chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Little bit of headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 23Feb2021 as single dose for covid-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. She had a sore arm for a few days after the vaccine, but that it was typical. She had a little bit of headache, but it was not a big deal and it went away in less than a day. Scheduled for second dose 19Mar2021, which was canceled because the site closed down. Was rescheduled for 1Apr2021 at a different location. Event outcome of headache was recovered, of sore arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports a harden area approximately nickel size to left deltoid. Site painful to touch. Patient is able to have full range of motion, no other problems associated with site.
High fever, somnolence, twitching & irritability; Hospitalized; Appears well now;
VACCINE USE BY DATE 12/12/2021, VACCINE ADMINISTERED 12/13/2021
Four months subsequent to receiving one dose of varicella virus vaccine live the pt developed rash on her face. Gradually the rash spread to her neck, back and arms. The rash blistered and the pt was mildly sick. Pt was treated with Benadryl and oatmeal baths.
I noticed Left underarm tenderness as I woke up on 1/25/21. Upon further examination, I discovered that what I believe to be my left lymph node is noticeably swollen and tender to the touch. No treatment has been initiated at this time.
Mom reports a light red pin point non raised rash on back of right hand about 2 inches in diameter and the top part of thumb on the same hand. The same rash was reported on her nose, cheeks and under her mouth. Mom described the color red as if the child had drank koolaid and had a stain mark. Mom reports she called the Emergency Room and was told to apply Benadryl cream to the rash areas. I called mom on November 8th at 9 am and she reported that the rash was gone and was no longer applying the cream. Mom also reported that the child did not get sick or have a fever.
Got the 3rd dose without being immunocompromised; Loose bowels/diarrhea; Can't eat; Little to no appetite; Very weak; Nausea; Tired/extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak) and NAUSEA (Nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included CELECOXIB (CELEBREX), CORTISONE, BIMATOPROST (LUMIGAN) and GABAPENTIN for an unknown indication.    On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced OFF LABEL USE (Got the 3rd dose without being immunocompromised). In September 2021, the patient experienced DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak), NAUSEA (Nausea) and FATIGUE (Tired/extremely fatigued). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. On 12-Sep-2021, OFF LABEL USE (Got the 3rd dose without being immunocompromised) had resolved. At the time of the report, DIARRHOEA (Loose bowels/diarrhea), DYSPHAGIA (Can't eat), DECREASED APPETITE (Little to no appetite), ASTHENIA (Very weak), NAUSEA (Nausea) and FATIGUE (Tired/extremely fatigued) had not resolved.       Concomitant medication included Thyroid medications 75 mg once a day.  It was reported that patient was not immunocompromised and the pharmacists indicated to get the shot.  The patient discontinued the medication Gabapentin after Dose 3 because of nausea.  A week after, Patient started having loose bowels and nausea and  had to go to the ER.   This case was linked to MOD-2021-354559, MOD-2021-354564 (Patient Link).
This spontaneous case was initially received on 08-Feb-2016. The case report was received from a Health Professional and concerns a 61 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 01-Feb-2016 - 01-Feb-2016, Batch no: U51309, Route of administration: intramuscular, Dose: 0.5 ml. No additional drugs suspected. A temperature excursion occurred with the AFLURIA PFS at 34.9 degrees Fahrenheit for 4 hours on 20-Jan-2016. On 01-Feb-2016, the patient experienced received AFLURIA administered by a medical assistant after first temperature excursion/medication error, (patient received) AFLURIA (administered by a medical assistant after] first temperature excursion. No vaccine has been administered after the second temperature excursion. No adverse event has been reported by the patient. AFLURIA was discontinued. For relevant tests results see appropriate report section. Reporter's assessment/comment: The reporter reported the term 'medication error'. Case correction 04-Mar-2016: AE re-coded to LLT vaccination error.
About 48 hours, post vax, pt developed a fever to 105F (at home). Seen in office with a fever of 103.5F. Right thigh, at DTAP site, slightly red with minimal induration. Resolved in a few days.
Inconsolable screaming for over an hour. Swollen, red, and hot skin at vaccine location. Swollen area was about the size of a baseball.
Pt with immediate wheal and flare at injection of vaccination which spread to 2-3 inches from injection site w/in 1 minute. No resp or GI sx, VSS. BENADRYL given and sx resolved.
ACHING, PAIN ALL OVER BODY, FEVER OF 103.7, HEADACHE AND JOINT PAIN. THIS BEGAN AT 2 AM ON 4/17/18 AND ENDED ON 4/18/18. ABLE TO RETURN TO WORK ON 4/19/18.
sore left arm; Patient received expired vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was pregnant and pregnancy due date was Nov 2021. No concomitant medication information were provided. No treatment medication information was given.  This case involves a 32-year-old female subject with n information on medical history who experienced the unlisted non-serious adverse event of expired product administered and the listed adverse event of vaccination site pain at her second vaccination. The patient was pregnant at the time of both vaccinations. The due date of the pregnancy has been reported for November 2021. The pregnancy has not been impacted by the vaccinations The re-challenge is positive for vaccination site pain.   The benefit-risk relationship of mRNA-1273 is no affected by this report.   This case was linked to MOD-2021-336915 (Patient Link).; Sender's Comments: This case involves a 32-year-old female subject with n information on medical history who experienced the unlisted non-serious adverse event of expired product administered and the listed adverse event of vaccination site pain at her second vaccination. The patient was pregnant at the time of both vaccinations. The due date of the pregnancy has been reported for November 2021. The pregnancy has not been impacted by the vaccinations The re-challenge is positive for vaccination site pain.   The benefit-risk relationship of mRNA-1273 is no affected by this report.
Felt strange; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt strange ) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history information  was reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Felt strange ). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt strange ) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.   This case was linked to MOD-2021-313642 (Patient Link).
Severe inflammatory responses beginning on 4/5/21 ER visit: Extreme pain and sensitivity in breast/chest.   Severe inflammation, pain and redness in lower leg.  ER Visit 5/25/21 Gastritis.  Abdominal swelling and pain.  (scheduled to see GI)  Pain, swelling in joints.  Inflammation of bladder lining.  Blood tests show inflammatory issues.  All former autoimmune issues are pronounced.
Localized redness of injection site. Mother was called. Benadryl given per protocol with permission. No further s/s.
After administration of the covid-19 booster- site on injection immediately  became red, swollen, and hard.   Pt became nauseous.
Dizziness and fainting for few seconds   Provided support so that patient does not fall. Monitored airway and breathing. Once patient got conscious , provided water and gatorade.  Monitored her for 45 minutes and kept checking how alert and oriented she was.
Effusion of right knee. Swelling. I saw my doctor who has referred me to an orthopeadic
Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history, drug reactions or allergies reported, who "about a year ago", in approximately 2009, was vaccinated with the first dose of GARDASIL (route and lot # unknown). There was no concomitant medication. In approximately 2009, "about a year ago", after the patient received the first dose of GARDASIL she fainted. No lab diagnostic studies performed. The patient did not seek medical attention. The physician reported that the patient recovered after fainting and was able to leave the office that same day. Additional information has been requested.
13SEP93 pt devel inc temp of 102, h/a, painful knee joint, no rash; 14SEP93 no painful knee joint; no inc temp, poor appetite;
Patient had myalgias at day 7 post vaccine. Severe headache global x <24 hours. Severe muscle weakness. Severe fatigue, symptoms routine except headache which disappeared in 24 hours.  03/07/8/07-records received from rheumatology consultation for DOS 03/02/07-Impression: Myalgias, dysethesias hands and feet, increased fatigability, oral ulceration/cankers;possible rare reaction to either flu or Gardasil. Rule out vasculitis, lupus and other connective tissue disease. C/O severe body pain, weakness, headache lasted 1 day but has had persistent generalized muscle pain. Transient numbness in hand, face and feet. Eyes feel sore, some twitching of eyelids. PMH: Seizure as infant after pertussis vaccine and never completed the series. No recurrence of seizure and did not appear to be febrile seizure.  Mother has multiple sclerosis.  PE:Muscles tender to palpation pretty uniform throughout body, not so much in hands as in forearms, arms, trunks, legs, calves.
QUARTER SIZED SWELLING AT VARICELLA VACCINATION SITE (RIGHT BACK OF THE ARM). HAS SINCE SWELLED TO 40MM IN DIAMETER. NO TREATMENT OR MEDS AT THIS TIME.
Vomiting   diarrhea  Chills  Nausea  Fatigue (all severe) all lasted 7 days  except vomiiting lasted 2 days
This spontaneous report as received from the healthcare worker refers to an multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot number: 1010595 and expiry date: 12-NOV-2016) (dose, frequency and route of administration was not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of the 4 reports from the same reporter. Additional information has been requested.
Ten hours after the vaccine, I ran a fever of 100.5. I had the chills, body aches, and a headache. The next morning, I felt fine. It lasted about 12 hours.
Vomiting began about 2 hrs. after injection, on Weds, 9/29/2010, nausea and vomiting Weds-Friday, on Friday went to hospital, was given nausea meds and sent home, returned to hospital on Sunday and was admitted for fluids, in hospital as of 10/5/2010.
After 2nd dose following events occur deteriorating overall health. I don't have any preexisting health conditions. 1. On May 24th at around 12.15 am, I started experiencing 100 degree fever followed by chills. The blood pressure shot up to 165-95 and heart rate was around 140. Was feeling breathless and sweaty and was being rushed to ER . 2. On 30th May again experienced BP at 165-90 and pulse was at 150 and rushed to ER 3.Again on May 31st, BP shoot up to 170-90 and pulse 145 and ER visit. 4. Consulted cardiologist and on Metoprolol medicine 5. Always feeling dizzy and lightheaded with unprovoked rise in BP and pulse. 6.Unable to resume regular day to day activities including office work. 7. Daily fluctuation in BP and pulse observed till now since 2nd dose of vaccine.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Chills, Congestion, Sore Throat Narrative:
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm 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's relevant medical history included: "Hypoglycemia" (unspecified if ongoing); "Leaky Gut" (unspecified if ongoing); "Muscle Spasms" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Antibiotics-cillians, reaction(s): "Allergy", notes: Name of Drug as Reported: Antibiotics-cillians, Reaction: Allergy. The following information was reported: COVID-19 (medically significant) with onset Jan2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jan2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received any other medications (Larin Fe 1.5/30 MG-MCG TAB) within 2 weeks of vaccination. Patient took Paxlovid (lot no. GE3014) antiviral COVID 19 treatment form 29Jan2023 to 02Feb2023. Felt very good until about 8pm Friday. Exhaustion hit. Slept almost all of Saturday and Sunday. Cold like symptoms started Monday - throat and nose. Continued progression. Lots of sneezing currently (Thursday 09Feb), fatigue, exhaustion, chest pain, shortness of breath. Symptoms have increased each day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
red mark at injection site - 5 inches, arm swelling 6 inches down from site, itchy, fever, cellutlitis looking
burning in arm after injection greatly surpassed 2 previous shots...lasted approx 1 hour. ringing in ears started approx 3 hours after injection (1030 am) headache followed severe at first for approx 8 to 10 hours then tapered off to dull throb lasting approx 3 days. Flu like symptoms kicked in approx 4 to 5 hours following shot. tearing of eyes, runny nose, head congestion, ear stuffiness/ slight ringing... all these symptoms still persisted for 3 days after shot received. Self treat with Motrin, various over counter cold / flu treatments. Here on 4 day just starting to subside.  no reactions like this to first 2 shots 15 dec and 29 dec 2002.
Neck, shoulder, arm, trunk pain.  chills.  neck and axilla adenopathy.  possibly related to using NSAIDS around vaccination
March 28:  Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache.  Unable to function, think clearly, or eat/drink.  No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this.  Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped.   Have been on the BRAT diet since April 4th.  Began taking a prescription from doctor to help with diahhrea on April 8.   Still experiencing dizzyness, lack of clarity.
was dizzy; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (was dizzy) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced DIZZINESS (was dizzy) and PRODUCT DOSE OMISSION ISSUE (Missed dose). On 25-May-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. At the time of the report, DIZZINESS (was dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Patient stated that he is under medications but not specified.   Reporter did not allow further contact
Onset 4:30 pm itchy rash to face, chest, back, upper arms, under arms. Temp 101.1 at 11:00pm. Today generalized rash. Concurrent therapy Bactrim, Cephalexin for insect bite, allergy to cats. TX: Kenalog, CLARINEX.
pt devel clonic movements of arms & legs post-ictal periods;this activity cont for next 24hr;
Pt here for more vaccination reports after had Hep B & Inactivated Typhoid vaccine in left arm. Arm started to feel sore felt lightheaded/sick then HA. Symptoms went away later in day.
A nurse reported that a 32 year old female received Pnu-Imune-23 and Td vaccine on 04/11/01 On 04/12/01, the patient developed an injection site reaction characterized by redness, soreness and induration at the site of Pnu-Imune-23 administration. As of 04/14/01, her symptoms persisted. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 470-592). FOLLOW-UP information received from the physician on 07/03/01 indicated that the patient received vaccines on 04/12/01. On 04/13/01, the patient developed an injection site reaction characterized by a 3-inch area of redness and soreness which "continued to enlarge over the next several days." On 04/14/01, the patient was advised to treat her symptoms with "local care, including ice" On 04/16/01, the patient was seen by the physician who noted that the patient had developed an area of erythema, "slight warmth, "Mild" induration and tenderness "covering the shoulder and half-way down the elbow." The physician considered the reaction to be "possibly a cellulitis" and treated the patient with "IV" Rocephin (ceftriaxone). The patient was subsequently treated with unspecified oral antibiotics. A blood culture was negative and the patient's white blood cell count was 9,100 cells/cubic mm. the physician indicated that the patient recovered "completly."
Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in case numbers 2014SA071241, 2014SA071253, 2014SA071262, 2014SA071266, and 2014SA071260. A 13-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
two unspecified patients, who were over the age of 64 years old and already had cervical cancer; two unspecified patients, who were over the age of 64 years old and already had cervical cancer; No adverse events; This spontaneous report was received from a pharmacist via a company representative and refers to a female patient over the age of 64 years old. The patient had already experienced cervical cancer.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse events were reported.   This is one of two reports received from the same reporter (linked with MARRS # 1909USA004120).; Sender's Comments:  US-009507513-1909USA004120:
HPV & Flu vaccine administered in Both thigh pt stood up and passed out; Hit trash can Bruise on Left eyebrow
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011:
Spontaneous burning sensation on the skin, reflux, skin infections, muscle and joint pain, arthritic, weight gain.
Headache, Myalgia, UrticariaPruritus, Knott on the arm at the site, urticarial rash only at the site of the injection Narrative: Employee taking Ibuprofen every 8 hours for the myalgias