chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: HEART RATE OF 110; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-SEP-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 30-SEP-2021, the patient experienced heart rate of 110. Laboratory data included: Heart rate (NR: not provided) 110. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate of 110 on 30-SEP-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: PERSISTENT FATIGUE SINCE GETTING THE SHOT; 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 not reported, batch number: Unknown) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced persistent fatigue since getting the shot. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from persistent fatigue since getting the shot. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID TEST POSITIVE; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced covid test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000195707.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: PAIN; NAUSEA; HEADACHES; FATIGUE; This spontaneous report received from a parent concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced pain. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced headaches. On SEP-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain, and had not recovered from nausea, headaches, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site mass, Injection site pain, Migraine, Pain in extremity
Clinical narrative: CLENCHED JAW; LUMP AT INJECTION SITE; MIGRAINE; ARM PAIN; HEADACHE; THROBBING/INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 patient experienced clenched jaw, lump at injection site, migraine, arm pain, headache, and throbbing/injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, had not recovered from arm pain, and the outcome of clenched jaw, headache, throbbing/injection site pain and lump at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Trismus
Clinical narrative: CLENCHED JAW; LUMP AT INJECTION SITE; MIGRAINE; ARM PAIN; HEADACHE; THROBBING/INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 patient experienced clenched jaw, lump at injection site, migraine, arm pain, headache, and throbbing/injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, had not recovered from arm pain, and the outcome of clenched jaw, headache, throbbing/injection site pain and lump at injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRAION OF EXPIRED VACCINE TO AT LEAST MINIMUM 20 PATIENTS; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administraion of expired vaccine to at least minimum 20 subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administraion of expired vaccine to at least minimum 20 patients was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART CONDITION; This spontaneous report received from a patient via social media concerned a 25 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was used to be healthy before vaccination. 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 patient experienced heart condition. The action taken with covid-19 vaccine was not applicable. The outcome of heart condition was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cough, Epistaxis
Clinical narrative: BLOOD PRESSURE HIGH; COUGHED; NOSE BLEED; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, penicillin allergy, and allergy to almonds and himalayan salt. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and talc. 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, 1 total, administered on 11-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, after five months of vaccination, the patient had blown nose hard and had a smaller nosebleed that stopped on its own. On 17-AUG-2021, the patient coughed hard and had a big nosebleed occurred it was gushing. She took a picture of what came out in the sink she stated that it was a huge blood clot. The patient taken to emergency room via ambulance and patient stated that it was huge blood clot and was holding a shoe box to catch the blood in the ambulance and the patient's blood pressure (BP) was measured and it was 198/126 mm/Hg and patient stated that she could have had heart attack or stroke. On 17-AUG-2021, the patient admitted to emergency room and patient received anesthetic and catharized it. The patient didn't remember if any test or blood work done and on same night (AUG-2021), the patient was discharged and nose bleeding didn't occur again. On an unspecified date in 2021, the patient's blood pressure measure and it was high but not like previously measured on 17-AUG-2021. The patient stated that, "it was hard to tell with my diabetes cause it was similar symptoms. On 02-OCT-2021, the patient came to get flu shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed, was recovering from blood pressure high, and the outcome of coughed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211004085-Covid-19 vaccine ad26.cov2.s- Blood pressure high, Nose bleed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHES; This spontaneous report received from a consumer concerned three patients. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches. This report was non-serious. This case, from the same reporter is linked to 20211004108.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Malaise, Nausea
Clinical narrative: FEELING GENERALLY UNWELL; EXTREME NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 280 pounds, and height was 69 inches. The patient's concurrent conditions included: non-smoker, alcohol user, pre-diabetes (type 2), and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included semaglutide for pre-diabetes (type 2). On an unspecified date, the patient experienced feeling generally unwell, and extreme nausea. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme nausea, and feeling generally unwell. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: TERRIBLE HEADACHE; 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 was not reported, administered on 18-AUG-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 an unspecified date, the patient experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible headache. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash pruritic, Skin test
Clinical narrative: RASH AND ITCHING ON FACE, TOP OF THE HEAD AND ALL OVER THE BODY; ALLERGIC REACTION; This spontaneous report received from a consumer concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient has allergies to unspecified medicine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced rash and itching on face, top of the head and all over the body. On 16-MAR-2021, the patient experienced allergic reaction. Laboratory data (dates unspecified) included: Skin test (NR: not provided) Medicine allergy. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from allergic reaction, and rash and itching on face, top of the head and all over the body. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Injection site pain, Nausea, Tinnitus
Clinical narrative: PRESSURE IN HER EARS; LOUDER RINGING IN EARS; QUEASY WHEN STANDS UP TOO FAST; REALLY HURT WHEN VACCINE WAS ADMINISTERED; DIZZY; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 178 pounds, and height was 66 inches. The patient's past medical history included: motion sickness, and concurrent conditions included: herpes, smoker, non alcohol user, and cholesterol, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug. The patient experienced drug allergy when treated with chlorphenamine maleate/phenylpropanolamine hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. Concomitant medications included valaciclovir for herpes, and ergocalciferol. On 29-SEP-2021, the patient experienced dizzy. On 29-SEP-2021, the patient experienced really hurt when vaccine was administered. On an unspecified date, the patient experienced pressure in her ears, louder ringing in ears, and queasy when stands up too fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, louder ringing in ears, pressure in her ears, and queasy when stands up too fast, and the outcome of really hurt when vaccine was administered was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: HERPES SIMPLEX 2 BREAK  OUT; 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 concurrent conditions included: herpes simplex type ii. 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 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient experienced herpes simplex 2 break out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from herpes simplex 2 break out on 26-AUG-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-SEP-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 30-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN THE EARS GOT REALLY LOUD; 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 patient experienced ringing in the ears got really loud. The action taken with covid-19 vaccine was not applicable. The patient recovered from ringing in the ears got really loud. This report was non-serious.  This case, from the same reporter is linked to 20211004089.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: BITTER TASTE (HORRIBLE AND BAD) IN MOUTH UPON EATING; DISTORTION IN TASTE/VILE TASTE; 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 pre-existing medical conditions included: Patient had no health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced bitter taste (horrible and bad) in mouth upon eating. On SEP-2021, the patient experienced distortion in taste/vile taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bitter taste (horrible and bad) in mouth upon eating and distortion in taste/vile taste was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody increased, Blood test abnormal, Burning sensation, Hypoaesthesia, Muscle spasms
Clinical narrative: BITTER TASTE (HORRIBLE AND BAD) IN MOUTH UPON EATING; DISTORTION IN TASTE/VILE TASTE; 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 pre-existing medical conditions included: Patient had no health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced bitter taste (horrible and bad) in mouth upon eating. On SEP-2021, the patient experienced distortion in taste/vile taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bitter taste (horrible and bad) in mouth upon eating and distortion in taste/vile taste was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Spinal X-ray, Taste disorder
Clinical narrative: BITTER TASTE (HORRIBLE AND BAD) IN MOUTH UPON EATING; DISTORTION IN TASTE/VILE TASTE; 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 pre-existing medical conditions included: Patient had no health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced bitter taste (horrible and bad) in mouth upon eating. On SEP-2021, the patient experienced distortion in taste/vile taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bitter taste (horrible and bad) in mouth upon eating and distortion in taste/vile taste was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Ultrasound scan
Clinical narrative: BITTER TASTE (HORRIBLE AND BAD) IN MOUTH UPON EATING; DISTORTION IN TASTE/VILE TASTE; 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 pre-existing medical conditions included: Patient had no health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced bitter taste (horrible and bad) in mouth upon eating. On SEP-2021, the patient experienced distortion in taste/vile taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bitter taste (horrible and bad) in mouth upon eating and distortion in taste/vile taste was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Inappropriate schedule of product administration
Clinical narrative: ADVERSE EVENT NOS; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported, and dose was not reported, administered on 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 an unspecified date, the patient experienced adverse event nos, and inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from adverse event nos, and the outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211004088 and 20211004677.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial paralysis, Fine motor skill dysfunction, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: I received the vaccine on Aug 28th, 2021. I awoke on the morning on September 13th, 2021 with  right side facial paralysis and was immediately taken to ER. I had a stroke work up and was admitted. On September 16th my loss of motor skills had spread to include my right leg.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: I received the vaccine on Aug 28th, 2021. I awoke on the morning on September 13th, 2021 with  right side facial paralysis and was immediately taken to ER. I had a stroke work up and was admitted. On September 16th my loss of motor skills had spread to include my right leg.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Heart rate increased, Presyncope
Clinical narrative: 4:30 PM same day, sudden near syncope, rapid heartrate, chest pain
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Aphasia, Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: September 28: Presented with pain, redness, and swelling at injection site; body aches started that afternoon; slight fever (99.4); shortness of breath (used rescue inhaler once at work and later on that evening) September 29: Presented with pain, redness, and swelling at injection site; body aches; slight fever (99.6) that resolved by that afternoon; increased shortness of breath (used rescue inhaler multiple times that day at least 5 times); that evening difficulty speaking at times (straining to get words out/neck muscles started to contract when speaking)  September 30: Presented with pain, redness, and swelling at injection site; body aches; no fever; increased shortness of breath; continue difficulty speaking September 30: Went to urgent care and was seen at 7:45 am  due to increased shortness of breath and was prescribed Flovent HFA 110 mcg  October 1-2: Continued symptoms as day prior October 3: Increased shortness of breath and difficulty speaking; only redness at injection site October 4: Returned to urgent care around 4pm due to shortness of breath and difficulty speaking; given triamcinolone acetonide injection and prescribed prednisone 50 mg  and instructed to continue with Flovent October 5: shortness of breath is improving
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Muscle contracture, Pain, Speech disorder
Clinical narrative: September 28: Presented with pain, redness, and swelling at injection site; body aches started that afternoon; slight fever (99.4); shortness of breath (used rescue inhaler once at work and later on that evening) September 29: Presented with pain, redness, and swelling at injection site; body aches; slight fever (99.6) that resolved by that afternoon; increased shortness of breath (used rescue inhaler multiple times that day at least 5 times); that evening difficulty speaking at times (straining to get words out/neck muscles started to contract when speaking)  September 30: Presented with pain, redness, and swelling at injection site; body aches; no fever; increased shortness of breath; continue difficulty speaking September 30: Went to urgent care and was seen at 7:45 am  due to increased shortness of breath and was prescribed Flovent HFA 110 mcg  October 1-2: Continued symptoms as day prior October 3: Increased shortness of breath and difficulty speaking; only redness at injection site October 4: Returned to urgent care around 4pm due to shortness of breath and difficulty speaking; given triamcinolone acetonide injection and prescribed prednisone 50 mg  and instructed to continue with Flovent October 5: shortness of breath is improving
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: SORENESS; CHILLS; SMALL FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced soreness, chills, and small fever  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, chills, and small fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: TIRED; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 patient experienced tired, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and injection site pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: TIRED; FEVER FOR A DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tired, and fever for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and fever for a day. This report was non-serious. This case, from the same reporter is linked to 20211004413.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: TIRED; FEVER; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced tired, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20211004362.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: HEADACHE; NAUSEA; This spontaneous report received from a parent via a company representative concerned multiple patients. 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 was not reported, administered on APR-2021 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 patient experienced headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; 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. The patient's past medical history included: covid-19 infection. 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 22-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: STRONG CHEMICAL SMELL IN THE URINE; 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 is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced strong chemical smell in the urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of strong chemical smell in the urine was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hernia, Pain, Psoriasis, Rash papular, Vaccination site pain
Clinical narrative: BILATERAL HERNIA; SORE AFTER COVID VACCINE; MINOR PLAQUE PSORIASIS FLARE UP; COUPLE OF SPOTS WITH TINY BUMPS; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced bilateral hernia, sore after covid vaccine, minor plaque psoriasis flare up, couple of spots with tiny bumps, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from sore after covid vaccine, and vaccination site pain, and had not recovered from bilateral hernia, minor plaque psoriasis flare up, and couple of spots with tiny bumps. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE/TIREDNESS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease.  No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue/tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue/tiredness. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Weight increased
Clinical narrative: FELL; GAIN WEIGHT; This spontaneous report received from a consumer concerned a 35 year old male. The patient's height, and weight were not reported. The patient's past medical history included: chipped bone thumb, gall stone, gall bladder removed, and pain, and concurrent conditions included: depression, anxiety, shaking, urinary urgency, and multiple sclerosis and other pre-existing medical conditions included: The patient was on store brand multivitamins. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included clonazepam, cyanocobalamin, ergocalciferol, escitalopram, fish oil, naproxen sodium, ocrelizumab, oxybutynin. On an unspecified date, the patient experienced fell, and gain weight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fell and gain weight was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Nausea
Clinical narrative: SWOLLEN TONGUE; STOMACH ACHE; CHILLS; NAUSEA; HEADACHE; FATIGUE AGGRAVATED; This spontaneous report received from a consumer concerned a 50 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, intramuscular, 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 patient experienced swollen tongue, stomach ache, chills, nausea, headache, and fatigue aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen tongue, stomach ache, chills, nausea, headache, and fatigue aggravated. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: SWOLLEN TONGUE; STOMACH ACHE; CHILLS; NAUSEA; HEADACHE; FATIGUE AGGRAVATED; This spontaneous report received from a consumer concerned a 50 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, intramuscular, 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 patient experienced swollen tongue, stomach ache, chills, nausea, headache, and fatigue aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen tongue, stomach ache, chills, nausea, headache, and fatigue aggravated. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Pain, Rash
Clinical narrative: DIZZINESS; BODY ACHES; CHEST PAIN; HEADACHE; RASH BREAKING OUT BECAUSE SHE'S ALLERGIC TO SOMETHING IN THE AIR; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 129 pounds, and height was 60 inches. The patient's concurrent conditions included: alcohol user, non smoker, and allergic to something in the air, and other pre-existing medical conditions included: The patient had no known drug allergies and had no drug abuse or illicit use. The patient was not pregnant at the time of vaccination. The patient takes a multi-vitamin, she did not have anything that she knew regarding medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1820096 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced rash breaking out because she's allergic to something in the air. On 01-OCT-2021, the patient experienced dizziness. On 01-OCT-2021, the patient experienced body aches. On 01-OCT-2021, the patient experienced chest pain. On 01-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, headache, body aches, chest pain and rash breaking out because she's allergic to something in the air was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: VACCINATION SITE PAIN/ ARM WAS SORE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfonamide allergy, and moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 15-SEP-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for moderate to severe rheumatoid arthritis.  On SEP-2021, the patient experienced vaccination site pain/ arm was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination site pain/ arm was sore. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Drug hypersensitivity, Pain in extremity
Clinical narrative: VACCINATION SITE PAIN/ ARM WAS SORE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfonamide allergy, and moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 15-SEP-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for moderate to severe rheumatoid arthritis.  On SEP-2021, the patient experienced vaccination site pain/ arm was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination site pain/ arm was sore. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: ARM SORE; ALLERGIC TO SULFUR DRUGS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-SEP-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On SEP-2021, the patient experienced arm sore form covid vaccination. On SEP-2021, the patient experienced allergic to sulfur drugs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from arm sore form covid vaccination, and allergic to sulfur drugs. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Drug hypersensitivity, Pain in extremity
Clinical narrative: ARM SORE; ALLERGIC TO SULFUR DRUGS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-SEP-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On SEP-2021, the patient experienced arm sore form covid vaccination. On SEP-2021, the patient experienced allergic to sulfur drugs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from arm sore form covid vaccination, and allergic to sulfur drugs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK FROM YOUR VACCINE; This spontaneous report received from a patient via a company representative (via social media) 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 is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick from your vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick from your vaccine was not reported. This report was non-serious.