chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse refers to a 13 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 24-JAN-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) for prophylaxis (incorrect product storage) (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 34.70 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922.
Developed red, indurated area 5 1/2 x 5 1/2 cm over site of DTaP injection Left deltoid.
ARMS AND LEGS STARTED SHAKY AND HE THEN FELL TO THE FELL.  DENIES LOC  HAPPENED THE NEXT DAY FEB 20,2021 ATTHE TIME OF REPORT THIS WAS ALSO ON FEB 20TH STATED THAT HE WAS FEELING FINE JUST WANTED US TO KNOW.
SYRINGE FAIL, VACCINE LEAKED OUT; PATIENT GOT ROUGHLY HALF THE DOSE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced syringe fail, vaccine leaked out, and subject got roughly half the dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the syringe fail, vaccine leaked out and patient got roughly half the dose was not reported. This report was non-serious. This case is associated with product quality complaint-90000172700.
About 3 am, I woke up with fever, chills, body aches and I had a temp of 100.6. I took some Tylenol and within an hour, I no longer had a fever. Body aches were gone about 7 am and around noon (on 27th) that same lump flared up again. It got large was painful but within another 24 hours the pain  had resolved but the lump was still there. On February 2, I had a consult with Dr and he said that it was a lymph node and he thought we should get it removed and I had a pre-op on Feb 23 and I am having surgery on March 15th.
Evening of 2nd injection started with dull headache.   Next morning still had dull headache but by early afternoon headache got worse, then full body aches...head to ankles.    Back pain was especially severe.   Mild fever and chills for only a very short time.   By 6:16 pm on the 11th I took 2 Extra-Strength Tylenol and in about 1-1/2 hours felt much better.    The pain had been pretty intense.   Next day I was fine.
booster; vomiting; headache; sleepiness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 Immnuization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HEADACHE (non-serious), outcome "unknown", described as "headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No immediate reaction aside from minor fatigue on 11/13.  Awoke on 11/25 with hives-like bumps at waistline and right armpit.  This progressed over the next week to 60-70% of body, including legs, almost entire torso, arms, face (forehead and cheeks), back of neck, hairline.  Saw PCP on 11/26 who prescribed prednisone & benadryl.  Helped affected areas but continued to spread to other areas.  Saw PCP on 11/29.  Rash was very atypical but some potential Lyme-type patterns on back of knee.  Prescribed doxycycline on suspicion & hydroxyzine.  Lyme test negative, but finished 14-day doxycycline course and ramped down prednisone.  Acute reaction with active hive-like bumps went away by 12/6. However, high sensitivity of skin has persisted.  Highly itchy, and when I itch, skin turns bright red and leaves raised lines in skin.  I have red blotches that come and go on forehead (these have subsided).  I also have regular acute itching 'attacks' about every 3 days, typically in the evening where I am super itchy.  I have taken hydroxyzine to help with these symptoms and get to sleep.  Symptoms have resolved by the next morning in each case. I also avoid wearing certain fabrics (e.g., flannel-type material is an irritant)
Facial twitching on the left side of his face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8735; NDC number: unknown, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 21Apr2021 09:00 as single dose for COVID-19 immunisation (Because he travels internationally for work once that opens up and for safety purposes). There was no patient medical history (no diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity). There was no family medical history relevant to AE, they all were pretty healthy. The patient did not take concomitant medications (no other products). There was no 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). There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). There was no AE following prior vaccinations. On 22Apr2021 he noticed facial twitching on the left side of his face, which is same side that he was administered the Pfizer Covid Vaccine injection given in his left arm. He does not have any droopiness, just the facial twitching on the left side of his face. He asked for further information regarding this event relative to the Pfizer Covid Vaccine. Facial twitching on the left side of his face: outcome persistent, about the same, just annoying. Onset time is unknown, just sometime on 22Apr2021. He mentioned that he read some clinical reports where people you know ended up getting the bell's palsy on the second one, so if he is already getting twitching he does not want to get the second dose of the Pfizer Covid Vaccine and end up with this for 6 months or bell's palsy. His second dose was going to be 13May2021, but he has permanently stopped product in response to this event. There was no emergency room or physician office visit. There was no relevant test. Seriousness for event was unspecified. The patient was not hospitalized. There was no investigation assessment. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from Healthcare worker refers to a 60 year old patient. The patient's medical history included chicken pox as a child. On 16-DEC-2013 the patient was vaccinated with the first dose of VARIVAX (merck), 0.5 ml, lot# H016577, exp. 05-SEP-2014, subcutaneous. The patient inadvertently received single (first) dose of VARIVAX (merck) instead of ZOSTAVAX (Merck). The outcome of event was unknown. No adverse effects reported. Additional information has been requested.
1st Vaccine 2/14/21; same day onset RLQ ABD pain with nausea and vomiting; seen at ED on 2/19/21 for ongoing symptoms; d/c'd home from ED same day to follow up with primary care as outpatient.  Dx in ED: 1. Acute abdominal pain in right lower quadrant   2. Non-intractable vomiting with nausea, unspecified vomiting type
Achy; Slight fever that got to 100.1-100.4 lasting for 36-48hrs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and PYREXIA (Slight fever that got to 100.1-100.4 lasting for 36-48hrs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21 and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Achy) and PYREXIA (Slight fever that got to 100.1-100.4 lasting for 36-48hrs). At the time of the report, PAIN (Achy) outcome was unknown and PYREXIA (Slight fever that got to 100.1-100.4 lasting for 36-48hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 100.1 (High) Lasting 36-48 hours. and 100.4 (High) Lasting 36-48 hours.         Concomitant product use was not provided.   Treatment information was not provided.     This case was linked to MOD-2021-322480 (Patient Link).
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (two male patients) of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patients were healthy prior vaccination. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. It was unspecified whether an autopsy was performed or not. As per reporter, "I have 2 former healthy brothers now dead due to it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230105724.; Sender's Comments: V0: 20230105739- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
He got his vaccine, he didn't have any reactions when he first got the vaccine.  Later that evening his shoulders were sore from the shots.   The next day he had two sore shoulders as he had gotten 2 vaccines, one flu in one arm and the COVID in the other.  He did feel a little weak, but felt like he was under the weather.  The next day 10/7/22 he had an irregular heart beat, he felt tired and weak, had shortness of breath and felt sick, nausea.  He started having body aches, hips, shoulders and lower back.  On 10/8/22 he had the same symptoms with headache when he woke up and restless/jittery at night.  He still had the other symptoms continuing from the 7th as well.  On 10/9/22 he had the same symptoms including the previous ones continuing.  He was sleeping poorly.  Then on 10/10/22 he still felt bad.  On 10/11/22 when he woke up that morning he did not have the irregular heart beat which was intermittent and then started having it in the afternoon and then started coughing a lot.  He went to his doctor and said that he was having a reaction to the vaccine.  He asked for an EKG and this was done and normal earlier and had no irregular heart beat when he saw the doctor.  His condition got worse that afternoon. irregular heart beat started again and as the day went on in the evening with the coughing, still coughing and feeling sicker, but feeling a little better.  He called back the doctor, and saw the medical assistant and they did a COVID test which was positive, and he did have a fever on 10/12/22 of 101.7.  They prescribed Paxlovid tablets which he took for 5 days, and also told him to take Tylenol and Coricidin HBP for cough.   He is feeling better than he did, but still not feeling great, feels still short of breath, coughing, nose issues.  Cough medicine is helping.   He has no history of irregular heart beat in the past.
no adverse event; 17-year-old patient was administered booster dose of Vaqta which was adult dose of Vaqta on 24/JUN/2019; 17-year-old patient was administered booster dose of Vaqta which was adult dose of Vaqta on 24/JUN/2019; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.   On 24-JUN-2019, the patient was vaccinated with booster dose of hepatitis a vaccine, inactivated (VAQTA) lot # S003755, expiration date 15-NOV-2019 (route of administration, anatomical location and dose were not provided) for prophylaxis. It was reported that the patient received an adult dose of hepatitis a vaccine, inactivated (VAQTA). No adverse effect was reported.
Slight sore arm initially; last 3 days arm sore and swollen and sorer; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight sore arm initially) and VACCINATION SITE SWELLING (last 3 days arm sore and swollen and sorer) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4496160) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Slight sore arm initially) and VACCINATION SITE SWELLING (last 3 days arm sore and swollen and sorer). At the time of the report, PAIN IN EXTREMITY (Slight sore arm initially) and VACCINATION SITE SWELLING (last 3 days arm sore and swollen and sorer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provid   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: FU was added on 16-APR-2021 and it contains NNI
Severe chills, body aching, profound and completely incapacitating exhaustion, severe dysautonomia, brain fog, neuropathy (burning feet) beginning immediately after vaccination and continuing now, fifteen weeks later. Unable to work, unable to walk more than a few feet, dysautonomia wildly unstable. Skin infection began in immediate aftermath of injection, currently on antibiotics, infection continuing.
earache; 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 09Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing), notes: She previously had a headache that developed into the earache. The patient's concomitant medications were not reported. The following information was reported: EAR PAIN (non-serious) with onset 10Mar2021, outcome "unknown", described as "earache".  No follow-up attempts are possible. No further information is expected.
REDNESS, SWELLING, PAIN AT SITE. FEVER, NAUSEA, DECREASED APPETITE
ON 04/01/2021 @ Vaccination drive through clinic safe room site - pt received 2nd dose Moderna vaccine in Left deltoid. Approx 5 minutes after injection, pt reported "lump in throat" stated was same reaction as 1st dose which sulosided in 30 minutes. Pt assessed by nurse V/S  144/84, HR 62, P18, PT given Benadryl 25mg po pt stated she felt better. stated she was going home 5 min from site
Groggy, sweating, has trouble concentrating and talking, dizzy, trouble sleeping, and confused. Pt thought was in Mexico. Symptoms are normal, if they do not subside within a few days seek medical help.
severe headache; chills; pain around the eyes; pain inbones; spinal pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 24Apr2021 10:00 (at the age of 47-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included high pressure and no known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included lisinopril, iron supplement, vitamin b and vitamin c taken for an unspecified indication. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8732) administered in left arm on 03Apr2021 10:00 as 1st dose, single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. Since the vaccination, the patient had not been tested for COVID-19. Three days after the second dose of vaccination on 27Apr2021 at 16:00, the patient got severe headache, chills, pain around the eyes, bone pain, spine pain and nausea. After a week the symptoms returned. On 17May2021, the patient went to the emergency room for severe headaches and eye pain. As a result of the events, the patient visited to a doctor's office or other health professional. Therapeutic measures were taken because of severe headache, chills, pain around the eyes, pain in bones, spinal pain, and nausea with pain pills. The patient was not recovered from the events.
Fever, chills, headache and aching all over.  Site of Injection is swollen, extremely hot to the touch and sore. Beginning taking Benadryl per GP instruction given today (7/30/2020) and will ice intermediately.
Throw-up, Feaver (101.7), Diarrhea, Nausea. Taken Pepto-Bismol
Permanent, raised, discolored keloid scar formed at site of the intradermal injection and has not went away .
Pain and soreness to left deltoid on 9/2/09, fever 101 degrees, child was very weak, tired, HA on 9/2/09, redness am of 9/3/09. Area 5 1/2 cm x 5 cm covering left deltoid, no swelling, deltoid hot to touch.
Pt's mother reports that she noticed pt was warm around 1pm and checked her temp. which was 104 degrees F. Stated pt very pale, crying, dry cough, was vomiting, and refusing to eat Given Motrin(infant) 1/2 tsp after taking with infant Tylenol 1/4 tsp. 08/23/2002 temp down to 101 degrees. Follow up T/C to parent on 08/26/2002 per mom-infant well today. 8/26/2002 In talking to parent today she stated that infant crying Sat. and half Sun. and vomiting consisted through Sat.
After 1 to 2 minutes after the administration of vaccine the patient fainted and complaint of chest numbness. The blood pressure was taken it result of 116/73mmHg pulse 80bpm
No adverse event @ this time;pt presented to clinic 23APR98 w/note from planned parenthood that was approx 6wk pregnant;pt was concerned because recv vax 19MAR98;
Vertigo / hangover-like symptoms; hangover-like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 at 15:00(at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 14:00(at the age of 30-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14May2021 at 12:00 after 3-4 days of second dose, the patient experienced vertigo / hangover-like symptoms. The symptoms was lasted at least 24 hours. The patient reported that he had no medical history of vertigo or onset dizziness prior to vaccination. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event vertigo and hangover-like symptoms was resolved on 15May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
a patient received a dose of Fluzone High Dose which had expired on 22Mar2019/no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves an unknown demographic patient who received a expired dose of vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] (dosage form: prefilled syringe) lot UI871AB, expiry date: 22-ar-2019 via unknown route in unknown administration site on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It is a case of actual medication error due to expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After my sons appointment we came home and he took a nap. After he woke up, I was holding him and we noticed he started having spasms. They progressed over the weekend so we took him in to the hospital.
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 44-year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had medical history of atopy: anaphylaxis, asthma, allergic rhinitis and 'other (ASA)'. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). Less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included generalized pruritus and rash, wheeze, shortness of breath, throat tightening, hoarse voice, cough, vomited and diarrhoea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with parenteral antihistamines, oral steroids, oxygen and bronchodilators. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.