chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Rash, Skin reaction
Clinical narrative: skin turned bright red everywhere; rash went away after 30 minutes.; dizzy; This is a spontaneous report from a contactable consumer (reporting on herself) of 34-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) (at the age of 34-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included bleeding disorder FACTOR V Leiden and cartilage grew backward. The patient's concomitant medications were not reported. It was reported that patient received the Pfizer first shot on 07Apr2021, 15 minutes after getting the vaccine her skin turned bright red everywhere, she was rushed to the hospital, the rash went away after 30 minutes.  Caller states, they only gave her something for nausea, because she felt dizzy. She turned into something out of the walk of lands, turned red and blotchy, if you pressed on her skin the imprint would stay about a minute. They didn't give her anything for a rash. Caller states, it was not a rash, felt like my blood was trying to escape her skin. Caller states, when she scheduled for the second dose, they told her no. She would like to know how she can get the second shot. Her doctor said maybe she just shouldn't get it. Response received regarding the second dose confirmation was if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Outcome of the event dizzy was unknown. Outcome of the other events was recovered on unspecified date in 2021.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Physical examination normal
Clinical narrative: I am experiencing worsening headaches today, which are constant, front right side.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: I am experiencing worsening headaches today, which are constant, front right side.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Rash
Clinical narrative: Patient started with rash 1 week after first dose of vaccine. Was hospitalized and diagnosed with DVT of LLE, placed on Xarelto. Rash then covered 90% of his body after 2nd dose of vaccine. Patient was placed on oral steroids, then steroid cream, and tried light therapy. All did not hep the patient. In the mean time patient was diagnosed with PE, DVT must have traveled and is now on Coumadin Patient is now receiving Dupixent every 14 days which has helped the rash subside. Patient has to pay about 500 dollars out of pocket for each injection.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Pulmonary embolism, Rash
Clinical narrative: Patient started with rash 1 week after first dose of vaccine. Was hospitalized and diagnosed with DVT of LLE, placed on Xarelto. Rash then covered 90% of his body after 2nd dose of vaccine. Patient was placed on oral steroids, then steroid cream, and tried light therapy. All did not hep the patient. In the mean time patient was diagnosed with PE, DVT must have traveled and is now on Coumadin Patient is now receiving Dupixent every 14 days which has helped the rash subside. Patient has to pay about 500 dollars out of pocket for each injection.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dermatitis, Rash, Skin exfoliation, Thrombosis, Tremor
Clinical narrative: Patient started with rash 1 week after first dose of vaccine. Was hospitalized and diagnosed with DVT of LLE, placed on Xarelto. Rash then covered 90% of his body after 2nd dose of vaccine. Patient was placed on oral steroids, then steroid cream, and tried light therapy. All did not hep the patient. In the mean time patient was diagnosed with PE, DVT must have traveled and is now on Coumadin Patient is now receiving Dupixent every 14 days which has helped the rash subside. Patient has to pay about 500 dollars out of pocket for each injection.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Patient started with rash 1 week after first dose of vaccine. Was hospitalized and diagnosed with DVT of LLE, placed on Xarelto. Rash then covered 90% of his body after 2nd dose of vaccine. Patient was placed on oral steroids, then steroid cream, and tried light therapy. All did not hep the patient. In the mean time patient was diagnosed with PE, DVT must have traveled and is now on Coumadin Patient is now receiving Dupixent every 14 days which has helped the rash subside. Patient has to pay about 500 dollars out of pocket for each injection.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: My throat closed and it has gone downhill since then. My lungs have not stopped hurting since that day, I keep getting a rash and I react to sunlight. My vision is foggy, my eyes hurt. I have low back pain and I feel like my kidneys hurt. I get confused very easily now. My neck and my head hurt. I feel like a big ball of pain. I have been to ER 3 times since the 2nd dose. My normal doctor believes I had an autoimmune response to vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, C-reactive protein increased, Computerised tomogram head, Computerised tomogram neck, Confusional state
Clinical narrative: My throat closed and it has gone downhill since then. My lungs have not stopped hurting since that day, I keep getting a rash and I react to sunlight. My vision is foggy, my eyes hurt. I have low back pain and I feel like my kidneys hurt. I get confused very easily now. My neck and my head hurt. I feel like a big ball of pain. I have been to ER 3 times since the 2nd dose. My normal doctor believes I had an autoimmune response to vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Lumbar puncture, Pain, Photophobia, Rash
Clinical narrative: My throat closed and it has gone downhill since then. My lungs have not stopped hurting since that day, I keep getting a rash and I react to sunlight. My vision is foggy, my eyes hurt. I have low back pain and I feel like my kidneys hurt. I get confused very easily now. My neck and my head hurt. I feel like a big ball of pain. I have been to ER 3 times since the 2nd dose. My normal doctor believes I had an autoimmune response to vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness, Vision blurred
Clinical narrative: My throat closed and it has gone downhill since then. My lungs have not stopped hurting since that day, I keep getting a rash and I react to sunlight. My vision is foggy, my eyes hurt. I have low back pain and I feel like my kidneys hurt. I get confused very easily now. My neck and my head hurt. I feel like a big ball of pain. I have been to ER 3 times since the 2nd dose. My normal doctor believes I had an autoimmune response to vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Fatigue, Inflammation, Mental fatigue, Pain
Clinical narrative: Inflammation immediately after shot and four weeks later still lower half of body is inflamed.  Dr. gave me a steroid injection in my back and have scheduled an MRI; Inflammation immediately after shot and four weeks later still lower half of body is inflamed.  Dr. gave me a steroid injection in my back and have scheduled an MRI; This is a spontaneous report from a contactable consumer or other non health care professional (Patient, reported for self). A 63-years-old (non pregnant) female patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number ER8735), via an unspecified route of administration, administered in Arm Left on 05Apr2021 17:00 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus, sleep apnoea syndrome, spinal stenosis (Narrowing of spine), hypersensitivity (Known allergies: yes). Other medications in two weeks was reported as, Yes. No other vaccine was received in four weeks. No COVID prior vaccination. On 06Apr2021 the patient experienced inflammation immediately after shot and four weeks later still lower half of body is inflamed. COVID tested post vaccination, on 17May2021 patient underwent lab tests which included sars-cov-2 Nasal Swab test, Covid test result: negative. Event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result event includes Injection of steroid, it was reported that physician gave a steroid injection in her back and have scheduled an Magnetic resonance imaging. The outcome for both event was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, SARS-CoV-2 test
Clinical narrative: Inflammation immediately after shot and four weeks later still lower half of body is inflamed.  Dr. gave me a steroid injection in my back and have scheduled an MRI; Inflammation immediately after shot and four weeks later still lower half of body is inflamed.  Dr. gave me a steroid injection in my back and have scheduled an MRI; This is a spontaneous report from a contactable consumer or other non health care professional (Patient, reported for self). A 63-years-old (non pregnant) female patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number ER8735), via an unspecified route of administration, administered in Arm Left on 05Apr2021 17:00 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus, sleep apnoea syndrome, spinal stenosis (Narrowing of spine), hypersensitivity (Known allergies: yes). Other medications in two weeks was reported as, Yes. No other vaccine was received in four weeks. No COVID prior vaccination. On 06Apr2021 the patient experienced inflammation immediately after shot and four weeks later still lower half of body is inflamed. COVID tested post vaccination, on 17May2021 patient underwent lab tests which included sars-cov-2 Nasal Swab test, Covid test result: negative. Event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result event includes Injection of steroid, it was reported that physician gave a steroid injection in her back and have scheduled an Magnetic resonance imaging. The outcome for both event was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: muscle spasm/jerking/twitching; confusion; cognitive impairment; dizziness; falls/falling; unable to do "daily activities"; chills; migraines; nausea; fatigue, exhaustion; weakness; sweating; horrible feeling of "sickness" EVERYDAY!; became carsick even though I was driving; felt in a daze; tremors; affected my RLS; memory loss; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 55-years-old non-pregnant female patient received BNT162b2 (COMNITARY, solution for injection, Lot No: EW0162), via an unspecified route of administration, administered in left arm on 13Apr2021 10:30 AM (at the age of 55-year-old) as dose 2, single for covid-19 immunization. Medical history included bipolar disorder, anxiety, autoimmune thyroiditis, panic disorder from an unknown date and unknown if ongoing. Patient had known allergies to sulfa, Augmentin, Zomig, naproxen. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EN6208), via an unspecified route of administration in left arm on 19Mar2021 11:00 AM as dose 1, single for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); gabapentin (GABAPENTIN), lamotrigine (LAMOTRIGINE); sodium gualenate hydrate (GU) taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. On 14Apr2021 07:00 patient experienced fatigue, weakness, headache, chills, nausea, migraine, exhaustion, confusion, tremors, affected my RLS, memory loss, become carsick even through I was driving, felt in a daze, cognitive impairment, dizziness, fall/falling, sweating, muscle spasm/jerking/twitching, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY!. Therapeutic measurers were taken for all events are antibiotics, ondansetron, nausea med, migraine med, IV, muscle relaxant, lor. All the events resulted for Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of events nausea, migraines, chills, sweating, muscle spasm/jerking/twitching, confusion, dizziness, cognitive impairment, falling, weak, fatigue, exhaustion, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY! Recovered on unspecified date in 2021 and events became carsick even though I was driving, felt in a daze, tremors, affected my RLS, memory loss, headaches were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Asthenia, Chills, Cognitive disorder, Confusional state
Clinical narrative: muscle spasm/jerking/twitching; confusion; cognitive impairment; dizziness; falls/falling; unable to do "daily activities"; chills; migraines; nausea; fatigue, exhaustion; weakness; sweating; horrible feeling of "sickness" EVERYDAY!; became carsick even though I was driving; felt in a daze; tremors; affected my RLS; memory loss; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 55-years-old non-pregnant female patient received BNT162b2 (COMNITARY, solution for injection, Lot No: EW0162), via an unspecified route of administration, administered in left arm on 13Apr2021 10:30 AM (at the age of 55-year-old) as dose 2, single for covid-19 immunization. Medical history included bipolar disorder, anxiety, autoimmune thyroiditis, panic disorder from an unknown date and unknown if ongoing. Patient had known allergies to sulfa, Augmentin, Zomig, naproxen. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EN6208), via an unspecified route of administration in left arm on 19Mar2021 11:00 AM as dose 1, single for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); gabapentin (GABAPENTIN), lamotrigine (LAMOTRIGINE); sodium gualenate hydrate (GU) taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. On 14Apr2021 07:00 patient experienced fatigue, weakness, headache, chills, nausea, migraine, exhaustion, confusion, tremors, affected my RLS, memory loss, become carsick even through I was driving, felt in a daze, cognitive impairment, dizziness, fall/falling, sweating, muscle spasm/jerking/twitching, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY!. Therapeutic measurers were taken for all events are antibiotics, ondansetron, nausea med, migraine med, IV, muscle relaxant, lor. All the events resulted for Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of events nausea, migraines, chills, sweating, muscle spasm/jerking/twitching, confusion, dizziness, cognitive impairment, falling, weak, fatigue, exhaustion, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY! Recovered on unspecified date in 2021 and events became carsick even though I was driving, felt in a daze, tremors, affected my RLS, memory loss, headaches were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Fatigue, Feeling abnormal, Headache
Clinical narrative: muscle spasm/jerking/twitching; confusion; cognitive impairment; dizziness; falls/falling; unable to do "daily activities"; chills; migraines; nausea; fatigue, exhaustion; weakness; sweating; horrible feeling of "sickness" EVERYDAY!; became carsick even though I was driving; felt in a daze; tremors; affected my RLS; memory loss; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 55-years-old non-pregnant female patient received BNT162b2 (COMNITARY, solution for injection, Lot No: EW0162), via an unspecified route of administration, administered in left arm on 13Apr2021 10:30 AM (at the age of 55-year-old) as dose 2, single for covid-19 immunization. Medical history included bipolar disorder, anxiety, autoimmune thyroiditis, panic disorder from an unknown date and unknown if ongoing. Patient had known allergies to sulfa, Augmentin, Zomig, naproxen. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EN6208), via an unspecified route of administration in left arm on 19Mar2021 11:00 AM as dose 1, single for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); gabapentin (GABAPENTIN), lamotrigine (LAMOTRIGINE); sodium gualenate hydrate (GU) taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. On 14Apr2021 07:00 patient experienced fatigue, weakness, headache, chills, nausea, migraine, exhaustion, confusion, tremors, affected my RLS, memory loss, become carsick even through I was driving, felt in a daze, cognitive impairment, dizziness, fall/falling, sweating, muscle spasm/jerking/twitching, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY!. Therapeutic measurers were taken for all events are antibiotics, ondansetron, nausea med, migraine med, IV, muscle relaxant, lor. All the events resulted for Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of events nausea, migraines, chills, sweating, muscle spasm/jerking/twitching, confusion, dizziness, cognitive impairment, falling, weak, fatigue, exhaustion, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY! Recovered on unspecified date in 2021 and events became carsick even though I was driving, felt in a daze, tremors, affected my RLS, memory loss, headaches were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Illness, Loss of personal independence in daily activities, Migraine, Motion sickness
Clinical narrative: muscle spasm/jerking/twitching; confusion; cognitive impairment; dizziness; falls/falling; unable to do "daily activities"; chills; migraines; nausea; fatigue, exhaustion; weakness; sweating; horrible feeling of "sickness" EVERYDAY!; became carsick even though I was driving; felt in a daze; tremors; affected my RLS; memory loss; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 55-years-old non-pregnant female patient received BNT162b2 (COMNITARY, solution for injection, Lot No: EW0162), via an unspecified route of administration, administered in left arm on 13Apr2021 10:30 AM (at the age of 55-year-old) as dose 2, single for covid-19 immunization. Medical history included bipolar disorder, anxiety, autoimmune thyroiditis, panic disorder from an unknown date and unknown if ongoing. Patient had known allergies to sulfa, Augmentin, Zomig, naproxen. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EN6208), via an unspecified route of administration in left arm on 19Mar2021 11:00 AM as dose 1, single for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); gabapentin (GABAPENTIN), lamotrigine (LAMOTRIGINE); sodium gualenate hydrate (GU) taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. On 14Apr2021 07:00 patient experienced fatigue, weakness, headache, chills, nausea, migraine, exhaustion, confusion, tremors, affected my RLS, memory loss, become carsick even through I was driving, felt in a daze, cognitive impairment, dizziness, fall/falling, sweating, muscle spasm/jerking/twitching, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY!. Therapeutic measurers were taken for all events are antibiotics, ondansetron, nausea med, migraine med, IV, muscle relaxant, lor. All the events resulted for Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of events nausea, migraines, chills, sweating, muscle spasm/jerking/twitching, confusion, dizziness, cognitive impairment, falling, weak, fatigue, exhaustion, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY! Recovered on unspecified date in 2021 and events became carsick even though I was driving, felt in a daze, tremors, affected my RLS, memory loss, headaches were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Nausea, Restless legs syndrome, Tremor
Clinical narrative: muscle spasm/jerking/twitching; confusion; cognitive impairment; dizziness; falls/falling; unable to do "daily activities"; chills; migraines; nausea; fatigue, exhaustion; weakness; sweating; horrible feeling of "sickness" EVERYDAY!; became carsick even though I was driving; felt in a daze; tremors; affected my RLS; memory loss; headaches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 55-years-old non-pregnant female patient received BNT162b2 (COMNITARY, solution for injection, Lot No: EW0162), via an unspecified route of administration, administered in left arm on 13Apr2021 10:30 AM (at the age of 55-year-old) as dose 2, single for covid-19 immunization. Medical history included bipolar disorder, anxiety, autoimmune thyroiditis, panic disorder from an unknown date and unknown if ongoing. Patient had known allergies to sulfa, Augmentin, Zomig, naproxen. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EN6208), via an unspecified route of administration in left arm on 19Mar2021 11:00 AM as dose 1, single for COVID-19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline hydrochloride (ZOLOFT); gabapentin (GABAPENTIN), lamotrigine (LAMOTRIGINE); sodium gualenate hydrate (GU) taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. On 14Apr2021 07:00 patient experienced fatigue, weakness, headache, chills, nausea, migraine, exhaustion, confusion, tremors, affected my RLS, memory loss, become carsick even through I was driving, felt in a daze, cognitive impairment, dizziness, fall/falling, sweating, muscle spasm/jerking/twitching, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY!. Therapeutic measurers were taken for all events are antibiotics, ondansetron, nausea med, migraine med, IV, muscle relaxant, lor. All the events resulted for Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of events nausea, migraines, chills, sweating, muscle spasm/jerking/twitching, confusion, dizziness, cognitive impairment, falling, weak, fatigue, exhaustion, unable to do "daily activities" horrible feeling of "sickness" EVERYDAY! Recovered on unspecified date in 2021 and events became carsick even though I was driving, felt in a daze, tremors, affected my RLS, memory loss, headaches were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Fatigue, Feeling abnormal, Illness, Loss of personal independence in daily activities
Clinical narrative: CONFUSION; DIFFICULTY CONCENTRATING; WEIGHT LOSS; FEAR FOR DRIVING; FELT EXTREMELY TIRED; SICK TO MY STOMACH; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 80 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: 047A21A expiry: UNKNOWN) dose was not reported, administered on 10-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 felt extremely tired. On 10-APR-2021, the subject experienced sick to my stomach. On an unspecified date, the subject experienced confusion, difficulty concentrating, weight loss, and fear for driving. Laboratory data (dates unspecified) included: Loss of weight (NR: not provided) lost about 30 pounds or more maybe 35 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and sick to my stomach on 11-JUN-2021, and weight loss, had not recovered from felt extremely tired, confusion, and difficulty concentrating, and the outcome of fear for driving was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: CONFUSION; DIFFICULTY CONCENTRATING; WEIGHT LOSS; FEAR FOR DRIVING; FELT EXTREMELY TIRED; SICK TO MY STOMACH; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 80 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: 047A21A expiry: UNKNOWN) dose was not reported, administered on 10-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 felt extremely tired. On 10-APR-2021, the subject experienced sick to my stomach. On an unspecified date, the subject experienced confusion, difficulty concentrating, weight loss, and fear for driving. Laboratory data (dates unspecified) included: Loss of weight (NR: not provided) lost about 30 pounds or more maybe 35 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and sick to my stomach on 11-JUN-2021, and weight loss, had not recovered from felt extremely tired, confusion, and difficulty concentrating, and the outcome of fear for driving was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Disturbance in attention, Fatigue, Fear, Influenza like illness
Clinical narrative: CONFUSION; DIFFICULTY CONCENTRATING; WEIGHT LOSS; FEAR FOR DRIVING; FELT EXTREMELY TIRED; SICK TO MY STOMACH; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 80 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: 047A21A expiry: UNKNOWN) dose was not reported, administered on 10-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 felt extremely tired. On 10-APR-2021, the subject experienced sick to my stomach. On an unspecified date, the subject experienced confusion, difficulty concentrating, weight loss, and fear for driving. Laboratory data (dates unspecified) included: Loss of weight (NR: not provided) lost about 30 pounds or more maybe 35 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and sick to my stomach on 11-JUN-2021, and weight loss, had not recovered from felt extremely tired, confusion, and difficulty concentrating, and the outcome of fear for driving was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Weight decreased
Clinical narrative: CONFUSION; DIFFICULTY CONCENTRATING; WEIGHT LOSS; FEAR FOR DRIVING; FELT EXTREMELY TIRED; SICK TO MY STOMACH; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 80 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: 047A21A expiry: UNKNOWN) dose was not reported, administered on 10-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 felt extremely tired. On 10-APR-2021, the subject experienced sick to my stomach. On an unspecified date, the subject experienced confusion, difficulty concentrating, weight loss, and fear for driving. Laboratory data (dates unspecified) included: Loss of weight (NR: not provided) lost about 30 pounds or more maybe 35 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and sick to my stomach on 11-JUN-2021, and weight loss, had not recovered from felt extremely tired, confusion, and difficulty concentrating, and the outcome of fear for driving was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Chills, Fatigue, Feeling abnormal
Clinical narrative: Approximately 2 weeks after first COVID vaccination on 3/18/21, patient developed bilateral shoulder and hip pain with morning predominance, which persisted. One day after 2nd COVID vaccination on 4/16/21, patient developed severe left knee pain and swelling for which she received cortisone injection with orthopedics on 5/5/21, which resolved all pain (left knee, bilateral shoulder, bilateral hip pain). 4-5 days after cortisone injection, pain in bilateral shoulder/hip pain returned. She also had spontaneous rupture of right extensor pollicus longus tendon around 5/24/21 which required urgent hand surgery, performed on 6/3/21.  Subsequent labs and continued bilateral hip/shoulder pain resolved with steroids led to diagnosis of polymyalgia rhuematica around 6/10/21.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint swelling, Malaise, Pain in extremity, Pelvic pain, Platelet count increased
Clinical narrative: Approximately 2 weeks after first COVID vaccination on 3/18/21, patient developed bilateral shoulder and hip pain with morning predominance, which persisted. One day after 2nd COVID vaccination on 4/16/21, patient developed severe left knee pain and swelling for which she received cortisone injection with orthopedics on 5/5/21, which resolved all pain (left knee, bilateral shoulder, bilateral hip pain). 4-5 days after cortisone injection, pain in bilateral shoulder/hip pain returned. She also had spontaneous rupture of right extensor pollicus longus tendon around 5/24/21 which required urgent hand surgery, performed on 6/3/21.  Subsequent labs and continued bilateral hip/shoulder pain resolved with steroids led to diagnosis of polymyalgia rhuematica around 6/10/21.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Tendon rupture, Tenoplasty, Weight bearing difficulty
Clinical narrative: Approximately 2 weeks after first COVID vaccination on 3/18/21, patient developed bilateral shoulder and hip pain with morning predominance, which persisted. One day after 2nd COVID vaccination on 4/16/21, patient developed severe left knee pain and swelling for which she received cortisone injection with orthopedics on 5/5/21, which resolved all pain (left knee, bilateral shoulder, bilateral hip pain). 4-5 days after cortisone injection, pain in bilateral shoulder/hip pain returned. She also had spontaneous rupture of right extensor pollicus longus tendon around 5/24/21 which required urgent hand surgery, performed on 6/3/21.  Subsequent labs and continued bilateral hip/shoulder pain resolved with steroids led to diagnosis of polymyalgia rhuematica around 6/10/21.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Arthralgia, Blood creatine phosphokinase normal, C-reactive protein increased, Joint swelling
Clinical narrative: Approximately 2 weeks after first COVID vaccination on 3/18/21, patient developed bilateral shoulder and hip pain with morning predominance, which persisted. One day after 2nd COVID vaccination on 4/16/21, patient developed severe left knee pain and swelling for which she received cortisone injection with orthopedics on 5/5/21, which resolved all pain (left knee, bilateral shoulder, bilateral hip pain). 4-5 days after cortisone injection, pain in bilateral shoulder/hip pain returned. She also had spontaneous rupture of right extensor pollicus longus tendon around 5/24/21 which required urgent hand surgery, performed on 6/3/21.  Subsequent labs and continued bilateral hip/shoulder pain resolved with steroids led to diagnosis of polymyalgia rhuematica around 6/10/21.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Limb operation, Platelet count increased, Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Approximately 2 weeks after first COVID vaccination on 3/18/21, patient developed bilateral shoulder and hip pain with morning predominance, which persisted. One day after 2nd COVID vaccination on 4/16/21, patient developed severe left knee pain and swelling for which she received cortisone injection with orthopedics on 5/5/21, which resolved all pain (left knee, bilateral shoulder, bilateral hip pain). 4-5 days after cortisone injection, pain in bilateral shoulder/hip pain returned. She also had spontaneous rupture of right extensor pollicus longus tendon around 5/24/21 which required urgent hand surgery, performed on 6/3/21.  Subsequent labs and continued bilateral hip/shoulder pain resolved with steroids led to diagnosis of polymyalgia rhuematica around 6/10/21.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tendon rupture
Clinical narrative: Approximately 2 weeks after first COVID vaccination on 3/18/21, patient developed bilateral shoulder and hip pain with morning predominance, which persisted. One day after 2nd COVID vaccination on 4/16/21, patient developed severe left knee pain and swelling for which she received cortisone injection with orthopedics on 5/5/21, which resolved all pain (left knee, bilateral shoulder, bilateral hip pain). 4-5 days after cortisone injection, pain in bilateral shoulder/hip pain returned. She also had spontaneous rupture of right extensor pollicus longus tendon around 5/24/21 which required urgent hand surgery, performed on 6/3/21.  Subsequent labs and continued bilateral hip/shoulder pain resolved with steroids led to diagnosis of polymyalgia rhuematica around 6/10/21.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, Wrong product administered
Clinical narrative: Prescription for Tetanus vaccine was sent to pharmacy, patient inadvertently requested Covid vaccine, which was administered
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Prescription for Tetanus vaccine was sent to pharmacy, patient inadvertently requested Covid vaccine, which was administered
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Computerised tomogram: inconclusive (abnormal) Right lower lobe posterior pulmonary embolus.. On 30-May-2021, Ultrasound Doppler: inconclusive (abnormal) Duplex doppler and color sonography was performed of the deep veins. Noncompressible filling defect/thrombus with lack of vascular flow. No evidence of mass, adenopathy, or fluid collection..         Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-JUN-2021 contain Lab test data added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Pulmonary embolism, Ultrasound Doppler
Clinical narrative: Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Computerised tomogram: inconclusive (abnormal) Right lower lobe posterior pulmonary embolus.. On 30-May-2021, Ultrasound Doppler: inconclusive (abnormal) Duplex doppler and color sonography was performed of the deep veins. Noncompressible filling defect/thrombus with lack of vascular flow. No evidence of mass, adenopathy, or fluid collection..         Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-JUN-2021 contain Lab test data added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Groin pain, Pain, Positron emission tomogram normal
Clinical narrative: Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Computerised tomogram: inconclusive (abnormal) Right lower lobe posterior pulmonary embolus.. On 30-May-2021, Ultrasound Doppler: inconclusive (abnormal) Duplex doppler and color sonography was performed of the deep veins. Noncompressible filling defect/thrombus with lack of vascular flow. No evidence of mass, adenopathy, or fluid collection..         Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-JUN-2021 contain Lab test data added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Prothrombin time normal, Pulmonary embolism
Clinical narrative: Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Computerised tomogram: inconclusive (abnormal) Right lower lobe posterior pulmonary embolus.. On 30-May-2021, Ultrasound Doppler: inconclusive (abnormal) Duplex doppler and color sonography was performed of the deep veins. Noncompressible filling defect/thrombus with lack of vascular flow. No evidence of mass, adenopathy, or fluid collection..         Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on 29-JUN-2021 contain Lab test data added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.