chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Eye pain, Feeling abnormal, Gait disturbance
Clinical narrative: Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER,  twenty-one (21) days later, both eyes were extremely painful to move. Then I lost vision in right eye with extreme blurriness & partial blind spots resulting in a diagnosis of Optic Neuritis by Ophthalmologist and Neurologist. Confirmed optic Neuritis on MRI scan.  Twenty-four (24) days later, numbness in legs, feet and right arm started. Hard to walk up and down stairs. Twenty-six (26) days later, extreme pain in in muscles and skin along with tingles all over and numbness. Weakness and Chest pain. Flu like symptoms without fever ie: aches, pains, skin pain, confusion. Dizziness, feeling of being extremely anxious and out of sorts in space. Had to complete round of Steroids and numbness and tingles got better, but did not dissolve. After completion of IV steroids, thirty-four (34) days later all symptoms returned full force and worsening. Checked into ER 4/10 and admitted into hospital. Have not been able to complete normal routine or work level since March 27th due to neurological disturbance and symptoms.   Two (2) Eye exams, 3/30/21 confirming swollen optic nerves.  MRI 3/31/21 Blood work 4/2/21 CoVid Test 4/9/21 Negative  Hospital: April 10-12th.  MRI Extensive Blood work Spinal Tap Neuro-Opt exam  Outcome pending and further treatment pending results.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Influenza like illness, Loss of personal independence in daily activities, Lumbar puncture
Clinical narrative: Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER,  twenty-one (21) days later, both eyes were extremely painful to move. Then I lost vision in right eye with extreme blurriness & partial blind spots resulting in a diagnosis of Optic Neuritis by Ophthalmologist and Neurologist. Confirmed optic Neuritis on MRI scan.  Twenty-four (24) days later, numbness in legs, feet and right arm started. Hard to walk up and down stairs. Twenty-six (26) days later, extreme pain in in muscles and skin along with tingles all over and numbness. Weakness and Chest pain. Flu like symptoms without fever ie: aches, pains, skin pain, confusion. Dizziness, feeling of being extremely anxious and out of sorts in space. Had to complete round of Steroids and numbness and tingles got better, but did not dissolve. After completion of IV steroids, thirty-four (34) days later all symptoms returned full force and worsening. Checked into ER 4/10 and admitted into hospital. Have not been able to complete normal routine or work level since March 27th due to neurological disturbance and symptoms.   Two (2) Eye exams, 3/30/21 confirming swollen optic nerves.  MRI 3/31/21 Blood work 4/2/21 CoVid Test 4/9/21 Negative  Hospital: April 10-12th.  MRI Extensive Blood work Spinal Tap Neuro-Opt exam  Outcome pending and further treatment pending results.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal, Myalgia, Neurological examination abnormal, Neurological symptom, Ophthalmological examination abnormal
Clinical narrative: Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER,  twenty-one (21) days later, both eyes were extremely painful to move. Then I lost vision in right eye with extreme blurriness & partial blind spots resulting in a diagnosis of Optic Neuritis by Ophthalmologist and Neurologist. Confirmed optic Neuritis on MRI scan.  Twenty-four (24) days later, numbness in legs, feet and right arm started. Hard to walk up and down stairs. Twenty-six (26) days later, extreme pain in in muscles and skin along with tingles all over and numbness. Weakness and Chest pain. Flu like symptoms without fever ie: aches, pains, skin pain, confusion. Dizziness, feeling of being extremely anxious and out of sorts in space. Had to complete round of Steroids and numbness and tingles got better, but did not dissolve. After completion of IV steroids, thirty-four (34) days later all symptoms returned full force and worsening. Checked into ER 4/10 and admitted into hospital. Have not been able to complete normal routine or work level since March 27th due to neurological disturbance and symptoms.   Two (2) Eye exams, 3/30/21 confirming swollen optic nerves.  MRI 3/31/21 Blood work 4/2/21 CoVid Test 4/9/21 Negative  Hospital: April 10-12th.  MRI Extensive Blood work Spinal Tap Neuro-Opt exam  Outcome pending and further treatment pending results.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis, Pain, Pain of skin, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER,  twenty-one (21) days later, both eyes were extremely painful to move. Then I lost vision in right eye with extreme blurriness & partial blind spots resulting in a diagnosis of Optic Neuritis by Ophthalmologist and Neurologist. Confirmed optic Neuritis on MRI scan.  Twenty-four (24) days later, numbness in legs, feet and right arm started. Hard to walk up and down stairs. Twenty-six (26) days later, extreme pain in in muscles and skin along with tingles all over and numbness. Weakness and Chest pain. Flu like symptoms without fever ie: aches, pains, skin pain, confusion. Dizziness, feeling of being extremely anxious and out of sorts in space. Had to complete round of Steroids and numbness and tingles got better, but did not dissolve. After completion of IV steroids, thirty-four (34) days later all symptoms returned full force and worsening. Checked into ER 4/10 and admitted into hospital. Have not been able to complete normal routine or work level since March 27th due to neurological disturbance and symptoms.   Two (2) Eye exams, 3/30/21 confirming swollen optic nerves.  MRI 3/31/21 Blood work 4/2/21 CoVid Test 4/9/21 Negative  Hospital: April 10-12th.  MRI Extensive Blood work Spinal Tap Neuro-Opt exam  Outcome pending and further treatment pending results.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast, Vision blurred, Visual field defect
Clinical narrative: Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER,  twenty-one (21) days later, both eyes were extremely painful to move. Then I lost vision in right eye with extreme blurriness & partial blind spots resulting in a diagnosis of Optic Neuritis by Ophthalmologist and Neurologist. Confirmed optic Neuritis on MRI scan.  Twenty-four (24) days later, numbness in legs, feet and right arm started. Hard to walk up and down stairs. Twenty-six (26) days later, extreme pain in in muscles and skin along with tingles all over and numbness. Weakness and Chest pain. Flu like symptoms without fever ie: aches, pains, skin pain, confusion. Dizziness, feeling of being extremely anxious and out of sorts in space. Had to complete round of Steroids and numbness and tingles got better, but did not dissolve. After completion of IV steroids, thirty-four (34) days later all symptoms returned full force and worsening. Checked into ER 4/10 and admitted into hospital. Have not been able to complete normal routine or work level since March 27th due to neurological disturbance and symptoms.   Two (2) Eye exams, 3/30/21 confirming swollen optic nerves.  MRI 3/31/21 Blood work 4/2/21 CoVid Test 4/9/21 Negative  Hospital: April 10-12th.  MRI Extensive Blood work Spinal Tap Neuro-Opt exam  Outcome pending and further treatment pending results.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash erythematous
Clinical narrative: After the vaccine, the whole body has been allergic and itchy, and the skin will appear red rash when scratching.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Exposure during pregnancy, Fibrin D dimer increased, Full blood count, Immune thrombocytopenia
Clinical narrative: 25 yo G2P0 @ 37+1 pregnant with longstanding immune thrombocytopenia purpura with a routine CBC showing PLTs of 56 down from 119 1 month ago. Had J&J vaccine on 4/9.    - Lab repeated and confirmed - D/w MFM and Hematologist.  In an abundance of caution, will get coags, CMP, and P/cr urine ratio to evaluate for HELLP.  Will also get HIT antibodies to evaluate for possibility of Vaccine induced thrombocytopenia(VIT). - Will plan on treating with Dexamethasone 40mg Daily x 4 days to increase platelet count.  D/w hematologist, and he will see the patient and run the test for HIT antibodies (PF-4) and initiate IVIG treatment, which would help treat the low platelets either from exacerbation of ITP or VIT. If these come back positive, will likely transfer patient to HN for admission and delivery to be followed by therapeutic anticoagulation with non-heparin based therapy, consistent with usual therapy for HIT.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, SARS-CoV-2 test negative
Clinical narrative: 25 yo G2P0 @ 37+1 pregnant with longstanding immune thrombocytopenia purpura with a routine CBC showing PLTs of 56 down from 119 1 month ago. Had J&J vaccine on 4/9.    - Lab repeated and confirmed - D/w MFM and Hematologist.  In an abundance of caution, will get coags, CMP, and P/cr urine ratio to evaluate for HELLP.  Will also get HIT antibodies to evaluate for possibility of Vaccine induced thrombocytopenia(VIT). - Will plan on treating with Dexamethasone 40mg Daily x 4 days to increase platelet count.  D/w hematologist, and he will see the patient and run the test for HIT antibodies (PF-4) and initiate IVIG treatment, which would help treat the low platelets either from exacerbation of ITP or VIT. If these come back positive, will likely transfer patient to HN for admission and delivery to be followed by therapeutic anticoagulation with non-heparin based therapy, consistent with usual therapy for HIT.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Client c/o tingling and numbness of L arm.  Client seen by EMT (no v/s taken).  Client observed to be stable, no distress noted at the moment.  Client cleared to go home by EMT.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Echocardiogram, Retinal artery occlusion, Ultrasound Doppler
Clinical narrative: I HAVE A LOSS OF MY CENTRAL VISION IN MY RIGHT EYE DUE TO A BLOCKAGE IN MY RETINAL ARTERY (BRANCH RETINAL ARTERY OCCLUSION).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Herpes zoster, Influenza like illness, Pruritus
Clinical narrative: I started with a fever, chills and just general flu like symptoms that started the day of my 2nd vaccination(3/25/21) all which I knew I may experience. These started around 9pm on Thursday evening, and subsided by 6pm on Friday 3/26/21. On Saturday 3/27/21 I started to feel pain in my lower back. It wasn?t pain in the muscles it was itching of the skin that turned into a piercing pain that covered my lower back. I contacted my primary care and she said it sounded like shingles and asked if I had a rash. I did not. She started me on Gabapentin 300mg 1 capsule by mouth 3x a day as needed for pain. The symptoms lasted until approximately the evening of Tuesday 3/30/21. No rash ever appeared but the burning/itching/piercing pain is what stayed with me for those 3 days.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin burning sensation
Clinical narrative: I started with a fever, chills and just general flu like symptoms that started the day of my 2nd vaccination(3/25/21) all which I knew I may experience. These started around 9pm on Thursday evening, and subsided by 6pm on Friday 3/26/21. On Saturday 3/27/21 I started to feel pain in my lower back. It wasn?t pain in the muscles it was itching of the skin that turned into a piercing pain that covered my lower back. I contacted my primary care and she said it sounded like shingles and asked if I had a rash. I did not. She started me on Gabapentin 300mg 1 capsule by mouth 3x a day as needed for pain. The symptoms lasted until approximately the evening of Tuesday 3/30/21. No rash ever appeared but the burning/itching/piercing pain is what stayed with me for those 3 days.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary vein thrombosis, Deep vein thrombosis, Pain in extremity, Peripheral swelling
Clinical narrative: 4 days of right upper extremity pain and swelling with diagnosis of right upper extremity axillary vein DVT that was treated with DOAC apixaban.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Chest pain, Computerised tomogram, Echocardiogram
Clinical narrative: One day after shot: body aches, pain In both legs. Three days after shot: pain in shoulder and upper chest, particularly when inhaling Five days after shot: loss of voice, sharp shooting/crushing pain in left chest cavity, increased pain when breathing Six days after shot: diagnosed with Pulmonary embolisms in left lung, pleurisy, and inflamed lymph nodes near left lung.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Magnetic resonance imaging, Pain, Pain in extremity, Painful respiration
Clinical narrative: One day after shot: body aches, pain In both legs. Three days after shot: pain in shoulder and upper chest, particularly when inhaling Five days after shot: loss of voice, sharp shooting/crushing pain in left chest cavity, increased pain when breathing Six days after shot: diagnosed with Pulmonary embolisms in left lung, pleurisy, and inflamed lymph nodes near left lung.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy, Pulmonary embolism, Pulmonary thrombosis, Ultrasound scan, X-ray
Clinical narrative: One day after shot: body aches, pain In both legs. Three days after shot: pain in shoulder and upper chest, particularly when inhaling Five days after shot: loss of voice, sharp shooting/crushing pain in left chest cavity, increased pain when breathing Six days after shot: diagnosed with Pulmonary embolisms in left lung, pleurisy, and inflamed lymph nodes near left lung.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Formication, Injection site pain, Myalgia, Nausea
Clinical narrative: LIKE SOMETHING CRAWLING IN BLOOD; NAUSEA; MUSCLES ACHES; INJECTION SITE PAIN (IN LEFT ARM); SWELLING OF THE ARM; BURNING SENSATION IN THE LEFT ARM; ACHES AND PAINS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and venous insufficiency, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced aches and pains. On 09-APR-2021, the subject experienced swelling of the arm. On 09-APR-2021, the subject experienced burning sensation in the left arm. On 09-APR-2021, the subject experienced injection site pain (in left arm). On 10-APR-2021, the subject experienced like something crawling in blood. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced muscles aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from like something crawling in blood, nausea on 12-APR-2021, and muscles aches on 11-APR-2021, had not recovered from injection site pain (in left arm), and the outcome of swelling of the arm, burning sensation in the left arm and aches and pains was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: LIKE SOMETHING CRAWLING IN BLOOD; NAUSEA; MUSCLES ACHES; INJECTION SITE PAIN (IN LEFT ARM); SWELLING OF THE ARM; BURNING SENSATION IN THE LEFT ARM; ACHES AND PAINS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and venous insufficiency, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced aches and pains. On 09-APR-2021, the subject experienced swelling of the arm. On 09-APR-2021, the subject experienced burning sensation in the left arm. On 09-APR-2021, the subject experienced injection site pain (in left arm). On 10-APR-2021, the subject experienced like something crawling in blood. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced muscles aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from like something crawling in blood, nausea on 12-APR-2021, and muscles aches on 11-APR-2021, had not recovered from injection site pain (in left arm), and the outcome of swelling of the arm, burning sensation in the left arm and aches and pains was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTED; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient fainted approximately after 35 hours of being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:covid-19 vaccine ad26.cov2.s-fainted. 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: PAIN ON HER CHEST THAT WOULD  COME AND GO; PAIN ON RIGHT LEG FROM FOOT TO THE UPPER THIGH; SWELLING OF FOOT AND LEG; TINGLING OF TOES; CANNOT FLEX RIGHT FOOT THAT  MUCH; TONGUE FELT HEAVY; SWOLLEN PRONOUNCED VEINS ON BACK OF LEG; SWEATY; CHILLS; MALAISE; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included synthetic dyes allergy, egg allergy, meat allergy, dairy allergy, and non smoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. the patient is non alcoholic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain on her chest that would come and go, pain on right leg from foot to the upper thigh, swelling of foot and leg, tingling of toes, cannot flex right foot that much, tongue felt heavy, swollen pronounced veins on back of leg, sweaty, chills, malaise, headache, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue felt heavy, headache, and fatigue, had not recovered from fever, malaise, sweaty, chills, and pain on her chest that would come and go, and the outcome of pain on right leg from foot to the upper thigh, swelling of foot and leg, swollen pronounced veins on back of leg, tingling of toes and cannot flex right foot that much was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: PAIN ON HER CHEST THAT WOULD  COME AND GO; PAIN ON RIGHT LEG FROM FOOT TO THE UPPER THIGH; SWELLING OF FOOT AND LEG; TINGLING OF TOES; CANNOT FLEX RIGHT FOOT THAT  MUCH; TONGUE FELT HEAVY; SWOLLEN PRONOUNCED VEINS ON BACK OF LEG; SWEATY; CHILLS; MALAISE; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included synthetic dyes allergy, egg allergy, meat allergy, dairy allergy, and non smoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. the patient is non alcoholic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain on her chest that would come and go, pain on right leg from foot to the upper thigh, swelling of foot and leg, tingling of toes, cannot flex right foot that much, tongue felt heavy, swollen pronounced veins on back of leg, sweaty, chills, malaise, headache, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue felt heavy, headache, and fatigue, had not recovered from fever, malaise, sweaty, chills, and pain on her chest that would come and go, and the outcome of pain on right leg from foot to the upper thigh, swelling of foot and leg, swollen pronounced veins on back of leg, tingling of toes and cannot flex right foot that much was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tongue oedema, Vasodilatation
Clinical narrative: PAIN ON HER CHEST THAT WOULD  COME AND GO; PAIN ON RIGHT LEG FROM FOOT TO THE UPPER THIGH; SWELLING OF FOOT AND LEG; TINGLING OF TOES; CANNOT FLEX RIGHT FOOT THAT  MUCH; TONGUE FELT HEAVY; SWOLLEN PRONOUNCED VEINS ON BACK OF LEG; SWEATY; CHILLS; MALAISE; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included synthetic dyes allergy, egg allergy, meat allergy, dairy allergy, and non smoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. the patient is non alcoholic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain on her chest that would come and go, pain on right leg from foot to the upper thigh, swelling of foot and leg, tingling of toes, cannot flex right foot that much, tongue felt heavy, swollen pronounced veins on back of leg, sweaty, chills, malaise, headache, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tongue felt heavy, headache, and fatigue, had not recovered from fever, malaise, sweaty, chills, and pain on her chest that would come and go, and the outcome of pain on right leg from foot to the upper thigh, swelling of foot and leg, swollen pronounced veins on back of leg, tingling of toes and cannot flex right foot that much was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Headache, Injection site paraesthesia, Pain
Clinical narrative: SLIGHT SHORTNESS OF BREATH; BODY ACHES; TINGLING IN INJECTED ARM; FEVER OF 100-102; HEADACHE; This spontaneous report received from a patient concerned a 29 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced slight shortness of breath. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced tingling in injected arm. On 13-APR-2021, the subject experienced fever of 100-102. On 13-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 100-102, body aches, headache, tingling in injected arm, and slight shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SLIGHT SHORTNESS OF BREATH; BODY ACHES; TINGLING IN INJECTED ARM; FEVER OF 100-102; HEADACHE; This spontaneous report received from a patient concerned a 29 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced slight shortness of breath. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced tingling in injected arm. On 13-APR-2021, the subject experienced fever of 100-102. On 13-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 100-102, body aches, headache, tingling in injected arm, and slight shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHT HEADED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Pain in extremity, Swelling face
Clinical narrative: DISCOMFORT IN THE FACE; SWELLING IN THE RIGHT SIDE OF THE FACE; SORE ARM; This spontaneous report received from a parent concerned an adult 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 and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced discomfort in the face, swelling in the right side of the face, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort in the face, swelling in the right side of the face and sore arm was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VIAL LEFT IN ROOM TEMPERATURE MORE THAN 2 HOURS; This spontaneous report received from a pharmacist concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vial left in room temperature more than 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial left in room temperature more than 2 hours was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pyrexia
Clinical narrative: INSOMNIA; CHILLS ON AND OFF; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced insomnia. On 2021, the subject experienced chills on and off. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills on and off and insomnia was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling of body temperature change, Hot flush, Nausea
Clinical narrative: CHILLS; NAUSEA; HOT FLASHES; FEELING HOT AND COLD; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced hot flashes. On 05-APR-2021, the subject experienced feeling hot and cold. On 05-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, chills, nausea, and feeling hot and cold. This report was non-serious. This case, from the same reporter is linked to 20210424684.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysgeusia, Headache, Nausea
Clinical narrative: DIARRHEA; DIZZINESS; FUNNY TASTE; PAIN IN LEFT ARM; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic back pain, preexisting degenerative joint disease, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced funny taste. On 09-APR-2021, the subject experienced pain in left arm. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 11-APR-2021, dizziness, and nausea on 10-APR-2021, and funny taste on 09-APR-2021, and had not recovered from pain in left arm, and headaches. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: DIARRHEA; DIZZINESS; FUNNY TASTE; PAIN IN LEFT ARM; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic back pain, preexisting degenerative joint disease, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced funny taste. On 09-APR-2021, the subject experienced pain in left arm. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 11-APR-2021, dizziness, and nausea on 10-APR-2021, and funny taste on 09-APR-2021, and had not recovered from pain in left arm, and headaches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Movement disorder, Myalgia
Clinical narrative: FATIGUE; INJECTION SITE PAIN (LEFT SIDE); MUSCLE ACHES; HARD TIME MOVING HAND; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyoid, pollen allergy, and zofan allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced hard time moving hand. On 12-APR-2021, the subject experienced injection site pain (left side). On 12-APR-2021, the subject experienced muscle aches. On 13-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain (left side), muscle aches, and fatigue, and the outcome of hard time moving hand was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: LIGHT HEADEDNESS (HER HEAD DOES NOT FEEL CONNECTED TO HER BODY); LIGHT SENSITIVITY; FLU-LIKE SYMPTOMS; CHILLS; HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 106 pounds, and height was 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: 201A-21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced light sensitivity. On 12-APR-2021, the subject experienced light headedness (her head does not feel connected to her body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, chills, headache, and nausea on 11-APR-2021, and light sensitivity on 13-APR-2021, and was recovering from tiredness, and light headedness (her head does not feel connected to her body). This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Photophobia
Clinical narrative: LIGHT HEADEDNESS (HER HEAD DOES NOT FEEL CONNECTED TO HER BODY); LIGHT SENSITIVITY; FLU-LIKE SYMPTOMS; CHILLS; HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 106 pounds, and height was 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: 201A-21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced light sensitivity. On 12-APR-2021, the subject experienced light headedness (her head does not feel connected to her body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, chills, headache, and nausea on 11-APR-2021, and light sensitivity on 13-APR-2021, and was recovering from tiredness, and light headedness (her head does not feel connected to her body). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: DIZZINESS; NAUSEA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Poor quality product administered
Clinical narrative: VIAL PAST STORAGE REQUIREMENT; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced vial past storage requirement, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial past storage requirement and medication error was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hallucination, Headache, Nausea
Clinical narrative: FELT LIKE SHE WAS ON ACID TRIP/HER PHYSICAL BODY WAS FUNKY/WAS BIZARRE; CHILLS; FEVERISH; NAUSEA; HALLUCINATION; MORE SEVERE HEADACHE; This spontaneous report received from a consumer via company representative concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included concussion. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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.  It was reported that, after vaccination the patient experienced chills, feverish, headache, and nausea. On 10-APR-2021 (in the middle of the night), the patient started hallucinating with a more severe headache and she felt like she was on an acid trip and her physical body was funky. The patient felt like she wanted to stretch her muscles but felt like she did not have control. At the time of this report, the patient said it was bizarre. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more severe headache, and hallucination, and the outcome of feverish, chills, nausea and felt like she was on acid trip/her physical body was funky/was bizarre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-Hallucination. 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: MEDICAL HISTORY
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FELT LIKE SHE WAS ON ACID TRIP/HER PHYSICAL BODY WAS FUNKY/WAS BIZARRE; CHILLS; FEVERISH; NAUSEA; HALLUCINATION; MORE SEVERE HEADACHE; This spontaneous report received from a consumer via company representative concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included concussion. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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.  It was reported that, after vaccination the patient experienced chills, feverish, headache, and nausea. On 10-APR-2021 (in the middle of the night), the patient started hallucinating with a more severe headache and she felt like she was on an acid trip and her physical body was funky. The patient felt like she wanted to stretch her muscles but felt like she did not have control. At the time of this report, the patient said it was bizarre. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more severe headache, and hallucination, and the outcome of feverish, chills, nausea and felt like she was on acid trip/her physical body was funky/was bizarre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-Hallucination. 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: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Neck pain
Clinical narrative: NECK PAIN; CHILLS; SHOULDER PAIN; This spontaneous report received from a consumer concerned a 65 year old. 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: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the subject experienced neck pain. On 04-MAR-2021, the subject experienced chills. On 04-MAR-2021, the subject experienced shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, chills, and shoulder pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Chills, Eye swelling, Fatigue, Headache
Clinical narrative: COGNITIVE MEMORY RECALL ISSUES; EYE SWELLING; CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced cognitive memory recall issues. On APR-2021, the subject experienced eye swelling. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cognitive memory recall issues, eye swelling, chills, headache, fatigue, and fever on APR-2021. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COGNITIVE MEMORY RECALL ISSUES; EYE SWELLING; CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced cognitive memory recall issues. On APR-2021, the subject experienced eye swelling. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cognitive memory recall issues, eye swelling, chills, headache, fatigue, and fever on APR-2021. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.