chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; Fever; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (054550).  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "ER POSITIVE" (unspecified if ongoing); "NEOPLASM OF THE BREAST" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D3. Past drug history included: Enbrel, reaction(s): "Allergy:ENBREL"; Humira, reaction(s): "Allergy:HUMIRA"; Keflex, reaction(s): "Allergy:KEFLEX"; Levaquin, reaction(s): "Allergy:LEVAQUIN". The following information was reported: RHINORRHOEA (medically significant), outcome "unknown", described as "Runny nose"; PYREXIA (non-serious), outcome "unknown", described as "Fever".Clinical comment: She had a runny nose, and fever, this was also after obtaining the covid vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, a causal association between the reported events rhinorrhea, pyrexia and the suspect BNT162B2 cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Chest pain, Fatigue, Inappropriate schedule of product administration, Myocarditis
Clinical narrative: inflamed heart; Panic attack; Dose Number: 1 04Nov2021/Dose Number: 2 18Dec2021; tired; anxiety is still a little high; Chest pain thinking it's congestion; Chest pain thinking it's congestion; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 38-year-old male patient received bnt162b2, administered in arm left, administration date 18Dec2021 16:00 (Lot number: 331808A) at the age of 38 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 20:00), administration date: 04Nov2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: inappropriate schedule of product administration with onset 18Dec2021 16:00, outcome unknown: 1 04Nov2021/Dose Number: 2 18Dec2021; myocarditis with onset 18Dec2021 16:15, outcome unknown; panic attack with onset 18Dec2021 16:05, outcome unknown; fatigue with onset Dec2021, outcome not recovered; anxiety with onset Dec2021, outcome not recovered; chest pain, respiratory tract congestion all with onset Dec2021, outcome unknown. The events inflamed heart, panic attack, tired, anxiety is still a little high, chest pain thinking it's congestion and chest pain thinking it's congestion were evaluated at the emergency room visit. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past drug history was reported as none. Reporter stating events as non-serious. Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Panic attack, Respiratory tract congestion
Clinical narrative: inflamed heart; Panic attack; Dose Number: 1 04Nov2021/Dose Number: 2 18Dec2021; tired; anxiety is still a little high; Chest pain thinking it's congestion; Chest pain thinking it's congestion; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 38-year-old male patient received bnt162b2, administered in arm left, administration date 18Dec2021 16:00 (Lot number: 331808A) at the age of 38 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 20:00), administration date: 04Nov2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: inappropriate schedule of product administration with onset 18Dec2021 16:00, outcome unknown: 1 04Nov2021/Dose Number: 2 18Dec2021; myocarditis with onset 18Dec2021 16:15, outcome unknown; panic attack with onset 18Dec2021 16:05, outcome unknown; fatigue with onset Dec2021, outcome not recovered; anxiety with onset Dec2021, outcome not recovered; chest pain, respiratory tract congestion all with onset Dec2021, outcome unknown. The events inflamed heart, panic attack, tired, anxiety is still a little high, chest pain thinking it's congestion and chest pain thinking it's congestion were evaluated at the emergency room visit. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past drug history was reported as none. Reporter stating events as non-serious. Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Electrocardiogram normal, Palpitations
Clinical narrative: inflamed heart; Panic attack; Dose Number: 1 04Nov2021/Dose Number: 2 18Dec2021; tired; anxiety is still a little high; Chest pain thinking it's congestion; Chest pain thinking it's congestion; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 38-year-old male patient received bnt162b2, administered in arm left, administration date 18Dec2021 16:00 (Lot number: 331808A) at the age of 38 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 20:00), administration date: 04Nov2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: inappropriate schedule of product administration with onset 18Dec2021 16:00, outcome unknown: 1 04Nov2021/Dose Number: 2 18Dec2021; myocarditis with onset 18Dec2021 16:15, outcome unknown; panic attack with onset 18Dec2021 16:05, outcome unknown; fatigue with onset Dec2021, outcome not recovered; anxiety with onset Dec2021, outcome not recovered; chest pain, respiratory tract congestion all with onset Dec2021, outcome unknown. The events inflamed heart, panic attack, tired, anxiety is still a little high, chest pain thinking it's congestion and chest pain thinking it's congestion were evaluated at the emergency room visit. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past drug history was reported as none. Reporter stating events as non-serious. Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: inflamed heart; Panic attack; Dose Number: 1 04Nov2021/Dose Number: 2 18Dec2021; tired; anxiety is still a little high; Chest pain thinking it's congestion; Chest pain thinking it's congestion; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 38-year-old male patient received bnt162b2, administered in arm left, administration date 18Dec2021 16:00 (Lot number: 331808A) at the age of 38 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 20:00), administration date: 04Nov2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: inappropriate schedule of product administration with onset 18Dec2021 16:00, outcome unknown: 1 04Nov2021/Dose Number: 2 18Dec2021; myocarditis with onset 18Dec2021 16:15, outcome unknown; panic attack with onset 18Dec2021 16:05, outcome unknown; fatigue with onset Dec2021, outcome not recovered; anxiety with onset Dec2021, outcome not recovered; chest pain, respiratory tract congestion all with onset Dec2021, outcome unknown. The events inflamed heart, panic attack, tired, anxiety is still a little high, chest pain thinking it's congestion and chest pain thinking it's congestion were evaluated at the emergency room visit. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past drug history was reported as none. Reporter stating events as non-serious. Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Inappropriate schedule of product administration, Limb discomfort, Malaise
Clinical narrative: inflamed heart; Panic attack; Dose Number: 1 04Nov2021/Dose Number: 2 18Dec2021; tired; anxiety is still a little high; Chest pain thinking it's congestion; Chest pain thinking it's congestion; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 38-year-old male patient received bnt162b2, administered in arm left, administration date 18Dec2021 16:00 (Lot number: 331808A) at the age of 38 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 20:00), administration date: 04Nov2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: inappropriate schedule of product administration with onset 18Dec2021 16:00, outcome unknown: 1 04Nov2021/Dose Number: 2 18Dec2021; myocarditis with onset 18Dec2021 16:15, outcome unknown; panic attack with onset 18Dec2021 16:05, outcome unknown; fatigue with onset Dec2021, outcome not recovered; anxiety with onset Dec2021, outcome not recovered; chest pain, respiratory tract congestion all with onset Dec2021, outcome unknown. The events inflamed heart, panic attack, tired, anxiety is still a little high, chest pain thinking it's congestion and chest pain thinking it's congestion were evaluated at the emergency room visit. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past drug history was reported as none. Reporter stating events as non-serious. Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nasopharyngeal swab, Skin burning sensation
Clinical narrative: inflamed heart; Panic attack; Dose Number: 1 04Nov2021/Dose Number: 2 18Dec2021; tired; anxiety is still a little high; Chest pain thinking it's congestion; Chest pain thinking it's congestion; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 38-year-old male patient received bnt162b2, administered in arm left, administration date 18Dec2021 16:00 (Lot number: 331808A) at the age of 38 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 20:00), administration date: 04Nov2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: inappropriate schedule of product administration with onset 18Dec2021 16:00, outcome unknown: 1 04Nov2021/Dose Number: 2 18Dec2021; myocarditis with onset 18Dec2021 16:15, outcome unknown; panic attack with onset 18Dec2021 16:05, outcome unknown; fatigue with onset Dec2021, outcome not recovered; anxiety with onset Dec2021, outcome not recovered; chest pain, respiratory tract congestion all with onset Dec2021, outcome unknown. The events inflamed heart, panic attack, tired, anxiety is still a little high, chest pain thinking it's congestion and chest pain thinking it's congestion were evaluated at the emergency room visit. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past drug history was reported as none. Reporter stating events as non-serious. Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive; had all three Pfizer COVID vaccines; tested positive; had all three Pfizer COVID vaccines; third shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from  group.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: EW0187) at the age of 58 years as dose 3 (booster), single, administration date 19Feb2021 (Lot number: EN6201) as dose 2, single and administration date 29Jan2021 (Lot number: EL9261) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Sleep apnoea" (unspecified if ongoing), notes: Verbatim: Sleep apnea. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "third shot"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "tested positive; had all three Pfizer COVID vaccines". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Lymphadenopathy, Pain in extremity
Clinical narrative: Extreme Fatigue; headache; Sore Arm; swollen lymph nodes in the arm pit where she received the injection; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Dec2021 18:45 (Lot number: 330258D) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: ER8734, her glands under her chin were swollen on one side after one of the first or second vaccines), administration date: 21Apr2021, when the patient was 38 years old, for COVID-19 vaccination, reaction(s): "glands under her chin were swollen on one side after"; Bnt162b2 (Second Dose, Lot: EW0170), administration date: 12May2021, when the patient was 38 years old, for COVID-19 vaccination, reaction(s): "glands under her chin were swollen on one side after". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 18:45, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 23Dec2021 08:00, outcome "recovered" (27Dec2021), described as "Extreme Fatigue"; HEADACHE (non-serious) with onset 23Dec2021 08:00, outcome "recovered" (26Dec2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 23Dec2021 08:00, outcome "recovered" (25Dec2021), described as "Sore Arm"; LYMPHADENOPATHY (non-serious) with onset 23Dec2021 08:00, outcome "recovered" (26Dec2021), described as "swollen lymph nodes in the arm pit where she received the injection". Therapeutic measures were taken as a result of fatigue, headache, pain in extremity, lymphadenopathy.  Additional information: The patient stated that she wanted to report the side effects she experienced with the Booster Dose. The patient stated that most were standard symptoms and they lasted a solid 4 days after booster, some 4.5 to 5 days. The patient stated that they were extreme fatigue, headache, swollen lymph nodes in the arm pit where she received the injection, and sore arm. The patient stated that she received the Booster Dose on Wednesday evening at 6:45 p.m. and she started having the side effect when she woke up the next morning at 8:00 a.m. on Thursday 23Dec2021. The patient stated that she had to call off work and take multiple naps each day. The patient stated that she took Acetaminophen and when that didn't start to help she also took Aspirin and at different points she took Tylenol and Ibuprofen. Acetaminophen 1000mg; 2 500mg. The patient stated that it did help but the Tylenol and Ibuprofen were working better.
Sex: U
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Movement disorder, Ultrasound scan
Clinical narrative: Wife is pregnant and due with no exact date provided; not moving around that much/the baby was not moving well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transplacental (Batch/Lot number: unknown) as dose 1, single and transplacental, administration date 13Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The mother of the patient was 38 year-old. The mother had no relevant medical history. The mother had no concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Wife is pregnant and due with no exact date provided"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "not moving around that much/the baby was not moving well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: they went and checked on baby in the hospital and they kept the mother overnight. The baby was not moving around that much, but baby was okay. They did an 8 point test to make sure. They told them at the hospital to try and get a hold of PAXLOVID.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101871640 Mother / baby case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: We got vaccinated and boosted; we recently tested positive for COVID; we recently tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "we recently tested positive for COVID"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "We got vaccinated and boosted". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: we recently tested positive for COVID. It was reported that reporter husband and patient have pre-existing conditions, so we have isolated and wear masks on the rare occasions we go out. We got vaccinated and boosted with Pfizer as soon as we were eligible. Despite our continued efforts to stay safe, we recently tested positive for COVID. Thanks to your company, our symptoms are manageable. We are so grateful to you and your scientists for coming up with this life-saving vaccine on such short notice. We are in deep gratitude to your company.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101874392 Same reporter/drug/event for different patients.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: I?ve developed prettt extensive hives and a rash that won?t seem to go away just over a week after my 3rd dose of Moderna. Antihistamines and Prednisone have been prescribed, but aren?t fully helping. Nothing else has changed in my life- no new foods, personal care products, etc. the Vaccine has been the only change, and now the hives are pretty intense. Will be following up with an allergist.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient complained of rash all over her body and swelling of her hands. She has been taking oatmeal baths and benadryl to help but has had not resolution with these treatments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Suspected COVID-19
Clinical narrative: felt like they had stuck Covid in him; head pain; pain all over body; diarrhea; nose stopped up; nose running; sick; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (Lot number: EL3249) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 27Mar2020, stop date: 20Apr2020, notes: he had been in the hospital for Covid prior to the first dose. The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 15Feb2021, outcome "unknown", described as "felt like they had stuck Covid in him"; HEADACHE (medically significant) with onset 15Feb2021, outcome "recovered" (Feb2021), described as "head pain"; PAIN (non-serious) with onset 15Feb2021, outcome "recovered" (Feb2021), described as "pain all over body"; DIARRHOEA (non-serious) with onset 15Feb2021, outcome "recovered" (Feb2021), described as "diarrhea"; NASAL CONGESTION (non-serious) with onset 15Feb2021, outcome "recovered" (19Feb2021), described as "nose stopped up"; RHINORRHOEA (non-serious) with onset 15Feb2021, outcome "recovered" (Feb2021), described as "nose running"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat"; ILLNESS (non-serious) with onset 15Feb2021, outcome "unknown", described as "sick". The events "pain all over body", "diarrhea", "nose stopped up" and "nose running" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache, pain, nasal congestion, rhinorrhoea. He had on Covid 27Mar2020 and was cleared on 20Apr2020 prior to the shot. He stated that he knew what Covid felt like. When he got the shot on 15Feb2021 that he immediately got sick. He was well before with no problems, no symptoms. He was stated that the minute he got the shot that his body reacted really bad, and it took 4 days to recovered and he got back to his old self. He was recovered in 6-7 days from his head pain completely. Later clarified that he was not admitted to the hospital but in the emergency room on 16Feb2021 for 6 hours. He received antibiotics and was recovered from that pain all over his body from the first dose 5 days later completely. He recovered completely from diarrhoea from first dose in 3-4 days and was also recovered completely from nose stopped up from first dose in four days and his nose running from the first dose took about four days to recover completely. He recovered completely from real bad headache from the second dose in about three days. The fever from the second dose lasted for about two days and he recovered completely. He took Aleve for the fever about two days to recover completely from chills from second dose. He recovered completely from real bad body aches on third day.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Autoimmune disorder, Autoimmune thyroiditis, Blood cholesterol increased, Coeliac disease, Drug hypersensitivity
Clinical narrative: Autoimmune diseases: Thyroid issues (Hashimotos), Type 2 adult onset Diabetes, Mitro valve prolapse, high blood pressure, high cholesterol, Vertigo all day every day, possible stroke. The usual treatments of drug prescriptions that I turned out to be allergic to so quit taking them. All happened over the years of taking a flu vaccines.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Food allergy, Gluten sensitivity, Hypertension, Hypothyroidism, Laboratory test
Clinical narrative: Autoimmune diseases: Thyroid issues (Hashimotos), Type 2 adult onset Diabetes, Mitro valve prolapse, high blood pressure, high cholesterol, Vertigo all day every day, possible stroke. The usual treatments of drug prescriptions that I turned out to be allergic to so quit taking them. All happened over the years of taking a flu vaccines.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Mitral valve prolapse, Type 2 diabetes mellitus, Vertigo
Clinical narrative: Autoimmune diseases: Thyroid issues (Hashimotos), Type 2 adult onset Diabetes, Mitro valve prolapse, high blood pressure, high cholesterol, Vertigo all day every day, possible stroke. The usual treatments of drug prescriptions that I turned out to be allergic to so quit taking them. All happened over the years of taking a flu vaccines.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 15 years old and was given a Moderna Vaccine by mistake.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Constant and debilitating headaches lasted for 2 weeks since symptoms first appeared. Constant meaning daily with little to no pause in headache. Tylenol offered some and brief relief. Debilitating at times in which the pain alternates between the right and left side of the head as well as travels from the lower back of head to the top. During pain sessions, lymph nodes at back of head feel tender and swollen with heat and throbbing sensation traveling throughout the head.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dehydration, Diarrhoea, Fall, Head injury
Clinical narrative: Covid19 breakthrough.  1st vaccine 05/12/2021.  45y/o with PMHx of brain tumors with resection as child, seizures, developmental delay, HTN, DM, and hypothyroid presents to ER due to generalized tremors x1 day and a 2 day hx of emesis/diarrhea.  Pt found to be dehydrated, tacycardic and while in ED fell and hit her head, stroke alert called and teleneurology felt r/t seizures.  Admitted to ICU and loaded with Keppra/IV steroids and IV abx.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, SARS-CoV-2 test positive, Tachycardia, Tremor, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine 05/12/2021.  45y/o with PMHx of brain tumors with resection as child, seizures, developmental delay, HTN, DM, and hypothyroid presents to ER due to generalized tremors x1 day and a 2 day hx of emesis/diarrhea.  Pt found to be dehydrated, tacycardic and while in ED fell and hit her head, stroke alert called and teleneurology felt r/t seizures.  Admitted to ICU and loaded with Keppra/IV steroids and IV abx.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Covid19 breakthrough.  1st vaccine 05/12/2021.  45y/o with PMHx of brain tumors with resection as child, seizures, developmental delay, HTN, DM, and hypothyroid presents to ER due to generalized tremors x1 day and a 2 day hx of emesis/diarrhea.  Pt found to be dehydrated, tacycardic and while in ED fell and hit her head, stroke alert called and teleneurology felt r/t seizures.  Admitted to ICU and loaded with Keppra/IV steroids and IV abx.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: About a week after I received the booster I got Shingles.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Ear discomfort, Vertigo
Clinical narrative: after my second dose  i was expieriencing ear dicomfort, after my booster within 30 days i had full blown vertigo. I have never had that before. I still have it as of this report
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Injection site pain, Lymph node pain
Clinical narrative: fever, chills, headache. day 1. feeling very weak overall.  arm pain at injection and lymph node very sore (3 days)
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever, chills, headache. day 1. feeling very weak overall.  arm pain at injection and lymph node very sore (3 days)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Full body Dermatographia onset about a week after booster. Still exists 3 months later. Any scratch to skin causes hives and redness, inflamed skin.  Decrease after 30 min or so.  Zyrtec a few times a week helps.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Full blood count normal, Metabolic function test, Pruritus, Scratch
Clinical narrative: 2 weeks after receiving the booster shot, itching on hands and feet started moved into the rest of the body including trunk, neck, back. Get's worse when being scratched. Raised hives and red marks appear. Get's better after taking antihistamine, but continues to come and go throughout the day on a daily basis.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Skin swelling, Urticaria
Clinical narrative: 2 weeks after receiving the booster shot, itching on hands and feet started moved into the rest of the body including trunk, neck, back. Get's worse when being scratched. Raised hives and red marks appear. Get's better after taking antihistamine, but continues to come and go throughout the day on a daily basis.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Feeling abnormal, Seborrhoeic dermatitis
Clinical narrative: Severe scalp flareup unlike anything I?ve seen in over a decade. Severe fatigue. Brain fog. Feels like a really severe autoimmune flare. Has been going on for almost two months now. Taking supplemental medications prescribed by Dr.s office for recovery (would love to be reimbursed for these!!)
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dupuytren's contracture, Nodule, Plantar fascial fibromatosis
Clinical narrative: On or about 12/2/2021 I developed a  nodule in my right hand  and left foot and it has progressed very quickly. On 12/27/2021 went to Black Hills Orthopedic and PA stated I have dupuytrens/ledderhose. None of my family has this disease and believe it could be due to vaccine.  Looking into treatment now. the progression of the lump is rather unsettling. After doing research this could be a disabling event for my hands and feet.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood thyroid stimulating hormone, Differential white blood cell count, Dysphagia, Erythema
Clinical narrative: 1 week post 1/2 booster dose of moderna I developed a full body rash. Initially focused in ?hot areas? of the body (thighs, underarms, scalp, neck) In the acute phase this was extremely itchy and anywhere I scratched would develop raised welts. Treated myself with Benadryl and hydrocortisone crème with little improvement.  I also developed esophageal tightness and a feeling like food is stuck. This is not heartburn. I have difficulty swallowing at times including liquids.  Approx 1/7 I had a virtual urgent care visit and was prescribed prednisone 20mg BID x 5 days with non improvement and no worsening.  1/12 I had an in person visit, UA with culture, and was prescribed macrobid for UTI and another 7 days of prednisone. I finished the antibiotics but the prednisone made me very nauseous. I did not complete the course of prednisone.   12/9 I returned for another in person visit. Itchiness has improved however I am still experiencing redness and dermatographia. Started OTC fexofenadine and referral made to dermatologist.  At the time of this report 1/8/22, nearly 10 weeks after onset, the esophageal tightness (?stuck food?) and difficulty swallowing persists as well as the dermatographia
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Mechanical urticaria, Metabolic function test, Oesophageal disorder, Pruritus
Clinical narrative: 1 week post 1/2 booster dose of moderna I developed a full body rash. Initially focused in ?hot areas? of the body (thighs, underarms, scalp, neck) In the acute phase this was extremely itchy and anywhere I scratched would develop raised welts. Treated myself with Benadryl and hydrocortisone crème with little improvement.  I also developed esophageal tightness and a feeling like food is stuck. This is not heartburn. I have difficulty swallowing at times including liquids.  Approx 1/7 I had a virtual urgent care visit and was prescribed prednisone 20mg BID x 5 days with non improvement and no worsening.  1/12 I had an in person visit, UA with culture, and was prescribed macrobid for UTI and another 7 days of prednisone. I finished the antibiotics but the prednisone made me very nauseous. I did not complete the course of prednisone.   12/9 I returned for another in person visit. Itchiness has improved however I am still experiencing redness and dermatographia. Started OTC fexofenadine and referral made to dermatologist.  At the time of this report 1/8/22, nearly 10 weeks after onset, the esophageal tightness (?stuck food?) and difficulty swallowing persists as well as the dermatographia
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urinary tract infection, Urine analysis, Urticaria
Clinical narrative: 1 week post 1/2 booster dose of moderna I developed a full body rash. Initially focused in ?hot areas? of the body (thighs, underarms, scalp, neck) In the acute phase this was extremely itchy and anywhere I scratched would develop raised welts. Treated myself with Benadryl and hydrocortisone crème with little improvement.  I also developed esophageal tightness and a feeling like food is stuck. This is not heartburn. I have difficulty swallowing at times including liquids.  Approx 1/7 I had a virtual urgent care visit and was prescribed prednisone 20mg BID x 5 days with non improvement and no worsening.  1/12 I had an in person visit, UA with culture, and was prescribed macrobid for UTI and another 7 days of prednisone. I finished the antibiotics but the prednisone made me very nauseous. I did not complete the course of prednisone.   12/9 I returned for another in person visit. Itchiness has improved however I am still experiencing redness and dermatographia. Started OTC fexofenadine and referral made to dermatologist.  At the time of this report 1/8/22, nearly 10 weeks after onset, the esophageal tightness (?stuck food?) and difficulty swallowing persists as well as the dermatographia
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Started as hard knot at injection site, which was is bony part of shoulder/supper arm. The next morning (Dec 3) I had pain at the injection site and into my armpit, with a red streak (ca. 2 fingers wide near the injection site and going toward the front of my upper arm muscle, ca. 4-5 inches long.I slept almost all day, was up about 5-6 time for 10-20 minutes each time..  Dec. 4 armpit was swollen, sore, red streak not as bright.  Used heading pad.  Upper arm painful to the touch.  Dec. 5 Armpit not as sore, swelling lessening, pain moving along front of armpit to bottom of armpit.  Dec. 6 slight tenderness injection side and front, bottom of armpit, swelling mostly down, red streak fainter, beginning to itch.  Dec. 8 Red streak faint, but still there.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pruritus, Somnolence, Tenderness
Clinical narrative: Started as hard knot at injection site, which was is bony part of shoulder/supper arm. The next morning (Dec 3) I had pain at the injection site and into my armpit, with a red streak (ca. 2 fingers wide near the injection site and going toward the front of my upper arm muscle, ca. 4-5 inches long.I slept almost all day, was up about 5-6 time for 10-20 minutes each time..  Dec. 4 armpit was swollen, sore, red streak not as bright.  Used heading pad.  Upper arm painful to the touch.  Dec. 5 Armpit not as sore, swelling lessening, pain moving along front of armpit to bottom of armpit.  Dec. 6 slight tenderness injection side and front, bottom of armpit, swelling mostly down, red streak fainter, beginning to itch.  Dec. 8 Red streak faint, but still there.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain in the Deltoid- was sore the day after the vaccine was administered, but came back about 4-5 days later.  Extreme pain, loss of motility raising arm to the side.  Hurts to open and close the car door, putting on a jacket, any movement that is lateral.  I can not work out with my left arm since then.  I have gone to a chiropractor, had a massage and I am scheduled to go to PT next week, with the hopes of regaining motility with out pain.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Palpitations, Pyrexia
Clinical narrative: since the day after receiving the vaccine patient has been experiencing heart palpitations, fever, chills, fatigue, sleep disturbances, and headache
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: since the day after receiving the vaccine patient has been experiencing heart palpitations, fever, chills, fatigue, sleep disturbances, and headache
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Malaise, Suspected COVID-19
Clinical narrative: Booster; they got infected with covid19 two weeks after receiving the booster dose; they got infected with covid19 two weeks after receiving the booster dose; Feeling severely unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "they got infected with covid19 two weeks after receiving the booster dose"; MALAISE (non-serious), outcome "unknown", described as "Feeling severely unwell". Clinical course: The reporter stated that her sister-in-law feeling severely unwell after contracting the virus 2 weeks after getting the booster, the vaccines may as well not be "effective".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Dyspnoea, Interstitial lung disease
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 05/15/2021.  91 y/o presents to ED after witnessed syncopal episode.  Had total of 3 syncopal episodes in past week.  Pt c/o cough and SOB.  Initially room air sat 89% but improved to 96% so held off on Remdesivir.  CXR with increased interstitial lung markings. Treated with Steroids.
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Syncope, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 05/15/2021.  91 y/o presents to ED after witnessed syncopal episode.  Had total of 3 syncopal episodes in past week.  Pt c/o cough and SOB.  Initially room air sat 89% but improved to 96% so held off on Remdesivir.  CXR with increased interstitial lung markings. Treated with Steroids.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Bedridden, Chest pain, Condition aggravated, Hypoaesthesia
Clinical narrative: Extreme inflammation of sciatic nerve causing Extreme calf pain and numbness of right leg and foot. Onset on Oct 14, bed-ridden for 2 weeks until pain began to subside, still experience some pain and numbness now.  Anothr large decrease of pain/numbness by Dec 13.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Intervertebral disc protrusion, Pain, Pain in extremity, Sciatica, Scoliosis
Clinical narrative: Extreme inflammation of sciatic nerve causing Extreme calf pain and numbness of right leg and foot. Onset on Oct 14, bed-ridden for 2 weeks until pain began to subside, still experience some pain and numbness now.  Anothr large decrease of pain/numbness by Dec 13.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Spinal myelogram abnormal, X-ray
Clinical narrative: Extreme inflammation of sciatic nerve causing Extreme calf pain and numbness of right leg and foot. Onset on Oct 14, bed-ridden for 2 weeks until pain began to subside, still experience some pain and numbness now.  Anothr large decrease of pain/numbness by Dec 13.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pt was given pediatric booster instead of adult
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Condition aggravated, Discomfort, Immediate post-injection reaction, Injection site discomfort
Clinical narrative: AFTER I GOT THE THIRD DOSE ON JANUARY 5, 2021, I IMMEDIATELY FELT ONLY THE DISCOMFORT OF THE PINCH. THEN THE NEXT DAY I STARTED TO FEEL PAIN IN MY LEFT ARM AND LEFT BREAST, IT WAS PAIN IN BOTH AREAS. ON FRIDAY I CONTINUED WITH THE PAIN, BOTH IN THE ARM AND LEFT BREAST, BUT AN INFLAMMATION UNDER THE LEFT ARM WAS ADDED TO THIS, WHICH CAUSES ME PAIN AND DISCOMFORT AND AN OUT-OF-NORMAL PROTUBERANCE IN MY BODY. IT IS NECESSARY TO ONLY TAKE ACETAMINOPHEN ON THURSDAY AND FRIDAY ONLY ONE DOSE EACH DAY. TODAY SATURDAY, I WOKE UP WITH THE LEFT ARM INFLAMATED, RELATIVELY MY HAND FITS IN THE BULK THAT I HAVE UNDER IT, THE PAIN IN THE LEFT ARM REDUCES, ONLY THE ANNOYANCE REMAINS ON THE SAME, ALSO DISCOMFORT.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: AFTER I GOT THE THIRD DOSE ON JANUARY 5, 2021, I IMMEDIATELY FELT ONLY THE DISCOMFORT OF THE PINCH. THEN THE NEXT DAY I STARTED TO FEEL PAIN IN MY LEFT ARM AND LEFT BREAST, IT WAS PAIN IN BOTH AREAS. ON FRIDAY I CONTINUED WITH THE PAIN, BOTH IN THE ARM AND LEFT BREAST, BUT AN INFLAMMATION UNDER THE LEFT ARM WAS ADDED TO THIS, WHICH CAUSES ME PAIN AND DISCOMFORT AND AN OUT-OF-NORMAL PROTUBERANCE IN MY BODY. IT IS NECESSARY TO ONLY TAKE ACETAMINOPHEN ON THURSDAY AND FRIDAY ONLY ONE DOSE EACH DAY. TODAY SATURDAY, I WOKE UP WITH THE LEFT ARM INFLAMATED, RELATIVELY MY HAND FITS IN THE BULK THAT I HAVE UNDER IT, THE PAIN IN THE LEFT ARM REDUCES, ONLY THE ANNOYANCE REMAINS ON THE SAME, ALSO DISCOMFORT.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Syncope
Clinical narrative: 15 hours after vaccine, blacked out for a few seconds and fell from a standing position. Similar happened after 2nd dose
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking of body, sometimes arms, hands, head whole body, and fingers.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Feeling of body temperature change, Gait disturbance, Nausea, Oropharyngeal discomfort
Clinical narrative: 12/27/2021- at 4:00pm I noticed raised skin on the back of my neck and behind my ears.  12/28/2021- at 3:00am I awoke and soon after began experiencing a constant severe shooting sensation going from the bottom of my rib cage to the top of my throat. When I awoke again that morning at 7:00am that sensation was still there & continued on until approximately 7:00pm that night. I also began feeling my skin itching and noticed the bumps and welts were now going throughout my body and felt warm. I almost through up twice and my body was going in and out extreme heat and chills at 9:30am. After driving around to different urgent cares, I was finally seen around 2:00pm that day where the doctor witnessed my skin reaction worsening by the minutes. I was prescribed steroids and didn?t mention the vaccine as it didn?t cross my mind. That evening, my feet began to really hurt to walk on and my right foot swelled up.  12/29/2021- my feet began looking purple by the toes and the pain worsened. My skin continued breaking out everywhere but my throat wasn?t constantly having the shooting pain. 12/30/2021- I had a teladoc apt at which point the doctor pointed out this was an internal foreign body that entered my body approximately ten days before symptoms began presenting themselves. The Covid vaccine booster was exactly 10 days and 23 hours before my symptoms began and she said it is definitely a possibility for my reactions.  TODAY- my skin is still reacting but it?s mostly red rashes with raises skin and some tiny bumps.  It?s still happening across my body. My throat still isn?t healed yet and is uncomfortable and has a very faded version of the shooting sensation going up it during the day. I was also wheezing early on from this.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: 12/27/2021- at 4:00pm I noticed raised skin on the back of my neck and behind my ears.  12/28/2021- at 3:00am I awoke and soon after began experiencing a constant severe shooting sensation going from the bottom of my rib cage to the top of my throat. When I awoke again that morning at 7:00am that sensation was still there & continued on until approximately 7:00pm that night. I also began feeling my skin itching and noticed the bumps and welts were now going throughout my body and felt warm. I almost through up twice and my body was going in and out extreme heat and chills at 9:30am. After driving around to different urgent cares, I was finally seen around 2:00pm that day where the doctor witnessed my skin reaction worsening by the minutes. I was prescribed steroids and didn?t mention the vaccine as it didn?t cross my mind. That evening, my feet began to really hurt to walk on and my right foot swelled up.  12/29/2021- my feet began looking purple by the toes and the pain worsened. My skin continued breaking out everywhere but my throat wasn?t constantly having the shooting pain. 12/30/2021- I had a teladoc apt at which point the doctor pointed out this was an internal foreign body that entered my body approximately ten days before symptoms began presenting themselves. The Covid vaccine booster was exactly 10 days and 23 hours before my symptoms began and she said it is definitely a possibility for my reactions.  TODAY- my skin is still reacting but it?s mostly red rashes with raises skin and some tiny bumps.  It?s still happening across my body. My throat still isn?t healed yet and is uncomfortable and has a very faded version of the shooting sensation going up it during the day. I was also wheezing early on from this.