chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: FEVER; NAUSEA; 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  (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 numbers. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: A HARSH PAIN IN SHOULDER A DAY AFTER VACCINE SHOT; 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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced a harsh pain in shoulder a day after vaccine shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a harsh pain in shoulder a day after vaccine shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea, Pain in extremity
Clinical narrative: NOT MUCH APPETITE; ARM HURT; MILD NAUSEA; FATIGUE; 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  (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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced not much appetite, arm hurt, mild nausea, and fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild nausea, and the outcome of not much appetite, arm hurt and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: BOTH ANKLES WERE SWOLLEN; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included sunburn. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On 23-MAY-2021, the subject experienced both ankles were swollen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from both ankles were swollen. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: MAGNET STICKS TO ARM; This spontaneous report received from a patient 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  (suspension for injection, route of admin not reported) 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 numbers. No concomitant medications were reported. On an unspecified date, the subject experienced magnet sticks to arm. The action taken with covid-19 vaccine was not applicable. The outcome of magnet sticks to arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Injection site bruising
Clinical narrative: BRUISING AROUND THE INJECTION SITE AREA; KNOT (BUMP)  AROUND INJECTION SITE; INJECTION SITE SORENESS; REDNESS AROUND INJECTION SITE; FATIGUE; BODY ACHES; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, high blood pressure, and high cholesterol, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure, rosuvastatin for high cholesterol, and zolpidem tartrate for sleep. On 21-MAY-2021, the subject experienced body aches. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced fever. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 22-MAY-2021, the subject experienced bruising around the injection site area. On 22-MAY-2021, the subject experienced knot (bump) around injection site. On 22-MAY-2021, the subject experienced injection site soreness. On 22-MAY-2021, the subject experienced redness around injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, body aches, headache, bruising around the injection site area, knot (bump) around injection site, redness around injection site, fatigue, chills, and injection site soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Pain, Pyrexia
Clinical narrative: BRUISING AROUND THE INJECTION SITE AREA; KNOT (BUMP)  AROUND INJECTION SITE; INJECTION SITE SORENESS; REDNESS AROUND INJECTION SITE; FATIGUE; BODY ACHES; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, high blood pressure, and high cholesterol, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure, rosuvastatin for high cholesterol, and zolpidem tartrate for sleep. On 21-MAY-2021, the subject experienced body aches. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced fever. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 22-MAY-2021, the subject experienced bruising around the injection site area. On 22-MAY-2021, the subject experienced knot (bump) around injection site. On 22-MAY-2021, the subject experienced injection site soreness. On 22-MAY-2021, the subject experienced redness around injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, body aches, headache, bruising around the injection site area, knot (bump) around injection site, redness around injection site, fatigue, chills, and injection site soreness. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Dizziness, Headache
Clinical narrative: THROAT SWELLING; BODY ACHES; STOMACH ACHES; CHILLS; DIZZY; SEVERE HEADACHE; FEVER; INJECTION SITE BLEEDING; MILD SHOULDER PAIN; INJECTION SITE "BUBBLED UP"; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included many surgeries post traumatic car accident, and concurrent conditions included a lot of scar tissue on shoulder (at injection site), and high blood pressure.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A2114, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced injection site bleeding. On 18-MAY-2021, the subject experienced mild shoulder pain. On 18-MAY-2021, the subject experienced injection site "bubbled up". On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced throat swelling. On 19-MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced stomach aches. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced severe headache. On 19-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site bleeding, and injection site "bubbled up" on 18-MAY-2021, and mild shoulder pain, was recovering from severe headache, throat swelling, fever, chills, and body aches, had not recovered from dizzy, and the outcome of stomach aches was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site swelling, Pain, Pharyngeal swelling, Pyrexia
Clinical narrative: THROAT SWELLING; BODY ACHES; STOMACH ACHES; CHILLS; DIZZY; SEVERE HEADACHE; FEVER; INJECTION SITE BLEEDING; MILD SHOULDER PAIN; INJECTION SITE "BUBBLED UP"; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included many surgeries post traumatic car accident, and concurrent conditions included a lot of scar tissue on shoulder (at injection site), and high blood pressure.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A2114, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced injection site bleeding. On 18-MAY-2021, the subject experienced mild shoulder pain. On 18-MAY-2021, the subject experienced injection site "bubbled up". On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced throat swelling. On 19-MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced stomach aches. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced severe headache. On 19-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site bleeding, and injection site "bubbled up" on 18-MAY-2021, and mild shoulder pain, was recovering from severe headache, throat swelling, fever, chills, and body aches, had not recovered from dizzy, and the outcome of stomach aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: SEVERE CHILLS; HIGH TEMPERATURE; 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  (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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced severe chills, and high temperature. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine was not applicable. The outcome of the severe chills and high temperature was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Tremor, Vasodilatation
Clinical narrative: ARM FEELS VERY HEAVY; SORE ARM; MUSCLE QUIVERING; ENLARGED VEINS; This spontaneous report received from a patient concerned a 39 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced muscle quivering. On MAY-2021, the subject experienced enlarged veins. On 17-MAY-2021, the subject experienced arm feels very heavy. On 17-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm feels very heavy, sore arm, muscle quivering, and enlarged veins. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: CHILLS; FELT RUN DOWN; 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 (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 2021, the subject experienced chills. On 2021, the subject experienced felt run down. On 2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, felt run down, and fever on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via other company (Pfizer, report number: 2021503212) concerned multiple patients of unspecified age and sex. 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 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, reporter stated that patients experienced blood clots that scared people all the way around (no further information provided or obtained). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210547337 - COVID-19 VACCINE AD26.COV2.S-Blood clots. 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: Peripheral swelling
Clinical narrative: LEG SWELLING; 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  (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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced leg swelling. The action taken with covid-19 vaccine  was not applicable. The outcome of leg swelling was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH TO BELOW BOTH EYELIDS/ RASH AROUND BOTH EYES/RASH TO FOREHEAD/RASH TO SIDE OF FACE/ TO BOTH EARS/ TO SIDE OF NECK; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 180 pounds, and height was 55 inches. The patient's past medical history included surgeries for cleft lip and palate, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. the patient not pregnant at the time of vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced rash to below both eyelids/ rash around both eyes/rash to forehead/rash to side of face/ to both ears/ to side of neck. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from rash to below both eyelids/ rash around both eyes/rash to forehead/rash to side of face/ to both ears/ to side of neck. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Muscle spasms, Pain in extremity, Scan
Clinical narrative: LEG CRAMPS; HARD TO WALK; ACHY HIPS; ACHY LEGS; This spontaneous report received from a patient concerned an 81 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  (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced leg cramps. On 26-MAR-2021, the subject experienced hard to walk. On 26-MAR-2021, the subject experienced achy hips. On 26-MAR-2021, the subject experienced achy legs. Laboratory data (dates unspecified) included: Scan (NR: not provided) No blood clots, and X-ray (NR: not provided) No blood clots. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from hard to walk, and had not recovered from achy legs, achy hips, and leg cramps. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: LEG CRAMPS; HARD TO WALK; ACHY HIPS; ACHY LEGS; This spontaneous report received from a patient concerned an 81 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  (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced leg cramps. On 26-MAR-2021, the subject experienced hard to walk. On 26-MAR-2021, the subject experienced achy hips. On 26-MAR-2021, the subject experienced achy legs. Laboratory data (dates unspecified) included: Scan (NR: not provided) No blood clots, and X-ray (NR: not provided) No blood clots. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from hard to walk, and had not recovered from achy legs, achy hips, and leg cramps. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Spinal X-ray, Ultrasound Doppler
Clinical narrative: LEG CRAMPS; HARD TO WALK; ACHY HIPS; ACHY LEGS; This spontaneous report received from a patient concerned an 81 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  (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced leg cramps. On 26-MAR-2021, the subject experienced hard to walk. On 26-MAR-2021, the subject experienced achy hips. On 26-MAR-2021, the subject experienced achy legs. Laboratory data (dates unspecified) included: Scan (NR: not provided) No blood clots, and X-ray (NR: not provided) No blood clots. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from hard to walk, and had not recovered from achy legs, achy hips, and leg cramps. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hypersomnia, Injection site pain
Clinical narrative: PAIN AT SITE OF INJECTION; SLEPT THROUGHOUT THE DAY; FATIGUE; FELT LIKE NEEDLE HIT THE BONE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 109 pounds, and height was 61 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A201A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced felt like needle hit the bone. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 23-MAY-2021, the subject experienced slept throughout the day. On 23-MAY-2021, the subject experienced fatigue. On 24-MAY-2021, the subject experienced pain at site of injection. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fatigue on MAY-2021, pain at site of injection on 24-MAY-2021, and fever on 23-MAY-2021, and the outcome of felt like needle hit the bone and slept throughout the day was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Wrong technique in product usage process
Clinical narrative: PAIN AT SITE OF INJECTION; SLEPT THROUGHOUT THE DAY; FATIGUE; FELT LIKE NEEDLE HIT THE BONE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 109 pounds, and height was 61 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A201A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced felt like needle hit the bone. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 23-MAY-2021, the subject experienced slept throughout the day. On 23-MAY-2021, the subject experienced fatigue. On 24-MAY-2021, the subject experienced pain at site of injection. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fatigue on MAY-2021, pain at site of injection on 24-MAY-2021, and fever on 23-MAY-2021, and the outcome of felt like needle hit the bone and slept throughout the day was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Dizziness, Fatigue, Migraine, Myalgia
Clinical narrative: MIGRAINE HEADACHE; DIZZINESS; NAUSEA; MUSCLE ACHES; TIREDNESS/FEELING EXHAUSTED; BLIND SPOT IN LEFT EYE; AURA IN LEFT EYE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headaches, and concurrent conditions included allergy to sulpha, alcohol user, and non smoker. The patient experienced drug allergy when treated with metronidazole.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced blind spot in left eye. On MAY-2021, the subject experienced aura in left eye. On 19-MAY-2021, the subject experienced tiredness/feeling exhausted. On 20-MAY-2021, the subject experienced dizziness. On 20-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced muscle aches. On 24-MAY-2021, the subject experienced migraine headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from muscle aches on 22-MAY-2021, had not recovered from nausea, migraine headache, tiredness/feeling exhausted, and dizziness, and the outcome of blind spot in left eye and aura in left eye was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Visual field defect
Clinical narrative: MIGRAINE HEADACHE; DIZZINESS; NAUSEA; MUSCLE ACHES; TIREDNESS/FEELING EXHAUSTED; BLIND SPOT IN LEFT EYE; AURA IN LEFT EYE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headaches, and concurrent conditions included allergy to sulpha, alcohol user, and non smoker. The patient experienced drug allergy when treated with metronidazole.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced blind spot in left eye. On MAY-2021, the subject experienced aura in left eye. On 19-MAY-2021, the subject experienced tiredness/feeling exhausted. On 20-MAY-2021, the subject experienced dizziness. On 20-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced muscle aches. On 24-MAY-2021, the subject experienced migraine headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from muscle aches on 22-MAY-2021, had not recovered from nausea, migraine headache, tiredness/feeling exhausted, and dizziness, and the outcome of blind spot in left eye and aura in left eye was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: WIDESPREAD MORBILLIFORM ERUPTION; This spontaneous report was received. Widespread annular eruption after Johnson & Johnson COVID-19 Vaccine. Widespread annular eruption after Johnson & Johnson COVID-19 Vaccine. 2021 May. This report concerned a 74 year old male unknown race and ethnicity. 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, Expiry: UNKNOWN) dose was not reported, 1 total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the patient developed severe widespread morbilliform eruption, four days after received the J&J COVID-19 vaccine and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of widespread morbilliform eruption was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210532951.; Sender's Comments: V0: 20210547644-COVID-19 VACCINE AD26.COV2.S-Widespread Morbilliform Eruption. 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: Abdominal pain, Diarrhoea, Headache, Nausea
Clinical narrative: DIARRHEA; ABDOMINAL PAIN; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to anesthesia.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced diarrhea. On 23-MAY-2021, the subject experienced abdominal pain. On 23-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: loperamide hydrochloride, and electrolytes nos/glucose. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from abdominal pain, headache, diarrhea, and nausea. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED MORE THAN 6 HOURS OF VIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a 75 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, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced vaccine administered more than 6 hours of vial puncture. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine administered more than 6 hours of vial puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210547983.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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) 1 total, dose was not reported, administered on APR-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.  The patient's wife reported that, in MAY-2021 (over a month after vaccination), the patient was tested positive for COVID-19 (suspected clinical vaccination failure and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was associated with product Quality complaint: 90000180494. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210547734-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscle swelling, Muscle tightness, Pain in extremity, Vasodilatation
Clinical narrative: MUSCLE TIGHTNESS; VEIN BULGED; MUSCLE BULGED; ARM SORENESS; INJECTION SITE TENDERNESS; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-APR-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 muscle tightness, vein bulged, muscle bulged, arm soreness, and injection site tenderness. The action taken with covid-19 vaccine  was not applicable. The outcome of the muscle tightness, arm soreness, injection site tenderness, vein bulged and muscle bulged was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED AT 12 YEAR AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 12 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  (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced vaccine administered at 12 year age. On 24-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine administered at 12 year age and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210548034.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: WHOLE VIAL ADMINISTERED TO PATIENT; 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 (suspension for injection, route of admin not reported, batch number: Unk) 2.5 ml, administered on 21-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced whole vial administered to subject. The action taken with covid-19 vaccine  was not applicable. The outcome of whole vial administered to patient was not reported. This report was non-serious.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO 14 YEAR OLD; This spontaneous report received from a health care professional concerned a 14 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced off label use. On 24-MAY-2021, the subject experienced vaccine administered to 14 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 14 year old was not reported. This report was non-serious. This case, from the same reporter is linked to 20210547868.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Chills, Eye pain, Limb discomfort, Pain in extremity
Clinical narrative: SOME PAIN SPORADICALLY IN CHEST; PAIN IN EYE SOCKETS AN LOWER EXTREMITIES; CHILLS; PAIN IN LOWER EXTREMITIES; TIGHTNESS IN ARMS; FEVER; 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  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced some pain sporadically in chest. On MAY-2021, the subject experienced pain in eye sockets an lower extremities. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced pain in lower extremities. On MAY-2021, the subject experienced tightness in arms. On MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: Tylenol(paracetamol). The action taken with covid-19 vaccine  was not applicable. The patient recovered from some pain sporadically in chest, pain in eye sockets an lower extremities, chills, pain in lower extremities, tightness in arms, and fever on MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SOME PAIN SPORADICALLY IN CHEST; PAIN IN EYE SOCKETS AN LOWER EXTREMITIES; CHILLS; PAIN IN LOWER EXTREMITIES; TIGHTNESS IN ARMS; FEVER; 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  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced some pain sporadically in chest. On MAY-2021, the subject experienced pain in eye sockets an lower extremities. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced pain in lower extremities. On MAY-2021, the subject experienced tightness in arms. On MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: Tylenol(paracetamol). The action taken with covid-19 vaccine  was not applicable. The patient recovered from some pain sporadically in chest, pain in eye sockets an lower extremities, chills, pain in lower extremities, tightness in arms, and fever on MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder, Pyrexia
Clinical narrative: CANNOT MOVE; FEVER; 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  (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 cannot move, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever and cannot move was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Illness, Injection site pain, Pain in extremity
Clinical narrative: LIGHTHEADEDNESS; SICK; PAIN IN ARM; TIREDNESS; INJECTION SITE PAIN/ INJECTION SITE TENDERNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, administered on 20-MAY-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 21-MAY-2021, the subject experienced lightheadedness. On 21-MAY-2021, the subject experienced sick. On 21-MAY-2021, the subject experienced pain in arm. On 21-MAY-2021, the subject experienced tiredness. On 21-MAY-2021, the subject experienced injection site pain/ injection site tenderness. The action taken with covid-19 vaccine was not applicable. The patient recovered from lightheadedness, sick, pain in arm, tiredness, and injection site pain/ injection site tenderness on 23-MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscle spasms, Pain in extremity
Clinical narrative: MUSCLE SPASM; SORE ARM; MAJOR CHILLS; HEADACHE; FATIGUE; 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  (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 numbers. No concomitant medications were reported. On an unspecified date, the subject experienced muscle spasm, sore arm, major chills, headache, and fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from muscle spasm, sore arm, major chills, headache, and fatigue. This report was non-serious..
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: CHILLS; NAUSEA; RAN A TEMP OF 102°F; FEELING TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (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 numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, nausea, ran a temp of 102°f, and feeling tired.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine  was not applicable. The outcome of the chills, nausea, ran a temp of 102°f and feeling tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: ARM DID NOT HURT AS BAD AS EVERYONE MAKES IT OUT TO BE ONLY WITH A LOT OF PRESSURE; FEVER OF 100.3 IT SLOWLY WENT DOWN THROUGHOUT THE DAY THO PATIENT STILL FEEL A BIT HOT 2 DAYS LATER; VERY LIGHT HEADACHE; 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  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm did not hurt as bad as everyone makes it out to be only with a lot of pressure, fever of 100.3 it slowly went down throughout the day tho subject still feel a bit hot 2 days later, and very light headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.3 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever of 100.3 it slowly went down throughout the day tho patient still feel a bit hot 2 days later, and the outcome of very light headache and arm did not hurt as bad as everyone makes it out to be only with a lot of pressure was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Nausea
Clinical narrative: DIARRHEA; UPSET STOMACH; FATIGUE; WORST NAUSEA EVER; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient took gatorade.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced worst nausea ever. On 25-MAY-2021, the subject experienced diarrhea. On 25-MAY-2021, the subject experienced upset stomach. On 25-MAY-2021, the subject experienced fatigue. Treatment medications included: bismuth subsalicylate, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The outcome of the worst nausea ever, diarrhea, fatigue and upset stomach was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN POST EXPIRATION; This spontaneous report received from a health care professional concerned an adult 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, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced given post expiration. The action taken with covid-19 vaccine  was not applicable. The outcome of given post expiration was not reported. This report was non-serious.