chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: They do not know what vaccine was supposed to administered at this time; Kinrix was administered to a 4 month old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 13-MAR-2023, the patient received Kinrix. On 13-MAR-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: They do not know what vaccine was supposed to administered at this time) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 4 month old). 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-14-MAR-2023 The reporter reported that Kinrix was administered to a 4 month old.  They did not know what vaccine was supposed to administered at this time.  The reporter was consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. The Kinrix was administered to a 4 month old which led to inappropriate age at vaccine administration. They did not know what vaccine was supposed to administered at this time which led to wrong vaccine administered
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Biliary obstruction, Chest pain, Cholelithiasis, Computerised tomogram abdomen abnormal, Gallbladder obstruction
Clinical narrative: Got really sick (ER); Pain under sternum (ER); Diagnosed with gallstones (ER); Gallbladder duct obstructed, is going to remove the gallbladder (ER); Sore arm (ER); This serious case was reported by a consumer via call center representative and described the occurrence of gallbladder obstruction in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 01-MAR-2023, less than a day after receiving Shingrix, the patient experienced gallbladder obstruction (Verbatim: Gallbladder duct obstructed, is going to remove the gallbladder (ER)) (serious criteria GSK medically significant), pain in arm (Verbatim: Sore arm (ER)), sternal pain (Verbatim: Pain under sternum (ER)) and gallstones (Verbatim: Diagnosed with gallstones (ER)). On 01-MAR-2023 11:00, the patient experienced sickness (Verbatim: Got really sick (ER)). The patient was treated with analgesic, nos (Pain Medication). The outcome of the gallbladder obstruction and gallstones were not reported and the outcome of the pain in arm, sickness and sternal pain were unknown.   It was unknown if the reporter considered the gallbladder obstruction, pain in arm, sickness, sternal pain and gallstones to be related to Shingrix.     It was unknown if the company considered the gallbladder obstruction, pain in arm, sickness, sternal pain and gallstones to be related to Shingrix.   Additional Information: GSK Receipt date: 21-MAR-2023 The reporter reported that male patient that received his first dose of Shingrix 1-MAR-2023, and reports that his arm was sore right after the injection, but it was not bad.  The patient reported that around 11pm that same night, 1-MAR-2023, he got really sick, and experienced the worst pain he had ever had under his sternum, and that he went to the ER and stayed overnight until the afternoon of 2-MAR-2023.  The patient reports that he had a number of test done while he was in the ER, including a CT Scan, an Ultra Sound, and a Nuclear Medicine test that he could not remember exactly what it was called, and he was diagnosed with gall stones. The patient reports that the duct from his gall bladder was obstructed.  The patient also reports that he was given a pain medication (unknown product) during the Nuclear Medicine test, and he had no pain the rest of the day. The patient is going to have his gall bladder removed. The reporter did not consent to follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Immediate post-injection reaction, Laboratory test, Magnetic resonance imaging abdominal abnormal, Pain in extremity
Clinical narrative: Got really sick (ER); Pain under sternum (ER); Diagnosed with gallstones (ER); Gallbladder duct obstructed, is going to remove the gallbladder (ER); Sore arm (ER); This serious case was reported by a consumer via call center representative and described the occurrence of gallbladder obstruction in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 01-MAR-2023, less than a day after receiving Shingrix, the patient experienced gallbladder obstruction (Verbatim: Gallbladder duct obstructed, is going to remove the gallbladder (ER)) (serious criteria GSK medically significant), pain in arm (Verbatim: Sore arm (ER)), sternal pain (Verbatim: Pain under sternum (ER)) and gallstones (Verbatim: Diagnosed with gallstones (ER)). On 01-MAR-2023 11:00, the patient experienced sickness (Verbatim: Got really sick (ER)). The patient was treated with analgesic, nos (Pain Medication). The outcome of the gallbladder obstruction and gallstones were not reported and the outcome of the pain in arm, sickness and sternal pain were unknown.   It was unknown if the reporter considered the gallbladder obstruction, pain in arm, sickness, sternal pain and gallstones to be related to Shingrix.     It was unknown if the company considered the gallbladder obstruction, pain in arm, sickness, sternal pain and gallstones to be related to Shingrix.   Additional Information: GSK Receipt date: 21-MAR-2023 The reporter reported that male patient that received his first dose of Shingrix 1-MAR-2023, and reports that his arm was sore right after the injection, but it was not bad.  The patient reported that around 11pm that same night, 1-MAR-2023, he got really sick, and experienced the worst pain he had ever had under his sternum, and that he went to the ER and stayed overnight until the afternoon of 2-MAR-2023.  The patient reports that he had a number of test done while he was in the ER, including a CT Scan, an Ultra Sound, and a Nuclear Medicine test that he could not remember exactly what it was called, and he was diagnosed with gall stones. The patient reports that the duct from his gall bladder was obstructed.  The patient also reports that he was given a pain medication (unknown product) during the Nuclear Medicine test, and he had no pain the rest of the day. The patient is going to have his gall bladder removed. The reporter did not consent to follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Got really sick (ER); Pain under sternum (ER); Diagnosed with gallstones (ER); Gallbladder duct obstructed, is going to remove the gallbladder (ER); Sore arm (ER); This serious case was reported by a consumer via call center representative and described the occurrence of gallbladder obstruction in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 01-MAR-2023, less than a day after receiving Shingrix, the patient experienced gallbladder obstruction (Verbatim: Gallbladder duct obstructed, is going to remove the gallbladder (ER)) (serious criteria GSK medically significant), pain in arm (Verbatim: Sore arm (ER)), sternal pain (Verbatim: Pain under sternum (ER)) and gallstones (Verbatim: Diagnosed with gallstones (ER)). On 01-MAR-2023 11:00, the patient experienced sickness (Verbatim: Got really sick (ER)). The patient was treated with analgesic, nos (Pain Medication). The outcome of the gallbladder obstruction and gallstones were not reported and the outcome of the pain in arm, sickness and sternal pain were unknown.   It was unknown if the reporter considered the gallbladder obstruction, pain in arm, sickness, sternal pain and gallstones to be related to Shingrix.     It was unknown if the company considered the gallbladder obstruction, pain in arm, sickness, sternal pain and gallstones to be related to Shingrix.   Additional Information: GSK Receipt date: 21-MAR-2023 The reporter reported that male patient that received his first dose of Shingrix 1-MAR-2023, and reports that his arm was sore right after the injection, but it was not bad.  The patient reported that around 11pm that same night, 1-MAR-2023, he got really sick, and experienced the worst pain he had ever had under his sternum, and that he went to the ER and stayed overnight until the afternoon of 2-MAR-2023.  The patient reports that he had a number of test done while he was in the ER, including a CT Scan, an Ultra Sound, and a Nuclear Medicine test that he could not remember exactly what it was called, and he was diagnosed with gall stones. The patient reports that the duct from his gall bladder was obstructed.  The patient also reports that he was given a pain medication (unknown product) during the Nuclear Medicine test, and he had no pain the rest of the day. The patient is going to have his gall bladder removed. The reporter did not consent to follow-up.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Had both doses in 2019, had shingles in 2023/ Suspected vaccination failure; Diagnosed with shingles in eye; Eye swelling shut; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and MRNA 1345 for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (shingles in right eye 2018). Concurrent medical conditions included glaucoma (glaucoma in right eye (2018)).   On 11-JUN-2019, the patient received the 2nd dose of Shingrix. On 30-MAR-2019, the patient received the 1st dose of Shingrix. In JUN-2019, the patient received MRNA 1345. On an unknown date, an unknown time after receiving Shingrix and Shingrix and an unknown time after receiving MRNA 1345, the patient experienced vaccination failure (Verbatim: Had both doses in 2019, had shingles in 2023/ Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Diagnosed with shingles in eye) (serious criteria GSK medically significant) and eye swelling (Verbatim: Eye swelling shut). The patient was treated with steroids nos (Steroid (Not Specified)). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and eye swelling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and eye swelling to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and eye swelling to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 21-MAR-2023 On March 30 2019, the patient received 1st dose of Shingrix.. On June 11, 2019 the patient received 2nd dose of Shingrix. Around the time of dose 2 the patient volunteered for a (Moderna)  trial vaccine and was given mRNA -1345-P 301 vaccine. In February 2023 the patient visited the health care professionals with right eye swelling shut but no rash. The patient was diagnosed with shingles in the right eye. The treatment drug steroid eye drops for eye swelling which was not recovered. The patient reported the historical condition of glaucoma and shingles in the right eye on 2018. The patient did not consent to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: KILLED; This spontaneous report received from a consumer via media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered, 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 had death (killed) from an unknown cause. It was unknown whether an autopsy was performed or not. It was reported as "Just a quick reminder that the covid vaccine killed my Mom". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20230363489-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Physical examination, Scab, Scar, Tenderness
Clinical narrative: ARM WAS TENDER; KNOT/A SCAB ABOUT THE SIZE OF A PIN HEAD/SCABBING OVER AN INCH BIG, 8 INCH DEEP AND IT CONTINUE TO SCAB AND CONTINUE TO GET BIGGER; 1 INCH SCAR/IT IS SCABBING AROUND THE OUT SIDE OF THE SCAR AND IT CONTINUES TO GET BIGGER AND BIGGER/DOUBLE TO TRIPLE THE SCAR OF THE CHICKEN POX VACCINE/IT IS AWFUL; ARM SORENESS; This spontaneous report received from a patient concerned a 3 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 24 years old. No concomitant medications were reported. On an unspecified date, the patient experienced arm was tender, knot/a scab about the size of a pin head/scabbing over an inch big, 8 inch deep and it continue to scab and continue to get bigger, 1 inch scar/it is scabbing around the out side of the scar and it continues to get bigger and bigger/double to triple the scar of the chicken pox vaccine/it is awful, and arm soreness. Laboratory data (dates unspecified) included: Physical examination A scab about the size of a pin head. Scabbing over an inch big, 8 inch deep. 1 inch scar. Treatment medications (dates unspecified) included: hydrocortisone, and colecalciferol/fish liver oil/paraffin/paraffin, liquid/petrolatum/wool fat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness, knot/a scab about the size of a pin head/scabbing over an inch big, 8 inch deep and it continue to scab and continue to get bigger, and 1 inch scar/it is scabbing around the out side of the scar and it continues to get bigger and bigger/double to triple the scar of the chicken pox vaccine/it is awful, and the outcome of arm was tender was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Mar-2023, 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. On 16-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023).    No concomitant medications was reported.  Dosage text was reported as Initial Booster.  No treatment medications was reported.  This case contains information about Patient 2 out of 2 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-717122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717122: Patient 1 out of 2 Patients
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: Drug exposure during pregnancy; No adverse event; This spontaneous retrospective pregnancy case was reported by a patient family member or friend and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No medical history/conditions, allergy, concomitant diseases and risk factor.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved 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 MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy).    No concomitant and treatment medications were reported.  Reporter stated that the daughter in law was given 2 Moderna Covid-19 shots plus. Patient was pregnant in Mar 2021 and did not exactly know which dose was given at the time. The specific dates when these were administered, and the corresponding lot numbers were not known. The patient gave birth to a baby who was then 18 months old and who had dermatitis that never got away. This report was for the daughter in law.  Company Comment: This is a spontaneous case concerning an adult female patient, exact age unknown with no reported medical history and maternal exposure during pregnancy, who did not experience any adverse event. Patient received a dose of mRNA-1273 vaccine during pregnancy, gestation age at the time of vaccination was unknown. The baby was reported to have experienced dermatitis. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-716868 (Parent-Child Link).   See case US-MODERNATX, INC.-MOD-2023-716868 for details regarding the child case.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Inappropriate schedule of product administration
Clinical narrative: memory loss; First Primary monovalent dose on 08MAY2021 (Lot# 027C21A & Exp. Date: unknown).Shot #2: 2nd Primary monovalent dose on 09AUG2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AMNESIA (memory loss) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08MAY2021 (Lot# 027C21A & Exp. Date: unknown).Shot #2: 2nd Primary monovalent dose on 09AUG2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS7140C, 027C21A and 052E21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AMNESIA (memory loss) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08MAY2021 (Lot# 027C21A & Exp. Date: unknown).Shot #2: 2nd Primary monovalent dose on 09AUG2021). At the time of the report, AMNESIA (memory loss) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08MAY2021 (Lot# 027C21A & Exp. Date: unknown).Shot #2: 2nd Primary monovalent dose on 09AUG2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19-2
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 (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Mar-2023, 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. On 16-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023).    No concomitant medications were reported. BUD for vial was reported on 12-Mar-2023 No treatment details were reported.  This case is reported for Patient 1 out of 2 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-717126 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717126:Patient 2 out of 2 Patients
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (071B22A and first dose) on 13-Feb-2023. Past adverse reactions to the above products included No adverse event with Spikevax.    On 24-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 24-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.).    No concomitant information was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. It was reported that patient did not reported any adverse reaction. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (ACP wanted to know if this lot's number was bivalent or primary series Potential medication error (circumstances that could lead to an error).    No concomitant medications was reported. It was reported that product was unknown. No treatment drug details was reported.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023; No adverse event; Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.), PRODUCT STORAGE ERROR (The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 074B22A and 074B22A) for COVID-19 prophylaxis.     It was unknown if patient had allergies or was tested positive for COVID-19. It was also unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.), PRODUCT STORAGE ERROR (The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.) and PRODUCT STORAGE ERROR (The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023).    Concomitant drugs were not reported.  It was reported that a monovalent multi dose vial of size 5.5 ml was not exposed to any temperature excursion.  Treatment medications were not provided.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy.    On 21-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse event; When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches) and NO ADVERSE EVENT (no adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Mar-2023, the patient experienced UNDERDOSE (When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches).    No concomitant medications were reported. It was reported that patient asked the vaccinator what was the liquid and they said it was the vaccine but it was not very much. No treatment information was provided.   Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received a vaccine after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine after the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, 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 15-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine after the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine after the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received a vaccine after the 30 day use by date).    No concomitant medication were reported.  The patient received first Moderna Covid 19 vaccine primary series on 16-MAY-2021 with Lot number 022B21A and expiration date was 28-Sep-2021 in left Arm of administration, patient reported no Adverse Reactions. The patient received second Moderna Covid 19 vaccine primary series on 13-Jun-2021 Lot number 036C21A expiration date was 1-NOV-2021 left Arm of administration and patient reported no Adverse Reactions. The patient received first Moderna Covid 19 vaccine booster dose on 21-DEC-2021 Lot number 041J21A expiration date 28-APR-2022 was not known left Arm of administration and patient reported no Adverse Reactions. No treatment information was provided by the reporter.
Age: 96.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: hands and shoulder were tender, sore; His hands swelled; The fingers are stiff; painful/ hand pain/sore; bilateral shoulder pain / sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TENDERNESS (hands and shoulder were tender, sore), PERIPHERAL SWELLING (His hands swelled), MUSCULOSKELETAL STIFFNESS (The fingers are stiff), PAIN IN EXTREMITY (painful/ hand pain/sore) and ARTHRALGIA (bilateral shoulder pain / sore) in a 96-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PNEUMOCIN [PNEUMOCOCCAL VACCINE] (Pneumococcal conjugate PCV20) on 01-Dec-2020 and Janssen (0.5 ml) on 06-Aug-2021. Past adverse reactions to the above products included No adverse event with Janssen and PNEUMOCIN [PNEUMOCOCCAL VACCINE]. Concurrent medical conditions included Drug allergy (codeine (reaction: rash, itching)), Hypothyroidism and Hearing loss.    On 22-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 24-Feb-2023, the patient experienced TENDERNESS (hands and shoulder were tender, sore), PERIPHERAL SWELLING (His hands swelled), MUSCULOSKELETAL STIFFNESS (The fingers are stiff), PAIN IN EXTREMITY (painful/ hand pain/sore) and ARTHRALGIA (bilateral shoulder pain / sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of one time and MELOXICAM at an unspecified dose and frequency. At the time of the report, TENDERNESS (hands and shoulder were tender, sore), PERIPHERAL SWELLING (His hands swelled), MUSCULOSKELETAL STIFFNESS (The fingers are stiff), PAIN IN EXTREMITY (painful/ hand pain/sore) and ARTHRALGIA (bilateral shoulder pain / sore) had not resolved.        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.   The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Dosage text was reported as Initial booster.  The caregiver was advised to give the patient Benadryl, but that just made patient sleepy and wasn't helping, so she stopped it. The caregiver had said the shoulders aren't swollen, but the hands are swollen. They went into the emergency room on Tuesday 21-Mar-2023, and that provider was the one who notified the pharmacist. The pharmacist states that 24-Mar-2023 patient notes state: bilateral shoulder and hand pain, swelling in hand. They had been applying heat to the hands with some relief. The veteran feels run down. Patient did not report redness or swelling at the injection site. No other aggravating or alleviating factors. It hasn't changed at all over the past month.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026221B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 04-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient who received 1st dose of Moderna vaccine on 04-Jun-2021/second dose of Moderna vaccine on 04-Mar-2022).    No concomitant medications were reported.  The patient received 1st dose on 04-Jun-2021, lot no. 05DC21A.  No treatment medications were reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2 NOS), on 14Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered" (Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: Was testing negative at the end of the Paxlovid dosage period. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was treated with Paxlovid from 08Mar2023 to 12Mar2023 and was tested negative at the end of the dosage period. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300119454 Same patient, same reporter, different product, different events;
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). The reporter is the patient. A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: gh9694) at the age of 47 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: er8732), in left arm and on 26Apr2021 as dose 2, single (Lot number: ew0171), in left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 058h21a), in left arm for COVID-19 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: treated; "hypothyroidism" (unspecified if ongoing), notes: treated; "Known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications (treatment for high blood pressure and hypothyroidism). Past drug history included: Codeine, reaction(s): "Known allergies".  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 with PAXLOVID from 08Mar2023 until 12Mar2023.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (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 drug ineffective, covid-19 which includes Paxlovid from 07Mar20230 to 12Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.