chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 y/o male who received primary SPV L) arm & AVA #1 R) arm on 6/14/2007. 3 days post vaccination, he noticed increasing redness & swelling at SPV site, which progressed to involvement of "whole upper arm" with associated L) axillary tenderness, chills & HA; from 6/18-6/24/2007, he experienced mild DOE, described as "difficulty getting a deep breath" and steady substernal chest pain, described as an "ache" w/intensity up to "5/10", with pain radiating to his L) arm. During this time frame, he also noted L) shoulder & neck discomfort and palpitations described as his "heart pounding hard and fast; SM was admitted to hospital 6/24/2007 & subsequently diagnosed with myocarditis Symptom: Chest Pain Start: 06/18/2007 Comment: substernal Symptom: Dyspnea (shortness of breath) Start: 06/18/2007 Symptoms: Dyspnea on exertion Start: 06/18/2007 Symptoms: Palpitations Start: 06/18/2007 8/23/07-records received vaccinated on 6/14/07- and on 6/17/07-developed gradually worsening dull substernal chest pain without radiation and lasting 5 days continuously developed SOB with pain during inspiration and activity and worse pain laying down. Somewhat relieved with sitting up. 6/24/07-sent to ED diagnosed with vaccinia associated myopericarditis. Continues with residual intermittent complaints of chest pain mostly with exertion. Syncope and C/O fatigue after discharge.
My friend has HPV disease and the doctor told him to inject the GARDASIL4 vaccine (invasively) in 0, 1, and; My friend has HPV disease and the doctor told him to inject the GARDASIL4 vaccine (invasively); This spontaneous report was received from a consumer and refers to a male patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was prescribed quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, for papilloma viral infection (strength, dose,lot #, expiry date, and route of administration were not provided) (product prescribing issues) at 0,1 and 3 months (inappropriate schedule of product administration).
Initial and follow up information has been received from a registered nurse concerning a 15 female with acne who on 15-MAR-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot#659182/175U). Concomitant therapy BENZACLIN and RETIN-A. The patient developed widespread muscle aching and a low grade fever within hours of receiving her first dose which resolved in 1-2 days with out requiring treatment. On 10-JUN-2008 the patient was vaccinated IM with a second 0.5ml dose of GARDASIL (Lot#660391/0063X). After the second dose, the patient's mother contacted the office by phone to report her daughter's symptoms of muscle aching, low grade fever, as well as left knee pain that occurred within a few hours of the dose. Rest and ibuprofen were prescribed. At the time of the report, the patient had not recovered. The nurse did not known if the patient was scheduled to receive the third dose. Additional information has been requested.
Neuropathy in feet and (less so) hands being treated with Gabapentin 300mg
itchy, swollen, red hands; painful swollen joints in hands, knees & painful lt hip;
Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine; Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6198), on 19Apr2021 as dose 2, single (Lot number: EP7534), on 23Oct2021 as dose 3 (booster), single (Lot number: FA8839) and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "High Blood Pressure" (ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Oct2022, outcome "unknown" and all described as "Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2022) Positive, notes: Caller states her husband tested positive for Covid 19. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
12/31 (10:45am): brain fog, dizziness, shortness of breath. (11:30am) previous + difficulty swallowing, generalized muscular weakness. (1400/2:00pm) previous + inability to swallow thin liquids/dry solid foods, palpitations, HR of 106bpm, myalgia and joint pain in areas previously affected by injuries/tendonitis (R/L wrist, R elbow, R shoulder, C spine, lumbar spine, R hip joint, R sartorious muscle, R medial knee, R achilles/ankle)  - went to emergency room for allergic reaction evaluation; was experiencing similar reaction to food allergies.  (~1600/4:00pm) aspirated thin fluids (water/saliva) and tolerated solid foods, dizziness, myalgia, fatigue.   12/31-1/1: fell asleep at 7pm 12/31, did not wake up until 8:30pm 1/1. dizziness, nausea, weakness, vertigo, difficulty swallowing without pain, lack of appetite/thirst.  1/1-1/2: fell asleep at 9pm 1/1 and woke up at 12pm 1/2. dizziness, sensitivity to cold, nausea, generalized weakness, loss of appetite.   1/3: generalized vertigo throughout body, all day. greater intensity upon standing from sitting position or walking. loss of coordination, brain fog, speech pattern. spasms in muscles, jaw, and eyes. eyesight blurry and out of focus.
pt recv vax 9MAY98 & 20MAY98 pt exp rash that covers face;21MAY98 pt rash spread to chest, arms & legs & pt felt feverish;pt exp cervical lymphadenopathy;
MINI STROKE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient had a genetic predisposition and family history that resulted mini-strokes for him, also had several mini strokes in past before covid vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported with frequency 1 total administered on an unspecified date in MAR-2021 for prophylactic vaccination. 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 in APR-2021,a month of post vaccination, the patient experienced mini stroke and she was unsure if it was related to vaccine or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mini stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210941108-Covid-19 vaccine ad26.cov2.s -Mini stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021 at 8:20 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Reporter stated that there were some unpunctured Moderna COVID-19 vaccine vials at her facility that were stored in the refrigerator. Per her records, the vials use by date was 28 Nov 2021.The patient has not reported any adverse reactions to the dose so far.
"Half-dollar" size induration that produced "pus" and required topical steorid cream for treatment.
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingrix (received 1st dose on 23rd December 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: 10-Aug-2022. Reporter's Comments: The reporter stated that a patient did not receive the 2nd dose of Shingrix till the time of reporting. The reporter consented to follow up via postal. Additional Supportive Information: Till the time of reporting the patient did not receive the2nd dose of Shingrix, which led to incomplete course of vaccination.
Breakthrough case admission after three vaccines  Pfizer 1/30/21 no lot#;  Pfizer 2/18/21 no lot #;  Pfizer 10/14/21 Lot# FC3183
Patient was administered 0.5ml instead of 0.25ml booster 3rd dosage of vaccinations, patient was called on 1/18/2022 and stated he had flu like symptoms x 1 day and no other problems since vaccination. A letter was sent to patient informing him of dosage given.
Friday on 8/19/05- Couldn't move 1/2 of lips unable to blink left eye and couldn't control left nostril. Couldn't feel left side of face. Saturday- Symptoms increased. Went to ER. Started on Prednisone, eye QHS- eye patched.
Vaccine given to pt not of age. Age of patient at time of event: 4 months 25 days.
Pt had no reaction within 20 minutes, post vax. On 8/23/01, awakened with swelling, redness in left leg and a temperature of 101F-102F (ax). On 8/27/01, pt had a rash over entire body but no fever. Mother called doctor's office and was told to give Benadryl. On 8/28/01, the rash continued over entire body, no fever, but took child to see the doctor and was given Dexamethasone to be taken by mouth. On 8/29/01, the pt continued to have a rash but no fever, so took child to see another pediatrician in El Paso but no medicines given.
Right eye (only) - Edema & Erythema and mild to moderate pain lasting 24 hours. Treated with otc benedryl with no effect. Treated with cold compress alleviating the pain and some swelling.
Had migraines (frontal lobe with flashing lights-distorted vision and difficult to hold my eyes open) from 3/20-3/24. (one week after vaccine) I do not get headaches, so this was very strange. On 3/23, I woke up with a bright red Left thumb- it looked and felt like a sunburn.  The next day (3/24), it was still bright red (fire engine red), swollen, hot to the touch and had a blister in my webspace.   I went to the dr 3/23 pm who was not sure what was going on, but prescribed an antibiotic (Keflex). This reduced my pain and swelling. Today it is still red and is now flaky, but not swollen or hot to the touch.   The main thing was the migraines as I do not get headaches.   I'm not sure if that or the skin thing is related, but thought I should throw this information your way in case there have been others with similar symptoms.
Approx 45 minutes after injection, patient reported generalized itching.  Patient was given Zyrtec 10mg.  Itching continued.  Patient was given Diphenhydramine oral.  Itching resolved.
Td booster given on 11/19/03. None prior for over 20 years. Developed stiffness/swelling at site. Then over last months, left side of body has muscle swelling, fatigue, weakness. Seems to be progressing. Health department note: A couple of weeks ago, I called to let you know about my lingering effects of my DPT or Tetanus booster which I received through your office last fall. Here are the symptoms I have been experiencing: A stiffness in the left shoulder that has slowly migrated down to the elbow and toward my neck. Mobility is greatly reduced in my left arm, especially when I attempt to reach my left arm behind me. I have pain and stiffness when I try to turn my head to the left. It seems to be spreading even to the right side of my neck lately. Swelling in my left shoulder: when I stand in front of a mirror, the spot where the shot was given is definitely swollen compared to the right shoulder. It has never gone down since the shot. Swelling or puffiness on my entire left side: this is hard to explain and hard to link to the shot, but it is only in the past few months that I have noticed this. I should add that I had testicular cancer about 12 years ago. Part of my treatment was to have radiation on the right side of my body. This may explain why the right side of my body has less fat or puffiness in comparison to the untreated left side. However, the arms were not irradiated so the difference between the two arms is only due to the shot. In the last week, I have started to notice a dull lower back pain on the left side. This could be due to a number of things, but it seems strange that all the pain and stiffness is on the left side and gradually seems to still be spreading farther and farther from the site of the shot. I have not been to a doctor or chiropractor, but I am at a point where I feel I may have to see a doctor soon. If you have any ideas, please let me know.
Sweating; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), CHILLS (Chills) and VOMITING (Vomiting) in a patient of an unknown age and gender 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 HYPERHIDROSIS (Sweating), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, HYPERHIDROSIS (Sweating), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative; (07Sep2022) Positive, notes: Rebound covid 19 infection/symptoms came back and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  Additional Information: No other medication in 2 weeks was received. No known allergies was reported. Anti viral details: Product-COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 28Aug2022,Treatment stop date: 02Sep2022 for the treatment of COVID-19. Rebound Covid 19 infection - after testing negative and symptoms resolved, symptoms came back and tested positive. Patient was Recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 doses of fluzone QIV high dose was given to patient on the same day with no reported adverse event; Initial information was received on 20-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 88 years old female patient who received 2 doses of fluzone qiv high dose on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Sep-2023 at 8:00, the patient received a Dose 1 of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, route, lot, expiry formulation and strength: unknown) for immunization .  On 20-SEP-2023 at 13:15, the patient received a Dose 2, 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE(lot:UT8057AA and expiry:30-06-24) (formulation and strength: unknown) via intramuscular rout in left deltoid for immunization (extra dose adminsterered)  (latency same day).   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event 2 doses of fluzone qiv high dose was given to patient on the same 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 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.
78 year old white male with PMH significant for HTN, COPD, OSA, AFib, chronic pain, neuropathy, anemia, recent fall who reported feeling progressively weaker since receiving influenza vaccine on 10/11/17 to his PCP on 12/1/17. Patient reported concern at that time that the vaccine was the cause of his increase in weakness. Of not, Patient with bilateral lower limb weakness prior to administration of influenza vaccine.
2 hrs p/recvd HIBTITER, pt became lethargic, pale, limp & had a fever of 102-103; sx lasted 48 hrs, then resolved; no other vax given @ time of HIBTITER;
No adverse event occurred, but patient was given an expired dose of the vaccine. He was subsequently given a viable dose.
Pustule at VZV injection site on 5/12/09. No treatment needed.
Breakthrough case admission after 2 vaccines Pfizer 3/25/21 Lot# ER8730;  Pfizer 4/19/21 Lot# ER 8729
Patient stated that within 2-3 minutes following injection began experiencing dizziness, sweating, and "tingling everywhere". Prior to injection told nurse that she was petrified of needles. She did not indicate that she was experiencing anything until about 7-8 minutes following injection.  She was placed on the floor in Trendelenburg position and given coke to drink.  Her color was good, pulse normal, and was not diaphoretic.  She remained on the floor for about 10 minutes.  Left clinic site with no complaints.
Within 4 hours of injection pt had fever (>100 degrees) chills, body aches, red eyes. Next day pt had facial edema and swollen eyelids, edema was severe but resolved within 48 hours.
Shot on 10/13, symptoms started 10/15 and continues to present day: low grade fever, cough, congestion in upper chest, fatigue, muscle aches in chest & shoulders, heaviness in chest, sore muscles, headache, low appetite.   Treatment: tylenol, heating pad, rest
8-8-13 patient vaccinated with shingles. T/C 8-12-13 patient reports left arm, injection site, stiff, red, swollen and hot to touch, since HC not open for treatment, went to pharmacy who suggested BENADRYL which she found effective. 8/13/13 T/C reddened but better. 8-14-13 last BENADRYL yesterday - resolved.
received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 09-JUN-2022 Reporter's Comment: Pharmacist reported, that a patient received expired dose of Twinrix. The reporter consented to follow up. Additional Supportive Information: On 9th June 2022, patient received dose of Twinrix that was already expired on 8th February 2022, which led to expired vaccine used.
After receiving the Flu vaccine, 5 days later onset of sore throat, dry cough, nasal drain.  10 days later vaccine site sore to touch with touchable nodule, which lasted till mid-December.  From mid-December to current ROM for left arm has decreased, difficulty raising arm or lifting objects.
I DEVELOPED COVID ARM THE MORNING AFTER THE VACINATION.  IT IS RED, SWOLLEN AND ITCHY.  I AM ON DAY 4 AND IT HAS GOTTEN SOME BETTER, BUT IS STILL THERE.
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were vaccinated with that doses of LIQUID PEDVAXHIB (unspecified dose and route) (lot K016964 expiry date 16-JUL-2017). On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Shingles on arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The age at vaccination was not reported. The patient stated that after receiving the shingrix 10 days ago of the reporting date,  he developed shingles on his arm. The patient wanted to know how frequent was this and what to do for this consented to follow-up. No other information was available.
Lightheaded afterward / dizzy. Nurse jammed the needle into muscle improperly causing me to bleed like I've never done before. She immediately put pressure on it and it stopped, but feel this was done inaccurately. Not sure if it was the shot injection or the actual contents that caused the light headedness.