chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Injected limb mobility decreased, Injection site pain
Clinical narrative: injection arm  became sore, still sore, painful to lift it up; Still painful to lift it up over her head; Fatigue; Fever; Headache; 2nd dose administered  beyond 6 months; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 07th May 2022).   On 21st December 2022, the patient received the 2nd dose of Shingrix. On 21st December 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, fatigue, fever, headache and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the fatigue, fever and headache were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, fatigue, fever and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The patient was self-reported this case. The patient reported that she received Shingrix vaccine. The patient stated that on 21st December 2022, shortly after received Shingrix vaccine she experienced fatigue, fever, and headache. The patient reported that all these symptoms are resolved within 24 hours. The patient also reported that her injection arm right became sore and was still sore.   The patient stated that it was still painful to lift it up over her head.    The patient did not had any further information about the vaccine itself. The reporter did consent to follow up. The patient was beyond the 6 months of recommended time frame for getting her second vaccine.  Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: injection arm  became sore, still sore, painful to lift it up; Still painful to lift it up over her head; Fatigue; Fever; Headache; 2nd dose administered  beyond 6 months; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 07th May 2022).   On 21st December 2022, the patient received the 2nd dose of Shingrix. On 21st December 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, fatigue, fever, headache and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the fatigue, fever and headache were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, fatigue, fever and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The patient was self-reported this case. The patient reported that she received Shingrix vaccine. The patient stated that on 21st December 2022, shortly after received Shingrix vaccine she experienced fatigue, fever, and headache. The patient reported that all these symptoms are resolved within 24 hours. The patient also reported that her injection arm right became sore and was still sore.   The patient stated that it was still painful to lift it up over her head.    The patient did not had any further information about the vaccine itself. The reporter did consent to follow up. The patient was beyond the 6 months of recommended time frame for getting her second vaccine.  Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2021, didn´t receive the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th December 2021 from batch number 4CA93 with expiry date 31st March 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comments: The pharmacist reported that the patient received first dose of Shingrix and wished to know if they could receive the second dose or if they needed to restart the vaccine schedule. The reporter consented to follow up. The VAERS details reported corresponded to the 1st dose only as the 2nd dose was not administered at the time of reporting. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 20th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received first dose of Twinrix vaccine which was already expired on 01st January 2023. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received a Twinrix which was already expired, which led to expired vaccine used.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: oxicodone, trazidone, dextromethorphan hbr allergy, and chronic severe headaches (treated with botox injections, tylenol, and advil). The patient was previously treated with covid-19 vaccine ad26.cov2.s (Dose Number in Series 1) (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 12-JUL-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose Number in Series 1)  The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 02-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 47 years old.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2)  The patient additionally received non-company suspect drugs included: (Spikevax) Moderna bivalent booster (elasomeran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: AS7143C, expiry: UNKNOWN) dose was not reported, administered at right arm on 01-NOV-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included botox injections (botulinum toxin type A), Advil (ibuprofen), Tylenol (paracetamol) for chronic severe headaches, Cold Relief (acetylsalicylic acid/chlorphenamine maleate/phenylephrine bitartrate), (guaifenesin), and (pseudoephedrine hydrochloride). On unspecified date in 2022, the patient experienced suspected covid-19 infection (Dose number in series 3) and received non-company suspect drug Paxlovid for treatment of covid-19 (form of admin, route of admin were not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, administered from 05-DEC-2022 to 10-DEC-2022.  On 15-DEC-2022, the patient was sick (Dose number in series 3). Although he felt pretty good at the end of the Paxlovid treatment, a few days later he became extremely sick again and that lasted for over a week. He spoke with the physician and was told that this could happen for the next few months. Very slowly he began feeling better, but 2 days ago it started getting worse again. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract irritation, Urticaria
Clinical narrative: AIRWAY IRRITATION; HIVES; This spontaneous report received from a physician concerned a 48 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, and batch number were not reported) dose was not reported, administered on 25-JAN-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On an unspecified date, the patient experienced airway irritation, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives and airway irritation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-AUG-2021 into left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-NOV-2021 into left arm for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The patient received non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported administered on 05-JAN-2023 to 09-JAN-2023 for covid-19 treatment. After successfully completing Paxlovid course, 5 days later on 14-JAN-2023 patient had a rebound covid-19 infection. The patient's symptoms returned and was contagious again (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Discomfort, Dyspnoea
Clinical narrative: TIGHTNESS IN CHEST; CHEST PAINS AROUND HEART AND THEN MOVED INTO LEFT ARM AND PAIN GOING UP TO NECK; TOUGH TO BREATH; WANTED TO TAKE OFF ALL OF HIS CLOTHES/UNCOMFORTABLE IN HIS CLOTHES AND HAD HIS PANTIES IN A TWIST; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical history. 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 2021 for covid-19 prophylaxis. Age at time of vaccination 4 decade old. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JAN-2023, the patient experienced tightness in chest, chest pains around heart and then moved into left arm and pain going up to neck, tough to breath, and wanted to take off all of his clothes/uncomfortable in his clothes and had his panties in a twist. Treatment medications (dates unspecified) included: acetylsalicylic acid, ondansetron, morphine, and glyceryl trinitrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tightness in chest, chest pains around heart and then moved into left arm and pain going up to neck, tough to breath and wanted to take off all of his clothes/uncomfortable in his clothes and had his panties in a twist was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pain that feels like someone punched me in the stomach; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain that feels like someone punched me in the stomach) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 006B21A and 022M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteopenia (Severe) and Arthritis (arthritis in thumb).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In December 2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain that feels like someone punched me in the stomach). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for Stomach pain, at an unspecified dose and frequency; ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (MAALOX [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE;SIMETICONE]) for Stomach pain, at an unspecified dose and frequency and SUCRALFATE (CARAFATE) for Stomach pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain that feels like someone punched me in the stomach) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had been giving self an injection with a pen concomitantly for arthritis.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had stomach pain that feels like someone punched patient in the stomach since December 2021. Patient couldn't do sit ups and was on pepcid, maalox, and carafate and the medications had been improving symptoms. The pharmacist told to patient stomach pain will not go away.   This case was linked to MODERNATX, INC.-MOD-2023-700856 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-700856:Case for Bivalent dose
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-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) 1 dosage form. On 06-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent) 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 (50-year-old patient received 2nd primary dose of Moderna COVID-19 vaccine, But received Bivalent booster instead on Monovalent).    No concomitant medications were reported. On 09Dec2022 at 14:38 Pm, the patient received first dose of monovalent Moderna vaccine 0.5 mL intramuscularly in left deltoid (Lot number: 015B22A). No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Significant follow up received contains Reporter details and narrative updated
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, Suspected COVID-19
Clinical narrative: I feel I have the COVID for the past week, I'm unsure if it's COVID or if is as cold; Sore throat; Coughing; I'm unsure if it's COVID or if is as cold; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (I feel I have the COVID for the past week, I'm unsure if it's COVID or if is as cold), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and NASOPHARYNGITIS (I'm unsure if it's COVID or if is as cold) in a female patient of an unknown age 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 an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (I feel I have the COVID for the past week, I'm unsure if it's COVID or if is as cold), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and NASOPHARYNGITIS (I'm unsure if it's COVID or if is as cold). At the time of the report, SUSPECTED COVID-19 (I feel I have the COVID for the past week, I'm unsure if it's COVID or if is as cold), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and NASOPHARYNGITIS (I'm unsure if it's COVID or if is as cold) outcome was unknown.            No concomitant and treatment medications were reported.  Patient previous 4 vaccinations were from Moderna which therapy dates and batch numbers were not reported, and that patient had never received the Pfizer COVID-19 vaccine, however patient was scheduled to get a Pfizer COVID-19 booster.  Patient already had the vaccine and booster Moderna and felt having COVID for the past week, but unsure if it was COVID or was cold. Patient symptoms are sore throat and coughing. Patient just had a booster about 4 months ago.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  Vaccines were stored in the fridge on 30-Jun-2021.  The patient did not report any side effects.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: A patient got the first dose in 22Jun2022 and did not get the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (A patient got the first dose in 22Jun2022 and did not get the second dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (A patient got the first dose in 22Jun2022 and did not get the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (A patient got the first dose in 22Jun2022 and did not get the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) 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 PRODUCT ADMINISTRATION INTERRUPTED (A patient got the first dose in 22Jun2022 and did not get the second dose).    Concomitant and treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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. 023C22A) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration 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 (20 Patients received Spikevax past the 30 day expiration date).    This case was created for 15th patient of 20 patients Concomitant medication was not provided. Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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. 023C22A) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medication information was reported. No treatment medication information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-700683: Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-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 EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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. 023C22A) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration 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 (20 Patients received Spikevax past the 30 day expiration date).    This case was created for 18th patient of 20 patients Concomitant medication was not provided. Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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. 023C22A) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medication information was reported. No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125: case (1 of 56 patient)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-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 EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:case (1 of 56 patient)