chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 28 years 10 months.  No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code 80777-0273-99. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     In was unknown if the patient ever been diagnosed with/tested positive for Covid-19.  Acute illness at the time of vaccination and up to one month before was unknown.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient age was reported as 68 years and 9 months On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. Vaccine NDC code was reported as 80777-0273-99. No treatment medication was provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had acute illness at the time of vaccination and up to one month before.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 22 years 8 months. No concomitant medications were reported It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. No treatment medication were reported. On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 prophylaxis.     It was unknown if patient ever had tested or diagnosed positive for COVID. It was unknown if patient had Acute or Chronic/ long-standing illnesses at the time of vaccination or up to 1 month prior to vaccination. Information about other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown.     On 12-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Reporter stated that patient did not had any adverse reactions after the administration of vaccines.  No treatment medication was provided.   This case was linked to MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-542869:Crosslink case(MCN)
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  Patient age was reported as 58 years and 10 months.  Ndc Code was mentioned. It was reported that on 10-Jun-2022 Medical was notified of an audit that was done and were then made aware of vaccines that were administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Illness, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: My fingers were so stiff when I woke up.; I was crazy sick; I had  throbbing pain, like needles, in my legs; Horrible body aches; Tremendous arm pain in my left arm where I got the injection. I was in an enormous amount of pain in that arm/My arm is still sore today, but it's much better; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (My fingers were so stiff when I woke up.), ILLNESS (I was crazy sick), PAIN (I had  throbbing pain, like needles, in my legs), MYALGIA (Horrible body aches) and VACCINATION SITE PAIN (Tremendous arm pain in my left arm where I got the injection. I was in an enormous amount of pain in that arm/My arm is still sore today, but it's much better) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder (Thyroid issues), Trigger finger and Cataract operation (Cataract implants). Concurrent medical conditions included Hair loss (Hair loss for a long time, even before the patient got the injection), Diabetic, Arthritis, Hypertension and Osteoarthritis (In my fingers).   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, the patient experienced MYALGIA (Horrible body aches), VACCINATION SITE PAIN (Tremendous arm pain in my left arm where I got the injection. I was in an enormous amount of pain in that arm/My arm is still sore today, but it's much better) and FATIGUE (Fatigue). On 22-Jun-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (My fingers were so stiff when I woke up.), ILLNESS (I was crazy sick) and PAIN (I had  throbbing pain, like needles, in my legs). At the time of the report, MUSCULOSKELETAL STIFFNESS (My fingers were so stiff when I woke up.), ILLNESS (I was crazy sick), PAIN (I had  throbbing pain, like needles, in my legs), MYALGIA (Horrible body aches), VACCINATION SITE PAIN (Tremendous arm pain in my left arm where I got the injection. I was in an enormous amount of pain in that arm/My arm is still sore today, but it's much better) and FATIGUE (Fatigue) had not resolved.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-594298 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My fingers were so stiff when I woke up.; I was crazy sick; I had  throbbing pain, like needles, in my legs; Horrible body aches; Tremendous arm pain in my left arm where I got the injection. I was in an enormous amount of pain in that arm/My arm is still sore today, but it's much better; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (My fingers were so stiff when I woke up.), ILLNESS (I was crazy sick), PAIN (I had  throbbing pain, like needles, in my legs), MYALGIA (Horrible body aches) and VACCINATION SITE PAIN (Tremendous arm pain in my left arm where I got the injection. I was in an enormous amount of pain in that arm/My arm is still sore today, but it's much better) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder (Thyroid issues), Trigger finger and Cataract operation (Cataract implants). Concurrent medical conditions included Hair loss (Hair loss for a long time, even before the patient got the injection), Diabetic, Arthritis, Hypertension and Osteoarthritis (In my fingers).   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, the patient experienced MYALGIA (Horrible body aches), VACCINATION SITE PAIN (Tremendous arm pain in my left arm where I got the injection. I was in an enormous amount of pain in that arm/My arm is still sore today, but it's much better) and FATIGUE (Fatigue). On 22-Jun-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (My fingers were so stiff when I woke up.), ILLNESS (I was crazy sick) and PAIN (I had  throbbing pain, like needles, in my legs). At the time of the report, MUSCULOSKELETAL STIFFNESS (My fingers were so stiff when I woke up.), ILLNESS (I was crazy sick), PAIN (I had  throbbing pain, like needles, in my legs), MYALGIA (Horrible body aches), VACCINATION SITE PAIN (Tremendous arm pain in my left arm where I got the injection. I was in an enormous amount of pain in that arm/My arm is still sore today, but it's much better) and FATIGUE (Fatigue) had not resolved.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-594298 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue, Visual impairment
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient returned to pharmacy around 30 minutes after vaccination reporting narrowing of vision angle and possible swelling around the eyes.  Administered 50mg Benaryl orally and monitored patient for around 30 minutes.  Patient reported no further progression of symptoms while waiting and patient decided to return home.  Instructed patient to continue to monitor and followed up by phone encounter around 3 hours later.  Patient stated no further progression of syptoms at that time.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Vomiting
Clinical narrative: Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: doctor mentioned that patient got diarrhoea. and should not have got the boostrix vaccine
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: POTENTIALLY SUBPOTENT VACCINE
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: POTENTIAL SUBPOTENT DOSE
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: POTENTIAL SUBPOTENT VACCINE.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: POTENTIAL SUBPOTENT VACCINE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: POTENTIAL SUBPOTENT DOSE
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: POTENTIAL SUBPOTENT DOSE
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report has been received from a physician referring a patient of unknown age and gender. The patient's pertinent historical condition, concurrent condition, drug reactions/allergies or concomitant medication was not provided.   On 04-MAY-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) at dose 0.5 milliliter (ML), via subcutaneous (SQ), (lot number U022321, expiration date 15-JUL-2023) for prophylaxis (strength and frequency were not reported) that after temperature excursion 6 Fahrenheit (F) for 30 minutes (product storage error).There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID-19 vaccine (1st and 2nd dose received couple of years ago from the date of reporting), DTPA vaccine (received couple of years ago from the date of reporting) and Flu vaccine (received couple of years ago from the date of reporting).   On 21st August 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: This case was considered as invalid as unspecified adverse event was reported (It was no cake walk...I had a pretty rough 24 hours- refers unspecified adverse event as we can't assume feeling abnormal).   Follow-up information received on 20th June 2022. This follow-up was considered significant. Reporter's comment: The patient stated it was nothing as painful as the Shingles vaccine. The patient stated that he/she had 2 Covid vaccines, TDPA and the flu shot in the past couple of years from the date of reporting. The patient also stated that his/her mom and brother got it (Shingles vaccine) and it was horrible. Summary of Changes: This case became valid with the addition of the follow-up information. The case classification changed. The new event pain was added with its causality narrative details were updated.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: headache; light-headed; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced headache and light headedness. On an unknown date, the outcome of the headache and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the headache and light headedness to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comment: The patient reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced headache and felt light-headed a week after the vaccine. The patient asked was it possible to still have a headache and feel light-headed a week after the vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick as can be, like having them over again; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's comments: This case was reported by consumer via interactive digital media. The case was reported by the consumer for himself/herself. The patient stated that he/she got the last shot, and had a reaction being sick as could be, like having them over again.  The patient was very sensitive with all shots down for the count (5-6 days). The reporter stated it was worth not getting Shingles again.  The reporter hoped that more people would read this and learn from his/her experience. Additional supportive information: Follow-up would not possible, as no contact details were available
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden
Clinical narrative: Suffered for 2 months/Bedbound; This case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included disability.   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 bedridden. On an unknown date, the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the bedridden to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient had 1st vaccine few months prior to the reporting and suffered for 2 months. The patient was bedbound. The patient did not take 2nd shot under doctor's advice. The patient was disabled, and she believed that nature of her disability caused this. The patient husband had vaccine at same time, and he was fine. The patient stated that please check with your doctor before taking vaccine.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: left on the counter, temperature excursion; This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received Hepatitis B vaccine (batch number 97kt7, expiry date unknown) and (batch number f22ez, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's comments: The reporter stated that 4 boxes were left on the counter in their labor and delivery area. The pharmacy sent those up at 11 AM and they were brought back down to pharmacy at room temperature at 3 PM. The reporter stated that he/she had separated those boxes from the rest of the vaccines and put back in refrigeration and enquired of the next steps. 3 boxes had LOT number 97kt7 and 1 box had LOT number f22ez. The consent to follow up was granted. Additional Supportive Information: The reporter stated that the boxes were left at the counter and then later kept at room temperature, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made me really sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The patient self-reported this case. The patient received vaccine and it made her or him really sick. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 28-feb-20 didn´t get the 2nd yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th February 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: 23-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient was planning on getting the second today (on the day of reporting). The patient asked would it still be effective. 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 follow-up would not possible, as no contact, details were available.
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: pt was given an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva520a, expiry date 30th April 2022) for prophylaxis.   On 20th June 2022, the patient received Menveo (intramuscular) .5 ml. On 20th June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The pharmacist reported that a dose of Menveo was given to the patient in an unknown arm and it was already expired. The reporter did not report that the patient was experiencing any side effects.  This was one of two cases, reported by the same reporter. The reporter consented to follow up. Additional Supportive Information: The use of Menveo dose which was already expired on 30th April 2022, which led to expired vaccine used. This case has been linked to US2022095701, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095701:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, visual
Clinical narrative: hallucinogenic episodes; This case was reported by a consumer via call center representative and described the occurrence of visual hallucinations in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st May 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced visual hallucinations (serious criteria GSK medically significant). On an unknown date, the outcome of the visual hallucinations was not recovered/not resolved.   It was unknown if the reporter considered the visual hallucinations to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received the second dose of Shingrix and had been having hallucinogenic episodes in which patient saw people appearing in her house that should not be there. The patient had a doctor's appointment this afternoon (reporting day). The reporter did not wish to provide further information.  The reporter reported that she might call back with further information. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain-Barre syndrome, hospitalized as a result; 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 (Shingrix) for prophylaxis.   On 11th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization, GSK medically significant and life threatening). 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 Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The reporter was patient husband. The reporter stated that the patient received the first dose of the vaccine and then developed Guillain-Barre syndrome. The patient had been hospitalized as a result and had received two complete rounds of intravenous immunoglobulin infusions. The reporter give consent to follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Headache
Clinical narrative: HEADACHE WORSENED; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: Patient did not report any relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced headache worsened. Laboratory data (dates unspecified) included: Blood test not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The outcome of headache worsened was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: WENT THROUGH HELL FOR A WHILE AFTER VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced went through hell for a while after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of went through hell for a while after vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: TEMPERATURE EXCURSION OF RISING TO 9.9 DEGREES C FOR 30 MINUTES; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist 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 prophylactic vaccination. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced temperature excursion of rising to 9.9 degrees c for 30 minutes, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and temperature excursion of rising to 9.9 degrees c for 30 minutes was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. Patient was not pregnant a the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: unknown) dose was not reported, 1 total administered on 21-MAY-2021 to right arm for prophylactic vaccination. Patient had no any booster dose of any kind. Age at time of vaccination 29 years old. No concomitant medications were reported.  On 27-MAY-2022, the patient experienced fever. On 28-MAY-2022, fever was resolved. On 30-MAY-2022, she experienced headache, cough, congestion, diarrhea, nausea, fatigue and lack of hunger. Laboratory data included: COVID-19 antigen test positive. Thus patient had suspected covid-19 infection and suspected clinical vaccination failure. On 02-JUN-2022, events headache, congestion, diarrhea, nausea, fatigue and lack of hunger was resolved. Patient was recovering from cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000237266.; Sender's Comments: V0:20220647743-Covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; ADMINISTERED JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLE TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 11-JAN-2022, the patient experienced administered janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650014, 20220650111, 20220649137, 20220649421, 20220649488, 20220649803, 20220649884, 20220649915, 20220649417, 20220650185 and 20220649626. This report was associated with product quality complaint: 90000237042.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; PATIENT RECEIVED JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLE TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 04-JAN-2022, the patient experienced patient received janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000237039. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650014, 20220650111, 20220649045, 20220649488, 20220649417, 20220649421, 20220649626, 20220649803, 20220649884, 20220649915, 20220650185 and 20220650933.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE THAT WAS EXPOSED TO MULTIPLE TEMPERATURE EXCURSIONS; This spontaneous report received from a health care professional 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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 21-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 21-JAN-2022, the patient experienced administration of vaccine that was exposed to multiple temperature excursions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine that was exposed to multiple temperature excursions and incorrect product storage was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000237054. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650111, 20220650014, 20220649045, 20220649488, 20220649417, 20220649137, 20220649488, 20220649626, 20220649915, 20220649803, 20220650185 and 20220649884.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 11-JAN-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000237049. This case, from the same reporter is linked to 20220649045, 20220649137, 20220649370, 20220649417, 20220649488, 20220649626, 20220649803, 20220649804, 20220649884, 20220649915, 20220649704, 20220649421, 20220650185 and 20220650111.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 05-MAR-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649704, 20220649045, 20220649137, 20220649370, 20220649421, 20220649804, 20220650014, 20220649488, 20220649626, 20220649803, 20220649884, 20220649915, 20220650185 and 20220649417.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLE TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional 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 not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 21-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 21-JAN-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiple temperature of excursion and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220650014, 20220649804, 20220649370, 20220649704, 20220649045, 20220650111 and 20220649488.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site lymphadenopathy
Clinical narrative: swelling under my arm pit/reaction to the shot/I've had it for a couple months now; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swelling under my arm pit/reaction to the shot/I've had it for a couple months now) and HYPERSENSITIVITY (allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swelling under my arm pit/reaction to the shot/I've had it for a couple months now) and HYPERSENSITIVITY (allergic reaction). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swelling under my arm pit/reaction to the shot/I've had it for a couple months now) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            Concomitant medications was not provided by the reporter. The patient did not remember when he got his first dose. He wanted to know if there were situations where it took an extended period of time for that swelling to go down. Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient was given a Moderna booster dose on 16Jun2022 and his wife called on 22Jun2022, to inform that her husband should have received a full dose because he is immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given a Moderna booster dose on 16Jun2022 and his wife called on 22Jun2022, to inform that her husband should have received a full dose because he is immunocompromised) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 076C21A and 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Type 2 diabetes mellitus, Cardiovascular disease, unspecified, COPD, Hypertension and Psoriasis.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient was given a Moderna booster dose on 16Jun2022 and his wife called on 22Jun2022, to inform that her husband should have received a full dose because he is immunocompromised). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was given a Moderna booster dose on 16Jun2022 and his wife called on 22Jun2022, to inform that her husband should have received a full dose because he is immunocompromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Information on allergy was not known. The reporter did not whether patient ever had COVID positive test or diagnosis. It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No treatment was given.