chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose with expiration of 26Aug2021 was given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose with expiration of 26Aug2021 was given) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Penicillin drug allergy).   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose with expiration of 26Aug2021 was given). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (dose with expiration of 26Aug2021 was given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 07-sep-2021included Race information , allergic condition ,height and weight,first and second dose information
This is a spontaneous report obtained from a contactable physician. A patient of an unspecified age, race and gender received meningococcal group B Rlp2086, single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced an intense migraine that recovered after 15 days.
Patient called health department on 3/29/22 to let us know about reaction she developed 25 hours after her booster shot. She notified her allergist Dr. At her December visit about it, and he told her to let us know that maybe it could have been a reaction but he was unsure. she did not call us until 3/29/22 to report. She stated that on 9/22 around 5pm she felt a tickle in her throat that caused SOB and coughing episodes couldn't catch her breath, she felt the tickle for about an hour. Immediately she took benadryl  and within in an hour it went away. She did not have any issues with first 2 vaccines.
patient experienced dizziness, lightheadedness approx 20 minutes after dosing.  VS WNL BP 100/70, HR 80.  Pt sat and drank water and put ice on her neck for approx 30 mintues
administered frozen dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31st March 2023) 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.   On 16th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's comment: The licensed practice nurse (LPN) reported having administered a frozen dose of Bexsero. The adverse event report contained all information provided by LPN at this time. The LPN gave consent for safety to follow up.  The reporter consented to follow up. Additional supportive information: The nurse administered a frozen dose of Bexsero, which led to incorrect storage of vaccine. This case has been linked to the case US2022081278, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081278:Same reporter
Tension in body; Brain fogg; Memory issues; Headache; COVID-19; COVID-19; This is a solicited report from a Non-Interventional Study based on information received by Pfizer.  Solicited report by a non-contactable 31-year-old male patient with events of non-serious COVID, tension in body, brain fogg, memory issues and headache with HUMIRA (adalimumab). PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Medical history and concomitant medications were not reported. On unspecified date, patient started to receive adalimumab (HUMIRA) subcutaneous, at unspecified dose, for moderate to severe adult Crohn's disease and ankylosing spondylitis. On 09Jul2021, patient received COVID-19 Vaccine (manufactured by Pfizer/biontech, lot number and expiration date were unknown) at the age of 31-years-old as dose 1, single, for COVID-19 immunization. On an unknown date in 2021, the patient experienced COVID. Patient showed a positive SARS-CoV-2 test on unspecified date in 2021.  In Jul2021, the patient experienced tension in body, brain fogg, memory issues and headache. In 2021, the tension in body, brain fogg, memory issues and headache were resolved. On an unknown date in 2021, COVID was resolved. Action taken with adalimumab was unknown.  Causality for Humira (ADALIMUMAB): The reporter's causality for the event COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of tension in body, brain fogg, memory issues and headache were not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN): The reporter's causality for the event COVID-19 was not reported, while for events muscle tension, foggy feeling in head, memory impaired, and headache was possible.  Change History: On 09Sep2021, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. The events of "tension in body", "brain fogg", "memory issues" and "headache" were added.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed upon receipt of follow-up information.   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.
Patient arrived on site at Hospital vaccine clinic and checked in to receive a second dose of Moderna vaccine; however, patient was directed to a Pfizer vaccination station. The RN screening the patient verbally confirmed that patient was there to receive second dose Pfizer; patient confirmed, but then the nurse was not able to find the patient on the schedule. The nurse went up to the registration desk to confirm if the patient was registered. During that time, the patient sat down at the vaccination station and another nurse came over and vaccinated the patient with Pfizer vaccine. In the meantime, it was discovered that the patient was actually to receive a second dose Moderna vaccine. No adverse effects experienced. Pharmacist and nurse reviewed error with patient. Patient notified that his vaccine course is considered complete after receiving the two separate mRNA vaccine doses.
A large red spot on her arm at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 73-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 18Oct2023, outcome "unknown", described as "A large red spot on her arm at the injection site". Therapeutic measures were not taken as a result of vaccination site erythema.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
1705, Immunization shot was given to minor participant. Participant had flu in the past no problems. He was advised to get the flu shot.
The patient got an annual Flucelvax Quad shot and a Moderna Bivalent Booster on 9-16-22.  He was fine on Friday and Saturday but was found unresponsive on Sunday, 9-18.  He was taken to the hospital and died later that day.
Tinnitus one approximately three days after vaccine. This symptom has not stopped since the vaccination administration as well as increased in severity.
Vaginal HSV-1 primary outbreak and left buttock Shingles outbreak with corresponding dermatome neuralgia
left forearm /  Area was swollen, red and hot / visible patch on left forearm; left forearm /  Area was swollen, red and hot / visible patch on left forearm; left forearm /  Area was swollen, red and hot / Right forearm was also hot and irritated; Right forearm was also hot and irritated; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. It was unknown if the patient was pregnant. The patient had allergy to chicken meat and buckwheat. Concomitant medications included montelukast sodium (SINGULAIR), taken for an unspecified indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. On 19Apr2021 at 09:00, 6 days post vaccination, the patient experienced delayed reaction on the left forearm, the area was swollen, red and hot. The right forearm was also hot and irritated but did not have a visible patch like left forearm. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left forearm area was swollen, red and hot with a visible patch and right forearm was hot and irritated were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SWOLLEN LIPS, different areas of lips at different times of occurrences. Lips will stay swollen for2-3 days at different degrees,reoccurrence  4-5 days from from last occurrence.Lips feel thick , firm to touch. I?ve taken an antihistamine , which decreases the swelling somewhat, but comes back.
Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy spells). At the time of the report, DIZZINESS (Dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.No treatment medications were reported.   This case was linked to MOD-2021-346572 (Patient Link).
Employee had aches,nausea, vomitting, fever of 100 starting approx 24 hrs later. Over course of next 3 weeks, sxs worsened, temp up to 102.9, and then hospitalized July 12-16 for fever, pain, neuralgia, possible encephalopathy. Continues on steroids and acyclovir.
SEPSIS; This spontaneous report received from a health care professional (nurse) via social media via a company representative concerned a male of an unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after vaccination the patient experienced sepsis 2 times. The reporter stated "After taking J and J my husband was septic 2 times. The second time he sided. I never took it I m a nurse didn't trust it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sepsis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221209844-Sepsis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
The evening after receiving the shots she began having chest pain, heart palpations, nausea, and headaches. Was brought to ER and admitted. Test were run and could not find any problems with pt. States still feeling bad with those symptoms.
Second covid-19 vaccine (Pfizer) on 6/1/21 Says about 5 minutes later he got a temporary electrical pain that radiated from the right scapula up into the right scalp  Also developed injection site pain, fever, chills, severe arthralgias within the first 24-48 hours Then on 6/4, developed right neck and scalp rash Burning, electrical pain and also some swelling Also on the right anterior neck area Some ear pain  No facial involvement  Diagnosed with Shingles June 7, 2021.
Following my second dose of the Moderna vaccine, my period came two weeks early and was super heavy - gushing. I was in the middle of a birth control pack and always have on-time regular periods. I have never experienced anything like this. My period lasted 11 days and it usually lasts 5.
My experience when I took the vaccine on 03/11, was that I felt fine. Six days later, I woke up and went into the bathroom and noticed a big lump near my elbow and under both of my armpits. I called my doctor and scheduled an appointment. She noticed that the lumps were soft. I had an ultrasound completed and blood work drawn. My doctor said that everything looked fine. A few days later I started experiencing fatigue and diarrhea for a few days. The doctor had me take Aleve to relieve some of the inflammation and pressure. It took three weeks to a month to feel better. I went back after three months and the swelling has gone down. It is not completely gone, but my doctor said that it may take 4-6 months to go away. I still take Aleve to help with the inflammation and the pain has gone down.
Cardiopulmonary arrest,  D-Dimer 55,000, TNKase administered, ACLS, needle thoracostomy, persistent PEA arrest, decompensated into asystole , pronounced
Had PE two weeks after covid 19 booster and 1 day after influenza (yearly) vaccine.
I received my second COVID-19 booster, which was from Moderna, on 4/14/2022. On about 6/3/2022, I was informed that one of my colleagues had tested positive for COVID-19. I did a home that day, and I got a positive result. On about 6/4/2022, I contacted a telehealth, and I was sent to a place to get a PCR, which ultimately also yielded a positive result. I was prescribed a 5-day course of Paxlovid. On the evening of 6/5/2022, I started to get a sore throat, fever, sweating, chills, body aches, nausea, and diarrhea. The symptoms continued and then they improved on 6/9/2022 or 6/10/2022. At one point, I thought I had gotten over it, but then I had a rebound around 7/4/2022. During my rebound, my symptoms were more focused in the sinuses. I also developed an ear infection, for which I took amoxicillin.  At the time of this writing, I'm mostly over it, though I have sniffles, a lingering cough and a ticklish sensation in the throat. It's possible that they're residual symptoms of COVID-19, but they could also possibly be due to allergies. In fact, I am due to see an allergist sometime soon.
headache; stomachache; cannot get out of bed; A spontaneous report  was received from a caregiver concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, stomachache, cannot get out of bed.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) headache, stomachache, cannot get out of bed.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, stomachache, cannot get out of bed was unknown.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and drug reactions and allergies were not provided. On 27-OCT-2017, the patient was vaccinated with an expired dose of PROQUAD, subcutaneously, for prophylaxis (lot # M017337, expiry date: 05-OCT-2017). Concomitant therapies included sterile diluent (MERCK) (lot # M045717, expiry date: 31-MAY-2019). No adverse effects were reported.
Patient developed rash on face with bumps along with rash on arms & legs within 2 minutes of receiving all 6 vaccines. Doctor evaluated patient was given ORAPRED and monitor for 45 mins in office.
stiff neck on same side as shot administered large welt at injection site achy muscles migraine headache
Weakness in arm; This case was reported by a physician via sales rep and described the occurrence of weakness of arms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weakness of arms. On an unknown date, the outcome of the weakness of arms was unknown.   It was unknown if the reporter considered the weakness of arms to be related to Shingrix.     Additional Information: GSK receipt date: 17-Aug-2022 Reporter's comments: The reporter was a GSK staff employee. During a population based decision maker meeting and during a discussion of Shingrix, one of the medical directors or consultants shared that patient had a reaction after first dose of Shingrix injection. The patient experienced weakness in arm.  The patient delayed the second injection of the 2 dose series in hopes that arm weakness would abated.  The medical directors or consultants did not pursue the line of questioning further since this was during a formal meeting with multiple attendees. The reporter agrees to follow up from GlaxoSmithKline.
Patient is a nursing home resident and was reportedly tested at nursing home prior to admission as there was an outbreak at nursing home.
HYPOXIC; LIGHT HEADED; HEAD FLOATING; ARMS AND LEGS FEEL LIKE CONCRETE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for the case. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced hypoxic, light headed, head floating, arms and legs feel like concrete, and nausea. Patient told that he was light headed and nauseous all day. The feeling was like he was on boat and hypoxic at the same time. Arms and legs felt like concrete. No treatment was needed. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the nausea, light headed, head floating, arms and legs feel like concrete and hypoxic was not reported.  This report was serious (Other Medically Important Condition).  Additional information was received on 25-MAR-2021. Following information was updated into the case: Due diligence updated, other identification numbers. Upon review, following corrections were performed in the case: Event onset date captured as 16-MAR-2021 for all the events. Vaccination date added in the tab and narrative. Reporter causality sentence removed from the narrative.; Sender's Comments: V1: Additional information  received in current version was regarding due diligence and other identification numbers. The following information was amended event onset date, vaccination date and narrative amended for reporter causality statement. This updated information received does not alter prior causality assessment of reported event. 20210333343-COVID-19 VACCINE AD26.COV2.S-hypoxic. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
our last booster was about 6 months ago, but we both had covid; our last booster was about 6 months ago, but we both had covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "our last booster was about 6 months ago, but we both had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Unknown result, notes: our last booster was about 6 months ago, but we both had covid in September.  Clinical course: Patient explained our last booster was about 6 months ago, but we both had covid in September.  When can we get our next booster, we're both high-risk..  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201233438 Same reporter/drug/event, different Patient;