chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Productive cough, Pyrexia, SARS-CoV-2 test, Sinus congestion
Clinical narrative: DRY COUGH; SNEEZING; FEELING REALLY CRUDDY; PAIN IN MY ARM; LOW GRADE FEVER; HEADACHE; CHILLS; CONGESTED; CLEAR MUCOUS; BODY ACHE; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 209 pounds, and height was 67 inches. The patient's past medical history included covid-19, got really sick, fever, body ache, dry cough, and mucus was really green, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 14-JUL-2021, the subject experienced body ache. On 14-JUL-2021, the subject experienced congested. On 14-JUL-2021, the subject experienced clear mucous. On 14-JUL-2021, the subject experienced chills. On 14-JUL-2021, the subject experienced pain in my arm. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. On 15-JUL-2021, the subject experienced dry cough. On 15-JUL-2021, the subject experienced sneezing. On 15-JUL-2021, the subject experienced feeling really cruddy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Not Provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, body ache, headache, dry cough, congested, clear mucous, chills, feeling really cruddy, pain in my arm, and sneezing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: DRY COUGH; SNEEZING; FEELING REALLY CRUDDY; PAIN IN MY ARM; LOW GRADE FEVER; HEADACHE; CHILLS; CONGESTED; CLEAR MUCOUS; BODY ACHE; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 209 pounds, and height was 67 inches. The patient's past medical history included covid-19, got really sick, fever, body ache, dry cough, and mucus was really green, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 14-JUL-2021, the subject experienced body ache. On 14-JUL-2021, the subject experienced congested. On 14-JUL-2021, the subject experienced clear mucous. On 14-JUL-2021, the subject experienced chills. On 14-JUL-2021, the subject experienced pain in my arm. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. On 15-JUL-2021, the subject experienced dry cough. On 15-JUL-2021, the subject experienced sneezing. On 15-JUL-2021, the subject experienced feeling really cruddy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Not Provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, body ache, headache, dry cough, congested, clear mucous, chills, feeling really cruddy, pain in my arm, and sneezing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE OUTSIDE OF PRODUCT LABELLING; USE OF VIAL WITH EXACT TIME FRAME UNSURE, AT LEAST 24 HOURS PUNCTURED IN REFRIGERATION; This spontaneous report received from a pharmacist 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: 043A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administration of vaccine outside of product labelling, and use of vial with exact time frame unsure, at least 24 hours punctured in refrigeration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine outside of product labelling and use of vial with exact time frame unsure, at least 24 hours punctured in refrigeration was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dysphagia, Epistaxis, Feeling hot
Clinical narrative: CONSTANT DRIP OF BLOOD DOWN THROAT; COUGHED UP BLOOD WITH SMALL BLOOD CLOTS PRESENT; BLOOD COME OUT OF LEFT NOSTRIL; FELT GUSH DOWN THROAT THAT FELT LIKE POST NASAL DRIP, POST NASAL DRIP SENSATION; TROUBLE SWALLOWING; REFLEX TO COUGH/COUGHING; SENSATION OF WARMTH AT THE BASE OF SKULL/NECK; FELT LIGHTHEADED; THROAT FEELING AS ITCHY; STRESS; This spontaneous report received from a patient concerned a 51 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's past medical history included ovarian cancer, and congestive heart failure (CHF), and concurrent conditions included primary biliary cirrhosis, thyroid issues, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AZ1A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 to left arm for prophylactic vaccination. Concomitant medications included ursodeoxycholic acid for primary biliary cholangitis, and levothyroxine for thyroid disorder.  On 19-JUL-2021, the patient felt gush down throat that felt like post nasal drip and patient went back to work computer right after post nasal drip sensation and began coughing and coughed up blood with small blood clots present and had blood come out of left nostril. The patient had trouble swallowing and a reflex to cough and also had a sensation of warmth at the base of skull or neck that could have been related to stress and patient felt lightheaded and this symptom occurred around 15:30 and lasted for 20 to 30 minutes, but patient started to feel sensation again and coughed actively and coughed up a small blood clot. The patient was stated that they saved tissues with blood on them to show HCP and were tasting blood and continued to cough and patient's throat was bothersome and throat feeling as itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of warmth at the base of skull, neck on 19-JUL-2021, had not recovered from coughed up blood with small blood clots present, blood come out of left nostril, constant drip of blood down throat, trouble swallowing, felt lightheaded, and throat feeling as itchy, and the outcome of felt gush down throat that felt like post nasal drip, post nasal drip sensation, stress and reflex to cough, coughing was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210741246- covid-19 vaccine ad26.cov2.s-CONSTANT DRIP OF BLOOD DOWN THROAT, COUGHED UP BLOOD WITH SMALL BLOOD CLOTS PRESENT .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Haemoptysis, Pharyngeal haemorrhage, Stress, Throat irritation, Upper-airway cough syndrome
Clinical narrative: CONSTANT DRIP OF BLOOD DOWN THROAT; COUGHED UP BLOOD WITH SMALL BLOOD CLOTS PRESENT; BLOOD COME OUT OF LEFT NOSTRIL; FELT GUSH DOWN THROAT THAT FELT LIKE POST NASAL DRIP, POST NASAL DRIP SENSATION; TROUBLE SWALLOWING; REFLEX TO COUGH/COUGHING; SENSATION OF WARMTH AT THE BASE OF SKULL/NECK; FELT LIGHTHEADED; THROAT FEELING AS ITCHY; STRESS; This spontaneous report received from a patient concerned a 51 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's past medical history included ovarian cancer, and congestive heart failure (CHF), and concurrent conditions included primary biliary cirrhosis, thyroid issues, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AZ1A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 to left arm for prophylactic vaccination. Concomitant medications included ursodeoxycholic acid for primary biliary cholangitis, and levothyroxine for thyroid disorder.  On 19-JUL-2021, the patient felt gush down throat that felt like post nasal drip and patient went back to work computer right after post nasal drip sensation and began coughing and coughed up blood with small blood clots present and had blood come out of left nostril. The patient had trouble swallowing and a reflex to cough and also had a sensation of warmth at the base of skull or neck that could have been related to stress and patient felt lightheaded and this symptom occurred around 15:30 and lasted for 20 to 30 minutes, but patient started to feel sensation again and coughed actively and coughed up a small blood clot. The patient was stated that they saved tissues with blood on them to show HCP and were tasting blood and continued to cough and patient's throat was bothersome and throat feeling as itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of warmth at the base of skull, neck on 19-JUL-2021, had not recovered from coughed up blood with small blood clots present, blood come out of left nostril, constant drip of blood down throat, trouble swallowing, felt lightheaded, and throat feeling as itchy, and the outcome of felt gush down throat that felt like post nasal drip, post nasal drip sensation, stress and reflex to cough, coughing was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210741246- covid-19 vaccine ad26.cov2.s-CONSTANT DRIP OF BLOOD DOWN THROAT, COUGHED UP BLOOD WITH SMALL BLOOD CLOTS PRESENT .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a parent via a company representative concerned a 22 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, 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 subject experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test positive (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.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as  non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia, Thrombosis
Clinical narrative: THROMBOSIS; THROMBOCYTOPENIA; This spontaneous multiple patient report was received from two physicians via a company representative and concerned 2 female patients in their 50s of unspecified race and ethnicity.  Initial information was processed with additional information received on 21-JUL-2021. The patients' weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, vaccination site, start therapy date were not reported for prophylactic vaccination. Batch numbers were not reported and will be requested. No concomitant medications were reported.  On unspecified dates, the patients experienced thrombosis with thrombocytopenia; no further details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombosis with thrombocytopenia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous multiple patient report was received from two physicians via a company representative and concerned 2 female patients in their 50s of unspecified race and ethnicity who experienced thrombosis and thrombocytopenia. No past medical history, concomitant medications, clinical details, event latency, diagnostics, treatment, or outcomes were reported. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the relationship of the events to vaccination is considered unclassifiable due to insufficient information. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Muscle spasms, Muscle twitching, Paraesthesia
Clinical narrative: NUMBING AND TINGLING SENSATION IN ARMS, HANDS AND FEET; MUSCLE SPASMS IN ARMS AND LEGS; TWITCHES; CHEST DISCOMFORT WHICH COMES AND GOES WITH HER CYCLE; ANXIETY WHICH INCREASES WITH HER CYCLE AND IS RELIEVED AFTER HER CYCLE; INCREASED PMS SYMPTOMS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline hypertensive, and pms symptoms, and other pre-existing medical conditions included patient had no known drug allergies. patient was not taking any current medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced numbing and tingling sensation in arms, hands and feet, muscle spasms in arms and legs, twitches, chest discomfort which comes and goes with her cycle, anxiety which increases with her cycle and is relieved after her cycle, and increased pms symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest discomfort which comes and goes with her cycle on 08-JUL-2021, and the outcome of numbing and tingling sensation in arms, hands and feet, muscle spasms in arms and legs, twitches, anxiety which increases with her cycle and is relieved after her cycle and increased pms symptoms was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Premenstrual syndrome
Clinical narrative: NUMBING AND TINGLING SENSATION IN ARMS, HANDS AND FEET; MUSCLE SPASMS IN ARMS AND LEGS; TWITCHES; CHEST DISCOMFORT WHICH COMES AND GOES WITH HER CYCLE; ANXIETY WHICH INCREASES WITH HER CYCLE AND IS RELIEVED AFTER HER CYCLE; INCREASED PMS SYMPTOMS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline hypertensive, and pms symptoms, and other pre-existing medical conditions included patient had no known drug allergies. patient was not taking any current medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced numbing and tingling sensation in arms, hands and feet, muscle spasms in arms and legs, twitches, chest discomfort which comes and goes with her cycle, anxiety which increases with her cycle and is relieved after her cycle, and increased pms symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest discomfort which comes and goes with her cycle on 08-JUL-2021, and the outcome of numbing and tingling sensation in arms, hands and feet, muscle spasms in arms and legs, twitches, anxiety which increases with her cycle and is relieved after her cycle and increased pms symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Discomfort, Headache, Nausea
Clinical narrative: ABDOMINAL PAIN FOR 8 DAYS; SKIN FELT COLD TO TOUCH; BODY FELT LIKE LEAD; LEG PAIN AT BACK OF LEG; FEVER OF 100.7 F; HEADACHE FOR 5 DAYS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. 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 JUL-2021 for prophylactic vaccination. . The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced abdominal pain for 8 days. On JUL-2021, the subject experienced skin felt cold to touch. On JUL-2021, the subject experienced body felt like lead. On JUL-2021, the subject experienced leg pain at back of leg. On JUL-2021, the subject experienced fever of 100.7 f. On JUL-2021, the subject experienced headache for 5 days. On JUL-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache for 5 days on JUL-2021, had not recovered from leg pain at back of leg, and the outcome of abdominal pain for 8 days, nausea, fever of 100.7 f, body felt like lead and skin felt cold to touch was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: ABDOMINAL PAIN FOR 8 DAYS; SKIN FELT COLD TO TOUCH; BODY FELT LIKE LEAD; LEG PAIN AT BACK OF LEG; FEVER OF 100.7 F; HEADACHE FOR 5 DAYS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. 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 JUL-2021 for prophylactic vaccination. . The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced abdominal pain for 8 days. On JUL-2021, the subject experienced skin felt cold to touch. On JUL-2021, the subject experienced body felt like lead. On JUL-2021, the subject experienced leg pain at back of leg. On JUL-2021, the subject experienced fever of 100.7 f. On JUL-2021, the subject experienced headache for 5 days. On JUL-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache for 5 days on JUL-2021, had not recovered from leg pain at back of leg, and the outcome of abdominal pain for 8 days, nausea, fever of 100.7 f, body felt like lead and skin felt cold to touch was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema of eyelid, Eye inflammation, Eye irritation, Eye pruritus
Clinical narrative: RED WATERY EYES; A LITTLE ITCHY EYES; IRRITATED EYES; REDNESS TO BOTTOM OF EYE LIDS; INFLAMMATION TO EYE; FEVER; This spontaneous report received from a patient concerned a 51 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, and batch number: 201A21A) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced red watery eyes. On 09-APR-2021, the subject experienced a little itchy eyes. On 09-APR-2021, the subject experienced irritated eyes. On 09-APR-2021, the subject experienced redness to bottom of eye lids. On 09-APR-2021, the subject experienced inflammation to eye. Laboratory data (09-APR-2021) included: Body temperature (NR: not provided) 100.3. Treatment medications (dates unspecified) included: naproxen sodium, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, red watery eyes, a little itchy eyes, irritated eyes, redness to bottom of eye lids, and inflammation to eye on 09-APR-2021. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pyrexia
Clinical narrative: RED WATERY EYES; A LITTLE ITCHY EYES; IRRITATED EYES; REDNESS TO BOTTOM OF EYE LIDS; INFLAMMATION TO EYE; FEVER; This spontaneous report received from a patient concerned a 51 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, and batch number: 201A21A) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced red watery eyes. On 09-APR-2021, the subject experienced a little itchy eyes. On 09-APR-2021, the subject experienced irritated eyes. On 09-APR-2021, the subject experienced redness to bottom of eye lids. On 09-APR-2021, the subject experienced inflammation to eye. Laboratory data (09-APR-2021) included: Body temperature (NR: not provided) 100.3. Treatment medications (dates unspecified) included: naproxen sodium, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, red watery eyes, a little itchy eyes, irritated eyes, redness to bottom of eye lids, and inflammation to eye on 09-APR-2021. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Decreased appetite, Diarrhoea
Clinical narrative: DIARRHEA; SICK; FEVER; COULD NOT BREATH DEEPLY; LOSS OF TASTE; LOSS OF SMELL; SALIVA LIKE FOAM; DRY COUGH WITH NO SECRETIONS; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 60 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced loss of taste. On 27-JUN-2021, the subject experienced loss of smell. On 27-JUN-2021, the subject experienced saliva like foam. On 27-JUN-2021, the subject experienced dry cough with no secretions. On 27-JUN-2021, the subject experienced could not breath deeply. On 28-JUN-2021, the subject experienced sick. On 28-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced diarrhea. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Twice Negative. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste, loss of smell, saliva like foam, dry cough with no secretions, and fever, and the outcome of sick, could not breath deeply, loss of appetite and diarrhea was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Foaming at mouth, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: DIARRHEA; SICK; FEVER; COULD NOT BREATH DEEPLY; LOSS OF TASTE; LOSS OF SMELL; SALIVA LIKE FOAM; DRY COUGH WITH NO SECRETIONS; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 60 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced loss of taste. On 27-JUN-2021, the subject experienced loss of smell. On 27-JUN-2021, the subject experienced saliva like foam. On 27-JUN-2021, the subject experienced dry cough with no secretions. On 27-JUN-2021, the subject experienced could not breath deeply. On 28-JUN-2021, the subject experienced sick. On 28-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced diarrhea. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Twice Negative. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste, loss of smell, saliva like foam, dry cough with no secretions, and fever, and the outcome of sick, could not breath deeply, loss of appetite and diarrhea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: BIT DROWSY; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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 subject experienced bit drowsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bit drowsy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210744057 and 20210744116.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) 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 subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210744057 and 20210744087.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: ACHY; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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 subject experienced achy, and flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and flu-like symptoms. This report was non-serious. This case, from the same reporter is linked to 20210744488.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus, General physical health deterioration
Clinical narrative: HEALTH DECAYING; DIAGNOSED AS DIABETIC; This spontaneous report received from a consumer concerned a 22 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) dose was not reported, 1 total administered on 08-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUL-2021 (since vaccination), the patient's health was decaying and he had good health before vaccination. On an unspecified date in JUL-2021, the patient was diagnosed as diabetic and his sugar level was unstable. Laboratory data included: Blood glucose (NR: not provided) Unstable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from health decaying, and diagnosed as diabetic. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210744411-covid-19 vaccine ad26.cov2.s  Diagnosed as Diabetic  This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: DEEP DRY COUGH; FEVER; 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 15-JUL-2021, the subject experienced deep dry cough. On 15-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from deep dry cough. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210744182.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: DROWSINESS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced drowsiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drowsiness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210744116 and 20210744057.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: RIGHT ARM WAS FULLY NUMB FROM ELBOW TO HAND/ WHOLE PINKY IS STILL NUMB; This spontaneous report received from a patient 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: Unk) 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 subject experienced right arm was fully numb from elbow to hand/ whole pinky is still numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm was fully numb from elbow to hand/ whole pinky is still numb. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache
Clinical narrative: CHILLS; FEELS COLD AND CAN NOT SEEM TO SHAKE IT; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 26 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, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the subject experienced chills. On 21-JUL-2021, the subject experienced feels cold and can not seem to shake it. On 21-JUL-2021, the subject experienced fatigue. On 21-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and the outcome of headache, fatigue and feels cold and can not seem to shake it was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 207A21A,expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUL-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Cold sweats, headache, body aches, nausea and relative flu like symptoms that lasted for about a day and a half.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives, itchiness; still present as of 7/23
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: FEELS LIKE SICKNESS; HEADACHE FOR ONE HOUR; This spontaneous report received from a patient concerned a male of unspecified age. 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 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUL-2021, the subject experienced headache for one hour. On 21-JUL-2021, the subject experienced feels like sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache for one hour on 20-JUL-2021, and the outcome of feels like sickness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: SLIGHT PAIN IN THE ARM FOR THE FIRST TWO DAYS; SEVERE NERVE PAIN IN THE ARM AFTER TWO OR THREE WEEKS; This spontaneous report received from a patient 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: 042A21A expiry: 05-AUG-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced severe nerve pain in the arm after two or three weeks. On 09-APR-2021, the subject experienced slight pain in the arm for the first two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight pain in the arm for the first two days on 11-APR-2021, and had not recovered from severe nerve pain in the arm after two or three weeks. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: INJECTION SITE HOT TO TOUCH; INJECTION SITE KNOT; EXPIRED VACCINE USED; INJECTION SITE SORENESS/PAIN; This spontaneous report received from a patient concerned a 72 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 allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 10-JUL-2021) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced injection site hot to touch. On 10-JUL-2021, the subject experienced injection site knot. On 10-JUL-2021, the subject experienced expired vaccine used. On 10-JUL-2021, the subject experienced injection site soreness/pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site hot to touch, injection site knot, injection site soreness/pain and expired vaccine used was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING IN FEET; TIGHT MUSCLES/TIGHTNESS IN LEGS; PAIN IN LEGS; WEAKNESS IN ARMS; TORSO FEELS STIFF; This spontaneous report received from a patient concerned a female of unspecified age. 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUL-2021, the subject experienced torso feels stiff. On an unspecified date, the subject experienced tingling in feet, tight muscles/tightness in legs, pain in legs, and weakness in arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in feet, and tight muscles/tightness in legs, and the outcome of pain in legs, weakness in arms and torso feels stiff was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: SHOULDERS PAIN; RIGHT ARM GET SORE SO FAR/FULL ARMS PAIN; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. The batch  number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shoulders pain. On 21-JUL-2021, the subject experienced right arm get sore so far/full arms pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm get sore so far/full arms pain, and shoulders pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: KNOT AT INJECTION SITE; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. 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 19-JUL-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 JUL-2021, the subject experienced knot at injection site. On JUL-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and knot at injection site was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: SWOLLEN ARM; TINGLING IN LEG/VACCINATED ARM/HANDS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUL-2021, the subject experienced swollen arm. On 19-JUL-2021, the subject experienced tingling in leg/vaccinated arm/hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in leg/vaccinated arm/hands, and the outcome of swollen arm was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Neuralgia, Neuropathy peripheral
Clinical narrative: Neuropathy; intermittent numbness in fingers; nerve pain; feeling pins and needles sensation going into limbs including both arms and legs; nerve pain, muscle pain, and joint pain at the site where she received her  vaccine; joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Fibromyalgia since 11-Apr-2020, Allergy to antibiotic (Bactrim), Allergy to antibiotic (Erythromycin) and Osteoporosis. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) from 12-May-2012 to an unknown date for Osteoporosis, CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), HYPOAESTHESIA (intermittent numbness in fingers), NEURALGIA (nerve pain), PARAESTHESIA (feeling pins and needles sensation going into limbs including both arms and legs), VACCINATION SITE PAIN (nerve pain, muscle pain, and joint pain at the site where she received her  vaccine), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), HYPOAESTHESIA (intermittent numbness in fingers), NEURALGIA (nerve pain), PARAESTHESIA (feeling pins and needles sensation going into limbs including both arms and legs), VACCINATION SITE PAIN (nerve pain, muscle pain, and joint pain at the site where she received her  vaccine), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain) 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20 JUL 2021. Reporter information added, Patient's demographics added, Medical history added, Dose route and anatomical location updated, Concomitant medication added, Vaccination facility information added, One Event  Neuropathy added.; 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; however, concurrent medical condition of Fibromyalgia could be a contributory factor for the events.