chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the first vaccine, I had a severe migraine for over 48 hours. I had to contact my neurologist for rescue medication.  After the second dose, I had chills, sweats, body aches, migraines, nausea, and dizziness for 24 hours.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 02-JUL-2008, patient received the first dose of GARDASIL (dose, route and lot number were not reported). On 13-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not reported), which was late. The patient then, on 14-OCT-2013, received the third dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. No symptoms reported. Additional information has been requested.
Vaccine administered after it was stored at room temperature for 18 hours; Headache; Muscle aches; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LISINOPRIL, FUROSEMIDE, METOPROLOL and WARFARIN for an unknown indication.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received and new events were added.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 07-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Three hours post vaccination, the patient experienced generalized spots, fever and itching. Medical attention was sought. No further information is available.
"Deceased (11.17.21); Hospitalized (11.16.21); COVID-19 positive (11.13.21); Fully vaccinated. x2  Discharge Disposition: Deceased   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: CO2 narcosis [R06.89] Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] COVID-19 [U07.1] Acute respiratory failure with hypoxia and hypercapnia [J96.01, J96.02]   HOSPITAL COURSE: 73 yo male who is a resident of facility.  Patient presented to the emergency room with several days of worsening dyspnea and decreased responsiveness.  He had had a positive COVID-19 test on November 13. In the emergency department he had a blood gas demonstrating a pH of 7.16 with a P CO2 of 104. He was do not resuscitate and do not intubate status.  He was treated with BiPAP in the emergency department and had improvement in his blood gas to a pH of 7.26 and pCO2 of 75, with resulting improved alertness.  He was admitted to intensive care unit and started on IV remdesivir and IV Decadron and was continued on BiPAP.  A repeat blood gas at 1:55 a.m. showed pH 7.04 and a pCO2 of 120, and was associated with decreased responsiveness.. He subsequently had oxygen desaturation and became completely unresponsive.  In the morning repeat arterial blood gas showed a pH of 6.83 with a pCO2 greater than 150. I contacted his legal guardian and reported his declining condition with a grave prognosis.  He subsequently developed bradycardia followed by ventricular fibrillation and expired at 10:56 a.m..
01/31/22 presents to ED for "Fall and electrolytes abnormality". PMHx of "chronic abdominal/suprapubic pain due to pelvic floor dysfunction, urinary retention s/p SP catheter placement, recurrent UTI, PTSD, anxiety, seizure disorder, schizoaffective disorder"
9SEP98 parents report pt balance is off;pt falling down on lt leg;lt leg warm since Friday p/vax;fussy/crying Wednesday AM;calmed down p/battle;scratch on ear from fall;
This spontaneous report was received from a healthcare worker (medical assistant) and refers to multiple unspecified patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies. On unknown dates, the patients might have been vaccinated with improperly stored doses GARDASIL 9 (lot # M007764 and expiration date 30-JAN-2018, lot # M021407 and expiration date 30-APR-2018, lot # M018810 and expiration date 28-MAY-2018; site, doses and route of administration were not reported) for prophylaxis. The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature between 8.4 and 14.5 Celsius degrees for 368 hours. No previous temperature excursion was reported. No adverse effects were reported. The reporter stated that after she became aware of the temperature excursion, no vaccines were administered to the patients that were improperly stored. This is one of the several reports received from the same source. The attempt to contact the reporter on 22-DEC-2016 has been unsuccessful. Additional information is not expected as no further information is available. Reporter information and narrative were updated. Sender's Comments: US-009507513-1611USA001675: US-009507513-1611USA001676: US-009507513-1611USA001677: US-009507513-1611USA001674: US-009507513-1611USA000940: MERCK 1611USA001678: Mfr number.
24 hours after vaccination-rt arm red hot (extended from shoulder to mid torso). Also flu symptoms & slight fever. Worsened symptoms on 2md day. Treated with ibuprofen & APAP. Began to improve on day 2. By am of day 4 symptoms gone.
Patient describes day after receiving vaccine developing a big red lump (~5" in diameter). She also developed nausea, a headache, extreme lethargy, and severe diarrhea.
From initial information received on 10/28/03 from the patient regarding an adverse event occurring in the USA, it was reported that the 62 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1090AA, administered in the left deltoid ( route of administration not reported) on 10/04/03. Within 24 hours, the patient developed fever, night sweats, chills, muscle aches and persisting weakness. The patient had lymphocytic leukemia at the time of vaccination. The patient's recovery status is unknown.
pt had been treated for a cold & ear infect approx wk p/vax; vax given 10NOV93 pt died of SIDS 4DEC93;
chest congestion and wheezing started about 2 minutes after injection.  I thought I was having a panic attack so I didn't report it.  Wheezing continued for approximately 18 hours.  I took Zyrtec and Pepcid, as well as used steroid inhaler for relief.
Felt immediately dizzy, lasted several hours, somewhat nauseous and slight headache now 9 hours later and still currently active with these symptoms.
a patient received the Pfizer Bivalent COVID Vaccine for adults on Day 71 after being placed in the refrigerator; a patient received the Pfizer Bivalent COVID Vaccine for adults on Day 71 after being placed in the refrigerator; anxiety; psychotic; ADHD; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 38-year-old female patient 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 completed; Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "a patient received the Pfizer Bivalent COVID Vaccine for adults on Day 71 after being placed in the refrigerator"; ANXIETY (non-serious), outcome "unknown"; PSYCHOTIC DISORDER (non-serious), outcome "unknown", described as "psychotic"; ATTENTION DEFICIT HYPERACTIVITY DISORDER (non-serious), outcome "unknown", described as "ADHD". Therapeutic measures were taken as a result of anxiety, psychotic disorder, attention deficit hyperactivity disorder.  Additional information: Caller wanted to get information after a patient received the Pfizer Bivalent COVID Vaccine for adults on Day 71 after being placed in the refrigerator. Caller confirmed that the vaccine did not have any excursions. Caller stated that her colleague had already called to report the AE. Caller did not have patient details. She is on anti anxiety, anti psychotic and ADHD medications.  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.  Follow (29Jun2023): This is a spontaneous follow-up report received from a contactable Pharmacist. This Pharmacist reported in response to the Non-HCP letter via email follow up that included: Updated information: new events added  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.
Vaccine was given in multiple doses aver the course of. 5 hours due to history of MCAS. Post second  dose GI manifestations of mast cell activation. Syndrome started - abdominal and esophageal pain which were treated with Pepcid ac. 48 hours post vaccine facial flushing and hives appeared all over both arms. Extreme fatigue, shaking, gi pain, etc. Mast cell activation syndrome was well controlled pre vaccine post vaccine it is out of control with increased scores. Serious anaphylaxis first occurred two days post vaccine (10 April 21) and required two epi pens to stop. since then there have been daily mast cell attacks consisting of headaches, fatigue, gipain, hives all over arms, and legs, shaking,. Patients Xolair dose was increased and Zyrtec was increased on 22 Apr 2021) to no avail. I continue to have daily debilitating mast cell symptoms. I had serious anaphylaxis again on 23 APR 2021 - full body hives, flushing, vomiting, difficulty breathing, low blood pressure is chin required epinephrine. I fear for my life and wish I had never gotten the vaccine. This is completely debilitating.
Bad reaction; felt like almost paralysis/could not move; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction) and MOBILITY DECREASED (felt like almost paralysis/could not move) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 038K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (2 eye drops a day for Glaucoma.) and Sulfonamide allergy (Suspicion of Sulfa allergy). Concomitant products included VITAMIN D3 for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction) and MOBILITY DECREASED (felt like almost paralysis/could not move). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Bad reaction) was resolving and MOBILITY DECREASED (felt like almost paralysis/could not move) outcome was unknown.            Concomitant medication also included unspecified 2 eye drops for glaucoma. Patient did not had positive COVID test or diagnosis.
pt recv vax 17JUL98 in the afternoon;by that noc had fever 104 & irritability & fussines;no other sx;had nl exam x/flushed cheeks;sx resolved p/2 days;
Case number PHHY2013US109495 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with RABAVERT (batch number: not reported) on an unknown date. Two days after vaccination, the patient developed systemic arthus type allergic reaction with facial edema and urticaria. The outcome of the events was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Patient started to not feel well on 2/21/2021.  Symptoms progressed throughout the week.  Patient was seen for a clinic appointment 2/26 and was then admitted to the hospital.  Patient complains of generalized weakness, body aches, fever, chills, cough and increased shortness of breath at rest and with activity. He was diagnosed with Pneumonia due to COVID-19 infection and started on oxygen, dexamethasone and remdesivir.
Patient presents to the emergency department complaining of intense abdominal pain. He has been having nausea, vomiting and decreased appetite. He was found to have acute appendicitis. He was subsequently brought to surgery and remains hospitalized at this time.
She said that her girlfriend had blood clots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, 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: THROMBOSIS (medically significant), outcome "unknown", described as "She said that her girlfriend had blood clots". Clinical Course: She said that her girlfriend "almost lost her leg" and had "blood clots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fatigue; headaches; shortness of breath; nausea; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Aug2023 at 16:00 as dose 1, single (Lot number: GK0928) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 28Aug2023, outcome "not recovered"; INFLUENZA LIKE ILLNESS (non-serious) with onset 28Aug2023, outcome "not recovered", described as "flu like symptoms"; HEADACHE (non-serious) with onset 28Aug2023, outcome "not recovered", described as "headaches"; NAUSEA (non-serious) with onset 28Aug2023, outcome "not recovered"; DYSPNOEA (non-serious) with onset 28Aug2023, outcome "not recovered", described as "shortness of breath". The events "fatigue", "headaches", "shortness of breath", "nausea" and "flu like symptoms" required physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, dyspnoea, nausea, influenza like illness.  Additional Information: The patient has not taken any other vaccination in four weeks. 5 mental health treatment medications were taken in two weeks. The patient has been experiencing fatigue, headaches, shortness of breath and nausea. More flu like symptoms in the mornings and evenings. The patient was diagnosed with covid prior to vaccination and was not diagnosed with covid post vaccination. Has no known allergies
12-15 hours following the vaccination: uncontrollable shivering without a cold sensation, hot flashes, headache, muscle pain, joint pain, skin sensitivity.
Patient states she felt numbness in both hands approximately 3 hours after receiving vaccine.  Approximately 6 hours after receiving vaccine, she states she began experiencing palpitations.  Later in the evening she felt she had a fever (Temp 99.4).  She states that she felt things were blurry at that time.  Patient stated that she felt weak later in the evening, and continues to feel weak the next morning.  She plans to visit her doctor today.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-APR-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 216 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medication and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
she experienced nausea and shakiness; she experienced nausea and shakiness; This is a spontaneous report from a contactable pharmacist. A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: unknown), dose 2 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunisation. On an unspecified date, the patient experienced nausea and shakiness. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Slight cough; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (Slight cough) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced COUGH (Slight cough). At the time of the report, COUGH (Slight cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient age was reported as 3.5 years.  Concomitant medication information was not provided by the reporter.  Reporter wanted to know if the vaccine can cause a false positive from the antigen test before they give the child the antigen test.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Within 15 min of receiving vaccine patient felt she had  severe dryness in her mouth and throat. she felt a lump in her throat and tingling of her tongue. For the next one hour she was monitored. Her BP was in the 150/85 range, P  from 94-84 bpm range and pO2 was between 94 - 96%. she was given 25 mg Diphenhydramine PO and was sent home independently. since her symptoms had improved. She was referred to the clinic's allergist and encouraged to contact her primary care provider.
arm soreness; mild to moderate headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient was 5 months pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; HEADACHE (non-serious), outcome "unknown", described as "mild to moderate headache".  This (Age: 34; Unit: Unknown) female consumer reported for herself. 24 hours following receipt of the second dose of Pfizer's COVID-19 vaccine, patient experienced arm soreness and mild to moderate headache. Patient is in month 5 of pregnancy and elected to receive. Patient in month 5 of pregnancy and elected to receive vaccine after discussion with doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Twelve days post injection the patient experienced a sore throat, with a rash at the back of her throat. The patient also had a rash on her face and arms and blisters on her nose and ears. The patient saw her PCP on 08/07/2001 and was treated with prednisone and 4D. The patient feels febrile but has not monitored temp.
ONE WEEK FOLLOWING 1ST INJECT, PT DEVELPD ABDOMINAL PAIN/CRAMPS, DIARRHEA. A STOOL CULTURE WAS ORDERED. AS OF 4-19-90 NO TREATMENT GIVEN AND ALL SYMPTOMS PERSIST.
Around 3 pm, patient's arm started aching, really red and swollen, painful and also feverish.
Resident had a temperature of 103.1 and complained of a severe headache. Truncal ataxia noted. Resident received booster dose of Moderna Vaccine on 12/14/21. Transferred to the ER for STAT head CT to rule out intracranial bleed.
Fever over 7 days....blood red eyes, abdominal pain, swelling tongue, swollen glands.
Received vaccine July 29 menstrual cycle came on time on Aug 6th.  Received 2nd Vaccine on August  19th  got another period on August 28th. September period on time. October I had no period took pregnancy test was negative. I have been regular with my periods my whole life. Never had two periods in one month nor have I ever missed a period except when I was pregnant. Even with my thyroid issues I never had issues with my periods until now.