chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough\was a dry cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26May2021 (Lot number: ER8727) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autism" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0175), administration date: 27Apr2021, when the patient was 33 years old, for COVID-19 immunization.  The following information was reported: COUGH (non-serious) with onset 2021, outcome "not recovered", described as "cough\was a dry cough". The event "cough\was a dry cough" was evaluated at the physician office visit. Therapeutic measures were taken as a result of cough.  Additional Information: Reporter states that her son developed a cough after receiving the 2nd dose of the Covid 19 vaccine. She has taken her son to his general practitioner and a pulmonologist, and is going to a 2nd pulmonologist tomorrow. Her son received his 2nd dose on 26May2021 (Time the Vaccination Was Given: 1:30-2pm) and within a week or two a cough developed. The cough is everyday, several times a day, and was a dry cough. Cough was reported as worsened. The patient did not received any other vaccine prior 4 weeks of vaccination. Patient was not having any AE prior vaccination. The family medical history relevant to event was reported as none. Relevant test reported as none. The primary doctor gave him steroids which didn't work. She doesn't know the name of the steroids, and states that she threw away the packaging, so can't provide the product name, Lot/NDC/Expiry. The 1st pulmonologist gave him an inhaler and some pills to take, neither of which did any good, and now his cough sounds like it's getting a little deeper, so she is taking him to a 2nd pulmonologist tomorrow. Breo Inhaler, 1 puff once daily, Lot: D59R, Expiry: Dec2022. Benzolate 200mg, 3 times a day, discard after 25Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Feeling hot, Loss of personal independence in daily activities, Syncope
Clinical narrative: I felt fine for the first 25 minutes after the injection, then felt hot and dizzy.  Medics helped me for the next 90 minutes and measured high blood pressure, 5 rounds of syncope, and shaking that looked like a seizure.  I have a history of convulsive syncope with dysautonomia, and assume the 5 episodes were convulsive syncope.  The shaking lasted 5 hours.  I was dizzy and unable to stand much for 3 days. I continued to have dizziness episodes and was unable to function for 1 week.  Full recovery took 4 weeks.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I felt fine for the first 25 minutes after the injection, then felt hot and dizzy.  Medics helped me for the next 90 minutes and measured high blood pressure, 5 rounds of syncope, and shaking that looked like a seizure.  I have a history of convulsive syncope with dysautonomia, and assume the 5 episodes were convulsive syncope.  The shaking lasted 5 hours.  I was dizzy and unable to stand much for 3 days. I continued to have dizziness episodes and was unable to function for 1 week.  Full recovery took 4 weeks.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Full body rash and hives; Full body rash and hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 12:45 (Lot number: FE3591) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Craniotomy", start date: 16Oct2009 (unspecified if ongoing), notes: Craniotomy for removal for ruptured AVM 16Oct2009; "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE. The following information was reported: RASH (non-serious), URTICARIA (non-serious) all with onset 07Oct2021 15:30, outcome "recovered with sequelae" (2021) and all described as "Full body rash and hives". Therapeutic measures were taken as a result of rash, urticaria.  Additional Information: Patient had facility type vaccine Pharmacy or Drug Store and no other vaccine in four weeks and had Lamotrigine as other medications in two weeks. Patient had covid prior vaccination and not covid tested post vaccination. Patient had no known allergies. The patient provides information regarding the adverse event(s) with the use of the product and Pfizer had a causal effect to the adverse event. The time course of the anaphylactic reaction is 1-2 hours after vaccine. The patient requires medical intervention and takes antihistamine. The event requires the initiation of new medication or other treatment or procedure and takes Benadryl. The patient didn't receive any recent vaccines for any other conditions prior to the event being reported and didn't receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient didn't receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Cough, Discomfort, Dysgeusia
Clinical narrative: I developed a metallic taste in my mouth an hour after the vaccine.  Within a few hours after receiving the vaccine I developed a headache and pressure on the right side of my face - nose/sinus area.  I also had a 102 temperature for a week,  cough, shortness of breath, fatigue, muscle aches and bruising on my right upper thigh.  The bruises to my upper thigh subsided but the area is still tender.  I also had slight visual changes.  I have had ongoing headaches since the vaccine.   I was monitored by employee health and had two covid tests which were negative.  I was seen by my PCP for clearance to return to work.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Facial discomfort, Fatigue, Headache, Myalgia
Clinical narrative: I developed a metallic taste in my mouth an hour after the vaccine.  Within a few hours after receiving the vaccine I developed a headache and pressure on the right side of my face - nose/sinus area.  I also had a 102 temperature for a week,  cough, shortness of breath, fatigue, muscle aches and bruising on my right upper thigh.  The bruises to my upper thigh subsided but the area is still tender.  I also had slight visual changes.  I have had ongoing headaches since the vaccine.   I was monitored by employee health and had two covid tests which were negative.  I was seen by my PCP for clearance to return to work.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination, SARS-CoV-2 test negative, Visual impairment
Clinical narrative: I developed a metallic taste in my mouth an hour after the vaccine.  Within a few hours after receiving the vaccine I developed a headache and pressure on the right side of my face - nose/sinus area.  I also had a 102 temperature for a week,  cough, shortness of breath, fatigue, muscle aches and bruising on my right upper thigh.  The bruises to my upper thigh subsided but the area is still tender.  I also had slight visual changes.  I have had ongoing headaches since the vaccine.   I was monitored by employee health and had two covid tests which were negative.  I was seen by my PCP for clearance to return to work.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea
Clinical narrative: headache; nausea; fever; joint pain; dizziness; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 15Oct2021 16:00 (Lot number: FD0810) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "quadruple bypass", start date: 2008 (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TOPROL (ongoing); CRESTOR taken for blood cholesterol (ongoing); ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (1st Dose, LOT: EL3246), administration date: 18Jan2021, when the patient was 68 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose, LOT: EM9810), administration date: 08Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Oct2021, outcome "not recovered", described as "headache"; NAUSEA (non-serious) with onset 16Oct2021, outcome "unknown", described as "nausea"; PYREXIA (non-serious) with onset 16Oct2021, outcome "unknown", described as "fever"; ARTHRALGIA (non-serious) with onset 16Oct2021, outcome "unknown", described as "joint pain"; DIZZINESS (non-serious) with onset 16Oct2021, outcome "unknown", described as "dizziness"; CHILLS (non-serious) with onset 16Oct2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of headache, nausea, pyrexia, arthralgia, dizziness, chills.  Additional information: He got the booster about 4:00pm on Friday. About 2:00am he started to exhibit symptoms of headache, nausea, fever, joint pain, dizziness and severe chills. Clarified that by Friday, the caller was referring to Friday, 15Oct2021 and that the symptoms started 2:00am, 16Oct2021. He was not experiencing these symptoms right now except that he has a slight headache. He was in bed all day Saturday and half of the day Sunday. Sunday afternoon, it slowly started to subside. Treatment: He took one Tylenol on Saturday afternoon and that was it. Caller states that with the second dose, it was all of the same symptoms, the headache, nausea, fever, joint pain, dizziness and severe chills. The onset was a little sooner after getting the vaccine. It was probably a little more in severity. That time, it lasted the same amount of time, about 48 to 72 hours.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; nausea; fever; joint pain; dizziness; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 15Oct2021 16:00 (Lot number: FD0810) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "quadruple bypass", start date: 2008 (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TOPROL (ongoing); CRESTOR taken for blood cholesterol (ongoing); ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (1st Dose, LOT: EL3246), administration date: 18Jan2021, when the patient was 68 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose, LOT: EM9810), administration date: 08Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Oct2021, outcome "not recovered", described as "headache"; NAUSEA (non-serious) with onset 16Oct2021, outcome "unknown", described as "nausea"; PYREXIA (non-serious) with onset 16Oct2021, outcome "unknown", described as "fever"; ARTHRALGIA (non-serious) with onset 16Oct2021, outcome "unknown", described as "joint pain"; DIZZINESS (non-serious) with onset 16Oct2021, outcome "unknown", described as "dizziness"; CHILLS (non-serious) with onset 16Oct2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of headache, nausea, pyrexia, arthralgia, dizziness, chills.  Additional information: He got the booster about 4:00pm on Friday. About 2:00am he started to exhibit symptoms of headache, nausea, fever, joint pain, dizziness and severe chills. Clarified that by Friday, the caller was referring to Friday, 15Oct2021 and that the symptoms started 2:00am, 16Oct2021. He was not experiencing these symptoms right now except that he has a slight headache. He was in bed all day Saturday and half of the day Sunday. Sunday afternoon, it slowly started to subside. Treatment: He took one Tylenol on Saturday afternoon and that was it. Caller states that with the second dose, it was all of the same symptoms, the headache, nausea, fever, joint pain, dizziness and severe chills. The onset was a little sooner after getting the vaccine. It was probably a little more in severity. That time, it lasted the same amount of time, about 48 to 72 hours.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Frustration tolerance decreased
Clinical narrative: Bruise; She is frustrated because the symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Sep2021 (Lot number: FC3182, Expiration Date: Oct2021) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Light asthma" (unspecified if ongoing), notes: Verbatim: light asthma, diagnosed about 5 or 6 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot number: FC3182, Anatomical site of injection: Left arm), administration date: 01Sep2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: CONTUSION (non-serious) with onset Sep2021, outcome "not recovered", described as "Bruise"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "She is frustrated because the symptoms". Therapeutic measures were not taken as a result of contusion.  Additional Information: Patient is disturbed. Patient is calling about the covid vaccine. She is calling about side effects. She has always been paranoid of shots and is conscience of her body. She did not wish to get it done till it is approved it. She is frustrated because the symptoms started two weeks ago. She was planning to go to withheld on Monday to ask about it since she does not have a doctor. She chose to get the shot in her left shoulder incase something went wrong, she is a right hander. She noticed a pale like bruise, two of them that she can see on her arm. About two days ago 6 more bruises have occurred and are very noticeable. She wears things that are sleeveless and looking at it, it is not a good sight. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available see details above for first dose Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations was None. What is recommended. She is not accustomed to having these very visible blemishes on her. It looks like someone took marker and made blemishes on her arm. She is counting and there is 9 in the upper arm. She is holding off on the booster since she does not trust it.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Erythema, Pain in extremity, Tenderness
Clinical narrative: had sore arm for 3 days; some redness for 3days right arm; 4th day slightly tender site; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Sep2021 17:40 (Lot number: EW0176) at the age of 79 years as dose 1, signle for covid-19 immunisation. Relevant medical history included: "Lymphocytosis", start date: 2020 (ongoing); "Hashimoto's", start date: 1972 (ongoing), notes: Since 30 years age; "Allergies: Numerous allergies food", start date: 1963 (ongoing); "Allergies: Drug", start date: 1963 (ongoing); "Allergies: Environmental", start date: 1963 (ongoing); "Lichen Plantos", start date: 2021 (ongoing). Concomitant medication(s) included: SYNTHROID taken for autoimmune thyroiditis, start date: 1972 (ongoing). Past drug history included: Polysorbate 80, reaction(s): "allergy".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "had sore arm for 3 days"; ERYTHEMA (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "some redness for 3days right arm"; TENDERNESS (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "4th day slightly tender site". The events "some redness for 3days right arm" and "4th day slightly tender site" 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 erythema, tenderness.  Additional information: Concomitant medication Homeopathic Mag-CArp taken for Lichen Plantos on an unknown date in 2021 via oral route.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Heart rate irregular
Clinical narrative: Irregular heartbeat; rundown; joint pain; arm pain; headache; dizziness; low blood pressure; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 22:15 (Lot number: FL3183) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: Some antibiotics" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "possible IBS" (unspecified if ongoing); "irregular heartbeat at times" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "gummy prenatal vitamins" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 10Sep2021; FLUOXETINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 8982, Location of injection: Arm Left, Vaccine Administration Time: 08:15 PM), administration date: 22Jan2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 12Feb2021, for COVID-19 immunization. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "Irregular heartbeat"; ASTHENIA (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "rundown"; ARTHRALGIA (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "joint pain"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "arm pain"; HEADACHE (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "headache"; DIZZINESS (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "dizziness"; HYPOTENSION (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "low blood pressure". The events "irregular heartbeat", "rundown", "joint pain", "arm pain", "headache", "dizziness" and "low blood pressure" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of heart rate irregular, asthenia, arthralgia, pain in extremity, headache, dizziness, hypotension.  Additional information: Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pain in extremity
Clinical narrative: Irregular heartbeat; rundown; joint pain; arm pain; headache; dizziness; low blood pressure; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 22:15 (Lot number: FL3183) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: Some antibiotics" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "possible IBS" (unspecified if ongoing); "irregular heartbeat at times" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "gummy prenatal vitamins" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 10Sep2021; FLUOXETINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 8982, Location of injection: Arm Left, Vaccine Administration Time: 08:15 PM), administration date: 22Jan2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 12Feb2021, for COVID-19 immunization. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "Irregular heartbeat"; ASTHENIA (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "rundown"; ARTHRALGIA (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "joint pain"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "arm pain"; HEADACHE (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "headache"; DIZZINESS (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "dizziness"; HYPOTENSION (non-serious) with onset 24Sep2021 21:30, outcome "recovered" (2021), described as "low blood pressure". The events "irregular heartbeat", "rundown", "joint pain", "arm pain", "headache", "dizziness" and "low blood pressure" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of heart rate irregular, asthenia, arthralgia, pain in extremity, headache, dizziness, hypotension.  Additional information: Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Contusion, Headache
Clinical narrative: Fever of 102.4; Chills; Injection site soreness; weakness; Headache; Muscle aches; Random  bruising on hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 19:15 (Lot number: FF2587) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypermobility" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; VITAMIN B; CALCIUM; VITAMIN D; MELATONIN. Past drug history included: Morphine, reaction(s): "allergy".  The following information was reported: PYREXIA (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Fever of 102.4"; CHILLS (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Injection site soreness"; ASTHENIA (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "weakness"; HEADACHE (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Headache"; MYALGIA (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Muscle aches"; CONTUSION (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Random bruising on hip". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, vaccination site pain, asthenia, headache, myalgia, contusion.  Additional information: No other vaccine were received in four weeks. Not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 102.4; Chills; Injection site soreness; weakness; Headache; Muscle aches; Random  bruising on hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 19:15 (Lot number: FF2587) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypermobility" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; VITAMIN B; CALCIUM; VITAMIN D; MELATONIN. Past drug history included: Morphine, reaction(s): "allergy".  The following information was reported: PYREXIA (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Fever of 102.4"; CHILLS (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Injection site soreness"; ASTHENIA (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "weakness"; HEADACHE (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Headache"; MYALGIA (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Muscle aches"; CONTUSION (non-serious) with onset 16Oct2021 10:00, outcome "recovered" (Oct2021), described as "Random bruising on hip". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, vaccination site pain, asthenia, headache, myalgia, contusion.  Additional information: No other vaccine were received in four weeks. Not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: Trouble swallowing; right side of throat feels swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 10:15 (Lot number: FE3590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: BARICITINIB; DROSPIRENONE AND ETHINYL ESTRADIOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Right, Vaccine Administration Time: 10:15 AM), administration date: 08Apr2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 10:15 AM), administration date: 18Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: DYSPHAGIA (non-serious) with onset 22Oct2021 03:45, outcome "not recovered", described as "Trouble swallowing"; PHARYNGEAL SWELLING (non-serious) with onset 22Oct2021 03:45, outcome "not recovered", described as "right side of throat feels swollen". Therapeutic measures were not taken as a result of dysphagia, pharyngeal swelling. Additional information The patient did not receive any other vaccine in last four weeks. Other medications in two weeks were Rinvoq and Loryna bcp. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not have any Known allergies  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: swelling and soreness at the injection site; swelling and soreness at the injection site; swollen lymph nodes; elevated heart beat; muscle pain; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 65 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 (Dose 1; Lot/Batch# UNKNOWN; MANUFACTURERE UNKNOWN), for Covid-19 immunization; Bnt162b2 (Dose 2; Lot/Batch# UNKNOWN; MANUFACTURERE UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Oct2021, outcome "unknown" and all described as "swelling and soreness at the injection site"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "swollen lymph nodes"; HEART RATE ABNORMAL (non-serious) with onset Oct2021, outcome "unknown", described as "elevated heart beat"; MYALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "muscle pain"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and soreness at the injection site; swelling and soreness at the injection site; swollen lymph nodes; elevated heart beat; muscle pain; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 65 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 (Dose 1; Lot/Batch# UNKNOWN; MANUFACTURERE UNKNOWN), for Covid-19 immunization; Bnt162b2 (Dose 2; Lot/Batch# UNKNOWN; MANUFACTURERE UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Oct2021, outcome "unknown" and all described as "swelling and soreness at the injection site"; LYMPHADENOPATHY (non-serious) with onset Oct2021, outcome "unknown", described as "swollen lymph nodes"; HEART RATE ABNORMAL (non-serious) with onset Oct2021, outcome "unknown", described as "elevated heart beat"; MYALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "muscle pain"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Pain in extremity, Pruritus, Rash
Clinical narrative: Burning; Arm got sore; rash/a long strip of rash on her buttocks; Itching; she is considering it could be shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 (Lot number: 30155BA) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "DCIS", start date: Feb2020 (ongoing), notes: Patient Medical comments  , Verbatim: DCIS; "Bones" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for bone disorder (ongoing); ANASTROZOLE taken for intraductal proliferative breast lesion (ongoing). Vaccination history included: Bnt162b2 (First dose, LOT- EN6198, Left arm ), administration date: 08Mar2021, when the patient was 67 years old, for Covid-19 immunization; Bnt162b2 (Second Dose, LOT- EP7534, Left arm ), administration date: 31Mar2021, when the patient was 67 years old, for Covid-19 immunization, reaction(s): "little fever". The following information was reported: BURNING SENSATION (non-serious) with onset 18Oct2021, outcome "not recovered", described as "Burning"; PAIN IN EXTREMITY (non-serious) with onset 18Oct2021, outcome "not recovered", described as "Arm got sore"; RASH (non-serious) with onset 18Oct2021, outcome "not recovered", described as "rash/a long strip of rash on her buttocks"; PRURITUS (non-serious) with onset 18Oct2021, outcome "not recovered", described as "Itching"; HERPES ZOSTER (non-serious) with onset 18Oct2021, outcome "not recovered", described as "she is considering it could be shingles". Therapeutic measures were taken as a result of burning sensation, rash, pruritus.  Additional information: Patient had a long strip of what looked like a rash on her buttstocks, nowhere else. Stated she has been putting polyisoprene cream on it, she was not sure if something bite her or if it's a reaction to the vaccine. She was just calling to see if it was connected. She states if it's not related then she will feel foolish for calling, but she was trying to figure out what this might be and if see needs to see her doctor or not. She also mentioned that it woke her up in the middle of the night and she went on the internet and it said you can take an antihistamine for the itching so she did that for the itching that started, and the burning.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: B-lymphocyte count, Biopsy lymph gland abnormal, C-reactive protein increased, Computerised tomogram neck, Culture
Clinical narrative: approximately 2 weeks post-vaccine devleoped severe pharyngitis (pos strep test) and bilat cervical LAN ultimately requiring hospital admission. She underwent LN biopsy with finding of necrotizing granulomas.  Testing at facility with broad range mycobacterial PCR positive for Mycobacterium intracellulaire.  Symptoms resolved without antimicrobial treatment or steroids.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Flow cytometry, Gomori methenamine silver stain, Gram stain negative, Granuloma, Granulomatous lymphadenitis
Clinical narrative: approximately 2 weeks post-vaccine devleoped severe pharyngitis (pos strep test) and bilat cervical LAN ultimately requiring hospital admission. She underwent LN biopsy with finding of necrotizing granulomas.  Testing at facility with broad range mycobacterial PCR positive for Mycobacterium intracellulaire.  Symptoms resolved without antimicrobial treatment or steroids.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Immunophenotyping, Lymphadenopathy, Mycobacterium test negative, Mycobacterium test positive, Pharyngitis streptococcal
Clinical narrative: approximately 2 weeks post-vaccine devleoped severe pharyngitis (pos strep test) and bilat cervical LAN ultimately requiring hospital admission. She underwent LN biopsy with finding of necrotizing granulomas.  Testing at facility with broad range mycobacterial PCR positive for Mycobacterium intracellulaire.  Symptoms resolved without antimicrobial treatment or steroids.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test positive, T-lymphocyte count normal, Tonsillar hypertrophy, Tonsillar inflammation
Clinical narrative: approximately 2 weeks post-vaccine devleoped severe pharyngitis (pos strep test) and bilat cervical LAN ultimately requiring hospital admission. She underwent LN biopsy with finding of necrotizing granulomas.  Testing at facility with broad range mycobacterial PCR positive for Mycobacterium intracellulaire.  Symptoms resolved without antimicrobial treatment or steroids.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray abnormal, Chest pain, Dizziness, Echocardiogram abnormal
Clinical narrative: Tachycardia, followed by chest pain, dyspnea, and chronic fatigue.  Diagnosed with Pericarditis by myself and cardiology.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Palpitations, Pericarditis, Vaccination complication
Clinical narrative: Tachycardia, followed by chest pain, dyspnea, and chronic fatigue.  Diagnosed with Pericarditis by myself and cardiology.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue
Clinical narrative: Tachycardia, followed by chest pain, dyspnea, and chronic fatigue.  Diagnosed with Pericarditis by myself and cardiology.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Tachycardia
Clinical narrative: Tachycardia, followed by chest pain, dyspnea, and chronic fatigue.  Diagnosed with Pericarditis by myself and cardiology.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Vaccination site pain
Clinical narrative: after first dose minor pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after first dose minor pain in arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021 at 5:00 AM, the patient experienced PAIN IN EXTREMITY (after first dose minor pain in arm). At the time of the report, PAIN IN EXTREMITY (after first dose minor pain in arm) had not resolved. Not Provided    mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant and treatment medication details were reported.   This case was linked to MOD-2022-474346, MOD-2022-474417 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: after first dose minor pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after first dose minor pain in arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021 at 5:00 AM, the patient experienced PAIN IN EXTREMITY (after first dose minor pain in arm). At the time of the report, PAIN IN EXTREMITY (after first dose minor pain in arm) had not resolved. Not Provided    mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant and treatment medication details were reported.   This case was linked to MOD-2022-474346, MOD-2022-474417 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: SWOLLEN LIPS; SWOLLEN KNEES; SWOLLEN FACE; SWELLING UNDERNEATH TONGUE; This spontaneous report received from a patient concerned an 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, red dye allergy, mango allergy, clam allergy, and cardiovascular disease, and other pre-existing medical conditions included: Patient had no adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, ascorbic acid, calcium carbonate/colecalciferol, enalapril, fish oil, folic acid, lysine, magnesium oxide, metoprolol succinate, tocopherol, and vaccinium macrocarpon.  On 17-NOV-2021, the patient experienced swollen lips, swollen knees, swollen face, and swelling underneath tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lips, swollen knees, swollen face, and swelling underneath tongue. This report was non-serious.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: Patient had redness, induration, pain and swelling to her entire right arm fairly quickly within an hour or so after the vaccine. She developed fever by the evening of the date of vaccination. She also developed stomachache, nausea, fatigue, irritability, mild cough, and sore throat.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Cough, Erythema, Fatigue, Induration
Clinical narrative: Patient had redness, induration, pain and swelling to her entire right arm fairly quickly within an hour or so after the vaccine. She developed fever by the evening of the date of vaccination. She also developed stomachache, nausea, fatigue, irritability, mild cough, and sore throat.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability, Nausea, Oropharyngeal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had redness, induration, pain and swelling to her entire right arm fairly quickly within an hour or so after the vaccine. She developed fever by the evening of the date of vaccination. She also developed stomachache, nausea, fatigue, irritability, mild cough, and sore throat.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Patient had redness, induration, pain and swelling to her entire right arm fairly quickly within an hour or so after the vaccine. She developed fever by the evening of the date of vaccination. She also developed stomachache, nausea, fatigue, irritability, mild cough, and sore throat.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: The day after receiving my booster shot of the Moderna vaccine, I developed a severe migraine. From that point on for about the next month, I struggled with headaches and migraines continually. While I don't believe the booster continued to be the cause of the migraine/headaches after the initial one on 11/18/21, I do believe it triggered the series. After about a month or so of dealing with it, I saw my primary care physician. She proscribed me a 5 day dose of a steroid to stop the migraines. The steroid certainly helped, but it took another few weeks for me to feel regularly free of the headaches/migraines.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Skin swelling, Urticaria
Clinical narrative: Hives, raised welts, skin remains raised when I scratch it (dermtographia or something like that). Began 14 days after booster shot, has slowly decreased over the last 6 weeks, reflared up again today, 6.5 weeks after first symptom
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypokinesia, Inflammation, Muscle spasms, Nerve compression
Clinical narrative: Shooting pains down all of my limbs. Muscle spasms down my right shoulder and arm. Tingling in fingers. 50% loss of strength in right arm and loss of movement.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Shooting pains down all of my limbs. Muscle spasms down my right shoulder and arm. Tingling in fingers. 50% loss of strength in right arm and loss of movement.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chills, Fatigue, Pyrexia
Clinical narrative: 104 fever, fatigue, chills for 3 days. 99-101 fever for 14 days. Hasn't resolved.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Chronic Hives started ~2 weeks after getting this booster. They are still occurring today.  I have never had hives in my life before this.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Mechanical urticaria, Pruritus, Throat irritation, Urticaria
Clinical narrative: Generalized wipe spread hives, throat itching, tongue numb, generalized itching with long term dermatographias and intermittent itching. Required prednisone, hydroxyzine, epi pen, and Zyrtec still daily
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Since receiving vaccine I have been dealing with unmanaged rash. This has resulted in 2 urgent care visits and several visits with dermatologist. It started with a rash to left arm. It then progressed to both arms and both ankles. Now it is on both arms, both ankles, left side, lower back, and neck. I have done oral prednisone, dexamethasone, doxycycline.  Topical I have tried triamcimilone, clobetasol, betamethasone, non-steroidal cream, and several moisturizers and soaps recommended by dermatologist. Also did 3 months of every 2 week injections of Dupixent.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: My husband and I  received our 2nd Covid vaccines and 6-1/2 days later he died.   He had no heart issues and was tall, slim, healthy and very active.   He had 2 heart attacks before the ambulance came and 3 more in the ambulance on the way to the Hospital.   The next attack was as they were unloading him in the ER and he died.    I have the ambulance report, the ER report and his last blood work and checkup reports and there is no doubt the vaccine caused his death.   I showed his reports to a heart doctor that I know and he agreed that it has killed some people.   I know of 2 other people that live in my town that had the same thing happen to them.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Hives occurred 11 days after booster. Now at 3 months. First started with itchy scalp and then dermatographia towards the end.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electromyogram, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Numbness / tingling, pain, starting in left leg, occasionally left arm, then both legs.  Headaches daily Dizziness Severe fatigue Body aches
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Numbness / tingling, pain, starting in left leg, occasionally left arm, then both legs.  Headaches daily Dizziness Severe fatigue Body aches