chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented for influenza vaccine. IM vaccine was given in the left deltoid. Pt tolerated the vaccine well and was then observed for 15 minutes for any adverse reactions. Pt called the office 2 1/2 hours after receiving the vaccine and states that approximately an hour after receiving the vaccine, he developed severe left shoulder pain and difficulty moving his arm. With being a rare but potential reaction from the vaccine as listed on the VIS form, pt was advised to apply an ice pack to the area and take ibuprofen for the discomfort. A follow up phone call was attempted the next day, but a return call was not made.
Shivering; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivering) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, PRAZOSIN, ATORVASTATIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Shivering). On 05-Mar-2021, CHILLS (Shivering) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Diagnosed with Bells Palsy 2 days post H1N1/Influenza A vaccine.
On 7/14/08 125 PM, pt came to office for evaluation of rash for 3-4d. Started on trunk and spread to face and neck. Very itchy per mom. Rash started 1-2 days after rec'd varicella vaccine on 7/9/08 at 2 P. Pt was given Orapred PO and 1 tsp Benadryl at 137 P 7/14/08. Rash: widespread, very small papules across chest, neck, face and back. Pt was given rx Orapred 1/2 tsp BID x 5d and Benadryl 1tsp 6 hrs PRN.
couldn't go to work; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (couldn't go to work) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (couldn't go to work). At the time of the report, VACCINATION COMPLICATION (couldn't go to work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
This spontaneous report as received from a Department of Health Agency Service Representative refers to patients of unknown age. On unknown dates, the patients might have received improperly stored doses of GARDASIL 9 (dose, route lot number and expiration date not reported). No adverse events have been reported. Temperature excursion was 0.5 C for 1209 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008793.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 07/15/2021. PATIENT FULLY VACCINATED ON 02/17/2021.
Patient called this evening stating that her arm was hurting her. She said it was itchy, warm, and she had some swelling in her arm.
Nov 13 ER visit for <24hr duration acute most pleuritic pain with SOB. No hypoxia, afebrile. Dx: Pericardial Inflammation. Tx: Torodal IM- home with anti-inflammatory meds.
excessive thirst; pain at injection site; tired; This is a spontaneous report from a contactable Other HCP (patient). A 62-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL6198) via an unspecified route of administration in left arm on 03Mar2021 at 11:00 (at the age of 62-year-old) in left arm for COVID-19 immunisation. Patient had no known allergies and had no medical history. Cncomitant medication was not reported. Patient did not receive any other medication in two weeks and did not receive any other vaccination in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 05Mar2021, at 12:00, two days and one hour after receiving vaccination, patient experienced excessive thirst, pain at injection site and was tired. Patient was not treated for the reported adverse events. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
passing blood in stool; stomach cramping; This is a spontaneous report from a contactable consumer.  A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248), via an unspecified route of administration at single dose on 18Jan2021 for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced passing blood in stool on 21Jan2021, stomach cramping on 20Jan2021, he had a couple of bowel movements this morning much more dark, not bright red blood like they were before on 22Jan2021. The patient was hospitalized for passing blood in stool from 21Jan2021 to 22Jan2021. The outcome of passing blood in stool was recovered on 22Jan2021, of stomach cramping was recovered on 21Jan2021, of had a couple of bowel movements this morning, much more dark, not bright red blood like they were before was unknown
Information has been received from a physician concerning a female who was vaccinated with Gardasil and experienced severe pain at the injection site. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Soreness and tightness at injection site.  Loss of range of motion in arm.  Discomfort in arm
Pfizer-BioNTech COVID-19 Vaccine EUA Pain at injection site, fever, chills, muscle soreness, fatigue, loss of appetite
A month after I received the vaccine I started to have random hot flashes, night sweats, nausea etc. That continues to go on until this day.
Case number PHEH2013US009500, is an initial spontaneous report received from a nurse on 25 Apr 2013 and a follow up received from a nurse on 16 May 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medications was not reported. She received only Men C, Y, W-135 liquid conjugated of MENVEO vaccine, (batch number: X11079A) intramuscularly in her left deltoid, without being reconstituted with Men A component on 18 Apr 2013. On the same day she was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B093BA) at a dose of 0.5 ml intramuscularly in her right deltoid. It was reported that the patient had no redness or swelling at the injection site. The reporter assessed this case as non-serious. Follow up information received from a nurse on 16 May 2013: Updated concomitant vaccination, site of MENVEO vaccination, seriousness, and confirmed that the patient had no vaccination site reactions.
This spontaneous report was received from an internal medicine and geriatrics specialist physician, referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions. On an unknown date, the patient received a version of ZOSTAVAX INJECTION in another country (dose, route of administration, lot number and expiration date were not provided) for prevention of shingles and then, on an unspecified date, she was revaccinated with ZOSTAVAX in this country. Concomitant therapies included sterile diluent (MRK INJ). On an unknown date, "several months later", the patient developed shingles (herpes zoster) after receiving latter version of the vaccine. It was also reported that the patient sought medical attention. The outcome of the patient for herpes zoster was unknown. At the reporting time the causality assessment between ZOSTAVAX and herpes zoster was unknown.
I have not had a period in over a year and I had one on the  03/05/2021 after my shot on the 1st. My doctor told me to report it.
Sore throat, runny nose, cough, sneeze,, slightly elevated temperature, fatigue.
Patient had headache 2 days after injection lasting 8 days. Patient had vessicular rash left abdomen and reddened area left face within three days of injection. Patient was diagnosed with Zoster on 3/12/2007 and treated with Famvir.
1 of 3 pts vaxed from the same vial exp inj site rxn;pt recvd vax 4MAY94 & w/in 24hrs exp inj sit rxn of erythema & swelling;treated w/ice;not seen by MD
This spontaneous report as received from a physician via a company representative, refers to a female patient in her early 70's. The patient's concurrent conditions and medical history were not reported.   In approximately 2011, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prevention of shingles. There were no concomitant therapies reported. In approximately January 2017 (reported as about a month ago), 6 years after received ZOSTAVAX, the patient developed shingles. The patient sought medical attention by office visit. No product quality complaint was involved. The patient was recovered from the event on an unknown date in 2017. The causality between ZOSTAVAX and the event was not provided. This is one of two cases from the same reporter.  Additional information is not expected as no permission to contact the physician was provided. Sender's Comments: US-009507513-1702USA004751.
tested positive on a home test for covid about one month ago/ Pain/ Bad cold; tested positive on a home test for covid about one month ago/ Pain/ Bad cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9269) intramuscular, in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 02Sep2021 as dose 3 (booster), single (Lot number: FF8841) and on 05May2022 as dose 4 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "tested positive on a home test for covid about one month ago/ Pain/ Bad cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive, notes: Covid Home Test; It was either 01May2023 or 06May2023 somewhere around there. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported initially that the patient had three previous doses of Pfizer COVID 19 vaccine; patient is aware that there is another dose of the covid vaccine from Pfizer, does not know specifically which formulation he had had. The patient reported that he tested positive on a home test for Covid about one month ago. The patient asked when he may receive another dose of the vaccine. The Covid test was done either on 01May2023 or 06May2023 somewhere around there (as reported). The treatment received was Over the Counter stuff for Pain, it was like bad cold. Patient could not tell if the lot number was  FK9596 or FK9598, but he thought it was FK9596.The vaccination time for first, second and third vaccination was reported as sometime during day time. The prior vaccinations (within 4 weeks) was reported as None. The Adverse event did not require visit to Physician office or Emergency room. The patient's thought process was if got bad, where to read about it and he felt it was like allergies too. It was not bad enough to go, therefore he stayed home. The patient stated he was calling to determine if he has had covid and according to the testing he did he wants to know if there is a waiting period; asked if he kept getting notified about getting the booster thing for someone his age, he asked if he should wait.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Interchange of vaccine products; Severe diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Jul2023 at 19:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna (DOSE 1, SINGLE, Batch/Lot number: 026A21A), administration date: 05Mar2021, for COVID-19 immunisation; moderna (DOSE 2, SINGLE, Batch/Lot number: 044A214), administration date: 02Apr2021, for COVID-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 065F21A), administration date: 10Nov2021, for COVID-19 immunization; moderna (DOSE 4(BOOSTER), SINGLE, Batch/Lot number: 056A22A), administration date: 21Apr2022, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot number: 6H9697), administration date: 23Nov2022, for COVID-19 immunisation, reaction(s): "Interchange of vaccine products". The following information was reported: DIARRHOEA (non-serious) with onset 19Jul2023, outcome "recovering", described as "Severe diarrhea"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "recovering". The event "severe diarrhea" required physician office visit. Therapeutic measures were taken as a result of diarrhoea.  Additional Information: The patient Initially stated the diarrhea was resolved and clarified it started to resolve after four Imodium and Pepto Bismol and the diarrhea started to resolve yesterday and it was not completely resolved but was improved. For other medical conditions the patient stated there are not really any; no further details were provided. Regarding the diarrhea, she called her doctor and he said he trusted her to know if needed to go to the hospital and she considered it but she figured she was better off at home. Patient had no investigations. Expiry Date of Pfizer bivalent booster Covid vaccine was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient experienced redness that went down arm and "spread" like an infection. With soreness. Patient went to doctor because thought it might be an infection.
I have COPD.  48 house after i had my PREVNAR 13 VACCINE I STARTED GETTING MORE SHORT OF BREATH, FEELING VERY UNCOMFORTABLE AND STARTED GAINING FLUID ON MY ABDOMEN.  JUST FEELING SICK ALL OVER.  I AM FEELING WORSE AFTER THE DATE OF MY VACCINE.
Patient was monitored for 1 hour after receiving his vaccine as requested by his primary care provider due to history of reaction to a previous vaccine. Patient monitored by EMS provider x 1hr, no s/s adverse reaction. Patient started walking out of facility on his own and came back reporting he felt dizzy. He was initially hypertensive with a pulse of 70, respiratory rate 12, systolic BP 188.  We had him lay down and about 10 minutes later his blood pressure was 140/70.   After another 10 minutes or so we had him sit and drink water but his dizziness, while improved, did not go away and he started to have chills and was visibly shaking so 911 was called as we did not feel he could drive himself home. Patient was monitored in the emergency department at Hospital x 1hr and released with blood pressure WNL.
I wake up with a very sharp pain going down my leg to my ankle. I would not put any weight on my leg. The sharpness would go up and down my leg. It would have stabbing pain sometimes. That pain continued and off for a week. I went to quick care. They though that I might have Lyme disease or sciatica. They gave me gabapentin for the pain. It has helped a little. They took a Lyme disease test, negative result. They are going to referred me to physical therapy and for a MRI. They gave me a steroid for the inflammation.
sore arm; a little bit of fatigue; 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 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine, for covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "a little bit of fatigue".  Additional information: Patient and his wife received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday. Other than sore arm and a little bit of fatigue, they did not feel any other side effects Consumer wants to know if the vaccine would still work even if they did not experience any other side effects. Patient asked how they would know if the Pfizer-BioNTech Covid-19 Vaccine already worked on him and his wife.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cherry color pin point papules. V.S. O 4 x 24 O2 sats.
Acute onset of chest pain about 4 days post flu shot (and 3-4 weeks post viral URI-COVID neg on home test X2) that was retrosternal and compressive. Associated symptom: shortness of breath. No fever, no URI or GI symptoms, no rash. Hemodynamically stable. Labs showed troponin of 8,980 at maximum. EKG with low voltage precordial leads. Echo normal. Respiratory panel negative. COVID and enterovirus negative.  Received supportive care and on telemetry for about 36 hrs. Troponin trended down. Following with cardiology.
Red Rash from top of deltoid muscle(injection site) down under arm and into arm pit also hot to the touch
Began with headaches 2 days after vaccination then became dizzy and light headed and high heart rate and have now been diagnosed with POTS 3 weeks later.
This spontaneous report was received from a registered nurse via a company representative refers to a 8 year old child of unknown gender. Information on patient's pertinent medical history, drug reactions/ allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with GARDASIL dose 1, 20 days before turning 9 years old (route, strength, lot number and expiration date were unreported) (Inappropriate schedule of drug administration). The nurse asked on behalf of physician, if a GARDASIL dose would "count if a patient received the first dose of GARDASIL 20 days before turning 9 years old which is outside of the recommendations in the GARDASIL Quadrivalent prescribing information. No adverse effect reported. No product quality complaints were reported. No further information was provided. Additional information has been requested.
p/vax pt devel inj site rxn by swelling; redness; warmth which extended from shoulder to elbow; no tx
HPV 0.5 ml IM R Deltoid.  Patient with syncopal episode and head trauma.  Patient in trendelenberg position.  Water given, vital signs monitored and patient discharged stable.
12:00 am till 7:00 am of severe body aches, chills, fever, vomiting 1 series of 4 times.  On the up-swing at 7:00 am. Now sleeping and in recuperation.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Since 23-JUN-2015, the patients were vaccinated with doses of GARDASIL lot # K009482, expiration date: 06-MAR-2017 which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
My adverse event started on 03/26/2023 in the late afternoon. I started feeling pain under my sternum. I was sure it was gallbladder attack. I would rate the pain 8/10. I was in extreme pain. I was in pain from 4-10pm.The next day I called my doctor who told me to go to the ER to make sure I wasn't having Cardia event since the symptoms I describe were similar At the ER they told me that in my gallbladder there was stone which was causing the pain. They  recommended to get my gallbladder removed. I am waiting to get my gallbladder removed but I haven't had any pain since the last time.
Day 1 Nausea & Vomiting extreme fatigue, Day 2 Slept all day and fitfully through night. 2.  Slept all day,  no food consumed, water in huge amount. Day3. Diarrhea, slept again most of day and did eat lightly. Day 4. fell normal but tied and sleepy buy less so than previous.
Narrative: 80yo male patient died on 3/16/2022 at community hospital outside facility after had  had presented to community hospital on 3/8/22. Chief compliant: Kidney Failure Pt was admitted and sent to ICU, sedated and on a vent with Palliative Care. On 3/16/2022 patient expired. Cause of death renal failure. Pt received a covid vaccine on 4/8/2021 (J&J). This death is not related to this vaccine given pt's advanced age and cause of death defined as renal failure.
26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient received first booster dose. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-548975 (Patient Link).
Patient is having throbbing pain coming from the injection site and has also developed reddness that is spreading from the reaction site down and around her left arm. The size is about 3 inches wide by 9 inches long proceeding down her arm toward her hand. Patient says it is hot to the touch, hard and the throbbing is the worst part.