chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscular weakness, Pallor
Clinical narrative: CAN NOT HOLD ANYTHING WITH THAT ARM; ARM PAIN/ARM REALLY HURT WHEN TRIED TO GET THE NEEDLE IN/ SHARP PAIN AT VACCINE SITE; TURNED WHITE AS A GHOST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: cellulitis, and concurrent conditions included: non-alcohol user, non-smoker, pacemaker, kidney disease, and tattoos. The patient was previously treated with potassium; and experienced drug allergy when treated with citalopram hydrobromide, gabapentin, morphine, nystatin, codeine phosphate/paracetamol, and bupropion hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the patient experienced turned white as a ghost. On 30-APR-2021, the patient experienced arm pain/arm really hurt when tried to get the needle in/ sharp pain at vaccine site. On an unspecified date, the patient experienced can not hold anything with that arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain/arm really hurt when tried to get the needle in/ sharp pain at vaccine site, and the outcome of turned white as a ghost and can not hold anything with that arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: LETHARGIC; JOINT PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lethargic, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargic and joint pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211130207.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: LETHARGIC; JOINT PAIN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lethargic, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargic and joint pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211130190.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: ARM PAIN; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm pain, headache, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, headache and low grade fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Paraesthesia, Pyrexia
Clinical narrative: SMALL BURNING SENSATION ON INNER THIGH OF RIGHT LEG; TINGLING AND BURNING BEHIND KNEE (COMES AND GOES); CHILLS (ON AND OFF)/ COLD; FEVER; VERY TIRED; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-NOV-2021, the patient experienced chills (on and off) / cold. On 12-NOV-2021, the patient experienced fever. On 12-NOV-2021, the patient experienced very tired. On 13-NOV-2021, the patient experienced small burning sensation on inner thigh of right leg. On 13-NOV-2021, the patient experienced tingling and burning behind knee (comes and goes). Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills (on and off)/ cold, fever, small burning sensation on inner thigh of right leg, very tired and tingling and burning behind knee (comes and goes) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hangover, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: SUPER SWEATY; FEELS LIKE A HANG OVER; LOW FEVER; MILD NAUSEA; RAGING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 13-NOV-2021, the patient experienced super sweaty. On 13-NOV-2021, the patient experienced feels like a hang over. On 13-NOV-2021, the patient experienced low fever. On 13-NOV-2021, the patient experienced mild nausea. On 13-NOV-2021, the patient experienced raging headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super sweaty, low fever, mild nausea, raging headache and feels like a hang over was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chest pain, Chills, Diarrhoea
Clinical narrative: FEELS LIKE GETTING A HEART  ATTACK; STOMACH PAIN; SORENESS AND BODY ACHES; CHEST PAIN; SHORTNESS OF  BREATH; CHILLS; WEAKNESS IN THE LIMBS; SIGNIFICANT SEVERE PAIN AT INJECTION SITE; DIARRHEA; FEVER; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced feels like getting a heart attack. On NOV-2021, the patient experienced stomach pain. On NOV-2021, the patient experienced soreness and body aches. On NOV-2021, the patient experienced chest pain. On NOV-2021, the patient experienced shortness of breath. On NOV-2021, the patient experienced chills. On NOV-2021, the patient experienced weakness in the limbs. On NOV-2021, the patient experienced significant severe pain at injection site. On NOV-2021, the patient experienced diarrhea. On NOV-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the significant severe pain at injection site, diarrhea, stomach pain, fever, soreness and body aches, chest pain, weakness in the limbs, shortness of breath, chills and feels like getting a heart attack was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pain, Muscular weakness, Pain, Pyrexia
Clinical narrative: FEELS LIKE GETTING A HEART  ATTACK; STOMACH PAIN; SORENESS AND BODY ACHES; CHEST PAIN; SHORTNESS OF  BREATH; CHILLS; WEAKNESS IN THE LIMBS; SIGNIFICANT SEVERE PAIN AT INJECTION SITE; DIARRHEA; FEVER; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced feels like getting a heart attack. On NOV-2021, the patient experienced stomach pain. On NOV-2021, the patient experienced soreness and body aches. On NOV-2021, the patient experienced chest pain. On NOV-2021, the patient experienced shortness of breath. On NOV-2021, the patient experienced chills. On NOV-2021, the patient experienced weakness in the limbs. On NOV-2021, the patient experienced significant severe pain at injection site. On NOV-2021, the patient experienced diarrhea. On NOV-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the significant severe pain at injection site, diarrhea, stomach pain, fever, soreness and body aches, chest pain, weakness in the limbs, shortness of breath, chills and feels like getting a heart attack was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic, Skin discolouration
Clinical narrative: RED AND ITCHY SPOTS ON BODY/ARMS/LEG/FACE/BUTTOCKS; MORE AND MORE STAINS EVERYDAY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2021, the patient experienced more and more stains everyday. On 12-NOV-2021, the patient experienced red and itchy spots on body/arms/leg/face/buttocks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red and itchy spots on body/arms/leg/face/buttocks, and more and more stains everyday. This report was non-serious.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED (3 DAYS PAST EXPIRATION DATE); This spontaneous report received from a consumer concerned a 44 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered (3 days past expiration date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (3 days past expiration date) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132362, 20211132383, 20211132415 and 20211121650.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED (3 DAYS PAST EXPIRATION DATE); This spontaneous report received from a consumer concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered (3 days past expiration date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (3 days past expiration date) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132288, 20211132383, 20211132415 and 20211121650.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED (3 DAYS PAST EXPIRATION DATE); This spontaneous report received from a consumer concerned a 55 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered (3 days past expiration date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (3 days past expiration date) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132288, 20211132362, 20211132415 and 20211121650.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient had itching horrible for three weeks; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient had itching horrible for three weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 (Patient had itching horrible for three weeks). At the time of the report, PRURITUS (Patient had itching horrible for three weeks) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: follow up received on 8-Nov-21 contain no additional information, outcome of event updated to recovered from previous version captured as unknown. narrative updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Feeling abnormal, Myalgia, Pain in extremity
Clinical narrative: red spot in her arm that keeps getting bigger,arm is all bright red; brain fog; joint pain; muscle pain; Sneezing; Runny nose; arm is hurting, sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red spot in her arm that keeps getting bigger,arm is all bright red), PAIN IN EXTREMITY (arm is hurting, sore), FEELING ABNORMAL (brain fog), SNEEZING (Sneezing) and RHINORRHOEA (Runny nose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Joint pain (before getting the vaccine) and Muscle pain (before getting the vaccine). Concurrent medical conditions included Urticaria, Fibromyalgia since 1985, Degenerative disc disease (worse), Bell's palsy (worse), Hay fever and Ascites. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, DEXAMETHASONE, NEOMYCIN, POLYMYXIN B (NEOPOLYDEX) from 10-Nov-2021 to an unknown date for Eye disorder, IBUPROFEN for an unknown indication.   On 24-Jul-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm is hurting, sore). On 25-Jul-2021, the patient experienced SNEEZING (Sneezing) and RHINORRHOEA (Runny nose). On an unknown date, the patient experienced ERYTHEMA (red spot in her arm that keeps getting bigger,arm is all bright red), FEELING ABNORMAL (brain fog), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 26-Jul-2021, PAIN IN EXTREMITY (arm is hurting, sore) had resolved. At the time of the report, ERYTHEMA (red spot in her arm that keeps getting bigger,arm is all bright red), FEELING ABNORMAL (brain fog), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.            Reported that patient took allergy medication.   This case was linked to MOD-2021-378327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up received on 08-Nov-2021-Events, medical history and concomitant medications added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: red spot in her arm that keeps getting bigger,arm is all bright red; brain fog; joint pain; muscle pain; Sneezing; Runny nose; arm is hurting, sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red spot in her arm that keeps getting bigger,arm is all bright red), PAIN IN EXTREMITY (arm is hurting, sore), FEELING ABNORMAL (brain fog), SNEEZING (Sneezing) and RHINORRHOEA (Runny nose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Joint pain (before getting the vaccine) and Muscle pain (before getting the vaccine). Concurrent medical conditions included Urticaria, Fibromyalgia since 1985, Degenerative disc disease (worse), Bell's palsy (worse), Hay fever and Ascites. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, DEXAMETHASONE, NEOMYCIN, POLYMYXIN B (NEOPOLYDEX) from 10-Nov-2021 to an unknown date for Eye disorder, IBUPROFEN for an unknown indication.   On 24-Jul-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm is hurting, sore). On 25-Jul-2021, the patient experienced SNEEZING (Sneezing) and RHINORRHOEA (Runny nose). On an unknown date, the patient experienced ERYTHEMA (red spot in her arm that keeps getting bigger,arm is all bright red), FEELING ABNORMAL (brain fog), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 26-Jul-2021, PAIN IN EXTREMITY (arm is hurting, sore) had resolved. At the time of the report, ERYTHEMA (red spot in her arm that keeps getting bigger,arm is all bright red), FEELING ABNORMAL (brain fog), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.            Reported that patient took allergy medication.   This case was linked to MOD-2021-378327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up received on 08-Nov-2021-Events, medical history and concomitant medications added.
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: received dose from vial refrigerated more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days). At the time of the report, PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant Follow up, patient details added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-381057:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache; Feeling extremely dizzy/dizzy all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling extremely dizzy/dizzy all day) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia, Gout, Arthritis and Vertigo.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Feeling extremely dizzy/dizzy all day). On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with TRAMADOL for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling extremely dizzy/dizzy all day) had not resolved and HEADACHE (Headache) outcome was unknown.            Patient is on medications for high blood pressure, cholesterol, gout and arthritis.  It was reported that the patient had done some exercises for vertigo but they only helped a little.   This case was linked to MOD-2021-370207, MOD-2021-370192 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Expired product administered, Headache, Malaise
Clinical narrative: Malaise; Headache; joint pain; received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise), HEADACHE (Headache), ARTHRALGIA (joint pain) and EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 041L20A and 037K20A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for Vaccination.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021). On 30-Oct-2021, the patient experienced ARTHRALGIA (joint pain). On 30-Oct-2021 at 8:00 AM, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) had resolved. At the time of the report, MALAISE (Malaise), HEADACHE (Headache) and ARTHRALGIA (joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related. No further causality assessments were provided for ARTHRALGIA (joint pain) and EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021).    No treatment information provided.   This case was linked to MOD-2021-382061 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received- New event added : Joint pain On 09-Nov-2021: Significant follow up appended - updated patient demographics, added concomitant medication VLAURIX and added events. On 09-Nov-2021: Significant Follow up received and Added event.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: left sided chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (left sided chest pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (well controlled, worse after booster) since 1994, Hypertension (well controlled) since 2012, Type 2 diabetes mellitus (well controlled) since 2012, High cholesterol since 2012, Anxiety, Drug allergy and Drug allergy. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes, ROSUVASTATIN for High cholesterol, AMLODIPINE for Hypertension, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and IRON for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (left sided chest pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency; ALBUTEROL [SALBUTAMOL] for Asthma, at a dose of UNK, inhalation; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and ALPRAZOLAM (XANAX) for Adverse event, at a dose of 0.5 milligram. On 08-Mar-2021, CHEST PAIN (left sided chest pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-370271, MOD-2021-370396, MOD-2021-369443 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Significant follow-up(contact info updated, Form contains medical history and conmeds updated) On 04-Nov-2021: Follow up received and contains no new information On 05-Nov-2021: Follow up received  contains NNI.; Sender's Comments: This case concerns a 43-year-old, female, with relevant reported medical history of Type II Diabetes, Hypertension, Asthma, High Cholesterol and Anxiety, who experienced the non-serious unexpected event of Chest pain. The event occurred 15 minutes after the administration of the first dose of mRNA-1273. At the time of the report, the outcome for the event is Recovered/Resolved. The Rechallenge is positive because the SD states that the patient recovered from the event after receiving the first dose, but the same event appeared after receiving the second dose. The reported medical history of Type II Diabetes, Hypertension, Asthma, High Cholesterol and Anxiety remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 32.0
Sex: M
Vaccine: COVID19, DTAPHEPBIP
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired moderna vaccine; a dose was given with the vial being more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (a dose was given with the vial being more than 30 days in the refrigerator) and EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 immunisation: PFIZER BIONTECH COVID-19 VACCINE (first dose(0.3ml) on 19-mar-2021 and second dose(0.3ml) on 22-apr-2021 and lot and expiration date was unknown) from 19-Mar-2021 to 22-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Drug allergy (sulfa drugs). Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) from 02-Apr-2020 to an unknown date and FINASTERIDE from 19-Mar-2021 to an unknown date for an unknown indication.    On 01-Nov-2021 at 9:23 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (a dose was given with the vial being more than 30 days in the refrigerator). On 01-Nov-2021 at 9:23 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine). On 01-Nov-2021, PRODUCT STORAGE ERROR (a dose was given with the vial being more than 30 days in the refrigerator) had resolved. On 01-Nov-2021 at 9:23 AM, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Reporter stated that a patient was given a low dose booster of the Moderna COVID-19 vaccine, whose expiration date was on 29-October-2021 and it was given on 01-November-2021. But, after providing the look up tool to the caller it was confirmed that their lot numbers expiration date was extended, also it was discovered that the dose was given with the vial being more than 30 days in the refrigerator. Vial was initially stored in the refrigerator on 26-September-2021 and it was on the refrigerator until 01-November-2021 when it was provided to the patient.  The patient took Engerix (Hepatitis B) vaccine (2nd dose) lot number was T041337 on Left deltoid intramuscularly, on the same day as Moderna vaccine was administered.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up information received on 05-NOV-2021 contains no new information. On 08-Nov-2021: Follow-up information included: Reporters information updated, vaccination time added, Anatomical site updated, Concomitant medication added and outcome of the event as no adverse event after Expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered with vaccine that had undergone temperature excursion; 10 vials were all administered to patients. Does not know the number of patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Administered with vaccine that had undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (10 vials were all administered to patients. Does not know the number of patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) 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 PRODUCT STORAGE ERROR (Administered with vaccine that had undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (10 vials were all administered to patients. Does not know the number of patients). At the time of the report, PRODUCT STORAGE ERROR (Administered with vaccine that had undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (10 vials were all administered to patients. Does not know the number of patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The temperature log had a date when the refrigerator reached 34 and 32 degrees F. The storage temperature was too cold. 10 vials were all administered to patients. No concomitant product was reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Added batch/lot number and expiry date
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: not feeling all that great today; arm hurt a lot; chills; feeling feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Nov-2021 and was forwarded to Moderna on 03-Nov-2021.    This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling all that great today), VACCINATION SITE PAIN (arm hurt a lot), CHILLS (chills) and PYREXIA (feeling feverish) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling all that great today), VACCINATION SITE PAIN (arm hurt a lot), CHILLS (chills) and PYREXIA (feeling feverish). At the time of the report, MALAISE (not feeling all that great today), VACCINATION SITE PAIN (arm hurt a lot), CHILLS (chills) and PYREXIA (feeling feverish) outcome was unknown.            Patient got the previous two doses without any problems.  No concomitant medication reported. No treatment medication reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna COVID19; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID19) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID19). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received contain reporter's details updated and patient's initial, date of birth and gender has been updated.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Headache, Hypertension, Liquid product physical issue
Clinical narrative: Left leg and hip joint pain; Left leg and hip joint pain; Headache; Nausea; elevated blood pressure on phase 2 (146/93); I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (elevated blood pressure on phase 2 (146/93)), PAIN IN EXTREMITY (Left leg and hip joint pain), ARTHRALGIA (Left leg and hip joint pain), LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.) and HEADACHE (Headache) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep disorder. Concomitant products included MELATONIN for Sleep disorder, ZINC, VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.). On 25-Oct-2021, the patient experienced HYPERTENSION (elevated blood pressure on phase 2 (146/93)), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left leg and hip joint pain) and ARTHRALGIA (Left leg and hip joint pain). The patient was treated with LOSARTAN for Blood pressure high, at a dose of once or twice daily. On 24-Oct-2021, LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.) had resolved. On 27-Oct-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. On 28-Oct-2021, HYPERTENSION (elevated blood pressure on phase 2 (146/93)) had resolved. At the time of the report, PAIN IN EXTREMITY (Left leg and hip joint pain) and ARTHRALGIA (Left leg and hip joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Blood pressure measurement: 146/93 (High) 146/93. On 26-Oct-2021, Blood pressure measurement: both diastolic and systolic were high (High) both diastolic and systolic were high. On 27-Oct-2021, Blood pressure measurement: systolic was high (High) systolic was high. On 28-Oct-2021, Blood pressure measurement: normal (normal) Normal.         Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: non-significant follow up appended
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Left leg and hip joint pain; Left leg and hip joint pain; Headache; Nausea; elevated blood pressure on phase 2 (146/93); I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (elevated blood pressure on phase 2 (146/93)), PAIN IN EXTREMITY (Left leg and hip joint pain), ARTHRALGIA (Left leg and hip joint pain), LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.) and HEADACHE (Headache) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep disorder. Concomitant products included MELATONIN for Sleep disorder, ZINC, VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.). On 25-Oct-2021, the patient experienced HYPERTENSION (elevated blood pressure on phase 2 (146/93)), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left leg and hip joint pain) and ARTHRALGIA (Left leg and hip joint pain). The patient was treated with LOSARTAN for Blood pressure high, at a dose of once or twice daily. On 24-Oct-2021, LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.) had resolved. On 27-Oct-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. On 28-Oct-2021, HYPERTENSION (elevated blood pressure on phase 2 (146/93)) had resolved. At the time of the report, PAIN IN EXTREMITY (Left leg and hip joint pain) and ARTHRALGIA (Left leg and hip joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Blood pressure measurement: 146/93 (High) 146/93. On 26-Oct-2021, Blood pressure measurement: both diastolic and systolic were high (High) both diastolic and systolic were high. On 27-Oct-2021, Blood pressure measurement: systolic was high (High) systolic was high. On 28-Oct-2021, Blood pressure measurement: normal (normal) Normal.         Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: non-significant follow up appended
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Crying, Depressed mood, Fatigue, Headache
Clinical narrative: little achy; slept all day; Anxious; trigger finder which was better was all bent when I woke up; Tired; Headache; very depressed; very weepy/crying; really sad feeling; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (very depressed), CRYING (very weepy/crying), PAIN (little achy), SOMNOLENCE (slept all day) and ANXIETY (Anxious) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027821A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Spice allergy (chili) and Thyroid disorder. Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid disorder NOS.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced DEPRESSED MOOD (very depressed), CRYING (very weepy/crying) and MALAISE (really sad feeling). On an unknown date, the patient experienced PAIN (little achy), SOMNOLENCE (slept all day), ANXIETY (Anxious), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), FATIGUE (Tired) and HEADACHE (Headache). The patient was treated with DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for Adverse event, at a dose of 50 milligram once a day; LORAZEPAM for Adverse event, at a dose of .5 milligram twice a day; VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Adverse event, at an unspecified dose and frequency and DESVENLAFAXINE at a dose of 50 mg. At the time of the report, DEPRESSED MOOD (very depressed), CRYING (very weepy/crying) and ANXIETY (Anxious) had not resolved, PAIN (little achy), SOMNOLENCE (slept all day), TRIGGER FINGER (trigger finder which was better was all bent when I woke up), FATIGUE (Tired) and HEADACHE (Headache) had resolved and MALAISE (really sad feeling) was resolving.            She went to neurologist and had EEG  and was seeking for therapy and transcranial magnetic stimulation and breathwork  to try to under control.   This case was linked to MOD-2021-375416, MOD-2021-380319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received added patient's demographics, concomitant and treatment medications were added and new events were added.