It was unknown if the reporter considered the chills, pain and cold to be related to Shingles vaccine.  Additional details were reported as follows: Additional details were provided are as follows: The age at vaccination was not reported. The patient self reported the case. The patient stated that, the shots were good but also suck for a couple of days when first get them. After the 2nd shot which was due several weeks later, the patient had the same reaction as like 1st shot including cold, chills and was achy; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156018:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: M
Vaccine: MEN
Symptoms: Seizure
Clinical narrative: had a seizure with the Men B vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 17-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   The reporter considered the seizure to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by the parents of the patient. The age at vaccination was not reported. The reporter stated that, his or her 17 year old son had a seizure with the Meningococcal B vaccine. No further information was reported.
Age: 59.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: administration of 1-adult dose of Havrix followed by 1-pediatric dose of Havrix; Adult use of child product; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 59-year-old patient who received HAV (Havrix 720) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult (1st dose received on 4th November 2020).   On 11th May 2021, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated, the administration of 1 adult dose of Havrix followed by 1 pediatric dose of Havrix with patient, which led to underdose and adult use of a child product. The reporter did not consent to follow up. This case was linked with case US2021152078, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152078:Same reporter
Age: 59.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Product expiration date issue, Product packaging confusion
Clinical narrative: expiration date of the box was different than the vials inside. Based on the expiration date on the box, it was not expired at the time, however the vials did; expiration date of the box was different than the vials inside. Based on the expiration date on the box, it was not expired at the time, however the vials did; received an expired dose / expired on Nov 30, 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA207A, expiry date 30th November 2020) for prophylaxis. This case was associated with a product complaint.   On 16th May 2021, the patient received Menveo. On 16th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the patient experienced product packaging confusion and product expiration date issue. On an unknown date, the outcome of the expired vaccine used, product packaging confusion and product expiration date issue were unknown.  Additional details were provided as follows: The patient received expired dose of Menveo which expired on 30th November 2020 which led to expired vaccine used.  Healthcare professional mentioned that, the expiration date of the box was different than the vials inside which led to product packaging confusion.  Based on the expiration date on the box, it was not expired at the time, however the vials did which led to product expiration date issue. The reporter consented to follow up.  This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152087:Same reporter US-GLAXOSMITHKLINE-US2021152084:Same reporter
Age: 54.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Product expiration date issue, Product packaging confusion
Clinical narrative: expiration date of the box was different than the vials inside. Based on the expiration date on the box, it was not expired at the time, however the vials did.; expiration date of the box was different than the vials inside. Based on the expiration date on the box, it was not expired at the time, however the vials did.; received an expired dose / expired on Nov 30, 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 54-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA207A, expiry date 30th November 2020) for prophylaxis. This case was associated with a product complaint.   On 18th June 2021, the patient received Menveo. On 18th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the patient experienced product packaging confusion and product expiration date issue. On an unknown date, the outcome of the expired vaccine used, product packaging confusion and product expiration date issue were unknown.  Additional details were provided as follows: The patient received expired dose of Menveo which expired on 30th November 2020 which led to expired vaccine used.  Healthcare professional mentioned that, the expiration date of the box was different than the vials inside which led to product packaging confusion.  Based on the expiration date on the box, it was not expired at the time, however the vials did which led to product expiration date issue. The reporter consented to follow up.  This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152086:Same reporter US-GLAXOSMITHKLINE-US2021152084:Same reporter
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Administration of a pediatric dose of Engerix-B to an adult patient; Administration of a pediatric dose of Engerix-B to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 14th July 2021, the patient received Engerix B pediatric. On 14th July 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: A powder vial left in the box and not sure which patient didn't receive / they believe that a 16 year old patient; A powder vial left in the box and not sure which patient didn't receive / they believe that a 16 year old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA437A, expiry date unknown) for prophylaxis.   On 21st June 2021, the patient received the 2nd dose of Menveo. On 21st June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, they believe that a 16-year-old patient received a single dose but only received the diluent portion of the vaccine for the booster dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked that would it be harmful if a patient received an extra Menveo vaccination, as they were not sure if she received the 2nd dose. The reporter stated that, there were 3 patients that day that it was ordered but not sure which patient did not receive, there was a powder vial left in the box, but the reporter was going to offer them to come in and get another dose but not sure if it would be a 3rd dose. The reporter inquired about a 3rd dose. The reporter consented to follow up via email.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Needle issue, Wrong technique in product usage process
Clinical narrative: it was improper administration technique / needle leaked during administration of shingrix; needle leaked during administration unknown dose got it and rest leaked; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number ap545, expiry date 25th January 2023) for prophylaxis.   On 9th July 2021, the patient received the 2nd dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process and incomplete dose administered. On an unknown date, the outcome of the wrong technique in product usage process and incomplete dose administered were unknown.  Additional details were provided as follows: The reporter stated that, needle leaked during administration of Shingrix, unknown number of vaccine dose got in and rest leaked, which led to incomplete dose administered and no product complain it was improper administration technique, which led to wrong technique in product usage process. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Biopsy skin, Chills, Hyperhidrosis, Pruritus
Clinical narrative: non-raised red spots on/ top of both legs/ top of both feet to her toes/ top of both arms /are currently on /lower arms, torso, face and tongue; spots are itchy; vision is blurry currently.; spots are currently on her /tongue; she is allergic to the ingredients in the vaccine; sweating; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   On 4th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 4th March 2021, less than a day after receiving Shingrix, the patient experienced sweating, chills and fever. On 11th March 2021, the patient experienced red spotty rash, pruritus, blurred vision, rash tongue and allergy to vaccine. The patient was treated with prednisone and antihistamine. On 7th March 2021, the outcome of the sweating, chills and fever were recovered/resolved. On an unknown date, the outcome of the red spotty rash, pruritus, blurred vision and rash tongue were not recovered/not resolved and the outcome of the allergy to vaccine was unknown.   The reporter considered the sweating, chills, fever, red spotty rash, pruritus, blurred vision, rash tongue and allergy to vaccine to be related to Shingrix.  Additional details were provided as follows: The reporter reported after receiving her Shingrix vaccine she experienced sweating, chills, and fever that resolved in 3 days (did not share how soon they began after the vaccine).  The reporter stated that, on 11th March 2021, she began to break out in non-raised red spots on the top of both legs, the top of both feet to her toes, and the top of both arms. The reporter's HCP had put her on Prednisone dose packs which she had been on and off since 11th March 2021.  The reporter was currently maintained on Prednisone 10mg daily to keep the spots at bay. The spots were itchy and the prednisone helped with that and in addition to Prednisone she was taking an antihistamine.  The reporter also stated that, the spots went away when she was on the Prednisone dose pack, but when she finished the medication the spots reappeared in a different area. The spots were currently on her lower arms, torso, face and tongue.  The reporter stated her vision was blurry currently and she had been to her Healthcare professional, a dermatologist and an allergist.  The dermatologist performed a punch test and it came back as eczema was the cause of the rashes. The reporter does not think this was eczema. The allergist and Healthcare professional, said that this was a super auto immune response to the Shingrix vaccine.  The Healthcare professional did not recommend getting the second dose of Shingrix. The caller felt she was allergic to the ingredients in the vaccine. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash macular, Tongue eruption, Vision blurred
Clinical narrative: non-raised red spots on/ top of both legs/ top of both feet to her toes/ top of both arms /are currently on /lower arms, torso, face and tongue; spots are itchy; vision is blurry currently.; spots are currently on her /tongue; she is allergic to the ingredients in the vaccine; sweating; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   On 4th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 4th March 2021, less than a day after receiving Shingrix, the patient experienced sweating, chills and fever. On 11th March 2021, the patient experienced red spotty rash, pruritus, blurred vision, rash tongue and allergy to vaccine. The patient was treated with prednisone and antihistamine. On 7th March 2021, the outcome of the sweating, chills and fever were recovered/resolved. On an unknown date, the outcome of the red spotty rash, pruritus, blurred vision and rash tongue were not recovered/not resolved and the outcome of the allergy to vaccine was unknown.   The reporter considered the sweating, chills, fever, red spotty rash, pruritus, blurred vision, rash tongue and allergy to vaccine to be related to Shingrix.  Additional details were provided as follows: The reporter reported after receiving her Shingrix vaccine she experienced sweating, chills, and fever that resolved in 3 days (did not share how soon they began after the vaccine).  The reporter stated that, on 11th March 2021, she began to break out in non-raised red spots on the top of both legs, the top of both feet to her toes, and the top of both arms. The reporter's HCP had put her on Prednisone dose packs which she had been on and off since 11th March 2021.  The reporter was currently maintained on Prednisone 10mg daily to keep the spots at bay. The spots were itchy and the prednisone helped with that and in addition to Prednisone she was taking an antihistamine.  The reporter also stated that, the spots went away when she was on the Prednisone dose pack, but when she finished the medication the spots reappeared in a different area. The spots were currently on her lower arms, torso, face and tongue.  The reporter stated her vision was blurry currently and she had been to her Healthcare professional, a dermatologist and an allergist.  The dermatologist performed a punch test and it came back as eczema was the cause of the rashes. The reporter does not think this was eczema. The allergist and Healthcare professional, said that this was a super auto immune response to the Shingrix vaccine.  The Healthcare professional did not recommend getting the second dose of Shingrix. The caller felt she was allergic to the ingredients in the vaccine. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was given on 17Feb2021 / second dose on 29Jan2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 295S7, expiry date 9th October 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose receive on 17th February 2020, batch number KS43H, expiry date -unknown).   On 29th January 2021, the patient received the 2nd dose of Shingrix. On 29th January 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter called for information regarding validity of the administration of a second dose of Shingrix after almost 1 year since first dose. The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter was not sure about sharing too much patient information and only provided date of birth and gender. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product prescribing error
Clinical narrative: Patient / under age 50 and was prescribed / intentionally / Shingrix; This case was reported by a consumer via call center representative and described the occurrence of product prescribing error in a 49-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included scoliosis. Concurrent medical conditions included shingles. Concomitant products included valaciclovir (Valacyclovir).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown.  Additional details were provided as follows: This case was reported by the patient herself. The patient medical history included scoliosis and shingles. The patient was negative for rheumatoid arthritis. The age at vaccination was not reported but the patient was under 50 years of age. The patient was prescribed Shingrix intentionally because she had active outbreaks of shingles and wanted to prevent further outbreaks of shingles because she did not want to spread shingles to a family member who was immunocompromised, which led to product prescribing error. The patient also took valacyclovir blue pills made by pharmaceuticals.  She stated that she always had those same blue pills and never had/used brand name Valtrex.  She also reported the unexpected benefit of not having a cold while on valacyclovir. She thought that being on an antiviral protected her from the common cold virus. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: is past due for dose two of Shingrix / received dose one in September of 2019; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional detaails were provided as follows: The age at vaccination was not applicable for this report. The health care professional did not provide any patient demographics. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional did not provide complete address, lot number or expiration date of product. The health care professional did not specify what type of health care professional they were. The health care professional left web form and AE data collected from the submitted web form.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Subcutaneously  instead of Intramuscularly; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 27pa5, expiry date unknown) for prophylaxis.   On 17th July 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 17th July 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient patient was administered shingrix Subcutaneously  instead of Intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow up. This case was linked with case US2021137216, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021137216:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose 1 of Shngrix on 09/24/2018 and no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, no lot number or expiry date available at the moment. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: vaccinated /with an expired Shingrix vaccine.; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number N72HC, expiry date 9th June 2021) for prophylaxis.   On 21st July 2021, the patient received Shingrix. On 21st July 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The physician reported that the patient was vaccinated with Shingrix which was already expired on 9th June 2021, which led to expired vaccine used. The reporter consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, total 1 dose administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified side effects. He was hospitalized on an unspecified date for 1 week.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210740887-Covid-19 vaccine ad26.cov2.S Unspecified side effects. This event is considered unassessable. 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.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED VACCINE FAILURE; SUSPECTED COVID 19; ALLERGY SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information was processed with additional information received  on 20-Jul-2021. The patient's height, and weight were not reported. The patient's past medical history included hernia surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Patient had concomitant therapy of other therapeutic products unspecified. Patient thought that he had allergy symptoms which started on 14-JUL-2021. He also had hernia surgery on 16-JUL-2021. He lost taste and smell on 19-JUL-2021. On 19-JUL-2021, he was tested was positive for COVID.  Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Patient had suspected clinical vaccination failure and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and allergy symptoms was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210741495. This report was associated with product quality complaint: 90000186465.     .; Sender's Comments: 20210742023-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pain, Proctitis
Clinical narrative: FEVER; INFLAMMATION IN RECTAL MUSCLE; VERY SORE; MUSCLE PAIN; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced inflammation in rectal muscle. On JUL-2021, the subject experienced very sore. On JUL-2021, the subject experienced muscle pain. On JUL-2021, the subject experienced headache. On 18-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.4ºC. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle pain, headache, and fever, and the outcome of inflammation in rectal muscle and very sore was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; INFLAMMATION IN RECTAL MUSCLE; VERY SORE; MUSCLE PAIN; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced inflammation in rectal muscle. On JUL-2021, the subject experienced very sore. On JUL-2021, the subject experienced muscle pain. On JUL-2021, the subject experienced headache. On 18-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.4ºC. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle pain, headache, and fever, and the outcome of inflammation in rectal muscle and very sore was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Influenza like illness, Malaise
Clinical narrative: Pneumonia; flu like symptoms; Night Sweats; Malaise/fatigue; occasional cough or two; Malaise/ fatigue; intermittent Chills; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NIGHT SWEATS (Night Sweats), MALAISE (Malaise/fatigue), COUGH (occasional cough or two), FATIGUE (Malaise/ fatigue) and CHILLS (intermittent Chills). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), INFLUENZA LIKE ILLNESS (flu like symptoms), NIGHT SWEATS (Night Sweats), MALAISE (Malaise/fatigue), COUGH (occasional cough or two), FATIGUE (Malaise/ fatigue) and CHILLS (intermittent Chills) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  As per report in the month March 2021 patient started experiencing flu like symptoms and On the 06May2021 and currently he is feeling the same flu like symptoms.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Added new event added. This case is upgraded as serious as event pneumonia is added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pneumonia
Clinical narrative: Pneumonia; flu like symptoms; Night Sweats; Malaise/fatigue; occasional cough or two; Malaise/ fatigue; intermittent Chills; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NIGHT SWEATS (Night Sweats), MALAISE (Malaise/fatigue), COUGH (occasional cough or two), FATIGUE (Malaise/ fatigue) and CHILLS (intermittent Chills). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), INFLUENZA LIKE ILLNESS (flu like symptoms), NIGHT SWEATS (Night Sweats), MALAISE (Malaise/fatigue), COUGH (occasional cough or two), FATIGUE (Malaise/ fatigue) and CHILLS (intermittent Chills) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  As per report in the month March 2021 patient started experiencing flu like symptoms and On the 06May2021 and currently he is feeling the same flu like symptoms.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Added new event added. This case is upgraded as serious as event pneumonia is added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Chest X-ray normal, Computerised tomogram head normal, Coordination abnormal, Dyspnoea
Clinical narrative: Patient reported "stroke-like" symptoms about 1 hour after getting the 2nd Pfizer vaccine.  She described issues with coordination, weakness in hands, dystonia in her hands.  Numbness L side of her face, lips tingling, eyes felt strange with a burning sensation.  Very mild shortness of breath
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dystonia, Eye irritation, Hypoaesthesia, Muscular weakness, Neurological symptom
Clinical narrative: Patient reported "stroke-like" symptoms about 1 hour after getting the 2nd Pfizer vaccine.  She described issues with coordination, weakness in hands, dystonia in her hands.  Numbness L side of her face, lips tingling, eyes felt strange with a burning sensation.  Very mild shortness of breath
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Patient reported "stroke-like" symptoms about 1 hour after getting the 2nd Pfizer vaccine.  She described issues with coordination, weakness in hands, dystonia in her hands.  Numbness L side of her face, lips tingling, eyes felt strange with a burning sensation.  Very mild shortness of breath
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Good
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Peripheral swelling
Clinical narrative: Swelling in feet, abdomen and hands.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Paraesthesia
Clinical narrative: Tingling in my hands & feet, horrible pain in my neck and shoulders, bad headaches