chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles less than a month after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-NOV-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter reported that one of his/her cousins got the vaccine less than a month later got shingles. Additional supportive information: The follow-up could not be possible as no contact details were available
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Occupational exposure to product
Clinical narrative: Vaccine touched the pharmacist skin; Vaccine touched the pharmacist skin; This case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2022, the patient received Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced exposure via skin contact and occupational exposure while administering product. On an unknown date, the outcome of the exposure via skin contact and occupational exposure while administering product were unknown.   Additional Information: GSK receipt date: 04 Nov 2022 Reporter comment: This case was reported by pharmacist. The pharmacist reported that today (on the day of reporting) while she was administering a Shingrix vaccine to a patient, 4 to 5 droplets of the vaccine came out around the base of the needle where it attaches to the syringe while the syringe with the reconstituted vaccine was in the patient's arm.  The pharmacist reported that 4 to 5 droplets of the reconstituted Shingrix vaccine touched the skin when it came out of the syringe.  Reporter did not consent to follow up. Additional supportive information: 4 to 5 droplets of the reconstituted Shingrix vaccine touched the skin when it came out of the syringe, which led to exposure via skin contact and  occupational exposure while administering product. This case is linked with US2022161291 reported by the same reporter.; Sender's Comments:  US-GSK-US2022161291:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection is painful; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Oct-2022. Reporter's Comment::This case was reported by a consumer via interactive digital media. The reporter stated that already vaccinated that injection was painful but it's worth it.  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know how long he/she should expect the muscle aches, after receiving Shingrix, to last. Additional Supportive Information: The follow up would not possible as no contact details were available.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 6 months-old; Kinrix as 3rd dose of DTap and IPV; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-Nov-2022 Reporter's comment:  The registered nurse called to inquire how to proceed and what to look for. The registered nurse reported the patient was inadvertently administered Kinrix at their facility. The escalated to 2nd Line expert. Upon escalation expert noted patient was due for their DTap and IPV.  The Kinrix was their 3rd dose of each. The reporter did not consent to follow up. Additional supportive information: The 6 months old patient was inadvertently administered Kinrix, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Injection site pain, Testicular pain
Clinical narrative: Sore at injection site; Flu-like symptoms; Testicles are sore; 1st dose on spring/summer 2021, 2nd on 03Nov2022; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vasectomy. Previously administered products included Shingrix (received first Shingrix dose 0.5 ml intramuscular in spring or summer of 2021 in arm).   On 3rd November 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd November 2022, 4 hrs after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, testicular pain and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain, influenza-like symptoms and testicular pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and testicular pain to be related to Shingrix.     Additional Information: GSK receipt date: 04 Nov 2022 Reporter comment: The reporter was the wife of the patient. The reporter reported that patient received his second Shingrix vaccine in left arm. The reporter reported that about 4 hours after the injection patient's arm became sore at the injection site, he began to feel flu like symptoms patient awoke this morning, patient was better, but the symptoms have not resolved.  The patient testicles were sorer than when he had a vasectomy.  Caller does not give permission to contact HCP, they have not contacted him yet. Additional supportive information: As patient received 2nd dose of Shingrix lately which led to drug dose administration interval too long. Note: Patient route of administration is intramuscular, however in source document as per code it is Intraparietal, however intramuscular was captured conservatively.
Sex: F
Vaccine: UNK
Symptoms: Wrong technique in device usage process
Clinical narrative: PFS activated on 12Oct2022, administered on 23Oct2022; This case was reported by a nurse via call center representative and described the occurrence of wrong technique in device usage process in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 23rd October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process. On an unknown date, the outcome of the wrong technique in device usage process 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: 04-NOV-2022 Reporter's Comments:  Nurse reported that the patient received a dose of Flulaval on 23rd October 2022 and that prefilled syringe was originally reconstituted (cap was removed and needle attached to it) on 12th October 2022.  The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up.  Additional Supportive Information: The patient received a dose of Flulaval on 23rd October 2022 and that prefilled syringe was originally reconstituted (cap was removed and needle attached to it), which led to wrong technique in device usage process. This case had been linked with case US2022AMR161151, reported by the same reporter.; Sender's Comments:  US-GSK-US2022161284:Same reporter US-GSK-US2022AMR161151:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to a freezing temperature; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number FZ453, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra 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: 04-NOV-2022 Reporter's comments: The nurse had reported that a patient might had been administered a doses of Fluarix after it was exposed to a freezing temperature, 31 degrees Fahrenheit. The reporter stated that they were still investigating if any patients received doses after the exposure. The vaccine administration facility is the same as primary reporter. The reporter had consented to follow-up via email. Additional supportive information: The nurse had reported that a patient might had been administered a doses of Fluarix after it was exposed to a freezing temperature, which had led to Incorrect storage of drug. This was one of the five cases, which was reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: 4-5 droplets came out from syringe; Vaccine maybe touched patient´s arm; Vaccine maybe touched patient´s arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number P39N2, expiry date 25th September 2023) for prophylaxis.   On 4th November 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, exposure via skin contact and accidental exposure while administering drug. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and accidental exposure while administering drug were unknown.     Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's comment: Pharmacist reported that while she was administering a Shingrix vaccine in the right arm to a patient, 4-5 droplets of the vaccine came out around the base of the needle where it attached to the syringe while the syringe with the reconstituted vaccine was in the patient's arm. The pharmacist said 4-5 droplets of the reconstituted Shingrix vaccine when it came out of the syringe on the patient's pant and maybe the patient's arms.  The reporter did not consent to follow-up. Additional Supportive Information: The 4-5 droplets of the reconstituted Shingrix vaccine when it came out of the syringe on the patient's pant and maybe the patient's arms, which led incomplete dose administered, exposure via skin contact and accidental exposure while administering drug. The case US2022161294 was identified as duplicate of this case. The case US2022161294 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient. The case is linked to the case US2022AMR162313, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR162313:Same reporter
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: None - vaccine error
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Blood glucose normal, Blood pressure decreased, Cold sweat, Frequent bowel movements
Clinical narrative: On Saturday morning at 9:15am, while having several bowel movements w cramping, I felt extremely weak. I was pale, in a cold sweat. Needed to lie down on floor. Spouse called 911. Paramedics established that my BP had fallen to 68/40. Transported to Hospital ER. Traponen checked but was not elevated and BP had returned to normal, so I was released at about 3:30 pm and returned home. No further adverse effects.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gastrointestinal pain, Pallor, Troponin
Clinical narrative: On Saturday morning at 9:15am, while having several bowel movements w cramping, I felt extremely weak. I was pale, in a cold sweat. Needed to lie down on floor. Spouse called 911. Paramedics established that my BP had fallen to 68/40. Transported to Hospital ER. Traponen checked but was not elevated and BP had returned to normal, so I was released at about 3:30 pm and returned home. No further adverse effects.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itchy round rash, surrounding the injection site, approximately 4 inches across. Painful to palpation,  and some pain in armpit. No stolen lymph nodes noted. No worse at day 3 post injection.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Dyspnoea, Eye movement disorder, Glassy eyes, Headache
Clinical narrative: Pt. was calm before, during, and after his injection. He was talking for approximately 30 seconds after his 2nd injection, when his shoulders tensed, his neck outstretched backwards, and his eyes rolled back. This rigidity lasted about 30 seconds. When he started responding the first thing he said was ?it?s hard to breathe? and ?my head hurts?. BP was taken at this point and it was 139/97, sp02 98%, HR 54. He continued to have a glossy look, was tearful, and unlike himself. After another 15 minutes of the change in personality, he was moved to a bed. He put his legs up and 1 minute later he was noticeably different in speech patterns ?back to normal?. Sunday night he awoke to diarrhea, nausea, vomiting without fever, cough or other symptoms. Before bed on Monday evening he vomited again
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscle rigidity, Muscle tightness, Nausea, Personality change, Posture abnormal
Clinical narrative: Pt. was calm before, during, and after his injection. He was talking for approximately 30 seconds after his 2nd injection, when his shoulders tensed, his neck outstretched backwards, and his eyes rolled back. This rigidity lasted about 30 seconds. When he started responding the first thing he said was ?it?s hard to breathe? and ?my head hurts?. BP was taken at this point and it was 139/97, sp02 98%, HR 54. He continued to have a glossy look, was tearful, and unlike himself. After another 15 minutes of the change in personality, he was moved to a bed. He put his legs up and 1 minute later he was noticeably different in speech patterns ?back to normal?. Sunday night he awoke to diarrhea, nausea, vomiting without fever, cough or other symptoms. Before bed on Monday evening he vomited again
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Speech disorder, Tearfulness, Vomiting
Clinical narrative: Pt. was calm before, during, and after his injection. He was talking for approximately 30 seconds after his 2nd injection, when his shoulders tensed, his neck outstretched backwards, and his eyes rolled back. This rigidity lasted about 30 seconds. When he started responding the first thing he said was ?it?s hard to breathe? and ?my head hurts?. BP was taken at this point and it was 139/97, sp02 98%, HR 54. He continued to have a glossy look, was tearful, and unlike himself. After another 15 minutes of the change in personality, he was moved to a bed. He put his legs up and 1 minute later he was noticeably different in speech patterns ?back to normal?. Sunday night he awoke to diarrhea, nausea, vomiting without fever, cough or other symptoms. Before bed on Monday evening he vomited again
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling hot, Flushing, Throat irritation
Clinical narrative: Patient had a reaction to receiving the Moderna Bivalent at 1403. PT remained in waiting area under direct observation by Imms staff for 15 minutes post vaccination, the patient stated he was hot in the face and very itchy around the throat. Peds provider consulted on patient S/SX.  PT in no acute respiratory distress.  PT stated flush feeling in face and itching around the throat decreased after 15 minutes, but not resolved.  PT remained in waiting area for another 15 minutes of monitoring as care was coordinated with ED for patient to be transferred where additional treatment/monitoring was performed.  PT transferred via ambulatory measures to ED with MA as escort at 1435 14NOV
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram normal, Computerised tomogram normal, Hemiparesis, Hypoaesthesia, Magnetic resonance imaging head normal
Clinical narrative: 10/24/22 obvious left sided weakness, numbness, tingling sensation of left face, arm, torso, leg. 11/11 numbness tingling weakness presents bilaterally over all body, now with muscle cramps and pains in all extremities. Weakness in all extremities. No one knows what this is, my primary is at a loss. SOMEONE PLEASE HELP ME!
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging neck, Magnetic resonance imaging normal, Muscle spasms, Muscular weakness, Pain in extremity
Clinical narrative: 10/24/22 obvious left sided weakness, numbness, tingling sensation of left face, arm, torso, leg. 11/11 numbness tingling weakness presents bilaterally over all body, now with muscle cramps and pains in all extremities. Weakness in all extremities. No one knows what this is, my primary is at a loss. SOMEONE PLEASE HELP ME!
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: 10/24/22 obvious left sided weakness, numbness, tingling sensation of left face, arm, torso, leg. 11/11 numbness tingling weakness presents bilaterally over all body, now with muscle cramps and pains in all extremities. Weakness in all extremities. No one knows what this is, my primary is at a loss. SOMEONE PLEASE HELP ME!
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19 immunisation, Chills, Fatigue, Headache
Clinical narrative: This spontaneous report received from a patient via Pfizer concerned a 61-year-old female. The patient's weight was 111.13 kilograms, and height was 163 centimeters. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 01 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. On an unspecified date, the patient experienced really sick, terrible (dose number in series 1). The patient received non-company suspect vaccine included: tozinameran (dose number in series 2) (batch number: FG3527 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 22-NOV-2021 for covid-19 prophylaxis. On 22-NOV-2021, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). The patient received non-company suspect vaccine included: tozinameran (dose number in series 3) (batch number: GJ6665 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 27-OCT-2022 for covid-19 prophylaxis. No concomitant medications were reported. On 28-OCT-2022, the patient experienced extreme chills, severe joint pain, severe muscle pain, headache, nausea, and overall, just wiped out, extreme fatigue (dose number in series 3). On an unspecified date, the patient experienced huge, red area where injection was, swollen, has a lump and hot, arm really sore and painful (dose number in series 3). Hoping arm will continue getting better, but red spot started out the size of probably a quarter and now red spot was probably the size, can't think, maybe the size of a can, the circumference of a can. Painful lump in arm was never had that happen before, got sore after any kind of shot, but has never seen the red, warmth, or lump. Start date of adverse event: Doesn't think really started bothering until that night, woke up that morning sick and terrible, so guess would say arm started the next day, Saturday, 29-OCT-2022. Was bright red at first when started but was paler, so doesn't know if that means anything, as it has spread the color was pinker instead of bright red. The patient got the shot she was odd, shot didn't hurt at all, but the next day felt sick Iike with Covid, knows how that feels because caller had Covid before. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from extreme chills, severe joint pain, severe muscle pain, headache, nausea, and overall, just wiped out, extreme fatigue on 30-OCT-2022, had not recovered from huge, red area where injection was, swollen, has a lump and hot, and the outcome of revaccination with different covid-19 vaccine, really sick, terrible and arm really sore and painful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site reaction, Myalgia, Nausea, Pain in extremity
Clinical narrative: This spontaneous report received from a patient via Pfizer concerned a 61-year-old female. The patient's weight was 111.13 kilograms, and height was 163 centimeters. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 01 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. On an unspecified date, the patient experienced really sick, terrible (dose number in series 1). The patient received non-company suspect vaccine included: tozinameran (dose number in series 2) (batch number: FG3527 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 22-NOV-2021 for covid-19 prophylaxis. On 22-NOV-2021, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). The patient received non-company suspect vaccine included: tozinameran (dose number in series 3) (batch number: GJ6665 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 27-OCT-2022 for covid-19 prophylaxis. No concomitant medications were reported. On 28-OCT-2022, the patient experienced extreme chills, severe joint pain, severe muscle pain, headache, nausea, and overall, just wiped out, extreme fatigue (dose number in series 3). On an unspecified date, the patient experienced huge, red area where injection was, swollen, has a lump and hot, arm really sore and painful (dose number in series 3). Hoping arm will continue getting better, but red spot started out the size of probably a quarter and now red spot was probably the size, can't think, maybe the size of a can, the circumference of a can. Painful lump in arm was never had that happen before, got sore after any kind of shot, but has never seen the red, warmth, or lump. Start date of adverse event: Doesn't think really started bothering until that night, woke up that morning sick and terrible, so guess would say arm started the next day, Saturday, 29-OCT-2022. Was bright red at first when started but was paler, so doesn't know if that means anything, as it has spread the color was pinker instead of bright red. The patient got the shot she was odd, shot didn't hurt at all, but the next day felt sick Iike with Covid, knows how that feels because caller had Covid before. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from extreme chills, severe joint pain, severe muscle pain, headache, nausea, and overall, just wiped out, extreme fatigue on 30-OCT-2022, had not recovered from huge, red area where injection was, swollen, has a lump and hot, and the outcome of revaccination with different covid-19 vaccine, really sick, terrible and arm really sore and painful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEGS ACHED A LITTLE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient itself was healthcare professional (registered nurse). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced legs ached a little. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of legs ached a little was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POSSIBLE THAT PEOPLE GOT THE VACCINE WHEN STORED UNDER LACK OF TEMPERATURE MONITORING FOR 10 MONTHS; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced possible that people got the vaccine when stored under lack of temperature monitoring for 10 months, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible that people got the vaccine when stored under lack of temperature monitoring for 10 months and out of specification product use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19-2
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) 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 MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication information was reported. No treatment medication information was reported.  Company Comment: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced a fatal unexpected serious (medically Significant) of Myocardial Infarction 2 days after receiving a dose of mRNA-1273.222 vaccine. The details of previous doses were not provided. The cause of death was reported as died of natural causes. Death occurred on an unknown date. It is unknown if an autopsy was performed. There was no information provided about the patient's age, underlying medical conditions, concomitant medications, clinical course of the event, associated symptoms, final diagnosis, diagnostic and treatment details. The benefit-risk relationship of mRNA-1273.222 vaccine, is not affected by this report. This case was linked to MODERNATX, INC.-MOD-2022-670450 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced a fatal unexpected serious (medically Significant) of Myocardial Infarction 2 days after receiving a dose of mRNA-1273.222 vaccine. The details of previous doses were not provided. The cause of death was reported as died of natural causes. Death occurred on an unknown date. It is unknown if an autopsy was performed. There was no information provided about the patient's age, underlying medical conditions, concomitant medications, clinical course of the event, associated symptoms, final diagnosis, diagnostic and treatment details. The benefit-risk relationship of mRNA-1273.222 vaccine, is not affected by this report. MODERNATX, INC.-MOD-2022-670450:MOD-2022-670450 (Case for male patient); Reported Cause(s) of Death: Died of natural causes.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.; No adverse event; dose administered after 12 hours post puncture.; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 12 hours post puncture.), PRODUCT STORAGE ERROR (Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2022 at 10:12 AM, 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 10-Nov-2022 at 10:12 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 12 hours post puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 12 hours post puncture.), PRODUCT STORAGE ERROR (Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose administered after 12 hours post puncture.) and PRODUCT STORAGE ERROR (Date and time vial was first punctured: 09Nov2022 at 8:00 AM, Date and time of administration of vaccine: 10Nov2022 at 10:12 AM and the vial stored post puncture in Refrigerator.).    Concomitant products were not reported.  It was reported that the vial was individual vial with 2.5ml size, vial was initially stored in the refrigerator on 08-Nov-2022. Vial was first punctured on 09-Nov-2022 at 08.00 AM. The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. The vial was not exposed to room temperature for more than 24 hours.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2022: Live follow-up received: IRD has been updated.
Age: 69.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022; No adverse event; Administered expired dose to patient/expired dose was given after the 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose to patient/expired dose was given after the 30 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for an unknown indication.    No Medical History information was reported.   On 07-Nov-2022, 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 and dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) (Intramuscular) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose to patient/expired dose was given after the 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired dose to patient/expired dose was given after the 30 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022) 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 (Administered expired dose to patient/expired dose was given after the 30 days) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Oct-2022 and was administered on 7-Nov-2022).    No concomitant medications were provided. The reporter states that vaccine had been punctured and used. It was in their fridge for 32 days.  The vial size was 2.5 mL. The vial was initially stored in the refrigerator on 6-Oct-2022 The vial did not undergo any temperature excursion. It was reported that expired dose was given after the 30 days.  On 12-feb-2021, patient received 0.5 ml dose 1. On 12-mar-2021, patient received 0.5 ml dose 2 with batch number 032M020A. On 28-oct-2021, patient received 0.25 ml dose 3 with batch number 076C21A in left arm. On 31-mar-2022, patient had dose 4 with batch number 045J21A in left arm. No treatment medication was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocardial necrosis marker, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Injection site was aching; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site was aching) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent placement on 29-Jan-2021.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site was aching). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Injection site was aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Electrocardiogram: abnormal. On 28-Jan-2021, Myocardial necrosis marker: 9, likely had a heart attack in the past 24 hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was reported. It was reported that patient had fever and injection site was aching after first and second Monovalent booster. No treatment information was reported.   This case was linked to MOD-2022-670601, MOD-2021-039119 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient had a mild chest pain; After the bivalent booster, patient had a high fever 101 F; Patient right arm injection site was swollen and achy; Patient right arm injection site was swollen and achy; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Patient had a mild chest pain), PYREXIA (After the bivalent booster, patient had a high fever 101 F), VACCINATION SITE SWELLING (Patient right arm injection site was swollen and achy) and VACCINATION SITE PAIN (Patient right arm injection site was swollen and achy) in a 78-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.     No Medical History information was reported.    On 02-Nov-2022, 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 02-Nov-2022, the patient experienced CHEST PAIN (Patient had a mild chest pain), PYREXIA (After the bivalent booster, patient had a high fever 101 F), VACCINATION SITE SWELLING (Patient right arm injection site was swollen and achy) and VACCINATION SITE PAIN (Patient right arm injection site was swollen and achy). On 04-Nov-2022, CHEST PAIN (Patient had a mild chest pain), PYREXIA (After the bivalent booster, patient had a high fever 101 F), VACCINATION SITE SWELLING (Patient right arm injection site was swollen and achy) and VACCINATION SITE PAIN (Patient right arm injection site was swollen and achy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F (high).     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.   Patient received fifth vaccine as bivalent booster dose. No concomitant medication information was provided. After the bivalent booster, she had a high Fever 101 F, and her right arm injection site was swollen and achy. She also had mild chest pain, but she monitored herself. She did not think that it was necessary to go to the ER and she did not inform the cardiologist. All symptoms went away, 48 hours after the Bivalent vaccine. No treatment medication were provided.   This case was linked to MOD-2021-039119, MOD-2022-670597 (Patient Link).
Age: 1.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Placed in the fridge and given beyond the 30-day expiration to 7 patients; No adverse event; Dose given beyond 30-day expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event) in a 21-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (Placed in the fridge and given beyond the 30-day expiration to 7 patients).    The caller called and said that the vials were initially stored in the refrigerator on 06-Jul-2022. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown. The caller needed information on stability after 30 days and if there are recommendations on revaccination.  The vials did not undergo any temperature excursions.  No concomitant medication reported. No treatment medication reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: dose given beyond 30-day expiration date; dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date).    Concomitant products were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov. The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  Treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose given beyond 30-day expiration date; Dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date).    Concomitant products were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov. The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  The vial did not undergo any temperature excursions.  Treatment medications were not reported.