chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: given pediatric dose instead of adult dose; patient age 22 given pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number 34G75, expiry date 15th February 2024) for prophylaxis.   On 18th May 2022, the patient received Engerix B pediatric. On 18th May 2022, unknown after receiving Engerix B pediatric, 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.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: The reporter was an HCP (health care professional).  The reporter stated that this morning (on day of reporting) a patient received a dose Engerix B in right deltoid. The reporter stated that the patient was given pediatric dose of Engerix B instead of adult dose. The reporter also asked that if there was any information she needed to provide the patient. MI (Medical information) provided the phone number and reporter abandoned call prior to transfer. MI (Medical information) agent stated she would call reporter back. AE (adverse event) filed.  The reporter provided the limited information. Additional supportive information: The reporter reported that an adult patient received a pediatric dose of Engerix B, which led to underdose and adult use of child product.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 20th March 2022) for prophylaxis.   On 16th May 2022, the patient received Menveo. On 16th May 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: 18-MAY-2022 Reporter's Comments: The physician reported that a dose of Menveo was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Menveo dose which was already expired on 20th March 2022, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not sure if she got the second shot, first over 3years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix in left arm  on 31st January 2019 over 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-May-2022 Reporter's comment: The patient self reported this case. The patient was not sure if she got the second shot of Shingrix. The patient stated she could not found documentation of 2 vaccines. Did not consent to follow-up. Additional Supportive Information: Till the reporting the patient did not receive second of Shingrix, which led to incomplete course of vaccination. Note: Vaers details were added to second dose but it was related to first dose. No permission to follow up was granted, and no confirmation of a second dose was provided, incomplete course of vaccination was conservatively coded.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS IN LEFT LEG; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis, alcohol user (occasional average one drink per month), non-smoker, mobic allergy, latex-mild allergy, and drug allergy (Interferon Beta A-1). The patient had no drug abuse or illicit drug usage. On an unspecified date, the patient was previously received Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. On an unspecified date, following vaccination with Pfizer biontech covid-19 vaccine (tozinameran), the patient experienced severe anaphylactic reaction (Dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11-APR-2022) dose was not reported, 1 total administered in arm on 19-JAN-2022 for prophylactic vaccination. Age at time of vaccination 45 years old. No concomitant medications were reported.  Patient reported that he first noticed something with his leg in mid FEB-2022, and then it became worse in late MAR-2022 to early APR-2022 (Dose number in series 2). The patient was transported to emergency room. The patient experienced deep vein thrombosis in left leg (Dose number in series 2). On 27-APR-2022, the patient was admitted to the hospital. On 29-APR-2022, patient was discharged after having the blood clot removed (Dose number in series 2). The patient was hospitalized for 3 days. On around 02-MAY-2022 or 03-MAY-2022, the patient followed up with his PCP (Primary care physician). The patient visited physician office and emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from deep vein thrombosis in left leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220534919-Covid-19 vaccine ad26.cov2.s-deep vein thrombosis in left leg. 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.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF REFROZEN VACCINE TO THE PATIENTS; This spontaneous report received from a health care professional concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 20-MAY-2022) dose was not reported, administered on 24-APR-2022 for prophylactic vaccination. Age at time of vaccination 20 years old. No concomitant medications were reported.  On 24-APR-2022, the patient experienced administration of refrozen vaccine to the patients. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine to the patients and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537444, 20220537688, 20220538146, 20220538210, 20220538297, 20220538316, 20220537341, 20220538238, 20220537548, 20220538347, 20220539045, 20220538425, 20220538428, 20220538573, 20220538480, 20220537683, 20220538379, 20220538437, 20220538666, 20220540611, 20220538890, 20220540853, 20220541180, 20220540524, 20220540570, 20220540688 and 20220540420.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Body temperature decreased
Clinical narrative: ARTHRITIS WENT OUT OF CONTROL; LOW TEMP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis. 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 prophylactic vaccination. 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 arthritis went out of control, and low temp. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arthritis went out of control, and the outcome of low temp was not reported. This report was non-serious.; Sender's Comments: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS  REFROZEN; VACCINE WAS REFROZEN AND ADMINSTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821296 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Age at time of vaccination 49 years old. No concomitant medications were reported. On 24-MAY-2021, the patient experienced vaccine was refrozen and adminstered to patient. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and vaccine was refrozen and adminstered to patient was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537356, 20220537683, 20220538238, 20220537444, 20220537548, 20220539045, 20220538425, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220540435, 20220537688, 20220540474, 20220538890, 20220540853, 20220540611, 20220541180, 20220540524, 20220540570, 20220538316, 20220540688, 20220540420, 20220540765, 20220540814, 20220540816, 20220541085 and 20220538210.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 51 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously 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, administered on 05-APR-2021 for prophylactic vaccination. On an unspecified date, the vaccine was refrozen (Incorrect product storage) (Dose number in series 1) and on 05-APR-2021, the patient received refrozen vaccine (Out of specification product use) (dose number in series 1). The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 20-MAY-2022) dose was not reported, 1 total administered on 17-DEC-2021 in left arm for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported.  On an unspecified date, the vaccine was refrozen (Incorrect product storage) (Dose number in series 2) and on 17-DEC-2021, the patient received refrozen vaccine (Out of specification product use) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220537548. This case, from the same reporter is linked to 20220537683, 20220538238, 20220537532, 20220539045, 20220538428, 20220538573, 20220538480, 20220538149, 20220538627, 20220540853, 20220540611, 20220541180, 20220540524, 20220540570, 20220538316, 20220540688, 20220537688, 20220537507, 20220538437, 20220538666, 20220538292, 20220538411, 20220537356, 20220538425 and 20220538758.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 52 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, 1 total administered to left arm on 08-SEP-2021 for prophylactic vaccination and the patient experienced administration of refrozen vaccine following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 20-MAY-2022) dose was not reported, 1 total administered to left arm on 25-JAN-2022 for prophylactic vaccination. Age at time of vaccination 52 years old. No concomitant medications were reported. On an unspecified date, the vaccine was refrozen (Dose number in series 2) and on 25-JAN-2022, the patient experienced administration of refrozen vaccine (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220537688. This case, from the same reporter is linked to 20220538238, 20220537548, 20220537683, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220537688, 20220538627, 20220537341, 20220537444, 20220538292, 20220538411, 20220537356, 20220538693, 20220539045, 20220537532, 20220538146, 20220538316, 20220538210, 20220538758, 20220538437, 20220538425, 20220540435, 20220537507, 20220540853, 20220540611, 20220541180, 20220540524, 20220540570, 20220540688, 20220540474, 20220540765, 20220540420, 20220540814, 20220541085 and 2005084289.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 20-MAY-2022) dose was not reported, administered on 20-DEC-2021 for prophylactic vaccination. Age at time of vaccination 59 years old. No concomitant medications were reported. On 20-DEC-2021, the patient experienced janssen covid 19 vaccine was refrozen and administered. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen covid 19 vaccine was refrozen and administered and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537548, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538437, 20220539045, 20220538666, 20220537688, 20220540611, 20220538693, 20220540474, 20220538890, 20220540853, 20220541180, 20220540524, 20220540570, 20220538316, 20220540688, 20220538347, 20220540642, 20220540814, 20220540765, 20220540420, 20220540816 and 20220541085.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 19 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1821286 and expiry: 20-MAR-2022) dose was not reported, 1 total, administered to left arm on 24-AUG-2021 for prophylactic vaccination. The patient experienced administration of refrozen vaccine following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1).  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A and expiry: 20-MAY-2022) dose was not reported, 1 total, administered to left arm on 27-JAN-2022 for prophylactic vaccination. Age at time of vaccination 19 years old. No concomitant medications were reported. On an unspecified date, the vaccine was refrozen (Dose number in series 2) and on 27-JAN-2022, the patient experienced administration of refrozen vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, involving the same patient is linked to 20220537507. This case, from the same reporter is linked to 20220538428, 20220538573, 20220538480, 20220538149, 20220538379, 20220539045, 20220540611, 20220538693, 20220540435, 20220540524, 20220540474, 20220538890, 20220538347, 20220540853, 20220541180, 20220538292, 20220537683, 20220538316, 20220540688, 20220540642, 20220540765, 20220540420, 20220540814, 20220540816 and 20220541085.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 27 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 20-MAY-2022) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2022, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540435, 20220540524, 20220540474, 20220538758, 20220540688, 20220540642, 20220540536, 20220540570, 20220540816, 20220538627, 20220540524, 20220540853, 20220540474, 20220540324, 20220540420, 20220540435, 20220540765, 20220538146, 20220538297, 20220538316, 20220538210, 20220538238, 20220538758, 20220538428, 20220537532, 20220539045, 20220538693, 20220538411, 20220538292, 20220538666, 20220537444, 20220538437, 20220537341, 20220538149, 20220537507, 20220537683, 20220541180, 20220540814 and 20220541085.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient concerned a 6 decade old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. Age at time of vaccination 56 years old. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient was recovering from covid-19. This report was non-serious. This report was associated with a product quality complaint: 90000232041.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF FROZEN VACCINE; This spontaneous report received from a health care professional concerned a 46 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Age at time of vaccination 46 years old. No concomitant medications were reported.  On 09-SEP-2021, the patient experienced administration of frozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of frozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, involving the same patient is linked to 20220538693. This case, from the same reporter is linked to 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220537341, 20220537683, 20220537688, 20220538146, 20220538210, 20220538238, 20220538292, 20220538316, 20220538347, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538379, 20220538627, 20220538411, 20220538425, 20220538758, 20220538437, 20220538666, 20220540524, 20220540435 and 20220540611.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 31 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 and expiry: 20-MAR-2022) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. Age at time of vaccination 31 years old. No concomitant medications were reported. On 01-SEP-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540435, 20220540611, 20220540524, 20220540474, 20220538890, 20220540853, 20220541180, 20220537683, 20220540688, 20220541180, 20220541085, 20220540642, 20220540642, 20220540536, 20220541506, 20220540570, 20220540570, 20220540816, 20220540611, 20220540524, 20220540853, 20220541401, 20220540814, 20220537507, 20220540765 and 20220540420.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. Age at time of vaccination 60 years old. No concomitant medications were reported.  On 08-SEP-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540611, 20220540524, 20220540474, 20220538890, 20220541180, 20220537683, 20220538292, 20220538693, 20220537341, 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220538146, 20220538210, 20220538238, 20220538297, 20220538316, 20220541401, 20220541085, 20220540688, 20220540765, 20220540814, 20220540642, 20220540570, 20220540536, 20220540435, 20220540324, 20220539045, 20220537688, 20220538149, 20220538347, 20220538379, 20220538411, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538627, 20220538666, 20220538758, 20220541506 and 20220540853.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. Age at time of vaccination 44 years old. No concomitant medications were reported. On 09-AUG-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540611, 20220540524, 20220538292, 20220537341, 20220537356, 20220537444, 20220537683, 20220537688, 20220538146, 20220538149, 20220538210, 20220538238, 20220538297, 20220538316, 20220538411, 20220538425, 20220538428, 20220538437, 20220538627, 20220538666, 20220538758, 20220538890, 20220539045, 20220540324, 20220540420, 20220540435, 20220540536, 20220540570, 20220540642, 20220538480, 20220541180, 20220540765, 20220540814, 20220538693, 20220537507, 20220537532, 20220537548, 20220538347, 20220538573, 20220540688, 20220541401, 20220541506, 20220541085, 20220540765, 20220538379 and 20220540816.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION  OF FROZEN VACCINE; This spontaneous report received from a health care professional concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 and expiry: 20-MAR-2022) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Age at time of vaccination 62 years old. No concomitant medications were reported. On 06-JUL-2021, the patient experienced administration of frozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of frozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540611, 20220540524, 20220540474, 20220538890, 20220541180, 20220537683, 20220540688, 20220540570, 20220540324, 20220541085, 20220541506, 20220540816, 20220540853, 20220541401, 20220540435, 20220537507, 20220540642, 20220540765, 20220540814 and 20220540420.
Sex: F
Vaccine: 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 concerned a female of unspecified age. Initial information was processed along with additional information received on 20-MAY-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total was administered in right arm on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2022, the patient started developing symptoms. The patient had chest pain with cough, and felt tired. The patient was tested positive to covid-19 (confirmed covid-19 infection) and hence confirmed clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. 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 case was associated with product quality complaint: 90000232251.; Sender's Comments: V0:20220540807-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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENTS; This spontaneous report received from a health care professional concerned a 24 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. Age at time of vaccination 24 years old. No concomitant medications were reported.  On 13-JUL-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patients. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patients and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220541180, 20220537683, 20220540524, 20220540420, 20220540688, 20220540570, 20220540324, 20220540536, 20220540642, 20220540765, 20220540474, 20220540814, 20220540816, 20220538292, 20220538693, 20220537356, 20220537444, 20220537548, 20220538210, 20220538297, 20220538316, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538627, 20220538666, 20220538758, 20220539045, 20220540324, 20220540420, 20220540474, 20220540536, 20220540570, 20220540611, 20220540642, 20220537507, 20220537683, 20220537532, 20220538146, 20220538149, 20220538238, 20220538347, 20220538411, 20220540435, 20220540816, 20220540814, 20220540765, 20220540688, 20220541180, 20220541401, 20220538379, 20220540853, 20220541506, 20220538890 and 20220537341.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, Immunodeficiency
Clinical narrative: IMMUNOCOMPROMISED; NO COVID ANTIBODY RESPONSE FOLLOWING VACCINATION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 61 year old male of an unspecified race and ethnicity. Initial information was processed along with additional information received on 20-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: mantle cell lymphoma, and other pre-existing medical conditions included: No other concomitant drugs taken apart from ibrutinib. The patient previously received two doses of Moderna covid-19 vaccine (Elasomeran) (dose number in series 1) (form of admin unknown, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 01-MAR-2021, and on 30-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with two doses of Moderna covid-19 vaccine (Elasomeran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on 01-JUN-2021 for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered. Age at time of vaccination 61 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib for mantle cell lymphoma.  On an unspecified date, the patient was immunocompromised, had no covid antibody response following vaccination (low IgA, low IgE, low IgG, and low IgM) (dose number in series 2). Laboratory data (dates unspecified) included: IgA (NR: not provided) IgA decreased, IgE (NR: not provided) IgE decreased, IgG (NR: not provided) IgG decreased, and IgM (NR: not provided) IgM decreased (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from immunocompromised, no covid antibody response following vaccination, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232180. This case, involving the same patient is linked to 20220529781.; Sender's Comments: V0: 20220541341-COVID-19 VACCINE AD26.COV2.S-Immunocompromised. 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: MEDICAL HISTORY, UNDERLYING DISEASE. Therefore, this event(s) is considered not related.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Vaccine induced antibody absent
Clinical narrative: IMMUNOCOMPROMISED; NO COVID ANTIBODY RESPONSE FOLLOWING VACCINATION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 61 year old male of an unspecified race and ethnicity. Initial information was processed along with additional information received on 20-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: mantle cell lymphoma, and other pre-existing medical conditions included: No other concomitant drugs taken apart from ibrutinib. The patient previously received two doses of Moderna covid-19 vaccine (Elasomeran) (dose number in series 1) (form of admin unknown, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 01-MAR-2021, and on 30-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with two doses of Moderna covid-19 vaccine (Elasomeran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on 01-JUN-2021 for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered. Age at time of vaccination 61 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib for mantle cell lymphoma.  On an unspecified date, the patient was immunocompromised, had no covid antibody response following vaccination (low IgA, low IgE, low IgG, and low IgM) (dose number in series 2). Laboratory data (dates unspecified) included: IgA (NR: not provided) IgA decreased, IgE (NR: not provided) IgE decreased, IgG (NR: not provided) IgG decreased, and IgM (NR: not provided) IgM decreased (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from immunocompromised, no covid antibody response following vaccination, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232180. This case, involving the same patient is linked to 20220529781.; Sender's Comments: V0: 20220541341-COVID-19 VACCINE AD26.COV2.S-Immunocompromised. 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: MEDICAL HISTORY, UNDERLYING DISEASE. Therefore, this event(s) is considered not related.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED; This spontaneous report received from a health care professional concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 12-SEP-2021 for prophylactic vaccination. Age at time of vaccination 44 years old. No concomitant medications were reported. On 12-SEP-2021, the patient experienced incorrect product storage, and the janssen covid 19 vaccine was refrozen and administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and the janssen covid 19 vaccine was refrozen and administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220540524, 20220540420, 20220540688, 20220540570, 20220540324, 20220540536, 20220540611, 20220540642, 20220540765, 20220540474, 20220540814, 20220540816, 20220541085, 20220537548, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220538437, 20220539045, 20220538666, 20220537688, 20220538693, 20220540853, 20220541180, 20220538316 and 20220538347.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN (INCORRECT PRODUCT STORAGE); ADMINISTRATION OF REFROZEN VACCINE (OUT OF SPECIFICATION PRODUCT USE); This spontaneous report received from a health care professional concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and  expiry: 20-MAR-2022) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. Age at time of vaccination 66 years old. No concomitant medications were reported. On 07-JUL-2021, the patient experienced administration of refrozen vaccine (out of specification product use). On an unspecified date, the patient experienced vaccine was refrozen (incorrect product storage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine (out of specification product use) and vaccine was refrozen (incorrect product storage) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540524, 20220537683, 20220540688, 20220540570, 20220540324, 20220540536, 20220540611, 20220540642, 20220540765, 20220540474, 20220540814, 20220540420, 20220540816 and 20220541085.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: TASTE CHANGE / BITTERNESS IN MOUTH; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 56 year old adult male. The patient's height, and weight were not reported. The patient's past medical history included: gall bladder removed, COVID-19, and pulmonary embolism, and concurrent conditions included: sleep apnea, fatty liver, hypertensive disorder, and diabetes, and other pre-existing medical conditions included: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: unknown) dose was not reported, 1 total administered on 11-APR-2021 on left arm for prophylactic vaccination. Age at time of vaccination 55 years old. Concomitant medications included amlodipine, rivaroxaban, metformin and omeprazole. It was unknown if patient experienced any adverse reactions following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine tozinameran (Pfizer) (dose number in series 2) (form of admin, route of admin, were not reported, batch number: FH8030 and expiry: unknown) dose was not reported, administered on 21-NOV-2021 on left arm for prophylactic vaccination.   On 10-MAY-2022, the patient received Paxlovid (nirmatrelvir/rotinavir) (form of admin, route of admin were not reported, batch number: FY7031 and expiry: unknown) dose was not reported for treatment of Covid-19. On 11-MAY-2022 at 8:00, the patient experienced taste change / bitterness in mouth (dose number in series 2). The patient did not receive any treatment and was not hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from taste change / bitterness in mouth. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE FOR A DAY OR TWO; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on FEB-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced soreness at injection site for a day or two. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site for a day or two. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Vaccination site pain
Clinical narrative: PAIN ON THE HAND ON WHICH PATIENT HAD THE VACCINE; TINGLING FEELING ON THE HAND ON WHICH PATIENT HAD THE VACCINE; This spontaneous report received from a patient via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on DEC-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2022, the patient experienced pain on the hand on which patient had the vaccine, and tingling feeling on the hand on which patient had the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain on the hand on which patient had the vaccine and tingling feeling on the hand on which patient had the vaccine was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest pain, Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: ACID REFLUX; CHEST PAINS; SEVERE HEART BURN; This spontaneous report received from a patient concerned a 7 decade old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: 1162124 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. Age at time of vaccination 66 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced acid reflux, chest pains, and severe heart burn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the acid reflux, chest pains and severe heart burn was not reported. This report was non-serious.