chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: while administration vaccine was spill over her wrist; she think that full dose of vaccine was not administered; This spontaneous case was reported by a patient and describes the occurrence of DEVICE CONNECTION ISSUE (while administration vaccine was spill over her wrist) and UNDERDOSE (she think that full dose of vaccine was not administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 031L20A) 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 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (while administration vaccine was spill over her wrist) and UNDERDOSE (she think that full dose of vaccine was not administered). At the time of the report, DEVICE CONNECTION ISSUE (while administration vaccine was spill over her wrist) and UNDERDOSE (she think that full dose of vaccine was not administered) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.; Reporter's Comments: This report refers to a case of under dose and medication error for mRNA-1273, lot # 031L20A with no associated Adverse Events.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine doses of mRNA-1273 (Lot number: 027A21A), intramuscularly, on her left arm, for prophylaxis of COVID-19 infection.  The expiration date of the vial was reported as 22-Aug2-022.  On 11-MAR-2021, the vaccine was administered from a vial punctured more than 18 hours ago. Treatment for the event was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, vaccine administered from a vial punctured more than 18 hours ago, was considered resolved on 11-Mar-2021.; Reporter's Comments: This report refers to a case of Expired product administered for mRNA-1273, lot # 027A21A, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lip swelling, Throat tightness
Clinical narrative: Throat tightness; Swelling lips; Numbness of the body; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat tightness) and HYPOAESTHESIA (Numbness of the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced THROAT TIGHTNESS (Throat tightness) and HYPOAESTHESIA (Numbness of the body). The patient was treated with PREDNISONE at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Throat tightness) and HYPOAESTHESIA (Numbness of the body) outcome was unknown.            This case was linked to MOD21-052205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Patient Email added; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Urticaria
Clinical narrative: Broke out in hives spreading from his torso and under both breasts; Redness; Red inflammation under the patient's arms and down his sides; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives spreading from his torso and under both breasts), ERYTHEMA (Redness) and INFLAMMATION (Red inflammation under the patient's arms and down his sides) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Bullous pemphigoid, COPD since 06-Jan-2021 and Food allergy (Sensitivity to tomato). Concomitant products included PREDNISONE from 10-May-2020 to an unknown date for Bullous pemphigoid, ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced URTICARIA (Broke out in hives spreading from his torso and under both breasts), ERYTHEMA (Redness) and INFLAMMATION (Red inflammation under the patient's arms and down his sides). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. On 12-Mar-2021, URTICARIA (Broke out in hives spreading from his torso and under both breasts), ERYTHEMA (Redness) and INFLAMMATION (Red inflammation under the patient's arms and down his sides) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient demographics, rechallenge details and additional concomitant medications were updated. On 25-Jul-2021: No new information
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: Still has a bruise; A little blood came out during the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (A little blood came out during the injection) and VACCINATION SITE BRUISING (Still has a bruise) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (A little blood came out during the injection). On 12-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Still has a bruise). At the time of the report, VACCINATION SITE HAEMORRHAGE (A little blood came out during the injection) outcome was unknown and VACCINATION SITE BRUISING (Still has a bruise) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (Side effect) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effect). At the time of the report, ADVERSE EVENT (Side effect) 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 concomitant medication use was provided by the reporter.  Treatment of events was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Lip swelling, Malaise, Muscle twitching
Clinical narrative: low grade fever; headache; didn't feel wel, felt foggy; a little ear pain deep inside; sinus hurt; swollen lips; lip twitch; tingling in fingers/tingling in feet; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), HEADACHE (headache), MALAISE (didn't feel wel, felt foggy), EAR PAIN (a little ear pain deep inside) and SINUS PAIN (sinus hurt) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Endometriosis.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 UNK. On 11-Mar-2021, the patient experienced PARAESTHESIA (tingling in fingers/tingling in feet). On an unknown date, the patient experienced PYREXIA (low grade fever), HEADACHE (headache), MALAISE (didn't feel wel, felt foggy), EAR PAIN (a little ear pain deep inside), SINUS PAIN (sinus hurt), LIP SWELLING (swollen lips) and MUSCLE TWITCHING (lip twitch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) at a dose of UNK dosage form. At the time of the report, PYREXIA (low grade fever), HEADACHE (headache), EAR PAIN (a little ear pain deep inside), SINUS PAIN (sinus hurt), LIP SWELLING (swollen lips), MUSCLE TWITCHING (lip twitch) and PARAESTHESIA (tingling in fingers/tingling in feet) outcome was unknown and MALAISE (didn't feel wel, felt foggy) was resolving.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Sinus pain
Clinical narrative: low grade fever; headache; didn't feel wel, felt foggy; a little ear pain deep inside; sinus hurt; swollen lips; lip twitch; tingling in fingers/tingling in feet; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), HEADACHE (headache), MALAISE (didn't feel wel, felt foggy), EAR PAIN (a little ear pain deep inside) and SINUS PAIN (sinus hurt) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Endometriosis.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 UNK. On 11-Mar-2021, the patient experienced PARAESTHESIA (tingling in fingers/tingling in feet). On an unknown date, the patient experienced PYREXIA (low grade fever), HEADACHE (headache), MALAISE (didn't feel wel, felt foggy), EAR PAIN (a little ear pain deep inside), SINUS PAIN (sinus hurt), LIP SWELLING (swollen lips) and MUSCLE TWITCHING (lip twitch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) at a dose of UNK dosage form. At the time of the report, PYREXIA (low grade fever), HEADACHE (headache), EAR PAIN (a little ear pain deep inside), SINUS PAIN (sinus hurt), LIP SWELLING (swollen lips), MUSCLE TWITCHING (lip twitch) and PARAESTHESIA (tingling in fingers/tingling in feet) outcome was unknown and MALAISE (didn't feel wel, felt foggy) was resolving.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Mobility decreased, Pain in extremity, Product dose omission issue
Clinical narrative: Missed dose; left knee swollen; can barely move right arm due to soreness; can barely move right arm due to soreness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (left knee swollen), PAIN IN EXTREMITY (can barely move right arm due to soreness), MOBILITY DECREASED (can barely move right arm due to soreness) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced JOINT SWELLING (left knee swollen), PAIN IN EXTREMITY (can barely move right arm due to soreness) and MOBILITY DECREASED (can barely move right arm due to soreness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (left knee swollen), PAIN IN EXTREMITY (can barely move right arm due to soreness) and MOBILITY DECREASED (can barely move right arm due to soreness) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI On 25-Jun-2021: TCR received on 25 JUNE 2021 updated with Email address.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itching). On 08-Feb-2021, PRURITUS (Itching) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were taken by the patient. Treatment medications were unknown.    This case was linked to MOD-2021-230247 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains non-significant information.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 102 Fahrenheit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102 Fahrenheit) and CHILLS (Chills) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever of 102 Fahrenheit) and CHILLS (Chills). At the time of the report, PYREXIA (Fever of 102 Fahrenheit) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Pain in extremity
Clinical narrative: achy arm, very sore; feeling hot/cold; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm, very sore), FEELING OF BODY TEMPERATURE CHANGE (feeling hot/cold) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PAIN IN EXTREMITY (achy arm, very sore), FEELING OF BODY TEMPERATURE CHANGE (feeling hot/cold) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achy arm, very sore), FEELING OF BODY TEMPERATURE CHANGE (feeling hot/cold) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-042996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042996:MOD21-051913
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain getting worse) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain getting worse). At the time of the report, PAIN IN EXTREMITY (Arm pain getting worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Hypoaesthesia, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: Right arm went numb; Finger started tingling and became red; Neck issue; Had some headaches; arm started getting red; finger got all red; arm started getting swollen; arm started getting itchy; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm started getting red; finger got all red), PERIPHERAL SWELLING (arm started getting swollen), PRURITUS (arm started getting itchy), HYPOAESTHESIA (Right arm went numb) and PARAESTHESIA (Finger started tingling and became red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and HCTZ 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 02-Mar-2021, the patient experienced ERYTHEMA (arm started getting red; finger got all red), PERIPHERAL SWELLING (arm started getting swollen), PRURITUS (arm started getting itchy) and VACCINATION SITE RASH (rash at the injection site). On an unknown date, the patient experienced HYPOAESTHESIA (Right arm went numb), PARAESTHESIA (Finger started tingling and became red), MUSCULOSKELETAL DISCOMFORT (Neck issue) and HEADACHE (Had some headaches). At the time of the report, ERYTHEMA (arm started getting red; finger got all red), PERIPHERAL SWELLING (arm started getting swollen), PRURITUS (arm started getting itchy), HYPOAESTHESIA (Right arm went numb), PARAESTHESIA (Finger started tingling and became red), MUSCULOSKELETAL DISCOMFORT (Neck issue) and HEADACHE (Had some headaches) outcome was unknown and VACCINATION SITE RASH (rash at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       An additional concomitant medication reported was "clonipine" for an unknown indication.  The patient mentioned that on the day she was going to get the vaccine, she fell down the stairs and hit her head on the tiles before she received the vaccine.   Treatment information was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site rash
Clinical narrative: Right arm went numb; Finger started tingling and became red; Neck issue; Had some headaches; arm started getting red; finger got all red; arm started getting swollen; arm started getting itchy; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm started getting red; finger got all red), PERIPHERAL SWELLING (arm started getting swollen), PRURITUS (arm started getting itchy), HYPOAESTHESIA (Right arm went numb) and PARAESTHESIA (Finger started tingling and became red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and HCTZ 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 02-Mar-2021, the patient experienced ERYTHEMA (arm started getting red; finger got all red), PERIPHERAL SWELLING (arm started getting swollen), PRURITUS (arm started getting itchy) and VACCINATION SITE RASH (rash at the injection site). On an unknown date, the patient experienced HYPOAESTHESIA (Right arm went numb), PARAESTHESIA (Finger started tingling and became red), MUSCULOSKELETAL DISCOMFORT (Neck issue) and HEADACHE (Had some headaches). At the time of the report, ERYTHEMA (arm started getting red; finger got all red), PERIPHERAL SWELLING (arm started getting swollen), PRURITUS (arm started getting itchy), HYPOAESTHESIA (Right arm went numb), PARAESTHESIA (Finger started tingling and became red), MUSCULOSKELETAL DISCOMFORT (Neck issue) and HEADACHE (Had some headaches) outcome was unknown and VACCINATION SITE RASH (rash at the injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       An additional concomitant medication reported was "clonipine" for an unknown indication.  The patient mentioned that on the day she was going to get the vaccine, she fell down the stairs and hit her head on the tiles before she received the vaccine.   Treatment information was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Cough, Diarrhoea, Headache, Mass
Clinical narrative: sore throat; diarrhea; reaction 6 days later; cough; horrible headache/ different kind of headache; nausea; lump for 3 days; soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrible headache/ different kind of headache), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later) and COUGH (cough) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (for 6 weeks) in March 2020. Concomitant products included LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CLONAZEPAM (KLONOPIN), OMEPRAZOLE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MASS (lump for 3 days) and PAIN (soreness). On 10-Mar-2021, the patient experienced HEADACHE (horrible headache/ different kind of headache), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later), COUGH (cough) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, HEADACHE (horrible headache/ different kind of headache), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later), COUGH (cough) and NAUSEA (nausea) outcome was unknown and OROPHARYNGEAL PAIN (sore throat), MASS (lump for 3 days) and PAIN (soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: sore throat; diarrhea; reaction 6 days later; cough; horrible headache/ different kind of headache; nausea; lump for 3 days; soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrible headache/ different kind of headache), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later) and COUGH (cough) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (for 6 weeks) in March 2020. Concomitant products included LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CLONAZEPAM (KLONOPIN), OMEPRAZOLE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MASS (lump for 3 days) and PAIN (soreness). On 10-Mar-2021, the patient experienced HEADACHE (horrible headache/ different kind of headache), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later), COUGH (cough) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, HEADACHE (horrible headache/ different kind of headache), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later), COUGH (cough) and NAUSEA (nausea) outcome was unknown and OROPHARYNGEAL PAIN (sore throat), MASS (lump for 3 days) and PAIN (soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood sugar rose from baseline of 120mg/dl to 216mg/dl one day after first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar rose from baseline of 120mg/dl to 216mg/dl one day after first dose of vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Asthma and Type 2 diabetes mellitus. Concomitant products included METFORMIN and GLIPIZIDE for Diabetes.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar rose from baseline of 120mg/dl to 216mg/dl one day after first dose of vaccine). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar rose from baseline of 120mg/dl to 216mg/dl one day after first dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Warm transfer from customer service, customer service case number 00110071. Patient took first dose of the Moderna COVID-19 vaccine yesterday 11Mar2021 in left upper arm and today 12Mar2021 his blood sugar rose from base line of about 120mg/dl to 216mg/dl. He is a known type 2 diabetes mellitus patient with a well controlled blood sugar. His blood sugar is controlled with pills only. He does not use insulin. He wanted to know if we had any information from our clinical trials on a correlation between blood sugar and the moderna vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache) and FATIGUE (tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache), FATIGUE (tiredness), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (Arm Sore, redness). At the time of the report, DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache), FATIGUE (tiredness), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (Arm Sore, redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication use was provided by the reporter.  The patient reported treatment of events was with paracetamol (Tylenol).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient denied consent for further follow-up
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache) and FATIGUE (tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache), FATIGUE (tiredness), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (Arm Sore, redness). At the time of the report, DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache), FATIGUE (tiredness), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (Arm Sore, redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication use was provided by the reporter.  The patient reported treatment of events was with paracetamol (Tylenol).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient denied consent for further follow-up
Sex: F
Vaccine: COVID19
Symptoms: Skin discomfort
Clinical narrative: Caller read in news that people receiving moderna vaccine get skin problems; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced caller read in news that people receiving moderna vaccine get skin problems.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced the event caller read in news that people receiving moderna vaccine get skin problems.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of events caller read in news that people receiving moderna vaccine get skin problems was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Pain in extremity, Pityriasis rosea
Clinical narrative: "Harold patch" rash in her torso; right arm sore; breastfeeding; This spontaneous case was reported by a patient and describes the occurrence of PITYRIASIS ROSEA ("Harold patch" rash in her torso), MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) and PAIN IN EXTREMITY (right arm sore) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding). On 11-Mar-2021, the patient experienced PITYRIASIS ROSEA ("Harold patch" rash in her torso) and PAIN IN EXTREMITY (right arm sore). On 03-Mar-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) had resolved. At the time of the report, PITYRIASIS ROSEA ("Harold patch" rash in her torso) and PAIN IN EXTREMITY (right arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter. No treatment information was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Pain in extremity
Clinical narrative: Sore arm; Clammy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), COLD SWEAT (Clammy) and FATIGUE (Tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), COLD SWEAT (Clammy) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), COLD SWEAT (Clammy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Lightheadedness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) and HEADACHE (Headaches) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Lightheadedness) and HEADACHE (Headaches). At the time of the report, DIZZINESS (Lightheadedness) and HEADACHE (Headaches) had not resolved.            On 12 Mar 2021 post receiving the second dose of mRNA-1273 vaccine, the patient experienced some adverse events and wanted to know if they can take Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant product use was reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity, Sciatica
Clinical narrative: Aches in neck; Sciatica pain on the right side of body reported to have gotten worse after injection; Aches in shoulder; Electricity going down leg; pain along the leg; patient was not sure if administration was performed to correct area and whether appropriate needle size was used; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Electricity going down leg), NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection), PAIN IN EXTREMITY (pain along the leg) and VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HBS010ARIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatica (sciatic nerve). Concomitant products included CELECOXIB and LOVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Electricity going down leg), PAIN IN EXTREMITY (pain along the leg) and VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used). On an unknown date, the patient experienced NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection) and ARTHRALGIA (Aches in shoulder). At the time of the report, PAIN (Electricity going down leg), NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection), PAIN IN EXTREMITY (pain along the leg), VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used) and ARTHRALGIA (Aches in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included blood pressure medications and anti-inflammatory.  No treatment information was provided.   This case was linked to MOD-2021-095213 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow-up received on 22-Mar-2021 included no new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: Aches in neck; Sciatica pain on the right side of body reported to have gotten worse after injection; Aches in shoulder; Electricity going down leg; pain along the leg; patient was not sure if administration was performed to correct area and whether appropriate needle size was used; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Electricity going down leg), NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection), PAIN IN EXTREMITY (pain along the leg) and VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HBS010ARIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatica (sciatic nerve). Concomitant products included CELECOXIB and LOVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Electricity going down leg), PAIN IN EXTREMITY (pain along the leg) and VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used). On an unknown date, the patient experienced NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection) and ARTHRALGIA (Aches in shoulder). At the time of the report, PAIN (Electricity going down leg), NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection), PAIN IN EXTREMITY (pain along the leg), VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used) and ARTHRALGIA (Aches in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included blood pressure medications and anti-inflammatory.  No treatment information was provided.   This case was linked to MOD-2021-095213 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow-up received on 22-Mar-2021 included no new information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Headache; Fever of 102F; Chills; Fatigue; Nausea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). At the time of the report, HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included None.    Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache; Fever of 102F; Chills; Fatigue; Nausea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). At the time of the report, HEADACHE (Headache), PYREXIA (Fever of 102F), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included None.    Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Chills after 2nd shot; Pain in joints after 2nd shot; Slight fever after 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills after 2nd shot), ARTHRALGIA (Pain in joints after 2nd shot) and PYREXIA (Slight fever after 2nd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (Chills after 2nd shot), ARTHRALGIA (Pain in joints after 2nd shot) and PYREXIA (Slight fever after 2nd shot). At the time of the report, CHILLS (Chills after 2nd shot), ARTHRALGIA (Pain in joints after 2nd shot) and PYREXIA (Slight fever after 2nd shot) outcome was unknown.            No concomitant medicines reported. No treatment information reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Uterine dilation and curettage on 04-Nov-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 20-Jan-2021 to an unknown date for an unknown indication.    On 02-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 13-Oct-2021. On 02-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 02-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The pregnancy history of the patient included  a terminated pregnancy on 15 Oct 2020. The patient doesn't have any complications or acute illness during the pregnancy. No prenatal care has been established. The patient doesn't have any chronic or long standing health conditions.The patient doesn't have any record of substance abuse. On 03 Feb 2021, the patient had a positive pregnancy test and the estimated date of conception was on 17 Jan 2021. No treatment information was provided.