chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number MR75G, expiry date 13th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th December 2021) and Shingrix (received 2nd dose on 4th March 2022).   On 28th May 2022, the patient received the 3rd dose of Shingrix. On 28th May 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: 31-MAY-2022 Reporter's comment: The pharmacist reported patient received 3 doses of Shingrix.  The reporter consented to follow up. Additional Supportive Information: The patient received 3 doses of Shingrix which led to extra dose administered.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of Infanrix that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: The nurse reported that the patient received a dose of Infanrix that had expired. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received Infanrix which was already expired, which led to expired vaccine used.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The injected arm was red/The redness slowly faded away but it took a week to fully resolve; Swollen arm down to her elbow/The swelling slowly faded away but it took a week to fully resolve; Arm pain went down to her wrist/The pain lasted about 30 hours; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine (received Covid 19 vaccines on an unknown date), Covid 19 vaccine (received last booster dose in October 2021) and Zostavax (received in 2013). Concurrent medical conditions included asthma. Concomitant products included budesonide + formoterol fumarate (Symbicort).   On 9th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than 3 weeks after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were recovered/resolved.   The reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into left arm and experienced significant reaction to Shingrix. The injected arm was red and swollen down to her elbow and pain went down to her wrist.  The pain lasted about 30 hours. The swelling and redness slowly faded away but it took a week to fully resolve.  At the time of the report the patient said she was fine and all symptoms had resolved.  She did not know for sure if the injection was intramuscular. The patient had not (yet) reported this to her doctor. The patient did not have the lot number or expiration date of the shot because the pharmacy did not provide her with any paperwork. She had provided the pharmacy's contact information as they should have the route and lot and expiray date on file. The reporter consented to follow-up.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient received a dose that had already expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-week-old male patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment The registered nurse reported that the patient received a dose of Infanrix that had already expired. The reporter did not consent to follow-up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received Infanrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: Nurse reported that a patient received an expired dose of Havrix The reported consented to follow up. Additional Supportive Information: The patient received havrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: HEP, HEPA, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Administration of vaccines after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device and Shingrix. On an unknown date, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device and Shingrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: The vaccine coordinator reported a below temperature excursion for Havrix, Engerix B, Shingrix, Boostrix at 30.21 degree F for 30 hours. The health care professional stated this excursion occurred on December 2021 and there might have been some patients that received those vaccines. The HCP was not able to provide any details from patients and or vaccination details. The reporter consented to follow up. Additional Supportive Information: The patients received vaccine after temperature excursion which led to incorrect storage of drug.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 27th May 2022, the patient received Havrix. On 27th May 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: 31-MAY-2022 Reporter's comment: A medical assistant reported that a patient received an expired dose of Havrix. No symptoms reported. The reporter consented to follow up via email. Additional Supportive Information: The patient received havrix which was already expired, which led to expired vaccine used.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: Pain at injection site; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were unknown.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comment: The patient's wife reported this case. The patient received dose of Shingrix vaccine into left arm and experienced pain at injection site and fatigue. The reporter did not consent to follow-up. This is one of 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022086533:Same Reporter
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood test, Blood test abnormal, Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: BLOOD TEST ABNORMAL; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; PAIN; This spontaneous report received from a consumer via other manufacturer (Abbvie and Moderna) concerned a 54 year old male of unspecified race and ethnicity. Initial information processed along with the information received on 27-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis, and other pre-existing medical conditions included: There was no reported medical history. The patient was previously vaccinated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received additional 2 dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported, expiry: UNKNOWN) dose, start therapy date were not reported for second dose, and dose was not reported for third dose (booster dose) 1 total administered on 12-JAN-2022 for prophylactic vaccination which was off label use as an inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in 2022, the patient experienced pain. On an unspecified date, blood test abnormal. Laboratory data (dates unspecified) included: Blood test (NR: not provided) High (dose number in series 2).  Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported expiry: UNKNOWN) dose and frequency were not reported from 24-MAR-2021 for ankylosing spondylitis.  The patient received additional dose of non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (dose number in series 3) (form of admin unknown, intramuscular, batch number was not reported, expiry: UNKNOWN) dose, start therapy date were not reported one in once was administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 vaccine (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with elasomeran was not reported; and dose of adalimumab was not changed. The patient was recovering from pain, and the outcome of blood test abnormal, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19, 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 40 years old male of an unknown ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 014A21A, expiry: Unknown) dose was not reported, 01 total administered on 06-APR-2021 to left arm for prophylactic vaccination.  The patient was 40 years old at the time of his primary vaccine. No concomitant medications were reported. On 06-JAN-2022, the patient additional received Non-company suspect vaccine included: Spikevax (Elasomeran) (Dose number in series 2) (Form of admin and route of admin were not reported, batch number: 028K21A and expiry: Unknown) dose was not reported, administered to left arm for prophylactic vaccination. The patient was 41 years old at the time of his booster vaccine. On 26-MAY-2022, the patient had congestion and slight sore throat (suspected covid-19 infection) (dose number in series 2). The patient thought he had a cold later he developed a cough, body aches, back pain and his limbs feeling tired and achy (dose number in series 2). On 28-MAY-2022, Patient tested positive for Covid-19 Binax test (suspected clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s and with Spikevax (Elasomeran) was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report associated with product quality complaint: 90000233816.; Sender's Comments: V0-20220562528-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 is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Aneurysm, Death
Clinical narrative: DEATH; ANEURYSM; This spontaneous report received from a consumer concerned a 33 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the reporter stated that the patient got the Johnson and Johnson vaccine. Then he got the booster and got aneurysm (dose number in series 2). The reporter also mentioned that the patient passed away at the age of 33 (dose number in series 2). On an unspecified date, the patient died from unknown cause of death. It was unknown if the autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death was fatal, and the outcome of aneurysm was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220600785.; Sender's Comments: V0: 20220600703-covid-19 vaccine ad26.cov2.s- Death, Aneurysm. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS BREAK OUT; HAIR FALLING OUT; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total (first dose), administered on 01-MAR-2021 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 (suspension for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from 22-DEC-2021 for moderate to severe rheumatoid arthritis, and moderate to severe chronic plaque. Age at time of vaccination 56 years old. No concomitant medications were reported.  On 27-APR-2022, the patient experienced hair falling out. On an unspecified date, the patient experienced rheumatoid arthritis break out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from hair falling out, and the outcome of rheumatoid arthritis break out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:  20220601424-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis break out. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Age: 59.0
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 59 year old female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 1808980, expiry: 15-FEB-2022) dose was not reported, 1 total, administered on right arm on 07-APR-2021 for prophylactic vaccination. Age at time of vaccination 59 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered to right arm 09-NOV-2021 for prophylactic vaccination. Age at time of vaccination 59 years old. No concomitant medications were reported.  On 31-MAY-2022, the patient experienced cough and felt chilly (suspected covid-19 infection and suspected clinical vaccination failure) (Dose number in series 2). On 01-JUN-2022, the patient experienced bad headache and fever (Dose number in series 2). On same day, the patient tested positive with home covid test which led to suspected clinical vaccination failure (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered 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; 90000233758.; Sender's Comments: V0: 20220601985- 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: Adverse event
Clinical narrative: 3 DIFFICULT DAYS; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age and sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received first and second dose of Sinovac (covid-19 vaccine inact (vero) cz02) (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported administered for prophylactic vaccination.  It was reported that the patient was perfect and had no consequences, and mentioned work and sport at 100 percent following vaccination with first and second dose of Sinovac (covid-19 vaccine inact (vero) cz02) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (third dose) (dose number in series 2) (suspension for injection, route of admin, batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered  for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified adverse event and it was stated that the patient still remember 3 difficult days (coded as adverse event nos) after the covid-19 vaccine ad26.cov2.s (third dose) (dose number in series 2) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received fourth dose of Novavax (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported administered for prophylactic vaccination and mention the patient was perfect. It was stated that, " 24 hours after the (4th ag. COVID19) vaccination with Novavax : how is my Mother, how am I, We are perfect: absolutely no consequences, Work and sport at 100 percent it is like after the 1st and 2nd with Sinovac". The outcome of 3 difficult days (coded as adverse event nos) was not reported. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old, female patient who was administered with the Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old, female patient who was administered with the Moderna Covid-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had a liver transplantation before first dose of vaccine.  Concurrent medical conditions included Immunocompromised.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old, female patient who was administered with the Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old, female patient who was administered with the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-569133, MOD-2022-569131, MOD-2022-569129 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 2:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 2:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter.  On 11-Jan-2021, Excursion time was 2 PM, temp was 35 ,condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 09 vial was moved to clinic. Vaccine BUD date was 07-Feb-2021.  Vial was stored on cooler 1 , on 11-Jan-2021, Excursion duration At 9 AM: 34, 10 AM: 37, 11 AM:37, 12 AM:35, 1PM : 36, 2 PM : 37, 3 PM: 37.  Vials only punctured right before administration  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment details was not reported by the reporter   This case was linked to MOD-2022-566976 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (rebound case, tested positive 5/25/22 after testing negative on 5/20/22) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Allergy. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 23-May-2022, the patient experienced COVID-19 (rebound case, tested positive 5/25/22 after testing negative on 5/20/22). At the time of the report, COVID-19 (rebound case, tested positive 5/25/22 after testing negative on 5/20/22) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 25-May-2022, SARS-CoV-2 test:   positive (Positive) Positive. Patient had allergic reaction to unspecified drug. Concomitant medication was not reported. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date : 25-May-2022. Company comment: This spontaneous case reported by a patient, concerns a 54-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (rebound case, tested positive 5/25/22 after testing negative on 5/20/22), about 6 months after receiving the 3 dose of mRNA-1273 vaccine in the Covid-19 vaccination series. It was reported that the patient received Nirmatrelvir, Ritonavir (Paxlovid) for 5 days from 14-May-2022, till 18 May 2022 for Covid-19 treatment. SARS-CoV-2 test was negative on 20 May 2022. She tested positive on 25 May 2022, 06 days after stopping Paxlovid. No details on concomitant and treatment medications was provided. The event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement. Sender's Comments: This spontaneous case reported by a patient, concerns a 54-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 (rebound case, tested positive 5/25/22 after testing negative on 5/20/22), about 6 months after receiving  the 3 dose of mRNA-1273 vaccine in the Covid-19 vaccination series. It was reported that the patient received Nirmatrelvir, Ritonavir (Paxlovid) for 5 days from 14-May-2022, till 18 May 2022 for Covid-19 treatment. SARS-CoV-2 test was negative on 20 May 2022. She tested positive on 25 May 2022, 06 days after stopping Paxlovid. No details on concomitant and treatment medications was provided. The event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood glucose normal, Blood test, Capillary nail refill test, Chest discomfort
Clinical narrative: Patient came into the Clinic for a Covid-19 vaccine (moderna). Patient received first dose and had a lightheaded episode. Patient did say he is very anxious because he gets nervous around medical staff. Patient was transferred to high monitoring area and kept there for 1 - 2 hours. Vital signs on 03/19/21 at 10:25 ? BP - 120/79, pulse ? 68, O2 ? 98%, RR ? 20, capillary refill - <2 secs. Patient was given ammonia inhaler to regain awareness. Glucose level ? 5.6 mmol/L. Repeat vitals ? BP ? 106/68, pulse 86, o2 ? 98%, RR ? 18. Patient was given 100 ml water. Over the course of 1 hour patient regained all normal ability
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram, Electrocardiogram normal, Myocarditis
Clinical narrative: Patient came into the Clinic for a Covid-19 vaccine (moderna). Patient received first dose and had a lightheaded episode. Patient did say he is very anxious because he gets nervous around medical staff. Patient was transferred to high monitoring area and kept there for 1 - 2 hours. Vital signs on 03/19/21 at 10:25 ? BP - 120/79, pulse ? 68, O2 ? 98%, RR ? 20, capillary refill - <2 secs. Patient was given ammonia inhaler to regain awareness. Glucose level ? 5.6 mmol/L. Repeat vitals ? BP ? 106/68, pulse 86, o2 ? 98%, RR ? 18. Patient was given 100 ml water. Over the course of 1 hour patient regained all normal ability
Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID after treatment) in a 57-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy.   On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Tested positive for COVID after treatment). At the time of the report, COVID-19 (Tested positive for COVID after treatment) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient's race was given. Concomitant medication list was not provided. No treatment was received. Company comment: This spontaneous case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The exact date of administration of an unknown dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. On May 14, 2022, patient was started on treatment regimen of Paxlovid however on, May 25, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious  of COVID-19. The exact date of administration of an unknown dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. On May 14, 2022, patient was started on treatment regimen of Paxlovid however on, May 25, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound COViD 19 infection after Paxlovid treatment; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Rebound COViD 19 infection after Paxlovid treatment) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     The patient's past medical history included Unspecified inflammatory polyarthropathy. Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: EN6198) on 25-Feb-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: ER8730 Location of injection: Arm Left) on 25-Mar-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: 30155BA Location of injection: Arm Left) on 07-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy (Name of drug not reported). Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 19-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound COViD 19 infection after Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COViD 19 infection after Paxlovid treatment) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Rebound COViD 19 infection after Paxlovid treatment. Device Date : 29-May-2022. Company comment: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 39 days after administration of fourth dose of mRNA-1273, there was no information provided regarding the initial three doses. Patient underwent treatment regimen of Paxlovid on May 17-21, 2022. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 39 days after administration of fourth dose of mRNA-1273, there was no information provided regarding the initial three doses. Patient underwent treatment regimen of Paxlovid on May 17-21, 2022. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: the patient had a resurgence of Covid symptoms on day 10 - mainly congestion; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (the patient had a resurgence of Covid symptoms on day 10 - mainly congestion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had previously received a COVID-19 vaccine.     On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (the patient had a resurgence of Covid symptoms on day 10 - mainly congestion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (the patient had a resurgence of Covid symptoms on day 10 - mainly congestion) was resolving.            No concomitant medications were reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that the device date was 29-May-2022.  Company Comment: This spontaneous case concerns a 44-year-old, female patient with no medical history reported who experienced the unexpected, non-serious, adverse event of special interest of COVID-19 which occurred on unknown interval after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however it was reported that COVID-19 symptoms recurred 10 days after the onset of event. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old, female patient with no medical history reported who experienced the unexpected, non-serious, adverse event of special interest of COVID-19 which occurred on unknown interval after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however it was reported that COVID-19 symptoms recurred 10 days after the onset of event. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19 prior to Pfizer (Z-PAK) treatment) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. Concurrent medical conditions included Sjogren's disease and Allergy. On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 prior to Pfizer (Z-PAK) treatment). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19 prior to Pfizer (Z-PAK) treatment) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 antibody test: positive (Positive) Positive. No concomitant medication was reported. Co-suspect product included Pfizer started from 7-May-2022 to 12-May-2022 for COVID-19 treatment. Patient had not taken any medications within 2 weeks of starting COVID-19 treatment. Treatment product included steroid inhaler. Device date was reported as 27-May-2022. Company Comment: This spontaneous case concerns a 67-year-old female with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Pfizer (Z-PAK)  from 7th May to 12th May 2022 and with steroid inhaler for Covid-19. 6 days after stopping treatment she had a resurgence of COVID symptoms and tested positive with rapid test. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 67-year-old female with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Pfizer (Z-PAK)  from 7th May to 12th May 2022 and with steroid inhaler for Covid-19. 6 days after stopping treatment she had a resurgence of COVID symptoms and tested positive with rapid test. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077c21b and 027B21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug).   On 21-Apr-2021 at 7:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021 at 7:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 23-May-2022, COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive Positive. On 23-May-2022, SARS-CoV-2 test: negative Negative. On 28-May-2022, SARS-CoV-2 test: positive Positive.         The patient did not taking any other medications, products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Company comment: This spontaneous case concerns a 65-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (tested positive for COVID-19) which occurred 5 months 25 days after the third dose of mRNA-1273 vaccine .However, it was stated that the patient took Nirmatrelvir + Ritonavir (Paxlovid) as SARS-CoV-2 test was positive on 17-May-2022,which was negative after 5 days and again positive as on 28-May-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 65-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (tested positive for COVID-19) which occurred 5 months 25 days after the third dose of mRNA-1273 vaccine .However, it was stated that the patient took Nirmatrelvir + Ritonavir (Paxlovid) as SARS-CoV-2 test was positive on 17-May-2022,which was negative after 5 days and again positive as on 28-May-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.