chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Product storage error, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swelling at the injection site (booster)), FRUSTRATION TOLERANCE DECREASED (she is frustrated) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Arm swelling at the injection site (booster)), FRUSTRATION TOLERANCE DECREASED (she is frustrated) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)). At the time of the report, VACCINATION SITE SWELLING (Arm swelling at the injection site (booster)), FRUSTRATION TOLERANCE DECREASED (she is frustrated) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)) outcome was unknown. Concomitant products were not provided. It was reported that patient was contacted by the pharmacy where she received her Moderna booster dose, and the pharmacist stated the dose she received came from a Moderna vial that was stored in a refrigerator without any type of temperature monitoring. Treatment medications were not reported. This case was linked to MOD-2022-525381 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain with the previous 3 doses/Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain with the previous 3 doses/Arm hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, 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 PAIN IN EXTREMITY (Arm pain with the previous 3 doses/Arm hurt). At the time of the report, PAIN IN EXTREMITY (Arm pain with the previous 3 doses/Arm hurt) had resolved.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-525546, MOD-2022-525602, MOD-2022-525616 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: The 3rd dose was a booster and she received another booster; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (The 3rd dose was a booster and she received another booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (The 3rd dose was a booster and she received another booster). At the time of the report, EXTRA DOSE ADMINISTERED (The 3rd dose was a booster and she received another booster) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient was concerned because she experienced arm pain with the previous 3 doses but not with this one. The patient felt because she was not having any side effects, she might had been given an expired vaccine. She believed because she received a vaccine so close to the expiration date the vaccine had lost a little potency.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-525546, MOD-2022-525602, MOD-2022-525609 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Neighbor had the same symptoms including fever, chills, and headache; Neighbor had the same symptoms including fever, chills, and headache; Neighbor had the same symptoms including fever, chills, and headache; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Neighbor had the same symptoms including fever, chills, and headache), CHILLS (Neighbor had the same symptoms including fever, chills, and headache) and HEADACHE (Neighbor had the same symptoms including fever, chills, and headache) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 PYREXIA (Neighbor had the same symptoms including fever, chills, and headache), CHILLS (Neighbor had the same symptoms including fever, chills, and headache) and HEADACHE (Neighbor had the same symptoms including fever, chills, and headache). At the time of the report, PYREXIA (Neighbor had the same symptoms including fever, chills, and headache), CHILLS (Neighbor had the same symptoms including fever, chills, and headache) and HEADACHE (Neighbor had the same symptoms including fever, chills, and headache) 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 medications were reported. No treatment information was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm  swelling; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (arm  swelling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm  swelling). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form twice a day and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of 1 dosage form twice a day. At the time of the report, PERIPHERAL SWELLING (arm  swelling) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PERIPHERAL SWELLING (arm  swelling) to be related.    Concomitant medication included Over the counter medication. Patient took steroids for 7 days as treatment and then Zyrtec and Allegra together, twice a day. Patient stated that the symptoms came back when she stopped taking the medicines.   This case was linked to MOD-2022-525727, MOD-2022-525739 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (each time she got the Moderna Covid-19 vaccine she got wipe out the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Allergy to Clindamycin). Concomitant products included AMLODIPINE BESYLATE for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day). At the time of the report, FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2022-525752, MOD-2022-525757 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Syncope
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (each time she got the Moderna Covid-19 vaccine she got wipe out the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Allergy to Clindamycin). Concomitant products included AMLODIPINE BESYLATE for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day). At the time of the report, FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2022-525752, MOD-2022-525757 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: each time she got the Moderna covid19 vaccine she got wipe out the next day,; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day,) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A, 013L20A and 939909) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Clindamycin). Concomitant products included AMLODIPINE BESYLATE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day,). At the time of the report, FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day,) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatments were reported.   This case was linked to MOD-2022-525757 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Syncope
Clinical narrative: each time she got the Moderna covid19 vaccine she got wipe out the next day,; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day,) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A, 013L20A and 939909) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Clindamycin). Concomitant products included AMLODIPINE BESYLATE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day,). At the time of the report, FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day,) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatments were reported.   This case was linked to MOD-2022-525757 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: when he received the Moderna booster dose, he spent 4 days in bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (when he received the Moderna booster dose, he spent 4 days in bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (when he received the Moderna booster dose, he spent 4 days in bed). At the time of the report, VACCINATION COMPLICATION (when he received the Moderna booster dose, he spent 4 days in bed) outcome was unknown.            No concomitant medications was provided. No treatment medications was provided.   This case was linked to MOD-2022-525755, MOD-2022-525891 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Lasting issues (Stomach)) and NAUSEA (Nauseous pretty often/Especially on empty stomach) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Chronic gastritis (Patient had Chronic gastritis before but free symptoms in years). Previously administered products included for Product used for unknown indication: BioNTech and J&J. Past adverse reactions to the above products included Stomach discomfort with BioNTech and J&J. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Lasting issues (Stomach)) and NAUSEA (Nauseous pretty often/Especially on empty stomach). At the time of the report, ABDOMINAL DISCOMFORT (Lasting issues (Stomach)) and NAUSEA (Nauseous pretty often/Especially on empty stomach) had not resolved. No concomitant medications was provided by the reporter. Patient stated that patient is curious because the patient had lasting issues (stomach) after Moderna, as well. No treatment medications was provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Feb-2021, the patient experienced FATIGUE (tired) and HEADACHE (headache). At the time of the report, FATIGUE (tired) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment drugs were reported.  Patient took second dose on 20 MAR 2021 and lot number 002B21A and booster dose sometime in the fall of 2021.   This case was linked to MOD-2022-525760, MOD-2022-525761 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Mar-2021, the patient experienced FATIGUE (tired) and HEADACHE (headache). At the time of the report, FATIGUE (tired) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  It was unknown which arm  the patient received his Moderna covid-19 vaccine. Also, the immunization card stated 1ml of Moderna Covid-19 for each of his primary doses, however later it was reported as 0.5ml for his primary series.  No treatment medications were reported.   This case was linked to MOD-2022-525750, MOD-2022-525761 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: The recent follow-up received on 29-MAR-2022 contains no new information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tired; Had a headache for 2 days.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and HEADACHE (Had a headache for 2 days.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, 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 FATIGUE (Tired) and HEADACHE (Had a headache for 2 days.). At the time of the report, FATIGUE (Tired) outcome was unknown and HEADACHE (Had a headache for 2 days.) had resolved.            No Concomitant product use was reported.  The reporter was reporting about their husband who was the patient. The patient received their Moderna Covid-19 booster dose sometime in the fall of 2021. The patient was tired and had a headache for 2 days.  The reporter mentioned that the patient's immunization card and other documents from Pharmacy said 1ml of Moderna Covid-19 vaccine for the patient's primary series. The reporter also stated that patient's records now said 0.5ml for the patient's primary series.  No treatment information was provided.   This case was linked to MOD-2022-525750, MOD-2022-525760 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: patient had a reaction after receiving the vaccine/patient has an issue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (patient had a reaction after receiving the vaccine/patient has an issue) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 VACCINATION COMPLICATION (patient had a reaction after receiving the vaccine/patient has an issue). At the time of the report, VACCINATION COMPLICATION (patient had a reaction after receiving the vaccine/patient has an issue) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported. It was reported that patient had reaction after receiving the vaccine, patient wanted to speak to a physician, because the patient wanted some guidance reporting this adverse event and want to talk about the issue the patient had. No Treatment medications were reported.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired work ability, Palpitations, Pyrexia
Clinical narrative: palpitations for a few weeks in her heart; Couldn't go to work; Dizzy; high fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations for a few weeks in her heart), IMPAIRED WORK ABILITY (Couldn't go to work), DIZZINESS (Dizzy) and PYREXIA (high fever) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     The patient's past medical history included Brain inflammation. Concurrent medical conditions included Drug allergy (Allergic to Aspirin), Seafood allergy and Neurologic disorder NOS (Neurologic problems) since 2020.    On 03-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitations for a few weeks in her heart), IMPAIRED WORK ABILITY (Couldn't go to work), DIZZINESS (Dizzy) and PYREXIA (high fever). At the time of the report, PALPITATIONS (palpitations for a few weeks in her heart) had resolved, IMPAIRED WORK ABILITY (Couldn't go to work) outcome was unknown and DIZZINESS (Dizzy) and PYREXIA (high fever) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Concomitant medication reported included antiverg.  The patient received the first dose of the Moderna Covid-19 vaccine on 03-Jan-2022 and stated that the patient got the vaccine because it was mandatory by their job and by the State, but the patient had a medical exception to get the second dose by the patient's doctor, because the patient had as a reaction to the vaccine high fever, and palpitations for a few weeks in their heart, and also the patient got dizzy, and couldn't go to work, and because of the patient's previous condition of Inflammation of the brain the doctor told the patient to delay the second dose, and on the patient's job they were asking to get the second dose, or the patient would lose their job and wanted to know how to get a second dose, with another vaccine.  Reportedly, the patient never had COVID + test or diagnosis. No, other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient had not experienced a similar event in the past. The patient also said that the symptoms improved but still were there.  The patient's height was 5 Foot.  No treatment information was provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered out a vial which experienced excursion for 4 hours; Doses administered out a vial which experienced excursion for 4 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial which experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial which experienced excursion for 4 hours) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 001J21-2A and 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial which experienced excursion for 4 hours). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial which experienced excursion for 4 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered out a vial which experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered out a vial which experienced excursion for 4 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The vials were returned to stable refrigerator temperature after 4 hours.   This case was linked to MOD-2022-525469, MOD-2022-525791 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered out a vial that experienced excursion for 4 hours; Dose administered out a vial that experienced excursion for 4 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered out a vial that experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered out a vial that experienced excursion for 4 hours) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered out a vial that experienced excursion for 4 hours). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered out a vial that experienced excursion for 4 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered out a vial that experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered out a vial that experienced excursion for 4 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.  The vials were returned to stable temperature of refrigerator after 4 hours. The patient received the booster dose.   This case was linked to MOD-2022-525790, MOD-2022-525469 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (with a horrible shooting pain down her right side that starts at the hip & goes down to the ankle) and VACCINATION SITE ERYTHEMA (after her 2nd dose that she described as a big red square at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (with a horrible shooting pain down her right side that starts at the hip & goes down to the ankle). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (after her 2nd dose that she described as a big red square at the injection site). In 2021, PAIN (with a horrible shooting pain down her right side that starts at the hip & goes down to the ankle) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (after her 2nd dose that she described as a big red square at the injection site) had resolved. Patient reported her experience after receiving 2nd dose of the Moderna Covid-19 Vaccine all in the left arm. She said she woke up with a horrible shooting pain down her right side that started at the hip & goes down to the ankle. She said that the same thing happened last year after her 2nd dose, it lasted for about a month, & got better after she went to a walk-in orthopedic clinic & got a steroid injection. She said that she also had Covid arm after her 2nd dose that she described as a big red square at the injection site, and said that she did not had that now. No concomitant medications details were reported. This case was linked to MOD-2022-525987 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site warmth, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Left arm hot at injection site; Allergic reaction after booster dose; Left arm red at injection site; Left arm swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Left arm hot at injection site), HYPERSENSITIVITY (Allergic reaction after booster dose), VACCINATION SITE ERYTHEMA (Left arm red at injection site) and VACCINATION SITE SWELLING (Left arm swollen at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 047C21A and 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Cholesterol.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2022, the patient experienced INJECTION SITE WARMTH (Left arm hot at injection site), HYPERSENSITIVITY (Allergic reaction after booster dose), VACCINATION SITE ERYTHEMA (Left arm red at injection site) and VACCINATION SITE SWELLING (Left arm swollen at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in March 2022 at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) in March 2022 at an unspecified dose and frequency. In March 2022, INJECTION SITE WARMTH (Left arm hot at injection site), HYPERSENSITIVITY (Allergic reaction after booster dose), VACCINATION SITE ERYTHEMA (Left arm red at injection site) and VACCINATION SITE SWELLING (Left arm swollen at injection site) had resolved.            Patient reported that she takes concomitant medication for her cholesterol.  Patient reported that she is currently not experiencing any symptoms. She stated that she did not experience any symptoms with the previous two doses of the Moderna COVID-19 vaccine.   This case was linked to MOD-2022-525887 (Patient Link).   Reporter did not allow further contact
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial did not undergo temperature excursions.  It was reported that date the vial was initially stored in the refrigerator was 31-Jan-2022.  No treatment medications were reported.   This case was linked to MOD-2022-525860.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that date the vial was initially stored in the refrigerator was 31-Jan-2022.   This case was linked to MOD-2022-525834, MOD-2022-525860, MOD-2022-525870, MOD-2022-525874, MOD-2022-525880, MOD-2022-525890, MOD-2022-525893, MOD-2022-525896, MOD-2022-525900, MOD-2022-525903, MOD-2022-525912, MOD-2022-525915, MOD-2022-525860 (Patient Link).
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient.; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient.) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient.). On an unknown date, the patient PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that the patient took half dose booster. Vial was initially stored in the refrigerator on 31-Jan-2022. It was reported that the vial did not undergo any temperature excursions. Treatment information was not provided.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.   Date the vial was initially stored in the refrigerator was 31 Jan 2022 The vial did not undergo any temperature excursion.   This case was linked to MOD-2022-525860.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Somnolence, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: black spots at injection site; red spots started to appear at the injection site; fever; tiredness; slept the whole day; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (black spots at injection site), SOMNOLENCE (slept the whole day), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE ERYTHEMA (red spots started to appear at the injection site) and PYREXIA (fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (patient tested positive) in December 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1, Lot number: EN6201, Expiration date: 30-Jun-2021) on 05-Mar-2021, Pfizer (Dose Number: 2, Lot number: EN6201 and Expiration date: 30-Jun-2021) on 26-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 23-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Mar-2022, the patient experienced SOMNOLENCE (slept the whole day), VACCINATION SITE PRURITUS (itching at the injection site), PYREXIA (fever) and FATIGUE (tiredness). On 25-Mar-2022, the patient experienced VACCINATION SITE ERYTHEMA (red spots started to appear at the injection site). On 28-Mar-2022, the patient experienced VACCINATION SITE DISCOLOURATION (black spots at injection site). On 25-Mar-2022, SOMNOLENCE (slept the whole day), PYREXIA (fever) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (black spots at injection site) and VACCINATION SITE PRURITUS (itching at the injection site) had not resolved and VACCINATION SITE ERYTHEMA (red spots started to appear at the injection site) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient is not on any concomitant medications. It was reported that the black spots are about an inch in diameter. No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: black spots at injection site; red spots started to appear at the injection site; fever; tiredness; slept the whole day; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (black spots at injection site), SOMNOLENCE (slept the whole day), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE ERYTHEMA (red spots started to appear at the injection site) and PYREXIA (fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (patient tested positive) in December 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1, Lot number: EN6201, Expiration date: 30-Jun-2021) on 05-Mar-2021, Pfizer (Dose Number: 2, Lot number: EN6201 and Expiration date: 30-Jun-2021) on 26-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 23-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Mar-2022, the patient experienced SOMNOLENCE (slept the whole day), VACCINATION SITE PRURITUS (itching at the injection site), PYREXIA (fever) and FATIGUE (tiredness). On 25-Mar-2022, the patient experienced VACCINATION SITE ERYTHEMA (red spots started to appear at the injection site). On 28-Mar-2022, the patient experienced VACCINATION SITE DISCOLOURATION (black spots at injection site). On 25-Mar-2022, SOMNOLENCE (slept the whole day), PYREXIA (fever) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (black spots at injection site) and VACCINATION SITE PRURITUS (itching at the injection site) had not resolved and VACCINATION SITE ERYTHEMA (red spots started to appear at the injection site) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient is not on any concomitant medications. It was reported that the black spots are about an inch in diameter. No treatment medications were reported.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that date the vial was initially stored in the refrigerator was on 31-Jan-2022. No temperature excursion. No treatment medications were reported.   This case was linked to MOD-2022-525860 (Patient Link).