chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: side effects as muscles soreness; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness 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 muscle soreness and tiredness. On an unknown date, the outcome of the muscle soreness and tiredness were unknown.   It was unknown if the reporter considered the muscle soreness and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Feb-2023 Reporter's comment: The patient stated that typically how long do the side effects last after the shot and had muscles soreness and tiredness were main ones. The patient stated that did not want to give out his/her information to random people. The reporter denied to follow-up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, SARS-CoV-2 test negative
Clinical narrative: Feeling fluish; Feeling crappy all over; This case was reported by a consumer and described the occurrence of influenza like illness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (he gets a lot shingles outbreaks often).   On 3rd February 2023, the patient received the 1st dose of Shingrix. On 22nd February 2023, 19 days after receiving Shingrix, the patient experienced influenza like illness and feeling unwell. On an unknown date, the outcome of the influenza like illness and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The reporter was a patient wife. The reporter reported that the patient was waited to receive his shingles vaccine for a long while and by the time he finally got a date and time to go and get the vaccine. The reporter stated that the patient was broke out with scalp shingles and a little bit on his lower back bone where he commonly get the shingles on regular basis so the patient stuck with the physician appointment. The reporter reported that when the patient received Shingrix vaccine he had an active case of shingles. The reporter stated that on 19th February 2023, 19 days after received Shingrix vaccine the patient experienced feeling fluish and just crappy all over. The patient done with the laboratory test Covid 19 test just in case with result negative. The reporter wanted to know if the patient going to be okay, or if he will need to get yet another shot after this outbreak finally leaves him. The reporter requested to consent the follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 26-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingles shot and got shingles right after. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: HIBV
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: Hiberix vaccine when the needle popped off and some of the vaccine splashed into her eye; vaccine splashed into eye; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while administering product in a adult female patient who received Hib (Hiberix) (batch number 97AP3, expiry date 9th November 2023) for prophylaxis.   On 21st February 2023, the patient received Hiberix. On 21st February 2023, unknown after receiving Hiberix, the patient experienced occupational exposure while administering product and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while administering product and exposure via eye contact were unknown.   Additional Information: GSK receipt date: 21-FEB-2023 Reporter comment: The practice manager reports an employee was going to administer a Hiberix vaccine when the needle popped off and some of the vaccine splashed into her eye. At the time of the call, the employee was going to start rinsing eye with water. The reporter consented to follow up. Additional Supportive Information: employee was going to administer a Hiberix vaccine when the needle popped off and some of the vaccine splashed into her eye, which led to occupational exposure while administering product , Exposure via eye contact.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3yrs ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-Feb-2023  Reporter's comment: The pharmacist reported that for unknown reasons patient did not receive his second dose. Nothing else was reported.  The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Received 2 Hep A doses. 3rd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 2 doses on an unknown date). Concomitant products included HEPATITIS B VACCINE (HEPLISAV-B).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 21-Feb-2023 Reporter's comment: A patient was supposed to receive the third dose of Twinrix but received Heplisav-B instead.  The reporter consented to follow up.  Additional supportive information: Till the time of reporting, the patient did not receive the third dose of Twinrix (for Hepatitis A antigen), which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Constant pain in left shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2022, the patient received the 1st dose of Shingrix (intramuscular). On 20th October 2022, less than a day after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Feb-2023 Reporter's Comments: The patient received a dose of Shingrix in her left arm and after the injection she developed pain in her left shoulder that had not gone away since then.  The patient stated the pain was constant, 5/10 and 7/10 at times.  The patient had been under medical attention, without relief. The reporter consented to follow up. As it was not clear from the narrative that 5/10 and 7/10 times was pain measurement scale result was provided or it was reporting for any other point therefore query was raised for the same and meanwhile this information was captured in narrative.
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the diluent was administered; only the diluent was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 47Y9A, expiry date 17th February 2025) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 17th January 2023, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 17th January 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose 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: 22-FEB-2023 Reporter's comment: The nurse called and reported an event in which only the diluent of Rotarix was administered to patient. The information about the vaccine and patient was collected.  The call was escalated to second line.  The vaccine administration facility was the same as primary reporter. Because the medical information letter was marked as expired, agent was advised to escalate to second line. The reporter consent to follow up. Additional Supportive Information: The patient received only diluent of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received dose at age of 49; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 22-FEB-2023 Reporter's comment: The reporter was the health care professional (medical assistant).  The patient was immunocompetent. Nothing else was reported.  The reporter consent to follow up. Additional Supportive Information: A 49 year old patient received Shingrix dose, which led to inappropriate age at vaccine administration.
Age: 74.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 22nd February 2023, the patient received Havrix. On 22nd February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-FEB-2023 Reporter's Comment: The reporter consented to follow up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 15 year old received Adult dose; 15 YO received Adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 15-year-old female patient who received HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13th December 2024) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 23-FEB-2023 Reporter's comment: The reporter consented to follow up via mail. Additional supportive information: 15 year old patient was administered an adult dose of Havrix, which led to adult product administered to child and overdose.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received the adjuvant component only; Received the adjuvant component only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 0729N, expiry date 31st May 2024) for prophylaxis.   On 23rd February 2023, the patient received the 1st dose of Shingrix. On 23rd February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-Feb-2023 Reporter's Comments: The pharmacist reported that earlier on the day of reporting, a patient was supposed to receive the first dose of Shingrix vaccine but received the adjuvant component only.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blood glucose increased, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: blood sugar increased to 308; Pain at the injection site; Dizziness; Shivering, so bad; Headaches; fever,; cracked a molar; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included diabetes.   On 20th February 2023, the patient received the 1st dose of SHINGRIX (intramuscular) and Flu vaccine. In February 2023, unknown after receiving SHINGRIX and Flu vaccine, the patient experienced injection site pain, dizziness, shivering, headache, fever and tooth fracture. On 22nd February 2023, the patient experienced blood sugar increased. On an unknown date, the outcome of the injection site pain, dizziness, shivering, headache, fever, tooth fracture and blood sugar increased were unknown.   It was unknown if the reporter considered the injection site pain, dizziness, shivering, headache, fever, tooth fracture and blood sugar increased to be related to SHINGRIX and Flu vaccine.     Additional Information: GSK Receipt date: 23-FEB-2023 reporter comment: The reporter was the patient The reporter stated that  she received her first dose of SHINGRIX vaccine in her right arm and has been with headaches, dizziness , pain at the injection site and shivering at night since then.  The patient also received a flu shot on her left arm. she did not know the name of the flu shot received.  The patient stated that she has been experiencing fever, headache, dizziness, soreness and injection site, and shivering after receiving her dose. The patient stated that her shivering is so bad that  she cracked a molar while she was sleeping.  The patient also stated that she is diabetic and her blood sugar increased to 308. Education provided on SHINGRIX side effects per content. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023030470:same reporter
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia, Tooth fracture
Clinical narrative: blood sugar increased to 308; Pain at the injection site; Dizziness; Shivering, so bad; Headaches; fever,; cracked a molar; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included diabetes.   On 20th February 2023, the patient received the 1st dose of SHINGRIX (intramuscular) and Flu vaccine. In February 2023, unknown after receiving SHINGRIX and Flu vaccine, the patient experienced injection site pain, dizziness, shivering, headache, fever and tooth fracture. On 22nd February 2023, the patient experienced blood sugar increased. On an unknown date, the outcome of the injection site pain, dizziness, shivering, headache, fever, tooth fracture and blood sugar increased were unknown.   It was unknown if the reporter considered the injection site pain, dizziness, shivering, headache, fever, tooth fracture and blood sugar increased to be related to SHINGRIX and Flu vaccine.     Additional Information: GSK Receipt date: 23-FEB-2023 reporter comment: The reporter was the patient The reporter stated that  she received her first dose of SHINGRIX vaccine in her right arm and has been with headaches, dizziness , pain at the injection site and shivering at night since then.  The patient also received a flu shot on her left arm. she did not know the name of the flu shot received.  The patient stated that she has been experiencing fever, headache, dizziness, soreness and injection site, and shivering after receiving her dose. The patient stated that her shivering is so bad that  she cracked a molar while she was sleeping.  The patient also stated that she is diabetic and her blood sugar increased to 308. Education provided on SHINGRIX side effects per content. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023030470:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Hypoaesthesia, Pain in extremity
Clinical narrative: left arm was very sore; left sided facial numbness; left side of face was very sore; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, numbness facial and facial pain. On an unknown date, the outcome of the pain in arm, numbness facial and facial pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, numbness facial and facial pain to be related to Shingrix.     Additional Information: GSK receipt date: 23-FEB-2023 Reporter comment: The medical assistant stating that a patient came to the office and reported that after he got the first Shingrix vaccine in left arm a few weeks ago, he had left sided facial numbness a few hours later that lasted until the following morning.   The patient also reported that the next morning the left side of his face and his left arm were very sore and that lasted for a few days.   All of his symptoms had resolved. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: 18JAN dose was 3rd of DTAP and IPV, 23FEB dose was the 4th of each; received an extra dose; 18JAN dose was 3rd of DTAP and IPV, 23FEB dose was the 4th of each; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number g9n2m, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number g9n2m, expiry date 14th April 2024) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2023, the patient received the 2nd dose of Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 18th January 2023, the patient received the 1st dose of Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 18th January 2023, not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device and unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On 23rd February 2023, the patient experienced inappropriate schedule of vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered, inappropriate schedule of vaccine administered and extra dose 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: 23-Feb-2023 and 27-Feb-2023. Reporter's Comment: Reporter stated that patient accidently received an extra dose of Kinrix. Patient stated that 1st dose of Kinrix was 3rd dose of DTP and IPV and 2nd dose of Kinrix was 4th dose of DTP and IPV. The reporter consent to follow up. Additional Supportive Information: Patient received an extra second dose of kinrix than the recommended schedule, which led to  extra dose administered. Patient received 1st dose of Kinrix as 3rd dose of DTP and IPV and 2nd dose of Kinrix as 4th dose of DTP and IPV than the recommended schedule, which led to inappropriate schedule of vaccine administered.
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: One dose in Mar2022, other in 25Feb2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in March 2022 ).   On 25th February 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   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: 27-FEB-2023 Reporter's Comment: The patient came in this Saturday was given a another dose of Twinrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Poor quality product administered, Product contamination
Clinical narrative: ONGOING DEBILITATING CONDITIONS; LOTS MANUFACTURED AT THE TIME OF KNOWN CONTAMINATION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a consumer 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 batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced ongoing debilitating conditions, lots manufactured at the time of known contamination, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ongoing debilitating conditions, and the outcome of lots manufactured at the time of known contamination and out of specification product use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000272579. The suspected product quality complaint has been confirmed to be voided since this record was identified as a duplicate/follow up to original complaint 90000193699 and all information in this record has been transferred and included in the original report. no new information was received that would impact the outcome of the original report under 90000193699- patient is describing a series of additional side effects for other people, including herself, results of her own investigation for lot 1805031 and general FDA document describing cross-contamination at one of the plants and is looking for safety to reach out to her directly about additional plants and products produced between nov-2020-mar-2021. No new PQCS were reported that weren't already covered under primary case 90000193699. complaints are linked and this case is being submitted for void approval, based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer via other manufacturer (Private group) 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 (dose number in series 1) (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 and has been requested. No concomitant medications were reported.  On an unspecified date in OCT-2021, the patient experienced covid-19 (Dose number in series 1). The patient additionally received booster dose of non-company vaccine included: Pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on an unspecified date in DEC-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
Age: 2.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 2-year-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, 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 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 6th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up information received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up information received includes suspect vaccine batch number was added. On 28-Feb-2023: Follow-up information received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Age: 0.75
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 9-month-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, 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 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 9th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up information received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up information received includes suspect vaccine batch number was added. On 28-Feb-2023: Follow-up information received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 monovalent were administered BUD to total of 15 recipients).    No concomitant medications were provided. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Vaccine details updated. On 28-Feb-2023: follow up received contains no new information. On 28-Feb-2023: Patient demographics and vaccine details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 1 of 15
Age: 2.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 2-year-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, 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 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 13th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up document received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Age: 1.5
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in an 18-month-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, 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 09-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 16th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up document received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Age: 4.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 4-year-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, 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 09-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case was created for patient 17 out of 17 patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up received contains Patient demographics updated On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Age: 0.5
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 6-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 11th of 15 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live follow-up document received includes patient demographics (initial and DOB), vaccine administration date were updated. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 1
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up received and added patient details, vaccine administration date and batch no. On 28-Feb-2023: Follow-up received and had no new information. On 28-Feb-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 12
Age: 2.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 bivalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 bivalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, 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 09-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 bivalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 bivalent were administered BUD) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 bivalent were administered BUD).    Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up received and added patient details. On 28-Feb-2023: Follow-up received and added batch no. and ROA for suspect. On 28-Feb-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 15