chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness, Swelling
Clinical narrative: FEVERISH INJECTION SITE; INJECTION SITE REALLY IRRITATED; ARMPIT SWELLING (CAN'T PUT RIGHT ARM DOWN DUE TO A HUMP IN THE ARMPIT THAT STICKS OUT WHEN ARM LIFTED UP); CONSTANT LEFT HIP PAIN/SHOOTING PAIN IN THE JOINTS; FEVERISH INSIDE; INJECTION SITE SWELLING; INJECTION SITE REDNESS (RED CIRCLE AROUND THE INJECTION SITE, THE SIZE OF A TANGERINE); ARM/HAND SHOOTING PAIN AND CONSTANT BIKINI LINE PAIN; ARMPIT MUSCLE TIGHTENED; UNABLE TO WALK; ITCHY INJECTION SITE; SLUGGISH; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seafood allergy, and other pre-existing medical conditions included: The patient had no medical history. The patient was allergic to unspecified antibiotic. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced itchy injection site. On SEP-2021, the patient experienced sluggish. On SEP-2021, the patient experienced armpit muscle tightened. On SEP-2021, the patient experienced unable to walk. Laboratory data included: Pain scale (NR: not provided) 10/10 (units unspecified). Treatment medications included: paracetamol. On 18-SEP-2021, the patient experienced injection site really irritated. On 18-SEP-2021, the patient experienced armpit swelling (can't put right arm down due to a hump in the armpit that sticks out when arm lifted up). On 18-SEP-2021, the patient experienced arm/hand shooting pain and constant bikini line pain. On 18-SEP-2021, the patient experienced constant left hip pain/shooting pain in the joints. On 18-SEP-2021, the patient experienced feverish inside. On 18-SEP-2021, the patient experienced injection site swelling. On 18-SEP-2021, the patient experienced injection site redness (red circle around the injection site, the size of a tangerine). On 20-SEP-2021, the patient experienced feverish injection site. The action taken with covid-19 vaccine was not applicable. The patient recovered from feverish inside on 20-SEP-2021, had not recovered from injection site swelling, injection site redness (red circle around the injection site, the size of a tangerine), injection site really irritated, armpit swelling (can't put right arm down due to a hump in the armpit that sticks out when arm lifted up), constant left hip pain/shooting pain in the joints, feverish injection site, itchy injection site, and arm/hand shooting pain and constant bikini line pain, and the outcome of sluggish, armpit muscle tightened and unable to walk was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Tinnitus
Clinical narrative: DIZZINESS; RINGING IN EARS; TIREDNESS; This spontaneous report received from a patient concerned a 60 year old female. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 21-OCT-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced dizziness. On 15-SEP-2021, the patient experienced ringing in ears. On 15-SEP-2021, the patient experienced tiredness. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness, tiredness, and ringing in ears. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINISTERED AFTER IT EXPIRED; This spontaneous report received from a health care professional concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient had no current medication usage, had no known medical conditions and did not mention any adverse effects. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 07:00 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced vaccine administered after it expired. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine administered after it expired was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 08:30 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced administration of expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: INJECTION SITE PAIN - DELTOID (UNKNOWN IF IT WAS RIGHT OR LEFT SIDE); MILD FEVER; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the patient experienced injection site pain - deltoid (unknown if it was right or left side). On MAR-2021, the patient experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain - deltoid (unknown if it was right or left side), and mild fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED BEYOND THE RECOMMENDED HOLD TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced incorrect product storage. On 20-SEP-2021, the patient experienced vaccine administered beyond the recommended hold time. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine administered beyond the recommended hold time and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: SHARP ABDOMINAL PAINS; NAUSEA; THREW UP; SORE ARM; FEVERISH; HEADACHE; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had takes a combination birth control pill. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808880, and expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced sore arm. On 15-SEP-2021, the patient experienced feverish. On 15-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced tired/fatigue. On 20-SEP-2021, the patient experienced sharp abdominal pains. On 20-SEP-2021, the patient experienced nausea. On 20-SEP-2021, the patient experienced threw up. Laboratory data (dates unspecified) included: Pregnancy test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm, feverish, headache, and tired/fatigue on 17-SEP-2021, and had not recovered from nausea, threw up, and sharp abdominal pains. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test, Pyrexia, Vomiting
Clinical narrative: SHARP ABDOMINAL PAINS; NAUSEA; THREW UP; SORE ARM; FEVERISH; HEADACHE; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had takes a combination birth control pill. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808880, and expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced sore arm. On 15-SEP-2021, the patient experienced feverish. On 15-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced tired/fatigue. On 20-SEP-2021, the patient experienced sharp abdominal pains. On 20-SEP-2021, the patient experienced nausea. On 20-SEP-2021, the patient experienced threw up. Laboratory data (dates unspecified) included: Pregnancy test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm, feverish, headache, and tired/fatigue on 17-SEP-2021, and had not recovered from nausea, threw up, and sharp abdominal pains. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 22 year old male. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Defaecation urgency, Erythema, Impaired driving ability, Malaise, Nausea
Clinical narrative: COULDN'T DRIVE; FELT LIKE HAD TO GO TO BATHROOM; FELT SICK; FELT LIKE THROW UP/NAUSEOUS; RED ARM; SWOLLEN ARM; PAIN; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 180 pounds, and height was 68 inches. The patient's concurrent conditions included: seasonal allergies, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21/SEP/2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced pain. On 16-SEP-2021, the patient experienced red arm. On 16-SEP-2021, the patient experienced swollen arm. On 19-SEP-2021, the patient experienced couldn't drive. On 19-SEP-2021, the patient experienced felt like had to go to bathroom. On 19-SEP-2021, the patient experienced felt sick. On 19-SEP-2021, the patient experienced felt like throw up/nauseous. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red arm, and swollen arm on 19-SEP-2021, was recovering from felt like throw up/nauseous, and the outcome of felt sick, felt like had to go to bathroom, pain and couldn't drive was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: COULDN'T DRIVE; FELT LIKE HAD TO GO TO BATHROOM; FELT SICK; FELT LIKE THROW UP/NAUSEOUS; RED ARM; SWOLLEN ARM; PAIN; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 180 pounds, and height was 68 inches. The patient's concurrent conditions included: seasonal allergies, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21/SEP/2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced pain. On 16-SEP-2021, the patient experienced red arm. On 16-SEP-2021, the patient experienced swollen arm. On 19-SEP-2021, the patient experienced couldn't drive. On 19-SEP-2021, the patient experienced felt like had to go to bathroom. On 19-SEP-2021, the patient experienced felt sick. On 19-SEP-2021, the patient experienced felt like throw up/nauseous. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red arm, and swollen arm on 19-SEP-2021, was recovering from felt like throw up/nauseous, and the outcome of felt sick, felt like had to go to bathroom, pain and couldn't drive was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned (4) multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patients experienced administration of expired vaccine. On 20-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of expired vaccine and off label use was not reported. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Insomnia, Pruritus, Rash erythematous
Clinical narrative: STOMACH ISSUES (ACID REFLUX); DIFFICULTY SLEEPING FROM THE ITCHINESS; LITTLE RED SPOTS ON HER LOWER LEGS, WHICH HAVE NOW TURNED BROWN (IT WORSE ON HER RIGHT LEG); ITCHY SKIN ALL OVER THE BODY THAT AFFECTS DIFFERENT PARTS AT DIFFERENT TIMES; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 132 pounds, and height was 63 inches. The patient's concurrent conditions included: acid reflux, non smoker, and drinks alcohol, and other pre-existing medical conditions included: The patient had no known allergies and did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included hydroxyzine for acid reflux, and omeprazole for acid reflux. On 05-AUG-2021, the patient experienced itchy skin all over the body that affects different parts at different times. On an unspecified date, the patient experienced stomach issues (acid reflux), difficulty sleeping from the itchiness, and little red spots on her lower legs, which have now turned brown (it worse on her right leg). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy skin all over the body that affects different parts at different times, and difficulty sleeping from the itchiness, and the outcome of stomach issues (acid reflux) and little red spots on her lower legs, which have now turned brown (it worse on her right leg) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: CHILLS FOR LIKE 12 HOURS; SORE ARM FOR ABOUT A WEEK; FEVER FOR LIKE 12 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills for like 12 hours, sore arm for about a week, and fever for like 12 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills for like 12 hours, sore arm for about a week, and fever for like 12 hours. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Dyspnoea, Insomnia, Muscle twitching
Clinical narrative: TWITCHING; LITTLE BIT SHORTNESS OF BREATH; COULD NOT SLEEP AS IF HAD NERVOUS CONDITION; RIGHT LEG KICKING OUT; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and concurrent conditions included: disabled, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and was receiving lot of medications including blood thinners. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-SEP-2021, the patient experienced twitching. On 19-SEP-2021, the patient experienced little bit shortness of breath. On 19-SEP-2021, the patient experienced could not sleep as if had nervous condition. On 19-SEP-2021, the patient experienced right leg kicking out. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from twitching, little bit shortness of breath, could not sleep as if had nervous condition, and right leg kicking out. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: POTENTIAL ADMINISTRATION ERROR USE OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a physician concerned a 71 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced potential administration error use of expired vaccine. On 20-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the potential administration error use of expired vaccine and off label use was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20210807937.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypokinesia, Pain, Pyrexia
Clinical narrative: COULD NOT GET UP FROM BED; BODY ACHING VERY BADLY; RUNNING A FEVER; HUGE HEADACHE; This spontaneous report received from a patient via a company representative concerned an 18 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUN-2021, the patient experienced could not get up from bed. On JUN-2021, the patient experienced body aching very badly. On JUN-2021, the patient experienced running a fever. On JUN-2021, the patient experienced huge headache. On JUN-2021, Laboratory data included: Body temperature (NR: not provided) 38.5 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not get up from bed, running a fever, body aching very badly and huge headache was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Fatigue, Headache, Myalgia, Odynophagia
Clinical narrative: WHEN SLEPT ON RIGHT HAND FELT EXTREMELY COLD (FREEZING COLD) FROM FINGER TIPS TO THE MIDDLE OF THE ARM; THROAT MUSCLE PAIN (AROUND THROAT MUSCLES) / THROAT GOT SORE (CONTINUED TO GET SORE); WHEN SWALLOWS THROAT AND HEADACHE PAIN INCREASES FROM THE LOWER EAR TO THE SHOULDERS AND UP TO THE CRANIUM / WHEN SWALLOWS FEELS LIKE PULLED MUSCLE; MUSCLE ACHE THAT STRETCHED FROM SHOULDER TO HIS NECK; HEADACHE; EXTREME FATIGUE; NO NORMAL BOWEL MOVEMENT SINCE VACCINATION; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included: contracted covid-19 (experienced headache, nausea, fatigue which lasted off and on), and concurrent conditions included: high blood pressure, sometimes smokes marijuana, alcoholic, and smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-SEP-2021 for prophylactic vaccination. Concomitant medications included metoprolol for high blood pressure, and nicotine for smoker. On SEP-2021, treatment medications included: paracetamol. On 12-SEP-2021, the patient experienced no normal bowel movement since vaccination. On 15-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced extreme fatigue. On 16-SEP-2021, the patient experienced throat muscle pain (around throat muscles) / throat got sore (continued to get sore). On 16-SEP-2021, the patient experienced when swallows throat and headache pain increases from the lower ear to the shoulders and up to the cranium / when swallows feels like pulled muscle. On 16-SEP-2021, the patient experienced muscle ache that stretched from shoulder to his neck. On 17-SEP-2021, the patient experienced when slept on right hand felt extremely cold (freezing cold) from finger tips to the middle of the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and the outcome of extreme fatigue, throat muscle pain (around throat muscles) / throat got sore (continued to get sore), when swallows throat and headache pain increases from the lower ear to the shoulders and up to the cranium / when swallows feels like pulled muscle, when slept on right hand felt extremely cold (freezing cold) from finger tips to the middle of the arm, muscle ache that stretched from shoulder to his neck and no normal bowel movement since vaccination was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral coldness
Clinical narrative: WHEN SLEPT ON RIGHT HAND FELT EXTREMELY COLD (FREEZING COLD) FROM FINGER TIPS TO THE MIDDLE OF THE ARM; THROAT MUSCLE PAIN (AROUND THROAT MUSCLES) / THROAT GOT SORE (CONTINUED TO GET SORE); WHEN SWALLOWS THROAT AND HEADACHE PAIN INCREASES FROM THE LOWER EAR TO THE SHOULDERS AND UP TO THE CRANIUM / WHEN SWALLOWS FEELS LIKE PULLED MUSCLE; MUSCLE ACHE THAT STRETCHED FROM SHOULDER TO HIS NECK; HEADACHE; EXTREME FATIGUE; NO NORMAL BOWEL MOVEMENT SINCE VACCINATION; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included: contracted covid-19 (experienced headache, nausea, fatigue which lasted off and on), and concurrent conditions included: high blood pressure, sometimes smokes marijuana, alcoholic, and smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-SEP-2021 for prophylactic vaccination. Concomitant medications included metoprolol for high blood pressure, and nicotine for smoker. On SEP-2021, treatment medications included: paracetamol. On 12-SEP-2021, the patient experienced no normal bowel movement since vaccination. On 15-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced extreme fatigue. On 16-SEP-2021, the patient experienced throat muscle pain (around throat muscles) / throat got sore (continued to get sore). On 16-SEP-2021, the patient experienced when swallows throat and headache pain increases from the lower ear to the shoulders and up to the cranium / when swallows feels like pulled muscle. On 16-SEP-2021, the patient experienced muscle ache that stretched from shoulder to his neck. On 17-SEP-2021, the patient experienced when slept on right hand felt extremely cold (freezing cold) from finger tips to the middle of the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and the outcome of extreme fatigue, throat muscle pain (around throat muscles) / throat got sore (continued to get sore), when swallows throat and headache pain increases from the lower ear to the shoulders and up to the cranium / when swallows feels like pulled muscle, when slept on right hand felt extremely cold (freezing cold) from finger tips to the middle of the arm, muscle ache that stretched from shoulder to his neck and no normal bowel movement since vaccination was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction after recieving Moderna Covid-19 vaccine; A spontaneous report  was received from a consumer concerning a 28-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an adverse reaction.  The patient's medical history was not provided. Relevant concomitant medication was not reported.  On 23 Dec 2020, prior to the onset of event, the patient received their planned dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced an adverse reaction.   No laboratory details was provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, adverse reaction after receiving Moderna COVID-19 vaccine was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Computerised tomogram, Dysarthria
Clinical narrative: Slurred speech; His lips were cracked; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Slurred speech) and CHAPPED LIPS (His lips were cracked) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSARTHRIA (Slurred speech) and CHAPPED LIPS (His lips were cracked). At the time of the report, DYSARTHRIA (Slurred speech) had not resolved and CHAPPED LIPS (His lips were cracked) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) CAT scan was clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Two days after the 1st dose, he started having slurred speech. Initially they thought his lips were cracked due to the professional mask he wears at work but as time went on, it became noticeable.  Lab data -  The patient had 62 tests  and all came back normal  and  scheduled for a MRI.  No Concomitant were provided. No treatment Medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Updated lab data. On 10-Sep-2021: Follow up received on 13Sep2021 includes no new information On 10-Sep-2021: Follow up received on 13Sep2021 includes no new information. On 11-Sep-2021: Follow up information was received include no new information. On 16-Sep-2021: Includes no new information.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Muscular weakness, Pain
Clinical narrative: Severe diarrhea; Both legs were weak that he find it hard to urinate standing; Pain in the entire body; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), MUSCULAR WEAKNESS (Both legs were weak that he find it hard to urinate standing), PAIN (Pain in the entire body) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Aloe vera rash).   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced DIARRHOEA (Severe diarrhea), MUSCULAR WEAKNESS (Both legs were weak that he find it hard to urinate standing), PAIN (Pain in the entire body) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Severe diarrhea), MUSCULAR WEAKNESS (Both legs were weak that he find it hard to urinate standing), PAIN (Pain in the entire body) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Followup information received include second dose information added.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Heart rate
Clinical narrative: a bit of dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a bit of dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (a bit of dizziness). At the time of the report, DIZZINESS (a bit of dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Fast pulse rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medications were not given.  The patient was easy and taking it all fine and had currently no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Significant follow up appended : updated reporter email and contact number, updated event outcome, deletion of event and added lab data
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epigastric discomfort, Fatigue, Flushing, Influenza like illness
Clinical narrative: Mild flu like symptoms; Minor gastro symptoms; Flushing; Chills; Temperature of 99 degrees Fahrenheit; Tired; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu like symptoms), EPIGASTRIC DISCOMFORT (Minor gastro symptoms), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Temperature of 99 degrees Fahrenheit) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu like symptoms), EPIGASTRIC DISCOMFORT (Minor gastro symptoms), FLUSHING (Flushing), CHILLS (Chills), PYREXIA (Temperature of 99 degrees Fahrenheit) and FATIGUE (Tired). On 23-Feb-2021, INFLUENZA LIKE ILLNESS (Mild flu like symptoms), EPIGASTRIC DISCOMFORT (Minor gastro symptoms), FLUSHING (Flushing), CHILLS (Chills), PYREXIA (Temperature of 99 degrees Fahrenheit) and FATIGUE (Tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Acupuncture.   This case was linked to MOD-2021-272312 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild flu like symptoms; Minor gastro symptoms; Flushing; Chills; Temperature of 99 degrees Fahrenheit; Tired; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu like symptoms), EPIGASTRIC DISCOMFORT (Minor gastro symptoms), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Temperature of 99 degrees Fahrenheit) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu like symptoms), EPIGASTRIC DISCOMFORT (Minor gastro symptoms), FLUSHING (Flushing), CHILLS (Chills), PYREXIA (Temperature of 99 degrees Fahrenheit) and FATIGUE (Tired). On 23-Feb-2021, INFLUENZA LIKE ILLNESS (Mild flu like symptoms), EPIGASTRIC DISCOMFORT (Minor gastro symptoms), FLUSHING (Flushing), CHILLS (Chills), PYREXIA (Temperature of 99 degrees Fahrenheit) and FATIGUE (Tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Acupuncture.   This case was linked to MOD-2021-272312 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Pain assessment, Product dose omission issue, Trigeminal neuralgia
Clinical narrative: She was one week past the second dose due date; Electrical shocks on the right side of her face; Trigeminal neuralgia became bilateral; Trigeminal neuralgia flare up; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She was one week past the second dose due date), ELECTRIC SHOCK SENSATION (Electrical shocks on the right side of her face), TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia became bilateral) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The patient's past medical history included Lumbar strain, Neurostimulator implantation (For Lumbar issue) and Microvascular decompression (2 failed surgeries for Trigeminal neuralgia) from May 2019 to December 2020. Concurrent medical conditions included Trigeminal neuralgia (Left side) since 2019 and Chronic kidney disease (Stage 3b) since 2008. Concomitant products included CARBAMAZEPINE (TEGRETOL), TRAMADOL and CARBAMAZEPINE from 01-Sep-2019 to an unknown date for Trigeminal neuralgia.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up). On 19-Jul-2021, the patient experienced ELECTRIC SHOCK SENSATION (Electrical shocks on the right side of her face) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia became bilateral). On 05-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was one week past the second dose due date). On 08-Jul-2021, TRIGEMINAL NEURALGIA (Trigeminal neuralgia flare up) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She was one week past the second dose due date) had resolved, ELECTRIC SHOCK SENSATION (Electrical shocks on the right side of her face) outcome was unknown and TRIGEMINAL NEURALGIA (Trigeminal neuralgia became bilateral) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 10/10 (High) 10/10.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported also include cold medicine occasionally for the trigeminal neuralgia.  The patient consulted a new neurologist and was about to start new medications.   This case was linked to MOD-2021-319322 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Patient details, Medical history, Lab data, Concomitant medication and Event updated
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypotonia, Weight decreased
Clinical narrative: My husband got the vaccine and within 2 weeks he had lost 18 pounds, All of the weight was muscle and no fat.; His arms and legs lost almost all muscle tone; He was also completely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (My husband got the vaccine and within 2 weeks he had lost 18 pounds, All of the weight was muscle and no fat.), HYPOTONIA (His arms and legs lost almost all muscle tone) and FATIGUE (He was also completely exhausted) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (My husband got the vaccine and within 2 weeks he had lost 18 pounds, All of the weight was muscle and no fat.), HYPOTONIA (His arms and legs lost almost all muscle tone) and FATIGUE (He was also completely exhausted). At the time of the report, WEIGHT DECREASED (My husband got the vaccine and within 2 weeks he had lost 18 pounds, All of the weight was muscle and no fat.) and HYPOTONIA (His arms and legs lost almost all muscle tone) outcome was unknown and FATIGUE (He was also completely exhausted) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.  Reporter said that her husband lost 18 pounds within 2 weeks of getting the vaccine.  Reporter said that her husband was tested for every kind of cancer and disease and everything came back negative.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Non-Significant Follow-up On 14-Sep-2021: Follow-up received with NNI
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain.  Symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Company Comment: This is a literature report of myocarditis in an adult male.  Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-245527, MOD-2021-284014, MOD-2021-284015, MOD-2021-284013, MOD-2021-284013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for a regulatory authority so Incorrect E2B Company Number was removed. Hence new reports generated with correct E2B Number. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male.  Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.