chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feel a little fussy; A lot of pain in my left arm to my shoulder and fingers; Vomit, vomited for about 20 minutes; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Feel a little fussy), PAIN IN EXTREMITY (A lot of pain in my left arm to my shoulder and fingers), VOMITING (Vomit, vomited for about 20 minutes), NAUSEA (Nausea) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN B NOS and COLECALCIFEROL (D) for an unknown indication.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced IRRITABILITY (Feel a little fussy), PAIN IN EXTREMITY (A lot of pain in my left arm to my shoulder and fingers), VOMITING (Vomit, vomited for about 20 minutes), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 04-Feb-2021, IRRITABILITY (Feel a little fussy), VOMITING (Vomit, vomited for about 20 minutes) and NAUSEA (Nausea) had resolved. On 07-Feb-2021, PAIN IN EXTREMITY (A lot of pain in my left arm to my shoulder and fingers) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021 contains non-significant information (Contact information updated).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: She got the vaccine then she was exposed to COVID + person; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (She got the vaccine then she was exposed to COVID + person) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced EXPOSURE TO SARS-COV-2 (She got the vaccine then she was exposed to COVID + person). On 23-Feb-2021, EXPOSURE TO SARS-COV-2 (She got the vaccine then she was exposed to COVID + person) had resolved.            No Concomitant products were reported. No treatment information was provided. Patient was tested following quarantine and did not test positive.   This case was linked to MOD-2021-257793 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Second dosing regimen added, hence action taken updated from unknown to not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Vaccination site pain
Clinical narrative: no energy; myalgia; tremendous pain in the injection site the whole deltoid region; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (no energy), MYALGIA (myalgia) and VACCINATION SITE PAIN (tremendous pain in the injection site the whole deltoid region) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ASTHENIA (no energy), MYALGIA (myalgia) and VACCINATION SITE PAIN (tremendous pain in the injection site the whole deltoid region). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (no energy) and MYALGIA (myalgia) had resolved and VACCINATION SITE PAIN (tremendous pain in the injection site the whole deltoid region) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Other treatment details included applying heating Pad on the Vaccinated site.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: A red spot then a 5x2 inch rash; A spontaneous report  was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red spot, 5x2 inch rash/Rash erythematous .  The patient's medical history includes allergy to seroquel. No relevant concomitant medications were reported.  On 16 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced the event(s) red spot, 5x2 inch rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red spot, 5x2 inch rash was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Every single bone where she has arthritis started to ache; Feels terrible; Felt like stabbing pains on body; Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body) and HEADACHE (Terrible headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Shingles (Had worse reactions now compared to shingles vaccine in past.). Past adverse reactions to the above products included Adverse reaction with Shingles. Concurrent medical conditions included Arthritis, High cholesterol, Migraine, Allergic rhinitis, Penicillin allergy and Allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body), HEADACHE (Terrible headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body), HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported.   The vaccine facility staff asked the patient to take 4 baby aspirin.   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm; Every single bone where she has arthritis started to ache; Feels terrible; Felt like stabbing pains on body; Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body) and HEADACHE (Terrible headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Shingles (Had worse reactions now compared to shingles vaccine in past.). Past adverse reactions to the above products included Adverse reaction with Shingles. Concurrent medical conditions included Arthritis, High cholesterol, Migraine, Allergic rhinitis, Penicillin allergy and Allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body), HEADACHE (Terrible headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body), HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported.   The vaccine facility staff asked the patient to take 4 baby aspirin.   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Injection site pain, Lethargy
Clinical narrative: Stomach pain; Chest tightness; Body aches; Lethargic; severe pain at injection site; Fever, hot to touch; chills; Extreme Nausea; A spontaneous report was received from a consumer concerning a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  extreme nausea/ nausea, stomach pain/ abdominal pain upper , chest tightness/ chest discomfort, fever, hot to touch/ pyrexia, chills, body ache/ pain, lethargic/ lethargy.  The patient's medical history was reported as allergies to sulfa, azithromycin, wheat, eggs. Concomitant medications taken by the patient included bupropion, birth control.  On 23 Dec 2020, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 025J20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route at right arm site for prophylaxis of COVID-19 infection.  On 24 Dec 2020, after the first dose patient experienced extreme nausea, stomach pain, chest tightness, fever, hot to touch, chills, body ache, lethargic. All these events lasted for three full days and was reported that the patient recovered from the events.  Treatment activities for event was done with paracetamol, ibuprofen.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, extreme nausea, stomach pain, chest tightness, fever, chills, body ache, hot to touch, lethargic was resolved on an unknown date.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Stomach pain; Chest tightness; Body aches; Lethargic; severe pain at injection site; Fever, hot to touch; chills; Extreme Nausea; A spontaneous report was received from a consumer concerning a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  extreme nausea/ nausea, stomach pain/ abdominal pain upper , chest tightness/ chest discomfort, fever, hot to touch/ pyrexia, chills, body ache/ pain, lethargic/ lethargy.  The patient's medical history was reported as allergies to sulfa, azithromycin, wheat, eggs. Concomitant medications taken by the patient included bupropion, birth control.  On 23 Dec 2020, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 025J20A) through intramuscular route at left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the event, the patient received second of their two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route at right arm site for prophylaxis of COVID-19 infection.  On 24 Dec 2020, after the first dose patient experienced extreme nausea, stomach pain, chest tightness, fever, hot to touch, chills, body ache, lethargic. All these events lasted for three full days and was reported that the patient recovered from the events.  Treatment activities for event was done with paracetamol, ibuprofen.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, extreme nausea, stomach pain, chest tightness, fever, chills, body ache, hot to touch, lethargic was resolved on an unknown date.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Allergic reaction on her arm; It's a bit warm; Reacting like a wasp type thing where it's a 3 by 3 large red circle pink in the center.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction on her arm), VACCINATION SITE WARMTH (It's a bit warm) and VACCINATION SITE ERYTHEMA (Reacting like a wasp type thing where it's a 3 by 3 large red circle pink in the center.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HYPERSENSITIVITY (Allergic reaction on her arm), VACCINATION SITE WARMTH (It's a bit warm) and VACCINATION SITE ERYTHEMA (Reacting like a wasp type thing where it's a 3 by 3 large red circle pink in the center.). At the time of the report, HYPERSENSITIVITY (Allergic reaction on her arm), VACCINATION SITE WARMTH (It's a bit warm) and VACCINATION SITE ERYTHEMA (Reacting like a wasp type thing where it's a 3 by 3 large red circle pink in the center.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Inflammation in the face; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLAMMATION (Inflammation in the face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history  is provided and concomitant drugs are provided.  Concomitant products included HYALURONIC ACID (RESTYLANE) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in the face). At the time of the report, INFLAMMATION (Inflammation in the face) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine; when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (when they administered the vaccine, it bubbled under the arm; that means it was an ineffective transmission of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment medications were reported   This case was linked to MOD-2021-028589 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up information received on 29 Apr 2021 contains non-significant information - Reporter's email address added On 20-Jul-2021: Follow-up information received on 20 Jul 2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pruritus, Rash
Clinical narrative: gotten progressively worse; rash; redness; itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (itchy), CONDITION AGGRAVATED (gotten progressively worse) and RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itchy) and RASH (rash). On 27-Feb-2021, the patient experienced CONDITION AGGRAVATED (gotten progressively worse). At the time of the report, ERYTHEMA (redness), PRURITUS (itchy), CONDITION AGGRAVATED (gotten progressively worse) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Anxiety
Clinical narrative: lost off my memory; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (lost off my memory) and ANXIETY (anxiety) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included METHOCARBAMOL (ROBAXIN), POTASSIUM CHLORIDE (KLOR-CON M20), PRAVASTATIN, AMLODIPINE BESILATE, VALSARTAN (AMLODIPINE/VALSARTAN), GABAPENTIN, APIXABAN (ELIQUIS), BUMETANIDE (BUMEX), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (lost off my memory) and ANXIETY (anxiety). At the time of the report, AMNESIA (lost off my memory) and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient woke up 2 days after the vaccine and forgot her whole life. She said she has changed and doesn't know how to function and doesn't know any of her people or her account numbers.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: Developed delayed cutaneous hypersensitivity "Covid arm"; Rash on the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Developed delayed cutaneous hypersensitivity "Covid arm") and RASH (Rash on the arm of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Developed delayed cutaneous hypersensitivity "Covid arm") and RASH (Rash on the arm of injection). At the time of the report, VACCINATION SITE REACTION (Developed delayed cutaneous hypersensitivity "Covid arm") and RASH (Rash on the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave potentially expired doses from a sealed vial to 9 patients; A spontaneous report was received from a non health professional concerning nine patients of unknown age or gender who received expired product administered.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On an unknown date, prior to the onset of the symptoms, the patient received their (dose unknown) of mRNA-1273 (Batch number: Batch number not provided) route of administration : unknown in the anatomical location for prophylaxis of COVID-19 infection.  On an unknown date,  nine patients received the expired vaccine.  Action taken with the drug in response to the events was not reported.  The outcome of the event was recovered/resolved; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Fever; Body Aches; Body does not feel right; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body Aches) and FEELING ABNORMAL (Body does not feel right) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MYALGIA (Body Aches) and FEELING ABNORMAL (Body does not feel right). At the time of the report, PYREXIA (Fever), MYALGIA (Body Aches) and FEELING ABNORMAL (Body does not feel right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Migraine, Mobility decreased, Muscle tightness
Clinical narrative: below.     The patient's past medical history included Lyme disease. Previously administered products included for an unreported indication: influenza vaccine (allergy to influenza vaccine.) since an unknown date.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FLUSHING (Sensation of flushing and heat), DIZZINESS (dizzy) and VACCINATION SITE PAIN (Minor injection site pain). On 11-Feb-2021, the patient experienced MOBILITY DECREASED (Immobility of her limb). On 19-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Developed red pinpoint dots on her chest and arms). On 21-Feb-2021, the patient experienced VISUAL IMPAIRMENT (loss part of her vision), PALPITATIONS (heart palpitation) and MIGRAINE (horrible migraine). On 25-Feb-2021, the patient experienced MUSCLE TIGHTNESS (tight arm) and VACCINATION SITE INDURATION (Developed a goose egg at the site of administration). On 10-Feb-2021, FLUSHING (Sensation of flushing and heat) and VACCINATION SITE PAIN (Minor injection site pain) had resolved. On 12-Feb-2021, MOBILITY DECREASED (Immobility of her limb) had resolved. On 21-Feb-2021, RASH ERYTHEMATOUS (Developed red pinpoint dots on her chest and arms) had resolved. At the time of the report, VISUAL IMPAIRMENT (loss part of her vision), DIZZINESS (dizzy), PALPITATIONS (heart palpitation), MIGRAINE (horrible migraine), MUSCLE TIGHTNESS (tight arm) and VACCINATION SITE INDURATION (Developed a goose egg at the site of administration) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Platelet count: negative (Negative) negative for abnormal platelet count..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Platelet count, Rash erythematous, Vaccination site induration, Vaccination site pain
Clinical narrative: below.     The patient's past medical history included Lyme disease. Previously administered products included for an unreported indication: influenza vaccine (allergy to influenza vaccine.) since an unknown date.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FLUSHING (Sensation of flushing and heat), DIZZINESS (dizzy) and VACCINATION SITE PAIN (Minor injection site pain). On 11-Feb-2021, the patient experienced MOBILITY DECREASED (Immobility of her limb). On 19-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Developed red pinpoint dots on her chest and arms). On 21-Feb-2021, the patient experienced VISUAL IMPAIRMENT (loss part of her vision), PALPITATIONS (heart palpitation) and MIGRAINE (horrible migraine). On 25-Feb-2021, the patient experienced MUSCLE TIGHTNESS (tight arm) and VACCINATION SITE INDURATION (Developed a goose egg at the site of administration). On 10-Feb-2021, FLUSHING (Sensation of flushing and heat) and VACCINATION SITE PAIN (Minor injection site pain) had resolved. On 12-Feb-2021, MOBILITY DECREASED (Immobility of her limb) had resolved. On 21-Feb-2021, RASH ERYTHEMATOUS (Developed red pinpoint dots on her chest and arms) had resolved. At the time of the report, VISUAL IMPAIRMENT (loss part of her vision), DIZZINESS (dizzy), PALPITATIONS (heart palpitation), MIGRAINE (horrible migraine), MUSCLE TIGHTNESS (tight arm) and VACCINATION SITE INDURATION (Developed a goose egg at the site of administration) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Platelet count: negative (Negative) negative for abnormal platelet count..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: below.     The patient's past medical history included Lyme disease. Previously administered products included for an unreported indication: influenza vaccine (allergy to influenza vaccine.) since an unknown date.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FLUSHING (Sensation of flushing and heat), DIZZINESS (dizzy) and VACCINATION SITE PAIN (Minor injection site pain). On 11-Feb-2021, the patient experienced MOBILITY DECREASED (Immobility of her limb). On 19-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Developed red pinpoint dots on her chest and arms). On 21-Feb-2021, the patient experienced VISUAL IMPAIRMENT (loss part of her vision), PALPITATIONS (heart palpitation) and MIGRAINE (horrible migraine). On 25-Feb-2021, the patient experienced MUSCLE TIGHTNESS (tight arm) and VACCINATION SITE INDURATION (Developed a goose egg at the site of administration). On 10-Feb-2021, FLUSHING (Sensation of flushing and heat) and VACCINATION SITE PAIN (Minor injection site pain) had resolved. On 12-Feb-2021, MOBILITY DECREASED (Immobility of her limb) had resolved. On 21-Feb-2021, RASH ERYTHEMATOUS (Developed red pinpoint dots on her chest and arms) had resolved. At the time of the report, VISUAL IMPAIRMENT (loss part of her vision), DIZZINESS (dizzy), PALPITATIONS (heart palpitation), MIGRAINE (horrible migraine), MUSCLE TIGHTNESS (tight arm) and VACCINATION SITE INDURATION (Developed a goose egg at the site of administration) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Platelet count: negative (Negative) negative for abnormal platelet count..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Soreness; little body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and MYALGIA (little body ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (little body ache). On an unknown date, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) and MYALGIA (little body ache) outcome was unknown. Not Provided          Treatment details not provided. concomitant details not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: couple of hrs later her arm got sore; had tingling and tingling sensation it was bizarre, scary; pain was on her left side down neck and 2ft of back side, also all the way down fingers and arm,; starting having pain at injecting to her fingers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (couple of hrs later her arm got sore), PARAESTHESIA (had tingling and tingling sensation it was bizarre, scary), PAIN (pain was on her left side down neck and 2ft of back side, also all the way down fingers and arm,) and VACCINATION SITE PAIN (starting having pain at injecting to her fingers) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (couple of hrs later her arm got sore), PARAESTHESIA (had tingling and tingling sensation it was bizarre, scary), PAIN (pain was on her left side down neck and 2ft of back side, also all the way down fingers and arm,) and VACCINATION SITE PAIN (starting having pain at injecting to her fingers). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 12-Feb-2021, PARAESTHESIA (had tingling and tingling sensation it was bizarre, scary), PAIN (pain was on her left side down neck and 2ft of back side, also all the way down fingers and arm,) and VACCINATION SITE PAIN (starting having pain at injecting to her fingers) had resolved. At the time of the report, PAIN IN EXTREMITY (couple of hrs later her arm got sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disturbance in attention, Fatigue, Headache
Clinical narrative: flu-like symptoms; Blurry vision; Difficulty focusing; Sweating; body aches; Headaches; fever of 104; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating) and PAIN (body aches) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating), PAIN (body aches), HEADACHE (Headaches), PYREXIA (fever of 104), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating), PAIN (body aches), HEADACHE (Headaches), PYREXIA (fever of 104), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) fever of 104 degree Fahrenheit.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Pain, Pyrexia, Vision blurred
Clinical narrative: flu-like symptoms; Blurry vision; Difficulty focusing; Sweating; body aches; Headaches; fever of 104; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating) and PAIN (body aches) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating), PAIN (body aches), HEADACHE (Headaches), PYREXIA (fever of 104), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating), PAIN (body aches), HEADACHE (Headaches), PYREXIA (fever of 104), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) fever of 104 degree Fahrenheit.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: worsened knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (worsened knee pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ARTHRALGIA (worsened knee pain). At the time of the report, ARTHRALGIA (worsened knee pain) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Head discomfort, Pain
Clinical narrative: hard to lift head; Body hurts/body aches; feels exhausted/fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (hard to lift head), PAIN (Body hurts/body aches), FATIGUE (feels exhausted/fatigue) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HEAD DISCOMFORT (hard to lift head), PAIN (Body hurts/body aches), FATIGUE (feels exhausted/fatigue) and CHILLS (chills). At the time of the report, HEAD DISCOMFORT (hard to lift head), PAIN (Body hurts/body aches), FATIGUE (feels exhausted/fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Flushing, Pain in extremity, Pharyngeal swelling
Clinical narrative: flushing; throat swelling; tight chest; blood pressure increased; Pain in arm; This spontaneous case was reported by a pharmacist and describes the occurrence of FLUSHING (flushing), PHARYNGEAL SWELLING (throat swelling), CHEST DISCOMFORT (tight chest), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN IN EXTREMITY (Pain in arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (morphine), Fragrance sensitivity, Allergy to chemicals (generally sensitive skin to dyes), Soap allergy and Allergy to plants (hay).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced FLUSHING (flushing), PHARYNGEAL SWELLING (throat swelling), CHEST DISCOMFORT (tight chest), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, FLUSHING (flushing), PHARYNGEAL SWELLING (throat swelling), CHEST DISCOMFORT (tight chest), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided. No concomitant medication were provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 30-Oct-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Warm to touch in that area; only hurts when touched; Still have a knot where the injection was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Still have a knot where the injection was), VACCINATION SITE WARMTH (Warm to touch in that area) and VACCINATION SITE PAIN (only hurts when touched) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder. Concomitant products included AMLODIPINE for Blood pressure, LEVOTHYROXINE for Thyroid disorder.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Still have a knot where the injection was) and VACCINATION SITE PAIN (only hurts when touched). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch in that area). At the time of the report, VACCINATION SITE INDURATION (Still have a knot where the injection was), VACCINATION SITE WARMTH (Warm to touch in that area) and VACCINATION SITE PAIN (only hurts when touched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm hurts; Temperature went up to 100F; Chills; Extremely tired; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), PYREXIA (Temperature went up to 100F), CHILLS (Chills), FATIGUE (Extremely tired) and HEADACHE (Head ache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012620A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), PYREXIA (Temperature went up to 100F), CHILLS (Chills), FATIGUE (Extremely tired) and HEADACHE (Head ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts), PYREXIA (Temperature went up to 100F), CHILLS (Chills), FATIGUE (Extremely tired) and HEADACHE (Head ache) outcome was unknown.            No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up information received on 29-Apr-2021 contains non-significant information