chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non-healthcare professional on 11-Apr-2017. This case involves a 30-year-old male patient who was vaccinated with a dose of ADACEL (batch number, expiry date, dose form and frequency not reported) intramuscularly in the left detoid on 06-Apr-2017. The illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The concomitant medications were not reported. Any other vaccinations within four weeks of vaccination were not reported. On 09-Apr-2017, three days following the vaccination, the patient developed red area at injection site on left arm which was three inches in diameter and hard lump at site. The patient was seen by a pharmacist on 10-Apr-2017. It was reported that, patient Required ER/doctor visit. Relevant laboratory investigations and corrective treatment was not reported. The patient had not recovered from the events. List of documents held by the sender: None
Within a few hours of administration, she reported blotchy red rash down the injection arm and that her face felt swollen & tingly.  She went to see her PCP by Friday 5/20/2022.  He prescribed a short 5 day oral steroid course.
Reported to pharmacy on 8/29 to report a potential adverse Rnx to Shigrix. Hives on arm. Advised to see her physician ASAP Patient has been taking Benadryl.
36 hours of aches and chills with exhaustion. swelling of underarm and down side of rib cage. Left breast shooting pain. Those pains lasted about 2 weeks.
Swelling arm, redness, fever, chills, fatigue, joint pain, my entire back hurts end to end and into joints, lymph nodes under both arms swollen and blood pressure raised 15 points above range, dizziness, inability to consentrate
When I woke up I was noxious and I took a pill for nausea, I throw out, Extreme headache, congestion, I was like this for 2 days, no fever. I took a COVID-19 test and it was Positive. I called the doctor, and he prescribed the medicine, I felt better.
Information has been received from a physician concerning a 10 year old African American female with no past medical history who on 22-Aug-2001 was vaccinated with a second dose of hepatitis A virus vaccine inactivated (lot #644075/0736M) (IM). There was no illness at the time of vaccination. The patient developed a "knot" in her upper arm and complained of pain. The patient had little bumps around the injection site. The patient's left upper arm showed mild edema. There was no heat. The patient had approximately "2 cm fullness and induration in deltoid muscle". There were fine papules scattered around site. The patient also had a temperature of 99.2 F. The patient was given diphenhydramine HCl (Benadryl) (2 tsps every 6-8 hours) and acetaminophen (Tylenol) (PRN). It was also reported that the patient had "developed hepatitis A". The patient sought unspecified medical attention. There were no relevant diagnostic tests or laboratory data performed. The patient did not experience any adverse events following prior vaccinations. It was reported that the patient recovered. No further information is expected.
a patient received the 1st dose 3 months ago and didn't receive the 2nd on time; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a patient received the 1st dose 3 months ago and didn't receive the 2nd on time) 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.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (a patient received the 1st dose 3 months ago and didn't receive the 2nd on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a patient received the 1st dose 3 months ago and didn't receive the 2nd on time) 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.   No treatment medications were provided.  No concomitant medications were provided.  Patient wants to know if the schedule should be restarted and no further information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Telephone contact report was attached which included no new information.
This spontaneous report as received from a pharmacist refers to a patient of unkonwn age. On 08-SEP-2014, the patient received improperly stored ZOSTAVAX, (dosage, route and lot number not provided). No adverse symptoms reported. The temperature excursion for the ZOSTAVAX was found to be supported by in-house stability data. Additional information has been requested.
Headache started one hour after administration and lasted 48 hours. Chills started 3 hours after administration and lasted 48 hours. Accompanied by minor muscle aches and mild fever. Left arm (where vaccine was administered) is still very sore after 48 hours and was extremely painful with intermittent numbness for the first 24 hours.  Took ibuprofen on the second day to ease symptoms.
This spontaneous case reported by a consumer, describes the occurrence of palpitations (experiencing heart palpitations/anxiety) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007B21A and 020B21A) for COVID-19 immunization. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Apr 30, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced palpitations (experiencing heart palpitations/anxiety). At the time of the report, palpitations (experiencing heart palpitations/anxiety) outcome: unknown. No concomitant and treatment medications reported.
Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2018, the patient received the 1st dose of Shingrix. On 14th September 2018, the patient received the 2nd dose of Shingrix. On 20th May 2019, 325 days after receiving Shingrix and 248 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient experienced shingles outbreak. This case was a suspected vaccination failure since the details regarding confirmatory lab test for shingles were unknown.
Blood clot; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's cousin) reported for a 37-year-old female patient (reporter's cousin) who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot/ number and Expiry date were unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had blood clot and died on an unspecified date. Reporter states that he as a cousin of 37 years old (patient) that passed away after getting the vaccine due to a blood clot. States she was forced to get the vaccine to protect her kids, and that is not the only person her knew that has died. It was not reported if an autopsy was performed. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Blood clot
CHILD PRESENTED IN OFFICE WITH RASH ON CHEST, ARMS, AND BACK FOR ONE WEEK. GIVEN ATARAX FOR ITCHING.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: patient was taken by ambulance to ER
There were no adverse effects.  CDC and State immunization program informed the clinic this vaccine can no longer be given as a booster October 12 and it was administered october 19th as  a booster.
Facial swelling; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 16:00, after 4410 minutes of the vaccination, the patient experienced facial swelling. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event facial swelling was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a 6 year old male who was vaccinated on 01/07/1999 with a dose of varicella virus vaccine live (Oka/Merck).  The patient was seen on 02/06/2003 with a prolonged breakout.  No other comments were provided.  The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was not product quality compliant.  No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
warts on her buttocks area went away after receiving 1st dose of GARDASIL 9; no adverse events; This spontaneous report was received from a nurse via company representative referring to a 23 year old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, lot number, expiry date and route of administration were not reported) for prophylaxis. On an unknown date, after receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), warts on the patient's buttocks area went away (therapeutic response unexpected ). No adverse events were reported. There was no product quality complaint present. The outcome of therapeutic response unexpected is unknown. The reporter's causality assessment between the event and the suspect therapy was not provided.
Swollen injection site arm after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen injection site arm after the booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen injection site arm after the booster dose). At the time of the report, VACCINATION SITE SWELLING (Swollen injection site arm after the booster dose) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-375323, MOD-2021-375331 (Patient Link).
temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Dose was administered post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 52-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Dose was administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine).    It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
SPONTANEOUS DIARRHEA ONE TIME 6 DAYS AFTER SHOT UPON WAKING PER PT WITH NO REGULAR HISTORY OF DIARRHEA. INDICATED DIETARY CHANGE PREVIOUS EVENING AS WELL
i had a flu vaccine at Health Dept on 1/29/2014, i am not sure the lot number or anything they would have that. I got eczema from it.
This spontaneous case was received from other-health professional on 03-Oct-2017, concerning a 34-year-old adult female patient. The patient did not have any relevant medical history. On 03-Oct-2017, the patient was administered with FLUCELVAC QIV (batch number: 195124, expiry date: Apr-2018, route of administration, anatomical location: not reported). On 03-Oct-2017, the same day after vaccination, at night the patient developed red at injection site, swelling, hard, painful, hot to touch. It was reported that, the patient felt arm sore and hard, and get hurts while lifting. On 09-Oct-2017, the patient recovered from the events. The reporter assessed the events as non-serious. Non significant follow up received on 25-Oct-2017 from a nurses: the patient did not have any relevant medical history. Significant case correction received with IRD 03-Oct-2017: Listedness for the event 'injection site swelling was corrected.
Localized inflammation/rash on arm. Warm and itchy. Current size 11cmX12.5cm.
Woke up sweaty. Ache in back, ankles and wrists. Restless but body exhausted.
I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that night but I couldn't hardly slee because of the pain. I had to call out because I could hardly walk. Steroid dose was for 9 days and after wards it resolved.
Thus far, I feel like I have the actual flu with moderate levels of nausea, muscular-skeletal pain throughout my entire body (seemingly generating from inside my bones & spreading outward to my muscles), sudden & stabbing pains that come and go in different areas of my body (including neck, spine, arms and legs), dizziness, diarrhea, swollen lymph nodes and headache.
aches, chills, weakness, chest pain, dizziness, diarrhea, vomiting, nausea, she was sent to ER after visiting a clinic
Sleeplessness, chills, feeling hot (but no fever), sore arm. Chills and feeling hot came and went for a little over 12 hours starting about 14 hours after vaccine.
Pt received Pneumovax prior to DC to home 1/12/11. On 1/17/11 evening she noted tingling in her toes which progressed to numbness in all of her limbs. Presented to hospital on 1/24/11 unable to walk, burning mouth syndrome. LP performed and negative for meningitis. Exam findings consistent with Guillain Barre per neurologist. IVIG 0.4 mg/kg IV x 4 days initiated 1/26/11. Transferred to inpatient neuro-rehab on 1/27/11 for comprehensive therapies.
After receiving the vaccines he fainted and rolled out of the chair to the floor to his side. Nurse placed client on his back and elevated his legs. Client's legs elevated and BP 100/50 at 11:20. Client color pale. Client stated he felt dizzy before he fainted. Client states he saw "black" before he rolled out of the chair. Client's color improved and lips pink and states he is not dizzy anymore. Client placed in sitting position and then placed in rolling chair for transport to an exam table for observation. BP 110/60 at 11:40, 100/60 at 11:50. Client place in sitting position at 12:15 and BP 100/62 and client reports he is a little dizzy. Client left clinic at 12:20 and BP 110/60. He reports "I feel good and not dizzy." Mother and client were told to inform other healthcare provider about fainting after an injection. I also explained to mother that she should contact her son's medical provider to inform him about the fainting episode.
Patient states temperature after vaccine injection.  She experienced fever, swelling, some difficulty breathing (SOB).  did not seek medical intervention.  Improved over night.  Seen in office after 24 hours; continuing improvement.
Pt recvd vax on 1JUN92 & w/in a few hrs of vax pt exp a stiff neck, nausea, dizziness, lightheadedness & a h/a; pt looked pale & felt cold & clammy; pt was examined by MD w/in a few hrs;
Large swollen area upper arm at injection site/ warm to touch/ large swollen bump in arm pit - 10/08/2021
HEART ATTACK 14 HOURS AFTER VACCINE. EMS TOOK TO ER. TAKEN DIRECT TO OPERATING ROOM, FOUND ONE 95% BLOCKAGE AND STENT PUT IN. HAS HEART DAMAGE NOW
System was not populating immunization record, member denied having immunizations within last 14 days. Vaccine given, record populated and patient had anthrax on 12/10/20
Temperature of 101 F, headache, chills, severe deep muscle and joint pain. Lasted from 12p-12a
2 vials of the COVID19 while mixing too much diluent was added none was given to any patient.  2 other separate vials of same lot we only got 3-4 doses out of them, this was reported after they were given and nurses could not remember which patients received these.
The same day of vax, the pt developed urticaria lesions at the injection site and face over eyebrow area.
Severe left shoulder pain and decreased ROM - diagnosed on 3/6/18 by orthopedist as left axillary neuritis following vaccination.
Initial unsolicited report received from a nurse on 23 December 2015. This case involves a three year old male patient who was vaccinated with a fifth dose of FLUZONE QIV (batch number UI516AB, expiry date 30 June 2016, route of administration were not reported) in left deltoid on 21 December 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was mild (excema) eczema. Patient had no other vaccinations within 4 weeks of vaccinations. On 22 December 2015, one following the vaccination patient's left arm had swelling from shoulder to below elbow with little blisters, vesicles on it and it was red and hot and allergic reaction. Patient required emergency room (ER)/doctor visit. Patient had no laboratory investigation. Corrective treatment was not reported. The outcome of event was not recovered. List of documents held by sender: none.
5 mins after administering vax, pt fell off chair to floor, became rigid,eyes rolling to back of head lasting 30 sec.Upon regaining conciousness,pt was aware of time,date,& person.
Pt reports got vaccine on 1/30. Reports severe itching and restlessness, severe body aches, fevers up to 102, sore throat. Symptoms were still present at time of televisit on 2/10. Influenza A/B, RSV, COVID and strep testing negative. Pt has history of severe reaction to flu shot resulting in hospitalization years ago
This spontaneous report was received from a registered nurse referring to a 17 year old female patient. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 17-JAN-2017 and on 23-FEB-2017, the patient received properly stored doses of injectable PROQUAD FOR prophylaxis (lot # M031943 with expiration date on 27-DEC-2017 and lot# M033216 with expiration date on 09-JAN-2018, respectively) (strength, dose, frequency, route of administration, anatomical location and albumin status were not reported). No adverse effects were reported. Additional information is not expected because the reporter did not consent for further follow up.
21NOV95 pt lt arm sore from flu shot;arm sore 4 or 5 days p/shot-no redness or swelling,but it hurts when move it;arm was stiff;local rxn p/flu vax;sneezing a lot,chest congestion & face swollen;limited motion of shoulder;tendonitis;
Information has been received from a physician concerning a 4.5 year old male with no history of chicken pox who in approximately 2003, reported as "at 13 months of age", was vaccinated with a dose of VARIVAX (Merck) and was healthy with no medical condition. "4 years ago", in February 2007 when the patient was 4.5 years old, he experienced 102 fever with left arm pain of unknown etiology and subsequently developed shingles on the left side of his body from neck to left wrist. The physician sent in the vesicle to CDC and it was confirmed as Merck strain. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.