chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had vaccine and still got them/Suspected vaccination failure; still got them. Nasty, nasty and sore; sore; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the vaccine and still got shingles.  The patient stated that it was nasty and sore. 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 not reported.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had two vaccine, gets shingles all the time/Suspected vaccination failure; Gets shingles all the time; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 details were provided as follows: The case was reported by patient's relative. The age at vaccination was not reported. The patient had the two vaccine and he get shingles vaccine all the time. The reporter stated that he/she was staying away from vaccine. 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 not reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain, Injection site swelling
Clinical narrative: Very swollen injection site; Very painful injection site; did not get the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Had shingles a year ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced injection site swelling, injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site swelling, injection site pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient's physician (MD) advised the vaccine even though the patient had shingles years ago. The patient had one of the two shots and had a reaction, very swollen painful injection site.  Till the time of reporting, the patient did not get the second shot, which led to incomplete course of vaccination. The patient stated that, the nurse friend advised against it and asked to let the physician know. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got vaccinated. Got again for 4th time/suspected vaccination failure; Got again for 4th time, it was worse; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient got shingles 3 times prior to vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got vaccinated with Shingles vaccine The patient got again shingles for 4th time, and unfortunately it was worse, so he/she guessed it depended on the person's immune system. The follow up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: INFANRIX administered to a pregnant patient; INFANRIX administered to a pregnant patientadministration; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included iron and minerals nos + vitamins nos (Prenatal Vitamins).   On 15th March 2022, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on 3rd September 2021 and estimated date of delivery was 10th June 2022. The patient received Infanrix at week 27 of the pregnancy. On 15th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse called to report that Infanrix vaccine was administered to a pregnant patient in her right arm, by mistake which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter would like to know if there were any contraindications and what she should do.  They representative spoke from content and package insert (PI). The warm transferred call to medical information and provided telephone number for future reference.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid conjugate portion; administered only the liquid conjugate portion; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a adolescent male patient who received Men ACWY-CRM NVS (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Physician reported that a patient was administered only the liquid conjugate portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Only month and year for expiration date so last day of the month was chosen for this form . The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Oropharyngeal pain, Rosacea, Swelling face, Throat irritation
Clinical narrative: Rosy Cheeks; puffy face; throat was irritated; uncomfortable to swallow; sore throat; This case was reported by a consumer via call center representative and described the occurrence of rosacea in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2022, the patient received the 2nd dose of Shingrix. On 17th March 2022, 2 days after receiving Shingrix, the patient experienced rosacea, facial puffiness, throat irritation, swallowing difficult and sore throat. On an unknown date, the outcome of the rosacea, facial puffiness, throat irritation, swallowing difficult and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the rosacea, facial puffiness, throat irritation, swallowing difficult and sore throat to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second dose of Shingrix vaccine in left arm and one day before reporting she had rosy cheeks, a puffy face, and her throat was irritated (sore throat, uncomfortable to swallow).   On the day of reporting, the patient stated that her symptoms were better, but had not subsided.   The patient was advised to follow up with health care professional (HCP). The patient gave consent to follow up with HCP (pharmacy). The patient provided limited information. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Malaise
Clinical narrative: first Shingrix 11/2019, hasn't gotten second; flu like symptoms; malaise; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, general malaise and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and general malaise were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms and general malaise to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient. The age at vaccination was not applicable for 2nd dose. About 12 hours of receiving Shingrix, the patient experienced flu like symptoms and general malaise.  These symptoms lasted for about 2 days Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to know how to proceed if he had not gotten his second yet but planned on doing so.  The patient referred to healthcare professional. The reporter did not consent to follow up. No health care professional for follow up.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered to patient younger than indicated age; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-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 7th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th January 2022, 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 details were provided as follows: Physician reported that a medical assistant inadvertently administered a dose of Kinrix to a patient. The patient was younger than the indicated age for Kinrix, which led to inappropriate age at vaccine administration.  The physician asked to provide the rest of the adverse event information via follow-up. The reporter consented to follow-up via email.
Age: 1.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 y/o patient received Bexsero; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 22-month-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 19th March 2022, unknown after receiving Bexsero and Bexsero 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 details were provided as follows: The 22 months old patient received dose of Bexsero, which led to inappropriate age at vaccine administration. No additional details available about adverse event. The parent and CDC were notified.  The patient was doing fine. The reporter consented to follow-up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not yet received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix adult) 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.   Previously administered products included Twinrix adult (1st dose of Twinrix adult received intramuscularly on 2nd September 2021, Dose:1ml, Batch number:a955s, Expiry date:22nd May 2022).   On an unknown date, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Twinrix adult till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HBV (Engerix B) (batch number unknown, expiry date December 2021) for prophylaxis.   On 18th March 2022, the patient received the 1st dose of Engerix B. On 18th March 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 details were reported as follows: The health care professional reported use of Engerix B dose to a patient and the vaccine was already expired three months ago, which led to expired vaccine used. The reporter consented to follow up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Sciatica
Clinical narrative: sciatica; This case was reported by a physician via call center representative and described the occurrence of sciatica aggravated in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sciatica.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced sciatica aggravated. On an unknown date, the outcome of the sciatica aggravated was unknown.   The reporter considered the sciatica aggravated to be unrelated to Shingrix.  Additional details reported were as follows: The age at vaccination was not reported. The patient reported sciatica flare three weeks after receiving Shingrix.  The patient had a past medical history of sciatica and was in construction work that were potential reasons for his sciatica flare. As a result of this sciatica flare occured after Shingrix immunization. MD did not believe Shingrix was the cause of sciatica flare.  This was not a patient of the reporter, just someone who routinely gone to this reporter for medical advice.  Therefore, no other information about the patient had been provided. Medical Doctor reported that they had a pharmacist who told the patient that his sciatica was a known side effect from the shot. The patient was now contemplating not getting his second shot. The patient did not consent to follow-up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Nausea, Pain, Pyrexia
Clinical narrative: SICK; BODY ACHE; CHILLS; LOW GRADE FEVER; NAUSEA; This spontaneous report received from a patient via other company concerned a 30 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Crohn's disease. In JAN-2021, the patient experienced flare up of Crohn's disease, and in AUG-2021, it got resolved. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number: Unknown, expiry: Unknown) dose and frequency were not reported from 2021 for moderate to severe adult Crohn's disease.  On an unspecified date in MAY-2021, the patient was sick and had body ache, chills, low grade fever, and nausea (dose number in series 1).  In NOV-2021, the patient's Humira pen went bad due to refrigeration purposes but it resolved on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, body ache, chills, low grade fever, and nausea on MAY-2021 (dose number in series 1). The patient additionally received non-company covid-19 vaccine included Pfizer-Biontech (Tozinameran) (dose number in series 2) (form of administration not reported, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date in DEC-2021 for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine Pfizer-Biontech (dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Hypoaesthesia, Weight, Weight decreased
Clinical narrative: DECREASED COORDINATION; WEIGHT LOSS (LOST 90 POUNDS); NUMBNESS IN HANDS; This spontaneous report received from a patient concerned a 45 year old female. 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, 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 decreased coordination, weight loss (lost 90 pounds), and numbness in hands. Laboratory data (dates unspecified) included: Weight (NR: not provided) loss 90 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the decreased coordination, numbness in hands and weight loss (lost 90 pounds) was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Ear pain, Hypoacusis, Tinnitus
Clinical narrative: LOST 25 PERCENT HEARING OF LEFT EAR/DISABLED ON THE LEFT SIDE/HEARING PROBLEMS; INNER EAR PAIN; BALANCE AFFECTED; HUMMING IN EARS/EARS SENSITIVE; This spontaneous report received from a patient and concerned a 58 year old. 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 (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805018 and expiry 21-NOV-2021) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On unspecified date in end of MAR-2021, the patient experienced hearing problems within few weeks of vaccination, Patient reported that his ears became sensitive, he had a little inner ear pain, he started fighting with neighbors about hearing their AC unit and called police and they measured the meter. The police said he should go to the doctor to check his hearing. Patient saw ENT (Ear Nose Throat) doctor because it comes and goes and affected his balance, test was performed, and ENT doctor sent him to the audiologist. Patient lost 25 percent of hearing in left ear. He reported that he hears a constant humming noise and was sensitive to noises. He said it was annoying. Patient reported that he was disabled on the left side and it messed up his balance. Some days it was bad, especially if humid or exposed to noise. Patient reported that it was like the noise under the water (dose number in series 1). The patient received Moderna booster vaccine (dose number in series 2), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of Moderna vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inner ear pain, balance affected, humming in ears/ears sensitive, and lost 25 percent hearing of left ear/disabled on the left side/hearing problems. This report was non serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 71 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (first dose) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 15-MAR-2021 for prophylactic vaccination. Patient did not experience any adverse events following vaccination (dose number in series 1). The patient received second dose of covid-19 vaccine ad26. cov2.s (dose number in series 2) (booster dose) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 16-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The patient received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 18-MAR-2022 at left deltoid for prophylactic vaccination which was off label use (without adverse event), and inappropriate schedule of vaccine administered (dose number in series 2).  The nurse explained that patient came in to get Janssen Covid 19 booster shot. Her vaccination card had the initial shot (given 15-MAR-2021) on one side of card and the first booster (second dose) of Janssen Covid 19 vaccine (given 16-NOV-2021) on other side of card. This led to confusion about the booster shot and a third dose was given. The nurse stated, they asked patient if she was here for her second and she said yes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter stated that "Had Omicron in January. Weekend, Saturday-Sunday. Very mild, no fever. Only stayed in because of infectiousness. Blessed. Thanks to God, vaccine and Booster Shots, Janssen, Hearing now re deltacron, covid deltacron hard hit. Masks work this summer, you watch" which was coded as suspected clinical vaccination failure, and suspected covid-19 infection (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. The patient received additionally covid-19 vaccine ad26. cov2.s (dose number in series 2) (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000222694.; Sender's Comments: V0:20220342357-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced very minimal side effects (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s, was not applicable. On an unspecified date, the patient received additional non-company suspect vaccine Tozinameran shot (Pfizer) (Dose number in series 2) (form of admin, route of administration, batch number and expiry were not reported) dose was not reported, administered for prophylactic vaccination.  On an unspecified date, following vaccination with Tozinameran shot, the patient experienced bad side effects (Dose number in series 2). The action taken with tozinameran was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation reaction, Injection site erythema, Pain in extremity
Clinical narrative: Tested positive for Covid; Lack of drug effect; Didn't feel good; Really sore arm; Fever after second dose; Red arm around injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), DRUG INEFFECTIVE (Lack of drug effect), VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm) and PYREXIA (Fever after second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema (Patient has gotten eczema patches in the past but nothing terrible).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm), PYREXIA (Fever after second dose) and INJECTION SITE ERYTHEMA (Red arm around injection site). In August 2021, the patient experienced COVID-19 (Tested positive for Covid) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid), VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm), PYREXIA (Fever after second dose) and INJECTION SITE ERYTHEMA (Red arm around injection site) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications include birth control pills.  Company comment: This is a spontaneous case regarding a 49-year-old female patient with no relevant medical history who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 33 days and who experienced non serious, AESI, unexpected event of COVID-19 which occurred approximately 6 months after the second dose. Patient developed pain and fever that lasted about 5 days and was treated with Tylenol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-515549, MOD-2022-515567 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 49-year-old female patient with no relevant medical history who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 33 days and who experienced non serious, AESI, unexpected event of COVID-19 which occurred approximately 6 months after the second dose. Patient developed pain and fever that lasted about 5 days and was treated with  Tylenol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Lack of drug effect; Didn't feel good; Really sore arm; Fever after second dose; Red arm around injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), DRUG INEFFECTIVE (Lack of drug effect), VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm) and PYREXIA (Fever after second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema (Patient has gotten eczema patches in the past but nothing terrible).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm), PYREXIA (Fever after second dose) and INJECTION SITE ERYTHEMA (Red arm around injection site). In August 2021, the patient experienced COVID-19 (Tested positive for Covid) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid), VACCINATION COMPLICATION (Didn't feel good), PAIN IN EXTREMITY (Really sore arm), PYREXIA (Fever after second dose) and INJECTION SITE ERYTHEMA (Red arm around injection site) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications include birth control pills.  Company comment: This is a spontaneous case regarding a 49-year-old female patient with no relevant medical history who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 33 days and who experienced non serious, AESI, unexpected event of COVID-19 which occurred approximately 6 months after the second dose. Patient developed pain and fever that lasted about 5 days and was treated with Tylenol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-515549, MOD-2022-515567 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 49-year-old female patient with no relevant medical history who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 33 days and who experienced non serious, AESI, unexpected event of COVID-19 which occurred approximately 6 months after the second dose. Patient developed pain and fever that lasted about 5 days and was treated with  Tylenol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Pinkish area of my face/Pink patches on face, hairline.; Hives on neck; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Perimenopause (they attribute a lot of things to hormonal changes.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck). At the time of the report, SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications was reported. It was reported that events caused by immune system and vaccine and it was not specified caused by 2nd dose or not.   This case was linked to MOD-2022-516211 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Rash, Seborrhoeic dermatitis, Skin discolouration, Urticaria
Clinical narrative: Pinkish area of my face/Pink patches on face, hairline.; Hives on neck; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Perimenopause (they attribute a lot of things to hormonal changes.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck). At the time of the report, SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications was reported. It was reported that events caused by immune system and vaccine and it was not specified caused by 2nd dose or not.   This case was linked to MOD-2022-516211 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Seborrhoeic dermatitis, Skin discolouration, Urticaria
Clinical narrative: Pinkish area of my face/Pink patches on face, hairline.; Hives on neck; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Perimenopause (they attribute a lot of things to hormonal changes.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck). At the time of the report, SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications was reported. It was reported that events caused by immune system and vaccine and it was not specified caused by 2nd dose or not.   This case was linked to MOD-2022-516211 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Seborrheic Dermatitis; Pinkish area of my face after doses/Pink patches on face, hairline; Hives on neck; This spontaneous case was reported by a nurse and describes the occurrence of SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 032L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Perimenopause.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck). At the time of the report, SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: it came back seborrheic dermatitis it came back Seborrheic Dermatitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) to be related.    No concomitant medications were reported.  The patient undergone a lot of hormonal changes.  It was reported that, the events got much worsen after the booster dose.  It was also reported that, the immune system and the vaccine caused the event.  The patient used Topical Roslumilast Foam (ARQ-154) (instead of the placebo) as a treatment medication which was used in COPD in a pill form.   This case was linked to MOD-2022-516171 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Rash, Seborrhoeic dermatitis, Skin discolouration, Urticaria
Clinical narrative: Seborrheic Dermatitis; Pinkish area of my face after doses/Pink patches on face, hairline; Hives on neck; This spontaneous case was reported by a nurse and describes the occurrence of SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 032L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Perimenopause.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck). At the time of the report, SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: it came back seborrheic dermatitis it came back Seborrheic Dermatitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) to be related.    No concomitant medications were reported.  The patient undergone a lot of hormonal changes.  It was reported that, the events got much worsen after the booster dose.  It was also reported that, the immune system and the vaccine caused the event.  The patient used Topical Roslumilast Foam (ARQ-154) (instead of the placebo) as a treatment medication which was used in COPD in a pill form.   This case was linked to MOD-2022-516171 (Patient Link).