chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a healthcare worker regarding a female patient. On an unknown date, at age 26 years and 4 months, the patient was vaccinated with her first dose of GARDASIL (dosage and route of administration not provided). She received the second dose of GARDASIL at 27 years old. No adverse effects reported. Additional information has been requested.
No additional AEs were reported; patient received less than the recommended dose of VAQTA.  An adult received a pediatric dose of VAQTA on 3/1/2022.   No additional AEs were reported, no further information provided.; An adult received a pediatric dose of VAQTA on 3/1/2022.; This spontaneous report, received from an HCP, refers to a 40-year-old female patient. The patient's concurrent conditions included neck pain, migraine, fibromyalgia, and general symptoms. Concomitant therapies and medical history were not reported.  On 01-MAR-2022, a medication error occurred in the dispensing process; the patient was vaccinated, by a trained healthcare professional, with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliters/one time, lot #U003450, expiration date: 02-MAY-2022, administered intramuscularly in the left arm for prophylaxis, with hepatitis b vaccine (HEPATITIS-B), lot #4345R, expiration date: 11-AUG-2023, administered intramuscularly (strenght, formulation, and indication were not provided); and coronavirus disease vaccine 2019 (COVID-19), lot #FK9894, expiration date: 30-Apr-2022 (strenght, formulation, route of administration, and indication were not provided). It was stated that the vaccine was not used in accordance with the instruction leaflet. The vaccine was not available for return or evaluation as it had been administered. The vaccination error was reported to the physician and manufacturer. No other adverse events were reported.
Patient called the pharmacy complaining of swelling inside of mouth, having spicy feeling, red in apperance.  It's not painful but uncomfortable according to the patient, can still taste, chew or eat normally.  No ulcer or bleeding.  Recommended the patient to start Benadryl right away at night to avoid drowsiness.
Patient a few minutes immediately felt uneasy after injection. States immediately felt dizzy, said pain down her spine and nerves. There was no issues of breathing, no injection site reaction.
required second dose, first was given on Mar 2nd 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd March 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. 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 Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: The pharmacist reported that a male patient required the second dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Myocarditis- within minutes  10-15 of being vaccinated: severe pain in the middle of my chest, pain in my right arm and a tightness, severe pain in the back of my neck, light headed, feeling sick. Nurse came in and ask me to move around and the intense pain went away after a few minutes are following her instructions. After months I am Continuing to have an unusual heart rhythm. And fast beats. Primary doctor sent me to cardiologist and cardiologist recommended electrophysiologist.
Pfizer-BioNTech COVID-19 ? Vaccine EUA. 2 weeks after vaccinated, first started with red itchy ears, then an actue skin rash developed all over body in about 3 days. Many small itchy red bumps developed over body, started from neck and spread all the way down.  3 days of Steroids, benadryl and anti itchy cream were prescribed by urgent care and  Dermatologist doctor.
Awoke morning after vaccine administered (7:00AM)with severe weakness, progressed to include fast heart beat and dizziness one hour later.  Symptoms lasted approximately 8 hours.  Did not seek medical treatment, as was unsure if it was truly a reaction to the vaccine. Did not report event, as patient works in the same public health department where vaccine administered, as an RN.
fatigue; arm soreness; injection site soreness in the arm soreness; 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 67-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FH8020) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot: EN6204), administration date: 18Mar2021, for Covid-19 immunization, reaction(s): "fatigue", "arm soreness", "injection site soreness in the arm soreness"; BNT162b2 (DOSE 2, SINGLE, lot: EN6204), administration date: 08Apr2021, for Covid-19 immunization, reaction(s): "fatigue", "injection site soreness in the arm soreness", "injection site soreness in the arm soreness". The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness in the arm soreness".  Additional information: Caller wanted to know if the Pfizer COVID-19 Bivalent Vaccine meant the vaccine was wearing off, the shelf life for the Pfizer COVID-19 Bivalent Vaccine, if there was safety information for the Pfizer COVID-19 Bivalent Vaccine administered after its beyond use date, if the side effects he experienced with the Pfizer COVID-19 Bivalent Vaccine meant the vaccine was working and if the Pfizer COVID-19 Bivalent Vaccine is different from the Monovalent. Per agent, caller got 4 covid vaccines, primary dose, 2 boosters, and bivalent booster, all of them from Pfizer. He mentioned that he usually felt fatigue and arm soreness for a while. He wanted to know if someone else has experienced this for this long and what to do to feel better. If there was a difference in the formulation that could have caused this. He also mentioned that he didn't have any COVID-19 symptoms, but that if one could get the vaccine with a previous infection of COVID-19 in case he had the infection without being aware. He also wanted to know why sometimes the expiry was placed as 6 months and other times as 10 weeks, given that his vaccine expires on 14May2023. He also wanted to know if his side effects meant that the vaccine was working and if the fact that we're constantly needing boosters means that the vaccine is wearing off. Typically, with the other injections, a few hours later, he started feeling fatigue and then later in the evening injection site soreness in the arm soreness. He had previously taken his original Pfizer Covid vaccinations when they first came out. He got the first two vaccines 2 weeks apart. Then, in 6-8 months he got his first booster. Then, 6-8 months later her got a second booster.  He had relatively the same side effects for those. His side effects were common and expected. They all cleared up by the following evening by the most part.  Sender's Comments: Linked Report(s): US-PFIZER INC-202300163844 same patient/event, different vaccine dose.
previous Moderna doses she felt arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (previous Moderna doses she felt arm sore) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (previous Moderna doses she felt arm sore). At the time of the report, PAIN IN EXTREMITY (previous Moderna doses she felt arm sore) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The patient felt arm sore for maybe a few days with previous Moderna doses, but with this new one, didn't feel anything at all, absolutely nothing and patient was also wanted to know, if it is possible that maybe the vaccination provider administered the vaccine wrong and maybe then the vaccine was not working.   This case was linked to US-MODERNATX, INC.-MOD-2023-746617 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746617:Same patient, different dose
Left Shoulder pain that started as ?oh I slept funny? to not going away with ice/heat or rest. Worsening in severity daily and spreading towards base of skull and eventually into clavicle. The pain became excruciating and I was unable to turn my head at all to the left. So bad I had to use my hands to lift my head up. I eventually went to the ED on 12/27/20. And overnight the pain became so unbareable and functionality so limited I couldn?t go to work or take care of my toddler. I returned the to ED on 12/28/20. Was advised to file adverse event and contact my employee health and safety department. I was initially examined in the ER the first time with a neck spasm. Sent home with an RX which didn?t work. At all. When I returned to the ER th next day, the physician felt my entire neck, shoulder and clavicle an noted swelling and prominent spasm. He diagnosed with a trapezius strain and a vaccine reaction. Gave me an RX for Valium which seems to help take the edge off.
Body aches (neck and shoulders), nausea, chills, headache, exhaustion (started at 1700 on February 17, 2021 and progressed through February 18, 2021).  As of February 19, 2021, a mild headache and sore neck and shoulders resolved and the other symptoms resolved prior.
Erythema multiforme fever > 103 degrees developed 48 hrs. post vaccination.
acute onset numbness/abnormal sensation/heaviness in  left cheek to left oral commissure (distribution in the maxillary branch of trigeminal n.)  & left forearm, predominantly sensory but possibly mild motor component/weakness, 8 hrs after left deltoid vaccination.  Symptoms persisted moderate level for ~ 5 min, then mild for ~ 30-45 min then resolved.  Also, mild left sided headache  15 hours after vaccination that persisted for ~ 10 - 15 min.
I had an autoimmune reaction following the Moderna vaccine.   One of the most significant symptoms were significantly elevated liver enzymes.  These started showing up in labs 6 weeks after my vaccine, continued to increase for about a month, and then gradually subsided over the next several months.   My doctor believes that the MRNA triggered my autoimmune disease which triggered antibodies to target my liver causing autoimmune hepatitis.  I also experienced  all of the following during the same time period: -elevated ANA screen IFA, ANA pattern & ANA Titer -positive for cryoglobulins -reactivation of EBV and CMV -heart palpitations for about a month whenever I would lie down
LITTLE COLD; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced little cold. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, headache and little cold was not reported. This report was non-serious.
This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 29 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degrees Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature exucrsion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA, (batch number T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Patient received an injection that was of a needle used on another patient. The vaccinator noticed the plunger did not move so then offered patient another injection with vaccine in it to ensure adequate vaccination. After root cause analysis it was discovered this med student practiced recapping her needles and therefor did not have her work station cleared prior to next patient and inadvertently grabbed the  used needle to inject the patient with.
Tingling in arms and hands. Constant on the first day and lasting on and off for 3 days. Feelings of itching and burning on 2nd and 3 rd days.
Measles like rash with hot flashes, persisting now, going on 2 weeks. Vaccination date 5/11/11, had 1 MMR as a child.
I woke up the next day quite early with shortness of breath. The first few days I had nausea and vomiting, but the prolonged symptoms have been dyspnea (worse in the morning), a productive cough, intermittent fever (worse at night), joint pain, and increasing weakness. I have had one outright asthma attack Thursday afternoon; treated with a DUONEB and steroids. Normally, I use my inhaler every 2-3 months, usually related to another illness (a cold caught from my son or a patient, for example). I used my inhaler 8 times on Saturday. Each day I have woken up with more shortness of breath than when I went to sleep, and the last couple of days I've been woken up in the middle of the night as well. When I realized I didn't have the energy to even get up and take care of my son this morning, I called my allergist (who has treated me with allergy shots), and asked for advice; I am taking prednisone, budesonide, and albuterol as a result, as well as dextromethorphan and guaifenesin. I'll see him tomorrow at 9 am. I am currently 29 weeks 5 days pregnant. I'm due 12/25, LMP 3/21/18. Pregnancy has been normal so far.
Acute diverticulitis - treated and released. Hospital admission within 6 weeks of receiving the COVID vaccine.
Sinusitis; This is a spontaneous report from a contactable consumer or other non-health care professional (husband) reported for his wife. A female patient (Age: 58; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, reporter stated that his wife started antibiotic treatment for sinusitis and said his wife was experiencing some symptoms prior to first dose. Reporter asked if there was any drug interaction with antibiotics and vaccine. Patient has scheduled for second dose of vaccination on 09Mar2021. Therapeutic measures were taken as a result of sinusitis. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
weakness lt side leg & arms, spastic, in trunk, seen by MD AUG92; had trouble walking, standing, sitting;
Patient claims he experienced a mild "flu" for 2 days after administration. Headache, sluggishness and generalized weakness. Denies temperature & GI effects.
Red, swollen arm with swelling down to fingers on side she received injection. She also had a low grade fever, fatigue, and aching all over. She was up all night last night with fever and pain in arm. The injection was given on 9/2/06. She was seen by a MD today and given a solumedrol injection, samples of Zyrtec (she declined Benadryl because it makes her feel bad) and Celebrex.
dose in 2021 received another dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number N254C, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix with an associated reaction of exposure during pregnancy (received 1st dose during pregnancy, refer linked case US2022016944).   On 29th January 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 29th January 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 details were provided as follows: The Medical Assistant reported that, a pregnant patient received a dose of Boostrix in September 2021 and delivered on 14th November 2021.  The patient returned for her postpartum visit on 29th January 2022 and received another dose of Boostrix, which led to extra dose administered. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016944:Same reporter and patient
Tired the evening of the shot (4/28). Then woke up with bad body aches and headache around 2am (4/29). By 8 am had a fever. Tried to sleep but could not get comfortable. Treaded with Tylenol cold and flu. Body aces gone by night (4/29) and headache gone the next morning (4/30).
Information has been received from a other health professional referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-JAN-2016 the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013202 with expiration date 27-JAN-2017, lot # L013206 with expiration date 29-JAN-2017, lot # L020865 with expiration date 09-FEB-2017, dose and route were unknown). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 01/30, Pfizer, dose #1 (hospital) 02/27, Pfizer, dose 2 (hospital) 1/1 COVID swab, result: detected 1/1 pt admit Medicine cc: "flu like illness" syx x 9 days with cough, shortness of breath, congestion, body aches generalized weakness: dx: COVID PNA LOS: 5 days 1/1 CXR IMPRESSION: Sternal retention wires in place. Intracardiac device is present consistent with reported history of prior surgical clipping of left atrial appendage and mitral valvuloplasty. Increased parenchymal markings left lung base. Presumed mild infiltrate. No other focal alveolar infiltrate/consolidation. No pleural effusion or pneumothorax. No congestive failure. Atherosclerotic vascular calcifications are coarse. No aneurysm. No mass lesions. No other acute findings. 1/2 CTA PE IMPRESSION: Consolidation in the left lower lobe and multiple additional multifocal patchy groundglass opacities in both lungs most compatible with an infectious/inflammatory process including atypicals such as COVID-19 pneumonia. No pulmonary emoblism. 12/23 pt CC: cough, shortness of breath, congestion, body aches generalized weakness exposure: unknown 1/5 CXR IMPRESSION: Pneumonic infiltrates, most obvious in the left lung, mildly increased since earlier chest x-ray. 1/13 clinically resolved
In spite of everything, I was able to amount a very good immune response; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events in spite of everything, i was able to amount a very good immune response, it is a very favorable reaction.  The patient's medical history was not provided. Concomitant medications reported were Ninlaro, Darzalex, IVIg for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, In spite of everything, I was able to amount a very good immune response, It is a VERY favorable reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, in spite of everything, i was able to amount a very good immune response,it is a very favorable reaction was unknown.
PT verbalized, "I had a terrible fever 100'F, I felt terrible with an awful headache and nausea for 3 days. I couldn't do anything." PT denies going to the ED.
Information has been received from a physician concerning a female patient who on 18-FEB-2008 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) for the prevention of shingles. The physician indicated that he was not sure if it was product confusion, although he stated that he had originally ordered the wrong product (varicella virus vaccine live, (Oka/Merck), then ordered zoster vaccine live (Oka/Merck). The physician indicated that both vaccines were in the freezer, and "they were not familiar with pediatric vaccines". No adverse experience was related to the the event. Current patient status was no reported. A product quality complaint was not reported. Additional information is not expected.
Narrative: Hospitalization - fully vaccinated, found to be COVID positive incidentally on admission. No symptoms, admitted for left ankle swelling and AKI in CHF patient.
Patient is having extreme, constant diarrhea. Patient is completely potty trained, but is now having to wear Pull-Ups 24/7 until this is resolved.
SWELLING LEFT DELTOID MUSCLE. OCCURRED 07/18/06 SWELLING STARTED LATE EVENING.  PER DR, TO TAKE CHILDREN'S TYLENOL ONE TABLET EVERY 4 HRS AS NEEDED. AND TO COME IN 24 HRS FOR FOLLOW UP.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Lot number: GH9693) for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Oct2021 as dose 1, single (Lot number: FF2590), on 09Nov2021 as dose 2, single (Lot number: FIT8028) and on 11Feb2022 as dose 3 (booster), single (Lot number: PK9893) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE, start date: Jul2022, stop date: Sep2023. Past drug history included: Ergotamines, reaction(s): "Known allergies: ergotamines"; Triptans, reaction(s): "Known allergies: triptans". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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.  No follow-up attempts are possible. No further information is expected.