chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine. Reporter did not had information available on the patient's first two doses.  Storage condition at the time of the excursion: refrigerated storage. Date vial(s) moved from freezer to refrigerator. 03 Mar 2022. Visual inspection was reported as vials were not visualized. Maximum Temperature was 49 degrees Farenheight and Minimum Temperature is 37.7 degrees Farenheight.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Received a Moderna booster shot but she needed a second dose of the Pfizer COVID 19 vaccine; Received a Moderna booster shot but she needed a second dose of the Pfizer COVID 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a Moderna booster shot but she needed a second dose of the Pfizer COVID 19 vaccine) and WRONG PRODUCT ADMINISTERED (Received a Moderna booster shot but she needed a second dose of the Pfizer COVID 19 vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID 19 vaccine (Dose: 1). Past adverse reactions to the above products included No adverse event with Pfizer COVID 19 vaccine.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a Moderna booster shot but she needed a second dose of the Pfizer COVID 19 vaccine) and WRONG PRODUCT ADMINISTERED (Received a Moderna booster shot but she needed a second dose of the Pfizer COVID 19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a Moderna booster shot but she needed a second dose of the Pfizer COVID 19 vaccine) and WRONG PRODUCT ADMINISTERED (Received a Moderna booster shot but she needed a second dose of the Pfizer COVID 19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history information was reported.  Concomitant medication of the patient was not reported.  The patient stated she already had two Pfizer shots and needed a booster. As, the patient needed booster dose of a COVID-19 vaccine, Moderna COVID-19 vaccine was administered (half the dose as it was a booster). It was later found out actually she needed a second dose of the Pfizer COVID 19 vaccine. The patient did not have her vaccination card at the time of vaccination.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14-year-old patient received the Moderna COVID-19 vaccine as the first dose in the primary series of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old patient received the Moderna COVID-19 vaccine as the first dose in the primary series of the vaccine) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old patient received the Moderna COVID-19 vaccine as the first dose in the primary series of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old patient received the Moderna COVID-19 vaccine as the first dose in the primary series of the vaccine) outcome was unknown.  For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.  The reporter worked as a clinical consultant at an urgent care center.  Concomitant medication of the patient was not reported.  The error was discovered when the patient returned for the second dose of Moderna COVID-19 vaccine. The reporter also mentioned that following vaccination no reaction was reported regarding the patient.  No treatment information was provided by the reporter.  Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Upon follow-up non-significant information was received and reporter email address was added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza
Clinical narrative: She feels horrible like she has the flu; She feels horrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (She feels horrible like she has the flu) and FEELING ABNORMAL (She feels horrible) in a 62-year-old female patient 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 INFLUENZA (She feels horrible like she has the flu) and FEELING ABNORMAL (She feels horrible). At the time of the report, INFLUENZA (She feels horrible like she has the flu) and FEELING ABNORMAL (She feels horrible) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant and treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received booster dose for third dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose for third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    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 ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose for third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose for third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: "didn't feel quite right" and mentioned "but that's normal"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("didn't feel quite right" and mentioned "but that's normal") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Annual Flu Vaccine (Annual Flu Vaccine intramuscular route) in 2021. Past adverse reactions to the above products included No adverse event with Annual Flu Vaccine. Concurrent medical conditions included Irritable bowel syndrome (Recent change in Status: No change) since 2010, Sulfonamide allergy (allergic to Sulfa), Allergy to antibiotic (allergic to ampicillin) and Drug allergy (allergic to indocin). Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ10 [UBIDECARENONE]), LUTEIN [XANTOFYL], GARLIC [ALLIUM SATIVUM] and ANTIOXIDANTS NOS;MINERALS NOS;VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced FEELING ABNORMAL ("didn't feel quite right" and mentioned "but that's normal"). At the time of the report, FEELING ABNORMAL ("didn't feel quite right" and mentioned "but that's normal") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient never had COVID positive test or diagnosis.  Other Concomitant medicine includes flex for knees and joints.  No treatment information were reported by the reporter.   This case was linked to MOD-2022-513916, MOD-2022-515151 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: "didn't feel quite right" (2ND dose); This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("didn't feel quite right" (2ND dose)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 002A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (Annual Flu Vaccine intramuscular route) in 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Allergy to antibiotic (ampicillin), Sulfonamide allergy (sulfa), Drug allergy (Indocin) and Irritable bowel syndrome (Recent change in Status: No change) since 2010. Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ-10), LUTEIN [XANTOFYL] and GARLIC [ALLIUM SATIVUM] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Apr-2021, the patient experienced FEELING ABNORMAL ("didn't feel quite right" (2ND dose)). At the time of the report, FEELING ABNORMAL ("didn't feel quite right" (2ND dose)) outcome was unknown.            Patient never had COVID positive test or diagnosis. There was no recent change in status such as improvement or worsening. Other Concomitant medicine includes flex for knees and joints and antioxidant for unknown indication. No treatment information were reported by the reporter.   This case was linked to MOD-2022-515150, MOD-2022-513916.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster dose received < 5 months from 2nd dose/Patient received booster dose a month or 2 early per HCP/Booster dose administered early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received < 5 months from 2nd dose/Patient received booster dose a month or 2 early per HCP/Booster dose administered early) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received < 5 months from 2nd dose/Patient received booster dose a month or 2 early per HCP/Booster dose administered early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received < 5 months from 2nd dose/Patient received booster dose a month or 2 early per HCP/Booster dose administered early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The hcp who stated that a patient had received primary series but received their booster dose a month or 2 early from their 2nd primary series dose which was on 19Nov2021 per the HCP. The HCP stated that she is aware that booster dose should be at least 5 months later after the 2nd dose and asked if they should be looked for any adverse reactions.  Treatment information was not provided.   This case was linked to MOD-2022-515204 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm) and PAIN (A few days later he had soreness all over did not go away for couple of days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The patient's past medical history included Polymyalgia rheumatica (Was treated for two years with Prednisone and was resolved itself after about 2 years) in 2013. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine J&J (First Dose of COVID-19 vaccine J & J, Intramuscular) on 07-Mar-2021 and Flu vaccine (Received flu vaccine last year.) in 2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine J&J and Flu vaccine. Concurrent medical conditions included Seafood allergy (Seaweed salad allergy). Concomitant products included Warfarin; Lisinopril; Rosuvastatin; Hydrochlorothiazide; Multivitamins [Vitamins NOS] for an unknown indication. On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness of arm) and PAIN (A few days later he had soreness all over did not go away for couple of days). At the time of the report, PAIN IN EXTREMITY (soreness of arm) and PAIN (A few days later he had soreness all over did not go away for couple of days) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 12 or 13 (High) C reactive poteen spiked to 12 or 13 for about 4 months. The patient called to report adverse event after receiving the Moderna booster dose. The patient reported that after the booster the patient expected soreness in arm which the patient had then a few days later the patient had soreness all over did not go away for couple of days. The patient also stated that the patient had quarterly blood work done from primary care physician and based on bloodwork results panel for C reactive protein spiked to 12 or 13 for about 4 months. The patient said that this never had spiked, and the level was supposed to be less than 8 and was always lower for years. The patient reported that it took until Feb-2022/Mar-2022 for C reactive protein to lower again. The patient's height was 6 ft. 3 in. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Nervousness
Clinical narrative: Anxiety; Felt tight for about 5 minutes while in the shower, then felt better, Tightness was not in chest, they were just nervous, it was their nerves; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety) and NERVOUSNESS (Felt tight for about 5 minutes while in the shower, then felt better, Tightness was not in chest, they were just nervous, it was their nerves) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety) and NERVOUSNESS (Felt tight for about 5 minutes while in the shower, then felt better, Tightness was not in chest, they were just nervous, it was their nerves). At the time of the report, ANXIETY (Anxiety) and NERVOUSNESS (Felt tight for about 5 minutes while in the shower, then felt better, Tightness was not in chest, they were just nervous, it was their nerves) had resolved.            No concomitant medications were reported. Patient received second dose and had no problem with it. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2022: Follow up received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Immunocompromised patient received a .25 mL dose instead of his 3 full dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Immunocompromised patient received a .25 mL dose instead of his 3 full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Immunocompromised patient received a .25 mL dose instead of his 3 full dose). At the time of the report, UNDERDOSE (Immunocompromised patient received a .25 mL dose instead of his 3 full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The reporter stated that then it was the time for his booster and they wanted to know if they should administer a  0.5 mL or 0.25 mL dose.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Throwing up) in an elderly female patient who received mRNA-1273 (Spikevax) for an unknown indication.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and VOMITING (Throwing up). At the time of the report, NAUSEA (Nausea) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastrointestinal disorder, Illness, Lethargy, Pyrexia
Clinical narrative: sick; stomach ache; lethargic; stomach problems; fever after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), ABDOMINAL PAIN UPPER (stomach ache), LETHARGY (lethargic), GASTROINTESTINAL DISORDER (stomach problems) and PYREXIA (fever after first dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Eczema (eczema patches in the past but nothing terrible.).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ILLNESS (sick), ABDOMINAL PAIN UPPER (stomach ache), LETHARGY (lethargic), GASTROINTESTINAL DISORDER (stomach problems) and PYREXIA (fever after first dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), ABDOMINAL PAIN UPPER (stomach ache), LETHARGY (lethargic), GASTROINTESTINAL DISORDER (stomach problems) and PYREXIA (fever after first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications include Birth control pill.   This case was linked to MOD-2022-515565, MOD-2022-515567.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired vaccine was given to a patient/Vial had been punctured at room temperature for almost 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired vaccine was given to a patient/Vial had been punctured at room temperature for almost 26 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K212A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 17-Mar-2022 at 2:44 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired vaccine was given to a patient/Vial had been punctured at room temperature for almost 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired vaccine was given to a patient/Vial had been punctured at room temperature for almost 26 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products reported included unspecified high blood pressure medication and high cholesterol medications.  Concurrent condition included high cholesterol.  Vial had been punctured at room temperature for almost 26 hours. Vial was open at 1:06 PM on 16-Mar-2022, and administered to the patient on 17-Mar-2022 at 2:44 PM.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30 days use by date; Moderna Covid-19 vaccine that was beyond its use-by date was given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given) and PRODUCT STORAGE ERROR (Dose administered after 30 days use by date) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given) and PRODUCT STORAGE ERROR (Dose administered after 30 days use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   On 06 Feb 2022 the vial was initially stored in refrigerator, it mentioned that the vial did not undergo any temperature excursions. No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-516063 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. The  concomitant medications on use were not provided. The vial was exposed at minimum temperature of 199.9 degree Celsius for 30 minutes. Storage condition at the time of the excursion was refrigerated storage. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: thinks she received 0.5 ml for booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (thinks she received 0.5 ml for booster dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 092L20A and 029L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Vaccine (High Dose Flu Vaccine Route of administration - IM) in September 2021. Past adverse reactions to the above products included No adverse event with Flu Vaccine.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (thinks she received 0.5 ml for booster dose). At the time of the report, ACCIDENTAL OVERDOSE (thinks she received 0.5 ml for booster dose) outcome was unknown.            No Concomitant Medications were provided by the reporter.      No Treatment Medications were provided by the reporter.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: He reports he was seen in the ER on 20 January prior to onset of his symptoms for epigastric pain felt to be due to gastritis due to NSAID use; he was given acetaminophen, famotidine, and sucralfate which he has continued to use. Since 20 January, shortly after he left the ER he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affects his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to the ER on 23 January where he was treated with oral antihistamine and corticosteroids with limited benefit. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 5 January, 15 days prior to onset of symptoms. He has used oral antihistamines with some benefit. He denies constitutional symptoms. score today is 4 (0, 0, 0, 0, 0, 0, 4, 0). No history of adverse reactions to prior vaccines.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin lesion, Urticaria
Clinical narrative: He reports he was seen in the ER on 20 January prior to onset of his symptoms for epigastric pain felt to be due to gastritis due to NSAID use; he was given acetaminophen, famotidine, and sucralfate which he has continued to use. Since 20 January, shortly after he left the ER he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affects his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to the ER on 23 January where he was treated with oral antihistamine and corticosteroids with limited benefit. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 5 January, 15 days prior to onset of symptoms. He has used oral antihistamines with some benefit. He denies constitutional symptoms. score today is 4 (0, 0, 0, 0, 0, 0, 4, 0). No history of adverse reactions to prior vaccines.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood cholesterol, Fatigue, Photosensitivity reaction, Skin atrophy
Clinical narrative: Caller adds that she experienced tiredness, it was temporary with the first vaccine.; just my skin is getting a little bit blister and a little bit, it is little clumpier; I got skin eruptions; Skin got thinner; Sensitivity to sun light; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mental Condition" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: allergy to a Neurotic; "panic attack" (unspecified if ongoing); "Loss of oxygen" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Caller adds that she experienced tiredness, it was temporary with the first vaccine."; BLISTER (non-serious), outcome "unknown", described as "just my skin is getting a little bit blister and a little bit, it is little clumpier"; SKIN DISORDER (non-serious), outcome "unknown", described as "I got skin eruptions"; SKIN ATROPHY (non-serious), outcome "unknown", described as "Skin got thinner"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "Sensitivity to sun light". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information- Patient took second dose on 11Oct2021 at 12:30 PM. Patient stated the thinning of the skin and sensitivity to the sunlight was getting little better with time. She took Haldol and Risperidone about a year ago and when she took it was about for a limited time like a day or so. She had low cholesterol even though she had Cheese non-stop. She took Viviscal hair vitamin, that was 3-4 years ago and mental medication (Geodon) 3 years ago, she got it for bipolar disorder. She had sodium bicarbonate water, which was dehydrating her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101596372 similar report from same reporter
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: Caller adds that she experienced tiredness, it was temporary with the first vaccine.; just my skin is getting a little bit blister and a little bit, it is little clumpier; I got skin eruptions; Skin got thinner; Sensitivity to sun light; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mental Condition" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: allergy to a Neurotic; "panic attack" (unspecified if ongoing); "Loss of oxygen" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Caller adds that she experienced tiredness, it was temporary with the first vaccine."; BLISTER (non-serious), outcome "unknown", described as "just my skin is getting a little bit blister and a little bit, it is little clumpier"; SKIN DISORDER (non-serious), outcome "unknown", described as "I got skin eruptions"; SKIN ATROPHY (non-serious), outcome "unknown", described as "Skin got thinner"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "Sensitivity to sun light". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information- Patient took second dose on 11Oct2021 at 12:30 PM. Patient stated the thinning of the skin and sensitivity to the sunlight was getting little better with time. She took Haldol and Risperidone about a year ago and when she took it was about for a limited time like a day or so. She had low cholesterol even though she had Cheese non-stop. She took Viviscal hair vitamin, that was 3-4 years ago and mental medication (Geodon) 3 years ago, she got it for bipolar disorder. She had sodium bicarbonate water, which was dehydrating her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101596372 similar report from same reporter
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling
Clinical narrative: Armpit pain and swollen; Armpit pain and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 15:00 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: AXILLARY PAIN (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 06Dec2021 07:00, outcome "unknown" and all described as "Armpit pain and swollen". Therapeutic measures were not taken as a result of axillary pain, peripheral swelling.  Additional Information: Batch/lot is Unknown due to Unable to locate or read the details. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks reported as Tylenol children's gummies vitamins. Prior to vaccination, Patient was not diagnosed with COVID-19. Since the vaccination, Patient not tested for COVID-19. No known allergy was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: headache; sore arm; he could no longer sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 06Dec2021 09:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 2, Lot number: Unknown, reason: Not available/provided to reporter at the time of report completion), administration date: Feb2021, for Covid-19 Immunization; Bnt162b2 (Dose number: 1, Lot number: Unknown, reason: Not available/provided to reporter at the time of report completion), administration date: Jan2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 07Dec2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "recovering", described as "sore arm"; INSOMNIA (non-serious) with onset 07Dec2021, outcome "recovering", described as "he could no longer sleep". It was unknown if therapeutic measures were taken as a result of headache, pain in extremity, insomnia.  Additional information included: It was reported that lot number was not available or not provided by the reporter at the time of report completion. It was unknown if patient had received any other vaccine in four weeks. It was unknown if patient received treatment. It was unknown if patient had COVID prior vaccination. It was unknown if patient tested COVID post vaccination.  Follow-up are completed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Little discomfort in the arm, in the right arm for a while; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Little discomfort in the arm, in the right arm for a while".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: arm is killing; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US266562_NS (RA).  A 64 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 64 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Dec2021, outcome "unknown", described as "arm is killing"; FATIGUE (non-serious) with onset 06Dec2021, outcome "unknown", described as "tired".  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Her son has a frightening low platelet count; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rare blood disorder" (unspecified if ongoing), notes: Rare blood disorder; "immunocompromise" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Her son has a frightening low platelet count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was a caregiver calling to find out how to give her 17-and-a-half-year-old son the booster dose. she states her son has a rare blood disorder and he was at risk for bleeding if he gets the Covid-19 infection. She states her son received two doses of the Pfizer BioNTech Covid-19 vaccine without any problems, her son received his 2nd dose in Apr2021. She states because he was 17 and a half years old, she cannot get him the booster. she states she would like some guidance to make it happen because the medical people she has been reaching out to have no idea and her son cannot wait another 6 months to get the vaccine, her son has a frightening low platelet count and the Covid infection can drop that even lower because it was already lower than anyone should have. It was upsetting that there was something out there that that could help, and her son does not have access it. She knows the booster has been authorized for people 16 years of age and older but 3 different facilities have told her that the FDA approval was only the first step and none of them will give it to a 17-year-old. She has a follow-up question asking if her 17-year-old son was considered immunocompromise would he be eligible for the booster. She states if her son was eligible for the vaccine who should she contact to get her son the booster dose. her son's hematologist was in full agreement that he should receive the booster, but he did not know how to make that happen before it was approved, and now that it was approved, she still cannot get it for him because will not allow her to make an appointment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac disorder, Cardiac stress test, Echocardiogram, Electrocardiogram
Clinical narrative: Heart issues like racing heart; Heart issues like racing heart; Blood pressure high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal Asthma" (unspecified if ongoing), notes: Seasonal Asthma and uses an inhaler. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01), administration date: 2021, when the patient was 19 years old, for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), PALPITATIONS (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Heart issues like racing heart"; HYPERTENSION (non-serious) with onset Apr2021, outcome "unknown", described as "Blood pressure high". The events "heart issues like racing heart", "heart issues like racing heart" and "blood pressure high" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: Heart issues like racing heart; Heart issues like racing heart; Blood pressure high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal Asthma" (unspecified if ongoing), notes: Seasonal Asthma and uses an inhaler. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01), administration date: 2021, when the patient was 19 years old, for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), PALPITATIONS (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Heart issues like racing heart"; HYPERTENSION (non-serious) with onset Apr2021, outcome "unknown", described as "Blood pressure high". The events "heart issues like racing heart", "heart issues like racing heart" and "blood pressure high" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.