chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Registered Nurse. A 65-year-old female patient received PREVNAR 13, (Lot # T36368, Expiry Date 31Jan2020) intramuscular at 0.5 ml, single at right deltoid on 18May2018 at 10:30 for immunization, administered at physician office. The patient medical history and concomitant medications were none. No history of all previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications, other medical conditions or relevant investigations to provide. No additional vaccines administered on same date of PREVNAR 13. No prior vaccinations (within 4 weeks). The patient was anxious on 18May2018 with outcome of unknown, experienced localized swelling at injection site that is the size of a softball on 22May2018 (or on 24May2018 as also reported) with outcome of not recovered, chest pain on 20May2018 with outcome of unknown, rash on 24May2018 with outcome of unknown, itching and warmth at injection site on 24May2018 reported as worsened, palpitations on 24May2018 with outcome of unknown. The events required a visit to Emergency Room and Physician Office. Course of events: The patient went to the ER twice and to the physician's office twice. The ER reported on 20May2018 indicating there were no acute findings. The patient reported a rash prior to the ER visit on the 24th. The itching, warmth and palpitations occurred about 20 minutes after the injection. The patient noticed the onset of itching and warmth at area about 20 minutes prior to her appointment with primary care doctor on 24May2018. The reporter added that the patient has an area the size of a softball with swelling at injection site. The reporting nurse assessed all events as Medically significant. Relatedness was reported as unknown for all events. Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of being anxious, localized swelling at injection site, chest pain, rash, itching and warmth at injection site and palpitations cannot be excluded, assuming a plausible temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
After receiving DTAP, pt had an unusual cry for 2 days. It was elected not to give him any further AP vaccine. He was subsequently diagnosed with profound hearing loss. The annual follow up states the pt has profound hearing loss.
Cold like symptoms - sore throat, runny nose, redness and warmth near injection site.
Extreme body aches, headache, extreme chills, fever, numbness in fingers and toes, dizzy and light headed, lasted for about 5 hours. then broke out into hives or rash on neck and chest,  underarms,  hips and upper thighs that are starting to subside 3 days later.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about the dates of 07-JUL-2016, 09-JUL-2016 and 20-JUL-2016, the patient was treated by a nurse practitioner for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 09-AUG-2016, the patient was treated by a physician for ongoing and worsening symptoms of shingles and nerve pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant ,medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Additional information has been requested.
Pt was given flu vaccination on 10/13/11 on 10/14/11 pt came into pharmacy & reported that both arms showed a rash 1 1/2 hours after getting shot, was gone by night time. Eyes burned Tuesday night. Friday noon noticed a large bruise on shoulder but ok otherwise.
Terrible headache; Chills; Severe body aches; The second dose is administered 14 days after the first dose.; This is a spontaneous report from a contactable consumer, the patient. A 31-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 07Jun2021 at 12:30(at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not have any known allergies. The patient did not receive any other medication within two weeks of vaccination. The patient previously 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 24May2021 at 12:30 (at the age of 31-years-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 08Jun2021 at 13:00, the patient experienced terrible headache, chills and severe body aches. 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, emergency room/department or urgent care. The clinical outcome of the event terrible headache, chills and severe body aches was not recovered at the time of this report.   The information about lot/batch number has been requested.
reports acute onset posterior headache, lightheadedness, and SOB post-vaccination (Pfizer) at 11:15 am. AMR emergency response notified, EKG benign. Pt hypertensive to 175/80, typical BP measurements reportedly 110s systolic. Pt reportedly has not had anything to eat for 8-12 hours. CBG on site at 97 per AMR. Transported to ED
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 12-year-old male patient received, on 16Nov2015, TRUMENBA intramuscular, in the left deltoid, at 0.5 ml, single dose. Relevant medical history was unknown. Concomitant medications included flu vaccine received in the left deltoid and HPV vaccine received in the right deltoid, both on 16Nov2015. The vaccines were administered at the private doctor's office and was purchased with commercial funds. On 16Nov2015, the patient was pale, had bradycardia, and fainted in office. On the same evening, family reported the patient was confused and was talking gibberish. No hospitalization, emergency room or doctor visit were required. Clinical outcome was unknown at time of this report.
During the day that I was administered the vaccine I had pain in my arm (area in where I was vaccinated). The next day, I woke up with general pain in the body, pain in the arm where the vaccine was injected and it swelled up a little the skin under the eyes (hives). As the day goes by, the pain in the arm has diminished, as well as the hives in the eyes.
About 10 min after vaccine felt fuzzy around my neck and alerted the vaccinator. I was exhorted to a curtained room where vitals were checked. I was given Benadryl 25mg and salumedrol IV. Before the 30 min mark I had tingling on the tip of my tongue and lips. I was monitored for 2+ hours and was sent home. The doctor prescribed 40mg prednisone for 4 days an Epipen, and antihistamines, recommended I see an allergist.  I saw APN 1/18/21 after the tingling and throat tightness persisted, she prescribed a taper of the prednisone.  Went to allergist 1/21/21 where we discussed continued symptoms and longer taper of prednisone and she asked me to call her 1/25/21. We spoke 1/25/21 and she recommended I see an ENT. Saw ENT on 1/29/21 who examined my throat with no concerns there. We discussed the ?burning mouth syndrome? symptoms and he recommended I return for medicated mouth wash if the symptoms continue. I am no longer taking any medication. I still have mild tingling on the lips and tongue, slight peppery feel/taste and occasional tightness at the base of my throat. We
This spontaneous report was received from a nurse referring to unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route, lot # and expiry date not reported). The vaccine was exposed to temperature of -13 degree Celsius for 5 hour. No previous temperature excursion and no adverse effects were reported. The call was not due to data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Starting on 3/12/2021, recurrent episodes of waking up at early AM (between 3:00 and 5:00 AM) with  palpitations (pounding heart)  lasting  from some minutes to several hours, sometimes involving  fast pulse rate up to about 105 bpm (normally 60 bpm,) a few times irregular pulse. Symptoms have recurred twice to 4 times per month. Palpitations almost always begin when sleeping lying down in bed on one side.   Checked of blood pressure at home  multiple times always with normal results (pressure ranging from about 110/70 to 135/85) . Fast walking for several minutes when palpitations were absent caused no adverse effects such as shortness of breath, dizziness, chest pain, etc., On 6/17/2021 visited primary care physician, who did an EKG, which turned out normal, and did detailed examination. At time of visit pulse rate was 100 BPM.  Discussion with physician indicated personal stressful situation and late evening sweet snacks as possible causes, due to blood sugar (but NO glucose intolerance diagnosed) or adrenaline spikes, sometimes palpitations were correlated with waking up after vivid dream episodes.   Reporting  event after 6 months VAERS check in and follow up call from VAERS because symptoms have improved but still present and they never happened before first vaccine dose.
Joint pain, muscle pain, neck pain, chronic fatigue, rashes, sweating, confusion, numbness in hands & feet, allergies, stomach problems, sensitive to light. Sick for 4 yrs. Dx rxn to vaccine. Has neuropathy. Follow-up: 1/28 Phone line trouble - unable to reach. 1/31 10:30 AM No Answer - will send medical release request and cover letter/see below. 2/1 11:20 AM No Answer. 2/2 10:09 AM No Answer - will wait for medical release. 2/15/00 She called to say that she had received the medical release request; she wanted information concerning what VAERS Program could do for her. Review'd information in VAERS flier; she understands. Asked her why claim forms were included in her information sent to us. She indicated that is was a mistake and wants those forms sent back to her. 2/16/00 Returned claim forms via mail; awaiting return of medical release to get information from Dr. concerning patient's current medical status. 2/18/00 Received signed copy of authorization for release of information; created letter and sent a copy of VAERS report filed and authorization for release of information form to physician per request of patient. 3/17/00 Received fax requested from Dr.'s office indicating that 200 pages of medical records are to be sent; they are asking for a fee of 230 dollars to procure those records; sent second request letter reiterating that a summary or pertinent medical records are being requested (not the entire chart) - also explained that the CDC requests that all fee be waived. 4/3/00 rec'd phone call from admin. assistant in Dr.'s office acknowledging that they had rec'd a letter asking for fee to be waived; wanted to know if we could pay a fee of 18 dollars - explained that we did not need entire medical record of 200 pages but we interested in a summary of medical events that might be correlated to hepatitis B vaccination. 4/12/00 Sent third and final request letter. 4/28/00 Record not rec'd. Case considered closed by default pending receipt of record at some future date. 5/10/00 received 210 pages of medical information related to lab work performed - no summary provided despite phone conversations and two letters requesting either a summary or pertinent medical records. Shared medical records with Dr. - all 210 pages scanned.
Shaking; Chills; Headache; Tired; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swelling at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03ZHZUA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with the fourth dose of RECOMBIVAX HB 5/0.5 microgram/milliliter (dose and route of administration were unknown) with lot number reported as M045653 and expiration date of 03-JUL-2019 for prophylaxis instead of a dose of VAQTA (strength, dose, route of administration, lot number and expiration date were unknown) for the same indication. No adverse effects were reported. Additional information has been requested.
Patient came in for flu shot. Said he needed one, wife called back and asked what was going to happen, he actually had one a couple weeks ago at the Dr's office. His memory is not very good.
Child suffered focal seizure on Monday, Sept. 3, 2018 at approximately 11:25 am - a little over 48 hours after receiving the vaccine. Seizure lasted less than 2 minutes and was witnessed by both parents. Parents called 911. First responders suggested that we take child to emergency room. She was seen and released from ER. No tests were completed at the ER. Follow up with a pediatric neurologist was recommended and was completed on 9/7/2018. Child is scheduled to undergo an MRI on 9/15 and EEG 9/25. The seizure causes lip smacking and left arm jerking.
On 10/1/2022 Rx 7277199 Pfizer Covid-19 Vaccine 5-11Y was administered to a pt. Upon receipt of the shipment of the vaccine w/ Lot #FL2757, we only used the Beyond Use Date (BUD) the QR code on the manufacturer box was not scanned and we did not document the expiration date given by the manufacturer.
Starting early morning  after vaccine, approximately 15 hours after vaccine, patient developed severe chest pain, shortness of breath, and tachycardia. Her fever was high throughout the day (often 102.8 even after Tylenol and Ibuprofen).  I am a physician and my husband is as well, we monitored her heart rate, oxygenation, temperature, and symptoms at home. We called her doctor and asked whether this could be myocarditis and whether we should go to the ER. She felt that we should just have her rest and monitor her vitals. I dosed her with two large doses of Ibuprofen (600 mg twice during the day), and by 6 pm on 6/4 her chest pain started to improve and her fever broke. The severe crushing chest pain lasted about 12 hours.
Nausea, dizziness, headache, dehydration (sickest I have ever been)
pain in shoulder (2 months later) limited range of motion (in shoulder) pain + soreness remain
No additional AE; Nurse reporting an AE for PROQUAD administered on 14JUN2022 after expiration on 16MAR2022. Caller stated this was noticed when a coworker was checking the shot record. Per caller, the product underwent no temperature excursion before administration.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent condition or concomitant therapies was provided.  On 14-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot #T031825, expiration date: 16-MAR-2022 (strength and route of administration were not provided) for prophylaxis (Expired product administered). No adverse events were reported (No adverse event).
Initial and follow-up information has been received from a physician concerning a 5 year old male patient (birth weight was 7 pounds, 11 ounces) with allergy to AMOXIL who was previously vaccinated on 05-AUG-2008 with the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), Lot number 659704/0667, intramuscularly into the right thigh and fifth dose of DAPTACEL, Lot number C29343A, intramuscularly into the left thigh. On 08-SEP-2008, was vaccinated with the second dose of VARIVAX vaccine (Oka/Merck), Lot # 660671/0403X, 0.5 mL, subcutaneously into the right thigh and a fourth dose of IPOL (previously reported as poliovirus vaccine, unspecified), Lot number A04914, subcutaneously into the left thigh. On 08-SEP-2008 the patient experienced hives and redness after receiving the second dose of VARIVAX vaccine (Oka/Merck). The patient experienced the hives shortly after receiving the dose followed by redness in the area as the hives resolved. The lot number for the first dose was not available. In follow-up information the physician reported that the patient had no hives and the patient recovered from redness at site of VARIVAX vaccine (Oka/Merck) injection. Additional information is not expected.
My period has become extremely light or doesn't come at all, I feel signs of premenstrual syndrome  but it doesn't actually happen like it normally does I've had one actually period since I got the vaccine and it lasted almost 10 days.
Hospitalized 1/05/10 with Guillian-Barre by PCP. 1/6/10->1/9/10.
tested positive for covid; fuzzy mind; probems walking; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fuzzy mind), GAIT DISTURBANCE (probems walking) and SARS-COV-2 TEST POSITIVE (tested positive for covid) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced FEELING ABNORMAL (fuzzy mind) and GAIT DISTURBANCE (probems walking). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid). At the time of the report, FEELING ABNORMAL (fuzzy mind), GAIT DISTURBANCE (probems walking) and SARS-COV-2 TEST POSITIVE (tested positive for covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Patient recently tested positive for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
expired dose of ActHIB was inadvertently administered to a patient, administered on 14-Aug-2023 but expired on 13-Aug-2023 with no reported adverse event; Initial information was received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an expired dose of HIB (PRP/T) vaccine [ACT-HIB] was inadvertently administered to 1 years old female patient, administered on 14-Aug-2023 but expired on 13-Aug-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Prophylactic vaccination.  On 14-Aug-2023, the patient received an expired dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (strength: standard, dose: Unknown) (lot number: UJ803AA, expiration date: 13-Aug-2023) via intramuscular route in unknown administration site for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of acthib was inadvertently administered to a patient, administered on 14-aug-2023 but expired on 13-aug-2023 with no reported adverse event.  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 the 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.
This spontaneous report as received from a patient (about herself) refers to a 72 year old female patient. The patient's concurrent condition included arthritis, high cholesterol, osteoporosis. On 01-AUG-2014 (reported as first Friday in August 2014), the patient was vaccinated with ZOSTAVAX. Concomitant therapies included simvastatin (manufacturer unknown). Patient reported a bad reaction to ZOSTAVAX shot. On 04-AUG-2014 (reported as Monday), she could hardly walk (considered as disability), stiff all over with pain everywhere in her body. Patient reported muscle and joint pain for the past three (3) months. Patient reported having constant pain especially in her back and right leg. The patient now has a walking problem, and has been using a leg brace or a cane (considered as disability). The patient was treated with Ibuprofen (800 mg). No lab diagnostic tests were performed. The outcome of the events was reported as not recovered/not resolved. The patient sought medical attention, and visited the physician. Causality was not reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Had nausea & vomiting 24OCT91 seen by MD BP 130/90 @ end of visit BP 120/80 normal; Phenergan supositories given; pt had relief of sx w/in a few hrs;