chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: possibility some doses were administered, were already expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received Men B NVS (Bexsero) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 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: 18-Nov-2022 Reporter's comment: The pharmacist reported that a box of bexsero expired doses had some activated syringes. Once he found that box, he reported that exists the possibility that some doses were administered in spite they were already expired.  The reporter did not had information about potential patients. The reporter did not consent to follow-up. Additional supportive information: The patients received an expired dose of Bexsero, which led to expired vaccine used. The case kept valid as master case based upon the reported possibility of administration of doses.
Sex: F
Vaccine: UNK
Symptoms: Chromaturia, Discomfort, Flatulence, Nasal congestion, Nausea
Clinical narrative: Nausea; extreme discomfort of gas; Chills in her hand; bright neon yellowurine / today was brown; congestion in her nose.; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. In November 2022, 5 days after receiving FluLaval Quadrivalent 2022-2023 season and an unknown time after starting Flulaval Tetra Pre-Filled Syringe Device, the patient experienced nausea, gas, cold hands, urine coloring yellow and nasal congestion. On an unknown date, the outcome of the nausea, gas, cold hands and nasal congestion were unknown and the outcome of the urine coloring yellow was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. The reporter considered the gas, cold hands, urine coloring yellow and nasal congestion to be unrelated to FluLaval Quadrivalent 2022-2023 season. It was unknown if the reporter considered the gas, cold hands, urine coloring yellow and nasal congestion to be related to Flulaval Tetra Pre-Filled Syringe Device. 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: 18-NOV-2022 Reporter's Comment: Five days after vaccination in the left arm the patient experienced extreme discomfort of gas, chills in her hand, urine turned bright neon yellow, nausea, and congestion in her nose.  Today (on the day of reporting) when patient went to restroom and stated her urine was brown.  The reporter did not want to give any of her information as far as name, number, address, or date of birth.  The reporter consented to follow up.
Sex: F
Vaccine: UNK
Symptoms: Peripheral coldness
Clinical narrative: Nausea; extreme discomfort of gas; Chills in her hand; bright neon yellowurine / today was brown; congestion in her nose.; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. In November 2022, 5 days after receiving FluLaval Quadrivalent 2022-2023 season and an unknown time after starting Flulaval Tetra Pre-Filled Syringe Device, the patient experienced nausea, gas, cold hands, urine coloring yellow and nasal congestion. On an unknown date, the outcome of the nausea, gas, cold hands and nasal congestion were unknown and the outcome of the urine coloring yellow was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. The reporter considered the gas, cold hands, urine coloring yellow and nasal congestion to be unrelated to FluLaval Quadrivalent 2022-2023 season. It was unknown if the reporter considered the gas, cold hands, urine coloring yellow and nasal congestion to be related to Flulaval Tetra Pre-Filled Syringe Device. 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: 18-NOV-2022 Reporter's Comment: Five days after vaccination in the left arm the patient experienced extreme discomfort of gas, chills in her hand, urine turned bright neon yellow, nausea, and congestion in her nose.  Today (on the day of reporting) when patient went to restroom and stated her urine was brown.  The reporter did not want to give any of her information as far as name, number, address, or date of birth.  The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: pt under 4 years received Kinrix; Kinrix was third Dtap and IPV dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2PP74, expiry date 10th June 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: This was patient's third Dtap and IPV dose. The reporter did not consent to follow-up. Additional supportive information: The patient received Kinrix under 4 years of age by error, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The dose number was captured as per reported verbatim, 'This was patient's third Dtap and IPV dose.'
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm still hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-Nov-2022 Reporter's comment: The reporter was the patient, who received her dose of Shingrix in the left arm last week.  She stated that her left arm still hurts after a week. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint, Product container issue, Skin laceration
Clinical narrative: Small cut on hand from a broken vial; Adjuvant was in hand / the entire bottom of the bottle came out; Adjuvant was in hand / the entire bottom of the bottle came out; vial issue; Had a broken vial of SHINGRIX adjuvant/ PQC filed; This case was reported by a other health professional via call center representative and described the occurrence of laceration of hand in a adult male patient who received Herpes zoster (Shingrix) (batch number 2J5BF, expiry date 6th October 2023) and (batch number HY975, expiry date 6th October 2023) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced laceration of hand, occupational exposure while preparing product for administration, exposure via skin contact, product vial breakage and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of hand, occupational exposure while preparing product for administration, exposure via skin contact, product vial breakage and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of hand to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comment: The reporter was a customer who is a pharmacy technician. The reporter stated that they had a broken vial of Shingrix adjuvant. The reporter reported that it was not noticed that the vial was cracked, until a colleague was warming the adjuvant in his hand, and the entire bottom of the vial came off.  The colleague received a small cut on his hand from this vial. The reporter stated that after partial use of the pack during the preparation this defect was discovered and the product was not administered to the patient. The healthcare professional who was preparing or administering the vaccine was an experienced person. Due to the vial was discarded the pictures are not available and there was package, carton or blisters tray are not damaged. There was no any evidence of leakage of product in package or carton. The reporter reported that there was a hairline crack that went all around the bottom of the vial. The crack was observed on the bottom of the vial. The suspect vial was not available for return as it was discarded. Additional supportive information: The vial was cracked and warmed on the patient hand which led to, occupational exposure while preparing product for administration and exposure via skin contact
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 03-Mar-2022, 2nd not received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd March 2022).   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: 18-Nov-2022 Reporter's comment: The patient did not receive the 2nd dose as of yet, which was past the 6 month recommendation.  The reporter mentioned that she will administer, however the patient was not in the office at the time of the call. No reactions were reported. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The details were reported for 1st dose of Shingrix.
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluarix administered to a 1-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 53Y2G, expiry date 30th June 2023) for prophylaxis.   In November 2022, the patient received Fluarix Quadrivalent 2022-2023 season. In November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: During this call, the reporter did not had the opportunity to ask the health care professional, if follow up was ok to be included. Additional supportive information: The patient received Fluarix at inappropriate age, which led to inappropriate age at vaccine administration. Suspect was coded as solution for injection as no formulation was reported in source document.
Age: 0.58
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Possible administration of Havrix pediatric and MMR to a 7-month-old; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-month-old patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   On an unknown date, the patient received Havrix pediatric and MMR vaccine. On an unknown date, unknown after receiving Havrix pediatric and MMR vaccine, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: The reporter reported that provider had a 7 month old patient.  Provider ordered MMR and Havrix Pediatric for patient. No further information shared other than what was noted in reporter's comments. Brand of MMR was not provided so unsure if Priorix or not. The reporter consented to follow-up. Additional supportive information: The patient received MMR Havrix Pediatric at inappropriate age, which led to inappropriate age at vaccine administration. The case was kept valid in worst approach considering that the patient had received both vaccine at age 7 month and for further clarification query was raised.
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Havrix adult administered to child; Havrix administered to a 1-week-old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-day-old male patient who received HAV (Havrix adult) (batch number 95DB2, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th November 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 18th November 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose 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: 18-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter gave consented to follow-up via phone. Additional supportive information: An adult dose of Havrix had been given to a child patient, which led to overdose and inappropriate age at vaccine administration.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administered instead of Infanrix; Kinrix administred to a 18-month-old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th November 2022, unknown after receiving Kinrix and Kinrix 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: 18-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received Kinrix dose instead of Infanrix vaccine at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 1 year ago/ restart series; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 1 year ago from the date of reporting).   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: 22-NOV-2022 Reporter's comment: The reporter would like information on if patient should restart series after 1 year of the 1st dose. No further information available.  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.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Loss of consciousness
Clinical narrative: loss of consciousness/passed out; dizziness/ feeling light-headed; This case was reported by a consumer via regulatory authority and described the occurrence of loss of consciousness in a 31-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 4RK3C, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) (batch number 4302MF023, expiry date unknown) for prophylaxis.   The patient's past medical history included presyncope and drug hypersensitivity (Drug hypersensitivity with Bactrim (sulfamethoxazole and trimethoprim)). Concurrent medical conditions included milk allergy.   On 22nd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device and the 2nd dose of NOVAVAX COVID-19 VACCINE (intramuscular) 10 mg/ml. On 22nd October 2022, less than a day after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced loss of consciousness (serious criteria medically significant and other: serious as per reporter) and dizziness. On 22nd October 2022, the outcome of the loss of consciousness and dizziness were recovered/resolved.   It was unknown if the reporter considered the loss of consciousness and dizziness to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 21-NOV-2022 Reporter's Comment: The reporter reported that the patient received a dose of FluLaval Quadrivalent into right arm at military facility for influenza immunization and second dose of Novavax Covid-19 Vaccine adjuvanted 10 ug/mL into left arm at a military facility and on the same day after vaccination, the patient experienced loss of consciousness and dizziness (felt light-headed, then passed out while resting in chair). The doctor immediately attended to patient and blood pressure was 125/75 and heart rate was 104 (no units reported)  The patient reported this was a common reaction for him when receiving vaccinations.  The patient assisted to a lying position with his legs elevated as treatment. It was reported that the patient had an office visit as treatment.  No concomitant medications were reported. At the time of reporting, the event outcomes of dizziness and loss of consciousness were recovered/resolved. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events was considered possible.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DIED IN JANUARY FROM DIFFERENT  THINGS BECAUSE OF THE VACCINE; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age.. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 01 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. It was reported that " They are coming out with more side effects from the vaccine my sister died in January from different things because of the vaccine." It was unspecified if an autopsy was performed. On an unspecified date, the patient died due to different things because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221152314-died in january from different  things because of the vaccine. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: DIFFERENT THINGS BECAUSE OF THE VACCINE
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: MAJOR PROBLEMS WITH THEIR HEALTH; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced major problems with their health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major problems with their health was not reported. This report was non-serious. This case, from the same reporter is linked to 20221152669, 20221152816 and 20221152749.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RED RASHES IN SEVERAL LOCATIONS OF THE BODY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 red rashes in several locations of the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rashes in several locations of the body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: RIGHT ARM HURTS CONSTANTLY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced right arm hurts constantly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm hurts constantly. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Swelling face
Clinical narrative: facial swelling; angioedema; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING FACE (facial swelling) and ANGIOEDEMA (angioedema) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2022, the patient experienced SWELLING FACE (facial swelling) (seriousness criteria medically significant and life threatening) and ANGIOEDEMA (angioedema) (seriousness criteria medically significant and life threatening). At the time of the report, SWELLING FACE (facial swelling) and ANGIOEDEMA (angioedema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Company comment- This spontaneous case concerns a 25-year-old male patient with no reported medical history, who experienced unexpected, serious (life-threatening, medically significant) event of Swelling face and Angioedema 8 days after vaccination with a first dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. 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 concerns a 25-year-old male patient with no reported medical history, who experienced unexpected, serious (life-threatening, medically significant) event of Swelling face and Angioedema 8 days after vaccination with a first dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea, COVID-19, SARS-CoV-2 test
Clinical narrative: She has contracted the covid-19 virus/tested positive for Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (She has contracted the covid-19 virus/tested positive for Covid) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included End stage renal disease and Kidney transplant. Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (She has contracted the covid-19 virus/tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) ongoing since an unknown date for COVID-19 treatment, at a dose of 300 mg, 100 mg dose pack. At the time of the report, COVID-19 (She has contracted the covid-19 virus/tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood urea: Result awaiting and Normal. On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the patient was prescribed paxlovid for the treatment of COVID-19 and she was not able to swallow the pills because it could not be crushed or split. She further stated, it has been sometime since she had COVID so this would precautionary reason for her to receive paxlovid. It was not within 5 days treatment.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Received Bivalent Booster that went through temperature excursion; Received Monovalent Vaccine that went through temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received Bivalent Booster that went through temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received Monovalent Vaccine that went through temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received Bivalent Booster that went through temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received Monovalent Vaccine that went through temperature excursion) and NO ADVERSE EVENT (No Adverse Event). On 21-Nov-2022, NO ADVERSE EVENT (No Adverse Event) outcome was unknown. At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received Bivalent Booster that went through temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Received Monovalent Vaccine that went through temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received Bivalent Booster that went through temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Received Monovalent Vaccine that went through temperature excursion).    No concomitant medication details were reported. It was reported that 27 unknown patients received Moderna COVID-19 vaccine that went through excursion. 7 vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator from 8-NOV-2022 to 21-NOV-2022 and there are 2 unpunctured Monovalent vials were remaining in the refrigerator. Unbroken carton vials were used. Maximum 48.1 F and minimum 42.5F temperatures reached. Excursion duration was 312 hours. Vials moved from the freezer to refrigerator every morning. No Visual inspection was done. They noticed the excursion on 21-NOV-2022. No treatment medication details were reported. On 28-Nov-2022, this case was found to be invalid as there was no single patient identifier.   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Live Significant follow up- Email added.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain increased; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain increased) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis.    Concurrent medical conditions included Psoriasis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient experienced PAIN (Pain increased). At the time of the report, PAIN (Pain increased) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The patient reported after taking COVID vaccines pain increased from mild to severe.  The reporter causality for the event of pain increased with Risankizumab was not provided.  No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthritis, Back pain, COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), BACK PAIN (Back pain) and COVID-19 (COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.     The outcome of the event was recovering.  Patients' age, medical history of Ankylosing spondylitis and non-serious event of back pain remain as confounders for the event Arthritis. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Myalgia
Clinical narrative: COVID-19; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and MYALGIA (Body aches) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 4782590) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On an unknown date, the patient experienced COVID-19 (COVID-19) and MYALGIA (Body aches). At the time of the report, COVID-19 (COVID-19) was resolving and MYALGIA (Body aches) outcome was unknown.     It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Treatment details were not reported by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Inflammation, Peripheral swelling, Skin discolouration
Clinical narrative: ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION; ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION; PAIN IN THE SHOULDER; FEET AND HANDS WERE SWOLLEN; FINGER TIPS STILL NUMB; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (FEET AND HANDS WERE SWOLLEN), INFLAMMATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION), SKIN DISCOLOURATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION), HYPOAESTHESIA (FINGER TIPS STILL NUMB) and ARTHRALGIA (PAIN IN THE SHOULDER) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis aggravated.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In August 2022, the patient experienced PERIPHERAL SWELLING (FEET AND HANDS WERE SWOLLEN) and HYPOAESTHESIA (FINGER TIPS STILL NUMB). On an unknown date, the patient experienced INFLAMMATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION), SKIN DISCOLOURATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION) and ARTHRALGIA (PAIN IN THE SHOULDER). At the time of the report, PERIPHERAL SWELLING (FEET AND HANDS WERE SWOLLEN), HYPOAESTHESIA (FINGER TIPS STILL NUMB) and ARTHRALGIA (PAIN IN THE SHOULDER) outcome was unknown and INFLAMMATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION) and SKIN DISCOLOURATION (ARMS, FACE AND LIPS WERE TURNING PURPLE DUE TO TOO MUCH INFLAMMATION) had not resolved.            Concomitant product use was not provided by the reporter.  It was reported that Humira was not improving the symptoms. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.   The Moderna MPID was 4782589.  The reporter's causality for the events of arm, face and lips were turning purple due to too much inflammation. feet and hands were swollen, finger tips still numb, Humira was not improving symptoms, pain in the shoulder Adalimumab Solution for Injection was not provided  Treatment information was not provided.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired first primary dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7-Nov-2022 which expired on 17-Nov-2022 and was administered on18-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received an expired first primary dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7-Nov-2022 which expired on 17-Nov-2022 and was administered on18-Nov-2022).    No concomitant medications were reported. The vial size was 2.5 mL. The vial was initially stored in the refrigerator on 7-Nov-2022. Th vial did not  undergo any temperature excursions. No treatment medications were reported.
Sex: M
Vaccine: COVID19-2, UNK, UNK
Symptoms: Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (inflamed all over body from psoriasis/psoriasis symptoms worsened) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.      No concomitant drug information was provided.  Moderna daily dose was reported as one in once.    The reporter's causality with Skyrizi for the events of Humira did not stop the spread after six years of taking it, inflamed all over body from psoriasis/psoriasis symptoms worsened and symptoms of psoriasis affected ability to work and perform daily activities was not provided.   It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2022: Follow-up received, added patient medical history, co-suspect drug, new events and updated narrative.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Inflammation, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles), INFLAMMATION (Internal inflammation) and VACCINATION SITE PAIN (pain on Left side/The side that had the shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (    No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Specific product reported as yes, specific product known from provided information.  Concurrent medical conditions included Dust allergy, Allergy to animals and Diabetic. Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and METFORMIN for an unknown indication.       mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that shortly after her first vaccine she started getting pain on her left side. The side that had the shot and it was diagnosed as Shingles but with no redness and blisters, later It moved to the right side and was going for physical therapy to get rid of it.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, COVID-19, Inflammation, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles), INFLAMMATION (Internal inflammation) and VACCINATION SITE PAIN (pain on Left side/The side that had the shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (    No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Specific product reported as yes, specific product known from provided information.  Concurrent medical conditions included Dust allergy, Allergy to animals and Diabetic. Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and METFORMIN for an unknown indication.       mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that shortly after her first vaccine she started getting pain on her left side. The side that had the shot and it was diagnosed as Shingles but with no redness and blisters, later It moved to the right side and was going for physical therapy to get rid of it.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Inflammation, Vaccination site pain
Clinical narrative: Pain in  My left breast; got covid; inflammation flared up again/inflammation has come back and it was on the top of my Left rib cage; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (inflammation flared up again/inflammation has come back and it was on the top of my Left rib cage), BREAST PAIN (Pain in  My left breast) and COVID-19 (got covid) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067h21a, 030m20a and 039k20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (she just had diabetic but she was perfectly healthy), Dust allergy and Allergy to animal (Cats allergy). Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and METFORMIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced INFLAMMATION (inflammation flared up again/inflammation has come back and it was on the top of my Left rib cage). On 24-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (got covid). On an unknown date, the patient experienced BREAST PAIN (Pain in  My left breast). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLAMMATION (inflammation flared up again/inflammation has come back and it was on the top of my Left rib cage) and BREAST PAIN (Pain in  My left breast) had not resolved and COVID-19 (got covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2022, SARS-CoV-2 test: Positive.         On 24-Jul-2022, patient got COVID and shortly after the inflammation flared up again. She also had pain in her left breast, and she had been to the gynecologist. The Endocrinologist, her family doctor agreed that it was muscular, and it seems that the inflammation had come back. It was on the top of her left rib cage; they all agreed that it was muscular. She had gynecologist, endocrinologists, rheumatologist, immunologist and primary physician visits for events. Patient further stated that, events were ongoing, and it was terrible painful in her left breast and under her left breast where the ends, the other doctors ruled out any other causes.  The patient stated that, the symptoms were improved for a short time and now they were worse.  Patient had not experience similar events in the past.   This case was linked to MOD-2022-676036 (Patient Link).