chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & reports dull sharp pain @ inj site & rt eye pulsation;time to onset & duration sx not reported;pt was reported to have had blood test & EKG but findings not stated;pt taking zantac;
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 16 days post expiry) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A and 011J20A) for COVID-19 immunization. No medical history reported. On Dec 29, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 22, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 22, 2021, patient administered expired product (vaccine given 16 days post expiry). On Nov 22, 2021, administered expired product (vaccine given 16 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-395985 (patient link).
Numbness and tingling in fingers and toes, tingling in mouth and mouth feeling hot, itching on trunk
No adverse event; PRODUCT STORAGE ERROR; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 mL (dose, route of administration, anatomical location not provided) as prophylaxis, which reported to had been under temperature excursion (product storage error) on 18-DEC-2020 (lot # T022294, expiration date: 26-MAR-2022, and lot # T032003, expiration date: 08-MAY-2022, both stablished as valid; and lot # T02003, expiration date: 08-MAY-2022) as recorded by data logger. In addition, it was reported that the temperature and time frame for the vaccine was below 2°C (1.3C) for 0 hours 24 minutes, with previous temperature excursion below 2°C (1.6C) for 24 minutes.   Lot number T02003 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). Lot number T02003 does not match any company product as confirmed by Lot verification team. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
One hour after flu shot given developed burning in throat, reacted to BA did not report until 12/21/2000. 11/19/2001 came for flu shot, states tongue also swelled, difficulty after flu shot 12/2000. no flu shot give 11/2001.
At approximately 750 pm client received 3 vaccines.  Within 1 minute of administering MMR, client developed a dime size wheal with redness about one inch from injection site.  Ice was applied to area.  Clinic supervisor notified and doctor called.  At approximately 8 pm, client was fidgety, upset and crying, which continued for 10 minutes at 810 pm client began complaining of itching at right thigh area where DTaP had been given.  A small wheal (about 1/8 ") with redness noticed.  No reaction observed at IVP site.  At that time parents advised to take client to hospital emergency room and agreed to go to hospital.  Clinic supervisor contacted emergency room of impending arrival.  835 pm client's father phoned verifying emergency room arrival.  8/29/06 Telephone call to mother of client who stated client was in the emergency room for 1 1/2 hours after receiving BENADRYL liquid.  The doctor believes the incident was a local reaction to the vaccines and that BENADRYL by mouth for two days should be administered in the future before any vaccines are given.  The wheals and redness on left arm disappeared at the injection site by the time the family left to the emergency room and the child rested comfortably at home during the night. (next vaccines due 2012).  8/30/06 Phone call for additional information to complete report.  Mom states injection site of DTaP right leg still raised and red so she called the pediatrician who advised continued use of BENADRYL and an office visit if conditions worsens.  Child playful otherwise.
headache since shot Left arm soreness from fingertips to shoulder. Mainly sore in the elbow. Pain when lifting things with the left arm. Soreness in hips. Numbness in lower lips on and off
cold and clammy; is not energetic like normal; she is feeling a little bit anxious and she feels like her strength is not yet fully recovered.; she is feeling a little bit anxious and she feels like her strength is not yet fully recovered.; passed out; Vomiting; tired; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 04May2021 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was administered as first dose on 12Apr2021. Patient was not ill at the time of vaccination. The patient medical history and concomitant medications were not reported. She says well the first one is just the start, where it has the first dose. She clarifies she received the product so that her husband would be safe since he had his vaccine she figured she would get it too. He has a lot of health issues so she figured she should get it, now she wishes she had not but it is okay. She confirms for COVID 19 prevention. She says she takes no medications other than just Tylenol if she has a headache. On 05May2021 patient experienced passed out at 08:30AM, vomiting at 01:00 and tired. She would say the vomiting stopped at 5 am on 05May2021. This started 05May2021 for sure. The tiredness is ongoing, because last night she went to bed at 7, she is not doing half of what she used to do. It is awkward she does not know what else to blame but the vaccine. She is not energetic like normal, she is a healthy person. The tiredness has improved but she still has it. Also experienced cold and clammy, is not energetic like normal, she is feeling a little bit anxious and she feels like her strength is not yet fully recovered (anxiety and asthenia) on an unspecified date. Time the Vaccination Was Given as her appointment was at 10 so it was within 20 minutes. She would say it was 10:20 AM or so and then she had to wait 15 minutes. Her husband, when she came to, he wanted to call the paramedics she said no, she was fine. He called the Paramedics and they took vitals, they checked blood sugar, checked oxygen, EKG, blood pressure, O2 and everything was okay, all her vital signs were okay. They wanted to take her to the ER but since her vitals were okay she did not want to go into the ER with all the sick people so she had to sign a waver and they told her to follow up with her doctor. She is feeling better than how was but she doesn't feel that she is at 100 percent and she is a healthy person she didn't even want to get the vaccine. The outcome of the event fatigue was recovering and all the other events was unknown.   Follow-up (19May2021): This is a spontaneous report from a Pfizer-sponsored program. A 63-year-old female consumer (patient) reported that, added with event onset date and time.
RED RASH, CHILLS, HEADACHE, ACHEY MUSCLES ALL OVER BODY, ARM VERY SORE AND COULDN'T HOLD BLADDER. THIS HAS SINCE RESOLVED EXCEPT FOR THE RED RASH.
This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 22-year-old male patient who received BEXSERO. On 27th July 2016, the patient received the 1st dose of BEXSERO. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site induration, injection site redness, injection site swelling, injection site warmth and injection site bruising. On an unknown date, the outcome of the injection site induration, injection site redness, injection site swelling, injection site warmth and injection site bruising were recovering/resolving. It was unknown if the reporter considered the injection site induration, injection site redness, injection site swelling, injection site warmth and injection site bruising to be related to BEXSERO. Additional details were provided as follows: On 27th July 2016 (Wednesday), around noon, the patient received the 1st dose of BEXERO and showed his arm to his mother on Friday. The patient experienced injection site reactions in the arm where he received a dose of BEXSERO. The patient had an induration with a large red swollen area the looked like bull's eye. It was also hot to touch. The patient's mother noted a bruise in the area. The reporter stated that, she measured the size of reaction and from top to bottom it was 2 inches and across it was 2.5 to 3 inches. As of 1st August 2016, the events were improved but had not gone away.
The patient  received one dose of the Covid-19 Moderna vaccine at a mass vaccination event on 2/5/21.  The error was discovered on 3/1/2021 when the patients mother was trying to schedule her sons second dose.  A telemedicine visit was scheduled with mother and Moderna was consulted.  We explained to mother what had happened, and based on the recommendations from Moderna he should not proceed to the second dose.  Other than arm soreness at the injection site that lasted one day the patient did not have any other adverse effects or complications.
EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, stomach problem, penicillin allergy, aspirin allergy, allergies to alcohol, no alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on upper left arm, on 09-APR-2021 for covid-19 prophylaxis. for covid-19 prophylaxis. On an unspecified date following vaccination with covid-19 vaccine ad26. cov2.s, the patient experienced extreme tiredness (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 total, administered on upper left arm, on 05-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 68 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced extreme tiredness (dose number in series 2), and related that to may be being diabetic. The consumer first described the side effect as a little bit tired but then describe it as extreme tiredness. No fever, no pain just tired the patient was very pleased that she can handle that and was still functioning. The patient added that she and her mother who was around 90 years old took the vaccine and her mother did not have any side effect or pain. The patient also reported that, her husband, kids, and grandkids all got the Janssen vaccine and had no side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme tiredness was not reported. This report was non-serious. This case, involving the same patient is linked to 20220913642. This case, from the same reporter is linked to 20220911986.
9:40am:Client first reported dizziness, light-headedness, nausea and shaky , 12 minutes after administration, Vital signs taken.  9:43am client felt "tight in chest", 911 called,  and client used her Ventolin inhaler. 9:45am  0.5ml of 1:1000Aq Epinephrine administered at 9:45am in left thigh. 9:55am 0xygen 6 lpm per nasal cannula started. 10:05am paramedic arrived, administered IV Benadryl and transported to hospital at 10:20am.
3/14/09 Diagnosis of chickenpox Received VARICELLA vaccine 3/1/02.  Sibling had chickenpox - 2 wks prior had not received VARICELLA vaccine
Information has been received from a physician concerning a 12 year old 104 lb. 55 in. female who on 03-Oct-1996 at the age of 12 months, was vaccinated with the VARIVAX (Oka/Merck). On 29-Feb-2008, the patient developed breakthrough chicken pox after vaccination of approximately 50 lesions. There were no revenlant diagnostic and or laboratory studies performed. In March 2008 (day unspecified), the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
Fever, sever chills for 2 hours, sustained heart rate around 90~100 for more than 4 hours, intermittent headaches 24 hours, mild confusion for 4 hours,  loss of appetite for 48 hours
Thought I had vertigo from 2/17/21 - 7/20/21.  Went to the urgent care, but they sent me to the ER.  ER doctor ordered a CT, it was not vertigo, I had two strokes, one on left side, other pons.
10/19/09 Blurred vision 30 min after receiving influenza vaccine. Also mild nausea.
Local pain at injection site: Left deltoid. Pain with movement of left shoulder. No pruritis, swelling, or redness. Minimal tenderness
Pt started having headaches, nausea/vomiting, diarrhea, and very bad stomach cramps in the middle of the night after taking vaccine the previous day.
It started with a sorr arm and fatigue. The problem began after I was lying down in bed for 1 hr and 1/2. I laid down at 3:30am, but at 5am I was still awake and my left arm felt like it had fallen asleep. The problem was, I could not seem to wake it up. When I turned on my flashlight, I found that nearly all of the veins in my left hand were invisible, actually everything past the elbow on that side. I tried for about 10 mins while lying down to get blood flow back, but nothing was working. My face.felt very warm and the rest of my body felt very cold. When I finally got up to turn on my bedroom light, I found that all of my veins from my chest down were almost entirely invisible as well. I normally have very visible and easy to get blood from veins (except sometimes in my right arm), so this was very worrying to me. I got up and paced a little around my room to try and get blood flowing again, and I felt pretty shaky while doing this. My hands and feet would shake when I held them up. After about 5 minutes, I sat down on my bed because I did not feel well standing anymore, and I waited. Maybe 10 minutes later and things seem to be returning back to normal. I am still very tired but my whole body seems to have blood again. I am also currently on day 3 of my monthly cycle, but this has never happened in relation to that either.
Developed a 2 inch raised redness at injection site with a white center and then developed 3-4 inch sized painful lumps under skin in the forearm of the same arm vaccine was given- was seen 10/22 with left arm swelling most significant over inj site 4-5 cm milder swelling of forearm into left hand with 2 small wheals just distal to inj site. Painful to abduct arm and supinate.
accidentally administered expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022 with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2022SA417918(CLUSTER), 2022SA419905(CLUSTER) and 2022SA419905(CLUSTER).  This case involves an unknown age female patient who accidentally received last year's expired dose of fluzone high dose with no reported adverse event. (Influenza quadrival A-B high dose HV vaccine) [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s) and family history were not provided.   On 06-Oct-2022, the patient accidentally received last year's expired dose of influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (0.7 ml 1X)(lot number: UJ748AA; expiry date : 30-Jun-2022: strength, formulation unknown) via unknown route in left deltoid for immunization, with no reported adverse event (expired product administered) (latency : same day).  It was reported Pharmacist reporting that 3 patients accidentally received last year's expired dose of FLUZONE HIGH DOSE and requesting revaccination recommendations regarding dosing and timing of administration. A nurse practitioner (same as prescriber) accidentally administered 3 expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022. The pharmacist identified the administration of expired products today, 10OCT2022, stating that she did not know "why last year's formulation was in the fridge." Pharmacist inquired what the recommendations are for the timing and need for revaccination with current FLUZONE HIGH DOSE QIV. SRDs emailed to requestor. Pharmacist denied any untoward effects from the administration of the expired vaccines at this time and advised that the patients would be revaccinated with current FLUZONE HIGH DOSE QIV    Action taken with was not applicable.  At time of reporting, the outcome was Unknown for the 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.
heterotopic ossification; hunch back; This spontaneous case was reported by a consumer and describes the occurrence of PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shoulder operation NOS (shoulder) in March 2021.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) (seriousness criterion medically significant) and KYPHOSIS (hunch back). At the time of the report, PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) and KYPHOSIS (hunch back) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: Although a temporal; association exist, based on the information provided, it is unlikely that the reported event is associated with the administration of mRNA-1273 . subject is of an advanced age and event usually occur after spinal cord injury.; Sender's Comments: Although a temporal; association exist, based on the information provided, it is unlikely that the reported event is associated with the administration of mRNA-1273 . subject is of an advanced age and event usually occur after spinal cord injury
Shortly after receiving vaccine, experienced soreness at injection site.  Soreness continued to spread, encompassing area from shoulder to elbow.  Soreness lasted approximately 24 hours. No medications or treatments administered.
arm soreness; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness. It was reported that the event took place after use of the product. Outcome of the event was unknown.           No follow-up attempts are possible; information about lot/batch number cannot be obtained.
04/03/2006 child received MMR, DTAP, IPB in AM, child went home (also took one dose Amoxicillin by mouth), child woke up after a nap with swollen right upper lip, itchy rash on face, arms, chest.  Prescribed Decadron, epinephrine, and Benadryl.
Pt recvd 1st dose of Hep B vax 28JUL89 & later exp facial flushing,dizziness,lightheadedness,nausea & fatigue.Sx remitted spontaneously.
fever 102, rash mac pap x 4 days + cough, conjunctivitis, coryza, photophobia, h/a, joint pain, severe spinal pain, dry throat, discolored tongue,loss of appetite, lethargic, muscle spasms;being w/u for severe MMR rxn vs wild measles
patient received two doses of ADACEL two weeks apart with no adverse event; Initial information was received on 09-Feb-2022 regarding an unsolicited valid non-serious case from a other health professional via call center.  This case involves a 12 years old male patient who received two doses of adacel two weeks apart with no adverse event while receiving vaccine Diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine inact split 4v (Fluzone quadrivalent) and althaea officinalis root, cinnamomum camphora essential oil, citrus aurantium oil, eucalyptus globulus leaf essential oil, mentha x piperita essential oil (Gardisil).  On 12-JAN-2022, the patient received a first dose of suspect Diphtheria-2/tetanus/5 ac pertussis vaccine (strength, formulation, dose and frequency: unknown) (batch number: U6767AA, expiry date: unknown)  via intramuscular route in unknown administration site. On 26-Jan-2022, the patient received second dose of vaccine (strength, formulation, dose, batch number and expiry date: unknown) via intramuscular route in unknown administration site for immunization.  On 26-JAN-2022, the patient had received two doses of adacel two weeks apart with no adverse event (inappropriate schedule of product administration) (latency: 14 days) following the administration of Diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event patient received two doses of adacel two weeks apart with no adverse event.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L019298, expiry date: 22-JUN-2017; lot # M011838, expiry date: 09-AUG-2018 (incorrect product storage). Medical assistant reported that the vaccine underwent temperature excursion at 63.5 F for 36 hours. The vaccine was exposed to a temperature of 50 F for 12 hours previously as well. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.