chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive; Negative; Negative; Negative; Positive. Therapeutic measures were taken as a result of covid-19. Clinical information: No other medication in 2 weeks. No known allergies. She became symptomatic and tested positive again for covid after completing 5 days paxlovid which started from 30May2022 to 04Jun2022. She had already had 3 negative tests then became mildly symptomatic again after 7 days of completing paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Started with a cough on April 22nd, increasingly got worse. By April 25th high fever of 101.5 went to Urgent Care received an antibiotic Levofloxacin 500mg and Mucinex Expectorant. Ran a low grade fever for 4 days, cough increased, ribs hurt, wheezing with each inhale and exhale. I am not the type of person who thinks you get sick from shots. I get the flu shot every year. However I do think it is strange that I have never had an upper respiratory illness before in my life. Today is May 4th, no longer have fever, still coughing and bringing up mucus but feel better.
~2 weeks after injection  experienced N/T and pins/needles from injection site down to finger tips of left arm. Symptoms haven't changed in severity. When active symptoms, rates 7/10 in severity. Otherwise, 1/10 severity.
developed hives to injected arm (left, below IM shot site.  given Benadryl 25 mg PO by nursing staff.  later c/o of body itching to trunk.  EMS was present on site and made an assessment. VS:  1536;  127/78; p:  69; p.oX:  96%, r:  22 Advised to go home.
On day 14, woke up with very sore lymph nodes on either side of my throat. They almost felt happy. As the day went on, I felt more and more exhausted. Later in the day, I developed brief fever and chills along with nausea and vomiting. I figured those were normal reactions, but then on day 15 I started coughing and had night sweats. On day 18, started coughing up bloody mucus and went into ER. Diagnosed with pneumonia.
The patient was administered the Preschool Pfizer dose for 6mos to 4 years old instead of the 5-11-year-old dose
have two vacs and still got them again/Suspected Vaccination failure; got them again; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received two doses of shingles vaccine and still got shingles again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Eruption of generalized papular varicella-like rash with itching on 4/15/01. Varicella shot given on 4/13/01 in addition to Hep-B and Hep-A and PPD.
Restless legs, dizziness, heart rate greater than 120 at rest, nausea, vomiting, fever, headache, body aches, shaking, chills, and pain and swelling at the site of injection.
Flu; Initial information received on 16-Feb-2022 regarding an unsolicited valid  non-serious case received from patient.  This case involves Adult and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine once four years in row (with an unknown formulation, route, strength, batch number ,administration site and expiry date) produced by unknown manufacturer for immunization.   On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
From initial information received on October 10,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 37 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1253AA, expiration date June 30,2004, administered in the right deltoid (route of administration not reported) on October 17,2003 at 9:00AM.  At 11:00AM of the following day, the patient developed soreness in the right axilla down to the chest wall with edema.  The patient was recommended to use ice packs.  The patient's recovery status is currently unknown.
Developed shingles within 10 days of getting the shot.   I have never had shingles before.
ACCIDENTAL OVERDOSE; MEDICAL ADMINISTRATION ERROR; This spontaneous report received from a health care professional (HCP) concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 11-SEP-2021) 3 dosage, 1 total, administered on 06-AUG-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-AUG-2021, the patient experienced accidental overdose and medical administration error. The HCP accidentally gave a patient 3 doses of Covid-19 vaccine instead of one dose. She reported that she thought there was only 1 dose left in the vial. HCP was in a rush and did not provide patient information. Patient was notified, but she doesn't know if he contacted his physician or any other party. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the accidental overdose and medical administration error was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210815416- covid-19 vaccine ad26.cov2.s-Accidental overdose.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: SPECIAL SITUATIONS
My shoulder is crazy sore (3 days later) and my tongue was sore and I got a migraine.  The shoulder pain is the only one I still have.  But it is very challenging to lift my arm.  :-(  - Per pt.
No adverse event; a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Dec-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023).    No concomitant medications were reported.  Patient received first Monovalent Dose on 28Feb2021 and second Monovalent Dose on 01Apr2021. Patient received no any other vaccines in the 4 weeks prior to COVID-19.   No treatment medications were reported.
Anaphylaxis Tingly lips, sore throat Narrative:  Vitals: 1024 BP: 123/84, P: 91, T: 36.9C, R: 18, 2: 96% RA Vitals: 1032 BP: 138/83, P: 111, R: 20, 02: 97% RA Vitals: 1037 BP: 157/85, P: 99, R: 16, 02:96% RA Vitals: 1044 BP: 150/81, P: 101, R: 14, 02: 96% RA
Patient had Tdap and Varicella in right arm.  Patient later experienced redness, swelling and blisters to right arm.  Patient went to ER - received Prednisone and Antibiotics.  Patient seen Friday 9/5/08 in clinic.  Patient contacted Monday 9/8.  Mom reports patient doing better.
PCV13 vaccine (L) deltoid on 7-12-11. Hot & red 4 x 3 1/2". Dtap/IPV (R) deltoid on 7-12-11. Hot & red irreg shape 2 1/4 x 4".
Four minutes after vaccine administration, patient complained of chest tightness, followed by audible wheezing  and inability to speak clearly. Elevated blood pressure and pulse. Physician notified and course of treatment was epinephrine x3, Solu-medrol  x2 and Benadryl x1.  IV access obtained.  Code Blue called, 911 called for transport.  Adverse event began at 1547, code called at 1555, patient left facility at 1612  via stretcher for ems transport to hospital, code blue clear called at 1614.
pediatric patient received adult dose; pediatric patient received adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix 1440 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2022, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 19th May 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were 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: 20-MAY-2022 Reporter's Comments: The NP (nurse practitioner) reported that an adult dose of Havrix was given to the pediatric patient. The patient were twins. The reporter consented to follow up by postal. Additional supportive information: The use of an adult dose of Havrix to pediatric patient, which led to overdose, adult product administered to child. This case is linked with case US2022081896 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081896:Same reporter
The injection site was a bit sore but did not stay sore for long; Irritated throat; Trouble swallowing; Weak; Dizzy; Rapid hearth rate, pulse rate around 97; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid hearth rate, pulse rate around 97), VACCINATION SITE PAIN (The injection site was a bit sore but did not stay sore for long), THROAT IRRITATION (Irritated throat), DYSPHAGIA (Trouble swallowing) and ASTHENIA (Weak) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20K) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid hearth rate, pulse rate around 97), THROAT IRRITATION (Irritated throat), DYSPHAGIA (Trouble swallowing), ASTHENIA (Weak) and DIZZINESS (Dizzy). On an unknown date, the patient experienced VACCINATION SITE PAIN (The injection site was a bit sore but did not stay sore for long). At the time of the report, HEART RATE INCREASED (Rapid hearth rate, pulse rate around 97), VACCINATION SITE PAIN (The injection site was a bit sore but did not stay sore for long), THROAT IRRITATION (Irritated throat), DYSPHAGIA (Trouble swallowing), ASTHENIA (Weak) and DIZZINESS (Dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Patient went to see her doctor. Blood work was drawn and had an ultrasound performed. Results not provided.  Treatment information was not provided.
Pt fell night of vaccine and again the next day. Took her walker down with her and fell again in June after those falls. First & second fall was after the second dose. Third fall was end of July, fell flat on her head and had a brain bleed. That fall led to ambulance ride to trauma center and now she?s been discharged into a rehab facility.
Pain in arm, limited range of motion, per patient.  She said she is going to see her Dr this week to have her arm looked at.
One day post vax pt developed a rash on ;her head, neck and shoulders. The rash was described as red papules, five lesions at this time. There was no blistering. Physician subsequently determined that they were mosquito bites. This was not related to Varivax.
Swollen area next to vaccine, hard, painful.  Unable to move arm or to lay on left side.  Toward evening 101.3 fever. Following day red area, hard, burning, swollen.  Sunday red area continues to burn. Monday, red area is larger all the way down to elbow.  Feels like ants crawling.  Tuesday - red area continues - itchy.
Headache  Nausea with vomiting  Extreme fatigue  Pain in body Irritability  Congestion in sinus
The whole back of my head swelled up; very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "The whole back of my head swelled up"; MALAISE (non-serious), outcome "unknown", described as "very ill".  Additional information: The patient recently received an inquiry regarding the possibility of taking a booster shot this fall, if recommended. The patient's 1st bivalent shot made very ill. The whole back of head swelled up for over a week. The patient was scared to take another booster now.  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.
On 9/27/16 Lt deltoid was Warm to the touch, swollen. Next day 09/28/16 it was hard to touch, hot to touch and had an in duration of 33mm.
Four to five days following first CoVid 19 vaccination  began having dull pain in deltoid muscle where injection was given.  Increased pain with movement and discomfort at rest.  Lasted approximately 1 month. Reports very minimal injection site discomfort in first 2 days after vaccination.   Experienced same symptom following 2nd CoVid 19 injection.  Both injections were given in the right arm.  Again symptom began 4-5 days following injection and lasted approx. 1 month.  Booster dose was intentionally given in left arm.  4-5 days following booster dose experienced exact same dull pain with movement  in the right deltoid muscle.  Reports it feels like a "torn muscle".   Client reported incident due to symptom not always related to arm that injection was given in.
The patient fainted within a few minutes after receiving the vaccination. She was with her significant other who was sitting with her. It appeared that she was having difficulty breathing at one point while she was out. She came to within a minute or so and was disoriented. I had my technician call EMS who did a thorough screening. She was cleared and left the store on her own about 20 minutes later. She was provided with a bottle of water and a cold compress from store management.
Pt returned to pharmacy about 5 days later with a red itchy rash, fist size, located below the area the vaccine was administered (above elbow).  Both pharmacists on duty consulted and told pt to go to physician for further evaluation. Pt stated she felt fine, just rash was itchy.  She has since been back to the pharmacy several times and is doing good, still has small rash on her upper arm.  She is begin evaluated regularly by her physician.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient received the first dose in the HPV series with GARDASIL (dose, frequency were not reported). Then on an unspecified date, the patient received the second dose in the HPV series with GARDASIL 9 (dose, frequency were not reported) at another pharmacy. No adverse experiences were reported. Additional information has been requested.
Swelling 3 1/2" - 4" wide with redness, heat, et itching. Reported by child 24 hours after injection was given. Child was taken to Dr 5-6-16. Mom reports that doctor was unsure if this was inflammation or infection. She was treated with BACTRIM et triamcinolone. 5-11-16 Area/rash is resolving per mom.
Person received J&J as first vaccine and was administered Moderna. He thought he was given Moderna at another facility and needed a second dose. Did not have any reactions from either vaccine
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M042504, expiration date: 30-NOV-2017) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20 degrees Fahrenheit (F) >14°F but < 46°F for 14 hours and 24 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA010198:
Rash to extremeties within 5 minutes - Benadryl given - symptoms improved.
By 7pm I started feeling chills, I went to bed early woke up in middle of night with low grade fever. I stayed in bed for a day with the chills and it ran its coarse and I did have a headache all day. I took tylenol
I had Covid; I had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "I had Covid". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 11 day(s)). The event "i had covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient on the Paxlovid (Treatment).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.