chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a patient who was vaccinated with Gardasil. Subsequently the patient developed a headache. At the time of the report the patient had not recovered. Additional information has been requested.
Warm, tingly feeling on top of left foot and left ankle. Sensation started the day of shot, about 2 hours after injections. Continued to come and go for the next 7 days. Seems to be dissipating during 2nd and 3rd week, but still continues to come back from time to time. Warm feeling is not painful, but is abnormal and not something ever experienced before. Sensation comes on during morning, afternoon, and/or evening. Has continued into week 3 right before 2nd injection.
Case number PHEH2015US015786, is an initial spontaneous report from a health care professional received on 12 Aug 2015. This report refers to a 17 year old male patient. The patient had a history of past gluteal maximus cancerous tumor removal otherwise he was a healthy teen. Concomitant medications were none. The patient was vaccinated with MENVEO (batch number: not reported) on 03 Aug 2015. On 11 Aug 2015 the patient developed malaise, headache, fever and vomiting. Outcome of the events was unknown. Seriousness criteria and causality of the event were not reported.
got first dose on 10/1/2020 and just not trying to get 2nd dose /  had been 9 months since patient got first vaccine / wanted to know if patient had to start over or if she could give 2 vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 1st October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix (injection). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient was just not trying to get 2nd dose and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter stated that it had been 9 months since patient got first vaccine. The reporter wanted to know if patient had to start over or if she could give 2 vaccine. The reporter did not consent to follow-up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: positive COVID test for 4 days (so far). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine lot unknown reason: Unable to locate or read the details. The patient Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 23Jun2022, Treatment stop date: 27Jun2022, Indication: Treatment of COVID-19. The patient did not had any known allergies. Other medication on 2 weeks product: Lexapro.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 20 minutes after I received the Moderna vaccine, my body began to heat up and my tongue swelled and got heavy, I started to feel dizzy.  This lasted for approximately 3 minutes.
PT WAS FULLY VACCINATED WITH PFIZER VACCINE - DOSE 1 1/4/21 (LOT EL0140), DOSE 2 1/26/2021 (LOT ELO140). S/O 8/23/21, TESTED + 8/27/21
Provider history and physical 10/20/21: "PT is a 16 y.o. male patient without a significant past medical history who presents with shock in the setting of fevers, vomiting, and diarrhea.    Symptoms began on 10/17 with fever, body aches and headaches. Fevers have continued daily since that time, T 100-103F and managed at home with Advil. Vomiting and diarrhea onset on 10/18, with 2 episodes of vomiting per day over the past 3 days and "continuous" watery, non-bloody diarrhea. PO intake has been minimal due to the vomiting. He has not had any abdominal pain despite his symptoms. Headaches onset on 10/18 and are described as generalized and worse with movement. No neck stiffness or altered mental status. Mom noticed bilateral conjunctival injection on 10/18, which she attributed to dry heaving. He has not had any rashes. Denies any nasal congestion or rhinorrhea, however, does note preceding symptoms of nasal congestion on 10/4 that resolved by the 11th. Patient has had intermittent fatigue and general feeling of unwellness over the past several weeks but no other symptoms until 10/17.   Patient was seen by PCP on 10/18 because of lethargy and intermittent fever, report of negative COVID-19 test on 10/18, recommended symptomatic management. He attends school and wears a mask (although no other classmates do) - known COVID-19+ contact on 10/15. No known COVID-19+ contacts 1-3 months prior to presentation. Patient was vaccinated against COVID-19 in 4/2021. Most recent travel includes various states all over summer 2021. Pt has not had any hematuria, dysuria, respiratory distress, peripheral edema, or known sick contacts with the exception of the aforementioned close COVID contact.    On the day of presentation mom noticed that PT had cracked lips and tacky mucous membranes, which prompted presentation to an OSH ED.   In the ED, vital signs included BP 90/52, HR 112, RR 20, SpO2 99% in RA, T 37.9C. Exam notable for cool distal extremities with delayed capillary refill and conjunctival injection. He was given a total of 3L of NS for fluid resuscitation and given cefepime and vancomycin for empiric antibiotic coverage. Due to persistent hypotension (as low as 80s/60s) despite fluids CHW was consulted and he was transported to the CHW PICU for further management. "
10 days after receiving the shot,  redness around the site of the shot, warmth  at the site, arm soreness that had subsided since receiving the vaccine and returned, and a headache.
shows no antibody reaction to PNEUMOVAX 23; This spontaneous report was received from a physician referring to a male patient of unknown age. The patient's concurrent conditions included immunodeficiency. The patient's medical history, historical drugs and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route of administration, lot number and expiration date not reported) for prophylaxis.         On an unknown date, the patient showed no antibody reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (antibody test negative).      The outcome of antibody test negative and its causal relationship with the vaccine were not reported.
Information has been received from a registered nurse concerning a 54 year old female who on 10/24/05 at 4:30 pm was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 647661/0055R), in the right deltoid. Subsequently, she called the physician complaining of pain at injection site. The patient was seen in the office on 10/26/05 for cellulitis to right shoulder, induration, erythema in linear area below injection site and running medially around anterior aspect of shoulder and into axilla. It was also reported that the patient had developed erythema around injection site and a red line to the axillary area. The patient was treated with azithromycin (Zithromax) for 5 days and warm compresses. The patient recovered. The reporter considered the patients adverse experience to be an other medical event (OMIC). It was also reported that two other patients had an adverse experience following vaccination with Pneumococcal 23v polysaccharide vaccine WAES0511USA00419 and WAES0511USA00420.
After receiving vaccine patient was about to sit in observation chair, he started seizing and fainting. Hit his nose and had nose bleed. He was having panic attack due to injection. Called 911. We made him comfortable and then in 5 minutes he started to faint. Ex-Ems was next to him, he started asking him questions and make sure he was awake. Within 5 minutes EMS arrived and they took over, checked all his vitals and found out patient did not eat or drink for whole day and had phobia with needles. Patient refused to go to hospital. Per EMS recommendation patient had drink and a bagel. Patient's relative came and took him home.
Two weeks after she received her first injection of Engerix B, vaccinee passed a pale stool and experienced a metallic taste in her mouth. In addition, the smell of things around her stayed with her for a long time.
Red rash, very itchy, on right side of skin over ribs, and on both ankles; later rash on right side of abdomen. Treated with OTC 1% hydrocortisone cream; dermatologist on 11/30 prescribed stronger cream; delays at pharmacy meant I received it after rash had begin to clear up. Mostly clear by mid-December. Center of abdomen, a few red, itchy spots appeared on 12/29/22.
Passed out in his chair and hit the floor.  Possible seizure for 5 seconds.  He was the conscious over the next hour but would get light headed and need to lay down.
9 pm post dinner in order of occurance -BAD back ache  -Muscle aches all night -Chills -Fever of 102.5 -Vomiting  Fever lasted through the night, 101 in morning - finally broke at 11 am next morning
her twin sister also had the same experience, her psoriasis had flared up, too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, manufacture unknown.), for COVID-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "her twin sister also had the same experience, her psoriasis had flared up, too". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
increased eosinophilic levels; This case was reported by a pharmacist via call center representative and described the occurrence of blood eosinophils increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced blood eosinophils increased. On an unknown date, the outcome of the blood eosinophils increased was unknown.   It was unknown if the reporter considered the blood eosinophils increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received a dose of Shingrix vaccine and patient had increased eosinophilic levels. No further details were provided.
Fever, seizures. Septic work up, antibiotics. < 24 hours after DTP, Hib, IPV, Prevnar
temperature excursion at 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES, 2nd excursion 23 MINUTES, 3rd excursion 15 MINUTES, 4th excursion 8 MINUTES and 5th excursion 6HOURS and 16 MINUTES with no reported adverse event; received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA418179.  This case involves a 1 years old female patient who experienced received ipol from a punctured vial after it was exposed to a temperature excursion at 16.6 Celsius, 8.9 Celsius, +9.6 Celsius, +8.6 Celsius, +12.8 Celsius for 1st excursion 6 hours and 17 minutes, 2nd excursion 23 minutes, 3rd excursion 15 minutes, 4th excursion 8 minutes and 5th excursion 6hours and 16 minutes with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the IPV (VERO) was exposed to temperature excursion at 16.6 Celsius, 8.9 Celsius, +9.6 Celsius, +8.6 Celsius, +12.8 Celsius for 1st excursion 6 hours and 17 minutes, 2nd excursion 23 minutes, 3rd excursion 15 minutes, 4th excursion 8 minutes and 5th excursion 6hours and 16 minutes with no reported adverse event (product storage error).  On 28-Sep-2022, the patient received 0.5 mL total dose of suspect IPV (VERO) (lot V1B901M and expiry date: 22-Jun-2024) via unknown route in unknown administration site for prophylactic immunization.  On 28-Sep-2022, (latency: same day) the patient received ipol from a punctured vial after it was exposed to a temperature excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.; Sender's Comments:  01312611: 01312677: 01312679: 01312681: 01312683: 01312686: 01312658:
Patient had 11x15cm area of redness and swelling anterior left thigh, localized reaction vs. cellulitis. Prescribed oral augmentin and Benadryl.
In both Vaccine #4 (Moderna-014B22A on 6/23/22 and given after (+) Covid 4/7/22) and Vaccine #5 I have developed headaches, fatigue, shortness of breath,  body aches, low grade fever, intermittent night sweats.within a week of injection.  Vaccine #4 lasted approximately 3 weeks- which is when I was diagnosed with the LGLL.    Vaccine #5 symptoms developed approximately 3 days after completing Ceftin/Medrol pak for surgery I had 10/11/22.
He had non-protective post-Pneumovax titers; Information has been received from the authors in a published literature article, entitled as stated below, referring to a 12-year-old male who on an unspecified date presented with inflammatory bowel disease (IBD), multiple non-infectious pulmonary nodules, and splenomegaly.   On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).      At presentation, his work up revealed giardia infection decreased IgG (283), IgM (15), and  undetectable IgA. He had non-protective post- Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) titers (vaccination failure), and an absolute lymphocyte count of 640. He was diagnosed with common variable immunodeficiency (CVID) and started on intravenous IgG replacement. At age 25, he developed inflammatory arthritis of the right ankle and left wrist treated with sulfasalazine. Genetic testing revealed a pathogenic heterozygous variant in TNFAIP3.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report:
Patient stated her arm is really red today. I looked at it and it is. She got it on 9/18 same day as flu shot. She got flu in left and PREVNAR 13 in right. Her arm is red, shot was given IM. No discoloration or bruising. She said it is a little sore. Will call her PCP to let them know as well.
"COVID Arm" developed about a week after the vaccination.  Around 3-4 inches below injection site.  Large red welt area, warm to touch, swollen somewhat tender.  Using Benadryl and cortisone cream.  Not really painful, Swelling seems to be subsiding a little today, but red area has spread since first noticed.
Hand-Foot-Mouth disease; developed vesicles and it was diagnosed as chickenpox; the 6-year-old child was suspected to have spread the illness to the patient; This initial spontaneous report as received from a nurse concerning a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were unknown per reporter.       On 28-OCT-2021, another child of 6-years old was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route, Lot # and expiration date not reported) for prophylaxis.         On an unknown date in 2021, the child developed vesicles and it was diagnosed as chicken pox. The nurse stated that the 6-year-old child was suspected to have spread the illness to the patient, and it was reported that the children were in the same classroom. It was stated that after speaking with the nurses that day it was verify that the child did not seek medical attention and there was never a confirmed case of chicken pox. The nurse's supervisor stated that she did not think it was chicken pox and instead Hand-foot-mouth disease. It was unknown if treatment was given for the events.  The nurse also reported that they had spoken to the state immunization advisor about this situation and that the advisor was not considering this to be a confirmed case of varicella as there was not Polymerase Chain Reaction (PCR) testing performed.   At the time of the report, the outcome of varicella, secondary transmission and hand-foot-and-mouth disease was unknown.  The causal relationship between the events and vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.   This is one of several cases from the same source.; Sender's Comments:  US-009507513-2112USA005506: US-009507513-2111USA006313:
2nd dose was given too early.  First dose given 5/25/21 and second dose 6/9/21
Patient received Flumist, H1N1 vaccine and Hep A vaccine at the same time. The adverse reaction began with stomach pains on Friday evening 1/15; Saturday afternoon 1/16 he had a severe cough, Sunday morning 1/17 he couldn't keep his balance, Monday morning 1/18 severe vomiting, admittance to hospital. While in hospital, he experienced a grand mal seizure. Patient currently has short term memory loss and cannot answer questions about before Friday evening, 1/15 (this information is from text messages to his mother).
Patient experienced immediate reaction following MMR with a large 23mmx30mm hive with redness about 60mm in length. She also complained of itching. Right afterwards she developed hives on her arms, chest, neck, and back. No breathing problems. Physician came back in room and Benadryl was administered. Observed for 20 minutes then allowed patient to leave.
This spontaneous report was received from a registered nurse refers to 9 months old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 06-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot # N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004061, 1806USA004062, 1806USA004063 and 1806USA004065).
Varivax given on 8/29/02. Chicken pox on 4/13/004.
pain, swelling, tenderness lt arm, fever, gen aching/malaise, h/a;
This is a spontaneous report received from a contactable pharmacist and consumer. A 67-year-old female patient received PREVNAR 13 (lot number: R28322, expiry date: 31Mar2018), intramuscular on 10Aug2017 at 0.5 ml, single and influenza vaccine (manufacturer unknown), via an unspecified route of administration on 10Aug2017 at 1 DF, single both for immunisation. Medical history included thyroid problem, Alzheimer's disease and memory issue. Concomitant medication included ongoing levothyroxine at 50 mcg once daily for thyroid problem which the patient has been taking for 3 years and ongoing memantine at 5 mg once daily for Alzheimer's disease and memory issues. On 10Aug2017, the patient reported that her arm was hurting and warm to touch. The patient got pneumococcal 13-val conj vac (dipht crm197 protein) and flu shot but on opposite arms and was saying that the pneumonia arm was hurting and warm to the touch. The patient was advised to take ibuprofen and was applying ice pack. The outcome of the event was not recovered at the time of report.
This spontaneous report was received from a medical assistant and refers to 2 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 14-JUL-2016, the patients were administered subcutaneously with a 0.5 ml dose of VARIVAX (lot # reported as L050561, expiration date: 14-DEC-2017) during the temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Five new patients along with 7 previously reported were administered expired doses of the Moderna COVID-19 vaccine on 09 November; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Five new patients along with 7 previously reported were administered expired doses of the Moderna COVID-19 vaccine on 09 November) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Five new patients along with 7 previously reported were administered expired doses of the Moderna COVID-19 vaccine on 09 November). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Five new patients along with 7 previously reported were administered expired doses of the Moderna COVID-19 vaccine on 09 November) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported It was reported that the 5 new patients received expired dose of Moderna vaccine on 09-Nov-2021. No treatment medications were reported