chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 months old received kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 7-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was for 1 of 5 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022183609:Same reporter US-GSK-US2022183611:Same reporter US-GSK-US2022183612:Same reporter US-GSK-US2022183615:Same reporter
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 month old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 7-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was for 2 of 5 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022183610:Same reporter US-GSK-US2022183611:Same reporter US-GSK-US2022183612:Same reporter US-GSK-US2022183615:Same reporter
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 7-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was for 4 of 5 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022183610:Same reporter US-GSK-US2022183609:Same reporter US-GSK-US2022183611:Same reporter US-GSK-US2022183615:Same reporter
Age: 0.92
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 moths old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 7-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was for 5 of 5 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. Thanks and regards,; Sender's Comments:  US-GSK-US2022183609:Same reporter US-GSK-US2022183610:Same reporter US-GSK-US2022183611:Same reporter US-GSK-US2022183612:Same reporter
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Temperature excursion of 8.9,8.8, 8.4 °C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 24GY7, expiry date 30th June 2023), (batch number 9XL7N, expiry date 30th June 2023) and (batch number AS5RM, 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. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started 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: 7-Dec-2022 Reporter's comment: The registered nurse reported that their Fluarix QIV were exposed to an above temperature excursion of 8.9 degree Celsius for 30 minutes for Fluarix QIV. The vaccine was exposed on 13th September 2022 8.4 degree Celsius for 30 minutes, 28th September 2022 8.8 degree Celsius for 30 minutes and 29th September 2022 8.9 degree Celsius for 30 minutes. The reporter also stated these doses were already given to patients (no details available when asked). The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up (email was provided). Additional supportive information: The patients received the Fluarix QIV after temperature excursion, which led to incorrect storage of drug.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Child received 0.25 mL dose instead of a full 0.5 mL; This case was reported by a nurse via call center representative and described the occurrence of underdose in a child patient who received Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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: 7-Dec-2022 Reporter's comment: The nurse reported that there was a possibility a child might had received 0.25 ml dose of FluLaval QIV instead of a full 0.5 ml dose for their first influenza vaccine.   At the time of reporting, the nurse did not had any verified information including date of administration, lot number of the dose administered, or any patient information. The reporter consented to follow-up. This is 1 of 2 linked case, reported by same reporter. Additional supportive information: The patient received might had received 0.25 ml dose of Flulaval QIV instead of a full 0.5ml  dose, which led to underdose.; Sender's Comments:  US-GSK-US2022183617:Same reporter
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Underdose
Clinical narrative: Child received 0.25 mL dose instead of a full 0.5 mL; This case was reported by a nurse via call center representative and described the occurrence of underdose in a child patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, the 1st dose of FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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: 7-Dec-2022 Reporter's comment: The nurse reported that there was a possibility a child might had received 0.25 ml dose of FluLaval QIV instead of a full 0.5 ml dose for their first and second doses of influenza vaccine.   At the time of reporting, the nurse did not had any verified information including date of administration, lot number of the dose administered, or any patient information. The reporter consented to follow-up. This is 2 of 2 linked case, reported by same reporter. Additional supportive information: The patient received might had received 0.25 ml dose of Flulaval QIV instead of a full 0.5ml  dose, which led to underdose.; Sender's Comments:  US-GSK-US2022183616:Same reporter
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9YO received Infanrix instead of Boostrix; 9YO received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 9-year-old male patient who received DTPa (Infanrix) (batch number PAK443, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 21st September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 8-Dec-2022 Reporter's comment: The licensed practical nurse called to inquired that any recommendations or guidance or how to proceed. The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Infanrix instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the adjuvant; Received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA729A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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: 08-DEC-2022 Reporter's Comment: The reporter was clinical supervisor.  The reporter reported, one of their patient received only the adjuvant, instead of the reconstituted vaccine.  The reporter reported not being certain of whether this patient was the one who received only the adjuvant, as they had narrowed it down to two possible patients. The reporter consented to follow up.  Additional Supportive Information: The reporter reported, one of their patient received only the adjuvant, instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022184441:Same reporter
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HBV (Engerix B) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   On 8th December 2022, the patient received the 3rd dose of Engerix B. On 8th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment:  The nurse stated that when she looked at the expiration date she thought the year of expiration was 2023 and it was not until after the administration of the dose that she saw the year of expiration was 2022.  This was dose three in the patient's series. Permission granted for follow up from safety. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently given an expired dose of Engerix-B, which led to expired vaccine used.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: redness on back, underneath his right chest; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2022, the patient received the 1st dose of Shingrix. On 7th December 2022, 1 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: The patient said he got his first dose of Shingrix in the left arm and he noticed a redness on his back in the area right underneath his right chest. The patient did not know the lot number/expiration date of the shingrix shot he received. No further information was reported to the agent by the patient. The reporter did not consent to follow up.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric dose; Adult patient received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 774x47, expiry date 22nd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 3rd November 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022184453   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment: The reporter reported that a week after the administration of the incorrect dose a full adult dose was administered to the patient. Same patient on the same day received a pediatric dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The case was linked with case US2022184453, reported by same reporter for different product. Additional supportive information: The patient received a pediatric dose of Engerix B by mistake, which led to underdose and adult use of a child product.; Sender's Comments:  US-GSK-US2022184453:Same reporter
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric dose; Adult patient received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HAV (Havrix pediatric) (batch number ly35f, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 3rd November 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022184452   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment: The reporter reported that a week after the administration of the incorrect dose a full dose was adult dose of Havrix was administered.  Same situation happened with Engerix B and it was reported in related case. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The case was linked with case US2022184452, reported by same reporter for different product. Additional supportive information: The patient received a pediatric dose of Havrix by mistake, which led to underdose and adult use of a child product.; Sender's Comments:  US-GSK-US2022184452:Same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 16Sep2016, 2nd 07Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number P7K5P, expiry date 10th September 2023) for prophylaxis.   Previously administered products included Shingrix  (received first dose back on 16th September 2018).   On 7th September 2022, the patient received the 2nd dose of Shingrix. On 7th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment: The pharmacist called to inquired that any information available. The patient was wondering if needing an additional dose, since the doses were administered longer than recommended.  The reporter confirmed no additional doses administered just the 2 doses. Did not consent to follow-up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Application site rash, Injection site pain, Injection site rash, Rash, Rash erythematous
Clinical narrative: Soreness at injection site; injection site rash; Small red rash on thigh; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced injection site pain, injection site rash and red rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site rash was unknown and the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: Patient reported he received Shingrix dose in the right arm. He stated hours later he had soreness at injection site and noticed a small red, non-itchy rash on thigh (did not say if left or right). The patient suffered from skin rash at the application site. The patient asked if he could receive the second dose of Shingrix. The patient did not provide the information about the Shingrix dose that he received (lot number, expiration date). He stated he did go to HCP and they prescribed VALTREX for 1 week. His rash was almost subsided he said.  He asked if dose 2 would be worse. Medical disclaimer and medical information phone number was provided. Referred to HCP. Did not consent to follow-up. Additional supportive information:  The case US2022184469 was identified as duplicate of US2022184471. The case US2022184471would be voided, and all the future correspondence would be added in this case US2022184469 which stands as a case of record for this patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Pruritus
Clinical narrative: itching on neck line; burning on neck line, starting to burn like a sunburn; burned a little during administration; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix (intramuscular). In November 2022, immediately after receiving Shingrix, the patient experienced injection site burning. On an unknown date, the patient experienced pruritus and burning sensation. On an unknown date, the outcome of the injection site burning was recovered/resolved and the outcome of the pruritus and burning sensation were not recovered/not resolved.   The reporter considered the injection site burning, pruritus and burning sensation to be related to Shingrix.  Additional Information: GSK Receipt Date: 08-DEC-202 Reporter's Comment: The reporter was the patient.  She did not have email.  She had Shingrix about 2-3 weeks ago.  She did not know the exact date.  She did not have the lot number.  It was given in her left arm (deltoid).  It burned a little during administration.  It was administered at a pharmacy.  She had itching and burning on her neck line.  She said it was starting to burn like a sunburn but there was no rash and it was not red. (She was concerned that the itching and burning might be a case of shingles).  She had not seen a doctor about this yet.  She currently did not have a primary care physician.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Oct2019, 2nd Oct2022; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number XM22G, expiry date 31st August 2023) and (batch number G537F, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received first dose in October 2019).   On 1st October 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 1st October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago, 2nd not yet; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 1 year 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: 8-Dec-2022 Reporter's comment: The reporter asked that the second dose of Shingrix be administered outside of 1 year or did the series had to be restarted. No patient noted but submitting adverse event in the event that there was a specific patient for this inquiry.  This may or may not be a duplicate report.  No additional information was available.  Unknown if follow up was permissible with health care professional. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Ehlers-Danlos syndrome
Clinical narrative: FLARE UP OF EHLERS-DANLOS SYNDROME TO ENTIRE BODY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: ehlers-danlos syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced flare up of ehlers-danlos syndrome to entire body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flare up of ehlers-danlos syndrome to entire body. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dysstasia, Fatigue, Gait inability
Clinical narrative: LOST 60 POUNDS DUE TO A DEPRESSED APPETITE; CAN NOT WALK VERY FAR; CAN NOT STAND FOR LONG PERIODS; DEPRESSED APPETITE; SEVERE RASH OVER THE ENTIRE TRUNK OF HIS BODY; HE WAS TIRED ALL THE TIME; HE HAS NO ENERGY; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced lost 60 pounds due to a depressed appetite, can not walk very far, can not stand for long periods, depressed appetite, severe rash over the entire trunk of his body, he was tired all the time, and he has no energy. Laboratory data (dates unspecified) included: Weight loss lost 60 pounds due to a depressed appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the he was tired all the time, severe rash over the entire trunk of his body, he has no energy, lost 60 pounds due to a depressed appetite, can not walk very far, can not stand for long periods and depressed appetite was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Weight decreased
Clinical narrative: LOST 60 POUNDS DUE TO A DEPRESSED APPETITE; CAN NOT WALK VERY FAR; CAN NOT STAND FOR LONG PERIODS; DEPRESSED APPETITE; SEVERE RASH OVER THE ENTIRE TRUNK OF HIS BODY; HE WAS TIRED ALL THE TIME; HE HAS NO ENERGY; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced lost 60 pounds due to a depressed appetite, can not walk very far, can not stand for long periods, depressed appetite, severe rash over the entire trunk of his body, he was tired all the time, and he has no energy. Laboratory data (dates unspecified) included: Weight loss lost 60 pounds due to a depressed appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the he was tired all the time, severe rash over the entire trunk of his body, he has no energy, lost 60 pounds due to a depressed appetite, can not walk very far, can not stand for long periods and depressed appetite was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKER THAN A DOG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sicker than a dog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sicker than a dog was not reported. This report was non-serious.  This case, involving the same patient is linked to 20221232897 and 20221232989.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKER THAN A DOG; This spontaneous report received from a patient via a company representative via social media (Johnson and Johnson) concerned a patient of unspecified age, sex, 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, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total dose, start therapy date were not reported for covid-19 prophylaxis.  On an unspecified date, the patient experienced sicker than a dog (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sicker than a dog (Dose number in series 2). It was reported as "I wish the Covid boosters didn't make me so darn sick!!!"..."I got the. Johnson one shot, then I got the booster, then I got a 2nd booster! Everyone made me sicker than a dog!" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sicker than a dog was not reported. This report was non-serious. This case, involving the same patient is linked to 20221234602 and 20221234672.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: SORE SPOT AT THE VACCINATION, ABOUT THE SIZE OF A QUARTER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore spot at the vaccination, about the size of a quarter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore spot at the vaccination, about the size of a quarter. This report was non-serious. This case, involving the same patient is linked to 20221234779. This case, from the same reporter is linked to 20221234943 and 20221235149.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: SORE SPOT AT THE VACCINATION ABOUT THE SIZE OF A QUARTER; This spontaneous report received from a patient via a company representative via social media (Johnson & Johnson) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  The patient experienced sore spot at the vaccination about the size of a quarter with outcome recovered (duration 2 weeks) following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date (four months later after initial vaccine) for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sore spot at the vaccination about the size of a quarter (duration 2 weeks) (Dose number in series 2). The patient had no other noticeable reactions. The reporter stated that "I took the vaccination and 4 months later I took their booster, which was the same as the original vaccine. Both times I had a sore spot at the vaccination, about the size of a quarter for almost two weeks, but no other noticeable reactions". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore spot at the vaccination about the size of a quarter. This report was non-serious. This case, involving the same patient is linked to 20221234743.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caught Covid/ the husband got a mild case but the wife had a fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever). At the time of the report, COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Did not get 4th dose but had 3rd dose on Oct2021.  No concomitant medications were reported. No treatment medications were reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Product preparation error
Clinical narrative: patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline; No adverse event; Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline), ACCIDENTAL UNDERDOSE (Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient 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.     Concurrent medical conditions included Asthma.    On 13-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 13-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT PREPARATION ERROR (patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline), ACCIDENTAL UNDERDOSE (Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT PREPARATION ERROR (patient received a diluted vaccine/ toddler was administered a vaccine that was diluted with 1.3 ml normal saline) and ACCIDENTAL UNDERDOSE (Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years).    No concomitant medications were reported.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received previous doses and both doses were Moderna.   She received the 1st dose on 22-Jun-2022. The lot number was AS1414B, dosage was 25 mcg. She received the 2nd dose on 22-Jul-2022. The lot number was AS1414B.   Pharmacy manager calling to report a patient received a diluted vaccine. Toddler was administered a vaccine that was diluted with 1.3 ml normal saline. Patient received 0.2 ml dose from the reconstructed vaccine for 6 months to 5 years. The child was fine.   No treatment medication was provided.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; 0.5 dose of the Moderna Bivalent instead of the 0.25mL; This spontaneous case was reported by an other health professional and describes the occurrence of ACCIDENTAL OVERDOSE (0.5 dose of the Moderna Bivalent instead of the 0.25mL) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 12-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Dec-2022,  after starting , the patient experienced ACCIDENTAL OVERDOSE (0.5 dose of the Moderna Bivalent instead of the 0.25mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (0.5 dose of the Moderna Bivalent instead of the 0.25mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (0.5 dose of the Moderna Bivalent instead of the 0.25mL).    It was reported that this was the patients first dose with Moderna. Patient does not have any reactions to the vaccine. Patient previously had the primary series with Pfizer. No concomitant medication were reported. No treatment medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered
Clinical narrative: Moderna Bivalent Doses administered after 30 day use by date.; Moderna Bivalent Doses administered after 30 day use by date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Doses administered after 30 day use by date.), POOR QUALITY PRODUCT ADMINISTERED (Moderna Bivalent Doses administered after 30 day use by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Doses administered after 30 day use by date.), POOR QUALITY PRODUCT ADMINISTERED (Moderna Bivalent Doses administered after 30 day use by date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Doses administered after 30 day use by date.), POOR QUALITY PRODUCT ADMINISTERED (Moderna Bivalent Doses administered after 30 day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Doses administered after 30 day use by date.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Bivalent Doses administered after 30 day use by date.).    Treatment medication information was not provided by the reporter. No medical history was reported by the reporter.  Patient not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that  Moderna Bivalent Doses administered after 30-day used by date. 1 dose on 10-Dec-2022, 2 doses on 11-Dec-2022 and 1 Dose on 12-Dec-2022.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: But I had COVID. I still got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (But I had COVID. I still got COVID) in an elderly patient of an unknown gender 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 COVID-19 (But I had COVID. I still got COVID). At the time of the report, COVID-19 (But I had COVID. I still got COVID) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient was curious about the patient was given a booster shot, the patients second booster shot, which was through Moderna. But the patient had COVID. The patient still got COVID, so the patient was just curious maybe there was something the patient did not understand about it. This was the second day after the patient found that the patient had COVID.  Treatment information was not provided.