chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received on 29-SEP-2016 from the mother of a female patient (age unknown). Medical history and concomitant medications were not specified. On an unspecified date, the patient was vaccinated with GARDASIL 9 intramuscularly (lot number not reported). The mother reported that her daughter is experiencing "extensive adverse reactions to GARDASIL 9". The pt was experiencing a sore throat, congestion, joint pain, trouble walking and fatigue. The patient sought unspecified medical attention. When asked questions during her phone call, the mother stated "these questions can be answered by my attorney". The events were still present at the time of the report. Additional information is not expected as the mother did not provide contact information.
Fatigue on first day (Wed) 2 hours after through 72 hours, muscular aches 18-72 hours after, fever 100.9 around hour 24, chills hours 24-30 after, fever dropped to 99 on Fri-Sat, swollen lymph node under L arm 48 hrs after & continuing, lymph node swollen L collar bone area 72 hrs after & continuing.
Symptoms began within 3 days of 2nd dose. Chest pain/pressure off and on. Shortness of breath. Increased fatigue especially when exercising.   Symptoms have continued.
fever to 105, irritability unconsolable for 8-10hrs; hospitalized from 6SEP-9SEP95; Blood culture, viral culture p/72hrs; leukocytosis up to 27,000; observed in hosp w/o ATB; recovered by 48hrs, WBC dec to 11,000;
pt states her right ear has a very heavy  continuous ringing sound that started on 4/4/2021.  she says that her ear is very irritated and is causing her to having a headache.  She contacted a doctor by tele-visit on 4/4/2021 and was instructed to call us for medical advise and to FU w/ her PCP or ENT.
Got the shot, had shingles /Suspected vaccination failure; Shingles /worse than the shingles that I had; Busted out with blisters; This 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had vaccine but still got shingle. The reporter reported that they were busted out with blisters and they had shingles, no more shots, never again, no shots. The shingle shot of vaccine was terrible and they busted out and blisters which were worse than the shingles that they had. Additional supportive information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was reported at the time of reporting. Follow-up would not possible, as no contact details were available.
Within 48 hrs red welts down to forearm. Flu like symptoms. 1 week later red circle size of a dime appeared at injection site. Each day size increase with red bumps-appeared as a burn size of a half dollar. Used Benadryl tablets and cream/Claritin during day. After 6 weeks the area is still discolored and red bumps are still appearing.  12/01/05 Still have new red bumps appearing at site of injections.
Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-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 09Apr2021 at 17:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if its ongoing. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 13:00, the patient experienced headache and body aches. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and body aches was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
After receiving shots at times I felt tired, body ached especially in legs and muscles. I would then feel better so thought it was the virus, however as time went on leg pain and muscles hurt more and was continue although at times it was difficult to go up and down steps. I contacted manufacturer on 5/24/01 12:45pm and also FDA they listened but nothing else said they would put it on records. I received the first shot on 1/25/99 and the second shot on 2/24/99. At sometime, not sure just when I felt tired, legs and muscles ached and in general just felt bad.  Follow up on 11/26/03: "Recieved my first and second shots from MD, do not know lot #, for vaccine #1."
Severe pain, swelling, and tenderness at injection site, fever (don't know how high), chills, body aches, and headache that lasted for approximately 12 hours. Symptoms started approx. 30 hours after vaccination.
lndication reducing risk of serious infection with Covid 19; No AE reported.; This spontaneous report was received from a company representative and refers to a 56-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for covid-19 prophylaxis. On an unknown date, the patient experienced off label use (indication: reducing risk of serious infection with Covid 19) and no adverse event. The action taken with the suspect vaccine and the outcome of the events was unknown. Causality assessment was not provided.
Expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA640Z, expiry date 30th November 2022) for prophylaxis.   On 16th December 2022, the patient received Menveo. On 16th December 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The reporter asked if the patient had to be revaccinated. The reporter did not provide patient information. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
4 days after HPV #3 and MENACTRA leg pain - left upper only - more muscular than bony, increased CRP difficulty walking, missed day of school.  9/23/09 PCP records received DOS 8/10/09 to 8/30/09. Patient presents with c/o numbness right knee. Tender to touch, hard to walk, stand. Antalgic gait. Skin itchy on buttocks. Cold with chills, stuffy nose, cough. DX:  URI with limb pain. Leg myalgia. Cough-viral process.
Pt complained of Nausea for 5 days following vaccine and fever for 8 days (including today)
Pt developed a large area at right anterior thigh local reaction with erythema, tenderness, warmth and induration 3 1/2" X 2 1/2" which improved by 72 hours, after onset. Also had low-grade temperature for 48 hours that is now resolved. Still with erythema.
I developed Bell's Palsy in the left side of my face.  I already suffer with chronic Bell's Palsy in the right side of my face.  Treatment includes a course of prednisone and of valacyclovir, acupuncture, near infrared light therapy, physical therapy (microcurrent stimulation).
Patient reports that she received the vaccination on 1/15/21 at the outdoor clinic.  One week after vaccination she developed induration and swelling in the left deltoid where the injection was administered.  Patient reports that at the time of administration that she believed that the needle length was too short for penetration to the muscle in relation to the size of her upper arm and reported feeling the liquid from the injection flowing down her arm. Patient denies fever. Patient has been using Benadryl to manage the discomfort and presents to the clinic for advice and management.  As per collaborating Dr. patient should continue the Benadryl and use Zyrtec to relieve swelling and itching sensation.  Patient is advised by Dr. that this reaction should not preclude or contraindicate obtaining vaccine #2, but to specify that a needle of a minimum length of 1.5 inches be used to ensure IM penetration.
Instant heavy chest and shortness of breath. Rapid heart beat over 80 bpm at rest, extreme fatigue. I lost my feeling in my hands I couldn?t touch anything slightly warm it felt like it was on fire. Fever over 101 for 3 days. Body aches and pains. Sore throat. Hard to breath and catch my breathe.
Large, 3inch+ red patch at injection sight.  Patient treated it with hydrocortisone (x2), eventually resolved.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 12-Feb-2012. On 15-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Apr-2012 and incorporated into the narrative: No late occurring adverse events.
No ADR. Resident received a booster dose but was supposed to receive their 2nd primary dose
Patient given flu vaccine on 10/09. On night of 10/10 patient started to complain of top right arm hurting. Presented morning of 10/11 to immunization clinic with large hard hot nodule and wheezing.
3/10/201- Abdominal and back aches start, followed by the development of bilateral Bell's palsy. Seen by Dr., neurologist, on 3/19/2018 and started on prednisone and VALTREX. After her courses of these medications her abdominal and back aches recurred and restarted on prednisone, which she was told to taper on 04/02/2018.
COVID-19 infection: No hypoxic respiratory failure currently, on room air at present with O2 sats greater than 94%. Mild interstitial prominence on chest x-ray without acute infiltrate Treated with empiric Rocephin and azithromycin to cover any possible superimposed bacterial infection and transition to oral cefdinir and azithromycin on discharge to complete course of treatment. No current indication for remdesivir Treated with Decadron 6 mg daily and transition to p.o. prednisone short course discharge.
Red swollen itchy painful to the touch Applied ice cold rag on and off every 20 minutes as of today still have minor itching pain redness and swelling
Possible neuropathy? Experiencing nerve pain in teeth, some body parts and tinnitus.
patient's lips and tongue became numb 30 minutes after the shot; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6205), via unspecified route of administration, in the left arm, on 07Mar2021 at 11:45 (at the age of 57-years-old), as a single dose, for COVID-19 immunization. The patient's medical history included the seasonal allergies. No known allergies. Patient received unspecified other medications in two weeks. No covid prior vaccination. Patient was not tested for covid post vaccination. No other vaccine in four weeks. On 07Mar2021 at 12:15, patient's lips and tongue became numb 30 minutes after the shot, they stayed numb for about 6 hours. No treatment received for event. Outcome of the event was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
All day, day after vaccine: headache, joint pain All day, 2 days after vaccine: head rushes when standing up or sitting down, followed by  5-10 second headache All day, 3 and 4 days after vaccine: sensitive stomach and diarrhea Weeks after vaccine: extremely heavy period and more discomfort than normal
no additional adverse events; administration of an expired dose of MMR II; This spontaneous report was received from a medical assistant and refers to a 28-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 29-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 ml, single dose for prophylaxis (lot # S014436 was verified to be valid, expiration date reported and established to be 09-MAY-2021). There was no previous temperature excursion reported on the product. The patient did not experience any additional adverse reactions. The outcome, action taken and the causality assessment were not provided.
After 2nd dose (Pfizer EN6199, on 3/14/2021) I came to realize that the rash/outbreaks on my scalp started after my first Covid-19 vaccine. I was thinking it might have been caused by my use of drinking a tablespoon of the Olive Oil I started about a month ago. After it became worse in the last days, 2 days after my second dose and 6 days after had stopped with the Olive Oil, I think it might have been caused by the vaccine. I didn't change anything else. Same cosmetics and shampoo/conditioner for months.
approx 10-20mins p/flu shot;pt reported tingling @ top of forehead;erythema on face;pt states resolved in 20min;pt states same thing happened last year
Fever 101.1 in ER; treated temp with Tylenol and Motrin.  10/21/2010 Patient treated for Pneumonia with Amoxicillin, Tylenol and Motrin for fever.
after receiving a third dose the patient experienced lightheadedness, dizziness, a fever of 99.8, and body aches the day following administration
On Saturday I tested positive for COVID; On Saturday I tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:00 as dose 1, single (Lot number: Hh7595) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "melanoma" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Past drug history included: Taxotere, reaction(s): "known allergies:Taxotere". Vaccination history included: Covid-19 vaccine moderna (Dose number unknown, single), for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2023, outcome "unknown" and all described as "On Saturday I tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2023) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330285 Same patient/same product, different dose/event;
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 11 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single 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), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: investigation: positive, notes: got COVID.  Additional information: My family (children and husband) got COVID. They had previously received the Pfizer vaccine. Their COVID is mild.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out
Fever >100.4,  Subjective fever (felt feverish), Chills,  Fatigue or tiredness, Hospitalization, discharged from hospital with oxygen.
Post vax, the baby had been a bit irritable and had a low temperature; gave Tylenol. The baby had finally fallen asleep when suddenly she woke up crying hysterically non-stop; as the mother picked her up from her crib to comfort her, her arms and legs stiffened and she stopped breathing then went completely limp and fell into a deep sleep. The terrible ordeal lasted about 45 seconds. She slept the entire night. She seemed fine in the morning. Parents noted delay in milestones and at 6 months developed a seizure disorder. Parents states they were told later that the child had suffered a grand mal seizure due to adverse reaction to vax.
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 10-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Beginning 6 days after immunization had 3 days of fever followed by 3 days of slurred speech, wide-based gait, lethargy, and bizarre behavior, followed in turn by complete resolution.
Myalgia, Arthralgia,NauseaVomiting, chills, fatigue Narrative:
shortness of breath; malaise; woke up during the night with/ night sweats; she walked 10 feet and had shortness of breath; she had sweats this morning and she lied down; severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath) and HYPERHIDROSIS (she had sweats this morning and she lied down) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mitral valve disease, Blood disorder (Patient has rare blood condition ) and Polycythemia vera (PV). Concomitant products included CEFALEXIN (CEPHALEXINE) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath), HYPERHIDROSIS (she had sweats this morning and she lied down) and NAUSEA (severe nausea). At the time of the report, DYSPNOEA (shortness of breath), MALAISE (malaise), NIGHT SWEATS (woke up during the night with/ night sweats), DYSPNOEA EXERTIONAL (she walked 10 feet and had shortness of breath), HYPERHIDROSIS (she had sweats this morning and she lied down) and NAUSEA (severe nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: rapid heart beat High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Patient received high dose flu vaccine at pharmacy clinic. Following vaccination, I was entering information and identified that patient had already received High Dose Fluzone dose from physician clinic 8 days prior. Patient was notified and stated that he was unaware or did not remember that he had received the flu vaccine already. Stated that he is feeling fine and did not have any adverse side effects following flu vaccine admin.
I had ringing in both of my ears before the vaccine, but after taking the vaccine I had increased ringing in  both of my ears. Since the vaccine, the ringing has been more persistent and moderately severe. I had a fever for a day and a sore arm for about 8 hours.
Fluctuating temperature. Had a fever for 3 hours from 11 PM to 2 AM after the first shot that would range from 100 to 103. After the second shot, has had fatigue, body aches, shortness of breath, dizziness, memory loss, seizures, temperature fluctuations from as high as 104.9 to a normal temperature of 97.6 and then back up again within the span of hours. So far, have not had a fever free day for 45 days straight.
1 inch by 1.5 inch red hard bump on right thigh where vaccines were given. Itchy for patient. Advised cool wash cloth and provider advised BENADRYL, dose appropriate for weight.
Adult patient was administered a pediatric dose of Engerix-B; Adult patient was administered a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 10-MAY-2023, the patient received Engerix B pediatric. On 10-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient was administered a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: Adult patient was administered a pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The pharmacist informed that earlier on the day of reporting, a patient was administered a pediatric dose of Engerix-B. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product.