chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Presented to the ED with worsening tremors and difficulty walking. In the ED, she develop hallucinations, tachycardia, and agitation. She has a history of heavy alcohol use and abruptly stopped drinking 3 days prior. She received multiple doses of benzodiazepines and ultimately required intubation for airway protection. She was admitted to the ICU for concern for alcohol withdrawal. She was found to be covid positive on admission
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tachycardia; Heart palpitations; Exercise intolerance; heart rate to rise to dangerous levels; Chest pain; Extreme fatigue; Headaches; Dizziness; Positive ANA Screen / ANA Titer 1:320 / ANA Pattern nuclear speckled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3180) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "maybe penicillin" (unspecified if ongoing), notes: known allergies: maybe penicillin. The patient took concomitant medications. The following information was reported: TACHYCARDIA (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Tachycardia"; PALPITATIONS (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Heart palpitations"; EXERCISE TOLERANCE DECREASED (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Exercise intolerance"; HEART RATE INCREASED (non-serious) with onset 26Aug2021, outcome "not recovered", described as "heart rate to rise to dangerous levels"; CHEST PAIN (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Chest pain"; FATIGUE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Extreme fatigue"; HEADACHE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Headaches"; DIZZINESS (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Dizziness"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Positive ANA Screen / ANA Titer 1:320 / ANA Pattern nuclear speckled". The events "tachycardia", "heart palpitations", "exercise intolerance", "heart rate to rise to dangerous levels", "chest pain", "extreme fatigue", "headaches", "dizziness" and "positive ana screen / ana titer 1:320 / ana pattern nuclear speckled" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia, palpitations, exercise tolerance decreased, heart rate increased, chest pain, fatigue, headache, dizziness, antinuclear antibody positive.  Additional information: The patient did not receive any other vaccine in Four weeks. The patient did not have COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Chest pain, Dizziness, Exercise tolerance decreased
Clinical narrative: Tachycardia; Heart palpitations; Exercise intolerance; heart rate to rise to dangerous levels; Chest pain; Extreme fatigue; Headaches; Dizziness; Positive ANA Screen / ANA Titer 1:320 / ANA Pattern nuclear speckled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3180) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "maybe penicillin" (unspecified if ongoing), notes: known allergies: maybe penicillin. The patient took concomitant medications. The following information was reported: TACHYCARDIA (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Tachycardia"; PALPITATIONS (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Heart palpitations"; EXERCISE TOLERANCE DECREASED (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Exercise intolerance"; HEART RATE INCREASED (non-serious) with onset 26Aug2021, outcome "not recovered", described as "heart rate to rise to dangerous levels"; CHEST PAIN (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Chest pain"; FATIGUE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Extreme fatigue"; HEADACHE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Headaches"; DIZZINESS (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Dizziness"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Positive ANA Screen / ANA Titer 1:320 / ANA Pattern nuclear speckled". The events "tachycardia", "heart palpitations", "exercise intolerance", "heart rate to rise to dangerous levels", "chest pain", "extreme fatigue", "headaches", "dizziness" and "positive ana screen / ana titer 1:320 / ana pattern nuclear speckled" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia, palpitations, exercise tolerance decreased, heart rate increased, chest pain, fatigue, headache, dizziness, antinuclear antibody positive.  Additional information: The patient did not receive any other vaccine in Four weeks. The patient did not have COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Tachycardia; Heart palpitations; Exercise intolerance; heart rate to rise to dangerous levels; Chest pain; Extreme fatigue; Headaches; Dizziness; Positive ANA Screen / ANA Titer 1:320 / ANA Pattern nuclear speckled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3180) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "maybe penicillin" (unspecified if ongoing), notes: known allergies: maybe penicillin. The patient took concomitant medications. The following information was reported: TACHYCARDIA (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Tachycardia"; PALPITATIONS (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Heart palpitations"; EXERCISE TOLERANCE DECREASED (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Exercise intolerance"; HEART RATE INCREASED (non-serious) with onset 26Aug2021, outcome "not recovered", described as "heart rate to rise to dangerous levels"; CHEST PAIN (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Chest pain"; FATIGUE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Extreme fatigue"; HEADACHE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Headaches"; DIZZINESS (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Dizziness"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Positive ANA Screen / ANA Titer 1:320 / ANA Pattern nuclear speckled". The events "tachycardia", "heart palpitations", "exercise intolerance", "heart rate to rise to dangerous levels", "chest pain", "extreme fatigue", "headaches", "dizziness" and "positive ana screen / ana titer 1:320 / ana pattern nuclear speckled" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia, palpitations, exercise tolerance decreased, heart rate increased, chest pain, fatigue, headache, dizziness, antinuclear antibody positive.  Additional information: The patient did not receive any other vaccine in Four weeks. The patient did not have COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; Heart palpitations; Exercise intolerance; heart rate to rise to dangerous levels; Chest pain; Extreme fatigue; Headaches; Dizziness; Positive ANA Screen / ANA Titer 1:320 / ANA Pattern nuclear speckled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3180) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "maybe penicillin" (unspecified if ongoing), notes: known allergies: maybe penicillin. The patient took concomitant medications. The following information was reported: TACHYCARDIA (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Tachycardia"; PALPITATIONS (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Heart palpitations"; EXERCISE TOLERANCE DECREASED (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Exercise intolerance"; HEART RATE INCREASED (non-serious) with onset 26Aug2021, outcome "not recovered", described as "heart rate to rise to dangerous levels"; CHEST PAIN (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Chest pain"; FATIGUE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Extreme fatigue"; HEADACHE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Headaches"; DIZZINESS (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Dizziness"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 26Aug2021, outcome "not recovered", described as "Positive ANA Screen / ANA Titer 1:320 / ANA Pattern nuclear speckled". The events "tachycardia", "heart palpitations", "exercise intolerance", "heart rate to rise to dangerous levels", "chest pain", "extreme fatigue", "headaches", "dizziness" and "positive ana screen / ana titer 1:320 / ana pattern nuclear speckled" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia, palpitations, exercise tolerance decreased, heart rate increased, chest pain, fatigue, headache, dizziness, antinuclear antibody positive.  Additional information: The patient did not receive any other vaccine in Four weeks. The patient did not have COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint swelling
Clinical narrative: felt tired for days; swelling very painful joint; swelling very painful joint; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2022 (Lot number: FJ6369) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine: 1st dose COVID-19, Product name/Manufacture lot number: Pfizer FA7484), administration date: 10Aug2021, when the patient was 61 years old, for Covid-19 immunization; Bnt162b2 (Vaccine: 2nd dose COVID-19, Product name/Manufacture lot number: Pfizer FC3183), administration date: 31Aug2021, when the patient was 61 years old, for COVID-19 Immunization.The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt tired for days"; JOINT SWELLING (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "swelling very painful joint". No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101456485 Same patient, same product in different dose, partial same event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Lymphadenopathy, Pain, Pruritus
Clinical narrative: I felt like truck hit me; Swollen lymphnodes; fever; chills; body aches; My armpit lymph nodes swelled (Were super itchy) with both 2nd + 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200101186 (same patient, drug/ different dose and event).  A 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Mar2021 (Lot number: EN6206) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: intramuscular, Batch/lot number: EL9266), administration date: 14Feb2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08Mar2021 10:00, outcome "recovered", described as "Swollen lymphnodes"; PYREXIA (non-serious) with onset 08Mar2021 10:00, outcome "recovered", described as "fever"; CHILLS (non-serious) with onset 08Mar2021 10:00, outcome "recovered", described as "chills"; PAIN (non-serious) with onset 08Mar2021 10:00, outcome "recovered", described as "body aches"; PRURITUS (non-serious), outcome "recovered", described as "My armpit lymph nodes swelled (Were super itchy) with both 2nd + 3rd shot"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I felt like truck hit me". Therapeutic measures were not taken as a result of lymphadenopathy, pyrexia, chills, pain.  Additional information: Prior vaccination and Specific relevant test reported as none. 12-14 hrs after 2nd vaccine and booster shot, Patient felt like truck hit me. Patient got body aches, Chills, a fever + basically could not move. About 12-18 hrs. after these symptoms, everything resolved + it was like nothing happened. Patient fever was higher (up to 103) with booster shot. Patient did not take any meds since patient knew it was just the vaccine working as soon as the fever broke, Patient sweated like crazy + then felt great, Patient armpit lymph nodes swelled (Were super itchy) with both 2nd + 3rd shot + resolved within 2 weeks of both shots.    Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I felt like truck hit me; Swollen lymphnodes; fever; chills; body aches; My armpit lymph nodes swelled (Were super itchy) with both 2nd + 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200101186 (same patient, drug/ different dose and event).  A 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Mar2021 (Lot number: EN6206) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical site of injection: Left arm, Route of administration: intramuscular, Batch/lot number: EL9266), administration date: 14Feb2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08Mar2021 10:00, outcome "recovered", described as "Swollen lymphnodes"; PYREXIA (non-serious) with onset 08Mar2021 10:00, outcome "recovered", described as "fever"; CHILLS (non-serious) with onset 08Mar2021 10:00, outcome "recovered", described as "chills"; PAIN (non-serious) with onset 08Mar2021 10:00, outcome "recovered", described as "body aches"; PRURITUS (non-serious), outcome "recovered", described as "My armpit lymph nodes swelled (Were super itchy) with both 2nd + 3rd shot"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I felt like truck hit me". Therapeutic measures were not taken as a result of lymphadenopathy, pyrexia, chills, pain.  Additional information: Prior vaccination and Specific relevant test reported as none. 12-14 hrs after 2nd vaccine and booster shot, Patient felt like truck hit me. Patient got body aches, Chills, a fever + basically could not move. About 12-18 hrs. after these symptoms, everything resolved + it was like nothing happened. Patient fever was higher (up to 103) with booster shot. Patient did not take any meds since patient knew it was just the vaccine working as soon as the fever broke, Patient sweated like crazy + then felt great, Patient armpit lymph nodes swelled (Were super itchy) with both 2nd + 3rd shot + resolved within 2 weeks of both shots.    Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oral mucosal blistering, Stomatitis
Clinical narrative: metallic taste; mouth sores/blisters; mouth sores/blisters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 (Lot number: 30155BA) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing). Concomitant medication(s) included: ZINC; PHYTOESTROGEN; MAGNESIUM. The following information was reported: DYSGEUSIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "metallic taste"; STOMATITIS (non-serious), ORAL MUCOSAL BLISTERING (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "mouth sores/blisters". The events "metallic taste", "mouth sores/blisters" and "mouth sores/blisters" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysgeusia, stomatitis, oral mucosal blistering.  Additional information: The patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination and not tested covid post vaccination. Patient did not have any known allergies. Clinical course: It was reported that after first dose, patient developed mouth sores, blisters (1 plus week) and metallic taste (2 days). Patient received second dose of BNT162B2 on 01Nov2021 (lot number: FD0809) in left arm and experienced painful swollen lymph node in armpit near injection site size of a large gumball, flu-like symptoms and fatigue for 4 days, shortness of breath and cough for a month.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101849489 similar report from same reporter.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Metabolic encephalopathy, Toxic encephalopathy
Clinical narrative: o Altered mental status characterized by confusion likely due to dehydration in the setting of COVID-19 o Toxic metabolic encephalopathy secondary to above o Acute hypoxia secondary to COVID-19 pneumonia
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Menstruation stopped; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: EW0196) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. The following information was reported: AMENORRHOEA (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Menstruation stopped". Therapeutic measures were not taken as a result of amenorrhoea.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that patient's last period was on 08Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Influenza like illness, Muscle spasms, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Two weeks after the first dose, I started experiencing restless leg type symptoms at night.; Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Nov2021 05:00 (Lot number: FJ1620) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing). There were no concomitant medications. The following information was reported: RESTLESS LEGS SYNDROME (non-serious) with onset 12Dec2021, outcome "recovered", described as "Two weeks after the first dose, I started experiencing restless leg type symptoms at night."; LIMB DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 12Dec2021, outcome "recovered" and all described as "Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles.". The event "two weeks after the first dose, i started experiencing restless leg type symptoms at night." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of restless legs syndrome, limb discomfort, paranesthesia. Additional Information: Two weeks after the first dose, I started experiencing restless leg type symptoms at night. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. The patient was recovered with lasting effects. There was no known allergies. The patient did not have covid prior vaccination. The patient did not receive other vaccines in four weeks and other medication in two weeks of first dose. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Paraesthesia, Pyrexia, Sleep disorder
Clinical narrative: Two weeks after the first dose, I started experiencing restless leg type symptoms at night.; Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Nov2021 05:00 (Lot number: FJ1620) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing). There were no concomitant medications. The following information was reported: RESTLESS LEGS SYNDROME (non-serious) with onset 12Dec2021, outcome "recovered", described as "Two weeks after the first dose, I started experiencing restless leg type symptoms at night."; LIMB DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 12Dec2021, outcome "recovered" and all described as "Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles.". The event "two weeks after the first dose, i started experiencing restless leg type symptoms at night." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of restless legs syndrome, limb discomfort, paranesthesia. Additional Information: Two weeks after the first dose, I started experiencing restless leg type symptoms at night. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. The patient was recovered with lasting effects. There was no known allergies. The patient did not have covid prior vaccination. The patient did not receive other vaccines in four weeks and other medication in two weeks of first dose. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Paraesthesia, Restless legs syndrome
Clinical narrative: Two weeks after the first dose, I started experiencing restless leg type symptoms at night.; Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Nov2021 05:00 (Lot number: FJ1620) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing). There were no concomitant medications. The following information was reported: RESTLESS LEGS SYNDROME (non-serious) with onset 12Dec2021, outcome "recovered", described as "Two weeks after the first dose, I started experiencing restless leg type symptoms at night."; LIMB DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 12Dec2021, outcome "recovered" and all described as "Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles.". The event "two weeks after the first dose, i started experiencing restless leg type symptoms at night." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of restless legs syndrome, limb discomfort, paranesthesia. Additional Information: Two weeks after the first dose, I started experiencing restless leg type symptoms at night. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. The patient was recovered with lasting effects. There was no known allergies. The patient did not have covid prior vaccination. The patient did not receive other vaccines in four weeks and other medication in two weeks of first dose. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Heavy menstrual bleeding, Postmenopausal haemorrhage
Clinical narrative: menopausal (no periods for over a year), but after the first shot, I felt abdominal pains; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2021 09:30 (Lot number: EL9265) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Menopausal" (unspecified if ongoing), notes: (no periods for over a year). There were no concomitant medications. The following information was reported: abdominal pain(non-serious) with onset 2021, outcome "unknown", described as "menopausal (no periods for over a year), but after the first shot, I felt abdominal pains". Therapeutic measures were not taken as a result of abdominal pain.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain
Clinical narrative: menopausal (no periods for over a year), but after the first shot, I felt abdominal pains; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2021 09:30 (Lot number: EL9265) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Menopausal" (unspecified if ongoing), notes: (no periods for over a year). There were no concomitant medications. The following information was reported: abdominal pain(non-serious) with onset 2021, outcome "unknown", described as "menopausal (no periods for over a year), but after the first shot, I felt abdominal pains". Therapeutic measures were not taken as a result of abdominal pain.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: VAERS reporting as required by law, death occurred on 01/03/2022. Moderna COVID 19 vaccine completed on 2/9/2021 and 3/9/2021.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: VAERS reporting as required by law, death occurred on 01/03/2022. Moderna COVID 19 vaccine completed on 2/9/2021 and 3/9/2021.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: spotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 17Jun2021 (Lot number: ew0180) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 18Jun2021, outcome "not recovered", described as "spotting".  Additional information: Vaccination facility type was Pharmacy or drug store. There were no prior Vaccination. There were no Concomitant Drugs and the Patient had no medical history. There were no relevant Test and no Specific Relevant Test. Seriousness Criteria was an Important Medical Event. AE outcome was Not recovered. She began spotting after 1st vaccine the day after (very light). This was 15days before my period. She spotted again after the second vaccine. She skipped a normal period for 2 months. Then she got her period and it was very very heavy (need to change a pad every 1-2 hour) for 20-30 days per month for last 5 months. She get her period almost 28 days per month and may be get 1-2 days of rest. She had a normal period every month at the same time each month for the same duration per month every month upon the vaccine. Never an issue before ever.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: spotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 17Jun2021 (Lot number: ew0180) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 18Jun2021, outcome "not recovered", described as "spotting".  Additional information: Vaccination facility type was Pharmacy or drug store. There were no prior Vaccination. There were no Concomitant Drugs and the Patient had no medical history. There were no relevant Test and no Specific Relevant Test. Seriousness Criteria was an Important Medical Event. AE outcome was Not recovered. She began spotting after 1st vaccine the day after (very light). This was 15days before my period. She spotted again after the second vaccine. She skipped a normal period for 2 months. Then she got her period and it was very very heavy (need to change a pad every 1-2 hour) for 20-30 days per month for last 5 months. She get her period almost 28 days per month and may be get 1-2 days of rest. She had a normal period every month at the same time each month for the same duration per month every month upon the vaccine. Never an issue before ever.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis allergic, Nausea, Syncope, Urticaria, Vaccination complication
Clinical narrative: acute rash/ weals rash; wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet; wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Dec2021 (Lot number: FE3594) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing); "Known allergies: pennicillen" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; DULOXETINE. Past drug history included: Codeine, reaction(s): "Allergy"; Ibufrofen, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1 at 01:15 PM (Batch/Lot No: pfizer FH8020) Location of injection: Right Arm), administration date: Dec2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 24Dec2021 14:30, outcome "not recovered", described as "acute rash/ weals rash"; URTICARIA (non-serious), DERMATITIS (non-serious) all with onset 24Dec2021 14:30, outcome "not recovered" and all described as "wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, urticaria, dermatitis.  Additional information: Patient received second dose on unspecified date in Dec2021 at 02:30 PM at hospital. No other vaccine in four weeks. Adverse event: acute rash/ weals rash/ wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet. No Covid prior vaccination. Patient had Covid test post vaccination. Patient received Medrol prednisone 6 day dose pack/ hydroxyzine as treatment for adverse event.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Viral rash, Vomiting
Clinical narrative: acute rash/ weals rash; wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet; wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Dec2021 (Lot number: FE3594) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing); "Known allergies: pennicillen" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; DULOXETINE. Past drug history included: Codeine, reaction(s): "Allergy"; Ibufrofen, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1 at 01:15 PM (Batch/Lot No: pfizer FH8020) Location of injection: Right Arm), administration date: Dec2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 24Dec2021 14:30, outcome "not recovered", described as "acute rash/ weals rash"; URTICARIA (non-serious), DERMATITIS (non-serious) all with onset 24Dec2021 14:30, outcome "not recovered" and all described as "wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, urticaria, dermatitis.  Additional information: Patient received second dose on unspecified date in Dec2021 at 02:30 PM at hospital. No other vaccine in four weeks. Adverse event: acute rash/ weals rash/ wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet. No Covid prior vaccination. Patient had Covid test post vaccination. Patient received Medrol prednisone 6 day dose pack/ hydroxyzine as treatment for adverse event.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: acute rash/ weals rash; wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet; wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Dec2021 (Lot number: FE3594) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing); "Known allergies: pennicillen" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; DULOXETINE. Past drug history included: Codeine, reaction(s): "Allergy"; Ibufrofen, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1 at 01:15 PM (Batch/Lot No: pfizer FH8020) Location of injection: Right Arm), administration date: Dec2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 24Dec2021 14:30, outcome "not recovered", described as "acute rash/ weals rash"; URTICARIA (non-serious), DERMATITIS (non-serious) all with onset 24Dec2021 14:30, outcome "not recovered" and all described as "wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, urticaria, dermatitis.  Additional information: Patient received second dose on unspecified date in Dec2021 at 02:30 PM at hospital. No other vaccine in four weeks. Adverse event: acute rash/ weals rash/ wheals inflamed rash urticarial weals arms, legs feet chest breasts bottom of feet. No Covid prior vaccination. Patient had Covid test post vaccination. Patient received Medrol prednisone 6 day dose pack/ hydroxyzine as treatment for adverse event.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: VAERS reporting as required by law, death occurred on 01/16/2022. Moderna COVID 19 vaccines completed on 2/9/2021, 3/9/2021, 11/9/2021.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: VAERS reporting as required by law, death occurred on 01/16/2022. Moderna COVID 19 vaccines completed on 2/9/2021, 3/9/2021, 11/9/2021.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6199) at the age of 63 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset 01Apr2021, outcome "not recovered" and all described as "About 3 weeks after first injection, developed itchy skin rash at inside left elbow (just below injection site).". The event "about 3 weeks after first injection, developed itchy skin rash at inside left elbow (just below injection site)", and "about 3 weeks after first injection, developed itchy skin rash at inside left elbow (just below injection site)". Was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus. Additional information: The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The events cleared up after 3-4 weeks. No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6199) at the age of 63 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset 01Apr2021, outcome "not recovered" and all described as "About 3 weeks after first injection, developed itchy skin rash at inside left elbow (just below injection site).". The event "about 3 weeks after first injection, developed itchy skin rash at inside left elbow (just below injection site)", and "about 3 weeks after first injection, developed itchy skin rash at inside left elbow (just below injection site)". Was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus. Additional information: The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. Patient received no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The events cleared up after 3-4 weeks. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Acceleration of ADHD; Hives were all over mostly torso; Fever 103.2; Chills; Sweats; Brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 11:00 (Lot number: EW0772) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time: 10 am, Anatomical site of injection: Left upper arm, Batch/Lot number: EW0172), administration date: 20May2021, for Covid-19 immunization.  The following information was reported: ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Acceleration of ADHD"; URTICARIA (non-serious) with onset 26Dec2021, outcome "recovering", described as "Hives were all over mostly torso"; PYREXIA (non-serious) with onset 26Dec2021, outcome "unknown", described as "Fever 103.2"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 26Dec2021, outcome "recovering", described as "Sweats"; FEELING ABNORMAL (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Brain fog". The events "acceleration of adhd", "hives were all over mostly torso", "fever 103.2", "chills", "sweats" and "brain fog" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of attention deficit hyperactivity disorder, urticaria, pyrexia, chills, hyperhidrosis, feeling abnormal.  Additional information: No prior vaccination. The patient received the treatment for the events was Steroids, Hydroxyzine. Acceleration of ADHD which has continued. No family Medical history relevant to AE. Really, just wanted to let you know I self the odd brainthing after second shot. Then with this covid whatever it was, it does to brain, never went away. Thought may help with your studies as this goes forward. I am sure you know at this point there is no cure. Just control.  No follow-up attempts are possible. No further information is expected.