chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arthralgia; Fatigue; left arm is 2 inches bigger than her right; the area of injection became red, warm to touch and swollen; the area of injection became red, warm to touch and swollen; the area of injection became red, warm to touch and swollen; experiencing pain and on her left arm where she received the vaccine; soreness and muscle ache; headache; chills; A spontaneous report was received from a nurse concerning a 38-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle ache,headache,chills,injection site pain,swelling,warmth,erythema and peripheral swelling.   The patient's medical history, was not provided.Concomitant medications was not provided by the reporter. On 20 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On  20 Jan  2021, prior to receiving mRNA-1273, the patient felt muscle ache,headache,chills, and on 27 Jan 2021 injection site pain, and on 29 Jan 2021 injection site  swelling,warmth,erythema and 01 Feb 2021  peripheral swelling and she had went to the ER . Lab tests was done included ultrasound ,blood work and covid-19 swab and the results were not provided. Treatment for the events included IV fluid,Tylenol,Bactrim,Keflex,Claritin,Zyrtec,Pepcid,Benadryl and Hydrocortisone cream.Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the events, muscle ache,headache,chills, were considered resolved  and outcome of the events injection site pain,swelling,warmth,erythema and peripheral swelling was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Insomnia, Neuralgia, Pain in extremity
Clinical narrative: had developed shingles; red itchy rash on her back; I was in so much pain, nerve pain; can't sleep at night and it is torture; red; left arm was very sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (had developed shingles), PAIN IN EXTREMITY (left arm was very sore for a couple of days), PRURITUS (red itchy rash on her back), NEURALGIA (I was in so much pain, nerve pain) and INSOMNIA (can't sleep at night and it is torture) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm was very sore for a couple of days), INSOMNIA (can't sleep at night and it is torture) and ERYTHEMA (red). On 30-Jan-2021, the patient experienced PRURITUS (red itchy rash on her back) and NEURALGIA (I was in so much pain, nerve pain). On 04-Feb-2021, the patient experienced HERPES ZOSTER (had developed shingles). At the time of the report, HERPES ZOSTER (had developed shingles), PAIN IN EXTREMITY (left arm was very sore for a couple of days), PRURITUS (red itchy rash on her back), NEURALGIA (I was in so much pain, nerve pain), INSOMNIA (can't sleep at night and it is torture) and ERYTHEMA (red) 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.   Patient was treated with gabapentin (Neurontin), Valtrex and Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: No specific follow-up information recorded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: had developed shingles; red itchy rash on her back; I was in so much pain, nerve pain; can't sleep at night and it is torture; red; left arm was very sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (had developed shingles), PAIN IN EXTREMITY (left arm was very sore for a couple of days), PRURITUS (red itchy rash on her back), NEURALGIA (I was in so much pain, nerve pain) and INSOMNIA (can't sleep at night and it is torture) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm was very sore for a couple of days), INSOMNIA (can't sleep at night and it is torture) and ERYTHEMA (red). On 30-Jan-2021, the patient experienced PRURITUS (red itchy rash on her back) and NEURALGIA (I was in so much pain, nerve pain). On 04-Feb-2021, the patient experienced HERPES ZOSTER (had developed shingles). At the time of the report, HERPES ZOSTER (had developed shingles), PAIN IN EXTREMITY (left arm was very sore for a couple of days), PRURITUS (red itchy rash on her back), NEURALGIA (I was in so much pain, nerve pain), INSOMNIA (can't sleep at night and it is torture) and ERYTHEMA (red) 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.   Patient was treated with gabapentin (Neurontin), Valtrex and Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain in triceps; Redness in triceps; Swelling in triceps; A spontaneous report was received from healthcare professional concerning a 66-year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain, redness, and swelling in triceps.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 03 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly in the right arm triceps for prophylaxis of COVID-19 infection.  The patient reported that the nurse put it in the triceps instead of deltoid. On 04 Feb 2021, the patient experienced pain, redness, and swelling in triceps. Treatment information was not provided  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, pain, redness, and swelling in triceps, were ongoing.; 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: extreme pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme pain in the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2AO) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (extreme pain in the injection site). At the time of the report, VACCINATION SITE PAIN (extreme pain in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol every time the pain appears.   Reporter did not allow further contact
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Pyrexia
Clinical narrative: High fever; Strong headache; Pain in the injection site; pain in the joints of his whole body; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the injection site), ARTHRALGIA (pain in the joints of his whole body), HEADACHE (Strong headache) and PYREXIA (High fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No medical history was provided by the reporter.   On 19-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site), ARTHRALGIA (pain in the joints of his whole body), HEADACHE (Strong headache) and PYREXIA (High fever). At the time of the report, INJECTION SITE PAIN (Pain in the injection site), ARTHRALGIA (pain in the joints of his whole body), HEADACHE (Strong headache) and PYREXIA (High fever) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment for the event included Advil.  Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Had periods of diarrhea like 2 or 3 times a day/Had diarrhea three times a day for 4 days; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Had periods of diarrhea like 2 or 3 times a day/Had diarrhea three times a day for 4 days) 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 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (Had periods of diarrhea like 2 or 3 times a day/Had diarrhea three times a day for 4 days). At the time of the report, DIARRHOEA (Had periods of diarrhea like 2 or 3 times a day/Had diarrhea three times a day for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  Reportedly, the patient had no temperature, and the only symptoms she had was diarrhea. The patient did not go to doctor. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Additional information received included outcome of the event. On 19-Apr-2021: Additional information received included no new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site bruising, Injection site erythema, Limb discomfort, Lymphadenopathy
Clinical narrative: Itchy; Sore like it burns; Raised (bumped); Red; Ache; Swelled lymph node in the armpit; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm was hurting), PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)) and INJECTION SITE ERYTHEMA (Red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm was hurting). On 15-Jan-2021, the patient experienced PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)), INJECTION SITE ERYTHEMA (Red), PAIN (Ache) and LYMPHADENOPATHY (Swelled lymph node in the armpit). On 08-Jan-2021, LIMB DISCOMFORT (Arm was hurting) outcome was unknown. At the time of the report, PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)), INJECTION SITE ERYTHEMA (Red), PAIN (Ache) and LYMPHADENOPATHY (Swelled lymph node in the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant product details was not provided by the reporter Treatment Benadryl and "Sertac"   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Email address updated
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Itchy; Sore like it burns; Raised (bumped); Red; Ache; Swelled lymph node in the armpit; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm was hurting), PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)) and INJECTION SITE ERYTHEMA (Red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm was hurting). On 15-Jan-2021, the patient experienced PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)), INJECTION SITE ERYTHEMA (Red), PAIN (Ache) and LYMPHADENOPATHY (Swelled lymph node in the armpit). On 08-Jan-2021, LIMB DISCOMFORT (Arm was hurting) outcome was unknown. At the time of the report, PRURITUS (Itchy), BURNING SENSATION (Sore like it burns), INJECTION SITE BRUISING (Raised (bumped)), INJECTION SITE ERYTHEMA (Red), PAIN (Ache) and LYMPHADENOPATHY (Swelled lymph node in the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant product details was not provided by the reporter Treatment Benadryl and "Sertac"   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Email address updated
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: dizzy spell; fever; chills; froggy and weak; soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 21-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), DIZZINESS (dizzy spell), ASTHENIA (froggy and weak), PYREXIA (fever) and CHILLS (chills) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (soreness) and ASTHENIA (froggy and weak). On 20-Jan-2021, the patient experienced DIZZINESS (dizzy spell), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (soreness), DIZZINESS (dizzy spell), ASTHENIA (froggy and weak), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-Jun-2021 has updated AE outcomes. AE outcome updated
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experiencing a reaction, a week after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing a reaction, a week after the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history 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 VACCINATION COMPLICATION (Experiencing a reaction, a week after the shot). At the time of the report, VACCINATION COMPLICATION (Experiencing a reaction, a week after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site rash
Clinical narrative: Delayed reaction with rashes on my injected arm; Stabbing pain injected arm; noticed small red dots initially; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (noticed small red dots initially), INJECTION SITE RASH (Delayed reaction with rashes on my injected arm) and INJECTION SITE PAIN (Stabbing pain injected arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A? or D39K20A) for COVID-19 vaccination.     The patient's past medical history included T-cell lymphoma (cutaneous T cell lymphoma).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Jan-2021, the patient experienced ERYTHEMA (noticed small red dots initially) and INJECTION SITE PAIN (Stabbing pain injected arm). On 21-Jan-2021, the patient experienced INJECTION SITE RASH (Delayed reaction with rashes on my injected arm). At the time of the report, ERYTHEMA (noticed small red dots initially), INJECTION SITE RASH (Delayed reaction with rashes on my injected arm) and INJECTION SITE PAIN (Stabbing pain injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Treatment medication include Triamcinolone 0.025% cream   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Malaise, Pain, Vaccination site erythema
Clinical narrative: feeling generally unwell; fatigue; arm redness; Lymph nodes in the arm swell up; soreness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling generally unwell), PAIN (soreness), LYMPHADENOPATHY (Lymph nodes in the arm swell up), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (arm redness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Cholelithiasis (Gall stone dissolution drugs taken). Concurrent medical conditions included Anxiety (antidepressants were taken) since 2003, Psoriasis since 2004, Irritable bowel syndrome (Gastroparesis) since 2006 and Lactose intolerance. Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Anxiety, COLESEVELAM HYDROCHLORIDE (WELCHOL) for Gastrointestinal disorder therapy.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced PAIN (soreness). On 05-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in the arm swell up). On an unknown date, the patient experienced MALAISE (feeling generally unwell), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (arm redness). At the time of the report, MALAISE (feeling generally unwell), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (arm redness) had resolved, PAIN (soreness) was resolving and LYMPHADENOPATHY (Lymph nodes in the arm swell up) had not resolved.            The patient reported treatment of events with acetaminophen (Tylenol).  Patient under went mammogram  and ultrasound but results were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: follow-up received addition of current condition ,concomitant medication ,allergy to lactose,addition of three new event fatigue, malaise, vaccination site erythema
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound abdomen, Vaccination site pain
Clinical narrative: Pregnancy; Pain at the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Pain at the injection site) in a 28-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney stone on 01-Jan-1997. Concomitant products included FISH OIL from 20-Jan-2021 to an unknown date and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 20-Jan-2021 to an unknown date for Pregnancy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 12-Dec-2020 and the estimated date of delivery was 18-Oct-2021. On 11-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Pain at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound abdomen: Baby healthy.         No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: couldn't swallow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHAGIA (couldn't swallow) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DYSPHAGIA (couldn't swallow). At the time of the report, DYSPHAGIA (couldn't swallow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: joint pain in my shoulders, hands, and wrist/Joint Pain From Shoulder to Hands on Both Arms (After the First Vaccine); The joints all have severe swelling; Both Hands swelled up/hands still swell up like grapefruits; Hands tingle under fingernails like its falling asleep; Not Able to Use Hands (After the First Vaccine); Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Hypertension. Concomitant products included ALFUZOSIN for Benign prostatic hypertrophy, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)). The patient was treated with MELOXICAM at a dose of unknown; PREDNISONE at a dose of unknown and PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Significant follow up-New events are added On 01-Jun-2021: Non-Significant F/U Case On 23-Jul-2021: Significant Follow-up received-Events and outcome of the events updated.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: joint pain in my shoulders, hands, and wrist/Joint Pain From Shoulder to Hands on Both Arms (After the First Vaccine); The joints all have severe swelling; Both Hands swelled up/hands still swell up like grapefruits; Hands tingle under fingernails like its falling asleep; Not Able to Use Hands (After the First Vaccine); Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Hypertension. Concomitant products included ALFUZOSIN for Benign prostatic hypertrophy, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)). The patient was treated with MELOXICAM at a dose of unknown; PREDNISONE at a dose of unknown and PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, JOINT SWELLING (The joints all have severe swelling), PERIPHERAL SWELLING (Both Hands swelled up/hands still swell up like grapefruits), PARAESTHESIA (Hands tingle under fingernails like its falling asleep), MOBILITY DECREASED (Not Able to Use Hands (After the First Vaccine)) and MYALGIA (Muscle Pain From Shoulder to Hands on Both Arms (After the First Vaccine)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Significant follow up-New events are added On 01-Jun-2021: Non-Significant F/U Case On 23-Jul-2021: Significant Follow-up received-Events and outcome of the events updated.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: muscles are hurting; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued). At the time of the report, MYALGIA (muscles are hurting) and FATIGUE (extremely fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Some soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Some soreness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Some soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Some soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received the vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication, THYROID (ARMOUR THYROID).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Oct-2021. On 08-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (received the vaccine while pregnant). On 08-Feb-2021, EXPOSURE DURING PREGNANCY (received the vaccine while pregnant) had 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 treatment information provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration
Clinical narrative: Red knot at the injection site; red at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 21-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site). On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE INDURATION (Red knot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email added
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: experiencing an adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (experiencing an adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ADVERSE EVENT (experiencing an adverse event). At the time of the report, ADVERSE EVENT (experiencing an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Mechanical ventilation
Clinical narrative: Had a terrible time breathing; Had to use her oxygen more often; A spontaneous report was received from a consumer, concerning herself, a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a terrible time breathing and had to use her oxygen more often.  The patient's medical history reported included chronic obstructive pulmonary disease (COPD).  Concomitant product use was not provided by the reporter.  On 02 FEB 2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.  On 02 FEB 2021, since patient took vaccine, she had started to have a terrible time in breathing and has had to use her oxygen more often.  Treatments of these events included oxygen.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events had a terrible time breathing and had to use her oxygen more often were considered unknown at the time of this report.; Reporter's Comments: This report concerns a 72-year old female patient with medical history COPD who experienced non-serious events of dyspnea and increased use of oxygen within 2 days of his receiving the  mRNA-1273 (Lot # 039K20-2A). Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidity
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Joint swelling, Myalgia
Clinical narrative: back pain; knee swollen; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache). At the time of the report, BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: adverse events obtained via follow-up call
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: upper part of her arm started getting itchy; upper part of her arm started getting red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Bee sting hypersensitivity.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red). At the time of the report, VACCINATION SITE PRURITUS (upper part of her arm started getting itchy) and VACCINATION SITE ERYTHEMA (upper part of her arm started getting red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A and 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Factor V Leiden carrier since 2012. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ACETYLSALICYLIC ACID (BABY ASPIRIN), DOXYLAMINE and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-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 12-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine 29Dec2020 and the 2nd vaccine on 27Jan2021 and is Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2020, Pregnancy test: positive (Positive) Positive.         The date of positive pregnancy test was 08-Dec-2020.  The patient has an established prenatal care.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness Beneath the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness Beneath the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness Beneath the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness Beneath the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, SARS-CoV-2 test positive, Vomiting
Clinical narrative: chills; fever; nausea; throwing up vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (throwing up vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (throwing up vomiting). On 20-Jan-2021, CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and VOMITING (throwing up vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test positive: positive Tested positive for COVID 19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue
Clinical narrative: arthritis flare up; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis flare up) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    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 ARTHRITIS (arthritis flare up) and FATIGUE (tiredness). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, ARTHRITIS (arthritis flare up) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include on 8-Feb-2021; Sender'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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound foetal
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 7, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1ZM20A) for COVID-19 vaccination.  The patient's past medical history included Spontaneous abortion (x5) and Pregnancy (live-full term birth). Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Allergy (Allergy to bees) and Illness (Not feeling well due to pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, PROGESTERONE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Nov-2020 and the estimated date of delivery was 12-Sep-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixth week of the pregnancy. On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound foetal: normal (normal) normal.   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 information was provided.  07-Jan-2021: pregnancy test results positive  She had to do IVS and had 5 miscarriages, unexplained where it was natural.  Company Comment : This case involves a 34 year old pregnant female with LMP of 19 Nov 2021 and EDC of 13 Sep 2021 who received the mRNA-1273 on 13 Jan 2021. The causality for the event Maternal exposure during pregnancy is Not applicable.  Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Internal review on 29-Jul-2021 resulted to updated number of pregnancy, medical history, birth type and fetal outcome, event dates and outcome, new event and narrative.  Sender's Comments: This case involves a 34 year old pregnant female with LMP of 19 Nov 2021 and EDC of 13 Sep 2021 who received the mRNA-1273 on 13 Jan 2021. The causality for the event Maternal exposure during pregnancy is Not applicable.