chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Rash
Clinical narrative: LEFT-SIDED TORSO PAIN; FATIGUE; LEFT BREAST PAIN; RASH INFERIOR LEFT BREAST; LEFT BREAST REDNESS; LEFT BREAST INFLAMMATION; INJECTION SITE PAIN; SWELLING OF LEFT BREAST; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 126 pounds, and height was 57 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have ant drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swelling of left breast. On 09-APR-2021, the subject experienced injection site pain. On 17-APR-2021, the subject experienced left breast redness. On 17-APR-2021, the subject experienced left breast inflammation. On 17-APR-2021, the subject experienced left breast pain. On 17-APR-2021, the subject experienced rash inferior left breast. On 19-APR-2021, the subject experienced left-sided torso pain. On 19-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 16-APR-2021, had not recovered from left-sided torso pain, left breast redness, left breast inflammation, fatigue, left breast pain, and rash inferior left breast, and the outcome of swelling of left breast was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT; 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 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Insomnia, Pain, Tenderness
Clinical narrative: PAIN/EXCRUCIATING; DID NOT SLEEP; SORE TO TOUCH; HARDLY MOVE ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included bad shoulder, and concurrent conditions included spinal stenosis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain/excruciating. On APR-2021, the subject experienced did not sleep. On APR-2021, the subject experienced sore to touch. On APR-2021, the subject experienced hardly move arm. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain/excruciating, sore to touch, and hardly move arm, and the outcome of did not sleep was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cold sweat, Confusional state, Dry mouth
Clinical narrative: SWEATING; INCREASED BLOOD PRESSURE; EXTREME THIRST; SHAKINESS; CONFUSION; MILD HEADACHE; DRY MOUTH; CLAMMINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included normally had low blood pressure was at 170/92. 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced dry mouth. On APR-2021, the subject experienced clamminess. Laboratory data included: Blood pressure (NR: not provided) stabilized. On 18-APR-2021, the subject experienced extreme thirst. On 18-APR-2021, the subject experienced shakiness. On 18-APR-2021, the subject experienced confusion. On 18-APR-2021, the subject experienced mild headache. On 19-APR-2021, the subject experienced sweating. On 19-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) 170/92 mmHg. Treatment medications (dates unspecified) included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased blood pressure, and the outcome of extreme thirst, shakiness, confusion, mild headache, sweating, dry mouth and clamminess was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Thirst, Tremor
Clinical narrative: SWEATING; INCREASED BLOOD PRESSURE; EXTREME THIRST; SHAKINESS; CONFUSION; MILD HEADACHE; DRY MOUTH; CLAMMINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included normally had low blood pressure was at 170/92. 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced dry mouth. On APR-2021, the subject experienced clamminess. Laboratory data included: Blood pressure (NR: not provided) stabilized. On 18-APR-2021, the subject experienced extreme thirst. On 18-APR-2021, the subject experienced shakiness. On 18-APR-2021, the subject experienced confusion. On 18-APR-2021, the subject experienced mild headache. On 19-APR-2021, the subject experienced sweating. On 19-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) 170/92 mmHg. Treatment medications (dates unspecified) included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased blood pressure, and the outcome of extreme thirst, shakiness, confusion, mild headache, sweating, dry mouth and clamminess was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Haematochezia
Clinical narrative: BLOOD WITH NUMBER 2'S; COMPLICATIONS OF CHEST PAIN; This spontaneous report received from a consumer concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) start therapy date were not reported, 1 total administered on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that, on 15-APR-2021 (last thursday)  the patient had complications of chest pain. On 17-APR-2021 (saturday), she went to emergency room. The team of doctors stated that nothing was wrong with her. The reporter was unable to provide specific information regarding the lot number, date of vaccine received or the location but informed that he can obtain the information and provide it. The reporter was contacted again on 22-APR-2021, where details (age, date of birth) of the patient was provided but was unable to recall the specific date of vaccination. Providing further information it was reported that on 22-APR-2021, the patient had blood with number 2's, but did not had chest pain anymore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from complications of chest pain on 22-APR-2021, and had not recovered from blood with number 2's. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210444704-COVID-19 VACCINE AD26.COV2.S-Blood in stool. 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: Fatigue, Myalgia, Pyrexia, Sensory disturbance
Clinical narrative: VACCINE HIT LIKE A TON OF BRICKS; EVERY MUSCLE ACHED; SEVERE FATIGUE; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 vaccine hit like a ton of bricks, every muscle ached, severe fatigue, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine hit like a ton of bricks, every muscle ached, severe fatigue and mild fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Ultrasound scan, Venous thrombosis limb
Clinical narrative: BLOOD CLOTS IN THE LEG; BLOOD CLOT IN THE CHEST; This spontaneous report received from a consumer (calling on behalf of her husband) concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes mellitus, asthma, high blood pressure, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin: unknown, batch number: Unknown) on 12-APR-2021, into right arm, for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 18-APR-2021, the patient began experiencing pain and swelling in the left leg. His leg was very hot and red "like a fever" and the pain was radiating up to the chest and heart and also spread to the right side of the chest. The patient was experiencing a lot of pain and couldn't breath. On 19-APR-2021 the patient's wife called the doctor and he was admitted to hospital. An ultrasound was performed which confirmed blood clots in the leg and chest. At the time of this report patient was still in the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in the leg, and blood clot in the chest. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 60 year-old male with medical history significant for diabetes, high blood pressure, and asthma was hospitalized for blood clots in the leg and chest 7 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. Six days post-vaccination, the patient began experiencing left leg pain and swelling. His leg was red and hot and the pain would radiate from his leg to his chest. He was also experiencing difficulty breathing.  The following day (7 days post-vaccination), he was admitted to the hospital. An ultrasound confirmed blood clots in the leg and chest. Other diagnostic test results and corrective treatment were not reported.  As of the time of this report, the patient was still in the hospital. Based on the limited information, the relationship with Janssen Covid-19 vaccine is considered indeterminant. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) is being sought.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Illness, Magnetic resonance imaging, Peripheral swelling, Swelling
Clinical narrative: SWOLLEN NECK; SWOLLEN RIGHT ARM; 6 BLOOD CLOTS; SICK; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery. There was no history or family history of blood clots. Prior to vaccination, the patient had several physicals performed due to other health concerns and CAT-scans and MRIs were performed that showed his body was totally without any blood clots.  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 indication. Batch number was not reported and has been requested.  No concomitant medications were reported. After getting the vaccine patient was sick for 3 days. On an unspecified date, the patient woke with a with swollen neck, swollen right arm that was twice its normal size. The patient went to the hospital and they were concerned it was a blood clot further so he was then sent to hospital where they performed an ultrasound which revealed 6 blood clots. The patient was hospitalized and underwent surgery on his arm to "open up the vein that was causing the swelling". The patient reported he was scheduled for several more surgeries of this kind.  Corrective treatment included intravenous blood thinners.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen neck, swollen right arm, 6 blood clots, and sick. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This male patient of unspecified age noted swelling of righ arm and neck that the ultrasound showed 6 blood clots after an unspecified duration from receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient was hospitalized and underwent corrective surgery and was started on unspecified blood thinners.  No other details was reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: SWOLLEN NECK; SWOLLEN RIGHT ARM; 6 BLOOD CLOTS; SICK; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery. There was no history or family history of blood clots. Prior to vaccination, the patient had several physicals performed due to other health concerns and CAT-scans and MRIs were performed that showed his body was totally without any blood clots.  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 indication. Batch number was not reported and has been requested.  No concomitant medications were reported. After getting the vaccine patient was sick for 3 days. On an unspecified date, the patient woke with a with swollen neck, swollen right arm that was twice its normal size. The patient went to the hospital and they were concerned it was a blood clot further so he was then sent to hospital where they performed an ultrasound which revealed 6 blood clots. The patient was hospitalized and underwent surgery on his arm to "open up the vein that was causing the swelling". The patient reported he was scheduled for several more surgeries of this kind.  Corrective treatment included intravenous blood thinners.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen neck, swollen right arm, 6 blood clots, and sick. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This male patient of unspecified age noted swelling of righ arm and neck that the ultrasound showed 6 blood clots after an unspecified duration from receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient was hospitalized and underwent corrective surgery and was started on unspecified blood thinners.  No other details was reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Muscle spasms, Myalgia, Sinus pain
Clinical narrative: CRAMPS; MUSCLE PAIN; CHILLS; WEAKNESS; SINUS PAIN; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180525, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced sinus pain. On 19-MAR-2021, the subject experienced weakness. On 19-MAR-2021 01:00, the subject experienced chills. On 20-MAR-2021, the subject experienced cramps. On 20-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus pain, and weakness on 19-MAR-2021, and chills on 19-MAR-2021 05:00, and had not recovered from cramps, and muscle pain. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling abnormal, Headache
Clinical narrative: BOTH KNEES SWOLLEN AND UNCOMFORTABLE; KNEES WARM TO TOUCH; HEADACHE; ICKY; WEAK; TIRED; LOW GRADE FEVER; PAIN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included ankle replacement, and knee replacement, and concurrent conditions included penicillin allergy, nonsmoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with chloramphenicol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced icky. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced weak. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) over 100 F. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced both knees swollen and uncomfortable. On 20-APR-2021, the subject experienced knees warm to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from icky, headache, weak, and tired on 18-APR-2021, and low grade fever on 11-APR-2021, had not recovered from both knees swollen and uncomfortable, and the outcome of knees warm to touch and pain was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Joint warmth, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: BOTH KNEES SWOLLEN AND UNCOMFORTABLE; KNEES WARM TO TOUCH; HEADACHE; ICKY; WEAK; TIRED; LOW GRADE FEVER; PAIN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included ankle replacement, and knee replacement, and concurrent conditions included penicillin allergy, nonsmoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with chloramphenicol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced icky. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced weak. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) over 100 F. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced both knees swollen and uncomfortable. On 20-APR-2021, the subject experienced knees warm to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from icky, headache, weak, and tired on 18-APR-2021, and low grade fever on 11-APR-2021, had not recovered from both knees swollen and uncomfortable, and the outcome of knees warm to touch and pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscle spasms, Pyrexia
Clinical narrative: HEADACHE; FEVER; TIREDNESS; LEG CRAMPS; CHILLS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included hydrocephalus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 25-MAY-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced leg cramps. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps, chills, and tiredness on 27-MAR-2021, and fever on 25-MAR-2021, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Disorientation, Feeling hot, Headache
Clinical narrative: NECK NUMBNESS; NECK SWELLING; POPPING NOISES IN HEAD; FEELING HOT; HEART RACING; CHILLS; HEADACHE; FEVER OF 101.1; DISORIENTED; CONFUSED; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included cataracts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced disoriented. On APR-2021, the subject experienced confused. On APR-2021, the subject experienced fever of 101.1. Laboratory data included: Fever (NR: not provided) 101.1. On 07-APR-2021, the subject experienced neck numbness. On 07-APR-2021, the subject experienced neck swelling. On 07-APR-2021, the subject experienced popping noises in head. On 07-APR-2021, the subject experienced feeling hot. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck numbness, neck swelling, heart racing, and chills on 09-APR-2021, and popping noises in head, and feeling hot on APR-2021, and the outcome of headache, fever of 101.1, confused and disoriented was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Palpitations, Pyrexia, Swelling, Tinnitus
Clinical narrative: NECK NUMBNESS; NECK SWELLING; POPPING NOISES IN HEAD; FEELING HOT; HEART RACING; CHILLS; HEADACHE; FEVER OF 101.1; DISORIENTED; CONFUSED; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included cataracts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced disoriented. On APR-2021, the subject experienced confused. On APR-2021, the subject experienced fever of 101.1. Laboratory data included: Fever (NR: not provided) 101.1. On 07-APR-2021, the subject experienced neck numbness. On 07-APR-2021, the subject experienced neck swelling. On 07-APR-2021, the subject experienced popping noises in head. On 07-APR-2021, the subject experienced feeling hot. On 07-APR-2021, the subject experienced heart racing. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck numbness, neck swelling, heart racing, and chills on 09-APR-2021, and popping noises in head, and feeling hot on APR-2021, and the outcome of headache, fever of 101.1, confused and disoriented was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Body temperature, COVID-19, Dysphonia, Illness
Clinical narrative: SICKENESS WIPED OUT; VOICE WAS COMPLETELY GONE; COVID-19 INFECTION; HOARSE VOICE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included significant weight loss, and concurrent conditions included chest congestion. 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 11-APR-2021 12:20 for prophylactic vaccination. Concomitant medications included dextromethorphan polistirex for chest congestion, and cough, camphor/eucalyptus globulus oil/juniperus virginiana wood oil/menthol/myristica fragrans oil/pinus nigra oil/thymol, ibuprofen, and paracetamol.  On 14-APR-2021, the subject experienced hoarse voice. On 17-APR-2021, the subject experienced covid-19 infection. On 17-APR-2021, the subject experienced voice was completely gone. Laboratory data included: COVID-19 virus test (NR: not provided) postivite. On 18-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.1 C. On 19-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.4 C. On 20-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 C, 100.8 C. On 21-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 C. On 22-APR-2021, Laboratory data included: Fever (NR: not provided) 99 C. On an unspecified date, the subject experienced sickeness wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hoarse voice, and the outcome of voice was completely gone, sickeness wiped out and covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: SICKENESS WIPED OUT; VOICE WAS COMPLETELY GONE; COVID-19 INFECTION; HOARSE VOICE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included significant weight loss, and concurrent conditions included chest congestion. 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 11-APR-2021 12:20 for prophylactic vaccination. Concomitant medications included dextromethorphan polistirex for chest congestion, and cough, camphor/eucalyptus globulus oil/juniperus virginiana wood oil/menthol/myristica fragrans oil/pinus nigra oil/thymol, ibuprofen, and paracetamol.  On 14-APR-2021, the subject experienced hoarse voice. On 17-APR-2021, the subject experienced covid-19 infection. On 17-APR-2021, the subject experienced voice was completely gone. Laboratory data included: COVID-19 virus test (NR: not provided) postivite. On 18-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.1 C. On 19-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.4 C. On 20-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 C, 100.8 C. On 21-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 C. On 22-APR-2021, Laboratory data included: Fever (NR: not provided) 99 C. On an unspecified date, the subject experienced sickeness wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hoarse voice, and the outcome of voice was completely gone, sickeness wiped out and covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Dysmenorrhoea, Heavy menstrual bleeding, Rash macular
Clinical narrative: PEA-SIZED GROWTH IN RIGHT AXILLA (ARMPIT AREA); RED SPLOTCHES ON TRUNK (STOMACH AND CHEST) ON FRONT OF BODY; TINNITUS IN RIGHT EAR; RECURRING KNEE ACHES AND JOINT PAIN BEHIND KNEE CAPS (PARTICULARLY RIGHT KNEE); HEAVIER THAN NORMAL MENSTRUAL FLOW; DEBILITATING MENSTRUAL CRAMPS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced debilitating menstrual cramps. On 10-APR-2021, the subject experienced heavier than normal menstrual flow. On 14-APR-2021, the subject experienced recurring knee aches and joint pain behind knee caps (particularly right knee). On 15-APR-2021, the subject experienced tinnitus in right ear. On 17-APR-2021, the subject experienced red splotches on trunk (stomach and chest) on front of body. On 18-APR-2021, the subject experienced pea-sized growth in right axilla (armpit area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from debilitating menstrual cramps on 10-APR-2021, and heavier than normal menstrual flow on 11-APR-2021, was recovering from recurring knee aches and joint pain behind knee caps (particularly right knee), and had not recovered from tinnitus in right ear, red splotches on trunk (stomach and chest) on front of body, and pea-sized growth in right axilla (armpit area). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: PEA-SIZED GROWTH IN RIGHT AXILLA (ARMPIT AREA); RED SPLOTCHES ON TRUNK (STOMACH AND CHEST) ON FRONT OF BODY; TINNITUS IN RIGHT EAR; RECURRING KNEE ACHES AND JOINT PAIN BEHIND KNEE CAPS (PARTICULARLY RIGHT KNEE); HEAVIER THAN NORMAL MENSTRUAL FLOW; DEBILITATING MENSTRUAL CRAMPS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced debilitating menstrual cramps. On 10-APR-2021, the subject experienced heavier than normal menstrual flow. On 14-APR-2021, the subject experienced recurring knee aches and joint pain behind knee caps (particularly right knee). On 15-APR-2021, the subject experienced tinnitus in right ear. On 17-APR-2021, the subject experienced red splotches on trunk (stomach and chest) on front of body. On 18-APR-2021, the subject experienced pea-sized growth in right axilla (armpit area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from debilitating menstrual cramps on 10-APR-2021, and heavier than normal menstrual flow on 11-APR-2021, was recovering from recurring knee aches and joint pain behind knee caps (particularly right knee), and had not recovered from tinnitus in right ear, red splotches on trunk (stomach and chest) on front of body, and pea-sized growth in right axilla (armpit area). This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Irritability, Polymerase chain reaction
Clinical narrative: IRRITABLE; HEAD PAIN; EXTREME FATIGUE; STABBING PAINS IN ABDOMEN; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stabbing pains in abdomen. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced head pain. On 12-APR-2021, the subject experienced extreme fatigue. On 21-APR-2021, the subject experienced irritable. Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and PCR (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabbing pains in abdomen on 17-APR-2021, was recovering from extreme fatigue, and had not recovered from head pain, and irritable. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: IRRITABLE; HEAD PAIN; EXTREME FATIGUE; STABBING PAINS IN ABDOMEN; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stabbing pains in abdomen. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced head pain. On 12-APR-2021, the subject experienced extreme fatigue. On 21-APR-2021, the subject experienced irritable. Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and PCR (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabbing pains in abdomen on 17-APR-2021, was recovering from extreme fatigue, and had not recovered from head pain, and irritable. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test, Burning sensation, Electric shock sensation, Eye pain
Clinical narrative: IRRITABLE; HEAD PAIN; EXTREME FATIGUE; STABBING PAINS IN ABDOMEN; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stabbing pains in abdomen. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced head pain. On 12-APR-2021, the subject experienced extreme fatigue. On 21-APR-2021, the subject experienced irritable. Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and PCR (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabbing pains in abdomen on 17-APR-2021, was recovering from extreme fatigue, and had not recovered from head pain, and irritable. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Impaired quality of life, Loss of personal independence in daily activities
Clinical narrative: IRRITABLE; HEAD PAIN; EXTREME FATIGUE; STABBING PAINS IN ABDOMEN; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stabbing pains in abdomen. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced head pain. On 12-APR-2021, the subject experienced extreme fatigue. On 21-APR-2021, the subject experienced irritable. Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and PCR (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabbing pains in abdomen on 17-APR-2021, was recovering from extreme fatigue, and had not recovered from head pain, and irritable. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: SHARP HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not 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 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced fatigue. On 22-APR-2021, the subject experienced sharp headache. On 22-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 27-MAR-2021, and had not recovered from sharp headache, and nausea. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: FEVER; CHILLS; SWEATING; SORE ARM; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight, height, and medical history were not 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 07-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.7 F. On 08-APR-2021 02:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 08-APR-2021, sore arm on APR-2021, chills on 11-APR-2021, and fever on 12-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Diarrhoea
Clinical narrative: APPETITE ABSENT; WEAKNESS; FEVER 102.3; NAUSEA; LOOSE GREENISH STOOL; HEART RATE INCREASED; BODY ACHES; CHILLS; SLEEPING DIFFICULTY; FEELS AWFUL; HEADACHE; FLATULENCE; TIREDNESS; DIARRHEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis to penicillin, accident, vomiting, hives, low blood pressure, hospitalised, on iv fluids, redness of arm, swelling of arm, fever, anaphylaxis to tetanus vaccine, reaction to pneumovax vaccine, whipple surgery, adenocarcinoma in situ in pancreas, urinary tract infection, and yeast infection. The patient was previously treated with benzylpenicillin for accident, tetanus vaccine for accident, pneumococcal vaccine, pancrelipase for pancreas adenocarcinoma, and for urinary tract infection.  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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced flatulence. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced sleeping difficulty. On 10-APR-2021, the subject experienced feels awful. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced body aches. On 10-APR-2021 03:00, the subject experienced chills. On 11-APR-2021, the subject experienced loose greenish stool. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced fever 102.3. On 11-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 12-APR-2021, the subject experienced appetite absent. On 12-APR-2021, the subject experienced weakness. On APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, flatulence, chills, body aches, sleeping difficulty, feels awful, headache, fever 102.3, nausea, loose greenish stool, heart rate increased, weakness, appetite absent and diarrhea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured, Fatigue, Feeling abnormal, Flatulence, Headache
Clinical narrative: APPETITE ABSENT; WEAKNESS; FEVER 102.3; NAUSEA; LOOSE GREENISH STOOL; HEART RATE INCREASED; BODY ACHES; CHILLS; SLEEPING DIFFICULTY; FEELS AWFUL; HEADACHE; FLATULENCE; TIREDNESS; DIARRHEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis to penicillin, accident, vomiting, hives, low blood pressure, hospitalised, on iv fluids, redness of arm, swelling of arm, fever, anaphylaxis to tetanus vaccine, reaction to pneumovax vaccine, whipple surgery, adenocarcinoma in situ in pancreas, urinary tract infection, and yeast infection. The patient was previously treated with benzylpenicillin for accident, tetanus vaccine for accident, pneumococcal vaccine, pancrelipase for pancreas adenocarcinoma, and for urinary tract infection.  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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced flatulence. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced sleeping difficulty. On 10-APR-2021, the subject experienced feels awful. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced body aches. On 10-APR-2021 03:00, the subject experienced chills. On 11-APR-2021, the subject experienced loose greenish stool. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced fever 102.3. On 11-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 12-APR-2021, the subject experienced appetite absent. On 12-APR-2021, the subject experienced weakness. On APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, flatulence, chills, body aches, sleeping difficulty, feels awful, headache, fever 102.3, nausea, loose greenish stool, heart rate increased, weakness, appetite absent and diarrhea was not reported. This report was non-serious.