chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient did not receive 3rd dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 27th January 2022) and Twinrix (2nd dose received on 28th February 2022).   On an unknown date, the patient did not received the 3rd dose of Twinrix and hepatitis A and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Twinrix and hepatitis A and hepatitis B vaccine 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: 29-AUG-2022 Reporters comment: The patient received first dose on 27th Jan 2022 and second dose received on 28th Feb 2022.Later than 6 months between dose 2 and 3 patient yet did not received 3rd dose of twinrix vaccine. The reporter given consent to follow-up. HCP unable to provide additional AE details at that time, given permission for safety team follow up Additional Supportive information: Till the time of reporting the patient did not received 3rd dose of Twinrix, which led to incomplete course of vaccination.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Feeling hot, Hypersensitivity, Pruritus
Clinical narrative: Cellulitis/ ER diagnosis; Itching/ marks because of the itching; Redness; Swelling; Warm; Allergic reaction/ ER diagnosis; marks because of the itching; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring. The patient was treated with cefalexin (Keflex) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the cellulitis, pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring were unknown.   It was unknown if the reporter considered the cellulitis, pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: The pharmacist reported that patient received Shingrix first dose and had itching, mark because of the itching, redness, swelling and warm. The patient went to the ER (Emergency room) and the diagnosis was cellulitis- allergic reaction.  The patient's doctor did not agree with this diagnosis.  The patient was given Keflex and Benadryl in the ER (Emergency room). The reporter consent to follow up by email.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Scar, Swelling
Clinical narrative: Cellulitis/ ER diagnosis; Itching/ marks because of the itching; Redness; Swelling; Warm; Allergic reaction/ ER diagnosis; marks because of the itching; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring. The patient was treated with cefalexin (Keflex) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the cellulitis, pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring were unknown.   It was unknown if the reporter considered the cellulitis, pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: The pharmacist reported that patient received Shingrix first dose and had itching, mark because of the itching, redness, swelling and warm. The patient went to the ER (Emergency room) and the diagnosis was cellulitis- allergic reaction.  The patient's doctor did not agree with this diagnosis.  The patient was given Keflex and Benadryl in the ER (Emergency room). The reporter consent to follow up by email.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 25 feb 2022, 2nd on 28Aug2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female 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 (1st dose received on 25th Feb 2022).   On 28th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 28th August 2022, 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: 29-Aug-2022 Reporters comment:  The reporter given consented to follow up Additional Supportive information: The patient received second dose of Twinrix, later than recommended time interval, which led to lengthening of vaccination schedule.  .
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 6 months after dose 1; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female 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 (1st dose received on February 2022).   On 29th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 29th August 2022, 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: 29-AUG-2022 Reporter's Comment: The reporter reported that the patient received second dose of Twinrix vaccine after 6 months from first dose. The reporter stated that the patient received vaccinations at a pharmacy and not in his office. The reporter was unable to provide any additional details at the reporting time. The reporter consented to follow up.  Additional supportive information: The patient received 2nd dose of Twinrix later than recommended time frame, which led to lengthening of vaccination schedule.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero instead of menactra; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 4CY37, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Aug-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received Bexsero instead of Menactra, which led to wrong vaccine administered.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Accelerated dosing, did not receive 4th dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female 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 accelerated dosing for Twinrix back in 2011).   On an unknown date, the patient did not receive the 4th 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: 31-AUG-2022 Reporter's Comment:  The reporter reported that the patient started the accelerated dosing for Twinrix vaccine in 2011 but did not received the 4th dose of Twinrix vaccine. The reporter stated that the vaccine administration facility was the same as primary reporter. The reporter declined to provide patient initials and date of birth. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 4th dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The nurse reported that  a patient of unknown gender received an expired dose of Bexsero. The reporter did not had the patient's initials, gender or date of birth. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept 2022 Reporter's comment: The clinical supervisor reported that nurse administered an expired dose of Havrix to an adult patient. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired  vaccine used.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA588A, expiry date 31st August 2022) for prophylaxis.   On 1st September 2022, the patient received Menveo. On 1st September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-Sept 2022 Reporter's comment: The medical assistant called to inquired that the patient should be revaccinated. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Menveo on the day of reporting, which led to expired vaccine used.
Age: 22.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) 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.   On 1st September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case was linked with case US2022126915 and US2022126900, reported by same reporter.; Sender's Comments:  US-GSK-US2022126915:Same reporter US-GSK-US2022126900:Same reporter
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) 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.   On 1st September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case was linked with case US2022126915 and US2022126898, reported by same reporter.; Sender's Comments:  US-GSK-US2022126915:Same reporter US-GSK-US2022126898:Same reporter
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) 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.   On 1st September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case was linked with case US2022126900 and US2022126898, reported by same reporter.; Sender's Comments:  US-GSK-US2022126898:Same reporter US-GSK-US2022126900:Same reporter
Age: 36.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: a dose that expired was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA591A, expiry date 31st August 2022) for prophylaxis.   On 1st September 2022, the patient received Menveo. On 1st September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comments: The reporter reported that patient received expired dose of Menveo which was expired one day before reporting. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix instead of Tdap; inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st 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: 01-SEP-2022 Reporter's comment: Medical student reported that the patient inadvertently received Infanrix today (day of reporting) instead of Tdap. The reporter declined to provide patient information (and chose to stay anonymous).  The reporter did not consent to follow-up. Additional Supportive Information: The 11 year old patient inadvertently received Infanrix today (day of reporting) instead of Tdap, which led to Wrong vaccine administered and Inappropriate age at vaccine administration.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The licensed practical nurse reported administration of Bexsero, that had an expiration date of 31st July 2022. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: A NERVE GOT IMPACTED DURING THE PROCESS OF VACCINATION; This spontaneous report received from a physician 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 was not reported, 1 total, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, it was reported that "a nerve got impacted during the process of vaccination and patient had to have surgery". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a nerve got impacted during the process of vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220865061 -covid-19 vaccine ad26.cov2.s- A nerve got impacted during the process of vaccination. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Artery dissection
Clinical narrative: ARTERIAL DISSECTION; This spontaneous report received from a parent via social media via a company representative concerned an adult female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total 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 arterial dissection, it weakened her artery from neck to brain that it tore. Reporter stated "J and J almost killed my adult daughter. "Arterial Dissection". The specialist told us it was caused by the J and J shot. It weakened her artery from neck to brain that it tore". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arterial dissection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220865333-covid-19 vaccine ad26.cov2.s-Arterial dissection . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: GENERALIZED PAIN/BODY ACHES THROUGHOUT; HEADACHE; FEVER 101F; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 24-SEP-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 24-SEP-2021, the patient experienced generalized pain/body aches throughout, headache, and fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized pain/body aches throughout, and headache on 27-SEP-2021, and fever 101f. This report was non-serious. This parent/child case is linked to 20220901626.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease
Clinical narrative: CROHNS DISEASE AGGRAVATED; This spontaneous report received from a patient via other company concerned a 28 year old male of an unspecified race and ethnicity.   The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. Concomitant medications included prednisone.  On an unspecified date in 2022, the patient experienced Crohns disease aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of Crohns disease aggravated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220901987-covid-19 vaccine ad26.cov2.s-Crohns disease aggravated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:  UNDERLYING DISEASE (Crohn's disease). Therefore, this event(s) is considered not related.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a other company (Pfizer, Inc.) concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis (on Entyvio infusion), and allergy (Unspecified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total, dose 1 administered in right arm on 15-FEB-2022 10:30 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 44 years old. The patient received non-company suspect booster vaccine elasomeran (Moderna covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, dose 2 administered on 2022 (date and month unspecified) for covid-19 prophylaxis. Concomitant medications included vedolizumab for ulcerative colitis, butalbital/caffeine/paracetamol, and trazodone. On 2022 (Date and month unspecified), the patient had covid-19 (Dose number in series: 2). The patient received non-company suspect drug Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, from 16-AUG-2022 to 21-AUG-2022 for treatment of COVID-19. On 21-AUG-2022 14:30 (afternoon) following 5 days of treatment with Paxlovid, the patient still tested positive which was confirmed covid-19 infection (Dose number in series: 2) and had confirmed clinical vaccination failure (Dose number in series: 1). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran (Moderna covid-19 vaccine)was not applicable, and treatment discontinued with Paxlovid. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000249240.; Sender's Comments: V0: 20220904514-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other company (Pfizer) concerned a 37 year old male of unspecified ethnic origin. Initial information was processed along with the additional information received on 05-SEP-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies nor other medical history at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 35 years old. No concomitant medications were reported. The patient additionally received a non-company suspect vaccine included: tozinameran (Pfizer) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on NOV-2021 for covid-19 prophylaxis. The covid test had rebounded after finishing the Paxlovid treatment and remained positive for a week (confirmed clinical vaccination failure) (Dose number in series 1).  Mild cold like symptoms also occurred after the treatment (confirmed covid-19 infection) (Dose number in series 2). The patient received Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 10-AUG-2022 to 14-AUG-2022 for covid-19 treatment.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tozinameran was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000249245.; Sender's Comments: V0: 20220904972-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 36 year old female. Initial information was processed along with additional information on 05-SEP-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: idiopathic hypersomnia, anxiety, environmental allergies, and ceclor allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021 at left arm for covid-19 prophylaxis. Age at time of vaccination 34 years old. Concomitant medications included citalopram hydrobromide, fluticasone furoate, guaifenesin, loratadine, modafinil, naproxen sodium, paracetamol, phenylephrine hydrochloride, pseudoephedrine hydrochloride, and saccharomyces boulardii for drug used for unknown indication. The patient additionally received moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin and route was not reported, batch number: 037F21A expiry: Unknown) dose was not reported, administered on 04-NOV-2021 at left arm for covid-19 prophylaxis. On an unspecified date in AUG-2022, the patient had confirmed covid-19 infection (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). The patient received paxlovid (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 08-AUG-2022 to 12-AUG-2022 for covid-19 infection. From 12-AUG-2022 to 19-AUG-2022, the patient tested negative for covid-19. The patient stopped testing since it had been a week since end of paxlovid and no positive tests. On 20-AUG-2022, the patient had worse cough and thought may be due to covid bronchitis. The cough was with white mucus. On 21-AUG-2022 morning, covid-19 test was performed and found to be positive.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000249247.; Sender's Comments: V0:20220904994-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Made the patient sick) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Made the patient sick). At the time of the report, ILLNESS (Made the patient sick) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications was reported. It was reported that the patient really thought that lawsuit was selfish, the patient had not thought you know, and mentioned thank God Moderna was not in the patient. It was further reported that bad business and patients should turn the vaccine away for Pfizer. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 27Jul2022 and administration of vaccine on 31Aug2022.) and NO ADVERSE EVENT (No adverse event) in a child 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 31-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator on 27Jul2022 and administration of vaccine on 31Aug2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 27Jul2022 and administration of vaccine on 31Aug2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (initially stored in the refrigerator on 27Jul2022 and administration of vaccine on 31Aug2022). 3 kids who got the Moderna 6 month to 5-year-old lot number AS1412B yesterday 31Aug2022 and it looks like it expired on the 27th. The reporter like to know if we have information regarding re-administration for those doses and what to do? The vial was initially stored in the refrigerator on 27Jul2022. The date of administration of vaccine on 31Aug2022. The vial did not undergo any temperature excursions. All three patients were under 5 years old. Reporter declines providing any additional patient information.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm after each dose of the Moderna Covid-19 Primary Series Vaccine.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm after each dose of the Moderna Covid-19 Primary Series Vaccine.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm after each dose of the Moderna Covid-19 Primary Series Vaccine.). At the time of the report, VACCINATION SITE PAIN (sore injection site arm after each dose of the Moderna Covid-19 Primary Series Vaccine.) outcome was unknown.            Concomitant medication details were not reported. Treatment details were not reported by the reporter.   This case was linked to MOD-2022-637953 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of FALL (fell of the chair) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell of the chair). At the time of the report, FALL (fell of the chair) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. It was reported that, patient didn't have a reaction but fell of the chair after receiving the vaccine. No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Insomnia, Myalgia
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of feeling abnormal, insomnia (cannot get enough sleep), myalgia (body ache), headache(s) and fatigue (tired) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 29, 2022, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first and second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Aug 29, 2022, patient experienced feeling abnormal, insomnia (cannot get enough sleep), myalgia (body ache), headache(s) and fatigue (tired). At the time of the report, feeling abnormal, insomnia (cannot get enough sleep), myalgia (body ache), headache(s) and fatigue (tired) outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2022-637949 (patient link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: she experienced a slight reaction with slight fever the next day; she experienced a slight reaction with slight fever the next day; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (she experienced a slight reaction with slight fever the next day) and PYREXIA (she experienced a slight reaction with slight fever the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Patient had no allergies.  Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE and FOLIC ACID for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (she experienced a slight reaction with slight fever the next day) and PYREXIA (she experienced a slight reaction with slight fever the next day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In January 2021, VACCINATION COMPLICATION (she experienced a slight reaction with slight fever the next day) and PYREXIA (she experienced a slight reaction with slight fever the next day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient took Tylenol and felt fine after an hour.   This case was linked to MOD-2022-638295, MOD-2022-638298 (Patient Link).
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: no adverse event; administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose; administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose), COVID-19 IMMUNISATION (administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose) and NO ADVERSE EVENT (no adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FT9142) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 (0.2ml). Lot number: FT9142) on 07-Jul-2022. Past adverse reactions to the above products included No adverse event with Pfizer.    On 01-Sep-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Sep-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose) and COVID-19 IMMUNISATION (administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose), COVID-19 IMMUNISATION (administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose) and COVID-19 IMMUNISATION (administered Moderna Covid-19 vaccine to a patient who was administered with Pfizer as 1st dose).    No concomitant drug information was provided.  It was reported that patient was inadvertently administered Moderna COVID-19 vaccine by the nurse who was administered with Pfizer as first dose. No adverse events were reported at the time of the call.  No treatment drug information was provided.