chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: DIARRHEA, WENT TO THE BATHROOM 4 TIMES; NAUSEA; BODY WAS UNCOMFORTABLE; FEELING OF 5TH DIMENSION, LIKE FLOATING IN THE SKY; DID NOT FEEL LIKE DOING ANYTHING; CHILLS AS DAY WENT ON; WOKE UP WITH NOT FEELING WELL/ GENERAL MALAISE; This spontaneous report received from a patient concerned an 83 year old white male of unspecified ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine(dose number in series 1) (suspension for injection, route of admin not reported, and batch number were not reported) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No adverse event reported following vaccination with covid-19 vaccine. The patient received covid-19 vaccine (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 04-NOV-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 05-NOV-2021 Patient began to experience side effects. woke up not feeling well 12th at night, chills as day went on, nausea, but no vomiting. Claimed that he did not feel body pain, but stated that body was uncomfortable. Patient felt that he was in a 5th dimension, like he was floating in the sky. He did not feel like doing anything that day. On 06-NOV-2021, nausea and chills stopped, but general malaise continued. Night from Saturday 06-NOV-2021 to Sunday 07-NOV-2021, patient had diarrhea an went to the bathroom 4 times. He had not taken anything to stop the diarrhea and the diarrhea is resolving itself. Nothing else was taken to relieve other symptoms. The action taken with covid-19 vaccine was not applicable. The patient recovered from body was uncomfortable, and feeling of 5th dimension, like floating in the sky, and chills as day went on, and nausea on 06-NOV-2021, was recovering from diarrhea, went to the bathroom 4 times, had not recovered from woke up with not feeling well/ general malaise, and the outcome of did not feel like doing anything was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Tremor, Vertigo
Clinical narrative: UNCONTROLLABLE SHAKING; VERTIGO; DIZZINESS; HEART RATE ELEVATED; FEELING COLD AS HECK LIKE A FREEZING SENSATION; SHOT HURT LIKE HECK; LOT OF MUSCLE PAIN ESPECIALLY IN UPPER BACK ALONG THE SPINATUS MUSCLE; This spontaneous report received from a patient concerned a 60 year old adult male. The patient's weight was 127 pounds, and height was 68 inches. The patient's pre-existing medical conditions included: The patient was exposed to 5FU (Fluorouracil) and faced respiratory issue. The patient was previously on a steroid breather to help with his breathing. The patient received vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration was not reported, and batch number: 1802070 and expiry: Unknown ) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. On unspecified date following vaccination with covid-19 vaccine ad26.cov2.s (series 1), the patient experienced calf pains, calfs was enlarged and edema of ankles. Calf pains are resolved. calf swelling not recovered and outcome of ankle edema was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received covid-19 vaccine ad26.cov2.s (Dose number series 2) (suspension for injection, route of administration was not reported, batch number: 1822811 expiry: Unknown) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination.  On AUG-2021, The patient had a full workup done. On 09-NOV-2021, the patient had uncontrollable shaking, the patient stated the shot hurt like heck and that he can tolerate a lot of pain. On the same day he was experiencing a lot of muscle pain especially in his upper back along the spinatus muscle. He stated that his blood pressure was normal but that his heart rate seems elevated which he stated he usually has a heart rate of 45 beats per minutes (bpm) but that it was at 68-70 beats per minutes (bpm). Patient stated that he was experiencing vertigo and dizziness as well. He stated that he was feeling cold as heck, like a freezing sensation. but that his temperature was normal. He stated that he was allergic to Chloramphenicol, takes Flomax 0.4mg daily, Losartan 50mg daily, Amlodipine 10mg daily, Motrin as needed.  Laboratory data included: Blood pressure and Body temperature was normal. Cholesterol was 130 mg/dL, and Heart rate was 68-70 beats per minutes (bpm). On unspecified date unspecified laboratory tests showed with no blood clots, patient feels its possible that the smaller veins may have had clots but did not show up on measurable tests, and Pain scale 1 to 2 or more out of 4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling cold as heck like a freezing sensation, vertigo, shot hurt like heck, lot of muscle pain especially in upper back along the spinatus muscle, dizziness, and heart rate elevated, and the outcome of uncontrollable shaking was not reported. This report was non-serious. This case, involving the same patient is linked to 20211165581.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: VERTIGO; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date in MAY-2021, the patient was previously treated with covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown), 1 in total, dose was not reported (dose series 1) for prophylactic vaccination. Following vaccination with covid-19 vaccine , the patient tasted a metal taste in mouth and patient arm was a bit sore (dose series 1). On an unspecified date in AUG-2021, the patient suddenly began having vertigo (dose series 1).   The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown), 1 in total, dose was not reported (dose series 2), administered on 01-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On 05-NOV-2021, following vaccination with booster (dose series 2) of covid-19 vaccine, the patient experienced recurrence of vertigo (dose series 2). As per the report, patient stated that the vertigo started to get worse again on 05-NOV-2021 and 06-NOV-2021 and patient also stated that she "feels like I did when I first got it back in AUG-2021" (dose series 1).  The action taken with covid-19 vaccine as not applicable.  The outcome of vertigo  was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211118821.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Fall, Ill-defined disorder, Injection site pain
Clinical narrative: LOSS BOWEL CONTROL; LOSS BLADDER CONTROL; FALL OFF HER SEAT; WEAK MUSCLES IN ARM AND LEGS/ DID NOT HAVE ANY MUSCLES STRENGTH IN THE ARM AND LEGS; PAIN AT SITE OF INJECTION; EXTREMELY WEAK; COULDN'T GET UP FROM CHAIR; This spontaneous report received from a patient concerned an 89 year old female.  The patient's height, and weight were not reported. The patient's past medical history included: shoulder replacement surgery (date not specified), and hip replacement, and concurrent conditions included: orthopedic problems, and failed meniscus in right knee. The patient reported that she was young and healthy.  The patient was previously treated with influenza vaccine for prophylactic vaccination in SEP-2021.  On 03-APR-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (dose series 1).   The patient subsequently received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 in total, administered on 27-OCT-2021 around noon for prophylactic vaccination on her right arm (dose series 2). No concomitant medications were reported.  On 27-OCT-2021,around 23:30 that night the patient couldn't get up from her chair and had no muscles strength in the arm and legs/ weak muscles in arm and legs. She felt extremely weak. The patient fell off her seat and experienced loss of bladder control and bowels control. The patient pressed her emergency button to call paramedics who arrived right away and they were able to get her up. The patient was not taken to the hospital as she wasn't hurt. The paramedics helped the patient to get her walker from the garage. The patient had some problem in the past but never felt that weak.  The patient reported she had shoulder replacement surgery recently and was sleeping on a mechanical chair. The patient got up several times during the night but she felt weak.  By the morning she was better but reported it was almost four days for her "to return to normal self". The patient also experienced pain at the site of injection that was shadowed in the morning on 28-OCT-2021 (dose series 2).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from loss bowel control, loss bladder control, and weak muscles in arm and legs/ did not have any muscles strength in the arm and legs on an unspecified date, and recovered from pain at site of injection on 28-OCT-2021. The outcome for  extremely weak, of fall off her seat, and couldn't get up from chair  was not reported.  This report was non-serious.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Urinary incontinence
Clinical narrative: LOSS BOWEL CONTROL; LOSS BLADDER CONTROL; FALL OFF HER SEAT; WEAK MUSCLES IN ARM AND LEGS/ DID NOT HAVE ANY MUSCLES STRENGTH IN THE ARM AND LEGS; PAIN AT SITE OF INJECTION; EXTREMELY WEAK; COULDN'T GET UP FROM CHAIR; This spontaneous report received from a patient concerned an 89 year old female.  The patient's height, and weight were not reported. The patient's past medical history included: shoulder replacement surgery (date not specified), and hip replacement, and concurrent conditions included: orthopedic problems, and failed meniscus in right knee. The patient reported that she was young and healthy.  The patient was previously treated with influenza vaccine for prophylactic vaccination in SEP-2021.  On 03-APR-2021, the patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (dose series 1).   The patient subsequently received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 in total, administered on 27-OCT-2021 around noon for prophylactic vaccination on her right arm (dose series 2). No concomitant medications were reported.  On 27-OCT-2021,around 23:30 that night the patient couldn't get up from her chair and had no muscles strength in the arm and legs/ weak muscles in arm and legs. She felt extremely weak. The patient fell off her seat and experienced loss of bladder control and bowels control. The patient pressed her emergency button to call paramedics who arrived right away and they were able to get her up. The patient was not taken to the hospital as she wasn't hurt. The paramedics helped the patient to get her walker from the garage. The patient had some problem in the past but never felt that weak.  The patient reported she had shoulder replacement surgery recently and was sleeping on a mechanical chair. The patient got up several times during the night but she felt weak.  By the morning she was better but reported it was almost four days for her "to return to normal self". The patient also experienced pain at the site of injection that was shadowed in the morning on 28-OCT-2021 (dose series 2).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from loss bowel control, loss bladder control, and weak muscles in arm and legs/ did not have any muscles strength in the arm and legs on an unspecified date, and recovered from pain at site of injection on 28-OCT-2021. The outcome for  extremely weak, of fall off her seat, and couldn't get up from chair  was not reported.  This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: MUSCLE WEAKNESS, WEAKNESS IN USE OF THE ARM; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (unspecified manufacturer) on an unspecified date.  The patient subsequently received  covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, 1 in total, administered on 26-OCT-2021 as a booster for prophylactic vaccination on her left arm (dose series 2). No concomitant medications were reported.  On 02-NOV-2021, the patient experienced muscle weakness, weakness in use of the arm and pain at injection site. Patient stated that after about a week her arm pain and muscle weakness became progressively worse.  Patient stated that she had not taken any medication or treatment for this condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, and muscle weakness, weakness in use of the arm. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lymph node pain, Malaise, Neck pain, Pain in extremity
Clinical narrative: SORE GLAND ON NECK/ GLAND SORE TO TOUCH; SORE NECK; TENDERNESS/ INFLAMMED GLAND ON  LEFT SIDE OF NECK; FLU LIKE SYMPTOMS; NOT FEELING WELL; SORE ARM; This spontaneous report received from a patient concerned a 64-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies and minor asthma. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination on 13-MAR-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: Unknown) dose was not reported, 1 total administered at left arm (left shoulder) on 26-OCT-2021 for prophylactic vaccination (Booster dose). Concomitant medications included losartan for blood pressure, montelukast sodium for minor asthma, and loratadine/ pseudoephedrine for seasonal allergies.  On 26-OCT-2021, the patient experienced sore arm. On 28-Oct-2021, after the booster dose minor flu like symptoms started without fever, body chills, and was not feeling well. The event lasted 18-24 hours. On 28-Oct-2021, the patient experienced sore gland in neck (Sore Neck), while had no issues with breathing or swallowing, was sore to touch inflamed (tenderness/ inflamed gland on left side of neck). The patient was little concerned but it resolved after 3 -4 days. All events resumed to normal and the patient mentioned it was an immune system reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore gland on neck/ gland sore to touch, sore neck, and tenderness/ inflamed gland on left side of neck on 02-NOV-2021, flu like symptoms and not feeling well on 29-OCT-2021, and sore arm on 27-OCT-2021. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: SORE GLAND ON NECK/ GLAND SORE TO TOUCH; SORE NECK; TENDERNESS/ INFLAMMED GLAND ON  LEFT SIDE OF NECK; FLU LIKE SYMPTOMS; NOT FEELING WELL; SORE ARM; This spontaneous report received from a patient concerned a 64-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies and minor asthma. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination on 13-MAR-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: Unknown) dose was not reported, 1 total administered at left arm (left shoulder) on 26-OCT-2021 for prophylactic vaccination (Booster dose). Concomitant medications included losartan for blood pressure, montelukast sodium for minor asthma, and loratadine/ pseudoephedrine for seasonal allergies.  On 26-OCT-2021, the patient experienced sore arm. On 28-Oct-2021, after the booster dose minor flu like symptoms started without fever, body chills, and was not feeling well. The event lasted 18-24 hours. On 28-Oct-2021, the patient experienced sore gland in neck (Sore Neck), while had no issues with breathing or swallowing, was sore to touch inflamed (tenderness/ inflamed gland on left side of neck). The patient was little concerned but it resolved after 3 -4 days. All events resumed to normal and the patient mentioned it was an immune system reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore gland on neck/ gland sore to touch, sore neck, and tenderness/ inflamed gland on left side of neck on 02-NOV-2021, flu like symptoms and not feeling well on 29-OCT-2021, and sore arm on 27-OCT-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned 3 patients.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patients were previously treated with covid-19 vaccine (dose number in series 1) for prophylactic vaccination. No adverse events associated with pervious covid-19 vaccine were reported. (unspecified manufacturer)  The patient received an additional company suspect covid-19 vaccine ad26.cov2.s (dose number in series 2)(suspension for injection, intramuscular, batch number was not reported) 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 following vaccination with covid-19 vaccine ad26.cov2.s, three doses of expired vaccine were given to three patients as booster. (dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of expired vaccine used was not reported.  This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dizziness, Fall, Fatigue
Clinical narrative: CHILLS; FEVER (A LITTLE TEMPERATURE); LIGHTHEADED/ DIZZY; SLEEPY; FELL AGAINST THE WALL; SORE ARM; TIRED; This spontaneous report received from a patient via company representative on 10-NOV-2021 concerned a 52 years old female. The patient's height, and weight were not reported. The patient's past medical history included: previous fall, and concurrent conditions included: epilepsy, and shoulder dislocation. 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021 (one day after vaccination), the patient had a sore arm and felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the events of sore arm and felt tired was not reported. Additionally the patient received non-company suspect vaccine included: bnt 162 ( form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 04-NOV-2021 14:15 for prophylactic vaccination as booster dose. On 04-NOV-2021, the patient experienced lightheaded/ dizzy and fell against a wall and was also feeling sluggish/tired and sleepy. On 05-NOV-2021, the patient experienced chills and fever (a little temperature). Laboratory data included: Body temperature (NR: not provided).  The action taken with bnt 162 was not applicable. The patient was recovering from chills, and fever (a little temperature), and the outcome for the events of tired, lightheaded/dizzy, sleepy and fell against a wall was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: CHILLS; FEVER (A LITTLE TEMPERATURE); LIGHTHEADED/ DIZZY; SLEEPY; FELL AGAINST THE WALL; SORE ARM; TIRED; This spontaneous report received from a patient via company representative on 10-NOV-2021 concerned a 52 years old female. The patient's height, and weight were not reported. The patient's past medical history included: previous fall, and concurrent conditions included: epilepsy, and shoulder dislocation. 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAR-2021 (one day after vaccination), the patient had a sore arm and felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the events of sore arm and felt tired was not reported. Additionally the patient received non-company suspect vaccine included: bnt 162 ( form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 04-NOV-2021 14:15 for prophylactic vaccination as booster dose. On 04-NOV-2021, the patient experienced lightheaded/ dizzy and fell against a wall and was also feeling sluggish/tired and sleepy. On 05-NOV-2021, the patient experienced chills and fever (a little temperature). Laboratory data included: Body temperature (NR: not provided).  The action taken with bnt 162 was not applicable. The patient was recovering from chills, and fever (a little temperature), and the outcome for the events of tired, lightheaded/dizzy, sleepy and fell against a wall was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Breast pain, Breast swelling
Clinical narrative: ELEVATED BLOOD PRESSURE; FAINTING; STINGING PAIN ALL OVER THE BODY/ BODY ACHES; BLURRY VISION IN LEFT EYE; PERIPHERAL VISION AFFECTED; HEADACHE; BREAST AREA SWOLLEN (LEFT ARM UNDERNEATH); BREAST PAIN (ON LEFT UNDER SIDE ARM BESIDE BREAST); DIZZINESS/ LIGHT HEADNESS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 43 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: asthma, and hypoglycemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: unknown) dose was not reported, 1 total, administered on left arm at 11-NOV-2021 for prophylactic vaccination  (Dose number in series 1). No concomitant medications were reported.  On 21-NOV-2021, the patient experienced low grade fever.  On 23-NOV-2021, the patient experienced breast area swollen (left arm underneath), breast pain (on left under side arm beside breast) and dizziness/ light headness.  On 24-NOV-2021, the patient experienced blurry vision in left eye, peripheral vision affected, headache.  On 25-NOV-2021, the patient experienced stinging pain all over the body/ body aches (in front part of thigh/right leg, behind the knee on right knee, pains in stomach meeting chest area, chest pain and elbow and mid forearm, pain in mid-back on right side). On 27-NOV-2021, the patient experienced fainting, could not look down to see floor, paramedics called and offered ride to hospital which the patient declined. On an unspecified date, the patient experienced elevated blood pressure.  Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 171/90 ELEVATED, and Body temperature (NR: not provided) 100.2 F. 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 breast area swollen (left arm underneath), and breast pain (on left under side arm beside breast) on 25-NOV-2021, and low grade fever on 23-NOV-2021, was recovering from dizziness/ light headness, headache, stinging pain all over the body/ body aches, blurry vision in left eye, peripheral vision affected, and fainting, and the outcome of elevated blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211201944-Covid-19 vaccine ad26.cov2.s -Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia, Syncope
Clinical narrative: ELEVATED BLOOD PRESSURE; FAINTING; STINGING PAIN ALL OVER THE BODY/ BODY ACHES; BLURRY VISION IN LEFT EYE; PERIPHERAL VISION AFFECTED; HEADACHE; BREAST AREA SWOLLEN (LEFT ARM UNDERNEATH); BREAST PAIN (ON LEFT UNDER SIDE ARM BESIDE BREAST); DIZZINESS/ LIGHT HEADNESS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 43 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: asthma, and hypoglycemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: unknown) dose was not reported, 1 total, administered on left arm at 11-NOV-2021 for prophylactic vaccination  (Dose number in series 1). No concomitant medications were reported.  On 21-NOV-2021, the patient experienced low grade fever.  On 23-NOV-2021, the patient experienced breast area swollen (left arm underneath), breast pain (on left under side arm beside breast) and dizziness/ light headness.  On 24-NOV-2021, the patient experienced blurry vision in left eye, peripheral vision affected, headache.  On 25-NOV-2021, the patient experienced stinging pain all over the body/ body aches (in front part of thigh/right leg, behind the knee on right knee, pains in stomach meeting chest area, chest pain and elbow and mid forearm, pain in mid-back on right side). On 27-NOV-2021, the patient experienced fainting, could not look down to see floor, paramedics called and offered ride to hospital which the patient declined. On an unspecified date, the patient experienced elevated blood pressure.  Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 171/90 ELEVATED, and Body temperature (NR: not provided) 100.2 F. 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 breast area swollen (left arm underneath), and breast pain (on left under side arm beside breast) on 25-NOV-2021, and low grade fever on 23-NOV-2021, was recovering from dizziness/ light headness, headache, stinging pain all over the body/ body aches, blurry vision in left eye, peripheral vision affected, and fainting, and the outcome of elevated blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211201944-Covid-19 vaccine ad26.cov2.s -Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual field defect
Clinical narrative: ELEVATED BLOOD PRESSURE; FAINTING; STINGING PAIN ALL OVER THE BODY/ BODY ACHES; BLURRY VISION IN LEFT EYE; PERIPHERAL VISION AFFECTED; HEADACHE; BREAST AREA SWOLLEN (LEFT ARM UNDERNEATH); BREAST PAIN (ON LEFT UNDER SIDE ARM BESIDE BREAST); DIZZINESS/ LIGHT HEADNESS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 43 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: asthma, and hypoglycemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: unknown) dose was not reported, 1 total, administered on left arm at 11-NOV-2021 for prophylactic vaccination  (Dose number in series 1). No concomitant medications were reported.  On 21-NOV-2021, the patient experienced low grade fever.  On 23-NOV-2021, the patient experienced breast area swollen (left arm underneath), breast pain (on left under side arm beside breast) and dizziness/ light headness.  On 24-NOV-2021, the patient experienced blurry vision in left eye, peripheral vision affected, headache.  On 25-NOV-2021, the patient experienced stinging pain all over the body/ body aches (in front part of thigh/right leg, behind the knee on right knee, pains in stomach meeting chest area, chest pain and elbow and mid forearm, pain in mid-back on right side). On 27-NOV-2021, the patient experienced fainting, could not look down to see floor, paramedics called and offered ride to hospital which the patient declined. On an unspecified date, the patient experienced elevated blood pressure.  Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 171/90 ELEVATED, and Body temperature (NR: not provided) 100.2 F. 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 breast area swollen (left arm underneath), and breast pain (on left under side arm beside breast) on 25-NOV-2021, and low grade fever on 23-NOV-2021, was recovering from dizziness/ light headness, headache, stinging pain all over the body/ body aches, blurry vision in left eye, peripheral vision affected, and fainting, and the outcome of elevated blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211201944-Covid-19 vaccine ad26.cov2.s -Fainting. 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: Expired product administered
Clinical narrative: ADMINISTRATION ERROR, ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 21-SEP-2021) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced administration error, administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error, administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Limb amputation, Thrombosis
Clinical narrative: ENORMOUS BLOOD CLOT IN LEGS; LIMB AMPUTATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 (series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in the period of end of JUN-2021 and at the start of JUL-2021, patient's foot was swollen and was turning purple along with legs. The patient went to the hospital and they found enormous blood clot in legs they had to amputate it. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the enormous blood clot in legs and limb amputation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211203989-Covid-19 vaccine ad26.cov2.s-Enormous blood clot in legs, limb amputation. 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: Adverse event, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: SEVERE UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) dose was not reported, 1 total, Janssen series 1, 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 since vaccination, patient experienced severe unspecified adverse event and was admitted to the hospital (date unspecified). The patient had received 6 blood transfusion. The patient was unable to return to work at that time out for 7 weeks. The patient had numerous visits to physician and hospital. The patient had numerous Magnetic resonance imaging (MRI), Computed tomography scan (CT scan) and huge hospital bills. Consumer reported that vaccine was unsafe and should never had been approved. Consumer missed numerous days of work and more need to be missed. Number of hospitalization days were not reported. Laboratory data (dates unspecified) included: CT scan (NR: not provided) not reported, and MRI (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe unspecified adverse event was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211205582-COVID-19 VACCINE AD26.COV2.S-severe unspecified adverse event. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error was not reported. This report was non-serious.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: BODY ACHES; CHILLS; FEVERING; This spontaneous report received from a patient concerned a 35 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, Laboratory data included: COVID-19 virus test (NR: not provided) virus detected. On 01-DEC-2021, the patient experienced body aches. On 01-DEC-2021, the patient experienced chills. On 01-DEC-2021, the patient experienced fevering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fevering, chills, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: TERRIBLY SICK AND HE CAN STILL FEEL IT YET; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced terribly sick and he can still feel it yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terribly sick and he can still feel it yet. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: FEELING A LITTLE BLAH; FEVER; 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, 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 feeling a little blah, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and feeling a little blah was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: VACCINATION IN (PRIVACY) WAY USING AN AIR GUN INSTEAD OF NEEDLE; 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. 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 vaccination in (privacy) way using an air gun instead of needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination in (privacy) way using an air gun instead of needle was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Liver disorder
Clinical narrative: SOMETHING GOING ON WITH LIVER AND LIVER NUMBERS ARE REALLY HIGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No personal or family history of liver issues. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced something going on with liver and liver numbers are really high. Laboratory data (dates unspecified) included: Lab test (NR: not provided) liver numbers are high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of something going on with liver and liver numbers are really high was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: DRUG USE FOR UNAPPROVED POPULATION; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 29-MAY-2021, the patient experienced drug use for unapproved population. On 29-MAY-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug use for unapproved population and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PREFILLED SYRINGE VACCINE WAS GIVEN 9 HOURS AFTER BEING DRAWN INTO SYRINGE; STORED AT ROOM TEMPERATURE FOR 9 HOURS BEFORE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204B21A expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced prefilled syringe vaccine was given 9 hours after being drawn into syringe. On 01-DEC-2021, the patient experienced stored at room temperature for 9 hours before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the prefilled syringe vaccine was given 9 hours after being drawn into syringe and stored at room temperature for 9 hours before administration was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nephropathy, Occipital neuralgia, Platelet disorder
Clinical narrative: NEPHROPATHY; RIGHT SIDED OCCIPITAL NEURALGIA; PLATELET ISSUES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced nephropathy, right sided occipital neuralgia, and platelet issues. Treatment medications (dates unspecified) included: propranolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nephropathy, right sided occipital neuralgia, and platelet issues. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Rash erythematous, Swelling face, Swelling of eyelid
Clinical narrative: SWOLLEN EYE LID; SWOLLEN LIPS; SWOLLEN CHEEKS; RED SPOTS UNDER HAIR-LOOKED BURNED; ALLERGIC REACTION X 10 DAYS; HIVES; 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 MAY-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 an unspecified date, the patient experienced swollen eye lid, swollen lips, swollen cheeks, red spots under hair-looked burned, allergic reaction x 10 days, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction x 10 days, swollen eye lid, swollen lips, swollen cheeks, hives and red spots under hair-looked burned was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: SWOLLEN EYE LID; SWOLLEN LIPS; SWOLLEN CHEEKS; RED SPOTS UNDER HAIR-LOOKED BURNED; ALLERGIC REACTION X 10 DAYS; HIVES; 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 MAY-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 an unspecified date, the patient experienced swollen eye lid, swollen lips, swollen cheeks, red spots under hair-looked burned, allergic reaction x 10 days, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction x 10 days, swollen eye lid, swollen lips, swollen cheeks, hives and red spots under hair-looked burned was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; This spontaneous report received from a patient concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, 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 arm pain. The action taken with covid-19 vaccine was not applicable. The outcome of arm pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211206963.