chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding influenza virus vaccine was received from a 60 year old male consumer who received a dose in November 1964. The patient's concurrent illnesses include syncope vasovagal, anxiety, allergy to animal, hypersensitivity, and food allergy. Indication for influenza virus vaccine formula was immunization. Product was administered in November 1964. Dose regimen was not provided. Concomitant therapy included Clonazepam. The patient reported that he developed an injection site reaction, injection site arm redness, injection site arm hot, and injection site arm itching in November 1964. All symptoms resolved within 24 hours, without treatment. No additional information was available at the time of this report.
"intense" flu like symptoms for 48 hs / symptoms extreme / symptoms worse than when she had COVID-19 for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS ("intense" flu like symptoms for 48 hs / symptoms extreme / symptoms worse than when she had COVID-19 for 2 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("intense" flu like symptoms for 48 hs / symptoms extreme / symptoms worse than when she had COVID-19 for 2 days). On 06-Feb-2021, INFLUENZA LIKE ILLNESS ("intense" flu like symptoms for 48 hs / symptoms extreme / symptoms worse than when she had COVID-19 for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication are not reported  treatment information is not provided   This case was linked to MOD-2021-117900 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Added reporter Email address
Dose #1 given on 3/4/2021.  Pfizer Lot: EN6198 given in right deltoid
Pt vaccinated /w Influenza developed nausea & myalgia; /p 16 hrs chest pain, sweats & chills. Taken to ER dx by ER as "Panic Attack;" was hypervent. Released after resp. normal.
R upper arm cellulitis onset 1 day after vaccine given, treated with Bactrim.
missed the second shot of Shingrix; This case was reported by a consumer media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received 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 details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, did need to start over or took them both.
Moderna Arm -- rash at the sight of the vaccine shot -- starting two days after the shot.
rash/rash that broke out on both legs and now it's everywhere and especially legs; This is a spontaneous report from a contactable consumer wife reporting for her husband. A 70-year-old male patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknow), via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medication was unknown. A day later he had a little rash that broke out on both legs and now it was everywhere and especially legs. It was up and down both legs on an unspecified date. Reporter asked if it was ok for the patient to take a prednisone pack that was prescribed to him for a rash he got after getting the first dose of the COVID vaccine. She reported that her husband went to urgent care for the rash all over and they prescribed prednisone and she was not sure if he should take it. Event outcome was unknown.  Information about Lot/Batch number is requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (area being warm), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE ERYTHEMA (area being red) and VACCINATION SITE PRURITUS (area being  itchy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (area being warm), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE ERYTHEMA (area being red) and VACCINATION SITE PRURITUS (area being  itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (area being warm), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE ERYTHEMA (area being red) and VACCINATION SITE PRURITUS (area being  itchy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.
A few weeks after getting the vaccine had symptoms of hashimotos thyroiditis (hashitoxicosis). Found high thyroglobulin antibodies and high thyroid peroxidase antibodies from bloodtest. Symptoms include weight loss, anxiety, fatigue, hyperactivity, irritability, polyura, polydipsia, depression.
Going to suffocate; couldn't breathe very well; Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9269, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing stroke. Concomitant medications included warfarin which was taken for stroke; atorvastatin, telmisartan, doxazosin and atenolol were taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient had two side effects in which the number one was reported as the patient was going to suffocate and couldn't breathe very well which would be the feeling at bedtime and the second one was diarrhea on an unspecified date. No treatment was received by the patient for these events. The patient had a blood test in the last week with unknown results in Feb2021. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
It started off with the cough and congestion and then I had a headache off and on for a couple of days. Low grade fever Sunday and Monday. Felt a little bit achy on Sunday but not too bad. Didn't really have too many problems breathing, they gave me an inhaler and I think I may have used it once. I've had pneumonia in the past. It's day 9 and I feel pretty good but spit up mucus in the early morning and later in the day but it's clear. I also had fatigue too. Worst was on Monday.  Wednesday I received the infusion.
First reaction didn't happen until several hours after shot hives.  This morning I woke up with severe pain in injection sight neck pain , severe migraine and the chills,  Over all feeling of tiredness and ache all over.  not running a fever. chest is feeling slightly tight when trying to take a deep breath.
Rash on Elbow, Pain in elbow and wrist, Pins and needles progressively worsening on left hand
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 18-OCT-2015, the patient was vaccinated with a dose of improperly stored (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Possible Recurrent Pericarditis from 1968   Hospitalization and Dx and Tx.  Placed on medications to Tx inflammation with residual Atrial Fibrillation
pt. c/o headache 10 mins. after the vaccination. she also c/o of anxiety.  symptoms was resolved and patient went home.
Patient with known seizure disorder, had had a seizure on the afternoon of her second dose of Covid vaccine In January 2021. Was scheduled for a booster on 1/6/2022, Advised to give an extra dose of Keppra from 1/6-1/8 by her neurologist. Remained symptom-free until 1/9 when she had  breakthrough seizuresX2, responded to Nayzilam.
Arm is swollen double the normal size.  Swollen from elbow to shoulder.  Red and hot to the touch.  Painful to move
High fever (99-103F)  for about 12 -16 hrs, numbness in arm for 1.5 days, injection site soreness lasting 4-5 days Rested and hydrated for 2 days  Returned to work after 2 days
This spontaneous report was received from a 67 year old female patient who was reporting on herself. The patient's medical history included "many medical problems" (unspecified). Her concurrent conditions included an unspecified heart disorder, unspecified thyroid disorder and an unspecified allergy. None drug reactions/allergies were reported. In December 2014, the patient was vaccinated with the dose of ZOSTAVAX (subcutaneously; dose, lot # and expiration date were not reported). Concomitant therapies included NOROXIN, unspecified heart, allergy and thyroid pills and many unspecified medications. In April 2015, the patient experienced really bad back pain with a huge (2 inch) spot on her back and little spots around the big spot. The patient provided that the spots were blisters. The patient went to the doctor bit she could not get an immediate appointment, so she went to the hospital emergency room. She provided that she was diagnosed with shingles on an unknown date. She was treated with an unspecified type of ointment and pills. The blisters started to heal, but she was still in pain so her doctor sent her to the dermatologist. The dermatologist prescribed her an unspecified type of ointment to be used with an unspecified medication reported as Neosporin and with pain relief. The patient reported that after six months her back had healed but at the time of this report, she was still experiencing back pain. None lab diagnostics studies were performed. The outcome of the adverse event was recovering. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Four hours post: Large welt right arm, lasted three days Four hours post: Flu-like symptoms, fever, body soreness, lasted two days NINE DAYS POST: RASH ON VOLAR LEFT WRIST, VESICULAR, THEN ON POSTERIOR SURFACE LEFT PINNA, THEN DORSUM OF LEFT WRIST, ALSO ITCHING TO LEFT TORSO WITHOUT VISIBLE RASH (appearance consistent with herpetiform eruption)
temp of 100.7; cough; Muscle weakness (horrible!); fatigue; nausea; dizziness; total-body ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 11:45 (Lot number: EW0167) at the age of 79 years as dose 1, single and administered in arm left, administration date 11May2021 10:15 (Lot number: EW0167) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID prior vaccination: yes. The patient's concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "Muscle weakness (horrible!)"; FATIGUE (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "fatigue"; NAUSEA (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "nausea"; DIZZINESS (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "dizziness"; PAIN (non-serious) with onset 21Apr2021 16:00, outcome "recovered with sequelae", described as "total-body ache"; PYREXIA (non-serious) with onset 11May2021 14:00, outcome "recovered with sequelae", described as "temp of 100.7"; COUGH (non-serious) with onset 11May2021 14:00, outcome "recovered with sequelae", described as "cough". Therapeutic measures were not taken as a result of muscular weakness, fatigue, nausea, dizziness, pain, pyrexia, cough.  Additional information: Other vaccine in four weeks reported as none. other medications in two weeks reported as Several. Patient did have COVID prior vaccination and did not test COVID positive post vaccination.Known allergies: No  No follow-up attempts are possible. No further information is expected.
joint felt like they would break; fever; Terrible headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 05Apr2021 at 16:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient previously received SULPHA on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and carvedilol (MANUFACTURER UNKNOWN) all for unknown indication, from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 2021 at 17:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced headache. On 06Apr2021, the patient experienced joint ache and fever. It was reported that the patient experienced terrible headache by that evening, by the next morning every joint felt liked they would break and she started running a fever that got as high as 102.9. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fever and joint ache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Waiting to hear back from CDC about possible reactions, patients are being notified about possible increase of symptoms.
Initial reaction was noted on 6 hours after vaccine, excessive sweating, lose of taste, swollen tongue, face, difficulty talking or swallowing
Redness, swelling, warmth at the site (left shoulder), with tingling of parts of left arm.
She got her vaccine, she had a different person than the first one and didn't even feel anything and was fine.  With this one she felt when she was stuck with the needle.  She got a flush of heat that went down to her elbow.  She stayed there for the allotted time period and went home.  She got up the next morning, the first she realized that she could hardly stand up due to the pain and aching everywhere.  She then started getting chills, and went in to eat and not able to eat, but no appetite.  She laid around all day and started taking her temperature and the last time she took it it was 100, then didn't take it after that.  She had a massive headache, in fact that evening she put an ice pack on her head as was told not to take Tylenol.  She states that this lasted all day, she went to bed early and the next day had exhaustion, unable to do anything, took it easy.  She did have her appetite back, and was able to eat.  By the 3rd day she was back to her normal self.    She did call the paramedics to ask questions as they are around the corner, and they told her to wait 24 hours and see if it resolved, which she did.
2 wks ago. 2 patches, 1 on face 1 on neck - Started little blisters, burning, itching, swollen, flaking. Around arm after shot - red and swollen went away after 2 wks.
had a little goose egg here; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN MASS (non-serious), outcome "unknown", described as "had a little goose egg here"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Causality was reported related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient said the day after immunizations were given (10/17/19), the outside of her right arm was red and warm to the touch. The area was above elbow to below shoulder. She went to Center on Friday (10/18/19).  Dr put her on an antibiotic.
8/19/11 Pt. reported to RPh an injection site rash and small pustules on injection arm. Those cleared after application of BENADRYL cream. 8/25/11 she has a large rash on left jaw.
I was given the Tdap vaccine at my 31 week prenatal checkup August 7, 2018. 72 hours later I had severe diarrhea and braxton hicks and temp dropped to 96.0 degrees, the symptoms lasted for 3 days, then got better, exactly 2 weeks after vaccine, while doing dishes I had a stroke effecting the entire right side of my body, causing complete numbness and weakness and an inability to speak (33 weeks pregnant at time of stroke) I was taken to the emergency room and hospitalized for 3 days, MRI showing a stroke. I have been otherwise completely healthy up until this point of my pregnancy. Due Date 10/10/2018.
Information has been received from a health professional concerning a 16 year old female who was vaccinated with her second dose of GARDASIL (lot# not reported) and developed a case of genital warts. Concomitant therapy included rizatriptan benzoate, (dose, duration and indication not reported). Other concomitant therapy included hormonal contraceptives (unspecified). The patient's genital warts persisted and she sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. It was reported that no adverse effect occured. No additional information is expected.
Dizziness, difficulty breathing, increase in pulse, increase in blood pressure.  Within 5 minutes of shot.
lyophilized vaccine was reconstituted with sterile water, instead of its accompanying saline diluent with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7 months old and unknown gender patient for whom lyophilized HIB (PRP/T) vaccine [ACT-HIB] was reconstituted with sterile water, instead of its accompanying saline diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Jun-2023, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number, expiry date unknown) via intramuscular route in unknown administration site for immunization lyophilized vaccine was reconstituted with sterile water, instead of its accompanying saline diluent with no reported adverse event (product preparation error) (same day latency).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event lyophilized vaccine was reconstituted with sterile water, instead of its accompanying saline diluent with no reported adverse 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.
COVID-19 Acute viral pneumonia Duonebs q.6 hours  Short acting bronchodilator: Albuterol prn IV azithromycin and ceftriaxone for empiric coverage of secondary bacterial infection. Supplemental Oxygen therapy p.r.n. Incentive spirometer Antitussive therapy Patient to bring Paxilovid to the hospital for administration. Not hypoxic at this time, not meeting indication for dexamethasone IV or remdesivir.
"Moderna COVID?19 Vaccine EUA" developed red bumps/blister all over face after 2 days of vaccine. fever of 103 the day of and day after vaccine.
Pain at Injection site, overwhelming fatigue, headache, muscle/joint pains, L axillary LN, swelling - induration - erythema at injection site, nausea w/ loss of appetite started 8 hrs after injection - all Sx except fatigue, headache and arm pain / swelling / erythema resolved in 48hrs
3/24:  Positive  SARS-CoV-2 ORF1ab Resp Ql NAA+probe~COVID19 TEST Case had ongoing exposure to husband, who is symptomatic, tested positive, is fully vaccinated (Pfizer).  Temporary VAERS E-Report #:  384533
A non-serious spontaneous report of positive for flu was received from a consumer concerning a female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST in Oct-2009. Two weeks after receiving FLUMIST, the patient experienced fever and had a flu test positive for A and B viral strains. Neither outcome nor causality was reported.
daughter called and asked for future notification of vaccinations, pt already recieved covid vaccine; however patient didnt know and answered 'no, haven't recieved any covid vaccine' on covid vaccine conset questionnaire, daughter already notified pcp.
Fatigue; Headache; Feverish; This non-serious case was reported by a nurse via sales rep and described the occurrence of fatigue in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 36 hrs after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), headache (Verbatim: Headache) and fever (Verbatim: Feverish).  The outcome of the fatigue, headache and fever were not reported.   It was unknown if the reporter considered the fatigue, headache and fever to be related to Arexvy.     It was unknown if the company considered the fatigue, headache and fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient was self-reported this case. The patient received Arexvy vaccine and 36 hours after the vaccine she reported typical vaccine side effects such as fatigue, headache and feverish. Follow-up would not possible as no contact details were available.