chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The case was reported by a physician and describes the occurrence of fever in a 6-month-old female who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt had no adverse events following 2 previous doses with Haemophilus influenzae type b conjugate vaccine and 7-valent pneumococcal conjugate vaccine. On 09/20/2003, the pt received her 1st dose of Pediarix in her right leg. Concurrently, she received her 3rd dose of  with Haemophilus influenzae type b conjugate vaccine (manufacturer unknown) and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs). Approx 5 days post-immunization, on 09/25/2003, the pt developed a fever of 102.8 degrees F. The event was unresolved as of 09/26/2003. The physician considered the event probably related to vaccination with Pediarix.
4.5 hours after shot received: Agitation  Mild headache Flushing of face Loss of interest in activities Hard to swallow/ painful in throat Sensitivity to light, noise, and smell Fever 100.2 Chills Involuntary shaking/ teeth chattering Eyes burning, tearing Respiratory difficulty Swollen tongue Anxiety
At end of 1/2000, had myalgia (calf muscles); 2/2000, had difficulty walking steps, weakness in legs. Consult of neurologist, admission to hospital on 3/17/2000 through 4/03/2000, disabled 3/10/2000 ff. Dx'd with GBS;CHD;Sarcoidosis. On 6/16/2000, still has nerve damage and trouble walking, will call back in 2 weeks. Diagnosed with Chronic inflamatory demylelinating polymeuropathy
This spontaneous report as received from a nurse refers to a 15 year old female patient who in August 2013 was vaccinated with the first dose of GARDASIL 9 0.5 ml, intramuscular. The second dose was administered on 27-MAY-2015 and the third dose was administered on 13-AUG-2015 "a week early". No adverse effects were reported. "Based on date, first dose likely GARDASIL; nurse only referred to GARDASIL 9". It was unable to speak with nurse to confirm the first dose of GARDASIL. Additional information has been requested.
Approximately 18 hours after vaccination developed high fevers to 102.7, rigors, severe muscle and bone pain, cold extremities, lasting 12 hours.  An additional 6-8 hours of low grade temps <100.4, sore throat.
stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 20Feb2021 at 17:00 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, irritable bowel syndrome and benign prostatic hyperplasia. The patient previously took barium (MANUFACTURER UNKNOWN) and esomeprazole sodium (NEXIUM) for an unknown indication from an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ), doxazosin mesilate (CARDURA), amitriptyline hydrochloride (AMITRIPTYLENE) and finasteride (FINASTERID); all taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm on 29Jan2021 as a single dose for COVID-19 immunisation and experienced diarrhea and stomach cramps. On 20Feb2021 at 11:00 the patient experienced stomach cramps and diarrhea. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach cramps and diarrhea was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the agency, that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Right after receiving Pfizer Covid-19 vaccine, patient began to feel queasy.  I asked her whether she had eaten recently and she said she hadn?t.  Her eyes rolled back and up then her head fell backward.  I supported her head and her dad was checking her for awareness.  I gave her a bottle of water and she drank some of it.  She indicated that her vision was still not accurate.  Her dad brought her a candy bar and she ate the majority of it and drank the majority of the contents of the water bottle.   We gave her a few more minutes to feel comfortable then I asked whether she was ready to stand up.  She was not.  We gave her a bag of chips and she ate some and finished the water bottle.  After a few more minutes, she stood up and was able to walk without assistance.     Her father indicated that she had an incident like this before, but patient did not remember the previous incident.
Fever over 102 for 2 days. Swelling around injection area - Up to 3in X 3in and very painful. Treated with low level steroids.
Booster doesn't work; Booster doesn't work; Disgust; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Booster doesn't work"; AVERSION (non-serious), outcome "unknown", described as "Disgust". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vax, the pt developed redness to left upper thigh. Prescribed Augmentin for 10 day course.
chills, shaking, headache, exhaustion, extremely sore injection site, stomach cramps
606 doses were given after expiration date; Expired vaccine was stored in Refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored in Refrigerator) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in Refrigerator). On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored in Refrigerator) outcome was unknown. Not Provided      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.   No concomitant medication was reported. It was reported that vaccine was placed in refrigerator on 27-Nov-2021 and patient had no adverse events. There was no temperature excursion. No treatment medication was reported.
From mother of child: She had uncontrollable shaking of her Left arm, then vomiting, ashen skin to include face, lips, extremities, instant pounding headache, dizziness, nearly passed out. I had to pick her up and lift her back onto the table. We stayed for an extra hour to recover. Took immediate vitals. HR was 80 BP 90's/50's. I don't believe it was vasovagal, reaction occurred approx 7 minutes later after injection. Also, Right foot drop, she was swinging her right leg around to walk out after over an hour recovery. Also, pustule rash all over left arm.
Three days post-vaccine, I began to experience chest pressure and slight pain in my chest--directly under each of my armpits. After 3 hours I called my primary care physician's office and they suggested I call 911 and go to the Emergency Department to be sure I was not having a heart attack. Multiple EKGs, a chest xray, and blood tests revealed that my heart was in good shape. I have continued  to have very slight pressure in that area, but it is occasional and is almost gone. Even after 5 days since the vaccination, I am experiencing side effects although they have reduced in severity. Fatigue, occasional slight dizziness, occasional shortness of breath, occasional slight pain in various parts of my body.
The day after I woke up around 7am and I was dizzy. I had to grab onto the closet door so I wouldn't fall. I had to lay in bed until the swimming sensation in my eyes disappeared. It was at least 15 minutes. Then, I was able to get up and send a message to my doctor. I got a call back from one of the nurses who advised me that I have preexisting conditions and they don't believe it was vaccine related. They told me to go to the ER if it continued. It did not occur again. My oxygen levels have also decreased since the shot. They were around 99 but are now around 94.
This case was reported by a nurse and described the occurrence of extra dose administered in a 8-month-old patient who received ENGERIX B. Previously administered products included hepatitis b vaccine (dose 1), hepatitis b vaccine (dose 2) and hepatitis b vaccine (dose 3). On an unknown date, the patient received the 4th dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: 8 month old received 4 doses of Hep B, the 4th dose was ENGERIX B.
Experienced cold after the first dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. Patient experienced cold after 1st dose. Patient was scheduled for the second dose on 03May2021. He was asking if he can get the vaccine on 03May2021. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient is a 77 y.o. White or Caucasian male who presents with complaint of worsening weakness, nausea, vomiting.  Report of dark emesis prior to admission in facility.  Patient endorses that he hasnt felt well for approximately 2 week.  Primarily complaints to include weakness, fatigue, nausea and more recently past day or two emesis.  patient admitted on 1/6/22.  Booster was given on 12/21/2022.
Immediately after administering vaccine, site noted to be red and swollen.  Notified physician.  When I came back to the room, hives noted to pt's face.  Physician enters room; noted pt to be wheezing and have facial edema.
Low grade fever, nausea, diarreha, night sweats when Tylenol seemed to 'break' the fever...but did not actually end it.      Symptoms began late evening after the afternoon shot.     Were told to expect 1-3 days of "possible symptoms' so continued to treat with OTC meds  (Tylenol, pepto bisnol)...and bed rest.    Symptoms would moderate slightly but never went away.     Nausea and diarreha 'out ran' the ability to stay hydrated.     On the 6th day took my wife to ER.    She was given one bag of fluids and prescriptions.
Over the summer I was sick to my stomach and kept throwing, and was achy all over. Burning from stomach to esophagus. Was running a low grade fever, normal temperature for me is in the 97's and I was in the 99's. I just felt bad. My ears were also throbbing. I saw Dr. a few times she tested me for flu and Covid and both times it was negative and had me up the dosage of omeprazole. She also put me on Promethazine 12.5mg  1tab every 8 hrs, Ondansetron 4mg 1 tab 3x daily, Famtine 20mg 1 tab 2x daily. The medications were not working and she referred me to a specialist. I saw the specialist, and she wanted to do an upper endoscopy. She scheduled me for the following week. Do not have the results yet, She also scheduled me for Gastric emptying studying  since I am having trouble eating. It is scheduled and our appointment to go over the test results is later.
fatigue; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (Soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3 and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and MYALGIA (Soreness). At the time of the report, FATIGUE (fatigue) and MYALGIA (Soreness) outcome was unknown. Not Provided      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.   Other concomitant medication included herbal medicine Treatment medication was not provided   This case was linked to MOD-2021-078664 (Patient Link).
1. Erythema and induration at injection site and extending beyond 3cmx7cm - right upper arm. 2. Pain at injection site (deltoid area rt arm)
shortness of breath; 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 14May2021 (Lot number: EW0182, Expiration Date: 31Aug2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot EW0172 and expiry date 31Aug2021), administration date: 23Apr2021, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath".  Additional Information: She received her second dose and experienced shortness of breath over the summer. It seemed weird that the patient never had shortness of breath and after the shot she did. She Reporter wanted to know whether anyone else reported residual side effects of shortness of breath with Pfizer Covid vaccine. The patient needs to get a booster shot but should she because she did not want to have the shortness of breath. She wanted to know if she should tell about the event to her general doctor or cardiologist. She wanted to know if she get the booster, would she have the same problem or not.  No follow-up attempts are possible. No further information is expected.
Patient reports that she began to experience numbness in both arms and the appearance of small raised red bumps on both arms. When patient came for her second dose today, I observed that there were still some small pale pink bumps on her forearms, raised and about the width of a pea. Patient stated that she had no difficulty with breathing. Patient was advised to contact her primary care doctor if the problem persists or worsens.
Developed Covid symptoms 19May2022, positive home test 20May2022; Developed Covid symptoms 19May2022, positive home test 20May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 12:45 as dose 1, single (Lot number: EN5318), on 08Mar2021 at 10:00 as dose 2, single (Lot number: EL9269) and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 67 years for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: May2019; CETIRIZINE HYDROCHLORIDE, start date: Mar2012; NASACORT, start date: May2018; HCTZ, start date: 15Nov2021; AMLODIPINE, start date: 08Feb2022; LUTEIN ZEAXANTHIN; VITAMIN D3; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE; COLECALCIFEROL]; MAGNESIUM; MELATONIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "Developed Covid symptoms 19May2022, positive home test 20May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive; (26May2022) Positive, notes: very light positive line; (27May2022) Positive, notes: very light positive line; (31May2022) very dark line, notes: very dark line. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course Developed Covid symptoms 19May2022, positive home test 20May2022, ill on 19May2022, 20May2022, 21May2022. Took Paxlovid on 20May2022 - 25May2022. Home test on 26May2022 or 27May2022, very light positive line.Cold /allergy symptoms on 29 May2022, 30 May2022 and 31 May2022. Home test on 31May2022 very dark line. No Known allergies were reported. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.
Received H1N1 on 10-19-09. Miscarried 10-28-09. Received seasonal flu shot approx 2 wks prior.  11/17/09:  Prenatal records received.  DX:  SAB Assessment:  This G3 P1, LMP 8/17/09, EDC 5/24/10 experienced a spontaneous abortion on 10/28/09.
Information regarding PREVNAR 13 was received from a physician regarding a "population of patients" 5 years old and under who experienced pain and swelling at injection site when PREVNAR 13 and ROTATEQ were given together. The patients received a dose on unspecified dates. The patients experienced pain and swelling at injection site when PREVNAR 13 and ROTATEQ were given together. Outcome for event was unknown. No additional information was available at the time of this report.
Information has been received from a RN from the HD concerning "several weird cases of people who in 1968 were vaccinated with a monovalent measles vaccine and are presently exhibiting measles type symptoms". The nurse stated she did not feel this was measles, but something else. Unspecified medical attention was sought. Follow up information from the RN indicated that there were 15 confirmed cases of measles. The nurse could not elaborate on these cases. She also reported an individual developed a rash after vaccination and other rash illnesses that were not proved to be measles and had no definite diagnosis.
I had a positive HPV test on 6/18/19 and I decided to get the HPV vaccine based on the recent FDA recommendations. I received my first and only HPV vaccine on 7/23/19. Two days after the vaccination I had flu like symptoms including high temperatures, body aches, headaches, and fatigue. The body aches improved after a few days but high temperature and weakness continued to be a problem intermittently.  I had some labs done to rule out infection including CMP (normal). About one week following vaccination I went to urgent care and was given antibiotics for possible sinusitis. I finished the course of antibiotic with no improvements. The high temperatures were not intermittent anymore and I started having severe joint and bone pain around 8/14/2019. The pain was worst in my hands. My PCP ordered some inflammatory markers (ANA, ARP, RA factor, ESR) to rule out RA, the labs were all negative. It has been about 7 weeks since my vaccination now, bone and joint pain have improved but fatigue continues to be an issue. I sometimes experience the warm feeling (almost like hot flashes) and also miscellaneous body pains (abdominal pain, muscle and joint pain, headache).  I have to point out that prior to this event I was a perfectly healthy individual, I have no history of chronic diseases or reactions to vaccines. I am also a clinical pharmacist and completely pro-vaccine. I understand that current data and research does not support some of the current public concerns about this vaccine but I truly believe that a closer investigation needs to be done regarding these concerns.
SUSPECTED CLINICAL VACCINATION FAILURE; CANNOT WALK; COVID-19 PNEUMONIA/BREAKTHROUGH INFECTION; INCONTINENT; This spontaneous report received from a consumer concerned an 83 year old female. The patient's weight was 190 pounds, and height was 62 centimeters. The patient's concurrent conditions included chronic obstructive pulmonary disease, diabetes, atrial fibrillation, non smoker, non alcohol user, and morphine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, one total administered on right deltoid on 17-MAR-2021 around 1 to 2 pm for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, Laboratory data included: Pulse oximetry (NR: not provided) 100 %. On 20-JUL-2021, the patient experienced covid-19 pneumonia/breakthrough infection, incontinent and on 22-JUL-2021 experienced cannot walk. On 23-JUL-2021, the patient had suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient was sent to the hospital by daughter on 23-JUL-2021 where diagnosed with pneumonia, the patient ended up in ICU (intensive care unit) from July 23 to 29, where the patient had 100 percent oxygen, then transferred to regular bed after 29-JUL-2021 and was discharged on 02-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 pneumonia, suspected clinical vaccination failure, incontinent, cannot walk This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210810402-COVID-19 VACCINE AD26.COV2.S.-Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210810402-COVID-19 VACCINE AD26.COV2.S.-Covid-19 pneumonia/breakthrough infection, incontinent, cannot walk. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.