chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 25-May-2022 and the vaccine was administered on 27-Jun-2022.; administer a vaccine to a patient past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer a vaccine to a patient past the 30 day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25-May-2022 and the vaccine was administered on 27-Jun-2022.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 034F21A, 010M20A and 012L20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Allergy (Allergy to estrogens) and Drug allergy (Allergy to Toradol).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administer a vaccine to a patient past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25-May-2022 and the vaccine was administered on 27-Jun-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer a vaccine to a patient past the 30 day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25-May-2022 and the vaccine was administered on 27-Jun-2022.) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Patient did not receive any other vaccine one month prior to Moderna COVID-19 Vaccine. It was reported that use by date was on the 24-JUN-2022. Number of vials is 10 vials. Vial did not undergone any temperature excursions. AE does not cause patient to seek medical care. No treatment medication was reported.
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Vomiting
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of DISORIENTATION (Disoriented) and VOMITING (Throw up 4 times in a row like a lot) in a 14-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Patient had no allergies with medications, food and other products.  On 27-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (Throw up 4 times in a row like a lot). On an unknown date, the patient experienced DISORIENTATION (Disoriented). At the time of the report, DISORIENTATION (Disoriented) and VOMITING (Throw up 4 times in a row like a lot) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient mother reported that the events throw up 4 times in a row like a lot and disoriented symptoms were improved. No acute or chronic illnesses were reported. Patient height reported as 30 inch 2 months ago. Patient was immediately monitored by her pediatrician after the adverse events. No concomitant medications were reported. No treatment drugs were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: vial was first punctured on 27-Jun-2022 1:50PM, vial stored post puncture in refrigerator, administration of vaccine on 28-Jun-2022 at 8: 30 am; administer a booster vaccine from a vial that was left over night  past 12 hours to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer a booster vaccine from a vial that was left over night  past 12 hours to a patient) and PRODUCT STORAGE ERROR (vial was first punctured on 27-Jun-2022 1:50PM, vial stored post puncture in refrigerator, administration of vaccine on 28-Jun-2022 at 8: 30 am) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 prophylaxis.     Patient had no previous allergies. Patient had no acute and chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19.    On 28-Jun-2022 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022 at 8:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administer a booster vaccine from a vial that was left over night  past 12 hours to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 27-Jun-2022 1:50PM, vial stored post puncture in refrigerator, administration of vaccine on 28-Jun-2022 at 8: 30 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer a booster vaccine from a vial that was left over night  past 12 hours to a patient) and PRODUCT STORAGE ERROR (vial was first punctured on 27-Jun-2022 1:50PM, vial stored post puncture in refrigerator, administration of vaccine on 28-Jun-2022 at 8: 30 am) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  The vial was initially stored in the refrigerator on 27-Jun-2022. The vial did not undergo any temperature excursions. It was reported that patient did not seek medical care. Patient had not experienced a similar event in the past.  No treatment drug was reported.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: NUMBNESS RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE WRIST/HAND WERE LIKE THEY FALL ASLEEP; TINGLING RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE THE WRIST; PAIN IN HANDS; PAIN IN SHOULDER/WRIST; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (NUMBNESS RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE WRIST/HAND WERE LIKE THEY FALL ASLEEP), PARAESTHESIA (TINGLING RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE THE WRIST), PAIN IN EXTREMITY (PAIN IN HANDS) and ARTHRALGIA (PAIN IN SHOULDER/WRIST) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis aggravated.    No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced HYPOAESTHESIA (NUMBNESS RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE WRIST/HAND WERE LIKE THEY FALL ASLEEP), PARAESTHESIA (TINGLING RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE THE WRIST), PAIN IN EXTREMITY (PAIN IN HANDS) and ARTHRALGIA (PAIN IN SHOULDER/WRIST). At the time of the report, HYPOAESTHESIA (NUMBNESS RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE WRIST/HAND WERE LIKE THEY FALL ASLEEP), PARAESTHESIA (TINGLING RANDOMLY IN THUMB INDEX AND MIDDLE FINGER/IN HAND JUST ABOVE THE WRIST), PAIN IN EXTREMITY (PAIN IN HANDS) and ARTHRALGIA (PAIN IN SHOULDER/WRIST) outcome was unknown.            No concomitant medications were provided by the reporter.  Patient had taken Humira product in the form of Solution for injection in pre-filled pen.  No treatment information was provided.   This case was linked to MOD-2022-596094 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 and 2 received on 04-FEB-2021 and 04-MAY-2021, 3 Months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 04-FEB-2021 and 04-MAY-2021, 3 Months apart) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 04-FEB-2021 and 04-MAY-2021, 3 Months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 04-FEB-2021 and 04-MAY-2021, 3 Months apart) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2022-596093 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Dermatitis allergic, Pruritus, Skin mass, Skin swelling, Skin warm
Clinical narrative: SWOLLEN LUMP ON THIGH; SWOLLEN LUMP ON THIGH; IT WAS HOT AND ITCHY; IT WAS HOT AND ITCHY; Allergic skin reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (SWOLLEN LUMP ON THIGH), SKIN SWELLING (SWOLLEN LUMP ON THIGH), SKIN WARM (IT WAS HOT AND ITCHY), PRURITUS (IT WAS HOT AND ITCHY) and DERMATITIS ALLERGIC (Allergic skin reaction) in a 28-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (SWOLLEN LUMP ON THIGH), SKIN SWELLING (SWOLLEN LUMP ON THIGH), SKIN WARM (IT WAS HOT AND ITCHY), PRURITUS (IT WAS HOT AND ITCHY) and DERMATITIS ALLERGIC (Allergic skin reaction). At the time of the report, SKIN MASS (SWOLLEN LUMP ON THIGH), SKIN SWELLING (SWOLLEN LUMP ON THIGH), SKIN WARM (IT WAS HOT AND ITCHY) and PRURITUS (IT WAS HOT AND ITCHY) outcome was unknown and DERMATITIS ALLERGIC (Allergic skin reaction) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lower limb fracture
Clinical narrative: Broken leg; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of LOWER LIMB FRACTURE (Broken leg) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced LOWER LIMB FRACTURE (Broken leg) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, LOWER LIMB FRACTURE (Broken leg) outcome was unknown and COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication were reported.  Company Comment: This spontaneous case concerns an adult female patient (age not specified) with no medical history reported, who experienced the unexpected serious (medically significant) event of Lower limb fracture and unexpected non-serious AESI of Covid-19 unspecified days after a dose of mRNA-1273 vaccine (dose number not specified). No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event Covid-19 was reported as not resolved and the event Lower limb fracture reported as unknown. Current ongoing pandemic of Covid-19 could be confounding for the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient (age not specified) with no medical history reported, who experienced the unexpected serious (medically significant) event of Lower limb fracture and unexpected non-serious AESI of Covid-19 unspecified days after a dose of mRNA-1273 vaccine (dose number not specified). No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event Covid-19 was reported as not resolved and the event Lower limb fracture reported as unknown. Current ongoing pandemic of Covid-19 could be confounding for the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Overdose, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; sore arm; Booster (0.5 ml) 6oct2021 lot number 020F21A (not immunocompromised); This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and OVERDOSE (Booster (0.5 ml) 6oct2021 lot number 020F21A (not immunocompromised)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 031L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Pityriasis rosea. Concomitant products included NAPROXEN, LORATADINE, FISH OIL, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA, MULTIVITAMINS [VITAMINS NOS] and CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2021, the patient experienced OVERDOSE (Booster (0.5 ml) 6oct2021 lot number 020F21A (not immunocompromised)). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm). At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN IN EXTREMITY (sore arm) and OVERDOSE (Booster (0.5 ml) 6oct2021 lot number 020F21A (not immunocompromised)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first booster dose on 06-Oct-2021. No treatment medication information provided
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination.     Concomitant products included NAPROXEN, LORATADINE, FISH OIL, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), MULTIVITAMINS [VITAMINS NOS] and CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm). At the time of the report, PYREXIA (fever), CHILLS (chills) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It is reported as patient was not immunocompromised and patient none of family member had any reaction to the vaccine Patient look like had Pityriasis rosea (not official diagnosis). No treatment information were reported by the reporter.   This case was linked to MOD-2022-596241, MOD-2022-596367, MOD-2022-596143 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Refrigerator expiration date: 6/25/2022 (removed from freezer on 5/26/22), Administered to patient: 6/27/22; Vaccine that was administered after the refrigerator expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered after the refrigerator expiration date) and PRODUCT STORAGE ERROR (Refrigerator expiration date: 6/25/2022 (removed from freezer on 5/26/22), Administered to patient: 6/27/22) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered after the refrigerator expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Refrigerator expiration date: 6/25/2022 (removed from freezer on 5/26/22), Administered to patient: 6/27/22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered after the refrigerator expiration date) and PRODUCT STORAGE ERROR (Refrigerator expiration date: 6/25/2022 (removed from freezer on 5/26/22), Administered to patient: 6/27/22) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vaccine was administered after the refrigerator expiration date.    Refrigerator expiration date: 25-Jun-2022 (removed from freezer on 26-May-2022).  Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Nausea, Pain
Clinical narrative: felt hot at time; Ache; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot at time), PAIN (Ache), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 058F21A, 038A21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (felt hot at time), PAIN (Ache), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEELING HOT (felt hot at time), PAIN (Ache), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.            Concomitant product use was not provided by the reporter.  Patient received the second booster dose on 27-Jun-2022. It was reported that every time the patient took the vaccine, he had the same side effects. He had chills, headache, nausea, ache and felt hot at time. His symptoms usually lasted 3 days then went away. Patient received the 1st dose, 2nd dose, the 1st and 2nd booster shot of the vaccine in the left arm IM. The expiration dates were not provided. Patient was taking other medication. HCP was not aware of the patient's side effects.  No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Pain in extremity, Weight, Weight decreased
Clinical narrative: Weight loss; COVID-19; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss), COVID-19 (COVID-19) and PAIN IN EXTREMITY (Pain in arm) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Wrist surgery. Concurrent medical conditions included Rheumatoid arthritis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous). On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss), COVID-19 (COVID-19) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, WEIGHT DECREASED (Weight loss), COVID-19 (COVID-19) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: body weight lost Body weight lost.         No concomitant medication were provided No treatment details were provided  Company comment: This spontaneous case concerns a 54 year old male patient with concurrent condition of Rheumatoid arthritis, who experienced the unexpected non serious of COVID-19, unknown days after receiving the booster dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series with the same vaccine in an interval of 28 days. He received the booster dose, about 10 months after the second dose. The outcome of the event was unknown. No further details on detailed clinical course, investigations and treatment of the event were available in the report. Co-suspect adalimumab and the ongoing COVID-19 pandemic could be risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 54 year old male patient with concurrent condition of Rheumatoid arthritis, who experienced the unexpected non serious of COVID-19, unknown days after receiving the booster dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series with the same vaccine in an interval of 28 days. He received the booster dose, about 10 months after the second dose. The outcome of the event was unknown. No further details on detailed clinical course, investigations and treatment of the event were available in the report. Co-suspect adalimumab and the ongoing COVID-19 pandemic could be risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Headache, Pruritus
Clinical narrative: BALANCE ISSUES; Itchy skin; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (BALANCE ISSUES), PRURITUS (Itchy skin) and HEADACHE (Headaches) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BALANCE DISORDER (BALANCE ISSUES), PRURITUS (Itchy skin) and HEADACHE (Headaches). At the time of the report, BALANCE DISORDER (BALANCE ISSUES), PRURITUS (Itchy skin) and HEADACHE (Headaches) outcome was unknown.            No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of balance issues, itchy skin and headaches with humira(adalimumab) was reported as not related.  No treatment medication information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, Pruritus, Skin mass, Skin swelling
Clinical narrative: itching; slightly raised dots; Pityriasis rosea; slightly raised dots; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (itching), SKIN MASS (slightly raised dots), PITYRIASIS ROSEA (Pityriasis rosea) and SKIN SWELLING (slightly raised dots) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), SKIN MASS (slightly raised dots), PITYRIASIS ROSEA (Pityriasis rosea) and SKIN SWELLING (slightly raised dots). At the time of the report, PRURITUS (itching), SKIN MASS (slightly raised dots), PITYRIASIS ROSEA (Pityriasis rosea) and SKIN SWELLING (slightly raised dots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that patient's doctor had seen one other time after a booster dose what patient had with itching and slightly raised dots that patient's wife described more specifically as Pityriasis rosea.  No treatment details were provided.     This case was linked to MOD-2022-596143, MOD-2022-596260.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Four episodes of hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Four episodes of hallucinations) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In June 2022, the patient experienced HALLUCINATION (Four episodes of hallucinations) (seriousness criterion medically significant). In June 2022, HALLUCINATION (Four episodes of hallucinations) had resolved.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  Company comment: This is a spontaneous case concerning a 93-year-old, female patient with no reported medical history and with vaccine history of receiving unknown dose number of mRNA-1273 vaccine. Adalimumab (Humira) for moderate to severe rheumatoid arthritis was reported as co-suspect product with unspecified therapy dates. Patient experienced the unexpected serious (medically significant) event of hallucination (four episodes of hallucinations). The event hallucination (four episodes of hallucinations) occurred the same month with the administration of mRNA-1273 vaccine booster dose. No other information surrounding the event was reported. The outcome of the event was reported as resolved. The patient's advancing age remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 93-year-old, female patient with no reported medical history and with vaccine history of receiving unknown dose number of mRNA-1273 vaccine. Adalimumab (Humira) for moderate to severe rheumatoid arthritis was reported as co-suspect product with unspecified therapy dates. Patient experienced the unexpected serious (medically significant) event of hallucination (four episodes of hallucinations). The event hallucination (four episodes of hallucinations) occurred the same month with the administration of mRNA-1273 vaccine booster dose. No other information surrounding the event was reported. The outcome of the event was reported as resolved. The patient's advancing age remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Headache, Oropharyngeal pain, Pain, Taste disorder
Clinical narrative: Stomach upset; Problems with taste/ I couldn't taste the banana at all/problems tasting except sugar. Garlic, seasonings; I cannot taste.; Pains; Really bad sore throat; Had headaches; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), TASTE DISORDER (Problems with taste/ I couldn't taste the banana at all/problems tasting except sugar. Garlic, seasonings; I cannot taste.), PAIN (Pains), OROPHARYNGEAL PAIN (Really bad sore throat) and HEADACHE (Had headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    The patient's past medical history included Cataract operation and Operation NOS (Had four subsequent surgeries because they kept not getting it right). Concurrent medical conditions included Double vision and Visual impairment.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), TASTE DISORDER (Problems with taste/ I couldn't taste the banana at all/problems tasting except sugar. Garlic, seasonings; I cannot taste.), PAIN (Pains), OROPHARYNGEAL PAIN (Really bad sore throat) and HEADACHE (Had headaches). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), TASTE DISORDER (Problems with taste/ I couldn't taste the banana at all/problems tasting except sugar. Garlic, seasonings; I cannot taste.), PAIN (Pains), OROPHARYNGEAL PAIN (Really bad sore throat) and HEADACHE (Had headaches) outcome was unknown.            Ethnicity reported as Other. Patient had cataract surgery in the past, and then four subsequent surgeries because they kept not getting it right. Caller states that this had been an ongoing and worsening problem for her for the past 4-5 years. It was stated that, patient got Moderna 2nd booster the same thing; Moderna shots and the booster. It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. No treatment medication was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover.) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications information was reported.  Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record. The HCP stated there is no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. Therefore, it was unknown if a freezer temperature excursion actually occurred. There were no adverse events. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported.   No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Quality complaint number added.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature; Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature) and POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature) and POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover//potential sub potent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature).    Concomitant medications details were not reported by the reporter. It was reported that vaccines were stored, there were no monitoring of  the freezer temperature and those vaccines were administered to patients. Vaccination site had a data logger, but it was not set up to record. The HCP stated that there were no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. There were no adverse event, only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Quality complaint number added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.     On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications information was reported.  Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record. The HCP stated there is no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site.Therefore, it was unknown if a freezer temperature excursion actually occurred. There were no adverse events. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported.  The event did not cause the patient to seek medical care.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Quality complaint number added
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature excursion; Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion).    Concomitant medications details were not reported by the reporter. It was reported that vaccines were stored, there were no monitoring of  the freezer temperature and those vaccines were administered to patients. Vaccination site had a data logger, but it was not set up to record. The HCP stated that there were no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. There were no adverse event, only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live follow up : Quality complaint no. added