chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Middle insomnia
Clinical narrative: WAKING UP AT NIGHT; EXTREME PAIN IN EVERY JOINT ON THE BODY; FATIGUE; This spontaneous report received from a patient concerned a 68 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: not reported) dose was not reported, administered on 20-MAR-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 waking up at night. On APR-2021, the subject experienced extreme pain in every joint on the body. On APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme pain in every joint on the body, fatigue, and waking up at night. 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: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: COLD FOR 12 DAYS; SORE ARM; This spontaneous report received from a patient 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 was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced cold for 12 days, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold for 12 days and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: SKIN DISORDER/ARMS AND LEGS HAD BUMPS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies, had not taken any concomitant drugs and had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included risankizumab for moderate to severe chronic plaque psoriasis. On 30-JUN-2021, the subject experienced skin disorder/arms and legs had bumps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin disorder/arms and legs had bumps. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: FACIAL PARALYSIS; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, the patient experienced facial paralysis from last week after vaccination (second week of JUL-2021). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of facial paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210732631-Covid-19 vaccine ad26.cov2.s -Facial Paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle spasms
Clinical narrative: MUSCLE CRAMPING; JOINT PAIN; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced muscle cramping, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on MAR-2021, and had not recovered from joint pain, and muscle cramping. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Fatigue, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; LITTLE FATIGUED; This spontaneous report received from a patient concerned a 55-year-old male. Initial information was processed along with the additional information received from the Organization on 16-JUL-2021 The patient's height, and weight were not reported. The patient's concurrent conditions included chronic non-Hodgkin's lymphoma. Previously the patient had chemotherapy for chronic non-Hodgkin's lymphoma from on an unspecified date in Mar-2020 to Sep-2020. As per the report, currently patient was not being treated for chronic non-Hodgkin's lymphoma, and stated all was good. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little fatigue for about 3 days. On an unspecified date, the patient was tested for antibodies by his oncologist, results found to be none (RRT: Suspected immunological vaccine failure, LLT: Therapy non-responder). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little fatigued and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000186308.; Sender's Comments: V0: 20210733410-COVID-19 VACCINE AD26.COV2.S-Suspected 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: MEDICAL HISTORY.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; LITTLE FATIGUED; This spontaneous report received from a patient concerned a 55-year-old male. Initial information was processed along with the additional information received from the Organization on 16-JUL-2021 The patient's height, and weight were not reported. The patient's concurrent conditions included chronic non-Hodgkin's lymphoma. Previously the patient had chemotherapy for chronic non-Hodgkin's lymphoma from on an unspecified date in Mar-2020 to Sep-2020. As per the report, currently patient was not being treated for chronic non-Hodgkin's lymphoma, and stated all was good. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little fatigue for about 3 days. On an unspecified date, the patient was tested for antibodies by his oncologist, results found to be none (RRT: Suspected immunological vaccine failure, LLT: Therapy non-responder). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little fatigued and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000186308.; Sender's Comments: V0: 20210733410-COVID-19 VACCINE AD26.COV2.S-Suspected 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: MEDICAL HISTORY.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Incoherent
Clinical narrative: BLOOD CLOT IN BRAIN; BECAME NOT AS COHERENT; This spontaneous report received from a company representative via a health care professional concerned an adult female in her late 40s to early 50s. 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) 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.  On an unspecified date (within the 10 minutes after receiving the vaccine), the patient became not as coherent and the emergency services were called. On the same day, the patient was diagnosed with a blood clot in the brain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in brain and became not as coherent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a health care professional concerns a female in her late 40s to early 50s, unknown ethnicity, who was diagnosed with blood clot in the brain unspecified number of days after receiving the Janssen Covid-19 vaccine. Patient started to be incoherent and was brought to the emergency department.  Patient's height and weight were not reported. Patient's concurrent conditions, past medical/surgical history and concomitant medications were not reported. Information regarding past smoking history, illicit drug use and alcohol abuse were not provided. Information is limited in this case, and the occurrence of  blood clot in the brain could represent background incidence of such events in the general population. Hence, the relationship to the vaccination is considered unclassifiable. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious. This case, from the same reporter is linked to 20210731837 and 20210732421.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Emotional distress, Head titubation, Influenza like illness, Injection site pain
Clinical narrative: HEAD TREMORS; BLURRED VISION; CONSTANT MUSCLE FAILURE; FLU-LIKE SYMPTOMS; SEVERE MUSCLE WEAKNESS; INJECTION SITE SORENESS; WEAKNESS, NO ENERGY, NO STRENGTH; EMOTIONALLY  DEGRADING; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, 1 pack per day medical marijuana a joint per day for pain, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 15-SEP-2021) dose was not reported, administered on 03-JUL-2021 11:00:00 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the subject experienced emotionally degrading. On 04-JUL-2021, the subject experienced head tremors. On 04-JUL-2021, the subject experienced blurred vision. On 04-JUL-2021, the subject experienced constant muscle failure. On 04-JUL-2021, the subject experienced flu-like symptoms. On 04-JUL-2021, the subject experienced severe muscle weakness. On 04-JUL-2021, the subject experienced injection site soreness. On 04-JUL-2021, the subject experienced weakness, no energy, no strength. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and weakness, no energy, no strength on 06-JUL-2021, had not recovered from injection site soreness, severe muscle weakness, head tremors, blurred vision, and constant muscle failure, and the outcome of emotionally degrading was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Muscular weakness, Vision blurred
Clinical narrative: HEAD TREMORS; BLURRED VISION; CONSTANT MUSCLE FAILURE; FLU-LIKE SYMPTOMS; SEVERE MUSCLE WEAKNESS; INJECTION SITE SORENESS; WEAKNESS, NO ENERGY, NO STRENGTH; EMOTIONALLY  DEGRADING; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, 1 pack per day medical marijuana a joint per day for pain, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 15-SEP-2021) dose was not reported, administered on 03-JUL-2021 11:00:00 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the subject experienced emotionally degrading. On 04-JUL-2021, the subject experienced head tremors. On 04-JUL-2021, the subject experienced blurred vision. On 04-JUL-2021, the subject experienced constant muscle failure. On 04-JUL-2021, the subject experienced flu-like symptoms. On 04-JUL-2021, the subject experienced severe muscle weakness. On 04-JUL-2021, the subject experienced injection site soreness. On 04-JUL-2021, the subject experienced weakness, no energy, no strength. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and weakness, no energy, no strength on 06-JUL-2021, had not recovered from injection site soreness, severe muscle weakness, head tremors, blurred vision, and constant muscle failure, and the outcome of emotionally degrading was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Polymerase chain reaction, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 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, intramuscular, batch number: 1805022, expiry: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021, 00:40 to left deltoid for covid-19 prevention. No concomitant medications were reported.  On 12-APR-2021, the patient took first test of SARS-COV 2 AB (IGG spike, semi QN) and the result were more than 1 which was listed as being negative (confirmed immunological vaccine failure). On 09-JUL-2021, the patient second time took 3 tests at once a rapid test, Polymerase chain reaction (PCR) and antibody Immunoglobulin M (IGM), Immunoglobulin G (IGG) and all three tests came back as negative. 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: V0:20210733690 -COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Unevaluable event, Vein disorder, X-ray
Clinical narrative: ANXIETY THROUGH THE WHOLE MESS; PROBLEMS WITH THE VEINS IN LEGS; FELT LIKE JUST A MESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included big varicose veins, and problems with veins in legs.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 31-MAR-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 anxiety through the whole mess, problems with the veins in legs, and felt like just a mess. Laboratory data (dates unspecified) included: X-ray (NR: not provided) No blood clots or anything were observed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety through the whole mess, problems with the veins in legs and felt like just a mess was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: OFF BALANCE; DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUL-2021, the subject experienced off balance. On 09-JUL-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from off balance, and dizziness. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy partial responder
Clinical narrative: COVID ANTIBODIES LOW; This spontaneous report received from a consumer concerned a 60 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included jerking, restless legs, cane use, walker use, wheelchair use, and sinus infection, and concurrent conditions included high blood pressure, progressive multiple sclerosis, enlarged prostate, diabetes, blood thinner, vitamin D deficiency, stiffness, spasms, and loosen feet. 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, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Acetylsalicylic acid, Amlodipine besilate, Baclofen, Clonazepam, Colecalciferol, Fampridine, Glipizide/metformin, Losartan potassium, Ocrelizumab, Pramipexole, Semaglutide, and Tamsulosin.  On 21-JUN-2021, the patient had COVID-19 antibody test and result came as low antibodies.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low antibodies. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210733845-Covid-19 vaccine ad26.cov2.s-Covid antibodies low. 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: Adverse event
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Coordination abnormal, Decreased appetite, Dyskinesia
Clinical narrative: JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone.  On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fine motor skill dysfunction, Gait disturbance, Hypoaesthesia, Influenza like illness, Joint stiffness
Clinical narrative: JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone.  On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lip disorder, Muscle contracture, Muscle twitching, Oral pruritus, Paraesthesia
Clinical narrative: JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone.  On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Photopsia, Sensory disturbance, Tremor, Trismus
Clinical narrative: JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone.  On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Underdose
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; PATIENT RECEIVED 0.15 ML DOSE OF VACCINE (INCOMPLETE DOSE); OFF LABEL USE; This spontaneous report received from a physician concerned a 13 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) .15 ml, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced product administered to subject of inappropriate age. On 28-JUN-2021, the subject experienced subject received 0.15 ml dose of vaccine (incomplete dose). On 28-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age, off label use and patient received 0.15 ml dose of vaccine (incomplete dose) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210735433 and 20210663915.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: ARM IS SWOLLEN; FACE IS FULL OF RASH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUN-2021, the subject experienced arm is swollen. On 05-JUN-2021, the subject experienced face is full of rash. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm is swollen and face is full of rash was not reported. This report was non-serious.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Underdose
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; PATIENT RECEIVED 0.15ML DOSE OF VACCINE (INCOMPLETE DOSE); OFF LABEL USE; This spontaneous report received from a physician concerned a 14 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) .15 ml, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUN-2021, the subject experienced inappropriate age at vaccine administration. On 28-JUN-2021, the subject experienced subject received 0.15ml dose of vaccine (incomplete dose). On 28-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration, off label use and patient received 0.15ml dose of vaccine (incomplete dose) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210663915 and 20210735425.
Sex: U
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: ELECTRIC SHOCK TO THE BODY WHEN TRYING TO GO TO SLEEP; 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 electric shock to the body when trying to go to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of electric shock to the body when trying to go to sleep was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Head discomfort, Headache
Clinical narrative: PRESSURE IN HEAD; TREMENDOUS AMOUNT OF PAIN IN THE LOWER BACK; GENERALIZED PAIN OVER BODY; FATIGUE; HEADACHE WITH PRESSURE; INTERMITTENT HEART PALPITATIONS; VERTIGO; DIZZINESS; NUMBNESS/TINGLING IN  IN RIGHT HAND THEN SPREAD TO LEFT HAND.; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 129 pounds, and height was 68 inches. The patient's concurrent conditions included fibromyalgia, gluten allergy, casein allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient was not pregnant at the time of the event.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced numbness/tingling in in right hand then spread to left hand. On 01-JUL-2021, the subject experienced intermittent heart palpitations. On 01-JUL-2021, the subject experienced vertigo. On 01-JUL-2021, the subject experienced dizziness. On 01-JUL-2021, the subject experienced couldn't sleep. On 01-JUL-2021, the subject experienced headache with pressure. On 02-JUL-2021, the subject experienced generalized pain over body. On 02-JUL-2021, the subject experienced tremendous amount of pain in the lower back. On 02-JUL-2021, the subject experienced fatigue. On 16-JUL-2021, the subject experienced pressure in head. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache with pressure on 03-JUL-2021, was recovering from generalized pain over body, and vertigo, had not recovered from numbness/tingling in in right hand then spread to left hand., fatigue, intermittent heart palpitations, dizziness, and pressure in head, and the outcome of tremendous amount of pain in the lower back and couldn't sleep was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Palpitations, Paraesthesia, Vertigo
Clinical narrative: PRESSURE IN HEAD; TREMENDOUS AMOUNT OF PAIN IN THE LOWER BACK; GENERALIZED PAIN OVER BODY; FATIGUE; HEADACHE WITH PRESSURE; INTERMITTENT HEART PALPITATIONS; VERTIGO; DIZZINESS; NUMBNESS/TINGLING IN  IN RIGHT HAND THEN SPREAD TO LEFT HAND.; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 129 pounds, and height was 68 inches. The patient's concurrent conditions included fibromyalgia, gluten allergy, casein allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient was not pregnant at the time of the event.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced numbness/tingling in in right hand then spread to left hand. On 01-JUL-2021, the subject experienced intermittent heart palpitations. On 01-JUL-2021, the subject experienced vertigo. On 01-JUL-2021, the subject experienced dizziness. On 01-JUL-2021, the subject experienced couldn't sleep. On 01-JUL-2021, the subject experienced headache with pressure. On 02-JUL-2021, the subject experienced generalized pain over body. On 02-JUL-2021, the subject experienced tremendous amount of pain in the lower back. On 02-JUL-2021, the subject experienced fatigue. On 16-JUL-2021, the subject experienced pressure in head. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache with pressure on 03-JUL-2021, was recovering from generalized pain over body, and vertigo, had not recovered from numbness/tingling in in right hand then spread to left hand., fatigue, intermittent heart palpitations, dizziness, and pressure in head, and the outcome of tremendous amount of pain in the lower back and couldn't sleep was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chest discomfort, Eye irritation, Eye pain
Clinical narrative: Day one: pain in arm, extreme fatigue, nausea, fever, blurred vision, heavy chest, headache, eye burning pain, pain in side of neck and intonarmoit, pain in right calf, runny nose, burning in nose and throat, oversensitive to touch like clothes Day 2: runny nose, fatigue. congestion, headache, injection site pain Day 3: scratchy throat, watery eyes, arm sore at infection site, naseua, low energy Over the next four days symptoms lessened. At day seven finally felt back to normal. Day 18 &19- spotting blood, period is 9 days early which is not normal. I'm never this early or irregular
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersensitivity, Injection site pain, Intermenstrual bleeding
Clinical narrative: Day one: pain in arm, extreme fatigue, nausea, fever, blurred vision, heavy chest, headache, eye burning pain, pain in side of neck and intonarmoit, pain in right calf, runny nose, burning in nose and throat, oversensitive to touch like clothes Day 2: runny nose, fatigue. congestion, headache, injection site pain Day 3: scratchy throat, watery eyes, arm sore at infection site, naseua, low energy Over the next four days symptoms lessened. At day seven finally felt back to normal. Day 18 &19- spotting blood, period is 9 days early which is not normal. I'm never this early or irregular
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Menstrual disorder, Nausea, Neck pain, Oropharyngeal discomfort
Clinical narrative: Day one: pain in arm, extreme fatigue, nausea, fever, blurred vision, heavy chest, headache, eye burning pain, pain in side of neck and intonarmoit, pain in right calf, runny nose, burning in nose and throat, oversensitive to touch like clothes Day 2: runny nose, fatigue. congestion, headache, injection site pain Day 3: scratchy throat, watery eyes, arm sore at infection site, naseua, low energy Over the next four days symptoms lessened. At day seven finally felt back to normal. Day 18 &19- spotting blood, period is 9 days early which is not normal. I'm never this early or irregular
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea, Throat irritation, Vision blurred
Clinical narrative: Day one: pain in arm, extreme fatigue, nausea, fever, blurred vision, heavy chest, headache, eye burning pain, pain in side of neck and intonarmoit, pain in right calf, runny nose, burning in nose and throat, oversensitive to touch like clothes Day 2: runny nose, fatigue. congestion, headache, injection site pain Day 3: scratchy throat, watery eyes, arm sore at infection site, naseua, low energy Over the next four days symptoms lessened. At day seven finally felt back to normal. Day 18 &19- spotting blood, period is 9 days early which is not normal. I'm never this early or irregular
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: red rash near the private part, very itchy, lasted for a few days
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Mobility decreased, Neuropathy peripheral, Pain
Clinical narrative: in crease in the severity of my peripheral neuropathy. the increased pain levels caused significantly decreased physical ability and endurance due to increased pain levels.
Age: 15.0
Sex: U
Vaccine: UNK
Symptoms: Chest pain, Pain
Clinical narrative: Sharp chest pains like a knife to heart came when she lifted light groceries,  drove or hit a ball in backyard.    And after dinner.  Went away after i said do nothing just rest.