chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 years and 9 months / received / vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are provided are as follows: Health care professional called to report that 7 years and 9 months old patient received Infanrix vaccine, which led to inappropriate age at vaccine administration. No further events were reported at the time of call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Product administered at inappropriate site
Clinical narrative: given into the shoulder joint of the right arm; can hardly use his right arm.; arm / hurts bad (at the injection site area); This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included parkinson's disease and dementia.   On 9th July 2021, the patient received the 1st dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced injected limb mobility decreased and injection site pain. On an unknown date, the outcome of the injected limb mobility decreased and injection site pain were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   The reporter considered the injected limb mobility decreased and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The patient received the dose of Shingrix in right arm and less than 2 weeks after the vaccination the patient's right arm still hurt bad (at the injection site area) and he could hardly use his right arm. The reporter asked if the injection was given intramuscularly in the deltoid muscle,located below the shoulder and he stated that he thinks it was given into the shoulder joint of the right arm,which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received/ first dose / 3 years ago.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable to this report. Pharmacist reported that the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Pharmacist did not have information about the patient. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient is late for the second dose / No second dose provided; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose 2 years ago, from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. The pharmacist reported that a patient was late for the second dose. Till the time of reporting, the patient did not received 2nd dose which led to incomplete course of vaccination. No patient's identifiers provided. No LOT number and expiration date provided. No second dose provided. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix over a year ago / would like the second d; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2020, over a year ago before date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination and would like to receive the 2nd dose now. The pharmacist was unable to provide vaccine details.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Herpes zoster, Injection site vesicles, Pain
Clinical narrative: Suspected vaccination failure; blister at the injection site/painful blisters.; chills; fever; painful rash/rash with blisters/on various parts of their body/ the thigh, lips, buttocks, sides, and arms/always occurs on one side at a time; painful rash/painful blisters.; tingling pins and needles type sensation; outbreaks of what they suspect is Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced recurring outbreaks of what they suspect is shingles since receiving the second dose of shingrix). Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), injection site blisters, chills, fever, rash, pain, tingling and shingles. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the vaccination failure, injection site blisters and shingles were unknown and the outcome of the chills was recovered/resolved and the outcome of the fever, rash, pain and tingling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, injection site blisters, chills, fever, rash, pain, tingling and shingles to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. Patient herself is the reporter. The patient received the 2nd dose of shingrix approximately 2 years ago and experienced fever,chills,painful rash with blisters on the left side within 24 hours of receiving the dose. The patient also experienced blister at injection site. Patient reported had never experienced a shingles outbreak prior to receiving the shingrix vaccine. Patient reported that she did not experienced any symptoms after first dose of shingrix. Patient reported that she had experienced recurring outbreaks of what they suspect is Shingles since receiving the second dose of shingrix. Patient reported that rash typically begun with a tingling pins and needles type sensation before the development of the painful blisters. Patient reported that since receiving the second dose of the Shingrix vaccine, she had experienced rashes on various parts of their body including the thigh, lips, buttocks, sides, and arms. Patient reported that rash always occured on one side at a time (either the right or the left side). Reporter did not consented to follow-up. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; blister at the injection site/painful blisters.; chills; fever; painful rash/rash with blisters/on various parts of their body/ the thigh, lips, buttocks, sides, and arms/always occurs on one side at a time; painful rash/painful blisters.; tingling pins and needles type sensation; outbreaks of what they suspect is Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced recurring outbreaks of what they suspect is shingles since receiving the second dose of shingrix). Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), injection site blisters, chills, fever, rash, pain, tingling and shingles. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the vaccination failure, injection site blisters and shingles were unknown and the outcome of the chills was recovered/resolved and the outcome of the fever, rash, pain and tingling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, injection site blisters, chills, fever, rash, pain, tingling and shingles to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. Patient herself is the reporter. The patient received the 2nd dose of shingrix approximately 2 years ago and experienced fever,chills,painful rash with blisters on the left side within 24 hours of receiving the dose. The patient also experienced blister at injection site. Patient reported had never experienced a shingles outbreak prior to receiving the shingrix vaccine. Patient reported that she did not experienced any symptoms after first dose of shingrix. Patient reported that she had experienced recurring outbreaks of what they suspect is Shingles since receiving the second dose of shingrix. Patient reported that rash typically begun with a tingling pins and needles type sensation before the development of the painful blisters. Patient reported that since receiving the second dose of the Shingrix vaccine, she had experienced rashes on various parts of their body including the thigh, lips, buttocks, sides, and arms. Patient reported that rash always occured on one side at a time (either the right or the left side). Reporter did not consented to follow-up. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Mobility decreased, Muscular weakness
Clinical narrative: UNABLE  TO TURN NECK RIGHT OR LEFT; NEUROMUSCULAR WEAKNESS; PAIN ON LEFT SIDE/ PAIN BELOW CLAVICLE, TOWARD EAR/ PAIN IN DEEP IN CLAVICLE OF NECK; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was physically fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced pain on left side/ pain below clavicle, toward ear/ pain in deep in clavicle of neck. On MAR-2021, the subject experienced neuromuscular weakness. On 23-MAR-2021, the subject experienced unable to turn neck right or left. Treatment medications (dates unspecified) included: ibuprofen, diclofenac, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuromuscular weakness, pain on left side/ pain below clavicle, toward ear/ pain in deep in clavicle of neck, and unable to turn neck right or left. This report was non-serious. The suspected product quality complaint has been confirmed to be voided based on the evaluation/investigation performed. This case, from the same reporter is linked to 20210733561.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: LEFT ARM NUMBNESS SENSATION; LEFT ARM TINGLING SENSATION; SEVERE PAIN AT NIGHT; 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 JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On JUL-2021, the subject experienced left arm numbness sensation. On JUL-2021, the subject experienced left arm tingling sensation. On JUL-2021, the subject experienced severe pain at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm numbness sensation, severe pain at night and left arm tingling sensation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned multiple patients of unspecified age, sex, race and ethnic origin. The weight, height, and medical history of patients were not reported.  The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. The autopsy details were not provided. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210747770-Covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Cognitive disorder, Disturbance in attention, Gait disturbance
Clinical narrative: VISUAL IMPAIRMENT; DOES NOT FEEL AS MENTALLY ALERT OR AS FAST AS SHE WAS BEFORE THE VACCINATION; COGNITIVE DELAY BETWEEN HER THINKING AND ABILITY TO FORMULATE WORDS; DISORIENTED WHILE WALKING; BODY ACHES; FEEL UNBALANCED; WEAKNESS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced feel unbalanced. On APR-2021, the subject experienced weakness. On 06-APR-2021, the subject experienced does not feel as mentally alert or as fast as she was before the vaccination. On 06-APR-2021, the subject experienced cognitive delay between her thinking and ability to formulate words. On 06-APR-2021, the subject experienced disoriented while walking. On an unspecified date, the subject experienced visual impairment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from visual impairment, and the outcome of cognitive delay between her thinking and ability to formulate words, does not feel as mentally alert or as fast as she was before the vaccination, disoriented while walking, body aches, weakness and feel unbalanced was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Visual impairment
Clinical narrative: VISUAL IMPAIRMENT; DOES NOT FEEL AS MENTALLY ALERT OR AS FAST AS SHE WAS BEFORE THE VACCINATION; COGNITIVE DELAY BETWEEN HER THINKING AND ABILITY TO FORMULATE WORDS; DISORIENTED WHILE WALKING; BODY ACHES; FEEL UNBALANCED; WEAKNESS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced feel unbalanced. On APR-2021, the subject experienced weakness. On 06-APR-2021, the subject experienced does not feel as mentally alert or as fast as she was before the vaccination. On 06-APR-2021, the subject experienced cognitive delay between her thinking and ability to formulate words. On 06-APR-2021, the subject experienced disoriented while walking. On an unspecified date, the subject experienced visual impairment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from visual impairment, and the outcome of cognitive delay between her thinking and ability to formulate words, does not feel as mentally alert or as fast as she was before the vaccination, disoriented while walking, body aches, weakness and feel unbalanced was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Illness, Malaise, Nasopharyngitis
Clinical narrative: STARTING TO COME DOWN WITH A COLD; BEEN ILL; TOO SICK TO DO ANYTHING; RUNNING A SERIOUS FEVER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced starting to come down with a cold, been ill, too sick to do anything, running a serious fever, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) on and off 37.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the starting to come down with a cold, running a serious fever, been ill, fatigue and too sick to do anything was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: STARTING TO COME DOWN WITH A COLD; BEEN ILL; TOO SICK TO DO ANYTHING; RUNNING A SERIOUS FEVER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced starting to come down with a cold, been ill, too sick to do anything, running a serious fever, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) on and off 37.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the starting to come down with a cold, running a serious fever, been ill, fatigue and too sick to do anything was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: CHEST PAIN; UNABLE TO SLEEP; FEELING NAUSEOUS; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included nuts allergy, seafood allergy, dog allergy, and cat allergy. 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 22-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JUL-2021, the subject experienced chest pain. On 22-JUL-2021, the subject experienced unable to sleep. On 22-JUL-2021, the subject experienced feeling nauseous. On 22-JUL-2021, the subject experienced headache. On 22-JUL-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, unable to sleep, feeling nauseous, and fatigue on 23-JUL-2021, and had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Central nervous system lesion, Cerebrovascular accident, Hypoaesthesia, Pain
Clinical narrative: STROKE LIKE SYMPTOMS; LESIONS ON HIS BRAIN; EXTREME PAIN; FACE, ARM AND LEG NUMBNESS; 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,1 total, 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, after vaccine administration, a few week later the patient had extreme pain. Few months later he experienced lesions on his brain, stroke like symptoms and face, arm, and leg numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme pain, lesions on his brain, stroke like symptoms, and face, arm, and leg numbness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210752712-COVID-19 VACCINE AD26.COV2.S-stroke like symptoms. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Headache, Increased tendency to bruise, Injection site pain
Clinical narrative: SHORTNESS OF BREATH; BLURRED VISION; LEG SWELLING; TACHYCARDIA; EASY BRUISING; LEG PAIN; HEADACHES; INJECTION SITE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 48 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication.  On 28-MAY-2021, the subject experienced shortness of breath. On 28-MAY-2021, the subject experienced blurred vision. On 28-MAY-2021, the subject experienced leg swelling. On 28-MAY-2021, the subject experienced tachycardia. On 28-MAY-2021, the subject experienced easy bruising. On 28-MAY-2021, the subject experienced leg pain. On 28-MAY-2021, the subject experienced headaches. On 28-MAY-2021, the subject experienced injection site pain. On 28-MAY-2021, the subject experienced weakness. On 06-JUN-2021, Laboratory data included: Duplex ultrasound (NR: not provided) Negative. Treatment medications (dates unspecified) included: tramadol, and naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, blurred vision, tachycardia, easy bruising, headaches, injection site pain, and weakness, and had not recovered from leg pain, and leg swelling. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Tachycardia, Ultrasound Doppler, Vision blurred
Clinical narrative: SHORTNESS OF BREATH; BLURRED VISION; LEG SWELLING; TACHYCARDIA; EASY BRUISING; LEG PAIN; HEADACHES; INJECTION SITE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 48 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication.  On 28-MAY-2021, the subject experienced shortness of breath. On 28-MAY-2021, the subject experienced blurred vision. On 28-MAY-2021, the subject experienced leg swelling. On 28-MAY-2021, the subject experienced tachycardia. On 28-MAY-2021, the subject experienced easy bruising. On 28-MAY-2021, the subject experienced leg pain. On 28-MAY-2021, the subject experienced headaches. On 28-MAY-2021, the subject experienced injection site pain. On 28-MAY-2021, the subject experienced weakness. On 06-JUN-2021, Laboratory data included: Duplex ultrasound (NR: not provided) Negative. Treatment medications (dates unspecified) included: tramadol, and naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, blurred vision, tachycardia, easy bruising, headaches, injection site pain, and weakness, and had not recovered from leg pain, and leg swelling. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: HEADACHE; MUSCLE PAIN; 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 concurrent conditions included arthritis, and fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and muscle pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PNEUMONIA; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 78 year old female. Initial information was processed along with additional information received on 26-JUL-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic obstructive pulmonary disease (COPD), obesity, pneumonia, and atelectasis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 10-APR-2021 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUL-2021, patient was diagnosed with COVID by a confirmed PCR (polymerase chain reaction) test (confirmed covid-19 infection and confirmed clinical vaccination failure) and was hospitalized and was then discharged. Number of days hospitalized was not reported. On 17-JUL-2021 patient went back to the hospital and was still hospitalized. The patient experienced cough, shortness of breath and had low oxygen saturation. On an unspecified date, patient experienced pneumonia. Since the patient had an underlying condition of pneumonia, according to reporter it was not clear if the pneumonia was caused by COPD or due to COVID. On unspecified date in JUL-2021, laboratory data included: Oxygen saturation (NR: not provided) low. The patient was hospitalized for the events of pneumonia and confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000187079.; Sender's Comments: V0-20210752946- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20210752946- covid-19 vaccine ad26.cov2.s -Confirmed covid-19 infection, Pneumonia . These events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: ENTIRE LEFT ARM IS FEELING ACHEY; MUSCLE ACHE AT INJECTION SITE; 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, the subject experienced entire left arm is feeling achey. On 22-JUL-2021, the subject experienced muscle ache at injection site. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from entire left arm is feeling achey, and muscle ache at injection site. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: FATIGUE; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUL-2021 at 11:30 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, the subject experienced fatigue. On 23-JUL-2021, the subject experienced headache. On 23-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, headache, and fever. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 72 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: 1805025, and expiry: unknown) frequency one total, dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies to COVID-19. On 06-JUL-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies to COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210753139- Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Somnolence
Clinical narrative: PATIENT FELT GROGGY; VACCINE VIAL KEPT IN THE FRIDGE FOR MORE THAN 6 HOURS OF BEING PUNCTURED; EXPIRED DOSE RECEIVED; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 24-JUL-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the subject experienced expired dose received. On an unspecified date, the subject experienced subject felt groggy, and vaccine vial kept in the fridge for more than 6 hours of being punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired dose received, patient felt groggy and vaccine vial kept in the fridge for more than 6 hours of being punctured was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: NOT FEELING WELL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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. On 25-JUL-2021, Laboratory data included COVID-19 antigen test positive (NR: not provided) Positive. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT UNSPECIFIED; This spontaneous report received from a patient concerned an 82 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event unspecified was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza, Vomiting
Clinical narrative: DIARRHEA; THROWING UP; FLU SYMPTOMS(CHILLS, FEVER, HEADACHE, MUSCLE PAIN, TERRIBLE TIREDNESS); This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included fibromyalgia, and broken hip, and concurrent conditions included lupus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: 07-AUG-2021) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, the subject experienced diarrhea. On 22-JUL-2021, the subject experienced throwing up. On 22-JUL-2021, the subject experienced flu symptoms (chills, fever, headache, muscle pain, terrible tiredness). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 26-JUL-2021, and was recovering from throwing up, and flu symptoms(chills, fever, headache, muscle pain, terrible tiredness). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: MEMORY PROBLEMS; This spontaneous report received from a consumer concerned a 6 decade 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced memory problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from memory problems. This report was non-serious. This case, from the same reporter is linked to 20210755330.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VIAL STORED IN THE REFRIGERATOR AT 2 TO 8 DEGREES CELSIUS BEYOND 6 HOURS; ADMINISTERED VACCINE FROM A VIAL STORED IN THE REFRIGERATOR AT 2 TO 8 DEGREES CELSIUS BEYOND 6 HOURS; 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: 03-AUG-2021) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUL-2021, the subject experienced vial stored in the refrigerator at 2 to 8 degrees celsius beyond 6 hours. On 23-JUL-2021, the subject experienced administered vaccine from a vial stored in the refrigerator at 2 to 8 degrees celsius beyond 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial stored in the refrigerator at 2 to 8 degrees celsius beyond 6 hours and administered vaccine from a vial stored in the refrigerator at 2 to 8 degrees celsius beyond 6 hours was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Chills, Insomnia, Night sweats
Clinical narrative: MEMORY LOSS (SOMETIMES CAN'T REMEMBER THINGS); SORENESS THROUGHOUT THE BODY; INSOMNIA/CAN'T SLEEP; PAIN IN RIGHT ELBOW IS GETTING WORSE; CHILLS AFTER WIPING AWAY SWEAT AT NIGHT; HEAVY SWEATING AT NIGHT (DESCRIBING IT AS LITERALLY SWEATING BUCKETS, HAVE TO SLEEP ON TOWELS AND CAN'T SLEEP); This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no medical history, no known drug allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep). On 27-JUN-2021, the subject experienced soreness throughout the body. On 27-JUN-2021, the subject experienced insomnia/can't sleep. On 27-JUN-2021, the subject experienced pain in right elbow is getting worse. On 27-JUN-2021, the subject experienced chills after wiping away sweat at night. On 13-JUL-2021, the subject experienced memory loss (sometimes can't remember things). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep), memory loss (sometimes can't remember things), soreness throughout the body, insomnia/can't sleep, chills after wiping away sweat at night, and pain in right elbow is getting worse. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: MEMORY LOSS (SOMETIMES CAN'T REMEMBER THINGS); SORENESS THROUGHOUT THE BODY; INSOMNIA/CAN'T SLEEP; PAIN IN RIGHT ELBOW IS GETTING WORSE; CHILLS AFTER WIPING AWAY SWEAT AT NIGHT; HEAVY SWEATING AT NIGHT (DESCRIBING IT AS LITERALLY SWEATING BUCKETS, HAVE TO SLEEP ON TOWELS AND CAN'T SLEEP); This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no medical history, no known drug allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep). On 27-JUN-2021, the subject experienced soreness throughout the body. On 27-JUN-2021, the subject experienced insomnia/can't sleep. On 27-JUN-2021, the subject experienced pain in right elbow is getting worse. On 27-JUN-2021, the subject experienced chills after wiping away sweat at night. On 13-JUL-2021, the subject experienced memory loss (sometimes can't remember things). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep), memory loss (sometimes can't remember things), soreness throughout the body, insomnia/can't sleep, chills after wiping away sweat at night, and pain in right elbow is getting worse. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: BACK PAIN; SWEATS (SOAKED BED SHEETS); FEVER TO 103F; FATIGUED; This spontaneous report received from a parent via a company representative concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-JUL-2021, the subject experienced sweats (soaked bed sheets). On 23-JUL-2021, the subject experienced fever to 103f. On 23-JUL-2021, the subject experienced fatigued. Laboratory data included: Body temperature (NR: not provided) 103 F. On 24-JUL-2021, the subject experienced back pain. 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 back pain, sweats (soaked bed sheets), fever to 103f, and fatigued on 25-JUL-2021. This report was non-serious.