chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Rash pruritic
Clinical narrative: patient developed an itchy rash after receiving GARDASIL 9/ rash that started 3 days ago (2/6). She got her 1st HPV vaccine here on 1/31. Her rash was waist up, itchy. We are pretty sure it is not related to the vaccine; This spontaneous report has been received from a nurse, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On31-JAN-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular Injection (dose, vaccination scheme, anatomical location, route of administration, frequency, lot number and expiration date were not provided for any of the suspects) for prophylaxis.  On 06-FEB-2023 (reported as three days ago), the patient experienced a rash. Her rash was waist up, itchy (rash pruritic). The outcome of the event rash pruritic was not provided.  The causality assessment between the event rash pruritic with the suspect hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not related.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 09-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine but still got shingles. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had twice with shot/ Suspected vaccination failure; Had twice, not as bad 2nd time, they are nasty; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 and Shingles vaccine.     Additional Information: GSK receipt date: 09-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had received shot twice. The shot was not as bad second time. The reporter reported that shots were nasty. The reporter reported the insurance should pay. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Vaccination failure
Clinical narrative: Death Nos; Suspected vaccination failure; Shingles, treated w/remdesivir, died in 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included remdesivir for product used for unknown indication.   On an unknown date, the patient received Shingles vaccine and remdesivir at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with remdesivir was unknown. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure and shingles were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shot and got shingles 2 times after that. The reporter did not trust the Covid vaccine as the patient passed away last year from the remdesivir they treated and died in 4 days. It was unknown if the reporter considered the death nos, shingles to be related to remdesivir. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2023AMR023214 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR023214:Same reporter; Reported Cause(s) of Death: Death NOS
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness for 2 days; This case was reported by a consumer via call center representative and described the occurrence of pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2023018213   Additional Information: GSK Receipt Date: 06-Feb-2023: Reporter's Comment:  This case was self reported by the patient. The patient received first dose of Shingrix on right arm. The patient experienced soreness for 2 days, but did not clarify which dose this was referring to. The reporter did not consent to follow up. This case had been linked with US2023018213 same patient.; Sender's Comments:  US-GSK-US2023018213:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Mild fatigue; Light chills; This case was reported by a consumer via call center representative and described the occurrence of fatigue 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 fatigue and chills. On an unknown date, the outcome of the fatigue and chills were unknown.   It was unknown if the reporter considered the fatigue and chills to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR019709   Additional Information: GSK receipt date: 06-FEB-2023 Reporter comment:  The first one caused mild fatigue and light chills.  The patient read online these were not common. The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose refer case US2023AMR019709, reported with same reporter.; Sender's Comments:  US-GSK-US2023AMR019709:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Fatigue, Muscular weakness
Clinical narrative: Extreme fatigue; Legs feeling like rubber; Chills for hours; Slight headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of fatigue (For tolerance of 1st dose of shingles vaccine , refer case US2023AMR019685).   On 5th February 2023, the patient received the 2nd dose of Shingles vaccine. In February 2023, unknown after receiving Shingles vaccine, the patient experienced fatigue, muscle weakness lower limb, chills and headache. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fatigue, muscle weakness lower limb and headache were unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle weakness lower limb, chills and headache to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2023AMR019685   Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: The case was reported by the patient. The patient got shingles shot the day before reporting. This one was extreme fatigue, legs feeling like rubber, chills for hours and slight headache.  The reporter stated that he/she read online these were not common.; Sender's Comments:  US-GSK-US2023AMR019685:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza, Somnolence
Clinical narrative: Very sleepy; Sick with the flu; Sick with the flu; This case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sleepiness, sickness and influenza. On an unknown date, the outcome of the sleepiness, sickness and influenza were recovered/resolved.   It was unknown if the reporter considered the sleepiness, sickness and influenza to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 08-FEB-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient got the vaccine with the insurance that she/he had. The reaction was the next day and it made her/him very sleepy and sick with the flu. It lasted one day and with redacted blood covering her/him. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Age: 34.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 34 YO received Shingrix; was given Shingrix instead of varicella; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a 34-year-old 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 age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-FEB-2023 Reporter's Comment:  The reporter reported that the 34 years old patient received Shingrix vaccine instead of varicella vaccine. No adverse event. Additional supportive information: The patient received Shingrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administered varicella and inadvertently administered Shingrix instead of varicella, which led to wrong vaccine administered.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: diagnosed with Guillain-Barre Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 2nd October 2021, the patient received Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 31-Jan-2023 This case was self reported by the patient. The patient reported that advised to get the shingles vaccination and flu vaccine (unknown flu vaccine) by her former place of employment.  The patient reported that because of the vaccinations had been diagnosed with Guil-lain-Barre Syndrome.  The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm still sore, it hurts worse if he moves; Soreness for 2 days; This case was reported by a consumer via call center representative and described the occurrence of pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 20th July 2022 and experienced pain, refer case US2023AMR018900).   On 22nd September 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR018900   Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix into left arm and experienced soreness for 2 days but did not clarified which dose this referring to. The patient reported that although no super painful, the back of his upper left arm was still sore on the day of reporting and stated it hurts worse if he moves a certain way, and that the arm was not swollen. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023AMR018900:Same reporter
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Menveo adminsitered instead of Men-b; Received 2 doses previously of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date 28th February 2023) for prophylaxis.   Previously administered products included Menveo (Received 1st dose of Menveo on 20th February 2017) and Menveo (Received 2nd dose of Menveo on 17th June 2021).   On 6th February 2023, the patient received the 3rd dose of Menveo. On 6th February 2023, unknown after receiving Menveo, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter reported that patient received an accidental dose of the Menveo instead of Men-b.  The patient also received 2 doses of Menveo previously. No reactions were reported.  The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up via email.  Additional Supportive Information: The reporter reported that the patient received 2 doses of Menveo previously and now received an accidental dose of the Menveo instead of Men-b, which led to wrong vaccine administered and extra dose administered.
Age: 71.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 71-year-old female patient who received HAB (Twinrix adult) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received Twinrix adult (intramuscular) and Twinrix Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 07-FEB-2023 Reporter's Comment: The patient received an expired Twinrix adult vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received an expired Twinrix adult vaccine, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to get 2nd dose; This case was reported by a consumer 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 (Received 1st dose of Shingrix in in march 2022).   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: 07-FEB-2023 Reporter's Comment: The case was reported by the patient. He did not know exact date or location site of injections of Shingrix.  He stated that he moved and forgot to get dose 2 of Shingrix.  Medical information phone number and medical disclaimer provided.  Referred to healthcare professional. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023019049, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023019049:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose March2022, no 2nd dose yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in March 2022).   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: 07-FEB-2023 Reporter's Comment: The reporter called to report that a patient went to the facility to get a second dose of Shingrix. The professional did not administer the second dose yet. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-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: 07-FEB-2023 Reporter's Comment: The reporter was reporting a 12 years old patient received Kinrix.  The reporter did not have additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional Supportive Information: The reporter was reporting a 12 years old patient received Kinrix, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter. US-GSK-US2023AMR020880:Same reporter US-GSK-US2023AMR020895:Same reporter. US-GSK-US2023AMR020893:Same reporter. US-GSK-US2023AMR020894:Same reporter. US-GSK-US2023AMR020891:Same reporter US-GSK-US2023AMR020892:Same reporter US-GSK-US2023AMR020896:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Mar2022, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (in March 2020 patient received 1st dose).   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: 08-FEB-2023 Reporter's Comment: The pharmacist called to ask for information regarding a patient who received the first dose of Shingrix in March 2020 but never got the second dose.  The reporter asked if the patient had to receive a second dose or start over with the vaccination. The reporter did not provide data about the lot number and expiry date of the first Shingrix dose The reporter consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 68.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired Havrix administered; Dose given over 12 months after dose 1; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) 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 (Received 1st dose of Havrix on an unknown date).   On 9th February 2023, the patient received the 2nd dose of Havrix (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long 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: 09-FEB-2023 Reporter's Comment: The reporter reported that a patient received dose of Havrix in left deltoid at the time of reporting.  This dose was also late- given over 12 months after dose 1 of Havrix.  The reporter transferred to MI for more information. The reporter consented to follow up. Additional supportive Information: The reporter reported that a patient received dose of Havrix in left deltoid at the time of reporting and this dose was also late-given over 12 months after dose 1 of Havrix, which led to expired vaccine used and lengthening of vaccination schedule. The case had been linked to US2023021176, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023021176:Same reporter - male patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Sep2020, didnt get 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020).   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: 09-FEB-2023 Reporter's Comments: The patient called if she should restart her Shingrix series, having received the 1st dose, and not getting the 2nd dose. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  This case is linked with case US2023021219 reported by same reporter.; Sender's Comments:  US-GSK-US2023021219:Same reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 09-FEB-2023 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. Age at time of vaccination 63 years old. No concomitant medications were reported. On 09-FEB-2023, the patient experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 09-FEB-2023 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. Age at time of vaccination 19 years old. No concomitant medications were reported. On 09-FEB-2023, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: VACCINE INDUCED CIDP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 09-OCT-2021, on the following morning post vaccination, woke up with a burning sensation in feet, which over the course of days and weeks spread to upward. The patient had followed numerous emergency room and medical appointments, patient was diagnosed with vaccine induced CIDP (chronic inflammatory demyelinating polyneuropathy). The patient reported that 1.5 years later, patient still had constant pain (intense burning, numbness, tingling) and only with great difficulty able to walk and climb stairs.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine induced CIDP. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230226361- vaccine induced CIDP. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious. This case is a duplicate of 20230227379. This case, from the same reporter is linked to 20220429250 and 20230227517.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: INJURED WITH THE VACCINE; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced injured with the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injured with the vaccine was not reported. This report was non-serious. This case is a duplicate of 20230227379. This case, from the same reporter is linked to 20220429250.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anaphylactic reaction
Clinical narrative: She had an anaphylactic reaction and almost died; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (She had an anaphylactic reaction and almost died) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (She had an anaphylactic reaction and almost died) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 14 days due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (She had an anaphylactic reaction and almost died) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient had an anaphylactic reaction and almost died. She was in the hospital for 2 weeks.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 61-year-old female patient with no medical history reported, who experienced the expected serious (hospitalization, medically significant) event of Anaphylactic reaction (reported as She had an anaphylactic reaction and almost died) that occurred in the context of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination and onset date of the event was not available. Patient was hospitalized for two weeks. No further information regarding risk factors, clinical course, medical history, investigations, additional vaccination details and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 is not affected by this report.   This case was linked to MOD-2021-296245 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia
Clinical narrative: The individual was debilitated to the point that she could not get out of bed; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (The individual was debilitated to the point that she could not get out of bed) and PYREXIA (fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (The individual was debilitated to the point that she could not get out of bed) and PYREXIA (fever). At the time of the report, ASTHENIA (The individual was debilitated to the point that she could not get out of bed) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 for 10 days.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported the patient was sick for a month. The patient  approximated worst fever to be 101 for 10 days, and the fever lasted for 30 days total. The individual's immunologist recommended no further Moderna shots. The patient was told by an immunologist that  due to an overactive immune system, which may have caused the reaction. No treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Suffered ischemic stroke; This spontaneous case was reported by a patient and describes the occurrence of ISCHAEMIC STROKE (Suffered ischemic stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 016M20A and 013L20A) for COVID-19 prophylaxis.     The patient's past medical history included Bypass surgery (Heart bypass) in November 2012. Concurrent medical conditions included Type 2 diabetes mellitus and Drug allergy (Had allergic reaction to unspecified drug).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2023 at 10:00 AM, the patient experienced ISCHAEMIC STROKE (Suffered ischemic stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 1 day due to ISCHAEMIC STROKE. At the time of the report, ISCHAEMIC STROKE (Suffered ischemic stroke) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 29-Dec-2022 at 09:30am, patient took co-suspect dose 5, Pfizer bivalent in left arm. Patient received co-suspect dose 4 from Pfizer tris-sucrose (12+) SARS-COV-2 (batch number: FP4554) in arm.  The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  The adverse event result in Emergency room/department or urgent care. Patient had CT scan, MRI, EKG, neurology visit, heart monitor.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not had been tested for COVID-19.  No treatment medication was reported.  Company comment-This spontaneous case concerns a male patient aged 74 years with relevant medical history of Type 2 Diabetes reported, who experienced the unexpected serious (Medically significant/Hospitalization) AESI event of Ischaemic stroke that occurred in the context of a dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since date of vaccination was not disclosed. Patient had received initial 3 doses of mRNA-1273 and two doses Pfizer vaccines. It was reported that patient was hospitalized for one day, underwent CT, MRI, neurology review, EKG and heart monitor, details not reported. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment of the event was available in the report. Outcome of the event was resolving at the time of report. The relevant medical history remains as confounder and advancing age of the patient a risk factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: patient got first dose of primary series and card just has booster dose but the patient thinks he was administered the bivalent; He received primary dose but medical records saying he received the booster; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (patient got first dose of primary series and card just has booster dose but the patient thinks he was administered the bivalent), WRONG PRODUCT ADMINISTERED (He received primary dose but medical records saying he received the booster) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 083b22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (patient got first dose of primary series and card just has booster dose but the patient thinks he was administered the bivalent), WRONG PRODUCT ADMINISTERED (He received primary dose but medical records saying he received the booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (patient got first dose of primary series and card just has booster dose but the patient thinks he was administered the bivalent), WRONG PRODUCT ADMINISTERED (He received primary dose but medical records saying he received the booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (patient got first dose of primary series and card just has booster dose but the patient thinks he was administered the bivalent) and WRONG PRODUCT ADMINISTERED (He received primary dose but medical records saying he received the booster).    No concomitant medication was reported.    Patient got first dose of primary series and card just has booster dose but the patient thoughts he was administered with the bivalent what he was saying he received primary dose but medical records saying he received the booster. No treatment information was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Renal impairment
Clinical narrative: Has mild kidney function issues; This spontaneous case was reported by a patient and describes the occurrence of RENAL IMPAIRMENT (Has mild kidney function issues) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RENAL IMPAIRMENT (Has mild kidney function issues) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Has mild kidney function issues) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient was asking if he needs to get more than one bivalent booster dose. He stated that his first dose of the Moderna bivalent was on 22-Sep-2022. He stated that he had mild kidney function issues. No further information provided.  Treatment information was not provided. Company comment-This spontaneous case concerns an adult male patient of unknown age with no medical history reported, who experienced the unexpected serious (Medically significant) AESI event of Renal impairment that occurred in the context of a dose of mRNA-1273.222 bivalent vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of event was not disclosed. It was reported that patient had mild kidney function issues. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment of the event was available in the report. Outcome of the event was unknown at the time of report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.
Sex: F
Vaccine: COVID19-2
Symptoms: Epistaxis, Malaise, Vomiting
Clinical narrative: Feeling unwell; nosebleeds; vomiting; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling unwell), EPISTAXIS (nosebleeds) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell), EPISTAXIS (nosebleeds) and VOMITING (vomiting). At the time of the report, MALAISE (Feeling unwell), EPISTAXIS (nosebleeds) and VOMITING (vomiting) had not resolved.            No concomitant medications were reported.  Patient received the booster shot and she was feeling unwell. She was vomiting and having nosebleeds after receiving the booster dose. The patient asked for information on how long did it take to go away.  No treatment information was provided.