chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IMOVAX was administered to a patient/vaccine was out of its expiration date for 1 day, with no reported adverse event; Initial information was received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 60 years old female patient was received rabies (hdc) vaccine [Imovax rabies] and the vaccine was out of its expiration date for 1 day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 21-Jul-2023, the patient received a dose of suspect rabies (hdc) vaccine Powder and solvent for suspension for injection (strength: standard) at dose of 1 ml total once (lot number: U1D222M) vaccine was out of its expiration date for 1 day (expiration date: 20-Jul-2023) via unknown route in the right upper arm 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 imovax was administered to a patient/vaccine was out of its expiration date for 1 day, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the  authorization holder's compliance with the requirements set out in the guidelines. 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 authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
patient reports that on 9/13/2019 after the office visit she began a rash, described as erythematous, inflamed and itchy. with associated symptoms of headache, painful rash, pruritus, dizziness and vision changes.
tinnitus on the left side; felt swollen on the left side of her face; gives me anxiety; my ear clogged and swell up; my ear clogged and swell up; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported; Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, she was calling to report some side effects that she had from the first dose of the Pfizer vaccine. She was scheduled for second dose on this coming Saturday, but she was hesitant to go. It only gives her anxiety that's how bad the reaction was. Almost immediately after receiving the vaccine her ear clogged and swell up. She has tinnitus on the left side and it started within an hour after the vaccine and it's been like that for 3 weeks. She spoke to three different doctor they keep saying it's not associated with the vaccine. She don't know why everyone keep denying it. She felt helpless. She know tinnitus was correlated with vaccine. She follow a group on social media which was called tinnitus from the vaccine. There's 500 people on the page who have reported this side effects. She got a bad tinnitus from the vaccine. The doctor just gave me anxiety pills and didn't do anything else. The patient also felt swollen on the left side of her face, it was the same side she got her shot in. The caller is almost 100% sure this was from the vaccine because she has never had tinnitus before in her life. The caller doesn't know what to do and she didn't know if this was reported from other patients. Response received form medical information team, stating that however these may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine was still being studied in clinical trials. You should always talk with a vaccination provider, doctor, or other qualified health care professional about whether a specific treatment. They were in the best position to advise you about the suitability of a particular treatment as they have access to the details of your medical history, as well as to information on all medical products. The outcome of events was unknown at the time of reporting. The relatedness for the event of tinnitus on the left side was related with Covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Complete arm pain for 2 days, nausea on day 3, asthma attack multiple times after day 6
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Warm Transferred from Moderna Customer Care Case No.00135704. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine.  No concomitant medications were provided.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 003B21A)  with no associated adverse events.
stomach pains; diarrhea; bloatedness; tiredness; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Feb2021 at 15:00 at single dose in left arm for COVID-19 immunisation at the age of 51-year-old. Medical history included Penicillin allergies. Concomitant medications included atorvastatin (LIPITOR), melatonin. On 03Mar2021 at 15:00, the patient experienced stomach pains, diarrhea, bloatedness, tiredness. They lasted for two weeks and the doctors said there was no way this could be coming from the vaccine. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Light chills started at approximately 7:00 PM 18Oct2021. By 8:45 PM chills were bone deep and despite laying in bed with 4 blankets and a heating pad chills persisted with uncontrollable body shakes. By 10:00 PM I had got up and went to sit in a 104°F hot tub to ease the body shakes that were becoming painful. I sat in that for 20 minutes with minimal relief. I layer in bed from 10:30-11:00 PM shaking and eventually feel asleep. On 19Oct2021 I woke up at my typical 4 AM with shooting back pains upon sitting up. When I got up I was still lightly chilled but not violently shaking. I made my way to the kitchen after slowly sitting up and halfway there my vision began to black out and my head became super light. I sat on the floor for 3 minutes or so and then crawled back into my bedroom. I slept until 7:00 AM and once I woke I was greeted by another shooting back pain. I chugged the 20 Oz. Glass of water next to my bed and went back to sleep. I woke up again at 8:00 AM with a headache on a 8/10 scale. I went to the kitchen for Tylenol but again nearly passed out. I managed to get the Tylenol but had to sit on the floor again and crawl back to my bed. I laid back down again and woke up around 9:30 AM. My entire bed was drenched from sweat. I never sweat. Not even at the gym unless it's an unusually rough cardio day. I sat up and noticed a slight ping of pain on the left side of my chest. 5/10 scale. By this point all shakes were gone but the headache was still there and I was still actively sweating. I got up from bed to try and shower but I just had absolutely no energy. I made it to the kitchen and only felt slightly faint, got another round of Tylenol, grabbed 4 bottles of water, and went back to my bed. I stayed in bed until 12:00 PM and was eventually able to get up without any chest pain or a headache. I was able to walk about the house a bit but could not bend over else I would feel faint or a headache would start. Lastly, I have extremely regular bowel movements and my typical 6 AM movement never came today and I was nauseous through the whole day in various spurts. It is now 9:00 PM and the only issue is the lack of bowel movement, slight nausea, and an inability to bend over.
tremors in her left shoulder and left arm.; laughing uncontrollably; her muscle got twitching; her left hand is shaking and little bit of tremors in the fingers; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "tremors in her left shoulder and left arm."; MOOD ALTERED (non-serious), outcome "unknown", described as "laughing uncontrollably"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "her muscle got twitching"; TREMOR (non-serious), outcome "unknown", described as "her left hand is shaking and little bit of tremors in the fingers".  Additional Information: Reporter stated, the patient 15 min after she received the dose, she began having tremors in her left shoulder and left arm little bit in the left-hand fingers. She was also laughing uncontrollably. This was the patient's 1st Pfizer vaccine dose and she received it about one hour ago. What treatment recommendations or suggestions do you have? Response: Spoke to the HCP from the attached document. Encouraged him to use his best clinical judgement. NDC number of COVID-19 Vaccine: Unknown. UPC number of COVID-19 Vaccine: Unknown. Reason for no lot number: of COVID-19 Vaccine: Caller unwilling to complete the report. Expiry Date of COVID-19 Vaccine: Unknown. Reporter stated Alright, after the Vaccine her muscle got twitching her left hand that's where I gave her the shot in her left hand and her left hand is shaking and little bit of tremors in the fingers. So just wanted to report that you know so want to see if you had any suggestions or if you guys had any reporter who reported that or is that one of the side effects from the vaccine. Reporter was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM. When requested for probing, Reporter stated I would like to first speak to them. I have a patient here and I just want some advice and some guidelines first so we can take over the patient here. So I would have to call you back or I am not sure if I am able to call you back or not but we can do that a little bit later. But I do need to speak to somebody regarding this part. Further probing could not be done as reporter don't want to share further information. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Seen 10/20/10 at 1500 for well check h/o abdominal pain and dysmenorrhea. Back pain started with spasms that eve of body. Right arm & neck painful. Seen 10/21 office & 10/22 ER. Rx FLEXERIL, Rx IV Fluids.
report advesre reaction after she received her first moderna dose at 02/15/2021 at 1540. patient reported that she developed the next day (02/16/2021) arm redness swelling, warmth, itching. and headache. patient reported that she have no allergies. patient reported that she developed a reaction(headache) to shingrex that took her months to get over it. patient reported that she takes crestor for high cholesterol and omeprazole for ulcers. patient was instructed to apply cold compress to help with the arm redness, swelling, itching, and to take tylenol to help with the headache. patient was also instructed to monitor her symptoms and to seek medical attention if the symptoms got worse. called to discuss the adverse reaction and my recommendation
Within a week after both shots I suffered debilitating, crippling lower back pain. I could barely walk or move and was in constant severe pain. After the first shot I didn't realize the vaccine was the cause, I thought I had just injured my back. I made multiple trips to my chiropractor to see what the issue was, and not surprisingly he couldn't find anything mechanically wrong. It wasn't until after the second shot when I was on my way to the ER due to a resurgence in the lower back pain that I made the connection to the vaccine. Both shots I received on a Monday, and both times on Friday I was in severe pain. They gave me a shot of a steroid and something for the pain at the ER, but that didn't really do anything to ease the pain so a few days later I visited my family doctor. He diagnosed it as severe spasms due to my immune response to the vaccine and placed me on  Prednisone, which I took for about a month or so. That seemed to ease the pain so I could at least get around and be mobile.
On 5/2/2021, I noticed a firm lump with bruising on the inner aspect of my left lower leg during the afternoon  and I had not had any injury.  The next day, 5/3/2021, my left leg began to swell and feel warm to the touch.  Later in the day of 5/3/2021, my right lower leg began to swell, become red, and warm to the touch.  I developed 2 plus pitting edema to both lower legs  and more areas of firm lumps (4 of them).  It hurt to walk.  I contacted my physician and scheduled an appointment with her for 5/4/2021.  At this time, both lower legs were pink, warm, 2 plus pitting edema and very painful to walk.   My doctor saw me on 5/4/2021 and stated that it may be an adverse reaction to the Covid vaccine and that she could not find any other cause for these sudden symptoms.  She prescribed an antibiotic for me only.  The next day, I saw my nurse practitioner for a routine OB/gyne appointment and explained the situation to her.  She ordered a stat ultrasound of the legs to check for blood clots.  The ultrasound was negative.  A few days later I contacted my doctor to see if she was going to report this issue to VAERS and she said that she was not since she was not entirely sure that it was due to the Covid vaccine though she did not have any other explanation for the symptoms.  My symptoms went away gradually over the next 10 days.
pt started crying w/in hr of DTP vax; t103.5; pt given APAP; pt cont to be irritable; Pt seen by MD had OM; pt cont to be feverish, irritable & had a bad cough; vomit, turn red, hearing loss, lethargic, swollen, red, tender inject site;
Elevated WBCs; High Fever; Initial Report Received on 27-Oct-2022  This is a spontaneous report, received from a pharmacist regarding a male patient, aged 26 years, who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On 20-Apr-2022, dose 1 of HEPLISAV B (Lot #935840, expiration date 11-Sep-2022, NDC #43528-003-05), route not specified, was administered in the right arm for hepatitis B immunization.   On an unspecified date, a few days after having been vaccinated with HEPLISAV B, the patient went to urgent care with a high fever and elevated WBCs. The patient was given an antibiotic (name unknown), followed up with an ER visit 4-5 days post injection, and tested negative for COVID-19.  The physician instructed the patient not to get second dose.  No further information was available at the time of the report.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Pain at the injection site / only symptom that persisted; Fatigue / taking a nap at the 4 hour; Chills; Headache; This case was reported by a consumer and described the occurrence of injection site pain in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB27AA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) (batch number U68788BB ?, expiry date unknown) for prophylaxis.   On 3rd February 2021, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo). On 3rd February 2021, 3 hrs 30 min after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo), the patient experienced injection site pain, fatigue, chills and headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the fatigue, chills and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, chills and headache to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Meningococcal ACWY Vaccine (potential Menveo).   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the patient's parent. The reporter reported an adverse reaction, the patient experienced after receiving the 1st dose of Bexsero and MCV4 shot on the day of reporting. Approximately 3.5 hours after the receiving the vaccine, the patient started to experience the symptoms of fatigue, pain at the injection site and headache. The patient took 2 Advil (200mg ea) right before taking the nap at the 4 hours. The patient woke up 45 minutes later feeling better. The only symptoms that persisted was the pain at the injection site. The reporter plead to let her/ him know if there was any further action that they need to take. The information regarding consent to follow up was not reported.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L027719 and expiration date 28-APR-2017, lot # L044476 and expiration date 07-SEP-2017, orally, exact doses were not reported). No adverse effects were reported. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
MODERNA COVID VACCINE #3 GIVEN 8/19/21, LOT # 053E21A; pt was admitted to hospital and found to be positive for COVID; treated with decadron, remdesivir, O2 supplementation; increased hypoxemia requiring BiPAP at 100%; progressive hypotension renal azotemia; decreasing condition; family decided to transition pt to comfort care and she passed away in the hospital
4 weeks and 5 days after vaccination the patient presented with an acute ischemic infarct. The connection seems unlikely, but we felt ethically obligated to report it.
Participant completed a report before but new diagnoses have developed listed below are the dates and medications  2020. Jan 10, I was diagnosed with Fibromyalgia. Zolf to Savella. April 14, Diagnosed with inflammatory arthritis, hydroxychloroquine. May 19, Heart condition, metoprolol.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech Dose Number: 3 ; Moderna Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 09Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm and on 03Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Apr2022, outcome "unknown", described as "Pfizer / BioNTech Dose Number: 3 ; Moderna Dose Number: 4"; 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
Large, red, raised hives, covering entire body the day after flu shot and has continued for 8 days so far. Treated with Benadryl as recommended by clinic
This spontaneous report was received from a medical assistant, refers to an unspecified patients. No pertinent medical history was reported. Since 12-SEP-2014, an unspecified number of patients have been administered ROTATEQ (dose, frequency, route were not reported), all of which underwent supported temperature excursions. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Fever began around 3PM on August 24th. On August 25th around 8AM the patient had a seizure, turned blue, and vomited. He was transported by ambulance to the pediatric emergency room.