chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: General unwell feeling; fever of 102 F; Body chills; Headache; Tired; 1 mL for dose 1 and dose 2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) in a male patient of an unknown age 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.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 21-May-2021, the patient experienced MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache), FATIGUE (Tired) and ACCIDENTAL OVERDOSE (1 mL for dose 1 and dose 2). On 21-May-2021, ACCIDENTAL OVERDOSE (1 mL for dose 1 and dose 2) had resolved. On 22-May-2021, MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Body temperature: 102 (High) 102 F.         No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-403390 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up information included no new information
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Feeling abnormal, Hypoaesthesia
Clinical narrative: face feels like she came from the dentist office; annoying numbness; not severe but feels like Novocain is wearing off; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (face feels like she came from the dentist office), HYPOAESTHESIA (annoying numbness) and FEELING ABNORMAL (not severe but feels like Novocain is wearing off) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced FACIAL DISCOMFORT (face feels like she came from the dentist office), HYPOAESTHESIA (annoying numbness) and FEELING ABNORMAL (not severe but feels like Novocain is wearing off). At the time of the report, FACIAL DISCOMFORT (face feels like she came from the dentist office), HYPOAESTHESIA (annoying numbness) and FEELING ABNORMAL (not severe but feels like Novocain is wearing off) was resolving.        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.   Other concomitant medications included blood pressure medications. Patient reported of not taking anything for numbness. Treatment medications not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Limb discomfort, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Her arm was a little warm up there; the next morning she found big welts; hives and it was 4-5 inches; Redness was warm to the touch; itchy; does not know if the right arm the needle hit something in there like tissues; sore at the same time/nowshe has two sore arms; red around the injection site/It is still a little red near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch) and PRURITUS (itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot (left deltoid arm) on 25-Nov-2021. Past adverse reactions to the above products included No adverse reaction with flu shot. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), BIFIDOBACTERIUM LACTIS (DIGESTIVE PROBIOTICS ADVANCED), LANSOPRAZOLE (PREVACID), SIMVASTATIN and TROSPIUM for an unknown indication.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch), PRURITUS (itchy), LIMB DISCOMFORT (does not know if the right arm the needle hit something in there like tissues), PAIN IN EXTREMITY (sore at the same time/nowshe has two sore arms) and VACCINATION SITE ERYTHEMA (red around the injection site/It is still a little red near the injection site). At the time of the report, VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch), PRURITUS (itchy), LIMB DISCOMFORT (does not know if the right arm the needle hit something in there like tissues), PAIN IN EXTREMITY (sore at the same time/nowshe has two sore arms) and VACCINATION SITE ERYTHEMA (red around the injection site/It is still a little red near the injection site) outcome was unknown.            Patient put Ice on it and it cooled it down and took Acetaminophen.   This case was linked to MOD-2021-403759 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Her arm was a little warm up there; the next morning she found big welts; hives and it was 4-5 inches; Redness was warm to the touch; itchy; does not know if the right arm the needle hit something in there like tissues; sore at the same time/nowshe has two sore arms; red around the injection site/It is still a little red near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch) and PRURITUS (itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot (left deltoid arm) on 25-Nov-2021. Past adverse reactions to the above products included No adverse reaction with flu shot. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), BIFIDOBACTERIUM LACTIS (DIGESTIVE PROBIOTICS ADVANCED), LANSOPRAZOLE (PREVACID), SIMVASTATIN and TROSPIUM for an unknown indication.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch), PRURITUS (itchy), LIMB DISCOMFORT (does not know if the right arm the needle hit something in there like tissues), PAIN IN EXTREMITY (sore at the same time/nowshe has two sore arms) and VACCINATION SITE ERYTHEMA (red around the injection site/It is still a little red near the injection site). At the time of the report, VACCINATION SITE WARMTH (Her arm was a little warm up there), URTICARIA (the next morning she found big welts), URTICARIA (hives and it was 4-5 inches), FEELING HOT (Redness was warm to the touch), PRURITUS (itchy), LIMB DISCOMFORT (does not know if the right arm the needle hit something in there like tissues), PAIN IN EXTREMITY (sore at the same time/nowshe has two sore arms) and VACCINATION SITE ERYTHEMA (red around the injection site/It is still a little red near the injection site) outcome was unknown.            Patient put Ice on it and it cooled it down and took Acetaminophen.   This case was linked to MOD-2021-403759 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Nausea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Chest Pain and chest hurts if deep breathing; Nausea after booster shot; Pain on the injection Site Right Arm after booster; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain and chest hurts if deep breathing), VACCINATION SITE PAIN (Pain on the injection Site Right Arm after booster) and NAUSEA (Nausea after booster shot) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 039K20-2A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Asymptomatic) on 26-Nov-2021.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection Site Right Arm after booster). On 01-Dec-2021, the patient experienced NAUSEA (Nausea after booster shot). On 02-Dec-2021, the patient experienced CHEST PAIN (Chest Pain and chest hurts if deep breathing). At the time of the report, CHEST PAIN (Chest Pain and chest hurts if deep breathing), VACCINATION SITE PAIN (Pain on the injection Site Right Arm after booster) and NAUSEA (Nausea after booster shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2020, SARS-CoV-2 test: positive (Positive) PCR  test was positive and positive (Positive) Rapid test was positive.         No concomitant and medication information provided. No treatment information provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Impaired driving ability, Limb discomfort, Peripheral coldness
Clinical narrative: Frozen pain is annoying; Difficult when he drives; Difficult when he walk around; He started getting freezing feet, really cold, almost like ice blocks; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (He started getting freezing feet, really cold, almost like ice blocks), LIMB DISCOMFORT (Frozen pain is annoying), IMPAIRED DRIVING ABILITY (Difficult when he drives) and GAIT INABILITY (Difficult when he walk around) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 093M30A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PERIPHERAL COLDNESS (He started getting freezing feet, really cold, almost like ice blocks). On an unknown date, the patient experienced LIMB DISCOMFORT (Frozen pain is annoying), IMPAIRED DRIVING ABILITY (Difficult when he drives) and GAIT INABILITY (Difficult when he walk around). At the time of the report, PERIPHERAL COLDNESS (He started getting freezing feet, really cold, almost like ice blocks), LIMB DISCOMFORT (Frozen pain is annoying), IMPAIRED DRIVING ABILITY (Difficult when he drives) and GAIT INABILITY (Difficult when he walk around) outcome was unknown.            Patient reported that with first dose he was absolutely fine, had no problems. Patient had been to a neurologist, a heart specialist due to event and no one knows what the answer was. Patient received the Pfizer booster because his doctor told him he should go weaker just in case this thing intensifies. The patient had no adverse effects with the Pfizer booster. Reporter stated that doctors were reluctant to associate it with the injection, it all points to the injection but haven't discovered any cure. It was stated that frozen pain was annoying, difficult when he drives and walk around, he kept many socks, and it didn't do a damn thing. If he was laying down for a period of time, and his feet were covered they would get warmer. Reporter stated the rest of his body was not cold, his hands were fine. Patient has gone to a neurologist, spine doctor, and it had been 6 months. He stated it definitely came from the shot because it was 12 hours after. No concomitant medications information was not reported. No treatment medications.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: potential administration of expired vaccine/ administration of expired vaccine; temperature excursions; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (potential administration of expired vaccine/ administration of expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (potential administration of expired vaccine/ administration of expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (potential administration of expired vaccine/ administration of expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, the vial were stored in the refrigerator on 08-Oct-2021 and 05-Nov-2021. Also, it was reported that, both the vials were stored in an ultracold freezer since 08-Sep-2021. The second vial was moved from ultracold freezer to normal freezer on 26-Oct-2021. The vials stayed within recommended frozen storage temperatures until day of administration (05-Nov-2021).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up received includes updated lot number, additional event, drug start date, expiry date.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna vaccine was given to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-403798, MOD-2021-403791, MOD-2021-403794, MOD-2021-403796 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna vaccine was given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patient). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  Vial moved from freezer to refrigerator on 1DEC 2021.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID Arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID Arm (1st dose)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain damage (three years ago), Liver carcinoma (two years ago), Upper respiratory infection (approximately one month ago), Liver operation and Gallbladder operation. Concurrent medical conditions included Shellfish allergy, Fruit allergy (Strawberries), Fruit allergy (peach), Fruit allergy (Mango), Fruit allergy, Allergy to antibiotic (cillins), Drug allergy (codeine), Allergy to antibiotic (Cipro), Allergy to antibiotic (Flagyl), Drug allergy (Morphine), Drug allergy (Fentanyl) and Acetaminophen. Concomitant products included LISINOPRIL and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION COMPLICATION (COVID Arm (1st dose)). At the time of the report, VACCINATION COMPLICATION (COVID Arm (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-403813, MOD-2021-403816 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID Arm 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm 2nd dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory infection (one month ago), Carcinoma liver (Two years ago that required surgery of her liver and gallbladder) and Cancer surgery (Surgery of her liver and gallbladder for Liver cancer). Concurrent medical conditions included Shellfish allergy, Fruit allergy (Strawberries), Fruit allergy (Peach), Fruit allergy (Mango), Fruit allergy (Dragon fruit), Allergy to antibiotic (any antibiotic cillins), Drug allergy (Codeine), Allergy to antibiotic (Ciprofloxacin), Allergy to antibiotic (Flagyl), Drug allergy (Fentanyl), Drug allergy (Morphine), Drug allergy (Acetaminophen) and Brain damage (Permanent, three years ago and caused her not to be able to remember things). Concomitant products included LISINOPRIL and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (COVID Arm 2nd dose). At the time of the report, VACCINATION SITE REACTION (COVID Arm 2nd dose) outcome was unknown.            No treatment information was provided. Patient stated that she had never experienced symptoms like the events. There was no history of COVID-19 infection and myocarditis/Pericarditis.   This case was linked to MOD-2021-403801, MOD-2021-403816 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Vaccination site coldness
Clinical narrative: cold feeling in her left arm; a little chest pain that eventually subsided/excruciating pain in her chest; excruciating pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (cold feeling in her left arm), CHEST PAIN (a little chest pain that eventually subsided/excruciating pain in her chest) and PAIN IN EXTREMITY (excruciating pain in her arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain damage (the brain damage causes her not to be able to remember things.) and Liver, cancer of (she had liver cancer (HCC) two years ago that required surgery of her liver and gallbladder.) in 2019. Concurrent medical conditions included Shellfish allergy, Fruit allergy (strawberries, peach, mango, and dragon fruit), Penicillin allergy (antibiotic cillins), Drug allergy (Cipro,), Allergy to antibiotic, Drug allergy, Drug allergy (,), Drug allergy (fentanyl) and Drug allergy (acetaminophen). Concomitant products included LISINOPRIL and ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE COLDNESS (cold feeling in her left arm), CHEST PAIN (a little chest pain that eventually subsided/excruciating pain in her chest) and PAIN IN EXTREMITY (excruciating pain in her arm). At the time of the report, VACCINATION SITE COLDNESS (cold feeling in her left arm), CHEST PAIN (a little chest pain that eventually subsided/excruciating pain in her chest) and PAIN IN EXTREMITY (excruciating pain in her arm) outcome was unknown.            No treatment received. The patient had  little chest pain that eventually subsided. The chest pain lasted a few hours. On 02-Dec-2021, The patient experienced excruciating pain in her chest and arm. The pain stopped and then it hit again currently experiencing chest pain.   This case was linked to MOD-2021-403801, MOD-2021-403813 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Hyperhidrosis, Illness, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot) and PYREXIA (Ran a fever of 99.9) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 037K20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Breast cancer, Diabetes, Cholesterol, Depression and Anxiety. Concomitant products included BUSPIRONE for Anxiety, LETROZOLE for Breast cancer, ATORVASTATIN for Cholesterol, VENLAFAXINE for Depression, METFORMIN for Diabetes.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-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot), PYREXIA (Ran a fever of 99.9), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot), PYREXIA (Ran a fever of 99.9), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Body temperature: 99.9 (High) 99.9.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot) and PYREXIA (Ran a fever of 99.9) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 037K20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Breast cancer, Diabetes, Cholesterol, Depression and Anxiety. Concomitant products included BUSPIRONE for Anxiety, LETROZOLE for Breast cancer, ATORVASTATIN for Cholesterol, VENLAFAXINE for Depression, METFORMIN for Diabetes.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-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot), PYREXIA (Ran a fever of 99.9), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, ILLNESS (Started getting sick), VACCINATION SITE WARMTH (Injection site is hot), HYPERHIDROSIS (Sweating), FEELING HOT (I am hot), PYREXIA (Ran a fever of 99.9), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Body temperature: 99.9 (High) 99.9.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Somnolence, Speech disorder, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (Could barely talk after booster shot), MALAISE (Not feeling good after booster shot), SOMNOLENCE (Wants to sleep after booster shot), HEADACHE (Headache after booster shot) and VACCINATION SITE PAIN (Left arm injection site hurts after booster shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.On 01-Dec-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 02-Dec-2021, the patient experienced SPEECH DISORDER (Could barely talk after booster shot), MALAISE (Not feeling good after booster shot), SOMNOLENCE (Wants to sleep after booster shot), HEADACHE (Headache after booster shot) and VACCINATION SITE PAIN (Left arm injection site hurts after booster shot). At the time of the report, SPEECH DISORDER (Could barely talk after booster shot), MALAISE (Not feeling good after booster shot), SOMNOLENCE (Wants to sleep after booster shot), HEADACHE (Headache after booster shot) and VACCINATION SITE PAIN (Left arm injection site hurts after booster shot) outcome was unknown. Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter. The patient stated that she received 2 doses of Moderna COVID-19 vaccine more than 6 months ago.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass
Clinical narrative: Gynecologist found a lump in patient's breast after the 1st dose.  The lump was there before she received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Gynecologist found a lump in patient's breast after the 1st dose.  The lump was there before she received the 2nd dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced BREAST MASS (Gynecologist found a lump in patient's breast after the 1st dose.  The lump was there before she received the 2nd dose). At the time of the report, BREAST MASS (Gynecologist found a lump in patient's breast after the 1st dose.  The lump was there before she received the 2nd dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant and treatment medication information was not provided by the reporter. The gynecologist found a lump in patient's breast after the 1st dose.                           This case was linked to MOD-2021-403944 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Head discomfort, Impaired driving ability, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double Vision), NERVOUS SYSTEM DISORDER (Neurological medical condition), VACCINATION COMPLICATION (adverse reaction to the booster shot), HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around) and IMPAIRED DRIVING ABILITY (could not drive a car for 5 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Double vision and Cataract operation (Summer 2021) in 2021. Concurrent medical conditions included Diabetes and Hypothyroidism. Concomitant products included METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, INSULIN GLARGINE (LANTUS) for an unknown indication. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced DIPLOPIA (Double Vision), NERVOUS SYSTEM DISORDER (Neurological medical condition), HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around), IMPAIRED DRIVING ABILITY (could not drive a car for 5 days), DIZZINESS (She was very Dizzy) and NAUSEA (Nauseous). On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction to the booster shot). On 11-Nov-2021, HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around), IMPAIRED DRIVING ABILITY (could not drive a car for 5 days), DIZZINESS (She was very Dizzy) and NAUSEA (Nauseous) had resolved. At the time of the report, DIPLOPIA (Double Vision) had not resolved and NERVOUS SYSTEM DISORDER (Neurological medical condition) and VACCINATION COMPLICATION (adverse reaction to the booster shot) outcome was unknown.No treatment medications were reported. This case was linked to MOD-2021-404053, MOD-2021-404058 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Added the medical history (Cataract Surgery, Diabetes, Hypothyroidism, double vision),events (Dizzy, Nauseous, Double Vision, head discomfort,  impaired driving ability, Neurological disorder NOS), Concomitant medications (Metformin 1000mg BID, Synthroid, Lantus insulin.)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double Vision), NERVOUS SYSTEM DISORDER (Neurological medical condition), VACCINATION COMPLICATION (adverse reaction to the booster shot), HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around) and IMPAIRED DRIVING ABILITY (could not drive a car for 5 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Double vision and Cataract operation (Summer 2021) in 2021. Concurrent medical conditions included Diabetes and Hypothyroidism. Concomitant products included METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, INSULIN GLARGINE (LANTUS) for an unknown indication. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced DIPLOPIA (Double Vision), NERVOUS SYSTEM DISORDER (Neurological medical condition), HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around), IMPAIRED DRIVING ABILITY (could not drive a car for 5 days), DIZZINESS (She was very Dizzy) and NAUSEA (Nauseous). On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction to the booster shot). On 11-Nov-2021, HEAD DISCOMFORT (when she tried to hold her head up, she felt the room going around), IMPAIRED DRIVING ABILITY (could not drive a car for 5 days), DIZZINESS (She was very Dizzy) and NAUSEA (Nauseous) had resolved. At the time of the report, DIPLOPIA (Double Vision) had not resolved and NERVOUS SYSTEM DISORDER (Neurological medical condition) and VACCINATION COMPLICATION (adverse reaction to the booster shot) outcome was unknown.No treatment medications were reported. This case was linked to MOD-2021-404053, MOD-2021-404058 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Added the medical history (Cataract Surgery, Diabetes, Hypothyroidism, double vision),events (Dizzy, Nauseous, Double Vision, head discomfort,  impaired driving ability, Neurological disorder NOS), Concomitant medications (Metformin 1000mg BID, Synthroid, Lantus insulin.)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired booster doses given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster doses given) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster doses given). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired booster doses given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vials remained in frozen storage until day it was thawed then administered.  No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: I have a really bad pain in my left groin or thigh area/I can't cross my legs without severe pain; And my injection site is painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I have a really bad pain in my left groin or thigh area/I can't cross my legs without severe pain) and VACCINATION SITE PAIN (And my injection site is painful to the touch) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE in April 2021 and PFIZER BIONTECH COVID-19 Vaccine in May 2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 Vaccine.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (I have a really bad pain in my left groin or thigh area/I can't cross my legs without severe pain) and VACCINATION SITE PAIN (And my injection site is painful to the touch). At the time of the report, PAIN IN EXTREMITY (I have a really bad pain in my left groin or thigh area/I can't cross my legs without severe pain) and VACCINATION SITE PAIN (And my injection site is painful to the touch) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant product use was not provided by the reporter.No treatment information was provided.It was reported that vial was left at room temperature overnight post puncture.This case was linked to MOD-2021-403861 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). At the time of the report, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist thought she got a piece of rubber stopper in the syringe. Then, she looked better and there were like black specks floating in it.  No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: elbow is a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (elbow is a little swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Nov-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. In November 2021, the patient experienced JOINT SWELLING (elbow is a little swollen). At the time of the report, JOINT SWELLING (elbow is a little swollen) outcome was unknown.            Patient put ice on it as a corrective treatment.  Patient mentioned it could also be related to hitting her arm and not remembering it.  No concomitant drug information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). At the time of the report, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 32-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 PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). At the time of the report, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Sluggishness
Clinical narrative: tired; Severe, heavy chills; A little sluggish/Sluggish; Mild arm pain; Could not stop shaking; tenderness; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness) and PYREXIA (Feverish) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish) and CHILLS (Severe, heavy chills). On 25-Apr-2021, the patient experienced FATIGUE (tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 25-Apr-2021, SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish) and CHILLS (Severe, heavy chills) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.            No concomitant product reported by reporter.   This case was linked to MOD-2021-403962, MOD-2021-403962 (Patient Link).