chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Is is normal to feel worse the second day after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Is is normal to feel worse the second day after the first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Is is normal to feel worse the second day after the first shot). At the time of the report, MALAISE (Is is normal to feel worse the second day after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Four patients were administered only 0.125mL (25mcg) as their booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Four patients were administered only 0.125mL (25mcg) as their booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .125 milliliter. On an unknown date, the patient experienced UNDERDOSE (Four patients were administered only 0.125mL (25mcg) as their booster dose). At the time of the report, UNDERDOSE (Four patients were administered only 0.125mL (25mcg) as their booster dose) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The four patients received 0.125mL of the Moderna COVID-19 Vaccine (25mcg) for their booster dose. All four patients were intended to receive 50mcg (0.25mL) of the booster dose. No concomitant and treatment information were reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Urticaria
Clinical narrative: Hives on all over body; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of URTICARIA (Hives on all over body) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in an adult 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced URTICARIA (Hives on all over body) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, URTICARIA (Hives on all over body) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concamitant medication was reported by the reporter. No treatment medication was reported. Age of the patient was reported as 34 or 35 years and patient was going through post partum.
Sex: U
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: In some places they forget to take it out of the freezer and administer directly  to the patient. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (In some places they forget to take it out of the freezer and administer directly  to the patient.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (In some places they forget to take it out of the freezer and administer directly  to the patient.). At the time of the report, PRODUCT PREPARATION ERROR (In some places they forget to take it out of the freezer and administer directly  to the patient.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications information was not reported No treatment medications were provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Pain in extremity, X-ray
Clinical narrative: achy/had a very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy/had a very sore arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 088D21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2021.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced PAIN IN EXTREMITY (achy/had a very sore arm). At the time of the report, PAIN IN EXTREMITY (achy/had a very sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2021, Heart rate: 125-130 (High) heart rate jumps to 125-130 suddenly sometimes.Normal heart rate is around 58.On 17-Dec-2021, X-ray: negative (Negative) Chest X-ray showed negative.        Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-418112 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Listless, Myalgia, Somnolence
Clinical narrative: Sleeping much more; weak; listless; muscle pain from his shoulders down to his toes on both sides; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping much more), ASTHENIA (weak), LISTLESS (listless), MYALGIA (muscle pain from his shoulders down to his toes on both sides) and FATIGUE (Tiredness) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024H21B, 021B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Stroke. Concurrent medical conditions included Asthma, Diabetes, Neuropathic pain (That is isolated to his left side) and Heart disease, unspecified. Concomitant products included NORTRIPTYLINE and PREGABALIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (Sleeping much more), ASTHENIA (weak), LISTLESS (listless) and MYALGIA (muscle pain from his shoulders down to his toes on both sides). In December 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (Sleeping much more), ASTHENIA (weak), LISTLESS (listless), MYALGIA (muscle pain from his shoulders down to his toes on both sides) and FATIGUE (Tiredness) outcome was unknown.            It was reported that the patient was able to eat a hearty breakfast of French toast. And in the call the HCP recommended hydrating with fluids like Gatorade. The reporter also states that the patient does not feel like when his blood sugar is low, with the tiredness.  Treatment information was not reported   This case was linked to MOD-2021-418130 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Feeling abnormal, Feeling cold, Feeling hot
Clinical narrative: he was a little bit swollen; his head was ice cold/his arm was ice cold; he is shaking; I cannot move the legs; been in bed all week; he feels like he is going to pass out; cannot walk,; I ca n't walk I feel weak; becomes hot; nauseous; arm being swollen; painful; still red around where he took the shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs) and BEDRIDDEN (been in bed all week) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs), BEDRIDDEN (been in bed all week), FEELING ABNORMAL (he feels like he is going to pass out), GAIT INABILITY (cannot walk,), ASTHENIA (I ca n't walk I feel weak), FEELING HOT (becomes hot), NAUSEA (nauseous), VACCINATION SITE SWELLING (arm being swollen), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (still red around where he took the shot). At the time of the report, SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs), BEDRIDDEN (been in bed all week), FEELING ABNORMAL (he feels like he is going to pass out), GAIT INABILITY (cannot walk,), ASTHENIA (I ca n't walk I feel weak), FEELING HOT (becomes hot), NAUSEA (nauseous), VACCINATION SITE SWELLING (arm being swollen), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (still red around where he took the shot) outcome was unknown.            Patient mentioned that no medications outside of Tylenol or Aspirins.  No concomitant medications were provided.   This case was linked to MOD-2021-418188 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Mobility decreased, Nausea, Swelling, Tremor
Clinical narrative: he was a little bit swollen; his head was ice cold/his arm was ice cold; he is shaking; I cannot move the legs; been in bed all week; he feels like he is going to pass out; cannot walk,; I ca n't walk I feel weak; becomes hot; nauseous; arm being swollen; painful; still red around where he took the shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs) and BEDRIDDEN (been in bed all week) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs), BEDRIDDEN (been in bed all week), FEELING ABNORMAL (he feels like he is going to pass out), GAIT INABILITY (cannot walk,), ASTHENIA (I ca n't walk I feel weak), FEELING HOT (becomes hot), NAUSEA (nauseous), VACCINATION SITE SWELLING (arm being swollen), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (still red around where he took the shot). At the time of the report, SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs), BEDRIDDEN (been in bed all week), FEELING ABNORMAL (he feels like he is going to pass out), GAIT INABILITY (cannot walk,), ASTHENIA (I ca n't walk I feel weak), FEELING HOT (becomes hot), NAUSEA (nauseous), VACCINATION SITE SWELLING (arm being swollen), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (still red around where he took the shot) outcome was unknown.            Patient mentioned that no medications outside of Tylenol or Aspirins.  No concomitant medications were provided.   This case was linked to MOD-2021-418188 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: he was a little bit swollen; his head was ice cold/his arm was ice cold; he is shaking; I cannot move the legs; been in bed all week; he feels like he is going to pass out; cannot walk,; I ca n't walk I feel weak; becomes hot; nauseous; arm being swollen; painful; still red around where he took the shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs) and BEDRIDDEN (been in bed all week) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs), BEDRIDDEN (been in bed all week), FEELING ABNORMAL (he feels like he is going to pass out), GAIT INABILITY (cannot walk,), ASTHENIA (I ca n't walk I feel weak), FEELING HOT (becomes hot), NAUSEA (nauseous), VACCINATION SITE SWELLING (arm being swollen), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (still red around where he took the shot). At the time of the report, SWELLING (he was a little bit swollen), FEELING COLD (his head was ice cold/his arm was ice cold), TREMOR (he is shaking), MOBILITY DECREASED (I cannot move the legs), BEDRIDDEN (been in bed all week), FEELING ABNORMAL (he feels like he is going to pass out), GAIT INABILITY (cannot walk,), ASTHENIA (I ca n't walk I feel weak), FEELING HOT (becomes hot), NAUSEA (nauseous), VACCINATION SITE SWELLING (arm being swollen), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (still red around where he took the shot) outcome was unknown.            Patient mentioned that no medications outside of Tylenol or Aspirins.  No concomitant medications were provided.   This case was linked to MOD-2021-418188 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: A little red rash on the injection site  for a few days after first shot; A little red rash on the injection site  for a few days after first shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (A little red rash on the injection site  for a few days after first shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site  for a few days after first shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE RASH (A little red rash on the injection site  for a few days after first shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site  for a few days after first shot). On 07-Feb-2021, VACCINATION SITE RASH (A little red rash on the injection site  for a few days after first shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site  for a few days after first shot) 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 provided No treatment medications were provided.   This case was linked to MOD-2021-418203, MOD-2021-418208 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: A little red rash on the injection site for a few days after 2nd shot; A little red rash on the injection site for a few days after 2nd shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (A little red rash on the injection site for a few days after 2nd shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site for a few days after 2nd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE RASH (A little red rash on the injection site for a few days after 2nd shot). 05-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (A little red rash on the injection site for a few days after 2nd shot). On 07-Mar-2021, VACCINATION SITE RASH (A little red rash on the injection site for a few days after 2nd shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site for a few days after 2nd shot) had resolved.        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.   This case was linked to MOD-2021-418200, MOD-2021-418208 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Monocyte count, Vaccination site erythema, Vaccination site rash, White blood cell count
Clinical narrative: A little red rash on the injection site for a few days after 3rd shot; A little red rash on the injection site for a few days after 3rd shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (A little red rash on the injection site for a few days after 3rd shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site for a few days after 3rd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028F21A, 025A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 08-Sep-2021, the patient experienced VACCINATION SITE RASH (A little red rash on the injection site for a few days after 3rd shot). 08-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (A little red rash on the injection site for a few days after 3rd shot). On 10-Sep-2021, VACCINATION SITE RASH (A little red rash on the injection site for a few days after 3rd shot) and VACCINATION SITE ERYTHEMA (A little red rash on the injection site for a few days after 3rd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, Monocyte count: high (High) high Relative Monocyte. On 29-Nov-2021, White blood cell count: high (High) high WBC.. On 16-Dec-2021, Antibody test: 150.00 (Inconclusive) >150.00 index..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. Patient had blood test on 29 Nov 2021.Patient  is supposed to repeat the blood test in a month.   This case was linked to MOD-2021-418203, MOD-2021-418200 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling cold, Malaise
Clinical narrative: he is very cold; got tremors,/whole body is shaking; is not well; his temperature is  102.4°F; got the shivers; muscle hurt; joint  hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F) and CHILLS (got the shivers) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Dec-2021, the patient experienced FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F), CHILLS (got the shivers), MYALGIA (muscle hurt) and ARTHRALGIA (joint  hurts). At the time of the report, FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F), CHILLS (got the shivers), MYALGIA (muscle hurt) and ARTHRALGIA (joint  hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2021, Body temperature: 102.4 (High) Body temperature is 102.4°F.         Patient was fine when got home after vaccination  but at time of reporting, he was  very cold,  temperature was 102.4°F, got the shivers, got tremors, whole body was shaking, muscle hurt, joint hurts. No concomitant medication were reported. No treatment information were given.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: he is very cold; got tremors,/whole body is shaking; is not well; his temperature is  102.4°F; got the shivers; muscle hurt; joint  hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F) and CHILLS (got the shivers) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Dec-2021, the patient experienced FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F), CHILLS (got the shivers), MYALGIA (muscle hurt) and ARTHRALGIA (joint  hurts). At the time of the report, FEELING COLD (he is very cold), TREMOR (got tremors,/whole body is shaking), MALAISE (is not well), PYREXIA (his temperature is  102.4°F), CHILLS (got the shivers), MYALGIA (muscle hurt) and ARTHRALGIA (joint  hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2021, Body temperature: 102.4 (High) Body temperature is 102.4°F.         Patient was fine when got home after vaccination  but at time of reporting, he was  very cold,  temperature was 102.4°F, got the shivers, got tremors, whole body was shaking, muscle hurt, joint hurts. No concomitant medication were reported. No treatment information were given.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash in the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in the vaccination site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced VACCINATION SITE RASH (Rash in the vaccination site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash in the vaccination site) outcome was unknown.            Concomitant medication included blood pressure medication.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pins and needles throughout body
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: CSF cell count normal, CSF protein increased, Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillian Barre Syndrome -- specifically AIDP superimposed on probable CIPD. Patient presented to ED with progressive bilateral upper extremity and lower extremity weakness. Symptoms began a few days after vaccination and progressed over months. Two weeks prior to admission, his bilateral lower extremity weakness acutely worsened to the point that he was unable to ascend stairs, prompting him to come to ED. Lumbar puncture was performed, revealing elevated protein and normal cell counts, consistent with clinical picture of Guillian Barre Syndrome. He currently remains in hospital and is undergoing IVIG infusions.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture abnormal, Mobility decreased, Muscular weakness, Subacute inflammatory demyelinating polyneuropathy
Clinical narrative: Guillian Barre Syndrome -- specifically AIDP superimposed on probable CIPD. Patient presented to ED with progressive bilateral upper extremity and lower extremity weakness. Symptoms began a few days after vaccination and progressed over months. Two weeks prior to admission, his bilateral lower extremity weakness acutely worsened to the point that he was unable to ascend stairs, prompting him to come to ED. Lumbar puncture was performed, revealing elevated protein and normal cell counts, consistent with clinical picture of Guillian Barre Syndrome. He currently remains in hospital and is undergoing IVIG infusions.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Chills, Computerised tomogram head normal, Fibrin D dimer increased, Full blood count normal
Clinical narrative: Severe Migraine for 72 hours  in upper sinus migrating left to right before resolving , low grade fever, chills sleeplessness, lingering phantom tingling sensation in scalp
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, International normalised ratio normal, Migraine, Paraesthesia, Prothrombin time normal
Clinical narrative: Severe Migraine for 72 hours  in upper sinus migrating left to right before resolving , low grade fever, chills sleeplessness, lingering phantom tingling sensation in scalp
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Severe Migraine for 72 hours  in upper sinus migrating left to right before resolving , low grade fever, chills sleeplessness, lingering phantom tingling sensation in scalp
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood uric acid, Borrelia test, C-reactive protein, Dysmenorrhoea
Clinical narrative: One week after receiving the second dose I experienced the most painful period I have had in adulthood. I had debilitating menstrual cramps for multiple days (which is not something I've experienced since teen years) as well as an abnormally heavy flow for an abnormally long time.  Then on Dec 15 I started having a debilitating inflammatory reaction in my foot. So far I have missed 3 days of work and have had to be in a walking boot. I saw an orthopedist and had X-rays and labs taken. I've been diagnosed with sesamoiditis. The orthopedist agrees this could be linked to the vaccine as I have no typical history for developing sesamoiditis.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Impaired work ability, Inflammation, Laboratory test, Tendonitis
Clinical narrative: One week after receiving the second dose I experienced the most painful period I have had in adulthood. I had debilitating menstrual cramps for multiple days (which is not something I've experienced since teen years) as well as an abnormally heavy flow for an abnormally long time.  Then on Dec 15 I started having a debilitating inflammatory reaction in my foot. So far I have missed 3 days of work and have had to be in a walking boot. I saw an orthopedist and had X-rays and labs taken. I've been diagnosed with sesamoiditis. The orthopedist agrees this could be linked to the vaccine as I have no typical history for developing sesamoiditis.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb
Clinical narrative: One week after receiving the second dose I experienced the most painful period I have had in adulthood. I had debilitating menstrual cramps for multiple days (which is not something I've experienced since teen years) as well as an abnormally heavy flow for an abnormally long time.  Then on Dec 15 I started having a debilitating inflammatory reaction in my foot. So far I have missed 3 days of work and have had to be in a walking boot. I saw an orthopedist and had X-rays and labs taken. I've been diagnosed with sesamoiditis. The orthopedist agrees this could be linked to the vaccine as I have no typical history for developing sesamoiditis.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes virus infection, Lymphadenopathy, Nausea, Rash
Clinical narrative: Rash and herpes reaction same arm and ankle as  injection site (right arm) as well as labia, swellings lymph nodes under both arms, fatigue and nausea.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore joints: Knees and elbows for approximately a week.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Pain at injection Muscle pain Tiredness
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dizziness postural, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness/Lightheadedness-Mild, Systemic: Elevated blood pressure-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Hypertension-Medium, Additional Details: Patient felt syncope 10 minutes after vaccine administration. We gave bottle of water, orange juice and apple juice. Patient felt slightly better but felt dizzy upon standing. Took blood pressure 196/109 plus 90. Called 911. Patient alert and responsive/talking the whole time.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Syncope
Clinical narrative: Systemic: Dizziness/Lightheadedness-Mild, Systemic: Elevated blood pressure-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Hypertension-Medium, Additional Details: Patient felt syncope 10 minutes after vaccine administration. We gave bottle of water, orange juice and apple juice. Patient felt slightly better but felt dizzy upon standing. Took blood pressure 196/109 plus 90. Called 911. Patient alert and responsive/talking the whole time.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Injection site swelling, Pain
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: patient having muscle spasms in forearm shoulder and back since 2 days after 2 covid shot-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Severe, Additional Details: patient received covid shot on 12-8-21 . 2 days later she started having muscle spams in shoulder, back and forearm that continue today. She saw her doctor today and he told her to have us do report.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Pyrexia
Clinical narrative: FEVER, CHILLS, BLOOD SUGAR WENT UP.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular, Urticaria
Clinical narrative: Two weeks after receiving the booster vaccine I developed hives.  They would pop up, be red, bumpy and itchy for about a half hour, then go away.  I went on steroids for 5 days, which made it good, but as soon as I came off of them, the hives were back.  I would have a flair up in the morning, be good at work all day, then they would come back out between 5:30 and 7:00 in the evening.  I was taking Benadryl to get through the night for a few weeks, then I went to my primary doctor on 12-14-21.  She advised me to switch to Zyrtec D, which has been amazing, for one week then come off of it, that would be today.  I have had some red splotches develop while on the Zyrtec, but it has not been itchy.  The reason I believe it may be from the booster shot, is because 3 other people in my office who received the booster on the same day are going through the same symptoms.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: intermitted pains in hands and feet 1 month  after COVID vaccination
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: For a total of 9 days, the patient experienced severe head aches, extreme fatigue, dizziness, stomach pain, and joint pain.  He had to miss more than a week of school.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities
Clinical narrative: For a total of 9 days, the patient experienced severe head aches, extreme fatigue, dizziness, stomach pain, and joint pain.  He had to miss more than a week of school.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: tingling/ pain down arm-Medium
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: patient felt lightheaded after around 10-15 min of the vaccination , blood pressure checked was 150/90 then 148/87 after 10 min , offered water , lifted legs , offered to call 911 or the doctor
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: cellulitis at injection site-Medium, Additional Details: Patient called pharmacy and stated she had redness and swelling at injection site since Saturday. She went to doctor today (Monday 12/20/2021) and was diagnosed with cellulitis. She was given antibiotics.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Flushing, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient received 3rd Covid shot about 3-5 minutes later patient lost consciousness and fell out of chair he was sitting in. Patient was face down laying on the ground when rph got to his. He regained consciousness when rph went over to check on patient. He states he felt it coming his vision started to go and it went black when he came back to rph was next to him. Rph had patient remain on the ground  and went on to check on patient. Paramedics arrived and check out patient
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient received 3rd Covid shot about 3-5 minutes later patient lost consciousness and fell out of chair he was sitting in. Patient was face down laying on the ground when rph got to his. He regained consciousness when rph went over to check on patient. He states he felt it coming his vision started to go and it went black when he came back to rph was next to him. Rph had patient remain on the ground  and went on to check on patient. Paramedics arrived and check out patient
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Additional Details: Patient fainted after approxiamtely 5 minutes of Moderna administration. Patient was unconscious for approxiamately 30 second and then regained consciousness.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia, Seizure
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Seizure-Mild, Additional Details: Patient had seizure twice - within 5 minutes- reported some tingling in the arm of vaccine but after 5 minutes was feeling better
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: drop in blood pressure and blurred vision and feeling weak - called 911 and patients father -   patients recovered quick and left without going to er or seeking care -  felt slight chest pain next day she stated too
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: drop in blood pressure and blurred vision and feeling weak - called 911 and patients father -   patients recovered quick and left without going to er or seeking care -  felt slight chest pain next day she stated too
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Injection site pruritus, Lymphadenopathy, Mouth swelling, Pain
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: PT SEEING DR 12/21/2021
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: PT SEEING DR 12/21/2021
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer normal, Full blood count normal, Metabolic function test, Urticaria
Clinical narrative: Delayed urticaria, approximately 3 days after vaccine
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Illness, Infertility
Clinical narrative: I am infertile/no period , I have not been able to find help for this. Months after I have gotten sick more times than before. I have not contracted COVID one time during the pandemic I always stayed cautious I got the vaccine because of work and have been more sick than ever before that I?ve had family notice .
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium, Additional Details: pt visited clinic on sunday and they told her it was a side effect. she states around 7:30pm 12-20-21 that she is feeling better and just wants the side effect reported.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: About 10 days after my third Covid-19 Moderna vaccine (booster shot), I developed hives all over my body. The hives present as itchy red welts that last for about 20-30 minutes before dissipating, but the hives recur in different spots on my body shortly after.  I have had hives for a week so far.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Heart rate increased
Clinical narrative: HIGH BLOOD SUGAR READING -- WENT UP OVER 300 POINTS FROM MORNING READING. HEART RATE WENT UP DRAMATICALLY (UP TO 110, NORMALLY RUNS AROUNG 70-75 AT THAT TIME OF DAY.)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Aphthous ulcer, Arthralgia, Chest pain, Deafness unilateral
Clinical narrative: Severe chest pain in the left side of chest,  stretching to the left shoulder (December 19th) Throat felt full, pain stretching from chest to  throat (December 19th) Loss of hearing in right ear for approximately 2 hours (December 18th) Heightened anxiety (December 18th) Nausea and headache (December 18th) Canker sores, mouth ulcers, on the roof of the mouth, side of tongue, and under the tongue (December 19th-present) Suspected yeast infection/ vaginitis (December 19th-present)
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Headache, Mouth ulceration, Nausea, Oropharyngeal pain
Clinical narrative: Severe chest pain in the left side of chest,  stretching to the left shoulder (December 19th) Throat felt full, pain stretching from chest to  throat (December 19th) Loss of hearing in right ear for approximately 2 hours (December 18th) Heightened anxiety (December 18th) Nausea and headache (December 18th) Canker sores, mouth ulcers, on the roof of the mouth, side of tongue, and under the tongue (December 19th-present) Suspected yeast infection/ vaginitis (December 19th-present)
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tongue ulceration, Vaginal infection
Clinical narrative: Severe chest pain in the left side of chest,  stretching to the left shoulder (December 19th) Throat felt full, pain stretching from chest to  throat (December 19th) Loss of hearing in right ear for approximately 2 hours (December 18th) Heightened anxiety (December 18th) Nausea and headache (December 18th) Canker sores, mouth ulcers, on the roof of the mouth, side of tongue, and under the tongue (December 19th-present) Suspected yeast infection/ vaginitis (December 19th-present)
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Chest pain, Differential white blood cell count, Echocardiogram
Clinical narrative: Extreme chest on left side and heart pain, shooting pain down entire left arm, like heart attack symptoms. I have never before had chest pain or heart pain before. I also developed pleurisy. I have no known heart conditions or prior issues with blood clots, heart attacks, hypertension, or chest pain.  -chest pain -heart pain -chest tightness -entire left arm pain -pleurisy
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Full blood count, Myocardial infarction, Pain, Pain in extremity
Clinical narrative: Extreme chest on left side and heart pain, shooting pain down entire left arm, like heart attack symptoms. I have never before had chest pain or heart pain before. I also developed pleurisy. I have no known heart conditions or prior issues with blood clots, heart attacks, hypertension, or chest pain.  -chest pain -heart pain -chest tightness -entire left arm pain -pleurisy
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy
Clinical narrative: Extreme chest on left side and heart pain, shooting pain down entire left arm, like heart attack symptoms. I have never before had chest pain or heart pain before. I also developed pleurisy. I have no known heart conditions or prior issues with blood clots, heart attacks, hypertension, or chest pain.  -chest pain -heart pain -chest tightness -entire left arm pain -pleurisy
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Herpes zoster
Clinical narrative: Developed eczema on ankle. A few weeks later developed shingles.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, muscle ache, head ache, fatigue
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis ulcerative, Colonoscopy abnormal, Computerised tomogram, Localised infection, Rash
Clinical narrative: 1) 1st dose: Infection/rash on left arm treated w/doxycycline 2) 1st dose: developed Ulcerative Colitis four days later-diagnosed by colonoscopy on 3-23-21.  2nd dose on 3-21-21 increased symptoms. Hospitalized on 4-3-21. IV steroids administered. 2 infusions of Remicaid.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Breast enlargement, Breast pain, Joint dislocation
Clinical narrative: * 2X ENLARGEMENT OF BREASTS - PAIN   SEVERE ENLARGEMENT OF OVARY - APPROX 1 MONTH * EXTREME JOINT PAIN - MALFUNCTION-DISLOCATION W/ EXTREME MUSCLE PAIN LOSS OF RANGE OF MOTION * SEVERE MIDDLE PAIN * CONTINUES NO HELP FROM DOCTORS
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Laboratory test, Myalgia, Ovarian enlargement, Pain
Clinical narrative: * 2X ENLARGEMENT OF BREASTS - PAIN   SEVERE ENLARGEMENT OF OVARY - APPROX 1 MONTH * EXTREME JOINT PAIN - MALFUNCTION-DISLOCATION W/ EXTREME MUSCLE PAIN LOSS OF RANGE OF MOTION * SEVERE MIDDLE PAIN * CONTINUES NO HELP FROM DOCTORS
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast
Clinical narrative: * 2X ENLARGEMENT OF BREASTS - PAIN   SEVERE ENLARGEMENT OF OVARY - APPROX 1 MONTH * EXTREME JOINT PAIN - MALFUNCTION-DISLOCATION W/ EXTREME MUSCLE PAIN LOSS OF RANGE OF MOTION * SEVERE MIDDLE PAIN * CONTINUES NO HELP FROM DOCTORS