chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: diluent portion administered alone; diluent portion administered alone; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2022, the patient received Shingrix. On 29th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 1-Aug-2022 Reporter's comments: Medical assistant lead reported that the patient received the Shingrix diluent alone. The consented to follow up was granted. The follow up requested by postal. Additional Supportive Information: As patient received the Shingrix diluent alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the diluent portion; administered only the diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 01-AUG-2022 Reporter's comment: The Nurse reported that an unknown patient was administered only the diluent portion of the Menveo. They had discovered this after going to the clinic where they found one vial of the lyophilized vaccine. The reporter gave consent to follow up. Additional supportive information: The patient was administered only the only the diluent portion of the Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Administration of Pediarix with temperature excursion of 47.5 Fahrenheit/ 22 minutes; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a child female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comments: The health Care Provider called and reported that 2 patients were vaccinated with vaccines that were exposed to a temperature excursion of 47.5 degree Fahrenheit for 22 minutes.  The patient reported on this AE Report by providing lot number and Expiry date of Pediarix. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Pediarix which was went to temperature excursion of 47.5 degree Fahrenheit for 22 minutes, which led to incorrect storage of vaccine. This case was linked with US2022113810 reported by same reporter for different male patient received boostrix vaccine.; Sender's Comments:  US-GSK-US2022113810:Same reporter
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: patients exposed to vaccine with temperature excursion of 47.5°F/ 22 minutes; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27th October 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comments: The health Care Provider called and reported that 2 patients were vaccinated with vaccines that were exposed to a temperature excursion of 47.5 degree Fahrenheit for 22 minutes.  The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Boostrix which was went to temperature excursion of 47.5 degree Fahrenheit for 22 minutes, which led to incorrect storage of drug. This case was linked with US2022113808 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022113808:Same reporter
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 unknown, expiry date 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 August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 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-Aug-2022 Reporter's comment: A nurse reported that a patient received an expired dose of Bexsero on the day of reporting. The reporter did not had patient details (initials, date of birth, gender) at the time of report. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: received extra dose by error; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 22-year-old male patient who received HBV (Engerix B) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   On 29th July 2022, the patient received the 4th dose of Engerix B. On 29th July 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The nurse had two adult patients that received Engerix-B extra dose by error. The reporter consented to follow-up via email. This case is for 1 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received an extra dose of Engerix-B, which led to extra dose administered. As there is no information regarding the primary vaccination of Engerix therefore Extra dose administered event coded as it was clearly stated by error dose was administered and for the primary vaccination details follow-up query was raised.; Sender's Comments:  US-GSK-US2022113819:Same reporter
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose instead of adult one; pediatric dose instead of adult one; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 25N39, expiry date 16th March 2024) for prophylaxis.   On 15th July 2022, the patient received Engerix B pediatric. On 15th July 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: 01-Aug-2022 Reporter's comment: The reporter reported that the patient received a pediatric dose of Engerix instead of an adult one. The reporter consented to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix instead of an adult one, which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 1May2018, has not received dose two.; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01st May 2018).   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: 1-Aug-2022 Reporter's comment: The pharmacist reported that a patient had not receive dose two of Shingrix. The reporter did not want to share patient related information. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only diluent portion; administered only diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA602A, expiry date 13th May 2023) for prophylaxis.   On 29th July 2022, the patient received Menveo. On 29th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The registered nurse asked that how to proceed if by accident they administered only the diluent portion of Menveo. The reporter consented to follow-up. Additional supportive information: The patient was accidently administered only the diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 63.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Pediarix instead of Engerix-B; 63 year-old received Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 63-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose in December 2021) and Engerix B (received 2nd dose on 17th January 2022).   On 13th June 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Pediarix and Pediarix 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-Aug-2022 Reporter's comment: The patient received Pediarix vaccine instead of Engerix-B third dose. The reporter consented to follow-up. Additional supportive information: The patient received Pediarix vaccine instead of third dose of Engerix-B, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: got a third dose; got the second greater than 6 months from the first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose of Shingrix intramuscularly on 28th February 2020).   On 30th July 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 19th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 30th July 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The pharmacist stated that they had a patient that got 3rd dose of Shingrix vaccine. The patient also got the 2nd dose of shingrix vaccine greater than 6 months from the 1st vaccine (inappropriate schedule of vaccine).  The pharmacist did not had the lot or expiration of the vaccines. The reporter did not consent to follow-up. Additional supportive information: The patient received the 2nd dose of Shingrix in unknown arm later the recommended interval, which led to lengthening of vaccine schedule. The patient got the 3rd dose of Shingrix in left arm, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received only one dose of shingrix on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received one dose of Shingrix in 2019).   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: 01-Aug-2022 Reporter's comment: The pharmacist reported the patient had received only one dose of Shingrix. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccinated with an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th 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 29th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 29th July 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-Aug-2022 Reporter's comment: The registered pharmacist reported that the patient was vaccinated with an expired dose of Havrix. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Depression, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; DEPRESSIVE STATES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection and depressive states. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and depressive states was not reported. This report was non-serious. This case, from the same reporter is linked to 20220752365. This report was associated with a product quality complaint: 90000243836.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: RECEIVED THE VACCINE FROM A BATCH THAT WAS TO BE DISCARDED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 63 year old female. 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: 04-AUG-2022) dose was not reported, administered on 22-APR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 63 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 22-APR-2022, the patient experienced received the vaccine from a batch that was to be discarded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the vaccine from a batch that was to be discarded and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759337, 20220759052, 20220759222, 20220761815, 20220759160 and 20220759219.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant, Systemic lupus erythematosus
Clinical narrative: CANCER; LUPUS; This spontaneous report received from a patient via a social media and by a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, dose 1, 1 in total administered 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 following dose 1 vaccination with covid-19 vaccine ad26.cov2.s, the patient was diagnosed with cancer and lupus. It was reported that "Hey guess what Cancer diagnosis. Lupus diagnosis. Fully vaccinated". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cancer and lupus was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220759796.; Sender's Comments: V0: 20220759828- covid-19 vaccine ad26.cov2.s-Cancer. 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: NATURE OF EVENT. Therefore, this event(s) is considered not related.  20220759828- -covid-19 vaccine ad26.cov2.s- Lupus. The event(s) has a 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 antibody test
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's past medical history included: ascorbic acid over dose, myocarditis, and pericarditis, and concurrent conditions included: hay fever, sulfa allergy, non smoker, alcohol user (occasionally red wine), and drug abuse/illicit drug usage. The patient was previously treated with cortisone. The patient had experienced guillain-barre syndrome when treated with influenza vaccine for prophylactic 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: 1805025 expiry: 20-JAN-2022) dose was not reported, 1 total administered on 26-MAR-2021 to the right arm for covid-19 prophylaxis.  On an unspecified date the patient experienced a bump 2-3 inches below the top shoulder joint at the injection site, a little feverish, discomfort in arm, headache, not feeling well and soreness at the injection site (dose number in series 1). The soreness at the injection site, a little feverish and headache was for a week only. The patient 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: 211D21A, expiry: 08-SEP-2022) dose was not reported, 1 total administered on 11-DEC-2021 to the right arm for covid-19 prophylaxis. Age at time of vaccination 74 years old. No concomitant medications were reported. On MAY-2022, the patient experienced flu like symptoms (dose number in series 2). On 27-JUL-2022, Laboratory data included: SARS-CoV-2 antibody test spike antibodies was high around 250 and mentioned SARS /cov/ 2 spike protein total AB semi-quantitative exceeding 250U/mL (less then 0.80 u/ml negative for Anti SARS antibody). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious. This case, from the same reporter is linked to 20211240426 (dose number in series 1).
Sex: M
Vaccine: COVID19
Symptoms: Myocardial injury, Thrombosis
Clinical narrative: BLOOD CLOT IN WIDOWMAKER; HUGE DAMAGE TO HEART; This spontaneous report received from a consumer (patient's wife) via company representative via social media concerned a 58 year adult male. 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 was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date 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 had a blood clot in the widowmaker and died for 3 minutes with a huge damage to heart.  The reporter stated that "my husband's vaccine gave him a blood clot in his widowmaker and he died for 3 minutes and huge damage to his heart. He is only 58 and can never work again". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in widowmaker and huge damage to heart was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220801546..; Sender's Comments: V0: 20220801520-covid-19 vaccine ad26.cov2.s- Blood clot in widowmaker and huge damage to heart. The event(s) has a 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: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient via social media via a company representative concerned an 80 year old male 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, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots. Reported that "My 80+ year old husband got blood clots after getting J&J shot! My brother and I did not get blood clots! The medication cost has taken a toll on our budget as well as his health! And we have excellent insurance." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220802964-covid-19 vaccine ad26.cov2.s- Blood clots. The event(s) has a 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: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: CAN NOT FUNCTION; FEELING VERY TIRED AND EXTREMELY WORN OUT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced can not function, and feeling very tired and extremely worn out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling very tired and extremely worn out and can not function was not reported. This report was non-serious. This case, from the same reporter is linked to 20220760444.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; NO LONGER HAS THE ABILITY TO WALK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection, and no longer has the ability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no longer has the ability to walk, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date) and NO ADVERSE EVENT (No Adverse event) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date).    No concomitant medication reported.  It was reported that 65 doses/10 vials were administered after the 30 days use by date.  1 vial was initially stored in refrigerator on 7-Jun-2022 and for others no details were provided. It was unknown if the product had undergone any temperature excursion issue.  Date of administration of the product was Apr2022 and the vial was taken out at that time only. Different dates of administration were involved, however the reporter didn't had the details.  It was reported that the dates of administration of the vaccines were 1-Apr-2022, 5-Apr-2022, 6-Apr-2022,8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022,13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. No treatment medication details reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-616820, US-MODERNATX, INC.-MOD-2022-616822, US-MODERNATX, INC.-MOD-2022-616809, US-MODERNATX, INC.-MOD-2022-616826, US-MODERNATX, INC.-MOD-2022-616839, US-MODERNATX, INC.-MOD-2022-616874 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2022: Significant follow up received Patient identifier has been updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-616820:Master case US-MODERNATX, INC.-MOD-2022-616822:Master case US-MODERNATX, INC.-MOD-2022-616826: US-MODERNATX, INC.-MOD-2022-616809:Master case US-MODERNATX, INC.-MOD-2022-616839:Master case US-MODERNATX, INC.-MOD-2022-616874:Master case
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: had the blood clot after the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (had the blood clot after the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (had the blood clot after the vaccine) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (had the blood clot after the vaccine) outcome was unknown.            No concomitant medications was reported.  patient had blood clot in his leg and had the first two initial shots and then the first booster and mentioned that cant say that has anything to do with Moderna.  Company Comment: This spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious (medically significant and hospitalization), and adverse event of special interest, Thrombosis which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected, serious (medically significant and hospitalization), and adverse event of special interest, Thrombosis which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Coughing; COVID-19; had the boosters this year on April and May; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), COUGH (Coughing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had the boosters this year on April and May) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had the boosters this year on April and May). In June 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, COVID-19 (COVID-19), COUGH (Coughing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had the boosters this year on April and May) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication reported.  Patient received booster doses.  Patient asked for Moderna to not use citric acid in the formulation of the new booster to help people who had intolerance to citric acid.  It was reported that experienced coughing but did not run a fever.  No treatment medication reported.  Company comment: This spontaneous case concerns a 69 years-old female with no medical history, who experienced unexpected non serious AESI event covid-19, which occurred approximately 1 month after fourth dose of mRNA-1273 vaccine. Inappropriate schedule of product administration is also reported. SARS-CoV-2 test is Positive. patient experienced cough without fever. Outcome of the event reported as unknown. Current ongoing pandemia remains as confounder for the event covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-079664 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69 years-old female with no medical history, who experienced unexpected non serious AESI event covid-19, which occurred approximately 1 month after fourth dose of mRNA-1273 vaccine. Inappropriate schedule of product administration is also reported. SARS-CoV-2 test is Positive. patient experienced cough without fever. Outcome of the event reported as unknown. Current ongoing pandemia remains as confounder for the event covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: developed a fever of 39 C; swelling at the injection site; redness at the injection site; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (developed a fever of 39 C), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062H21A) for COVID-19 prophylaxis.     The patient had possibly copd.  Concurrent medical conditions included Fibromyalgia and Asthma.    On 21-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (developed a fever of 39 C), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, PYREXIA (developed a fever of 39 C), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 39 degree Celsius.         No concomitant medication was provided by reporter. On 21-Dec-2021, the patient received first booster dose. The patient developed a fever of 39 C and had swelling, redness and pain at the injection site.  No treatment information was provided by reporter.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: Patient experienced sweating after her second Moderna Covid-19 vaccine booster dose; Patient experienced fatigue after her second Moderna Covid-19 vaccine booster dose; Patient experienced chills after her second Moderna Covid-19 vaccine booster dose; Patient experienced sore arm after her second Moderna Covid-19 vaccine booster dose; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Patient experienced sweating after her second Moderna Covid-19 vaccine booster dose), FATIGUE (Patient experienced fatigue after her second Moderna Covid-19 vaccine booster dose), CHILLS (Patient experienced chills after her second Moderna Covid-19 vaccine booster dose) and PAIN IN EXTREMITY (Patient experienced sore arm after her second Moderna Covid-19 vaccine booster dose) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Patient experienced sweating after her second Moderna Covid-19 vaccine booster dose), FATIGUE (Patient experienced fatigue after her second Moderna Covid-19 vaccine booster dose), CHILLS (Patient experienced chills after her second Moderna Covid-19 vaccine booster dose) and PAIN IN EXTREMITY (Patient experienced sore arm after her second Moderna Covid-19 vaccine booster dose). At the time of the report, HYPERHIDROSIS (Patient experienced sweating after her second Moderna Covid-19 vaccine booster dose), FATIGUE (Patient experienced fatigue after her second Moderna Covid-19 vaccine booster dose), CHILLS (Patient experienced chills after her second Moderna Covid-19 vaccine booster dose) and PAIN IN EXTREMITY (Patient experienced sore arm after her second Moderna Covid-19 vaccine booster dose) outcome was unknown.            No concomitant medications were reported. Patient received Second Moderna Covid-19 vaccine booster dose. No treatment information were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had booster dose six months ago and then had COVID-19 six weeks ago from the date of report. On 11-Jul-2022, the patient received restylane kysse filler in lips. It was reported that patient had lack of effect post filler injection. No concomitant and treatment medication information was provided.  Company Comment: This spontaneous case concerns an elderly female patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 18 weeks after receiving the booster dose of mRNA-1273. The patient received mRNA-1273 as primary series of COVID-19 vaccination but administration dates were not provided. The clinical presentation, diagnostic evaluation including COVID-19 test and treatment information were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 18 weeks after receiving the booster dose of mRNA-1273. The patient received mRNA-1273 as primary series of COVID-19 vaccination but administration dates were not provided. The clinical presentation, diagnostic evaluation including COVID-19 test and treatment information were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia
Clinical narrative: Weakness; Had a fever of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and PYREXIA (Had a fever of 101 F) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis and Seasonal allergy.   On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced ASTHENIA (Weakness) and PYREXIA (Had a fever of 101 F). At the time of the report, ASTHENIA (Weakness) and PYREXIA (Had a fever of 101 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2022, Body temperature: 101 101 F.         Patient received COVID-19 booster on 22-Jul-2022.  No concomitant medications were reported.  On the night of 22-Jul-2022, patient began experiencing weakness and had a fever of 101 F.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2022: Live follow up received contains significant information: added suspect product dosage regimen.