chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Greater than six months since first dose / 2nd one yesterday; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14th January 2020).   On 26th April 2022, the patient received the 2nd dose of Shingrix. On 26th April 2022, 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 Information: GSK Receipt Date: 26-APR-2022 and 27-APR-2022 Reporter's Comment: The reporter stated that, he had a patient that it had been greater than six months since the first dose of Shingrix and indicated that, he administered the second dose to the patient. The patient informed that, two year between two shots and second one 26th April 2022. The patient told something about not taking Tylenol or Ibuprofen as it might decrease effectiveness even further. The patient said that, she was already below the normal coverage due to the delay and she didn't want to decrease it further.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070641:Same patient. Case created in error.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Muscle spasms
Clinical narrative: headache; leg cramps; shivering; dry cough; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022 15:00, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, 10 hrs after receiving Shingrix, the patient experienced headache, leg cramps, shivering and dry cough. On an unknown date, the outcome of the headache, leg cramps and shivering were not recovered/not resolved and the outcome of the dry cough was recovered/resolved.   It was unknown if the reporter considered the headache, leg cramps, shivering and dry cough to be related to Shingrix.  Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The case was reported by the patient.  The patient received Shingrix in the left arm. On 27th April 2022 at about 1 am, he started to get a headache, legs cramps, shivering and a dry cough.  The reporter reported that when he awoke, he still had all the symptoms except the dry cough, which had resolved.  The reporter believed that the dry cough might be related to the pollen in the air. The reporter did not consent to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Pain
Clinical narrative: Sharp, shooting pain in LEFT hip; Finds it difficult to walk; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 4KK43, expiry date 26th August 2023) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax.   On 22nd April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2022, less than a week after receiving Shingrix, the patient experienced walking difficulty. On 23rd April 2022, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was not recovered/not resolved and the outcome of the walking difficulty was unknown.   It was unknown if the reporter considered the pain in hip and walking difficulty to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The patient received Shingrix in the left deltoid. The next morning, she began experiencing a shooting pain in left hip. This had not yet resolved. She described the pain as sharp, shooting, and then it went away. She finds it difficult to walk. Less than a week after vaccination, the patient experienced difficulty in walking. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak after 1st dose; This case was reported by a nurse via call center representative and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The nurse reported that the patient wanted to be administered with the 2nd dose of Shingrix. The nurse reported that this patient suffered a shingles outbreak after the 1st dose.  The patient did not administer the second dose of Shingrix. The reporter gave consent to follow up.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 10 months old patient was administered Kinrix; Kinrix was the patient's 3rd dose of DTaP and IPV; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old female patient who received DTPa-IPV (Kinrix) (batch number e2l54, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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 Information: GSK Receipt Date: 28-Apr-2022 Reporter's Comments: The reporter stated that on the day of reporting, a 10 months old patient was administered Kinrix instead of Pentacel. During call with 2nd line agent HCP stated that she believed they were doing catch up for the 6 month vaccines and that the Kinrix was the patient's 3rd dose of DTaP and IPV. The reporter consented to follow up. Additional Supportive Information: The 10 months old patient was administered Kinrix as 3rd dose of series instead of Pentacel, which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itchiness all over body especially arms and torso/bumps which cause itching; hives all over body, especially arms and torso; rash, different parts of body/fine rash; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2022, the patient received the 1st dose of Shingrix. On 3rd March 2022, 3 days after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the patient experienced generalized pruritus and hives. The patient was treated with loratadine (Claritine). On an unknown date, the outcome of the generalized rash and generalized pruritus were not recovered/not resolved and the outcome of the hives was unknown.   It was unknown if the reporter considered the generalized rash, generalized pruritus and hives to be related to Shingrix.     Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient self-reported the case. After receiving Shingrix, the patient broke out in a fine rash. Less than 3 months after receiving Shingrix, the patient experienced hives and itchiness all over her body especially arms and torso. There was reportedly always a bump which caused the itching. Healthcare professional initially did not consent to follow-up, according to the caller but upon follow up the reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received three doses; Patient received three doses; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 34YF7, expiry date 23rd January 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 2393S, expiry date 20th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th March 2019, batch number EH9Z7, expiry date 08th March 2021).   On 20th January 2022, the patient received the 2nd dose of Shingrix. On 4th April 2022, the patient received Shingrix. On 20th January 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th April 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: Immunization coordinator reported that, the patient received three doses of Shingrix. The patient received 1st dose of Shingrix on 26th March 2019 and 2nd dose on 20th January 2022. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received three doses of Shingrix, which led to extra dose administered. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071360:Same Reporter US-GLAXOSMITHKLINE-US2022071347:Same reporter
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received a pediatric dose; Adult patient received a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 36-year-old male patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date unknown) for prophylaxis.   On 27th April 2022, the patient received Engerix B pediatric. On 27th April 2022, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: Immunization coordinator reported an adult patient received a pediatric dose of Engerix-B. The reporter did not consent to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix-B, which led to adult use of a child product and underdose. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071347:Same Reporter US-GLAXOSMITHKLINE-US2022071352:Same Reporter
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 36 year old adult given Infanrix instead of Boostrix.; 36 year old adult given Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 36-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 28th April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  GSK Receipt Date: 28-APR-2022 Reporters comment: The adult patient was given Infanrix instead of Boostrix. No other adverse event information was provided at this time by healthcare professional.  Healthcare professional gave permission for safety team to follow up. The reporter consented to follow up. Additional supportive information: The adult patient was given Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Because of the covid situation they didn't received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's Comments: The pharmacist reported that employees of the facility were late for the second dose of Shingrix, because of the COVID situation they did not receive the second dose of Shingrix.  No information provided because this happened 2 years ago. No adverse event was reported.  The reporter did not know how many employees were missing the second dose. No patient's identifiers provided. No LOT number and expiration date provided and no vaccination date provided. The reporter consented to follow up.  Additional Supportive Information: The pharmacist reported that employees of the facility were late for the second dose of Shingrix, because of the COVID situation they did not receive the second dose of Shingrix, which led to social problem. The Vaccine Administration Facility is the same as primary reporter. VAERS details were reported for the 1st dose of Shingrix.
Age: 1.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix vaccine to a 16 month old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old 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.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 29-APR-2022 Reporter's Comments:  The reporter stated that Kinrix vaccine was administered to a 16 months old patient. The reporter was upset about the mistake and wanted to be transferred to Medical information. No other demographics or information shared.The reporter was consented to follow up. Additional Supportive Information: The patient received Kinrix at 16 months age, which led to Inappropriate age at vaccine administration
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Four patients received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 73H93, expiry date 10th January 2022) for prophylaxis.   On 28th April 2022, the patient received Engerix B. On 28th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's Comment: The reporter reported that the patient received an expired dose of Engerix-B vaccine. The reporter consented to follow up. Additional Supportive Information: The reporter reported that the patient received an expired dose of Engerix-B vaccine, which led to expired vaccine used. This case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR072337:Same reporter US-GLAXOSMITHKLINE-US2022AMR072338:Same reporter US-GLAXOSMITHKLINE-US2022AMR072336:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient only received the ASO1B adjuvant; Patient only received the ASO1B adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 Information: GSK Receipt Date: 29-APR-2022 Reporter's Comments:  The reporter stated that patient only received the aso1b adjuvant of shingrix without being reconstituted. The reporter wanted to know what could be given since diluent provided was wasted. Additional Supportive Information:  The patient only received the aso1b adjuvant of shingrix without being reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received a second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine prior to COVID happening).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 29-APR-2022 Reporter's comments: The pharmacist reported that, patient received his first dose of Shingrix prior to COVID happening and patient did not receive second dose of Shingrix vaccine. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Incorrect dose administered
Clinical narrative: unsure how much of 0.1 mL patient received; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2022, the patient received the 1st dose of Shingrix. On 27th April 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK receipt date: 29-Apr-2022 Reporter's comment: Pharmacist reported that the patient came for first dose of Shingrix series. During administration, the patient jerked and pulled arm away and the syringe fell on the floor.  There was 0.1 mL gone from the syringe (0.4mL remaining in syringe).  There was also some liquid on the floor, so unsure how much of the 0.1 mL the patient actually received.  The reporter did not had lot number and expiration date information available.  At the time of reporting, the patient had not been redosed.  Consented to follow up. Additional Supportive Information: During administration, some liquid of the vaccine fell on the floor and it was unsure how much of 0.1 ml, the patient actually received, which led to accidental underdose.
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: received Infanrix instead of Boostrix; 13 year old received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-Apr-2022 Reporter's comment: Medical assistant reported that on the day of reporting 13 years old patient received Infanrix instead of Boostrix. Consented to follow-up. Additional Supportive Information: The patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. This one of two linked case, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071959:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number N3S45, expiry date 27th May 2023) for prophylaxis.   On 1st April 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient received Shingrix that was exposed to a low temperature excursion of 28.8 degree F. The vaccine was no longer viable. The consent to follow up was given. Additional Supportive Information: The patient received Shingrix that was exposed to low temperature, which led to incorrect storage of drug. This case was linked with case US2022072588, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022072588:same reporter
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received a dose  that was exposed to a low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, 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: 2-May-2022 Reporter's comments: The patient received Boostrix that was exposed to a low temperature excursion of 28.8 degree F. The vaccine was no longer viable. The consent to follow up was not given. Additional Supportive Information: The patient received Boostrix that was exposed to low temperature, which led to incorrect storage of drug. This case was linked with case US2022072584, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022072584:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: first dose  before the pandemic, second dose has not yet been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient received her first dose of Shingrix series before the pandemic began and did not follow through with receiving the second dose. The pharmacist did not have the date or lot number or expiration date of the first dose. The second dose had not yet been administered. The consent to follow up was given.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous report, received from a patient, concerned a male, of unspecified age, race and ethnic origin. The patient's height, weight, medical history, concomitant medications and concurrent conditions not reported. The patient received the COVID-19 vaccine ad26. cov2.s (dose number in series 1, suspension for injection, route of admin, batch/lot# not reported; expiry: unknown), dose not reported, 1 total, on Mar 9, 2021 for immunization. It was unknown whether patient had any adverse events following vaccination with first dose of COVID-19 vaccine ad26. cov2.s (dose number in series 1). The patient received additional booster dose of the COVID-19 vaccine ad26.cov2.s (dose number in series 2, suspension for injection, route of admin not reported, batch/lot# 1822811 and expiry date: Mar 20, 2022), dose not reported, 1 total, on Oct 22, 2021 for prophylactic vaccination. On an unspecified date, patient got Omicron (dose number in series 2).The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of got Omicron: not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Influenza like illness, Injection site pruritus, Pyrexia
Clinical narrative: MASSIVE ITCHINESS IN THE INJECTION AREA OF ARM; SEVERE COUGH; VERY FATIGUED; FEVER; RECURRING SEVERE FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 130 pounds, and height was 63 inches. The patient's concurrent conditions included: all kinds of terrible allergies (mainly environmental allergy), and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 46 years old. No concomitant medications were reported. On SEP-2021, the patient experienced recurring severe flu like symptoms, severe cough, very fatigued, and fever. On an unspecified date, the patient experienced massive itchiness in the injection area of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurring severe flu like symptoms, severe cough, very fatigued, and fever, and the outcome of massive itchiness in the injection area of arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: KNEE FELT LIKE HAD ALMOST NEEDED TO YANK IT TO MAKE IT FEEL REGULAR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was athletic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 30-APR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2022, the patient experienced knee felt like had almost needed to yank it to make it feel regular. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knee felt like had almost needed to yank it to make it feel regular was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Movement disorder, Pain
Clinical narrative: ANKLES SWELLING UP; BODY HURTS, ACHES AND PAINS; CAN BARELY GET UP THE STAIRS; LEFT SHOULDER HURTING ALL DAY; This spontaneous report received from a parent concerned a 22 year old male.  The patient's pre-existing medical conditions included: patient's mother has a history of genetic blood clotting issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 04-MAY-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2022, the patient experienced ankles swelling up, body hurts, aches and pains, can barely get up the stairs, and left shoulder hurting all day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ankles swelling up, body hurts, aches and pains, left shoulder hurting all day and can barely get up the stairs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: TEMPERATURE EXCURSION DOSES ADMINISTERED TO PATIENTS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced temperature excursion doses administered to subjects, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion doses administered to patients and incorrect product storage was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Diarrhoea, Headache, Illness
Clinical narrative: SICK 4 TO 5 TIMES SINCE RECEIVING THE JNJ VACCINE; COUGH; DIARRHEA; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 55 year old male. 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported. On 05-MAY-2022, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On an unspecified date, the patient experienced sick 4 to 5 times since receiving the JNJ vaccine, cough, diarrhea, headache, and low grade fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever (Low grade fever). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from sick 4 to 5 times since receiving the JNJ vaccine, cough, diarrhea, and low grade fever. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: SICK 4 TO 5 TIMES SINCE RECEIVING THE JNJ VACCINE; COUGH; DIARRHEA; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 55 year old male. 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported. On 05-MAY-2022, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On an unspecified date, the patient experienced sick 4 to 5 times since receiving the JNJ vaccine, cough, diarrhea, headache, and low grade fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever (Low grade fever). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from sick 4 to 5 times since receiving the JNJ vaccine, cough, diarrhea, and low grade fever. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Poor quality sleep, Pyrexia
Clinical narrative: got sick; flu like symptom; got a fever of 102°F; was up all night; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (was up all night), ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptom) and PYREXIA (got a fever of 102°F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056m21a, 027l20a, 015m20a and 017e21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Keflex).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced POOR QUALITY SLEEP (was up all night) and PYREXIA (got a fever of 102°F). On an unknown date, the patient experienced ILLNESS (got sick) and INFLUENZA LIKE ILLNESS (flu like symptom). At the time of the report, POOR QUALITY SLEEP (was up all night), ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptom) and PYREXIA (got a fever of 102°F) outcome was unknown.            Concomitant medication included Blood pressure medicines and cholesterol medicine. No treatment medication information provided.  Adverse events did not cause patient to seek medical attention. Patient has never had tested positive for COVID and never has been diagnosed. No historical condition related to adverse events and both acute and chronic illness at the time of vaccination was reported. No other vaccination given within 1 month prior to COVID-19 vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022; 10 patients were administered with an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) and PRODUCT STORAGE ERROR (vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 019F21A, 030L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022 at 3:27 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 3:27 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) and PRODUCT STORAGE ERROR (vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (vaccine expired on 24-Apr-2022 and stored in refrigerator on 25-Apr-2022).    Concomitant drugs were not reported.  It was reported that the vial was stored in refrigerator on 25-Apr-2022 and vial did not undergo any temperature excursion. Dose or volume of dose 1 and 2 were reported as 0.5 and 0.25 for dose 3.  Treatment medications were not provided.   This case was linked to MOD-2022-558779, MOD-2022-558776 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Follow-up received include new reporter, patient demographics, lab data, suspect product information, vaccination time and narrative updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever this time but not much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever this time but not much) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy.    On 02-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever this time but not much). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever this time but not much) outcome was unknown.            No concomitant medication was reported.  The patient got 3 previous Moderna COVID-19 vaccinations.  On 02-May-2022, the patient received Moderna COVID-19 booster vaccine. This shot did not seem to bother at all. The patient had a sore arm and fever this time but not much.  No treatment medication was reported.   This case was linked to MOD-2022-556947 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She states she was sick after these; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She states she was sick after these) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy and Immunocompromised.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ILLNESS (She states she was sick after these). At the time of the report, ILLNESS (She states she was sick after these) outcome was unknown.            No concomitant medication information provided.  Patient had prior doses of Moderna COVID-19 vaccinations.  No treatment information provided.   This case was linked to MOD-2022-556946 (Patient Link).   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Date the vial was initially stored in the refrigerator was not known. The vial did not undergo any temperature excursions. It was unknown if any of the patients experienced any symptoms. Treatment medication was not provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to 13 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 13 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Number of doses/vials was 13 doses from 2 vials. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was unknown if the patient experienced any symptoms.  No treatment medication information provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses/ vials administered 13doses from 2 vials. Date the vial was initially stored in the refrigerator was unknown. The vial had not undergone any temperature excursion.  No treatment medications were reported.