chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eye lids swollen twice the size.  Headache.  Then two days later a very bad cough, particularly at night began that has continued every night.  We are giving him Robitussan.  Otherwise he is feeling fine.  No fever, but the cough is bad enough to keep waking him up.  This is a kid who has never had a cough in his life, hasn't had to see a doctor in several years, and rarely if ever wakes up. We don't have heath insurance.  His energy level is high during the day and he has no fever but the cough has been going on now for about 5 days. We are very concerned about this.
About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.
developed rash 9 or 10 days post receiving MMR. Slight fever mom said low-grade eyes were a little red-watery, but not mattery. Mom treated symptoms and symptoms subsided within 4 or 5 days.
Cluster and single pustules, red in color, raised off the skin, itchy, scattered all over the body; Cluster and single pustules, red in color, raised off the skin, itchy, scattered all over the body; Patient was pregnant at the time of vaccination/ Gestation period: 16 weeks; COVID-19 vaccine start date: 10Sep2021 and Flu vaccine start date: 10Sep2021; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 18:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. The patient's last menstrual date was 18May2021, gestational period was 16 weeks and expected delivery date was 22Feb2022. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the COVID-19 vaccine which included first dose of influenza vaccine (FLU; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 for an unknown indication. The patient did not receive any concomitant medications. On 11Sep2021 at 11:00, the patient experienced cluster and single pustules, red in color, raised off the skin, itchy and scattered all over the body. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cluster and single pustules, red in color, raised off the skin, itchy, scattered all over the body was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
CLIENTS FATHER CALLED AND STATED THAT ON 7/29/2016 IN THE EVENING WHILE CLIENT WAS STAYING WITH HIS MOTHER, THE CLIENTS MOTHER STATED THE CLIENT COMPLAINED OF WEAKNESS AND SHAKING. THAT THE CLIENT HAD RECEIVED A RABIES VACCINE EARLIER IN THE DAY.
Presented with N/V; tested +Covid 1 day prior to arrival; dx Covid PNA; treated with steroid, antibiotics, Zinc, low O2, remdesivir; discharged to home
pain; had the shots and still have shingles/ suspected vaccination failure; shingles; blisters; rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shots and still have shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), blister (Verbatim: blisters) and rash (Verbatim: rash). On an unknown date, the patient experienced pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, blister, rash and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, rash and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, blister, rash and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 The case was received from the patient via interactive digital media. The reporter stated he/she had both the shots and still had the shingles. It was not itchy but had blisters, rash and pain. It had been about a week and they were not going away very quickly. They were not easy to deal. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Normal side effects immediately after injection. From 8/10 to 8/16 weight loss of 17 lbs with no changes to diet or activity level. On 8/16 started spotting, which lasted 7 days, then after starting, 1 day of clotty heavy flow,  2 days of abnormal light flow and still spotting as of today 8/28. I normally have EXTREMELY HEAVY periods that are painful. I normally have to wear adult diapers due to how heavy they are.  It definitely changed my cycle, honestly for the better.
tenderness at injection site; redness at injection site; swollen from shoulder to elbow; increased warmth at injection site; A spontaneous report was received from a consumer concerning a 82 year old female patient, whoreceived Moderna's COVID-19 vaccine (mRNA-1273) and experienced red and swollen arm.  The patient received their first of two planned doses of mRNA-1273 in(Lot number: 025LZ04 ) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 15/Jan/2021, the patient experienced arm felt warm and red and swollen, the outcome of the events are not reported.  Action taken with mRNA-1273 in response to the events was not reported.
Patient to clinic requesting Men B for college preregistration immunizations/physical. Patient received Menactra instead of Men B. Patient had 1 previous dose of Meningococcal vaccine in 11/11/2013. Patient returned to the clinic today and got the Men B shot. Shot record provided.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that the patient who was the cousin of his wife experienced severe reaction to the dose of SHINGRIX. The reporter said that he was sitting across the table from the patient and that she said that her arm was all swollen and that it hurt a lot. It was unknown if the reporter granted permission to be contacted, as he declined to answer any form questions, so no further details provided beyond what is already documented above.
08/31/22 presents to Birth Center Triage for "induction of labor". PMHx of "Gestational diabetes mellitus"
clammy, feels like passing out, dizzy. Evaluated by EMS-Refusal to transport.
GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 66 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total was administered on 06-DEC-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 65 years old. No concomitant medications were reported.  On 15-DEC-2021, the patient experienced excruciating back pain which had continued for 2 weeks. On 19-DEC-2021, the paralysis had started with her mouth while patient was at work. The paralysis continued all through the body all the way to her feet. She had been suffering from paralysis since 16 months at the time of reporting. The patient was completely disabled and all her muscles stopped working and she was in the hospital for almost a month from 05-FEB-2022 to 02-MAR-2022. The number of days of hospitalization was 25 days. The patient was unable to speak due to her paralysis, not able to move her lips and she has to take her hands to move her mouth to be able to eat. She had visited lot of doctors and was finally diagnosed with Guillain-Barre Syndrome. The physician stated that the vaccine had caused this syndrome in other patient's as well. The patient was previously working perfectly fine and at the time of reporting she was not able to walk or drive and was completely disabled.  The patient was able to take immunoglobulins to get her better health which were recommended by her physician. The patient hands were completely curled up and it was hard time typing on a keyboard but she was able to text on the phone. Her body stopped digesting food and the patient lost 41 pounds in 42 days and was not able to walk even with a walker, could only stand using a walker for a small amount of time. She had been visited rehabilitation for 3 times. The patient had been in the wheelchair whole time and initially she was bed bound when the guillain-barre syndrome first started. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain-barre syndrome. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0: 20230505030- Guillain-Barre syndrome. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Chickenpox, rash onset 9/28/1999, only 1 lesion, no fever. Sister had prior chickenpox.
inflamation of the Prostrate; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATITIS (inflamation of the Prostrate) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PROSTATITIS (inflamation of the Prostrate). At the time of the report, PROSTATITIS (inflamation of the Prostrate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. .   Reporter did not allow further contact
boostrix dose that was exposed to temperature higher than 77.9°F; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number DH3A2, expiry date 29-SEP-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: boostrix dose that was exposed to temperature higher than 77.9°F). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-May-2023 The reporter consented to follow-up. The patient received a dose of Boostrix that was exposed to temperature higher than 77.9 degree Fahrenheit, which led to incorrect storage of drug.
I had no symptoms but it took a week before the test was negative. I had absolutely nothing I tested for COVID-19 due to my wife's positive test.
Classic kidney stones symptoms in person with no prior history, and on no medications; headache; fatigue; This is a spontaneous report from a contactable physician. A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot Number: EN6203), intramuscular, administered in left arm on 26Feb2021 at 10:15, at a single dose, for covid-19 immunization. Medical history included early stage prostate cancer more than 2 years ago; surgery only, no meds. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. On 02Mar2021 at 8:00, the patient experienced classic kidney stones symptoms, with no prior history and on no medications. All other symptoms were more typically reported for the vaccine (ie. headache, fatigue, etc). Patient has pending doctor appointment. The outcome of events was unknown.    No follow-up attempts possible. No further information expected.
Headache, Diaharrea, Chills, Fever, Nausea, Muscle pain for aprox. 12 hours. Headache and Muscle pain continuing (this is just the next day that I am reporting the reaction.)
Fever 101 F for 2 days. Headache 1 day. Sore arm 4 days.
2-month old receiving an expired dose of Pentacel/no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a two months old female patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was expired before nine days (Box: Lot: UJ066ABA, Exp: 13-Jun-2020, ActHIB: Lot: UJ066AB, Exp: 13-Jun-2020 and Dtap-IPV: Lot: UJ100AA, Exp: 13-Jun-2020) on 22-Jun-2020 for prophylactic vaccination (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Arm pain (muscle) 3 hours after headache 12 hours after Nausea, chills, dizziness 17 hours after  Fever and vomiting 36 hours after
I was trying for a pregnancy and was likely pregnant but not detectable at vaccine number 1. Found out about pregnancy a week or so before vaccine 2.  (I was likely about 5 weeks pregnant then based on LMP of dec 22 with avg cycles of 35 days. Decided to get vaccine due to general advice that it is okay during pregnancy. (No known adverse effects). After dose 2, had about 10-12 hours of chills without fever and general fatigue. Shortly afterwards experienced mild cramps. This is my 5th pregnancy and I have no history of complications of any sort. Cramps are not usual for my pregnancies but I know it can be normal so I did not think anything of it. Mild spotting occurred but again did not think anything of it as I know it can be normal. I was scheduled for a first OB visit  Mar 3 where I should have been 10 weeks. (Initial positive pregnancy test was Jan 29). Ultrasound showed empty 5.6 week gestational sac with a yolk sac and subchorionic hemorrhage.   OB suspected pregnancy failure. We followed pregnancy with ultrasound of better quality 10 days later which showed a possible fetal pole and yolk sac but no heart beat and gestational sac measured at 6.0 weeks. Today March 18 awaiting repeat ultrasound tomorrow but started bleeding and cramping. Consistent with the start of the miscarriage. With no histories of abnormal pregnancies and with the gestational  sac consistently measure at 6 weeks (matching to about the time of shot#2), I am inclined to believe that the second covid shot stopped the progression of my pregnancy. I am a huge pro vaccine health care provider but would recommend now an investigation into first trimester covid vaccinations and possibly not recommend this during that time period.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 18-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Adverse event reported by mother that there was redness and swelling in the area of the injection site. Recommended to give Tylenol and apply cool compress. Mother was instructed to call or return for worsening or persistent symptoms.
10/20/2022 Began having headache, sore throat, and felt like I was beginning to get a cold.  That evening I began running fever with 102 degrees being the highest it got. Woke next morning feeling much worse and tested positive on at home test. Spoke with doctor later that day and was prescribed Paxlovid.  Began taking prescription that evening and began feeling better Sunday afternoon. Still feeling fatigued today.
Hours after the vaccination, my blood pressure was 179/92. My normal blood pressure is 135/82. Later that evening I had chills and a slight fever similar to the flu. My blood pressure returned to near normal in a few days. I will never take another Covid vaccination because it raised my blood pressure so high.
Cellulitis-like reaction with intense erythema and tenderness on left inner lower 2/3 of upper arm and tenderness over pectoralis muscle without erythema. Limited range of motion left shoulder. A febrile. Treated with oral antihistamine, 1%hydrocortisone topically and ice.
Noticed that entire arm was starting to swell. By the time she had went to health unit at DFAS entire R arm and hand was swollen and couldn't grip/hardly move hand to do sign language interpretation she does. Refused to be sent to ER by base EMS. No breathing or anaphylactic reaction.
Arm was sore and had a knot @ site the day after injection. On 10/27/2010 rash developed @ site. Advised to apply cool compresses to site and seek PMD if symptoms persist.
fatigue,headache, runny nose, dry nose, irtchy eyes, achy joints, anxiety
one week after # 2 JE and Rabies client's aunt reported that client had a temp 100.5 po on Tylenol tue pm after #2 doses. site was tender but no red or inflamed. General malaise and headache also reported. Did not go to school for one day. Resolved.
Right upper leg is red, swollen, hot and pain to touch. The redness is about 3 inches in diameter.
Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03169, 2012-03170, 2012-03171, and 2012-03172. A 61-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except for history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed hand and feet numbness, gait disturbance, weakness and parascapular pain. Neurological examination revealed "proximal weakness (4+/5) in all extremities: absent vibration and joint position at bilateral toes and ankles, reduced pin-prick and light touch at bilateral feet and hands, severe sensory ataxia, generalized loss of deep tendon reflex, and positive Romberg sign." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 58 mg/dl. Electrodiagnostic testing on Day 15 was "highly suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP) (sural sparing, prolonged distal latencies and absent or abnormal F responses)." The patient was diagnosed with Guillain-Barre syndrome with sensory ataxic variant. The patient was hospitalized and treatment included intravenous Immunoglobulin" (IVIG) (0.4g/kg/day x 5days)". The patient showed "rapid improvement of gait and balance, vibration and joint position. Numbness in hands and feet continued for a longer duration." The patient's outcome was not recovered. Authors indicated that since this patient did not have flaccid paralysis, one of the criteria for the case definition of GBS outlined in the recommendation by Brighton Collaboration Working group, the certainty of diagnosis was not been able to evaluate. Documents held by sender: None.
PATIENT EXPERIENCED RED SPOT ON HER LEG THE SAME NIGHT, WOKE UP WITH STUFFY NOSE & BUMP ON HER EYELID. FOLLOWED BY HIVES AROUND HER BELLY BUTTON, BACK & NECK.
17 pt's were vax w/ 2 doses varicella vax & lab eval 6-7wk post vax revealed 11 neg titers & 6 equivocal titers;
On 8/21/2004 mom called office to report area at DTaP injection is warm/red. No fever. No s/s infection. Activity level (+) reassured mom.
Pt reported that he felt faint and found himself to be shaking approx 10 min after receiving vaccine; pt was brought back and placed on abed; EMS was activated and pt was transferred to nearest ER
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        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.   The healthcare facility had an power outage on 01 April 2021. This dropped the temperature of the vials stored in freezer and refrigerator to -  Frozen vaccine 47 minutes -13.79 degree celsius Refrigerator 59 minutes 12 degree Celsius  Treatment information was not provided.  Concomitant medications were not reported.
Shortness of breath, difficulty swallowing (current)  Fever, joint pain, tiredness (former: ended on 4/25/21)