chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Vaccination site pain, Vaccination site rash
Clinical narrative: Headache; Left arm ache; Rash on her left arm.; Tiredness; The patient received her first Moderna Covid-19 vaccine in May of 2021 and second vaccine on 6JUN2022; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (Left arm ache), VACCINATION SITE RASH (Rash on her left arm.), FATIGUE (Tiredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her first Moderna Covid-19 vaccine in May of 2021 and second vaccine on 6JUN2022) in a 49-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concomitant products included TIMOLOL for an unknown indication.    On 06-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her first Moderna Covid-19 vaccine in May of 2021 and second vaccine on 6JUN2022). On an unknown date, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (Left arm ache), VACCINATION SITE RASH (Rash on her left arm.) and FATIGUE (Tiredness). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (Left arm ache), VACCINATION SITE RASH (Rash on her left arm.), FATIGUE (Tiredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her first Moderna Covid-19 vaccine in May of 2021 and second vaccine on 6JUN2022) outcome was unknown.            Patient had received her first Moderna Covid-19 vaccine in May of 2021 by intramuscular route on her left arm.  Concomitant medication reported as Steroid eye drops which was used as 2 shots of Steroids in eyes. The patient had not received any Moderna Covid-19 booster doses. No treatment information was reported.   This case was linked to MOD-2022-630451 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Circumoral swelling, Herpes zoster, Mass, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMORAL SWELLING (swelling around the mouth), SWELLING (swelling under the eyes), MASS (The patient experienced lumps) and HERPES ZOSTER (Patient also reports having shingles in June 2022.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product HYALURONIC ACID (RESTYLANE) for an unknown indication. Concomitant products included Levothyroxine; Amlodipine; Famotidine; and Raloxifene for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, the patient started HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced HERPES ZOSTER (Patient also reports having shingles in June 2022.). On an unknown date, the patient experienced CIRCUMORAL SWELLING (swelling around the mouth), SWELLING (swelling under the eyes) and MASS (The patient experienced lumps). The patient was treated with HYALURONIDASE at a dose of several injections. At the time of the report, CIRCUMORAL SWELLING (swelling around the mouth), SWELLING (swelling under the eyes) and MASS (The patient experienced lumps) had not resolved and HERPES ZOSTER (Patient also reports having shingles in June 2022.) outcome was unknown. Hyaluronic acid (Restylane) was injected for Patient under eyes and around the lips. Patient received several injections of Hyaluronidase (Restylane). It has been stated by treating HCP that for Patient nodules were palpable but not visually noticeable. Treatment information was not provided. This case was linked to MOD-2022-630467 (Patient Link).
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose).    This case contains information for the first patient (first child) of the two patients described by the reporter.  No concomitant medications was reported.  The pharmacist states that, 0.25ml of vaccine was pulled out of the Red Cap vial and administered to the patient on 17-Aug-2022.  No treatment drug details was reported.   Reporter did not allow further contact
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No Adverse event; Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Received the 2nd pediatric (6M-5Y) dose 0.25ml from the adult Red-Cap Vial/Caller states that this 2nd dose was a booster and the 2nd dose).    This case contains information for the second patient (second child) of the two patients described by the reporter.  No concomitant medications were reported.  The pharmacist states that, 0.25ml of vaccine was pulled out of the adult Red Cap vial and administered to patient. Pharmacist further states that this 2nd dose was a booster and the 2nd dose and patient only received 2 doses.  No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID-19 from a new strain even after being vaccinated; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got COVID-19 from a new strain even after being vaccinated) in an adult 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 COVID-19 (Got COVID-19 from a new strain even after being vaccinated). At the time of the report, COVID-19 (Got COVID-19 from a new strain even after being vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that a woman that the reporter knew and the husband of that woman (both were vaccinated), along with other people who went to a graduation, got COVID from a different strain than the previous ones. Reporter was not having any additional information about this case, the reporter only knew that the woman and the husband were older adults. Treatment information was not provided.  Company comment: This spontaneous case concerns an adult female patient with no medical history information reported, who experienced the unexpected non serious AESI of COVID 19. The event occurred on an unknown date after a dose of mRNA-1273. As reported, the patient got COVID-19 from a new strain even after being vaccinated. No information about vaccination schedule or dose number was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-630497 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an adult female patient with no medical history information reported, who experienced the unexpected non serious AESI of COVID 19. The event occurred on an unknown date after a dose of mRNA-1273. As reported, the patient got COVID-19 from a new strain even after being vaccinated. No information about vaccination schedule or dose number was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-630497:Wifes case
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Received a full dose for the 2nd booster instead of a half dose because he has an autoimmune disease; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a full dose for the 2nd booster instead of a half dose because he has an autoimmune disease) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055A22A, 065F21A, 012A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Cancer.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Received a full dose for the 2nd booster instead of a half dose because he has an autoimmune disease). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received a full dose for the 2nd booster instead of a half dose because he has an autoimmune disease) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  Doses patient received on 14-Nov-2021and 18-Aug-2022 were first and second boosters respectively.  Patient confirmed with the pharmacist that patient received a full dose for the 2nd booster instead of a half dose because patient had an autoimmune disease and had a history of cancer.  No treatment medications were reported.   This case was linked to MOD-2022-630567 (Patient Link).
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Vaccination site haematoma
Clinical narrative: Small hematoma; Needle was only 1/4 in, instead of being all the way into the muscle as it should; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMATOMA (Small hematoma) and PRODUCT ADMINISTRATION ERROR (Needle was only 1/4 in, instead of being all the way into the muscle as it should) in a 20-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 vaccination.     Patient did not had any allergies. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2022, the patient experienced VACCINATION SITE HAEMATOMA (Small hematoma) and PRODUCT ADMINISTRATION ERROR (Needle was only 1/4 in, instead of being all the way into the muscle as it should). At the time of the report, VACCINATION SITE HAEMATOMA (Small hematoma) and PRODUCT ADMINISTRATION ERROR (Needle was only 1/4 in, instead of being all the way into the muscle as it should) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not reported. The patient put the thigh away while the vaccine was being administered and so the needle was only 1/4 in, instead of being all the way into the muscle as it should. Patient did not seek medical care for the adverse event.  Treatment medications were not reported.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: no adverse event; 5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose) and NO ADVERSE EVENT (no adverse event) in a 5-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. In July 2022, the patient experienced ACCIDENTAL OVERDOSE (5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL OVERDOSE (5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (5 year old given 50 mcg (0.5ml) of the Moderna vaccine as 1st dose).    No concomitant drug information was provided.  It was reported that the patient got vaccine 4 weeks ago. The patient was 4-5 months short of being 6 years old.  No treatment drug information was provided.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Overdose
Clinical narrative: No adverse event; adult doses given to 2 children; adult doses given to 2 children; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (adult doses given to 2 children), INCORRECT DOSE ADMINISTERED (adult doses given to 2 children) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 12-Aug-2022, the patient experienced OVERDOSE (adult doses given to 2 children) and INCORRECT DOSE ADMINISTERED (adult doses given to 2 children). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (adult doses given to 2 children), INCORRECT DOSE ADMINISTERED (adult doses given to 2 children) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OVERDOSE (adult doses given to 2 children) and INCORRECT DOSE ADMINISTERED (adult doses given to 2 children).    No concomitant drug information was provided.  Reporter reported that two patients had received adult dose (100mcg) from a Moderna vial with red cap.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-630766 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-630766:MOD-2022-630766  (Another case by same reporter of 7 years old male)
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: localized reaction/area was about the size of a hand.; large red area around the injection site; Area was painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (localized reaction/area was about the size of a hand.), VACCINATION SITE ERYTHEMA (large red area around the injection site) and VACCINATION SITE PAIN (Area was painful) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 013F21A, 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia, Congestive heart failure, Kidney failure (Stage 4 kidney failure), Hypothyroidism and Hyperlipidemia. Concomitant products included APIXABAN (ELIQUIS), LEVOTHYROXINE, METOLAZONE, DILTIAZEM (CARDIZEM [DILTIAZEM]), ACETYLSALICYLIC ACID (ASPIRIN ENTERIC COATED K.P.), POTASSIUM CHLORIDE (KCL), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM CARBONATE AND VITAMIN D), CENTRUM SILVER [ASCORBIC ACID;BIOTIN;CALCIUM;CALCIUM PHOSPHATE DIBASIC;CHROMIC CHLORIDE;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL SULFATE;NICOTINAMIDE;PANTOTHENIC ACID;PHYTOMENADIONE;POTASSIUM CH, CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]), FUROSEMIDE (LASIX [FUROSEMIDE]), VITAMIN C [ASCORBIC ACID], PRAVASTATIN, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), HEMP and LORAZEPAM for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, the patient experienced VACCINATION SITE REACTION (localized reaction/area was about the size of a hand.), VACCINATION SITE ERYTHEMA (large red area around the injection site) and VACCINATION SITE PAIN (Area was painful). At the time of the report, VACCINATION SITE REACTION (localized reaction/area was about the size of a hand.), VACCINATION SITE ERYTHEMA (large red area around the injection site) and VACCINATION SITE PAIN (Area was painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Overdose
Clinical narrative: No adverse event; adult doses given to 2 children; adult doses given to 2 children; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (adult doses given to 2 children), INCORRECT DOSE ADMINISTERED (adult doses given to 2 children) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 12-Aug-2022, the patient experienced OVERDOSE (adult doses given to 2 children) and INCORRECT DOSE ADMINISTERED (adult doses given to 2 children). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (adult doses given to 2 children), INCORRECT DOSE ADMINISTERED (adult doses given to 2 children) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OVERDOSE (adult doses given to 2 children) and INCORRECT DOSE ADMINISTERED (adult doses given to 2 children).    No concomitant medication information provided. The nurse stated that the two children received 100 mcg from a Moderna vial with a red cap. No treatment information provided.
Age: 56.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Condition aggravated
Clinical narrative: FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Plaque psoriasis (Improved) in 2020. Concurrent medical conditions included Psoriatic arthritis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-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) UNK (Solution for injection in pre-filled pen). On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP). At the time of the report, CONDITION AGGRAVATED (FLARE UP) outcome was unknown.            No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Formulation for suspect Humira given as Solution for injection in pre-filled pen Causality for HUMIRA(adalimumab): The reporter causality for the events of PLAQUE PSORIASIS and FLARE UP was not provided. No treatment drug details was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: pretty sick with a high fever; pretty sick with a high fever; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (pretty sick with a high fever) and PYREXIA (pretty sick with a high fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (pretty sick with a high fever) and PYREXIA (pretty sick with a high fever). At the time of the report, ILLNESS (pretty sick with a high fever) and PYREXIA (pretty sick with a high fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that After each of the primary doses patient was pretty sick with a high fever.   No treatment details were reported.   This case was linked to MOD-2022-630786, MOD-2022-630787 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: Woke up not feeling good/started feeling so bad in the middle of the night; Reports a 101F fever; headache; back myalgia; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Woke up not feeling good/started feeling so bad in the middle of the night), PYREXIA (Reports a 101F fever), HEADACHE (headache) and MYALGIA (back myalgia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053B22A, 039F21A, 044A21A and 006M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Aug-2022, the patient experienced FEELING ABNORMAL (Woke up not feeling good/started feeling so bad in the middle of the night), PYREXIA (Reports a 101F fever), HEADACHE (headache) and MYALGIA (back myalgia). At the time of the report, FEELING ABNORMAL (Woke up not feeling good/started feeling so bad in the middle of the night), PYREXIA (Reports a 101F fever), HEADACHE (headache) and MYALGIA (back myalgia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2022, Body temperature: 101 101F Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient was wondering if she got too high of a dose, she saw that they gave her 0.5ml or if patient just had a brisk response to the dose. No treatment details were reported.   This case was linked to MOD-2022-630786, MOD-2022-630782 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood test abnormal, Inflammatory marker increased, Intervertebral disc degeneration
Clinical narrative: Multisystem inflammation; severe edema in both hands; severe bilateral shoulder and pain causing reduced range of motion, mulisystem neuropathy.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Magnetic resonance imaging abnormal, Multisystem inflammatory syndrome, Nerve conduction studies normal, Neuropathy peripheral
Clinical narrative: Multisystem inflammation; severe edema in both hands; severe bilateral shoulder and pain causing reduced range of motion, mulisystem neuropathy.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Multisystem inflammation; severe edema in both hands; severe bilateral shoulder and pain causing reduced range of motion, mulisystem neuropathy.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Confusional state, Transient global amnesia
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Confusion-Severe, Systemic: transglobal amnesia-Severe
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Systemic: Stroke-Medium.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: rash going down the back and sore to the touch-Severe, Additional Details: pt had fairly sore arm on 9/28/21 for dose#1 attributed to possible too high of a shot, recovered in 3 weeks and never told pharmacy.  2nd/final shot on 8/11 resulted in sore arm and sore back rash that sore to the touch and unable to comfortably wear clothing. recommended doctor visit, pt says she is improving
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion).    The patient had a weight of 29 (unit not specified).  No concomitant medication was reported by reporter.  Patient got 1st dose on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  There were no reported side effects.  No treatment medication was reported by reporter.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion).    The patient had a weight of 29.5 (unit not specified).  No concomitant medication was reported by reporter.  The patient had Moderna administration location on LQ (unspecified). It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that under went one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion. The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion. Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08Aug2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18Aug2022. Number of vials/ per doses impacted was 1 vial. The excursion occurred on 07Aug2022. The vials were not punctured until they were used for a patient and then discarded. No side effects were reported. Treatment information was not provided
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Skin disorder
Clinical narrative: TROUBLE WITH SPOTS ON ARM AND ANKLE; TROUBLE WITH AN INGROWN TOE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (TROUBLE WITH SPOTS ON ARM AND ANKLE) and PAIN IN EXTREMITY (TROUBLE WITH AN INGROWN TOE) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (TROUBLE WITH SPOTS ON ARM AND ANKLE) and PAIN IN EXTREMITY (TROUBLE WITH AN INGROWN TOE). At the time of the report, SKIN DISORDER (TROUBLE WITH SPOTS ON ARM AND ANKLE) and PAIN IN EXTREMITY (TROUBLE WITH AN INGROWN TOE) was resolving. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No concomitant medication information was provided.  The reporter's causality for the events of trouble with spots on arm and ankle and trouble with an ingrown toe with Humira (adalimumab) was reported as probable. No treatment medication was provided.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion).    Weight of the patient was reported as 18#14 oz was reported.  No concomitant medication was reported by reporter.  The patient had Moderna administration location on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was  with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  No treatment medication was reported by reporter.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Patient received a vaccine that under went a temperature excursion; Patient received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion). On 13-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion).    No concomitant medication was reported by reporter.  Patient weight was reported as 16 (units not specified) 3 Ounces(oz).  Patient received 1st dose on RQ and second dose on LQ.  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was  with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 08-Aug-2022. Those were administered and discarded. Proposed desired used by date was 18-Aug-2022. Storage condition at the time of the excursion was reported as refrigerated.  The patient side effects were reported as none.  No treatment medication was reported by reporter.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Psoriasis
Clinical narrative: PLAQUE PSORIASIS FLARE; Dose 1- 21-APR-2021; Dose 2-  28-MAY-2021; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS FLARE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 21-APR-2021; Dose 2-  28-MAY-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 21-APR-2021; Dose 2-  28-MAY-2021). On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS FLARE). At the time of the report, PSORIASIS (PLAQUE PSORIASIS FLARE) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1- 21-APR-2021; Dose 2-  28-MAY-2021) outcome was unknown. No concomitant medication was provided. On 08-MAR-2022 the patient received booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient had a flare after been taking the Covid Vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients received a vaccine that under went a temperature excursion; No adverse event; patients received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion).    The patient had a weight of 24 (unit not specified).  No concomitant medication was reported.  The patient had Moderna administration location on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  No treatment medication was reported.