chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 22 November 2010. A 4-year-old child, with a medical history of respiratory infections, ear infections and a urinary abnormality which required surgery, received on 01 November 2010 a right deltoid intramuscular injection of FLUZONE, lot number U3743AA. The patient's concomitant medications included albuterol PRN, permethrin 1% shampoo, and MIRALAX. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of FLUZONE. The patient had received several previous doses of flu vaccine. On 17 November 2010, the patient developed sniffles, an episode of staring and did not respond. He then crumpled to the floor and did not respond which lasted 30 minutes before he became himself again. The patient was taken to the Emergency Room (ER) where a computed tomography (CT) scan was performed and showed normal. The patient was hospitalized and kept overnight where no further episodes or symptoms were observed. The patient had used permethrin 1% shampoo (date and time not reported). The outcome was reported). The outcome was reported as recovered on 22 November 2010. Documents held by sender: None.
On 09/06/2021 I had 3rd vaccination. On 07/03/2022 I started to experience a scratchy throat and a general feeling of malaise. On 07/05/2022 I started to have a fever. I didn't test positive till the following day. My voice was hoarse and scratchy. I had lost taste and smell. I had a horrible headache. I had diarrhea with all the gastrointestinal symptoms. I tested COVID-19 positive on 07/06/2022. I was given a Z-PAK because it was deep in my chest and a pack of steroids for 7 days.
SUSPECTED COVID-19 INFECTION (LEG PAIN, HEADACHE, BACK PAIN, TIREDNESS WHEN SPEAKING); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced suspected covid-19 infection (leg pain, headache, back pain, tiredness when speaking). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection (leg pain, headache, back pain, tiredness when speaking). This report was non-serious.
This case was reported by a other health professional via patient support programs and described the occurrence of fainting in a 12-year-old male patient who received BOOSTRIX (batch number 4P9CL, expiry date unknown) for prophylaxis. Co-suspect products included MENVEO (batch number MI7077, expiry date unknown) for prophylaxis. On 21st August 2018, the patient received the 1st dose of BOOSTRIX and the 1st dose of MENVEO. On 21st August 2018, less than a day after receiving BOOSTRIX and MENVEO, the patient experienced fainting. On 21st August 2018, the outcome of the fainting was recovered/resolved. The reporter considered the fainting to be probably related to BOOSTRIX and MENVEO. Additional details were provided as follows: This case was received from other health professional via the vaccine patient assistant program. The patient fainted for approximately 5 seconds following the administration of BOOSTRIX and MENVEO. The reporter was unsure which vaccine caused the reaction. The reporter advised that oxygen was started as it dropped to 93 and slowly went up. The events did not require surgical medical intervention. The patient was not admitted to the hospital overnight or prolong an existing hospitalization. The health care professional did not consider the event as life threatening event. The health care professional did not consider the events to result in persistent or significant disability or incapacity. The event did not resulted in congenital anomaly or birth defect. This case has been linked with case US2018GSK152213, reported by same reporter.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer-sponsored program (134184). The reporter is the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her left arm just hurts from the injection"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "she cannot lift her arm/It is hard to move it"; CHILLS (non-serious), outcome "unknown", described as "Chills"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she can't do anything"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; FEELING COLD (non-serious), outcome "unknown", described as "She is just cold". Therapeutic measures were taken as a result of vaccination site pain, mobility decreased, chills, loss of personal independence in daily activities, malaise, anxiety, feeling cold. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized for 6  days with generalized bilateral extremity weakness. Asymptomatic for COVID
Cellulitis at site of injection; KEFLEX for 7 days & warm compress.
My blood pressure went higher. The top number is normally around 110-115 and it went up to 144-157. My head felt heavy, and I was off-balance, felt like I was going to pass out sometimes. I thought I might have a stroke with the blood pressure and after three days of symptoms it got better. Was very concerning to me.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jul2022 as dose 4 (booster), single (Lot number: 017B22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Cardiac Arrhythmia" (unspecified if ongoing); "Palpitations" (unspecified if ongoing); "AV Block 2° Type 1" (unspecified if ongoing); "PVC" (unspecified if ongoing); "PAC" (unspecified if ongoing); "Hypokalemia" (unspecified if ongoing); "Bipolar Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Substance Abuse Disorder" (unspecified if ongoing); "Opiate Dependence Disorder" (unspecified if ongoing); "known allergies: Bee Venom" (unspecified if ongoing), notes: known allergies: Bee Venom. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine, Cephalexin, Bee Venom; Cymbalta, reaction(s): "known allergies: Cymbalta", notes: known allergies: Cymbalta; Cephalexin, reaction(s): "known allergies: Cephalexin", notes: known allergies: Cephalexin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including paxlovid.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Moderna COVID-19 Vaccine EUA     first dose.  fever, chills, body aches, headache
Several hours after vaccines were administered, patient developed an erythmatous area to left lateral thigh. Patient was brought into ED the evening of 03/03/2020. The erythmatous area measured approximately 4cmx3cm at that time. Area was also warm to touch. Patien had also developed a fever of approximately 101. Provider, deemed the erythmatous area to be a skin infection and started patient on antibiotics. Patient followed up in the clinic the morning of 03/04/2020. Erythmatous area was decreased in size, however the patient's fever continued to increase. Patient was febrile at 102.2 during clinic visit. Patient was accompanied by siblings, one of which exhibited influenza symptoms. An influenza swab was performed on the patient at the clinic visit and patient was diagnosed with influenza B.
if she put ice or heat compress in her injection site because of pain; This is a spontaneous report from a sponsored program via a contactable consumer (self). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller wanted to know if she put ice or heat compress in her injection site because of pain, after the 1st dose of Covid-19 vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.
pt recvd vax & broke out sweat; became flushed; inject site bruised, indurated & tender;
48 hours after vaccine: diarrhea, stomach cramps, nausea, body aches. these lasted 4 days night sweats started and lasted 6 nights.  mild local discomfort at site of vaccine
Pt recvd HIB vax on 26DEC91 & on 5JUL92 & devel septic arthritis which most likely required hospitalization; no further details were provided;
Pain in right shoulder x3 days; tiredness x1 day; increase in volume of Tinnitus in Right ear-continuing; stiff neck and headache-continuing; Advil x2 day for stiff neck and headache-continuing.
On 12/13/99, the pt developed a mild rash, with less than 50 lesions and no fever. He sought unspecified medical attention.
Pt exp maculo papular rash w/in 24 hrs p/immun; Seen in office & treated w/oral DPH; Referred to allergist;
Received 3 doses; This non-serious case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Received 3 doses). The outcome of the extra dose administered was not reported.   Additional Information: GSK Receipt Date: 01-MAR-2023 The nurse explained to the reporter that the patient received 3 doses of Shingrix.  The patient came in for an appointment and could not recall whether they had received their 2nd dose or not and so they administered a shot and realized later that in fact the patient had already received dose 2. The reporter had no further details about the patient.  The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter had included the office manager's email address so that you could follow up.
Pt was administered both PPD (Tubersol) and Anthrax (BioThrax) vaccine at the same time. Both to the left arm. Technician injected 0.1ml Tubersol IM into pt left deltoid, and 0.5ml BioThrax Intradermal into left forearm. Pt reported back to Immunizations clinic during 48-72 hour window for f/u PPD screening. Pt was eval'd and released. Pt still being observed for adverse reactions at this time.
Headache, Diarrhea, NauseaVomiting, chills, body aches (unspecified), fatigue, dry mouth, pain at injection site Narrative:
Received an Expired Dose of Heplisav-B; Initial Report Received on 08-FEB-2023 and 09-FEB-2023.  A supervisor reported that a 58 year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 06-FEB-2023, the patient received a dose of HEPLISAV-B (Lot #935849, expiration date 13-JAN-2023 and NDC # 43528-003-01) intramuscularly in the right deltoid from a nurse.   On 06-FEB-2023, the patient received an expired dose of HEPLISAV-B. No adverse effects were reported by patient.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
When I woke up on Friday I woke up dizzy and a small headache with the stuffy nose. I took Tylenol for the headaches. The dizziness stopped after Saturday, that's when I found out I was positive for COVID-19.
low on energy; pain in the lymph node in the left armpit; fatigue; general body pain; chills; vaccination site pain; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 26Mar2021 at 10:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), quetiapine fumarate (SEROQUEL), clonazepam (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and caffeine, paracetamol and ibuprofen (IBUPRO); all taken for unknown indications and from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 08:00 (at the age of 44-years). On 26Mar2021, the patient experienced the event pain at the injection point in the left arm. On 27Mar2021 at 11:00, the patient experienced fatigue, body aches, and chills and on 28Mar, 2021 at 08:00, the patient experienced pain in the lymph node in her left armpit and the patient felt low on energy and bit achy. The persistent pain in the lymph node was the reason, the patient reported the event. Treatment was taken as a result of lymph node pain with ibuprofen 200mg. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events vaccination site pain, fatigue, general body pain, chills, lymph node pain and energy decreased was not recovered. No follow-up attempts possible. No further information expected.
was exposed to someone who was positive for COVID-19; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a female patient (wife) that of an unspecified age received first dose of BNT162B2 (PPFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration, on 02Mar2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medication were not reported. The reporter stated that he and her wife both got their first dose of the Pfizer COVID vaccine on 02Mar2021. The reporter tested himself and was positive for COVID-19. Then his wife (patient) exposed to who was positive for COVID-19. Now, both he and his wife were quarantined. They both due for their next shot on 22Mar2021, but caller stated they might have to miss that appointment due to their quarantine, and was wondering how long they could go before getting their second dose, without having to start the series over. The outcome of event was unknown.  Information on lot/ batch has been requested.
This initial spontaneous report was received from a physician referring to a 4 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 17-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Red area around inj sight.  No tenderness.  No pain.  No cellulitis.  Some itching.  Redness within 24 hr of shot.
The night of my vaccine, I had severe back pain in the kidney area to the point I could barely move. It subsided over the next day. Since then however, I have developed swollen and red calves & facial flushing. The psoriasis I was experiencing prior to the Covid vaccines has exponentially increased and the medications I've been prescribed to treat it do not work. I've developed ringing in my ears and my vision has worsened. Of note too, is that upon receiving my flu vaccine on 10/02/21, I developed within a week 2 welts on my neck. I still have 1 that is just now decreasing in size. I had labs run recently and I have developed high homocysteine, high catecholamine (high norepinephrine and elevated BUN.
Patient had redness and itching at the injection site for days following immunization and reported it to me 8/29/09.
rest of the vaccine dripped down his arm with no reported adverse event; dose was supposed to 0.50 ml , however only about half was injected with no reported adverse event; Initial information received on 16-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 25 years old male patient and it was reported that dose was supposed to 0.50 ml , however only about half was injected with no reported adverse event and rest of the vaccine dripped down his arm with no reported adverse event , while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Aug-2022, the patient was supposed to receive a  dose of 0.5 ml of suspect  , however only half was injected (incorrect dose administered) (latency: same day) and it involved vaccine INFLUENZA QUADRIVAL A-B VACCINE , prefilled syringe, (frequency: once) (lot : UT7682LA ; expiry date: 30-Jun-2023) via intramuscular route in the left upper arm  for immunization.  The reporter stated that  she attempted to inject FLUZONE QUADRIVALENT PFS 0.5mL into a patient's left upper arm. She inspected the needle 3 times. During injection, approximately half of the FLUZONE QUADRIVALENT leaked out where the needle is attached. The patient stated that he could feel some of the vaccine going in. The rest of the vaccine dripped down his arm (accidental exposure to product) (latency: same day). She asks if the vaccine was valid or if she should reinject   Action taken : not applicable.  Outcome: unknown  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.
Pt recvd 3 doses of Hep B vax & subsequent lab testing showed a pos test for Hep B core antibody; no further details were provided;
This is a spontaneous report from a non-clinical-study program from a non-contactable consumer. This is a spontaneous report from a non-contactable consumer or other non HCP. A 8-year-old male patient of an unspecified ethnicity received PREVNAR 13, on an unspecified date, and PREVNAR, on an unspecified date to an unspecified date. Medical history and concomitant medications were not reported. The patient experienced pneumonia last year in Jan2012 in both lungs with crackling in chest. Lab data included x-ray on unknown date. Unspecified antibiotics, nebulizer were prescribed as a result of the events and the patient recovered after 2 weeks. No follow up attempts possible. No further information expected.
Tingling in feet; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bone spur.   On 17th February 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 30 days after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details were reported as follows: The patient stated that he received dose 1 of Shingrix and felt a tingling in his feet one month later.  The reporter consented to follow up. The case has been linked to the case US2019156572, reported by same reporter for same patient.
Subsequent to receiving vax, the pt developed a mild local reaction which consisted of localized erythema.
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 17-JUL-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: