chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fluish [flu-like].; sore; feeling pretty poor [malaise]; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced influenza like illness, pain and malaise. On an unknown date, the outcome of the influenza like illness, pain and malaise were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness, pain and malaise to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient felt pretty poor (malaise), sore, and fluish (flu-like) after vaccination. The reporter declined to provide any further information for safety report.
At 1642 PM (~18mins post vaccination) pt c/o nausea and dizziness. Observation nurse noticed pt to also be diaphoretic. Pt brought inside and given water. NP made aware. VS taken: BP 149/88, HR 95, O2 100% on RA, Resp 18. Pt brought to the triage area to recline. Pt reported anxiety surrounding the vaccine administration. Pt VS rechecked at 1701 PM: BP 139/84, HR 85, SpO2 100% on RA. Pt stated that nausea and dizziness had resolved. No SOB or acute distress noted. Pt discharged from vaccination clinic in stable condition.
Post vaccination for about 10 minutes patient started feeling dizzy and fainted. As she fainted she hit her head on the wall. Patient was unconscious for about 1 minute before provider was able to render aid. Blood Pressure was 101/65 and pulse was 73. Patient left ambulating and parent was instructed to take patient to ER if patient was vomiting, sleepy or had a headache.
Pt seen in ofc sx: fever x 2d, "bumps" on chin. Dx: varicella - no Rx given - unsure if qualifies as "failed vaccine". Ordered by physician to report. Also advised by vaccine rep. to report.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
BLISTERS (NOT PAINFUL) ON HANDS. MOUTH FELT LIKE IT WAS BURNT ALL OVER.
Measles like rash covered entire body for about 4 days. Took her to the doctor. He said while it was in the window to be caused by the vaccine, it was unlikely. No treatment or follow up.
Patient stated within the first 24 hours after receiving the vaccine she had a welp at the injection site and redness (~2 inches in diameter).  Over the past 24 hours she experienced itching and pain in her entire arm.  Asked patient to contact her primary care provider to inform them of the reaction and to see if they would like to prescribe anything to help with pain/swelling. We also told her she could take diphenhydramine if she wanted something to help with the itching.
Patient states that a day after she received the vaccine she started running a fever and since receiving the vaccine she suffers from severe fatigue, dizziness and body aches daily.
This spontaneous report as received from a pharmacist referring to another male pharmacist of unknown age. The pharmacist had ZOSTAVAX powder (lot # L036454, expiration date: 22-DEC-2016) spill on his hands due to the vial being broken. No adverse effects were being reported. Product quality complaint (PQC) was filed. Additional information has been requested.
Patient is allergic to shellfish. Throat and eyelid swelling occurred 1 hr post vaccination. Also had difficulty swallowing.  Patient took Benadryl but did not feel better so went to the ED. Was observed for 3 hours and symptoms improved. Received more Benadryl in the ED as well as Solumedrol and Xopenex.
25 minutes after the vaccination I had restriction of my throat and coarness. I continually clreared my throat, I could not tell if there was swelling of my throat. At the same time I had some difficulty breathing. This continued for 10 minutes, then subsided and didn't come back. The first night I got a very tight head, but not a true headache, this continued through the next two days and nights and then went away.
pt recv vax 24SEP96 & 18hr p/vax pt exp metallic taste;
3cm diameter, erythematous, indurated and swollen region of right deltoid at the site of injection.
It was reported that a 2 year old male received a DTaP-Tripedia vaccination on 8/10/99. Reportedly the patient awakened the next morning with left arm red, swollen, hot and hard at injection site and almost down to elbow. No increased temperature and no apparent discomfort. Normal activities and diet. Used cool compresses, Tylenol times 1 or 2. Swelling resolved as of 8/14/99. From additional information received on 11/8/99, it was reported, reviewed, additional information box #18. Follow up #1 (8/12/02): During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (deleted fever) and (changed edema to injection site swelling).
Nausea, vomiting and seizures started post vax, after finishing speech therapy at home. Parents brought her to ER. Parents had permission for her to receive both vaccines prior to today's administration by DR. Pt was seen in ER and dx'd with probable viral gastroenteritis, right otitis media. She was kept in hospital overnight to control her vomiting and watch for potential aspiration and re-evalualte her in the AM.
Case number PHEH2012US018699 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and with a follow up received on 16 Oct 2012: This report refers to a 11 year old female child. Her medical history included asthma, gastrooesophageal reflux disease and appendicitis on 20 Mar 2012. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) into the right arm, intramuscular, on 31 Aug 2012 at 10 am. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. Vaccine was stable and okay to administer. No adverse event was reported following this administration error (incorrect storage of drug). Follow up received on 16 Oct 2012: Updated patient details, vaccination site, medical history and concomitant medications.
Mother called 10/17 with a complaint the child had a 2 inch circle around injection site that was red and warm to the touch, states the child complained of itching in the area, no other complaints. Encouraged to take Tylenol for discomfort and Benadryl and to call back if the reaction worsened. Mother called on 10/18 to report the reddened area had grown to 3-4 inches with center area returned to normal color and redness decreasing.
Patient received first dose of the moderna covid-19 vaccine series. Patient is under recommended age of administration. No adverse reactions noted onsite after vaccination.
Redness and soreness at the site, upper respiratory symptoms like diff breathing, sore throat, running nose and sneezing non stop, aches, dizziness.
Sedation, Arthralgia, Fever, Chills, Pain at injection site Narrative:
30SEP98 AM pt recv vax x 2 noted discomfort, stiffness & swelling in lt arm surrounding inj site @ 5PM;pt applied ice & took ecotrin for pain;shaking, chills during PM;swelling noted 2" above antecubital space;pain, warm & tender;T36.6;
Moderna COVID-19 Vaccine . Fatigue, headache, muscle pain, joint pain, chills, and fever for three-day duration.
This was a medication error in that PHN meant to give HPV and did not double check that it was correct. Boxes are very similar and this PHN incorrectly gave PCV13 rather than the HPV she intended. Client had a sore arm but no other adverse effects known to PHN.
It was reported that a 64 year old male pt received an IPOL vaccination administered in July 2001. The pt was found to have an immunoglobulin G spike on a "routine" physical on 10/1/01. The pt's outcome is unknown. From additional correspondence received at manufacturer on 8/6/02, it was reported that pt received IPOL (T0485) SQ to left deltoid, Engerix B (lot 5208A2) IM to right deltoid, Havrix (704A4) IM to right deltoid on 6/14/01. Pt also received Typhim VI (R1230-4) IM to left deltoid and Engerix B (5252A2) IM to right deltoid.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 11-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS-LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 504 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
drug allergy; Initial information was received on 03-May-2021 regarding an unsolicited valid non-serious case received from a consumer or other non-professional (from Novartis Pharmaceuticals Corporation).  This case involves a 66-year-old female patient who had drug allergy (drug hypersensitivity), after receiving TETANUS TOXOID.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious drug allergy (drug hypersensitivity), (unknown latency) following the administration of TETANUS TOXOID.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event (drug allergy).  At time of reporting, the outcome was unknown for the event drug hypersensitivity.  Result of assessment was reported as not reported.  There will be no information available on the batch number for this case.
Information has been received from a physician concerning a 4 year old patient who was vaccinated with a dose of varicella virus vaccine live (lot # not available). Subsequently, the patient developed an atypical rash. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Get her period 20 days late each month; no flow but its heavy blood and this happen as soon as she got her 1st vaccine; Get her period 20 days late each month; no flow but its heavy blood and this happen as soon as she got her 1st vaccine; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "Get her period 20 days late each month; no flow but its heavy blood and this happen as soon as she got her 1st vaccine"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: The report was not related to a study or programme. Reporter seriousness for the events was unspecified. Expiry Date of Pfizer BioNTech COVID-19 Vaccine was unknown. The reporter thought the patient was probably in her 30s. The reporter had weird female/hormonal side effects she gets her period 20 days late each month she says no flow but its heavy blood and this happen as soon as she got her 1st vaccine. She wrote headache and she never had headache before. Lot number Pfizer employee stated, "no, asked her she couldn't share that since she would but she hasn't yet I know there was specific time under which she have to report it so she never got it so don't have it.  QR Comment: Further clarifications unknown hence, patient is reporter tab left unchecked. Reporter type not probed over call hence captured as consumer or other non-hcp by default.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pure liquid diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (pure liquid diarrhea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIARRHOEA (pure liquid diarrhea). At the time of the report, DIARRHOEA (pure liquid diarrhea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included fewamount supplements and prescribed medications.  No concomitant medication was reported.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative from social media (twitter) concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total administered, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was diagnosed with the covid-19 infection (suspected clinical vaccination failure) and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210852374. This report was associated with product quality complaint.; Sender's Comments: V0:20210851820-COVID-19 VACCINE AD26.COV2.S-Suspected COVID-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210851820-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
FELT TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
local erythema c/u SC urticaria on entire upper arm; rx w/DPH
This spontaneous report was received from a nurse prescriber via company representative regarding a 12-year-old female patient. The patient's concurrent conditions, concomitant therapy and medical history were not reported. On an unknown date in July 2016, the patient was vaccinated with a shot of GARDASIL 9 (strength, dose, dose number, route of administration, lot # and expiry date was unknown) for prophylaxis (prevention of Human papilloma virus). Approximately, on an unknown date in October 2017 (reported as 15 months later), the patient was subsequently diagnosed with diabetes (diabetes mellitus). The outcome of diabetes mellitus was unknown. Causality assessment was not reported. No product quality compliant (PQC) was reported. Upon internal review, the event diabetes mellitus was determined to be medically significant.
Muscular pain in back and in back of thighs; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscular pain in back and in back of thighs) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     No medical History was provided by reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (Muscular pain in back and in back of thighs). At the time of the report, MYALGIA (Muscular pain in back and in back of thighs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported
The day after the event the patient presented with reports of pain and swelling in the left arm. There is some redness noted and appears to be a fluid collection in her arm leading below the injection site to the side.
Both hands are swelling; Hives all over both arm which is itchy; Hives all over both arm which is itchy; A spontaneous report was received from a consumer concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and who developed hives all over both arms which was itchy and both hands were swelling.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 29 Dec 2020 the patient received his first of two planned doses of mRNA-1273 (LOT-025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, 2 to 3 days after vaccination he started having hives all over both arm which was itchy.  On 03 Jan 2021, both of his hands had begun to swell.   Treatment for the event included diphenhydramine.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of hives all over both arms which was itchy and both hands were swelling were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sudden onset of hives on face after receiving shots. Few on right shoulder inferior to 2 bandaids covering MMR/Varivax shots. Started with redness/warmth 1 day ago to left arm. Increased in redness today 7.5cm x 8.5cm, some tenderness and hardness.
On 4-7-10 large welts, itchy, hot, red swollen upper right arm shots DTAP, IPV, VARIVAX given in right arm on 3-23-10. Gave BENADRYL/TYLENOL - reaction gone in a day. Same reaction happened again 3-4 weeks later. Same treatment of BENADRYL  and TYLENOL. 3rd episode on 5-9-10 same treatment of BENADRYL/TYLENOL- next day.
One day post vax, pt developed a fever of 100.9 F and was feeling sick.  Pt recovered within 24 hours.  the parent attributed this event to Orimune.
Mild Fever,  chills, headache, upset stomach,  congestion- started about 11 post injection and lasted 36 hours
Sick for 48 hrs after shot but now injection site is causing me pain in left arm.
Pain, swelling, redness, hardness around injection site, still ongoing 5 days later, but is slowly improving. Severe arm and shoulder pain, couldn't use arm for a full day. Fever, chills, nausea, headache, bodyache started 22 hours after injection and lasted about a day. Treated with motrin and ice, still healing.
Within 2 weeks of the second shot, I began to have tightness in chest, breathing issues, elevated heart rate and some pain.  On June 25th, it was troublesome enough to get it checked out at the Emergency Room.  Upon receiving an ultrasound of the heart with contrast, I tested with right ventricle inflammation (hypertrophy of the right ventricle) without hypertrophy of the left ventricle.  I was kept overnight for observation and was referred to a cardiologist for possible treadmill mill test.  Instead, they put in for a CT scan with contrast, which the insurance company denied, but upon a subsequent ER visit in July it was done.  The ER report again said 'right ventricle hypertrophy without left ventricle hypertrophy).  The cardiologist had put through an exam by MRI with and without contrast and by late August, the hypertrophy had gone back to normal. The elevated heart rate still remains to this day, the cardiologist says this should improve over time.
Information has been received concerning a female patient between 65 and 78 years old who on 22-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663888/0627Y).  Subsequently, the patient experienced a fever, severe swelling, redness and pain at the injection site after she received PNEUMOVAX 23.  The patient sought medical attention with the physician.  The patient was given unspecified oral antibiotics (manufacturers unknown).  At the time of the report, the patient recovered on an unspecified date.  All telephone attempts to obtain follow-up information have been unsuccessful.  The health care professional contacted during telephone follow-up could not supply the following information:  patient's name, or date of birth.  This is one of several reports received form the same source.  Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date and BUD date was 28-Jan-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and was administered on 31-JAN-2023) and NO ADVERSE EVENT (no adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.