chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, MENB, RV1
Symptoms: Product storage error
Clinical narrative: lack of vaccine temperature monitoring; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Engerix B, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Engerix B, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 10-NOV-2022 Reporter's comment: This case was reported by nurse. The nurse with state department of health reports there is a clinic site that had a lack of vaccine temperature monitoring data for several months.  There was no temperature data for 22 Jun 2021 to 03cFeb 2022, as well as 03 May 2022 to 19 Aug 2022.  There are partial manual logs for August 2022.  The affected vaccines are Pediarix, Kinrix, Engerix-B, Rotarix, Infanrix, and Bexsero. The nurse stated that there were vaccines administered during this timeframe, but does not know the number of vaccines administered, the dates administered, or any patient information.  The Reporter dose not have the vaccine lot numbers, expiration dates at the time of call. At the time of reporting, the vaccines have not been repeated for any of the affected patients.  The reporter consented to follow up. Additional supportive information: As vaccines were affected due to lack vaccine temperature monitoring which led to incorrect storage of drug.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Herpes zoster, Pain, Pain in extremity, Rash papular
Clinical narrative: Shingles outbreak on chin; Bumps under skin, look like acne; Look like acne; Acne which hurts; Arm pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 27th October 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, pain in arm, papular rash, acne and pain. On an unknown date, the outcome of the shingles, papular rash, acne and pain were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, papular rash, acne and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter was a patient. After receiving her dose of Shingrix, she thought that she was having another outbreak of shingles on her chin. She stated that there were bumps under her skin that look like acne which hurts. She had contacted her primary care physician regarding this and awaiting her phone call to see if it was Shingles. She also had arm pain after the first dose which lasted for two days. The reporter did not consent to follow-up.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; Boostrix administered to 15 months old; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 14-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 237ZH, expiry date unknown) for prophylaxis.   On 11th October 2022, the patient received Boostrix. On 11th October 2022, unknown after receiving Boostrix, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 10-Nov-2022 Reporter's comment:  The call was from licensed practical nurse. The nurse reported that the 15-month old patient was administered with Boostrix.  The reporter consented to follow up. Additional Supportive Information: The 15 month old patient was administered with Boostrix which led to underdose and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Insomnia
Clinical narrative: Anxiety (systemic effects); Sleeplessness (systemic effects); This case was reported by a pharmacist via call center representative and described the occurrence of anxiety in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included medication unknown (Epidural).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anxiety and sleeplessness. On an unknown date, the outcome of the anxiety and sleeplessness were unknown.   It was unknown if the reporter considered the anxiety and sleeplessness to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: She had a patient who had epidurals in their neck and was experiencing symptoms of anxiety, sleeplessness, etc.  She was certain patient was having systemic effects.  She was wondering if this was a good time for patient to receive 2nd dose of Shingrix.  The reporter attempted to callback RPh (registered pharmacist) 3 times at the time of reporting but unable to reach RPh (registered pharmacist). The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Platelet count decreased
Clinical narrative: Redness at the injection site; Pain at the injection site; Rash at the injection site; Difficulty raising arm; Platelet count dropped to 116; Systolic pressure over 200; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number DP2X9, expiry date unknown) for prophylaxis.   Concurrent medical conditions included immune thrombocytopenia and platelet count abnormal. Concomitant products included rituximab (Rituxan).   On 14th October 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a month after receiving Shingrix, the patient experienced platelet count decreased and blood pressure systolic increased. On an unknown date, the patient experienced injection site erythema, injection site pain, injection site rash and mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site rash were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the platelet count decreased and blood pressure systolic increased were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site rash and mobility decreased to be related to Shingrix. The reporter considered the platelet count decreased and blood pressure systolic increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter was was the patient.  The reporter reported receiving Shingrix, in the left arm.  The reporter reported that, having Immune Thrombocytopenia, which affected their platelet count.  The reporter reported having a platelet treatment with Rituxan on 13th September 2022 and being told the effects of the Rituxan lasts approximately 6 months and they should be ok to proceed with Shingrix dose by hematologist's assistant, despite hematologist advising patient not to receive vaccinations.  The reporter reported that, the platelet count was 241 after last treatment with Rituxan.  The reporter reported that, having platelet count checked last week and being advised their platelet count had dropped to 116, which was unusual for them so soon after Rituxan treatment.  The reporter reported that, systolic pressure was over 200, which was associated with the drop in platelet count.  The reporter reported that, belief drop in platelet count was due to receipt of Shingrix dose, as it had been over 2 and a half years since they experienced such a drop in their platelet count.  Th reporter also reported experiencing pain, redness, and a rash at the injection site.  The reporter reported experiencing difficulty raising their arm, due to the pain from the injection.  The reporter reported platelet count and blood pressure had yet to return to normal.  The reporter reported pain, redness, and rash at injection site had resolved. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Administration of an incomplete dose of Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) for prophylaxis.   On 10th November 2022, the patient received Fluarix Tetra 2022-2023 season. On 10th November 2022, unknown after receiving Fluarix Tetra 2022-2023 season, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter called to ask for information about the administration of an incomplete dose of Fluarix to a patient.  The reporter asked if the patient had to be re-vaccinated.  The reporter did not provide patient identifiers and data about the vaccine administered.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered with incomplete dose of Fluarix tetra, which led to incomplete dose administered.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: BREATHING COMPLICATIONS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included: Patient was perfectly healthy with no issues at all and worked out regularly. 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, 1 total administered 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 breathing complications, and was hospitalized (date unspecified). Patient was on medication for life. Number of days of hospitalization was not reported.  It was reported by consumer that, "My friend is now in an out of the hospital due to breathing complications and on medication for life just days after receiving the J and J vaccine. He is monitored regularly by a doctor. Sad because prior to the vaccine he was perfectly healthy with no issues at all and worked out regularly. Can barely do that now." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breathing complications. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20221135402-Breathing complications. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: LOST/PASSED AWAY; This spontaneous report received from a consumer via a company representative via social media concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition. 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, 1 total administered 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 lost/passed away from unknown cause of death. It was unspecified if an autopsy was performed. It was reported by consumer that, "I lost my 23 old granddaughter after getting the Johnson and Johnson vaccine. She had an existing heart condition. She passed away 3 months after getting the shot. Needs lots more testing and the real truth about the risk of the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221135528-lost/passed away. The event 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. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: BLOOD CLOT IN BRAIN; This spontaneous report received from a consumer via a social media and by a company representative concerned a female of unspecified age, race and ethnicity. 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, expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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 following vaccination with covid-19 vaccine ad26.cov2.s, the patient ended up dying (Death) for a blood clot in brain. It was unknown if an autopsy was performed. It was reported that "My sister got the J&J vaccine ended up dying for a blood clot in brain". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221135799.; Sender's Comments: V0: 20221135762-blood clot in brain. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT IN BRAIN
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: IMMEDIATE FLARE OF UNDERLYING AUTOIMMUNE DISEASE; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included: Underlying autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 immediate flare of underlying autoimmune disease, and was bedridden.  It was reported by patient as "I chose to receive the first J and J injection after much research and consideration. I had an immediate flare of my underlying autoimmune disease and was bedridden, on oral steroids for 3 weeks. I chose to not have further injections". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the immediate flare of underlying autoimmune disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221136694- immediate flare of underlying autoimmune disease. The event 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. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: HEART FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned an 18 year old male of an unspecified race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered 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 heart failure. It was reported as "my supervisor's daughter had her 18 year old best friend die of heart failure after his vaccine" On an unspecified date, the patient died from heart failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221137274.; Sender's Comments: V0: 20221137297- Heart failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: HEART FAILURE
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: EVERY SYMPTOM OF MYOCARDITIS; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. 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 and expiry date were not reported) dose, start therapy date were not reported, 1 total administered 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 every symptom of myocarditis. As per reporter, "Johnson and Johnson my coworkers wife has virtually every symptom of myocarditis after her vaccine, and both her doctor, and cardiologist refuse to even entertain the thought that it could be vaccine related. They will most likely lose their jobs if they do. Big pharma has far too much power over our medical industry, our media, and our politicians" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of every symptom of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221138832- possible myocarditis. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: MINOR SORE SHOULDER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2022 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 minor sore shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minor sore shoulder was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Osteomyelitis, Paralysis
Clinical narrative: Patient was paralysed by moderna; Osteomyelitis/ open wounds all the wayto the bone; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PARALYSIS (Patient was paralysed by moderna) and OSTEOMYELITIS (Osteomyelitis/ open wounds all the wayto the bone) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (Patient was paralysed by moderna) (seriousness criterion medically significant) and OSTEOMYELITIS (Osteomyelitis/ open wounds all the wayto the bone) (seriousness criterion medically significant). At the time of the report, PARALYSIS (Patient was paralysed by moderna) and OSTEOMYELITIS (Osteomyelitis/ open wounds all the wayto the bone) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Company Comment This spontaneous case concerns an unknown-years-old male patient, with  no medical history reported who experienced the unexpected seriousness criterion medically significant events of  paralysis and osteomyelitis unknown days after  a  dose of  mRNA-1273 bivalent vaccine.  The benefit-risk relationship of mrna-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Follow up received no new information.; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old male patient, with  no medical history reported who experienced the unexpected seriousness criterion medically significant events of  paralysis and osteomyelitis unknown days after  a  dose of  mRNA-1273 bivalent vaccine.  The benefit-risk relationship of mrna-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked); Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked); Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked); This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)), UNDERDOSE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) and NO ADVERSE EVENT (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, 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. In October 2022, the patient experienced DEVICE CONNECTION ISSUE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) and UNDERDOSE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)). On an unknown date, the patient experienced NO ADVERSE EVENT (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)). At the time of the report, DEVICE CONNECTION ISSUE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)), UNDERDOSE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) and NO ADVERSE EVENT (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) and UNDERDOSE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)).    It was reported that patient mentioned that 4 weeks ago she received the Moderna bivalent booster but the needle leaked while administering the vaccine unknown what volume leaked.  It was unknown if patient experienced any AE after the vaccine. It was unknown if any treatment was given for any symptom or if patient was under any concomitant or regular medication.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022; No adverse event; given bivalent dose which was beyond the 30 use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown. Acute illnesses at the time of vaccination and up to one month before was unknown.  Concurrent medical conditions included Drug allergy.    On 26-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (given bivalent dose which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Sep2022 and administered on 26Oct2022).    Concomitant medications were not reported.  Patient received dose 1 on 30Jun2022 and dose 2 on 12Aug2022. The vial was initially stored in refrigerator on 22Sep2022 12pm. The vial size was 2.5 ml and vial did not undergo any temperature excursion. They inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 days use by date today on 260ct2022. There was no other potential causes and unknown whether any similar experience happened in the past. No treatment medications were required.   This case was linked to US-MODERNATX, INC.-MOD-2022-673503, US-MODERNATX, INC.-MOD-2022-664543 (Linked Report). This case was linked to MOD-2022-673509 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673503:Same reporter US-MODERNATX, INC.-MOD-2022-664543:Same reporter
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today; the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Abilify, Haldol, Risperdol).   On 26-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 22-Oct-2022, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022). On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 3 doses of the bivalent vaccine which was beyond the 30 day use by date today) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 22Sep2022 administered on 26Oct2022).    No concomitant medication information was reported.  The patient took previously first dose on 18-May-2021, route of administration as unknown, second dose on 07-June-2021, route of administration as unknown.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-673501 (Linked Report). This case was linked to MOD-2022-673510 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673501:Same reporter
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 30-Jun-2022 and second dose on 12-Aug-2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jun-2022 and second dose on 12-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Ibuprofen).   On 30-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jun-2022 and second dose on 12-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jun-2022 and second dose on 12-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jun-2022 and second dose on 12-Aug-2022).    Concomitant medications were not reported.  The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown. Acute illnesses at the time of vaccination and up to one month before was unknown. No treatment medications were required.   This case was linked to MOD-2022-673501 (Patient Link).
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with covid) in a 94-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.     Concurrent medical conditions included Drug allergy.    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)) (Intramuscular) 1 dosage form. On 02-Oct-2022, the patient experienced COVID-19 (Diagnosed with covid). At the time of the report, COVID-19 (Diagnosed with covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2022, SARS-CoV-2 test: (Positive) The patient was not hospitalized..         No concomitant medication was reported.   The patient received all of the vaccines from Moderna but had no lot numbers.  Patient's symptoms started before diagnosis which included felt like a Cold and mucous. Patient had not experienced a similar event in the past.  The patient was treated with unspecified medication but could not recall.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: COVID-19 vaccination-associated Acute myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (COVID-19 vaccination-associated Acute myocarditis) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (COVID-19 vaccination-associated Acute myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (COVID-19 vaccination-associated Acute myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.  Company Comment: This literature non-study case concerns a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-673581 (Linked Report).; Sender's Comments: This literature non-study case concerns a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-673581:Male, patient 2
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Malaise, Vaccination site pain
Clinical narrative: Malaise; Dizziness; It hurt at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Malaise), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (It hurt at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 4), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Vision abnormal (Vision issues, vision was bad.).    On an unknown date, the patient received fifth 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 (Malaise), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (It hurt at the injection site). At the time of the report, MALAISE (Malaise), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (It hurt at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: temperature was elevated.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient's year of birth was1953. The patient want to report a mild reaction which had experienced after getting the Moderna Covid-19 Vaccine, Bivalent. It hurt at the injection site, temperature was elevated, malaise and dizziness. The lot number print was too small to read also patient had vision issues, it was bad.  No treatment medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: gave 0.25 mL to an older adult; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adult) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adult) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adult) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adult).    No concomitant medication was reported.  It was reported that they gave 0.5 but initially charted 0.25 and changed it afterwards to 0.5. There was over a milliliter left of vaccine still in the vial after supposedly 5 full doses might have been withdrawn.  The vial fill volume was possibly too high. The vial was punctured 5 times. 5 doses were extracted from the vial.  No treatment medication was reported.  This case was for Adult patient 2.   This case was linked to US-MODERNATX, INC.-MOD-2022-673533, US-MODERNATX, INC.-MOD-2022-673578, US-MODERNATX, INC.-MOD-2022-673580.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Additional follow-up received was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673533:Same reporter US-MODERNATX, INC.-MOD-2022-673578:Same reporter US-MODERNATX, INC.-MOD-2022-673580:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Acute myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Company Comment: This literature non-study case concerns a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.           This case was linked to US-MODERNATX, INC.-MOD-2022-673548 ( Linked Report).; Sender's Comments: This literature non-study case concerns a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-673548:Male, patient 1
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions; No adverse event; Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received monovalent Moderna Covid-19 vaccine that had undergone several temperature excursions).    No concomitant medications were provided.  It was reported that between 24-May-2022 and 3-Oct-2022 several patients received monovalent and bivalent Moderna Covid-19 vaccine that had undergone several temperature excursions.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673181, US-MODERNATX, INC.-MOD-2022-673644, US-MODERNATX, INC.-MOD-2022-673869, US-MODERNATX, INC.-MOD-2022-673878 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673181:same reporter US-MODERNATX, INC.-MOD-2022-673644:same reporter US-MODERNATX, INC.-MOD-2022-673869:same reporter US-MODERNATX, INC.-MOD-2022-673878:same reporter