chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NAUSEA; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported.     Concomitant medication included omeprazole for celiac disease.     The patient received nasal Flumist Quadrivalent (influenza vaccine (live, attenuated)) 0.2 ml, on an unknown date.     On an unknown date, the patient experienced nausea (preferred term: Nausea).     The outcome of the nausea was unknown.    The company Physician assessed the nausea as non-serious.
HIVES, SWELLING OF LIPS, PT WAS GIVEN BENADRYL AND A NEBULIZER BREATHING TX AND TAKEN TO ER
This spontaneous report was received from a registered pharmacist refers to an about eight patients of an unknown age, who on an unknown date were vaccinated with a dose of ZOSTAVAX (doses, routes and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that out of the twenty ZOSTAVAX injections that she had administered about eight patients had had injections site reaction of red, swelling of about one inch radius and two inches in diameter, no rash. The pharmacist reported that two patients had come in to show her the injection site reaction, but there had been about eight people in total who had the injection site reaction. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The relatedness for injection site reaction of red and swelling of about 1 inch radius and 2 inches in diameter was unknown for ZOSTAVAX. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 10-year-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medications included Multivitamins (Daily vitamin). On 19 September 2013 at 15:00 the subject mistakenly received a dose of PEDIARIX (unknown route, unknown deltoid), and experienced inappropriate age at vaccine administration. The subject was older than the indicated age for administration of PEDIARIX. On 20 September 2013, 1 day after vaccination with PEDIARIX, the subject experienced "arm discomfort" (arm discomfort at injection site). The event was reported as a local injection site reaction. At the time of reporting the outcome of the event was unspecified.
Erythema, warmth, swelling and tenderness at injection site. Lesion approximately 10 cm in circumference. Tender and enlarged axilla lymph node on the same side. Breast tenderness on the same side.
top of shoulder very sore; unable to raise arm w/o pain site of inject; shows no abnormalities; seen by MD who prescribed Anaprox DS;
Maculopapular rash starting on face and progressing to trunk.  No treatment needed c/w measles vaccine associated rash.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Irritated and itchy  skin all over body resulting in very pronounced raised hives and rash. First noticed in scalp but present on entire body.
Hives noted on arms, legs, torso, feet and hands on 12/26/20 (vaccine received 12/24/20)- went to an Urgent Care clinic on 12/28 and received Steroid 7-day pack.  After 5 days the hives resolved.
SIRVA - patient is complaining of pain in upper arm after the immunization and has seen her doctor. The pain has persisted for 3 months now and has gone to her fingers. She has been referred to a specialist.
PATIENT RECEIVED DOSE #2 TOO EARLY. RECEIVED DOSE #1 ON 2/24/21 AND SECOND DOSE ON 3/5/21. PATIENT REPORTS NO ILL EFFECTS. CDC DOES NOT REQUIRE ANY MORE DOSES. PATIENT NOTIFIED.
Blood pressure spike wouldn?t come down, rash on neck face and chest, happened with in 10 minutes of the shot. NP gave me a shot of 50mg of Benadryl monitor me for 1 1/2 hrs. Blood press was still high. Had taken my BP meds in the morning. I called my doctor from the parking lot. Had epi pen ready if needed.
worsening fatigue, brain fog, orthostatic intolerance, chest pain, SOB/breathlessness, headaches, rashes, pruritus, neuropathy and neuralgia
pt states she had extreme dizziness having to hold herself up. The extreme dizziness lasted about 2 days.  States she is still lightheaded.  The next night after after her spine hurt from neck down to lower back. pt seems better today but not completely well stating she still getting dizzy spells. pt states she no longer has any back pain.
Second dose had not yet been given; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 10 months ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Second dose had not yet been given). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Swollen, painful to touch, lymph node - cervical - left side  - just above clavicle.  I have not sought treatment, but wanted to report.
8 days after receiving my first dose, Just below the vaccination site on my left arm suddenly became very hot, swollen, and sore. A day later, a round patch just under the injection point remains and is about the diameter of an apple. At the time of the injection, my only side effects were a sore arm and a bruise. The soreness was gone but the bruise still remains.
very severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Lot number: ER8736) at the age of 19 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal allergy" (unspecified if ongoing); "Allergic to pollens" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN ALLERGIC taken for seasonal allergy. Vaccination history included: Bnt162b2 (Dose 1, LOT# EW0153), administration date: 09Apr2021, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "very severe headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient experienced very severe headache after the second dose of Pfizer COVID-19 vaccine and was wondering which medicine she should take. It was also reported that the patient took Aleve as treatment.   No follow-up attempts are possible. No further information is expected.
Patient presents to clinic with red rash estimated 4x2inch rash on right deltoid. History as follows:  Vaccine given 06/16/2023. Tenderness noted at right deltoid from 16th - 21st  06/21/2023 afternoon noted small, non-discolored bumps at the site. Itchiness at site. Patient applied cortisone cream at home and this helped.  Today patient noted red rash of 4x2 inch area. Bumps resolved. Outside of wound is itchy. Whole arm aches. site is tender. Kenalog cream and claritin oral ordered.
no adverse event; Nurse reports possible administration of improperly stored vaccines; This spontaneous report was received from Other Health Professional, referring to unspecified patients.  Nurse reported possible administration of improperly stored vaccines. No additional adverse events were reported.   The names of vaccines involved (including lot/exp): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9): Lot: 1775808  Expiration: 20-AUG-2023; Lot: T030749  expiration date: 16-MAR-2023; Lot: 1687293  expiration date: 30-APR-2023; hepatitis a vaccine, inactivated (VAQTA): Lot: T031202, expiration date; 14-JUN-2022, Lot: U026792 expiration date: 28-OCT-2022; hepatitis b vaccine (recombinant) (RECOMBIVAX HB): Lot: T021327, expiration date: 14-NOV-2022; Lot: U008328, expiration date: 16-DEC-2022.  All lot number were verified to be valid, (route and anatomical location were not reported) administered for prophylaxis.   It was reported that the vaccines had been incorrectly stored at -0.3C for 5 minutes and then at 0.3C for 45 minutes. There was no previous temperature excursion  Follow up information was received from the nurse on 09-JUN-2022.  The patient's demographics were provided for all the patients involved in previous event of improperly stored vaccines.  This spontaneous report was referring to a 15-year-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 05-MAY-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1687293, expiration date: 30-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).  This is one of multiple reports received from the same source.
Within an hour after getting the vaccine, I began to feel nauseous and had diarrhea. Upon calling the health center, they said that I may have eaten something bad. Around 6pm the same day, I started sweating but I was freezing, and had a headache and muscle pain. I had a 101 fever and that persisted until the next day (3/24/21). It is currently (3/24/21) and I have noticed sharp chest pains on the right side of my chest throughout the day, especially when exerting forces breathing (such as riding my bike or walking up stairs, or getting into and out of bed). I still have a slight fever and feel very cold, but I in fact, still have a slight fever of 100.4
Headache...muscle aches and pain...fever...nausea...for day and a half.  The second dose was worse and lasted almost 3 days.
developed swollen lymph nodes on the left side of his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 11:00 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, SINGLE, Time: around 11:00), administration date: 11Jul2021, for COVID-19 immunization, reaction(s): "arm pain".  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Aug2021, outcome "recovering", described as "developed swollen lymph nodes on the left side of his neck".  Additional information: The patient received his second dose of the Pfizer BioNTech Covid 19 vaccine on 01Aug2021 (reported as this past Sunday) on the left side. Since then he has developed swollen lymph nodes on the left side of his neck. He reported it was a little sore last night and he thinks it was a little better, not as big, and still there. It was on the side if his neck where he got the shot. Thinks it was slightly improved. He was told to put a permanent marker around the area and know how big it was and check it in the morning. It was a little sore yesterday but today the lymph node does not feel sore but he still feels it. He wanted to know if this was a normal side effect and if he should be concerned. The patient thinks first dose was on 11Jul2021, left arm, around 11 am. He was unsure of the date of his first dose but states it was 21 days prior to his second dose. Second dose was on Sunday 01Aug2021, left arm, around 11 am. He did have arm pain with his first dose and it only lasted for a day. He was a little worried since the lymph node felt like it was kind of big. The patient was administered vaccine in a pharmacy. No additional vaccines were administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room or physician's office. The patient's prior vaccinations (within 4 weeks) were none aside of the first dose. The patient's relevant test were none.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient became immediately flushed, states she felt light headed, asked for water and was given, mom elevated patient feet on chair.  patient stated she was ok to stand, was escorted to the observation area and asked to lay down on gurney, EMT's tended to, patient vomited 200 ml, rested, observed for 30 min, vitals initially 114/66 in L,  P 89, 14 R  5 min later 120/78, P 80, R 14, then 10 min later 120/82 in L, 86 P, 14 R.  After 30 min observation, regained color, no longer flushed, denied weakness and nausea,  patient mother present during episode, states states no reaction after first vaccine, states this was a normal reaction for the patient when needles and vaccines involved.  Mother denied further medical care.  Left facility without difficulty.
Bullous at site of DTAP.  All 4 injection sites red, warm, 3-5cm size.  Diffuse macular skin eruption.
On 14 October I received a flu shot at my work from the traveling team.  I am a retiree and was authorized to get the shot.  It was administered by injection in my left arm by an individual.  I started noticing some swelling and small dark red areas as well as some yellow areas of the skin a few days ago.  Today is day six and the yellow area appears to be spreading down my arm and the red spots seem more pronounced. Today I visted Clinic to ask someone to take a look at it. LTC will see the patient. She said that he will not have to take any more flu shots. This is a moderate reaction.
Cold sweats; Severe body ache; Headache; Started feeling extremely tired; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW051) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 17:00, the patient started feeling extremely tired. On the same day at 23:00, the patient experienced cold sweats, severe body ache and headache. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started feeling extremely tired, cold sweats, severe body ache and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
The vaccine was administered outside of the expiration date range. The patient did have an immune response to the vaccine in that she "felt sick".
Provider summary " 58-year-old female with a past medical history of asthma, sleep apnea, lupus, rheumatoid arthritis, type 2 diabetes, hypertension, hyperlipidemia, anxiety, and depression who presented to the emergency department today after her primary care provider send her for hypoxia after testing positive for COVID the same day. In the emergency department she was tachycardic, tachypneic, and hypoxic.  Her CBC and CMP were unremarkable. Her D-dimer was elevated at 580. Her chest x-ray showed ground-glass opacities and possible right pleural effusion, and a pulmonary CTA showed COVID pneumonia and mediastinal and hilar lymphadenopathy, but no pulmonary embolism. She was started on Decadron, remdesivir and Duo-nebs. She improved over the next few days and got 3 days of remdesivir. She was able to go off of oxygen on 12/10/21 and was discharged home in stable condition."
Report A0370552A describes unresponsiveness in a 9 month old male who received hep B vaccine recombinant (Engerix-B). This report was received from the vaccinee's mother and has not been verified by a physician or other healthcare professional. The pt's medical history included Down's syndrome and hydrocephalus. The vaccinee reportedly had not experienced any adverse events following previous vaccinations. Concomitant medication included Zantac. The mother stated that on unspecified dates, her son received his first and second injections of hep B vaccine Recombinant (Recombivax-HB). On 04/26/2002, the vaccinee received his third injection of hep B vaccine recombinant (Engerix-B) at a dosage reported as .05. The lot number reported was S230AZ; which is  not a valid Engerix-B lot number. In the evening of 04/26/2002, the vaccinee was reported to have became "extremely irritable"; he was "not like him at all." this adverse event reportedly resolved a few hours later. On 04/27/2002, the vaccinee reportedly had the following events: "very tired, very listless," "started fluttering of eyes" and would not eat for two days. The events of "very tired, very listless," "started fluttering of eyes" resolved on the same day, while the event not eating did not resolve until 04/28/2002. Beginning on 04/29/2002, the vaccinee reportedly was "pale and lifeless, would not respond to us at all" and had a "bright red rash on face." The mother reportedly sought ER attention on 04/29/2002 because of her son's unresponsiveness. The ER reportedly subsequently transferred the vaccinee to the hospital because of his history of Down's syndrome and hydrocephalus. The reporter stated that her son "stayed overnight" at the hospital. The mother stated that her son "did not have high fever." The outcomes of the adverse events unresponsiveness and rash were unknown. Additional info has been requested. On 11/4/02, the vaccine provider reported that the vaccinee was observed in the hospital overnight because of possible seizure-like movements. The results of an EEG were interpreted as normal. The vaccine provider stated that the events resolved and were possibly related to Engerix B administration.
Pt. had localized reaction to VZV immunization back of rt. arm that measures approx. 1x2 inches. Site appeared red, swollen, soft and warm to touch. Advised to apply cold compresses QID to site. RTC is sx worsen.
Patient presented with shortness of breath and generalized body aches on 3/26/21.  Patient has had symptoms for 3 days, with new diarrhea as well.  No nausea vomiting, positive fever and chills, no loss of taste or smell.  He has chest pain that is pleuritic in nature, central lower sternal region.  Patient admitted to the hospital setting from 3/26/21 and still in CCU as of today (4/30/21).
Weakness; Felt tired; Fever for a day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FATIGUE (Felt tired) and PYREXIA (Fever for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Felt tired) and PYREXIA (Fever for a day). In February 2021, PYREXIA (Fever for a day) had resolved. At the time of the report, ASTHENIA (Weakness) and FATIGUE (Felt tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant information was reported.  Doctor advised to not to get the booster dose yet.  No Treatment information was reported.    This case was linked to MOD-2022-517968, MOD-2022-517821 (Patient Link).
Fever; This is a spontaneous report from a contactable consumer (Patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, lot number was not reported) via intramuscular route of administration in Arm Right on 12May2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had not received any vaccination 4 weeks prior to COVID-19 vaccine. On an unspecified date in May2021, the patient experienced Fever. Patient received treatment with paracetamol for the reported event. Reporter seriousness for Fever was unspecified. Patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, lot number was not reported), via intramuscular route of administration in Arm Right on 01Jun2021 for covid-19 immunization. The outcome of event was recovered on an unspecified date in May2021.  Information on Lot/Batch number has been requested.
This spontaneous case reported by a consumer, describes the occurrence of swollen right eye lid in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced a swollen right eye lid. At the time of the report, swollen right eye lid outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. No concomitant medication or treatment information reported.