chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Pain, Wrong product administered
Clinical narrative: some chills; Feeling achy; different vaccine, gave second dose of Shingrix; second Shingrix 27 days after first dose; This case was reported by a physician via sales rep and described the occurrence of chills in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced chills, pain, wrong vaccine administered and drug dose administration interval too short. On an unknown date, the outcome of the chills and pain were recovered/resolved and the outcome of the wrong vaccine administered and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills and pain to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. Patient received her second Shingrix vaccine 27 days after the first dose which led to shortening of vaccination schedule. A new nurse in the clinic and when the patient presented to the clinic for a different vaccine one week ago, the nurse gave her second dose of Shingrix early, which led to wrong vaccine administered. The patient had one night of some chills and feeling achy, but otherwise had no other problems with the vaccine given early. Follow-up would not be possible as no contact details available.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 1 YOpatient was administered an adult dose; 1 YOpatient was administered an adult dose; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Havrix adult. On 27th October 2021, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: Physician reported that a 1 year old patient was administered the first dose of an adult dose of the Havrix vaccine inadvertently, which led to accidental overdose and adult product administered. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Dysphagia, Fatigue, Injection site pain
Clinical narrative: TROUBLE SWALLOWING; CHILLS; TIREDNESS/FATIGUE; DIARRHEA; TINGLING THROUGHOUT BODY/TINGLING FEELING IN HEAD; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right mastectomy, and lymph nodes removed under right arm and neck, and concurrent conditions included: cancer, celiac disease, alcohol user, non-smoker, and gluten allergy, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. 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 02-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-NOV-2021, the patient experienced trouble swallowing. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced tiredness/fatigue. On 02-NOV-2021, the patient experienced diarrhea. On 02-NOV-2021, the patient experienced tingling throughout body/tingling feeling in head. On 02-NOV-2021, the patient experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, chills, tiredness/fatigue, diarrhea, tingling throughout body/tingling feeling in head, and trouble swallowing. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: TROUBLE SWALLOWING; CHILLS; TIREDNESS/FATIGUE; DIARRHEA; TINGLING THROUGHOUT BODY/TINGLING FEELING IN HEAD; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right mastectomy, and lymph nodes removed under right arm and neck, and concurrent conditions included: cancer, celiac disease, alcohol user, non-smoker, and gluten allergy, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. 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 02-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-NOV-2021, the patient experienced trouble swallowing. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced tiredness/fatigue. On 02-NOV-2021, the patient experienced diarrhea. On 02-NOV-2021, the patient experienced tingling throughout body/tingling feeling in head. On 02-NOV-2021, the patient experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, chills, tiredness/fatigue, diarrhea, tingling throughout body/tingling feeling in head, and trouble swallowing. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Diarrhoea, Feeling abnormal, Headache, Palpitations
Clinical narrative: TROUBLE SWALLOWING; CHILLS; TIREDNESS/FATIGUE; DIARRHEA; TINGLING THROUGHOUT BODY/TINGLING FEELING IN HEAD; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right mastectomy, and lymph nodes removed under right arm and neck, and concurrent conditions included: cancer, celiac disease, alcohol user, non-smoker, and gluten allergy, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. 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 02-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-NOV-2021, the patient experienced trouble swallowing. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced tiredness/fatigue. On 02-NOV-2021, the patient experienced diarrhea. On 02-NOV-2021, the patient experienced tingling throughout body/tingling feeling in head. On 02-NOV-2021, the patient experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, chills, tiredness/fatigue, diarrhea, tingling throughout body/tingling feeling in head, and trouble swallowing. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Tachycardia
Clinical narrative: TROUBLE SWALLOWING; CHILLS; TIREDNESS/FATIGUE; DIARRHEA; TINGLING THROUGHOUT BODY/TINGLING FEELING IN HEAD; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right mastectomy, and lymph nodes removed under right arm and neck, and concurrent conditions included: cancer, celiac disease, alcohol user, non-smoker, and gluten allergy, and other pre-existing medical conditions included: No drug abuse or illicit drug usage. 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 02-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-NOV-2021, the patient experienced trouble swallowing. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced tiredness/fatigue. On 02-NOV-2021, the patient experienced diarrhea. On 02-NOV-2021, the patient experienced tingling throughout body/tingling feeling in head. On 02-NOV-2021, the patient experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, chills, tiredness/fatigue, diarrhea, tingling throughout body/tingling feeling in head, and trouble swallowing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned multiple patients of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient's had no underlying issues. The patient's 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, 1 total 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, reporter lost 3 friends (death). On an unspecified date, the patient's died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0. 20211112489-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS FOR 4 DAYS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: not in good health. 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sickness for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness for 4 days was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site pain
Clinical narrative: ITCHY; HIVES - RED RAISED BUMPS ON MY BODY; PAIN ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced itchy, hives - red raised bumps on my body and pain on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives - red raised bumps on my body, itchy and pain on the injection site was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Really really hot; Arm started itching; It's been extremely extremely sore; Actual size it's about an orange, Red; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Really really hot), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE PAIN (It's been extremely extremely sore), VACCINATION SITE ERYTHEMA (Actual size it's about an orange, Red) and PYREXIA (Slight fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Blood pressure, METFORMIN for Diabetes, CHOLESTEROL and OMEPRAZOLE for an unknown indication.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Really really hot), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE PAIN (It's been extremely extremely sore), VACCINATION SITE ERYTHEMA (Actual size it's about an orange, Red) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Really really hot), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE PAIN (It's been extremely extremely sore), VACCINATION SITE ERYTHEMA (Actual size it's about an orange, Red) and PYREXIA (Slight fever) outcome was unknown.            Relevant concomitant medications included Blood thinner.   This case was linked to MOD-2021-364084, MOD-2021-364075 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Non-significant follow up (Contact info. updated)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster dose/inadvertantly gave Moderna Covid vaccine after its expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose/inadvertantly gave Moderna Covid vaccine after its expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose/inadvertantly gave Moderna Covid vaccine after its expiration date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose/inadvertantly gave Moderna Covid vaccine after its expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. Treatment medication was not reported.  It was reported that the vaccine was past the 30 days in the refrigerator and the date the vial was initially stored in the refrigerator was 16sep21. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received on 29-oct-2021, added reporter occupation
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: When they wake up they cannot move; Both their knees are sore; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (When they wake up they cannot move) and ARTHRALGIA (Both their knees are sore) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetes (use an insulin pump). Concomitant products included INSULIN for Diabetes.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (When they wake up they cannot move) and ARTHRALGIA (Both their knees are sore). The patient was treated with MELOXICAM ongoing since an unknown date for Inflammation, at an unspecified dose and frequency and HYDROCODONE ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (When they wake up they cannot move) and ARTHRALGIA (Both their knees are sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient got the second dose on the right arm. After that they did not notice to much change, but the issues continued. They have consulted with several doctors and were prescribed medication for the inflammation and pain, that helped a little.   This case was linked to MOD-2021-367043 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dehydration, Fluid retention, Urinary retention
Clinical narrative: She became dehydrated and drank 9 bottles of water; She seemed to be retaining the fluid; She wasn't going to the bathroom; The vaccination made Cushing's disease worse; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (She became dehydrated and drank 9 bottles of water), FLUID RETENTION (She seemed to be retaining the fluid) and URINARY RETENTION (She wasn't going to the bathroom) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cushing's disease (Has had Cushing's disease for 32 years).    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (She became dehydrated and drank 9 bottles of water) (seriousness criterion medically significant), FLUID RETENTION (She seemed to be retaining the fluid) (seriousness criterion medically significant), URINARY RETENTION (She wasn't going to the bathroom) (seriousness criterion medically significant) and CONDITION AGGRAVATED (The vaccination made Cushing's disease worse). At the time of the report, DEHYDRATION (She became dehydrated and drank 9 bottles of water), FLUID RETENTION (She seemed to be retaining the fluid), URINARY RETENTION (She wasn't going to the bathroom) and CONDITION AGGRAVATED (The vaccination made Cushing's disease worse) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.  Company's comment: This case concerns a 66 year-old female patient with a history of pituitary-dependent Cushing's syndrome who experienced the unexpected serious events of dehydration, fluid retention, and urinary retention. The events occurred on an unknown date relative to the first dose of Moderna COVID-19 Vaccine. The medical history of Cushing's disease remains a confounder for dehydration, fluid retention, and urinary retention. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-367153 (Patient Link).; Sender's Comments: This case concerns a 66 year-old female patient with a history of pituitary-dependent Cushing's syndrome who experienced the unexpected serious events of dehydration, fluid retention, and urinary retention. The events occurred on an unknown date relative to the first dose of Moderna COVID-19 Vaccine. The medical history of Cushing's disease remains a confounder for dehydration, fluid retention, and urinary retention. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Product storage error
Clinical narrative: full dose instead of a half dose; Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 037K20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-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) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today). On 29-Oct-2021, ACCIDENTAL OVERDOSE (full dose instead of a half dose) and PRODUCT STORAGE ERROR (Five doses (lot # 017C21A) of the Moderna Covid-19 Vaccine were given to patients today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant Follow Up : Event added and Contact information (Fax No.) Updated
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. HCP confirmed number of patients.   This case was linked to MOD-2021-368725 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant Follow up- HCP confirmed number of patients
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Fear, Inguinal mass, Pain
Clinical narrative: That he was scared and frightened and that he didn't want to die; He feels that thing burning him; pain is horrendous; Egg between right upper thigh and groin, half egg above private parts, stomach has an egg,  It was very painful; This spontaneous case was reported by a consumer and describes the occurrence of INGUINAL MASS (Egg between right upper thigh and groin, half egg above private parts, stomach has an egg,  It was very painful), FEAR (That he was scared and frightened and that he didn't want to die), BURNING SENSATION (He feels that thing burning him) and PAIN (pain is horrendous) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1775978. FC3180) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure).    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced INGUINAL MASS (Egg between right upper thigh and groin, half egg above private parts, stomach has an egg,  It was very painful) and PAIN (pain is horrendous). On an unknown date, the patient experienced FEAR (That he was scared and frightened and that he didn't want to die) and BURNING SENSATION (He feels that thing burning him). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, INGUINAL MASS (Egg between right upper thigh and groin, half egg above private parts, stomach has an egg,  It was very painful), FEAR (That he was scared and frightened and that he didn't want to die), BURNING SENSATION (He feels that thing burning him) and PAIN (pain is horrendous) outcome was unknown.        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.   Concomitant medication include blood pressure medications. Treatment medication include cold compresses.  Patient felt like soft apple cut in his right upper thigh it felt like someone took a soft apricot and smashed it there and feels like its an open wound on his right thigh. Patient felt like it has been going downhill for him Patient visited three ER visits where doctors did X-rays, sonogram, MRI with the blue liquid. But they couldn't discover anything   This case was linked to MOD-2021-369310 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2021: Follow-up received, Patient age updated
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nasal congestion, Ocular discomfort
Clinical narrative: Feeling of sandpaper in eyes; Mild congestion; chills; Muscle aches; temp of 99.6; This spontaneous case was reported by a nurse and describes the occurrence of OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 007MZ0A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6). At the time of the report, OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99.6 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   No treatment medications were reported.   This case was linked to MOD-2021-368999 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling of sandpaper in eyes; Mild congestion; chills; Muscle aches; temp of 99.6; This spontaneous case was reported by a nurse and describes the occurrence of OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 007MZ0A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6). At the time of the report, OCULAR DISCOMFORT (Feeling of sandpaper in eyes), NASAL CONGESTION (Mild congestion), CHILLS (chills), MYALGIA (Muscle aches) and PYREXIA (temp of 99.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99.6 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   No treatment medications were reported.   This case was linked to MOD-2021-368999 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL, ATORVASTATIN CALCIUM, LISINOPRIL and AMLODIPINE for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        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.   Treatment information was not provided.   This case was linked to MOD-2021-369048, MOD-2021-369049 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dehydration, Dry skin, Dysphagia, Erythema
Clinical narrative: Beet red; Face was on fire; Severe dehydration; Drinking 3-5 times more than normal; Eyes felt like sandpaper; Could not swallow; Severely parched for a month; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Beet red), BURNING SENSATION (Face was on fire), DEHYDRATION (Severe dehydration), POLYDIPSIA (Drinking 3-5 times more than normal) and EYE DISORDER (Eyes felt like sandpaper) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Beet red), BURNING SENSATION (Face was on fire), DEHYDRATION (Severe dehydration), POLYDIPSIA (Drinking 3-5 times more than normal), EYE DISORDER (Eyes felt like sandpaper), DYSPHAGIA (Could not swallow) and DRY SKIN (Severely parched for a month). At the time of the report, ERYTHEMA (Beet red), BURNING SENSATION (Face was on fire), DEHYDRATION (Severe dehydration), POLYDIPSIA (Drinking 3-5 times more than normal), EYE DISORDER (Eyes felt like sandpaper), DYSPHAGIA (Could not swallow) and DRY SKIN (Severely parched for a month) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-369515, MOD-2021-369515 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Polydipsia
Clinical narrative: Beet red; Face was on fire; Severe dehydration; Drinking 3-5 times more than normal; Eyes felt like sandpaper; Could not swallow; Severely parched for a month; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Beet red), BURNING SENSATION (Face was on fire), DEHYDRATION (Severe dehydration), POLYDIPSIA (Drinking 3-5 times more than normal) and EYE DISORDER (Eyes felt like sandpaper) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Beet red), BURNING SENSATION (Face was on fire), DEHYDRATION (Severe dehydration), POLYDIPSIA (Drinking 3-5 times more than normal), EYE DISORDER (Eyes felt like sandpaper), DYSPHAGIA (Could not swallow) and DRY SKIN (Severely parched for a month). At the time of the report, ERYTHEMA (Beet red), BURNING SENSATION (Face was on fire), DEHYDRATION (Severe dehydration), POLYDIPSIA (Drinking 3-5 times more than normal), EYE DISORDER (Eyes felt like sandpaper), DYSPHAGIA (Could not swallow) and DRY SKIN (Severely parched for a month) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-369515, MOD-2021-369515 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients that were administered expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients that were administered expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 EXPIRED PRODUCT ADMINISTERED (Patients that were administered expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients that were administered expired doses) had resolved.        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. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant follow up includes email id updated.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Tremor
Clinical narrative: Sore Arm; he took his Velcour 5mg and he started shaking, started shaking like he was freezing; slept for 12 hours, which is unusual for him; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (he took his Velcour 5mg and he started shaking, started shaking like he was freezing), PAIN IN EXTREMITY (Sore Arm) and SOMNOLENCE (slept for 12 hours, which is unusual for him) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included SIMVASTATIN (ZOCOR) from 29-Oct-2021 to an unknown date for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced TREMOR (he took his Velcour 5mg and he started shaking, started shaking like he was freezing). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and SOMNOLENCE (slept for 12 hours, which is unusual for him). At the time of the report, TREMOR (he took his Velcour 5mg and he started shaking, started shaking like he was freezing), PAIN IN EXTREMITY (Sore Arm) and SOMNOLENCE (slept for 12 hours, which is unusual for him) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD-2021-370314 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Added reporter details, added patient initials, added product start date, added concomitant medication, added event details.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: arm  is tight where the got shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm  is tight where the got shot) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20, 011A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (arm  is tight where the got shot). At the time of the report, VACCINATION SITE INDURATION (arm  is tight where the got shot) outcome was unknown.            This case was linked to MOD-2021-369389, MOD-2021-369375 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Drooling, Dysgeusia, Glossodynia, Paraesthesia oral, Perioral dermatitis
Clinical narrative: Now that I'm speaking I'm drooling; perioral dermatitis; Had pain and needles sensation/ almost as if the nerves ending is on the very very surface/ it's wearing off my nerves; When puts something in the mouth the tongue reacts to it; Feeling a metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Had pain and needles sensation/ almost as if the nerves ending is on the very very surface/ it's wearing off my nerves), GLOSSODYNIA (When puts something in the mouth the tongue reacts to it), DYSGEUSIA (Feeling a metallic taste), DROOLING (Now that I'm speaking I'm drooling) and PERIORAL DERMATITIS (perioral dermatitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PARAESTHESIA ORAL (Had pain and needles sensation/ almost as if the nerves ending is on the very very surface/ it's wearing off my nerves), GLOSSODYNIA (When puts something in the mouth the tongue reacts to it) and DYSGEUSIA (Feeling a metallic taste). On an unknown date, the patient experienced DROOLING (Now that I'm speaking I'm drooling) and PERIORAL DERMATITIS (perioral dermatitis). At the time of the report, PARAESTHESIA ORAL (Had pain and needles sensation/ almost as if the nerves ending is on the very very surface/ it's wearing off my nerves) had not resolved and GLOSSODYNIA (When puts something in the mouth the tongue reacts to it), DYSGEUSIA (Feeling a metallic taste), DROOLING (Now that I'm speaking I'm drooling) and PERIORAL DERMATITIS (perioral dermatitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment details-Doctors wanted to put me on prednisone and didn't wanted to, Gave her Lidocaine 2% viscous solutions, it numbs the area it doesn't make it go away, so doesn't knows if will use it. The patient had seen a number of physicians, went to 2 dentist, and went to 3 EMT physicians, and would go to a pathologist for the mouth. The patient mentioned to be so highly sensitive.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea, Pallor
Clinical narrative: got really sick, got so sick that he need to laid down on the floor; she said he was "pale as a ghost"; was so nauseaous he need to laid down on the floor; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick, got so sick that he need to laid down on the floor), PALLOR (she said he was "pale as a ghost") and NAUSEA (was so nauseaous he need to laid down on the floor) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 02UD21A and 04UA21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-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. In October 2021, the patient experienced PALLOR (she said he was "pale as a ghost") and NAUSEA (was so nauseaous he need to laid down on the floor). On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (got really sick, got so sick that he need to laid down on the floor). At the time of the report, ILLNESS (got really sick, got so sick that he need to laid down on the floor) and NAUSEA (was so nauseaous he need to laid down on the floor) outcome was unknown and PALLOR (she said he was "pale as a ghost") had not resolved.            No Concomitant medication was reported Patient is not sure if he took Motrin or ibuprofen to treat his symptoms
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 an unknown date, the patient experienced VACCINATION COMPLICATION (I had side effects). At the time of the report, VACCINATION COMPLICATION (I had side effects) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Pyrexia, Vaccination complication
Clinical narrative: Intense adverse reaction; She was very very sick; Vomiting; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Intense adverse reaction), ILLNESS (She was very very sick), VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 025B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 1 dosage form. On 29-Oct-2021, the patient experienced VOMITING (Vomiting), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (Intense adverse reaction) and ILLNESS (She was very very sick). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Intense adverse reaction), ILLNESS (She was very very sick), VOMITING (Vomiting), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medications reported by reporter  The whole night patient experienced vomiting, fever, chills, and headache. Patient stated the shot itself was a weird experience because the person who administered it is an anti-vaxxer.  It was reported that patient received her first and second doses in her deltoid muscle.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: significant  follow-up received include additional information of reporter, patient, suspect product, treatment medication and new events.