chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.Patient took other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19,drug ineffective started on Jul2022 and stop date Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 09Jan2021 at 14:15 as dose 1, single (Batch/Lot number: unknown), in right arm, on 30Jan2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient had no relevant medical history and Known allergies: NKA. Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2015, stop date: 18Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 13Feb2021 as dose 1, single (Lot number: EL9261), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: Abbott antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient received no other medication in 2 weeks. Anti viral details product=COVID 19 Treatment, brand=Pfizer, treatment start date=11Jul2022, treatment stop date=15Jul2022. Adverse event relapse after paxlovid 5 day treatment. Symptoms resumed and tested positive on Abbott antigen test 7 days later. Adverse event start date 23Jul2022, not recovered, no treatment. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Diverticulitis
Clinical narrative: hospitalized due to diverticulitis; This case was reported by a consumer via other manufacturer and described the occurrence of diverticulitis in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) unknown for ulcerative colitis.   The subject's past medical history included diverticulitis. Previously administered products included Covid 19 Moderna (received third dose on 1st December 2021), Covid 19 Moderna (received second dose on 1st February 2021) and Covid 19 Moderna (received first dose on 1st January 2021). Concurrent medical conditions included ulcerative colitis (Moderate to severe).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Humira (subcutaneous) 40 mg at an unknown frequency. On 21st March 2022, the dose was changed to 80 mg twice daily (160 mg daily). On 13th July 2022, unknown after receiving Shingrix, the patient experienced diverticulitis (serious criteria hospitalization and GSK medically significant). Humira was discontinued on 11th July 2022 (Dechallenge was positive). On an unknown date, the outcome of the diverticulitis was recovering/resolving.   The reporter considered the diverticulitis to be probably related to Shingrix.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comment: The case was reported by the patient. The patient had no known allergies. The patient received a dose of Shingrix and experienced diverticulitis and was hospitalized. The patient thought it was either because she had some nuts or received her first Shingrix vaccine. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The reporter's causality for the event of diverticulitis with Humira (Adalimumab) was no reasonable possibility. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Leg swelling; This case was reported by a consumer via interactive digital media and described the occurrence of swelling of legs in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was unknown.   It was unknown if the reporter considered the swelling of legs to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient had leg swelling after Shingrix. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Product storage error
Clinical narrative: Temperature excursion 46.2 degree celsius; This case was reported by a consumer via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number TB3KN, expiry date unknown) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 7YA99, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B and Havrix. On an unknown date, unknown after receiving Engerix B and Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: The reporter stated that they had temperature excursion last night it went from a temperature of 46.2 degree Celsius at 7:14, at 9 o clock temperature went back to normal. It was unknown if the vaccine was administered to any patient. The reporter wanted to know if the vaccine still ok. Additional supportive Information: The Havrix and Engerix B stored at temperature of 46.2 degree Celsius, which leads to Incorrect storage of drug.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: received Pediarix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-JUL-2022 Reporter's comments: The health care professional (HCP) called on the day of reporting to report that a patient received Pediarix instead of the intended vaccine Infanrix. Medical Information given for future reference and warm transfer provided. The vaccine administration facility was the same as primary reporter. The consent to follow up was granted. Additional Supportive Information: As patient received Pediarix instead of Infanrix, which led to wrong vaccine administered.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: went below 32F, used after excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31st March 2023) 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, DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) and (batch number XM2N7, expiry date 1st April 2024) for prophylaxis, HBV (Engerix B) (batch number 5M93R, expiry date 5th April 2024) for prophylaxis, DTPa (Infanrix) (batch number LS444, expiry date 16th September 2023) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and Boostrix. On an unknown date, the patient received Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, 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: 27-JUL-2022 Reporter's Comments:  The practice coordinator reported that Bexsero, Boostrix, Engerix-B, Infanrix, Kinrix, and Pediarix vaccines went below 32 Fahrenheit on 3rd June 2022 and on 13th June 2022.  The lowest temperature was 31.8 Fahrenheit.  The practice Coordinator reported the vaccines were used after the excursions.  At the time of the call the reporter did not have information on the number of doses administered, any of the patient information, or dates of administration.  The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The patient received a dose of Bexsero, Boostrix, Engerix-B, Infanrix, Kinrix, and Pediarix which was went below 32 Fahrenheit and used after the excursions, which led to incorrect storage of vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Hemiplegia, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; PARTIAL PARALYSIS OF RIGHT SIDE; This spontaneous report received from a patient via a company representative of Johnson and Johnson Law Department and concerned a male patient of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in perfect health until after commencement of this COVID outbreak. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, start therapy date was 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. In JUN-2021, the patient experienced partial paralysis of his right side, which was for ten (10) months (JUN-2021 to APR-2022) and was quite severe, and once it abated, the residual effects were still thoroughly felt daily.  On an unspecified date, the patient experienced breathing difficulties that at times border on critical, loss of sense of taste and smell. Currently patient was suffering from "long-haul" effects that were yet to abate that resulted in injuries and injurious effects. The patient suffered from the COVID-19 virus (suspected covid-19 infection), and told that there were unknown possible to further complications that might happen down the line. The patient reported that due to the contracting of covid, the right side of body was slightly, yet impactfully, paralyzed and yet had to regain full function and movement. The patient had injuries and sickness. It was reported that partial paralysis of his right side, and the accompanying breathing difficulties, both of which persist in fluctuating percentages of severity: also, the loss of small and taste, which had yet to return to it's pre-infection state. The damage to the plaintiff, much of which appeared to be irreparable (paralysis of the right side, breathing problems, and a loss of taste and smell).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from partial paralysis of right side, and suspected covid-19 infection. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220752482. This report was associated with product quality complaint: 90000243775.; Sender's Comments: V0- Medical Assessment comment not required as per standard operating procedure for legal case
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a 30 year old 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 not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 03-JUN-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 30 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 03-JUN-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, 20220759113, 20220759160, 20220759219 and 20220761815.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, No adverse event
Clinical narrative: I have seen the announcement from the news that the shelf life has been extended for 2months but I am not so sure that the information which is showing after I search for Lot#940918on your website said it is expired since Jun 2022; No adverse event; I just got Moderna vaccine 2 days ago Lot#940918. After I got a shot I just realized that I haven't check the expiry date so I went to check with your website and it shown that it is expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I just got Moderna vaccine 2 days ago Lot#940918. After I got a shot I just realized that I haven't check the expiry date so I went to check with your website and it shown that it is expired), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I have seen the announcement from the news that the shelf life has been extended for 2months but I am not so sure that the information which is showing after I search for Lot#940918on your website said it is expired since Jun 2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 940918) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I just got Moderna vaccine 2 days ago Lot#940918. After I got a shot I just realized that I haven't check the expiry date so I went to check with your website and it shown that it is expired). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I have seen the announcement from the news that the shelf life has been extended for 2months but I am not so sure that the information which is showing after I search for Lot#940918on your website said it is expired since Jun 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I just got Moderna vaccine 2 days ago Lot#940918. After I got a shot I just realized that I haven't check the expiry date so I went to check with your website and it shown that it is expired), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I have seen the announcement from the news that the shelf life has been extended for 2months but I am not so sure that the information which is showing after I search for Lot#940918on your website said it is expired since Jun 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 26-JUL-22, administered on 28-JUL-222 nad expired on 22-NOV-22; Patient received Moderna Covid-19 vaccine more than 12 hours after the vial was punctured; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial was punctured) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-JUL-22, administered on 28-JUL-222 nad expired on 22-NOV-22) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 065F21A, 047A21A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2022 at 11:35 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2022 at 11:35 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial was punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-JUL-22, administered on 28-JUL-222 nad expired on 22-NOV-22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine more than 12 hours after the vial was punctured) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-JUL-22, administered on 28-JUL-222 nad expired on 22-NOV-22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator on 26-JUL-2022 and was first punctured on 27-JUL-2022 at 9:30AM. The vial was in a portable cooler with an ICE Pack with no temperature monitoring device, total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): less than 30 minutes and the vial did not undergo any temperature excursions. The patient had not reported any other adverse reactions or side effects after first, second and first booster dose. No treatment details was reported.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave dose of Moderna Covid-19 vaccine after the expiration date.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave dose of Moderna Covid-19 vaccine after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave dose of Moderna Covid-19 vaccine after the expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. On unknown date, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025l21b, 03921a, 028l20a and 042l20a) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No concomitant information was provided. No treatment information was provided.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Child received 2nd dose from from a vial left out for 16 hours) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Child received 2nd dose from from a vial left out for 16 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Child received 2nd dose from from a vial left out for 16 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Child received 2nd dose from from a vial left out for 16 hours). Concomitant medication was not provided. It was reported that a doctor called on behalf of a parent and parent reported that the pharmacy called parent on 28-Jul-2022, to advise that needed to come back to repeat their 2nd dose, because the vial used was left out for 16 hours. Doctor did not have any product information such as lot number, storage and stability information on the vial (unpunctured, punctured). Treatment information was not provided. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Dry throat, Pain in extremity
Clinical narrative: experience a dry throat; experience a dry mouth; sore arm; This spontaneous case was reported by a patient and describes the occurrence of DRY THROAT (experience a dry throat), DRY MOUTH (experience a dry mouth) and PAIN IN EXTREMITY (sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced DRY THROAT (experience a dry throat), DRY MOUTH (experience a dry mouth) and PAIN IN EXTREMITY (sore arm). At the time of the report, DRY THROAT (experience a dry throat) and DRY MOUTH (experience a dry mouth) had not resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment detail was not reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Feeling hot, Headache, Heart rate
Clinical narrative: not feeling well after second Moderna booster; her body felt hot; felt a bit weak; a bit of nausea; sore arm; very bad headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well after second Moderna booster), FEELING HOT (her body felt hot), ASTHENIA (felt a bit weak), NAUSEA (a bit of nausea) and PAIN IN EXTREMITY (sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052B22A and 939904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     On 2Jun2022 patient tested positive to COVID-19, and 4 days later she tested negative. It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Thyroidectomy (patient had no thyroid) on 09-Jan-2017. Previously administered products included for COVID-19 vaccination: Johnson & Johnson (Dose no : 1 Route of administration : Intramuscular Lot number : 1305029) on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Drug allergy (Methylprednisolone) and Allergy to antibiotic (cephalosporins). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy.   On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2022, the patient experienced FEELING HOT (her body felt hot), ASTHENIA (felt a bit weak), NAUSEA (a bit of nausea), PAIN IN EXTREMITY (sore arm) and HEADACHE (very bad headache). On 29-Jul-2022, the patient experienced MALAISE (not feeling well after second Moderna booster). On 28-Jul-2022, NAUSEA (a bit of nausea) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, MALAISE (not feeling well after second Moderna booster), FEELING HOT (her body felt hot) and HEADACHE (very bad headache) had not resolved and ASTHENIA (felt a bit weak) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2022, Blood pressure measurement: 124/65. On 28-Jul-2022, Heart rate: 72 pulse was 72 bpm.         The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experience a similar event in the past. After 2nd booster dose patient experienced a bit of nausea, and sore arm. She woke up at night and felt symptoms like having COVID-19. No treatment has been given for her symptoms.   This case was linked to MOD-2021-368752 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2022: Live Significant follow up received contains Reporter email id added, patient details, concomitant product updated, Event added, Case narrative updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain in extremity
Clinical narrative: not feeling well after second Moderna booster; her body felt hot; felt a bit weak; a bit of nausea; sore arm; very bad headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well after second Moderna booster), FEELING HOT (her body felt hot), ASTHENIA (felt a bit weak), NAUSEA (a bit of nausea) and PAIN IN EXTREMITY (sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052B22A and 939904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     On 2Jun2022 patient tested positive to COVID-19, and 4 days later she tested negative. It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Thyroidectomy (patient had no thyroid) on 09-Jan-2017. Previously administered products included for COVID-19 vaccination: Johnson & Johnson (Dose no : 1 Route of administration : Intramuscular Lot number : 1305029) on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Drug allergy (Methylprednisolone) and Allergy to antibiotic (cephalosporins). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy.   On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2022, the patient experienced FEELING HOT (her body felt hot), ASTHENIA (felt a bit weak), NAUSEA (a bit of nausea), PAIN IN EXTREMITY (sore arm) and HEADACHE (very bad headache). On 29-Jul-2022, the patient experienced MALAISE (not feeling well after second Moderna booster). On 28-Jul-2022, NAUSEA (a bit of nausea) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, MALAISE (not feeling well after second Moderna booster), FEELING HOT (her body felt hot) and HEADACHE (very bad headache) had not resolved and ASTHENIA (felt a bit weak) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2022, Blood pressure measurement: 124/65. On 28-Jul-2022, Heart rate: 72 pulse was 72 bpm.         The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experience a similar event in the past. After 2nd booster dose patient experienced a bit of nausea, and sore arm. She woke up at night and felt symptoms like having COVID-19. No treatment has been given for her symptoms.   This case was linked to MOD-2021-368752 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2022: Live Significant follow up received contains Reporter email id added, patient details, concomitant product updated, Event added, Case narrative updated.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Eye disorder, Fatigue, Frustration tolerance decreased, Gait disturbance
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She was very sick the night after receiving it) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 prophylaxis. It was reported that patient has never been diagnosed/tested positive for COVID-19. Concurrent medical conditions included Drug hypersensitivity (Sulfa drugs allergy) and Pain in arm (Pain in right arm). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (She was very sick the night after receiving it). On 27-Feb-2021, ILLNESS (She was very sick the night after receiving it) had resolved. Patient's current  condition included an affection on her upper right quadrant, with pain in her right arm, since she was 2 years old. The patient is not on any concomitant medication. Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not experience side effects after receiving the first dose.  No treatment information was provided. This case was linked to MOD-2022-615954 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Illness, Malaise, Vaccination complication, Visual impairment
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She was very sick the night after receiving it) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 prophylaxis. It was reported that patient has never been diagnosed/tested positive for COVID-19. Concurrent medical conditions included Drug hypersensitivity (Sulfa drugs allergy) and Pain in arm (Pain in right arm). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (She was very sick the night after receiving it). On 27-Feb-2021, ILLNESS (She was very sick the night after receiving it) had resolved. Patient's current  condition included an affection on her upper right quadrant, with pain in her right arm, since she was 2 years old. The patient is not on any concomitant medication. Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not experience side effects after receiving the first dose.  No treatment information was provided. This case was linked to MOD-2022-615954 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She was very sick the night after receiving it) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 prophylaxis. It was reported that patient has never been diagnosed/tested positive for COVID-19. Concurrent medical conditions included Drug hypersensitivity (Sulfa drugs allergy) and Pain in arm (Pain in right arm). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (She was very sick the night after receiving it). On 27-Feb-2021, ILLNESS (She was very sick the night after receiving it) had resolved. Patient's current  condition included an affection on her upper right quadrant, with pain in her right arm, since she was 2 years old. The patient is not on any concomitant medication. Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not experience side effects after receiving the first dose.  No treatment information was provided. This case was linked to MOD-2022-615954 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 24-Jun-2022 past the BUD date 23-Jun-2021.) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination. No Medical History information was reported. On 24-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 24-Jun-2022 past the BUD date 23-Jun-2021.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 24-Jun-2022 past the BUD date 23-Jun-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 24-Jun-2022 past the BUD date 23-Jun-2021.). Concomitant medications details were not reported by the reporter. It was reported vaccine was administered 1 day past the BUD. The event did not cause patient to seek medical care. Treatment details were not reported by the reporter.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given 7 days past beyond use date of 23-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given 7 days past beyond use date of 23-Jun-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given 7 days past beyond use date of 23-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given 7 days past beyond use date of 23-Jun-2022). No concomitant medications were reported. It was reported that vaccine was given 7 days past beyond use date of 23-Jun-2022. The moderna was contacted and the lot was analyzed. It was stated that as per moderna this lot was still active and patient was not needed to be revaccinated. No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: No adverse event; administration error; The vaccine was given 9 days past BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (administration error), EXPIRED PRODUCT ADMINISTERED (The vaccine was given 9 days past BUD) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 02-Jul-2022, the patient experienced PRODUCT ADMINISTRATION ERROR (administration error) and EXPIRED PRODUCT ADMINISTERED (The vaccine was given 9 days past BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (administration error) had resolved and EXPIRED PRODUCT ADMINISTERED (The vaccine was given 9 days past BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION ERROR (administration error) and EXPIRED PRODUCT ADMINISTERED (The vaccine was given 9 days past BUD).    No concomitant drug information was provided.  Beyond use date of the product was reported as  23-Jun-2022. It was unknown if the patient was ever diagnosed with or tested COVID-19 positive. It was also unknown if there was any acute illness at the time of vaccination or any chronic or long standing health conditions of the patient.  Reporter further reported that as per Moderna, the product was still active and patient need not to be re-vaccinated.  No treatment drug information was provided.   This case was linked to MOD-2022-599989 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (This vaccine was given 4 days past the beyond use date of 23-Jun-22) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (This vaccine was given 4 days past the beyond use date of 23-Jun-22). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (This vaccine was given 4 days past the beyond use date of 23-Jun-22) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (This vaccine was given 4 days past the beyond use date of 23-Jun-22). No concomitant drug information was provided. Beyond use date of the product was reported as  23-Jun-2022. It was unknown if the patient was ever diagnosed with or tested COVID-19 positive. It was also unknown if there was any acute illness at the time of vaccination or nay chronic or long standing health conditions of the patient.  Reporter further reported that as per Moderna, the product was still active and patient need not to be re-vaccinated. No treatment drug information was provided. This case was linked to MOD-2022-599989 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The vaccine was given 2 days past BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was given 2 days past BUD) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was given 2 days past BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was given 2 days past BUD) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was given 2 days past BUD).    No concomitant medication were provided No treatment details were provided