chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 7 days after giving Zostervacc patient experienced redness and flushing on face and neck.  The next day a pruritic rash followed on neck.  On the third day patient had generalized rash on back, chest, arms and legs. Patients' mouth also itched.  Took cortisone cream and used for symptom relief.  Patient was new to our clinic the first day we saw her was 12/10/08.  Now patient relates that three weeks previous she was given the pneumococcal shot and the flu shot at another docotr's office. Patient did not utilize any emergency services.  At evaluation today 12/30/08 she has not wheezing but there are remnants of rash on her back and chest and alittle on the legs.  clinically she is stablile and has had no further problems.
Erythema, warm, (can be expected) but very itchy and then vomited. Non tender. Occurred 12 hours after given. Same reaction last year. Parents wonder if allergic reaction. She has significant erythema of right upper arm from shoulder to lower bicep on 9/29/17.
Date of Admission: 6/2/2023  Discharge Date: 6/2/2023 Discharge Disposition: deceased COVID+ 6/2 presented to the ED - witnessed cardiac arrest due to multisystem organ failure.  037A21B 3/25/2021 045B21A 4/27/2021 939909 11/22/2021
Multiple erythematous lesions on chest and back. Generalized vaccinia. Treated with claritin.
Pain immediately after Tdap injection left deltoid and pain has persisted since then especially with pressure such as sleeping on that side or when he lifts his arm
Information has been received via a field representative from a physician assistant referring to two patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (route, dose, strength were unknown). The two patients experienced syncope while on GARDASIL. They sought unknown medical attention. The outcome of syncope was reported as recovered. The causality was not provided. Additional information has been requested.
PATIENT SAID AFTER SHE LEFT THE PHARMACY. SHE WAS WALKING AND SHOPPING. SHE STARTED FELT HER LIPS WERE  LITTLE BIT TINGLING  , SWOLLEN AND ITCHING. IT WAS LAST FOR 45 MINS.  SHE DID NOT NOTIFY EITHER PHARMACY OR HER DOCTOR.
having mild symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (having mild symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having mild symptoms). At the time of the report, VACCINATION COMPLICATION (having mild symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the patient is confused about getting the booster dose.  No concomitant and treatment drug information was provided.
About 8 hours after shot was administered, a severe, painful headache began. A temperature of over 102 with convulsing chills, hot and cold sweats, and fatigue and body aches. The fever did not drop below 100 for 2 days after the shot. The body aches lasted over 24 hours. Was not able to get out of bed for nearly 48 hours after symptoms began. I developed a dry cough that last for a week after all other symptoms subsided. The headaches came and went but never as severe as the first night. Usually just a dull throb. The pain in the injection site was far less than with the first shot but still sore for a few days post shot.
patient did not receive the vaccine since that is the only dose they have left in the Pharmacy; syringe that is attached to the saline water and the spike that goes to the vial fell apart; This is a spontaneous report received from a contactable reporter (Pharmacist), Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG DOSE OMISSION BY DEVICE (non-serious), described as "patient did not receive the vaccine since that is the only dose they have left in the Pharmacy"; DEVICE CONNECTION ISSUE (non-serious), described as "syringe that is attached to the saline water and the spike that goes to the vial fell apart ".  Additional information: The pharmacist reported that the Abrysvo vaccine that he is reconstituting had a problem; stated that the syringe that is attached to the saline water and the spike that goes to the vial fell apart. The patient did not receive the vaccine since that is the only dose they have left in the Pharmacy and will get the shot next week once they received the new order. The pharmacist also requested for a credit on the vial that was not reconstituted.   Causality for "patient did not receive the vaccine since that is the only dose they have left in the pharmacy" and "syringe that is attached to the saline water and the spike that goes to the vial fell apart " was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Missed her second Moderna; Got 104 F fever just 1 day before second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna) and PYREXIA (Got 104 F fever just 1 day before second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Got 104 F fever just 1 day before second dose). On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed her second Moderna) had resolved. At the time of the report, PYREXIA (Got 104 F fever just 1 day before second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 104 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received their first dose of Moderna vaccine 04-Feb-2021 and was perfectly fine after that dose, The patient's second dose was scheduled on 04-Mar-2021, but the patient missed their second Moderna dose as on 03-Mar-2021 in night the patient got 104 F fever.  The patient took Tylenol and Ibuprofen for the symptoms, but symptoms didn't go away. The patient visited doctors and they prescribed antibiotics and steroids.  Reportedly, the doctor said that if it was viral infection then the patient has to take these medications.  No Concomitant product use was reported.  Treatment medications prescribed to the patient included antibiotics and steroids.
pt recvd vax 17NOV95 & 19NOV95 930AM devel 3 welts horizon across lt arm; 2" long- 1/2" below site of DTP; about 5PM became 1 big welt; dec activity-whining;c/o sleeve of shirt rubbing @ site;warm to touch;swollen area
Information has been received from an unknown reporter via a company representative referring to a 16 years old female patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported. On 30-APR-2013, 03-JUL-2013 and 15-NOV-2013, the patient received her first, second and third dose of GARDASIL respectively, (lot number reported as 055AE, J00417 and 010AE; dose, route of administration and expiration date were unknown) for prophylaxis. In October 2018, the patient experienced stiff neck, sore throat and wasn't feeling good. The patient concurrently had mononucleosis. Lab or diagnostic studies showed that the patient's white blood cell count was normal, but she had elevated liver function test (LFT). In November 2018, the patient was admitted to the hospital and stayed for 5-months (Hospitalization End Date estimated in March 2019). The patient was diagnosed with acute disseminated encephalomyelitis (ADEM) /pulse-infections hemorrhagic leuko-encephalitis. The patient received chemotherapy and alternative medicine. The patient also had a stroke (start date unspecified). The patient's doctor said that the 17 years old he once knew was now developmentally like a 4-year-old. The outcome of the events was unknown. The causality assessment between the events and GARDASIL was unknown. Upon internal review, acute disseminated encephalomyelitis, acute hemorrhagic leukoencephalitis and stroke were determined to medically significant.
redness, pain and itching that spread from injection site to inside of elbow. looked like cellulits.
10-16-12 Pt. noted redness/swelling shortly after vaccine rec'd. By evening arm was red, swollen, hot to touch and "throbbing". Pt. reports multiple allergies. Took allergy med. and ADVIL. Stopped at MD's office, not seen by MD, told to report reaction to health dept. This RN I/S MD visit or ER visit.
AFTER INJECTION THE PATIENT GOT UP TO LOOK AT CARDS. WITHING 2 MINUTES HE PASSED OUT AND FELL TO THE FLOOR. 911 WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On an unknown date the patient may have been administered with an improperly stored dose of VARIVAX lot # R017636, subcutaneous for prophylaxis diluted with properly stored sterile diluent. No adverse effects reported. The vaccine was exposed to a temperature of -14 to -10 (-13.6) Celsius degrees for a timeframe of 11 hours. It was found because of a digital data logger. There were no previous excursions.
Systemic: seizure for a couple of seconds-Mild, Systemic: Headache-Mild, Systemic: Seizure-Mild
received VAR #2 vaacine.  Next day had redness, swelling, hot but soft to touch.  The following day redness was twice as large and center  was firm to touch.  Patient was put on Cephalexin 500 mg PO TID x 10 days and recovered.
About 2 hours after the vaccine, the patient felt like he was having a heart attack and felt like he could not breath. His throat felt swollen and could not swallow and he developed a severe headache. He went to the ER, and they gave him an IV and treated him overnight. Patient claims he had lots of testing done and the physician was not sure what was wrong with him.
Facial edema became 9/1/07 with weakness and generalized lymphadenopathy. Diagnosed with mono 9/6/07. Facial edema 9/1/07 - 9/10/07.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax vaccine. Subsequently the patient experienced shingles. No additional information was provided. There was no product quality complaint involved. Additional information has been requested.
First I got my 1st shot Sunday morning I sat in the observation, and for a brief period I got dizzy, and nauseated. It was brief.   Day two sore arm of course, and tired  felt like flu symptoms  Day 3 extremely tired, and couldn't keep my head up I was so lethargic. Felt like the Flu was coming on went to bed after work Thursday, Fri, and Sat my head was still feeling like I had a head cold. Fatigued still  Sunday I was in dream state when I jolted from a spinning feeling in my sleep. I opened my eyes and I couldn't even function. I couldn't get out of bed nor move I was completely spinning. I tried to make it to the bathroom and threw up bile. Took a anti nausea pill Zofran, and didn't work. Nothing was working. I fell asleep and woke up just constantly dry heaving. The vertigo was so bad I felt faint It was then at the point I was passing out when we called 911. I couldn't move I was perspiring, and couldn't keep liquids down. I was shaking, clamy, and my body turned numb. Thought I was having a stroke.   In the ambulance  narapathy started up, and down my arms and hands,, and my fingers locked up.  Chest was on fireI, and my whole body tingled with fighting off whatever it was..  The hospital IV me with Zofran several times. Antivert and Ativan. EkG fine CT head Brain CT head neck.  Ears were fine. No infection in ears.  Blood Glucose was high 182  CO2 was slightly low 22 Lymphocytes low 21.6 low Neutrophils Absolute 7.7 high Nothing else to do but send me home to follow up with  ENT and Nuero to make appts to follow up. I scheduled my primary qs well to look me over.
Very high resting heart rate; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included carvedilol, taken for unspecified indication, start and stop dates were not reported. On an unspecified date, after the first dose of vaccine, the patient experienced very high resting heart rate, around 108 beats per minute. The patient underwent lab test and procedure which included heart rate: around 108 beats per minute, on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch no. cannot be obtained.
Complaints of body aches, chills, temp but did not check temp, and generalized not feeling well. Arm redness at injection site.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case was linked with 2018SA284352 (Same reporter). This case involves a 26 years old patient (gender was not reported) who received 0.5 ml dose of vaccine TYPHIM VI (lot N1K121M, expiration date 10-Oct-2019) via intramuscular route in the left deltoid on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Deteriorated drug administered and Product storage error. It was reported that received vaccine was not good due to taking to long during shipping and we gave 2 doses. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received covid 19 treatment, Paxlovid, from 25Oct2022 to 29Oct2022. The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash and bump which was hot to the touch and felt like it was stinging.  Lasted a week.  Three weeks later I still have a lump under the skin and faint purple coloring.
Morning after shot right soreness in muscle from mid upper arm to right ear including across right shoulder front and back Treated with massage and aspirin Lasted until 10/22/2023
syncope, HR 44, O2 90% RA. gave 50 mg IM Benadryl, 1 dose Epi-Pen, JR. B/P after meds- 143/72 and 122/68, HR improved to 76
Initial unsolicited report received from a non-healthcare professional on 30 July 2015. A female patient had received a dose of FLUZONE HD (batch number: U5044BA, expiry date: 24 May 2015, dose, dose in series were not reported) intramuscularly in left deltoid in October 2014. Medical history and concomitant medications were not reported. Illness at the time of vaccination and the patients pre-existing physician diagnosed allergies, birth defects, medical conditions reported as not provided. In October 2014, after vaccination, the patient had developed pain in the left arm, arm was sore and she had difficulty with ROM. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Information has been received from a registered nurse concerning a 14 month old female patient who on 3/2/04 at14:00 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 644796/0336N). On 3/22/04 at 0900, the patient developed about 10 vesicular lesions. Medical attention was sought. On 3/23/04, the patient's mother called the medical office and reported one day of itching vesicles (approximately 10) on the patient's face, scalp, neck and torso. No other symptoms were noted. The mother treated with itching with Aveno and calamine lotion. On 4/2/04 the mother spoke to the medical office and stated the rash had resolved. A recovery date of 4/2/04 was noted. A product quality complaint was not involved. Additional information is not expected.
soreness and rash/itch on left breast incision site; started hydrocotisone ointment USP 1% application to site.  Dr. also suggested hydrocotisone ointment or topical benadryl.  rash and itchiness subsiding.
Covid 19 Johnson and Johnson, first and only dose ( not found above) Fever, chills, muscle aches, headache and loose stool Symptoms onset approximately 12hrs after shot lasting 36 hours Treatment Acetaminophen No medical professional consulted
8 pts were determined to be non-responders when titer was tested 6 months post 3rd vax;
No additional adverse effects reported; both of which were over the age of 12, were administered one dose of PROQUAD each; both of which were over the age of 12, were administered one dose of PROQUAD each; This spontaneous report has been received from a nurse, referring to a 16 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date in October 2019 (reported as last month), the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, route, lot# and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age and product use issue). No additional adverse effects reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA008978:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 20-MAR-2017, the patient inadvertently received an expired dose of ZOSTAVAX lot # K008883, expiration date 20-SEP-2015, subcutaneously (dose not provided) that was reconstituted with sterile diluent (manufacturer unknown) lot # M022416 and expiration date 17-DEC-2018. No adverse effects reported. Additional information has been requested.
Evacuated in RUE 4/1/07. Temp 98.9 2" right deltoid, redness, warmth, induration and pain. Denies itchiness. No rash noted. Dx: Right arm cellulitis - ?? allergic reaction.
This spontaneous report as received from a nurse practitioner refers to a 29-year old male patient, with a history of splenectomy and none drug reactions/allergies. The patient was vaccinated with a dose of PNEUMOVAX23 (lot# not reported) 0.5ml, IM in September 2011. No concomitant medications were reported. It was reported the patient experienced swelling, redness, fever and vomiting " a few hours later" after receiving PNEUMOVAX23 dose. The patient went to the ER at a local community hospital but later was transferred to other hospital and the patient was hospitalized. As the treatment the patient had an incision and drainage of fluid in the arm at injection site performed at unspecified date. At the time of report the outcome of patient was recovered, on an unspecified date. The events were considered to be disabling by nurse practitioner. Additional information is not expected.
Contracted hissing sound around same time of my wife VAERS #458377 on 4/15 4/16 but went away for now,.
Patient came to office for 4 year old well child exam requiring vaccinations. She received DTaP and IPV to left deltoid and MMR to right arm. She presented the next day with other complaining of redness, swelling and pain to left upper arm.
Awoke with symptoms of Bells Palsy - droopiness on left side of face, especially mouth, unable to lift left side
Pain & decreased ROM (L) shoulder glenohumeral/deltoid since receiving vaccination in (L) deltoid on 9/6/11. Pain was within 1 hour & persists despite use of NSAID's (ibuprofen). Referring to occupational med provider for further eval & Tx.
Hives and Rash developed approximately 24 hours after administration. Rash is located on arms and neck. Patient did not experience swelling of tongue, shortness of breath or any anaphylaxis.
Fever, fussy, severe rash on the neck, chest, back.  Treated with oral corticosteroid, hydrocortisone topical cream, Benadryl PO.  Referral to dermatology.
Pt said she feels the lumps in the injection site, there's a rash and the rash keeps getting worse on her left arm. Looks like pt is allergic to vaccines.
horrendous headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Apr2021, patient experienced horrendous headache. Stated received their Pfizer covid19 shot 2 days ago and came down with a horrendous headache. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
7 hr post vaccine given, sudden onset malaise, body aches, very fussy. Pt felt warm to parents with temp rose to 100 Ax; vomited x 2 approx 8 hr later. The following morning temp was 105 Ax, child was tried less active throughout most of the day. Fever resolved post 36 hr.
Extreme muscle pain that spread down my arm up into my shoulder that has caused severe spasms.  Had to go to Ed to get relief.  I am now taking a bunch of muscle relaxers and it?s making it tolerable but not going away.