chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received dose #2 Moderna COVID vaccine 1/26/21 @ Vaccine Clinic. Pt presented to PVH ED 1/29/21 @ 0732 for workup. "Patient states that she got her Covid vaccine 3 days ago, had 1 day of myalgias, flulike symptoms, yesterday she felt much better however she felt that her heart was beating irregularly and she was feeling anxious. This persisted through the night. She denies any chest pain, shortness of breath. Patient is scheduled for follow-up with her cardiologist later next week." Afib, tachycardia, palpitations. Rhythm self converted. Given NS bolus and discharged home without further escalation of care. Entered by PSS for tracking.
Severe vomiting and diarrhea sudden onset choking, difficulty breathing. Transported via ambulance to hospital there 24 hours.  12/7/06 Received medical records from hospital which reveal patient experienced vomiting & diarrhea x 9 days & was admitted to hospital on 11/21/06 after being treated & released from ER on 11/19/06 w/dx viral gastroenteritis.  Did well overnight & was d/c to home on 11/22/06. Final DX: mild colonic ileus, resolved.
Patient received inactivated influenza vaccine on 25 Oct '12. During the next month he developed fatigue, increased defecation and insomnia. Patient unsure if he had any of those sxs beginning before he received the vaccine, but knows definitively that he experienced them following the vaccine. On 19 Nov '12 he developed 'flashing lights' in the peripheral vision of left eye, evaluation negative for lesion. On 22 Nov '12 he developed palpitations and HR irregularity and was diagnosed with A-fib and admitted to CCU and cardioverted. One week later he again developed Afib. He was then diagnosed with hyperthyroidism and thyroid autoantibodies found. Currently receiving treatment for Graves Disease and symptoms starting to resolve. Had normal TSH in July. The clinic went into the serum repository with pt permission and tested his serum drawn prior to July 2013 and found it positive for thyroid autoantibodies, although pt had no clinical disease at that time.
anger, quick to get angry; adrenaline is really flowing; tearful; lot of sleeping; right gland by clavicle bone swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EN6198) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing); "acid reflux" (ongoing). Concomitant medication(s) included: CELEXA [CITALOPRAM HYDROBROMIDE] taken for anxiety (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EL9261, Anatomical location: right arm), administration date: 05Feb2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: ANGER (non-serious), outcome "not recovered", described as "anger, quick to get angry"; AGITATION (non-serious), outcome "unknown", described as "adrenaline is really flowing"; TEARFULNESS (non-serious), outcome "unknown", described as "tearful"; LYMPHADENOPATHY (non-serious) with onset 27Feb2021, outcome "recovering", described as "right gland by clavicle bone swollen"; HYPERSOMNIA (non-serious), outcome "unknown", described as "lot of sleeping".  Additional information: Patient stated she was calling regarding some side effects, not listed as far as emotional aspect, anger, quick to get angry, something that would normally send her into a rage and adrenaline is really flowing and that is not normal for her. She wanted to know if anyone else has reported this and if it could be related to the vaccine. Patient stated she received her second dose on 26Feb2021 and she noticed this symptom a couple of weeks after her second dose, exact date unknown. She stated it happened on Sunday with her son and she has never talked to him the way she did, never spoken to him with rage and anger, and it was not anything of significance that would make her react the way she did, she was tearful. She also experienced the gland by her clavicle bone was very swollen, still a little swollen. She read that it can last 12 weeks and she did a lot of sleeping after that second dose.   No follow-up attempts are possible. No further information is expected.
localized initial reaction with itch; localized initial reaction sith swelling; localized initial reaction with erythema; localized initial reaction with pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (localized initial reaction with itch), VACCINATION SITE SWELLING (localized initial reaction sith swelling), VACCINATION SITE ERYTHEMA (localized initial reaction with erythema) and VACCINATION SITE PAIN (localized initial reaction with pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (localized initial reaction with itch), VACCINATION SITE SWELLING (localized initial reaction sith swelling), VACCINATION SITE ERYTHEMA (localized initial reaction with erythema) and VACCINATION SITE PAIN (localized initial reaction with pain). At the time of the report, VACCINATION SITE PRURITUS (localized initial reaction with itch), VACCINATION SITE SWELLING (localized initial reaction sith swelling), VACCINATION SITE ERYTHEMA (localized initial reaction with erythema) and VACCINATION SITE PAIN (localized initial reaction with pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-052670 (Patient Link).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Higher blood pressure 145/100 from normal 130/82; Higher blood pressure 145/100 from normal 130/82; Faster heartbeat 95 from normal 78; Fatigue; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 at 17:30 (Lot number: FJ8762) at the age of 60 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (ongoing) and "Major depression" (unspecified if ongoing). The patient received unspecified concomitant medications (unspecified if ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6206; Anatomical site: left arm; Route of administration: unspecified; Administration time: 15:30), administration date: 04Mar2021, when the patient was 60 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8733; Anatomical site: left arm; Route of administration: unspecified; Administration time: 15:30), administration date: 25Mar2021, when the patient was 60 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 at 17:30, outcome "unknown", described as "Dose received: 3"; HYPERTENSION (non-serious) and CONDITION AGGRAVATED (non-serious), all with onset 03Dec2021 at 17:00, outcome "unknown", and all described as "Higher blood pressure 145/100 from normal 130/82"; HEART RATE INCREASED (non-serious) with onset 03Dec2021 at 17:00, outcome "unknown", described as "Faster heartbeat 95 from normal 78"; FATIGUE (non-serious) with onset 03Dec2021 at 17:00, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypertension, condition aggravated, heart rate increased and fatigue.  Additional information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Dizziness, called doctor. Just got up more slowly and walked slowly. Lasted about 1 hour or so, better today.
Dizziness, Headache, Fever, Diarrhea, NauseaVomiting, chest tightness and sypnea, chills, abdominal pain, sore throat Narrative: Symptoms slight improvement next day
Patient is beyond 6 weeks for his second dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is beyond 6 weeks for his second dose of the vaccine) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is beyond 6 weeks for his second dose of the vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is beyond 6 weeks for his second dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that consumer got his 1st dose of the Moderna COVID-19 vaccine over six weeks ago from reporting date 07-JUL-2021.   Concomitant medication not provided.  Treatment information not provided.
Death: CHRONIC COMBINED SYSTOLIC -CONGESTIVE- AND DIASTOLIC -CONGESTIVE- HEART FAILURE, COVID-19
PT experienced itchiness and a sore arm on 12/23/2020. Developed hives on 1/5/2021 at injection site
On day 5 of my first covid vaccine I was exhausted, c/o fatigue, day 6 I developed fatigue, body aches, chills, temp 100.5 and headache.  Day 7 my symptoms were gone.   After my second covid vaccine, 24 hrs later I developed body aches and a headache.  2 days later I had nausea and vomitting.  Vomiting went away after 8 hrs.  Nausea persisted for 4 days.
Pt arrived at facility requesting a Moderna booster dose. At approximately 1320, patient reported to RN a reaction to his 2nd dose of Moderna received on 2/26/21 (Patient reported no reaction to his 1st dose of Moderna received on 1/29/21). Patient reported chest pain accompanied with "bones aching like someone hit me". Symptom started one day after vaccination, lasted for one hour, and went away on its own. Patient also reported itchiness on both hands. Symptom started one day after vaccination, lasted for half a day and went away on its own. Patient denied rashes, difficulty breathing, and difficulty swallowing.  Patient reported no history of a similar reaction. Patient did not follow up with primary care provider. Patient currently takes losartan for hypertension and rosuvastatin for high cholesterol. RN notified Lead Nurse. Lead RN elevated situation to Clinical Supervisors. Supervisors elevated to medical consult team. Medical consult team approved patient for a Moderna booster dose. Lead RN contacted patient and notified patient he was approved to receive his Moderna booster dose. RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, to sign up on v-safe and to wait 30 minutes in observation. At approximately 1450, patient received his booster dose of Moderna (LOT#011F21A, exp. 1/19/22). At approximately 1520, RN assessed patient. Patient denied itchiness, rashes, hives, difficulty breathing and difficulty swallowing. At approximately 1521, patient left facility with unlabored respirations and steady gait.
Patient given undiluted dose of pediatric Pfizer vaccine. Patient's mom said he felt dizzy and was rubbing his eyes right after the vaccine; since then he felt fine with no other problems.
30DEc93 t103; vomiting; 5JAN94 generalized pruritic body rash, petechial in nature; swollen eyes; 5JAN events prompted MD visit;
This case was reported by a healthcare professional to a sales representative and described the occurrence of swelling at the injection site in a subject between 4-6 years of age (gender unspecified) who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site and injection site discomfort. At the time of reporting the outcome of the events was unspecified. These events occurred in three different subjects. It was reported that one of the subject's arms looked like it could have been drained due to the swelling. The swelling area was also described as similar to the pain of the hand. Follow-up was received on 27 November 2007 from the healthcare professional. The subject was a 2 year old female. The subject had no adverse events following receipt of prior immunizations. On an unspecified date, the subject received the 4th dose of Infanrix at an unspecified site of administration. On 5 November 2007, the subject experienced swelling injection site, injection site discomfort and cellulitis. The subject was treated with Co-trimoxazole (BACTRIM) and the events improved on 7 November 2007. The healthcare professional considered the events to possibly be related to vaccination with Infanrix. Comment: Cellulitis was assessed as medically serious by GSK.
Initial unsolicited report received from healthcare professional on 29 Dec 2014 and follow up received on 30 Dec 2014. A patient, whose age, gender and concomitant medications were not reported, had received a dose of flu vaccine (lot number, dose, dose number, route and site of vaccination not reported) on an unspecified date. The patient had a medical history of allergy to egg products. It was reported that the patient developed allergy (reaction) flu vaccine on an unspecified date. The patient had a medical history of allergy to egg products. It was reported that the patient developed allergy (reaction) flu vaccine on an unspecified date. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 06 February 2015. No additional information was provided. List of Documents held by sender: None.
This morning her temp at 8AM was 99.3 at 9:30AM her temp was 100.3. She got her PRN dose of Tylenol and now her temp is 99.8. She has no other symptoms.
feeling sick; cold; 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 female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Sep2021, outcome "unknown", described as "feeling sick"; NASOPHARYNGITIS (non-serious) with onset Sep2021, outcome "unknown", described as "cold". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported as patient received the first dose of the Pfizer COVID-19 vaccine beginning September. She is due for the second dose. She was feeling sick and she have a cold. she tested negative for COVID. She spoke to a pharmacist who recommended she wait until she feel better before getting the second dose. Caller didnt agree to speak to safety as she think this was not related to the vaccine. Response stared as noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Phone answered by consumer who states she was doing fine, states it was just a question she had and got a nice response to it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, severe headache, joint pain, fatigue, vomiting, unable to do daily functions
Runny nose, sweaty, large purple mark on arm 3" in diameter. Very painful for the last 3 days. No getting better.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Tingling to (L) side face and shoulder with blurred vision and temporary decreased motor coordination (L) arm and leg. Symptoms lasted approx. 1 hour.
Temperature Excursion Heplisav-B Administered to 15 Patients; Initial Report Received on 14-Sep-2021 and 15-Sep-2021  A Registered Medical Assistant reported that approximately 15 patients (age, gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. This report is for patient 5 of 15.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient 5 of 15 received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) after the vaccine was out of temperature range with multiple excursions over a maximum of 10 days. The route and site of vaccine administration were not reported.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Coughing, hives, given prednisone at quick care and told to take otc benadryl
Several hours after and the rest of the day she became light head. Two falling that she had a very sore arm. Third day she severe joint pains. By the 5th the joints pains increased. The 6th day her arm hands wrist and hip are sore. On day 7 very sore muscles and every joint she felt like she been ran over by a truck. The 8th through the 10th day her joints started hurting very very bad. 11th day her hip started again  and she started getting bad headaches, and day 12 she has swollen lymph nodes and a sore throat.
Inconsolable crying that lasted about 3-4 hours and then fussiness for 14 hours. Symptoms started 25 hours after DTaP and PCV7 given.
wheezing; DIFFICULTY BREATHING; ITCHY; SCRATCHY THROAT; SCRATCHY MOUTH; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezing), DYSPNOEA (DIFFICULTY BREATHING), PRURITUS (ITCHY), OROPHARYNGEAL DISCOMFORT (SCRATCHY THROAT) and ORAL DISCOMFORT (SCRATCHY MOUTH) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Scallops) and Adhesive tape allergy (Mastesol).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced WHEEZING (wheezing), DYSPNOEA (DIFFICULTY BREATHING), PRURITUS (ITCHY), OROPHARYNGEAL DISCOMFORT (SCRATCHY THROAT) and ORAL DISCOMFORT (SCRATCHY MOUTH). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Apr-2021 at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) on 29-Apr-2021 at an unspecified dose and frequency. On 30-Apr-2021, WHEEZING (wheezing), DYSPNOEA (DIFFICULTY BREATHING), PRURITUS (ITCHY), OROPHARYNGEAL DISCOMFORT (SCRATCHY THROAT) and ORAL DISCOMFORT (SCRATCHY MOUTH) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication not reported. treatment medication not reported.
2 WEEKS AFTER MY SECOND DOSE I FELT PAIN, BURNING SENSATION CLOSE TO THE AREA OF THE VACCINE ALSO LOCK OF MOVEMENT ON MY LEFT ARM MY DRF SAID IS KINF OF TENDINITIS  BUT THE WEIRD PART IS I FEEL PAIN ON THE VACCINE SPOT WHEN I TOUCH IT.
Vaccine administered 02/08/2021 , by Thursday 02/11/2021 patient almost nonverbal, by Monday 02/15/2021 patient went to the hospital with bruising, sores on her stomach and clots reported as thrombocytopenia, deceased by Friday 02/19/2021.
Severe itching; Stabbing pains on back, legs; Stabbing pains on back; Stabbing pains on back, legs; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus, leg pain, back pain and pain. On an unknown date, the outcome of the pruritus, leg pain, back pain and pain were unknown.   It was unknown if the reporter considered the pruritus, leg pain, back pain and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient reported that had severe itching and stabbing pain on back and legs.