chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date September 2022) for prophylaxis.   On 2nd November 2022, the patient received Havrix. On 2nd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 3-Nov-2022 The called had very limited information, as they were not at the office.  The caller was asked to call back in once at the office, to provide Lot for expired vaccine and patient demos. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose administered to a 19 y/o; Pediatric dose administered to a 19 y/o; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix 720) (batch number F7X23, expiry date 17th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th November 2022, the patient received Havrix 720 .5 ml and Havrix Pre-Filled Syringe Device. On 4th November 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The licensed practical nurse reported that they administered a pediatrix dose of Havrix to a 19 year old patient instead of the full adult dose. The LPN confirmed vaccine was administered in their facility. The reporter inquired how to proceed. The reporter did not consent to follow up. Additional Supportive Information: The adult patient received a pediatric dose of Havrix instead of full adult dose, which led to underdose and adult use of a child product.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 03Nov/2020, 2nd on Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number Y44ZT, expiry date 10th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd November 2020, batch number DN74H which corresponds to a Shingrix adjuvant).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comments: The reporter asked for information about a patient never got the second dose in the next 6 months.  The reporter did not provide the exact date of the dose administered in August 2022 The reporter asked if the first dose counted or patient had to receive an extra dose of shingrix.  The reporter was consented to follow up.  Additional Supportive Information: The patient received 2nd dose later than the recommended interval, which led to lengthening of the recommended interval between vaccine doses.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 Shingrix shots; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date, (4-6 months apart for each shot) ).   In October 2022, the patient received the 3rd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comments: The reporter stated that she was contacted by outpatient nurse regarding a patient who received 3 doses of Shingrix vaccine, few months apart each (4-6 months apart for each shot) with the last dose being administered sometimes in the last week.  THe reporter stated that she was no additional information related to this incident.  The reporter who declined consent for safety follow-up as she did not have additional information related to the incident.  The reporter could not provide the name of the outpatient nurse when asked.  Pharmacist could not provide product information including formulation, route/site of administration, lot numberor expiration date when asked. Pharmacist could not provide patient's initials, gender or DOB when asked The reporter did not consent to follow-up. Additional supportive information:  The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered doses that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The reporter was a clinic manager. The reporter reported that the patient received Havrix vaccine which was expired on 09th August 2022. The vaccine administration facility was the same as the primary reporter. The reporter consented to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used. This case was 1 of 6 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022162505:Same reporter US-GSK-US2022162503:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162508:Same reporter US-GSK-US2022162509:Same reporter
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered doses that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The reporter was a clinic manager. The reporter reported that the patient received Havrix vaccine which was expired on 09th August 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used. This case was 1 of 6 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022162501:Same reporter US-GSK-US2022162505:Same reporter US-GSK-US2022162509:Same reporter US-GSK-US2022162508:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162506:Same reporter
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The reporter was a clinic manager. The reporter reported that the patient received Havrix vaccine which was expired on 09th August 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used. This case was 1 of 6 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022162501:Same reporter US-GSK-US2022162503:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162508:Same reporter US-GSK-US2022162509:Same reporter
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gingivitis, Root canal infection
Clinical narrative: Infection on upper right gum/cheek, premolar root canal infection
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Injection was particularly painful and area was sore immediately following.  Soreness at the muscle grew steadily worse and now having difficulty raising the left arm overhead as it is too painful.  Shoulder/deltoid area is sore even when not in use.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 5-Year old patient was administered the Pfizer 5-11yr Bivalent Booster dose today 11/10/202 at the vaccination clinic, although patient has not yet completed the primary series.  Patient previously received Dose 1 and Dose 2 of the 3-dose Pfizer 6mth-4yr Monovalent Primary Series when she was 4 Years old.  Patient was scheduled for Pfizer 5-11yr Booster appointment today instead of the Pfizer 6mth-4yr Dose 3 appointment, which the patient's parent thought that they were coming in for. This was not caught and the Pfizer 5-11yr Bivalent booster was administered to the 5-Year old patient.   We have contacted the vaccine manufacturer (Pfizer Medical Information) on 11/10/2022, whose recommendation in this situation was "do not repeat dose" if a Pfizer Bivalent booster vaccine was administered in place of the primary series. They also directed us to see the vaccination error guidelines from CDC.  We also called patient's parents and informed them of the vaccine administration error that occurred on 11/10/2022, and of the recommendations we received from the vaccine manufacturer (Pfizer) and CDC guidelines. We also informed them that we will loop in patient's PCP, and the vaccine clinic's management will be following up with patient/parent
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Cardiac stress test, Echocardiogram, Electrocardiogram, Exercise tolerance decreased
Clinical narrative: Several days-weeks after receiving the covid vaccine, I noticed my heart rate dropping when I was attempting to workout
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Laboratory test, Magnetic resonance imaging heart
Clinical narrative: Several days-weeks after receiving the covid vaccine, I noticed my heart rate dropping when I was attempting to workout
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000257354. The suspected product quality complaint has been confirmed to be there was no product quality issue described in the information reported as there was no timeline for date of vaccination to contracting covid, no confirmatory test reported and no indication of symptoms experienced. based on the PQC evaluation/investigation performed.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Illness, Off label use
Clinical narrative: SICK; MIND HAS GONE DOWN THE TUBE; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer (wife) via a company representative through social media concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 07-NOV-2022. The patient's weight, height, and medical history were not reported. The patient received 2 doses of series 1 covid-19 vaccine ad26.cov2 s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was an off label dosing frequency. 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 got sick, and was hospitalized. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. Also reported that the patient's mind has gone down the tube. It was reported as "How bad were you sued from your poisonous Vax for covid. And how much do you have to pay out. My husband got sick from taking your Vax. And he has not been the same again. He ended up in the hospital twice with both of your jabs. He has not taken the boosters and has yet gotten sick, but his mind has gone down the tube. He is not the same man I married 30+ years ago." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, mind has gone down the tube, and off label dosing frequency was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be not voided and this customer preference case has been assessed and does not represent a product quality complaint. The disposition and root cause determination were documented properly based on the PQC evaluation/investigation performed.; Sender's Comments: V0: sick. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SKIN BREAKOUT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced skin breakout. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin breakout was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.).    No concomitant medication information was provided.  Patient received booster dose. It was reported that no adverse effects were noted.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2022: Follow up received contains non-significant information: Updated QE ID number. On 09-Nov-2022: Follow up received wherein patient's DOB and suspect drug dosage information updated.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: No adverse event; Patient became pregnant after receiving the first dose of the Moderna Covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a patient family member or friend and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Patient became pregnant after receiving the first dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Aug-2022, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Patient became pregnant after receiving the first dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 21-Aug-2022, MATERNAL EXPOSURE BEFORE PREGNANCY (Patient became pregnant after receiving the first dose of the Moderna Covid-19 vaccine) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   Concomitant and treatment medications were not reported.  Patient received her second Moderna Covid-19 vaccine today (at the time of reporting) and was told that she had to start the series all over again and that today was her first dose.  Company Comment: This spontaneous case concerns a 32-year-old female patient with no medical history reported, who experienced No adverse event after receiving the first dose of mRNA-1273 vaccine. Maternal exposure before pregnancy was reported in this case as patient became pregnant after receiving the first dose of the mRNA-1273 vaccine. Last menstrual period and estimated date of delivery were not provided. No details of clinical course, lab reports or treatment received was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-669156 (Patient Link).; Sender's Comments: This spontaneous case concerns a 32-year-old female patient with no medical history reported, who experienced No adverse event after receiving the first dose of mRNA-1273 vaccine. Maternal exposure before pregnancy was reported in this case as patient became pregnant after receiving the first dose of the mRNA-1273 vaccine. Last menstrual period and estimated date of delivery were not provided. No details of clinical course, lab reports or treatment received was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rheumatoid arthritis
Clinical narrative: Moderate to Severe Rheumatoid Arthritis; Throat pain; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (Moderate to Severe Rheumatoid Arthritis) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Moderate to Severe Rheumatoid Arthritis) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Throat pain). At the time of the report, RHEUMATOID ARTHRITIS (Moderate to Severe Rheumatoid Arthritis) and OROPHARYNGEAL PAIN (Throat pain) had not resolved.            No concomitant product reported by the reporter.  It was unknown if patient was enrolled in COVID-19 vaccine trials. Patient had throat pain due to her rheumatoid arthritis. Patient thought her monthly period hormones might be the cause. Reported that she wondered if the covid vaccine caused her rheumatoid arthritis. The reporter's causality for event of throat pain with Upadacitinib (Rinvoq) was not provided.  Company comment: This spontaneous case reported by a patient concerns a 30-year-old female patient, with no medical history reported, who experienced serious (medically significant) unexpected AESI of Rheumatoid arthritis. Patient also received 3 doses of mRNA-1273 vaccine. Latency could not be assessed as the date of administration of vaccine and date of onset of event are not reported. Patient received Upadacitinib for the treatment of rheumatoid arthritis. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient concerns a 30-year-old female patient, with no medical history reported, who experienced serious (medically significant) unexpected AESI of Rheumatoid arthritis. Patient also received 3 doses of mRNA-1273 vaccine. Latency could not be assessed as the date of administration of vaccine and date of onset of event are not reported. Patient received Upadacitinib for the treatment of rheumatoid arthritis. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient experienced a bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient experienced a bad reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient experienced a bad reaction). At the time of the report, IMMUNISATION REACTION (Patient experienced a bad reaction) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient experienced adverse reaction with booster dose. It was reported the patient experienced a bad reaction and that patient would not be getting another dose.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: Got autoimmune things/ Extremely sick; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Got autoimmune things/ Extremely sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 14-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Got autoimmune things/ Extremely sick) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (Got autoimmune things/ Extremely sick) outcome was unknown.            No concomitant product was reported. On 14-Nov-2021, the patient received a booster dose of Moderna COVID-19 Vaccine. No treatment information was reported.  Company Comment : This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced autoimmune disorder (was extremely sick and got autoimmune things) unspecified days after receiving a dose (reported as Booster) of mRNA-1273. The details of previous doses was not provided. There was no information provided about the patient's underlying medical conditions, concomitant medications, details of the autoimmune disorder, associated symptoms, final diagnosis, diagnostic and treatment details. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced autoimmune disorder (was extremely sick and got autoimmune things) unspecified days after receiving a dose (reported as Booster) of mRNA-1273. The details of previous doses was not provided. There was no information provided about the patient's underlying medical conditions, concomitant medications, details of the autoimmune disorder, associated symptoms, final diagnosis, diagnostic and treatment details. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: Patient experienced double vision for 3 months; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Patient experienced double vision for 3 months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLOPIA (Patient experienced double vision for 3 months). At the time of the report, DIPLOPIA (Patient experienced double vision for 3 months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Sex: M
Vaccine: COVID19
Symptoms: Chronic lymphocytic leukaemia stage 0
Clinical narrative: CLL (chronic lymphocytic leukemia) and it is at a state zero now.; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0 (CLL (chronic lymphocytic leukemia) and it is at a state zero now.) 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.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0 (CLL (chronic lymphocytic leukemia) and it is at a state zero now.) (seriousness criterion medically significant). At the time of the report, CHRONIC LYMPHOCYTIC LEUKAEMIA STAGE 0 (CLL (chronic lymphocytic leukemia) and it is at a state zero now.) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.  Company comment: This is a spontaneous case concerning a male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Chronic lymphocytic leukemia stage 0. The event occurred unknown days after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received.  At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Chronic lymphocytic leukemia stage 0. The event occurred unknown days after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received.  At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: Did not feel well; Achy; Frequent bowel movements; Unable to keep food down; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), PAIN (Achy), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), VOMITING (Unable to keep food down) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 03-Dec-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Did not feel well), PAIN (Achy), FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), VOMITING (Unable to keep food down) and PYREXIA (Fever). At the time of the report, MALAISE (Did not feel well) and FREQUENT BOWEL MOVEMENTS (Frequent bowel movements) outcome was unknown and PAIN (Achy), VOMITING (Unable to keep food down) and PYREXIA (Fever) had resolved.            It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No concomitant product reported by reporter.  The reporter's causality for the events of Did not feel well and Frequent bowel movements with Adalimumab Solution for Injection was not provided and for events of Achy, Fever and Unable to keep food down was no reasonable possibility.  No treatment medication reported by reporter.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: vaccine that underwent temperature excursions could have been administered to patient; No Adverse Event; vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022 at 11:54 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Sep-2022 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine that underwent temperature excursions could have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient).    Patient received vaccine in deltoid.  No concomitant product reported by the reporter.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No treatment medication reported by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    Concomitant medication not reported. Dose 1, dose 2, dose 3 were administered on unknown date by route intramuscular and on deltoid. Dose 4 administered by 3:16 PM with dose 0.5. Treatment medication not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022 at 2:41 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 2:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the local authority was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jul-2022 at 3:03 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jul-2022 at 3:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received later 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 1 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 5:29 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 5:29 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  Patient received the vaccine in deltoid muscle.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions reported for the patient.  No treatment medications were reported.