chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POOR QUALITY VACCINE ADMINISTERED; VACCINE THAT HAD BEEN SITTING IN THE FRIDGE FOR MORE THAN 6 HOURS; This spontaneous report received from a health care professional concerned a 50 year old male. 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: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced poor quality vaccine administered. On 11-MAY-2021, the subject experienced vaccine that had been sitting in the fridge for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and vaccine that had been sitting in the fridge for more than 6 hours was not reported. This report was non-serious.
Sore arm where injection was given since Sept. 14th 2013. X-ray negative. Physical therapy for 30 days, no improvement. Was told deltoid muscle damaged. Still hurts when I move arm a certain way. Return to orthopedic Dr. on 5-21-14.
Information has been received from a registered nurse concerning a 61 year old female patient with hyperlipidaemia, osteopenia and rosacea, with no drug reactions or allergies who on 18-MAY-2010 received for the first time a 0.5 ml dose of PNEUMOVAX 23 IM ( lot number 665270/1398Y).  Concomitant medication included "many unnamed medications".  Nurse reported that the patient experienced redness, swelling and tenderness of the left arm with streaking to the breast.  On 20-MAY-2010, she was sent to the emergency room with diagnosis of cellulitis.  Patient started on oral AUGMENTIN.  The next day, she called the office stating the area was warm to touch and the redness was wider.  She was advised to return to the emergency room if symptoms became worse.  At the time of reporting, the patient had not recovered from cellulitis.  Additional information has been requested.
The First episode:Very dizzy with rapid heart beat at 3:20pm then recovered. Second episode at 6:00pm: Very dizzy rapid heart beat in the 250's lasting a while,lungs filled with fluid due to rapid heart beat. Stayed in hospital ICU a few days.
20 minutes after the vaccine I felt very faint and weak. My blood pressure went up. My throat started to swell. This is a typical mast cell reaction for me. I took 20 mg of Fomatadine a few minutes later. I had already had 50mg Bendryl on board. About 20 minutes after the Fomatadine the swelling in the throat started to improve slightly. I left the facility where I had the shot after about an hour and my condition did not worsen. I fulle recovered in about 48 hours.
4 1/2hr p/vax had turned pale;non responsive w/staring episode;pt given emergency 02 & fluid;pt exp temp;
Headache, Myalgia, chills, fatigue, injection site pain/arm pain Narrative:
Vaccine given beyond-use-date. Vaccine received in refrigerator on 01/11/2022 and kept in appropriate temperature (2-8 Celsius). Vaccine administered to patient 16 days past the 30-day time in refrigerator.
Information has been received from a nurse with a Bachelor of Science in Nursing concerning an infant who "about 2 months ago", in approximately November 2010 was vaccinated orally with a dose of ROTATEQ (lot # 668334/0515Z, expired date 21-APR-2012). The nurse reported that the patient started screaming and vomited during administration. It was decided to repeat the dose with lot # 668334/0515Z. No treatment was given for this adverse event. Patient sought medical attention which happened in office. At the time of reporting, the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Member was identified as due for yellow fever vaccination. Vaccine was administered per unit policy and vaccine directions. Approximately thirty minutes after vaccination, the member complained of soreness/tightness in throat during swallowing. Member was evaluated by a provider and released to full duty with instructions to return to provider if symptoms worsened.
Information has been received from a physician's assistant concerning an 11 month old female who on 10/11/2001 was vaccinated with with a first dose of varicella in the right thigh. It was noticed for the first time shortly after the vaccinee was administered that the pt's right eye seemed to turn in more. The pt was referred to opthalmology. At the time of this report, it was unknown if the pt recovered. Conflicting additional info was received from the physician's assistant. Additional info states that the pt was vaccinated on 10/09/2001, and the onset of the pt's strabismus was 10/10/2001. No additional info is expected.
This spontaneous report as received from a other health professional refers to a 60 years old patient. The patient was vaccinated with, 1 DF VARIVAX (Merck) subcutaneous (Lot number was not provided) on 02-NOV-2012. The patient also received Influenza Virus Vaccine (manufacturer unknown). No concomitant medications were reported. On an unknown date the patient received VARIVAX instead of ZOSTAVAX. The patient is not experiencing any known symptoms. The outcome of received VARIVAX instead of ZOSTAVAX and the patient is not experiencing any unknown symptoms is unknown. Additional information has been requested.
Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. PT WAS HOSPITALIZED HAD RECEIVED THREE COVID-19 VACCINE AT THE TIME OF DEATH.
By the evening my left arm was extremely sore, which I expected as per the reports of other people having the shot.  However, during the night I developed a severe headache, chills (couldn't get warm) but burning up with 103.1 degree fever, and nausea.  These symptoms continued throughout Saturday morning.  Fever didn't start going down until Saturday afternoon.  I felt extremely sick and still do not feel well with headache and body aches.  I did have Covid-19 in March of 2020 and have given Covid plasma because my Covid antibodies were always quite high.  I'm just wondering if the reason I got so sick from the vaccine is because I had Covid before.  Do I still have to have a second shot? Really do not want to if this is the kind of reaction I can expect.
Little Cough; Burping taste of eggs; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Burping taste of eggs) and COUGH (Little Cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced TASTE DISORDER (Burping taste of eggs). On 11-Mar-2021, the patient experienced COUGH (Little Cough). On 28-Feb-2021, TASTE DISORDER (Burping taste of eggs) had resolved. At the time of the report, COUGH (Little Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Fever, diarrhea, lethargic. She was taken by ambulance to Hospital on 10/25/18.
05/15/20 family member called and said she felt like Patient was having an adverse reaction to a vaccine he received on 05/13/20. Stated child had swelling and redness to be around 3-4 inches in diameter at injection site on left arm and hot to touch. Child had no fever. Discussed vaccines can cause redness ans swelling at the injection site but to bring child by the clinic for us to look at arm and to take to PCP for evaluation. Family did not bring child to clinic. Tried to call unable to make contact by phone. 05/18 left message for child's grandmother, to give us a call. 5/21/20 grandmother called, she said her and her son are Patient's legal gaurdians, Child had telemediciane with APRN  child was started on benadryl and claritn  for possible reaction to vaccine. PCP does not want to make decision regarding future vaccine at this time. Redness and swelling went down 2 days after starting medication.
Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and fatigue.  I slept most of the day on Sunday after getting the shot the day before. I never checked my temperature to tell if I had a fever.  The night sweats continued into sunday night.   I took 600mg of advil for the body aches and went to bed.  When I woke up around 1:00 in the afternoon the body aches were gone and haven't returned.   Sunday night I was sweating most of the night and felt over heated until around 11:00 Monday morning.  I am always cold, I am the type who wears sweaters in the house all year long.  For me to be that hot in the house is very unusual.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional. This case was linked with 2018SA226678, 2018SA226687 and 2018SA226689. This case involves a 17 years old female patient who administered MENACTRA for which shipment was received at 3 days instead of 2 days and administered, while she received vaccine MENACTRA and TRUMENBA in the same visit. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Aug-2018, the patient received 0.5 ml second dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (lot U6016AA, expiry date- 09 Oct 2019) in the right deltoid. It was a case of actual medication error due to incorrect product storage and extra dose administered. 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.
Received call from Mom, stated child broke out in hives on torso, neck and legs. Recommended Benadryl.
(L) upper arm with large approx. 4" in diameter red, raised circular rash.
dehydration; increased serum creatinine level; Fever; Vomiting; Nusea; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 09Feb2021 at 16:45 (at the age of 66-years-old) (Lot Number: EM9809) as dose 1, single for COVID-19 immunisation.  Medical history included end stage renal disease and S/P Renal Transplant. The patient has no known allergies. The patient did not receive other vaccine in four weeks. Other medications were received in two weeks. The patient did not have COVID prior to vaccination and had been tested for COVID post-vaccination.  On 17Feb2021 at 08:00, the patient experienced nausea, vomiting, fever, dehydration, and increased serum creatinine level. Treatment was received for the events. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 18Feb2021. The outcome of the events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.
pt recv vax 15NOV96 & 28NOV96 staring speels (? absence sz) w/o fever 3-7seconds began started 28NOV then 11DEC by 27DEC96 up to >5day;3JAN97 epiosde x 20sec;
Rash on back, generalized, upper buttocks pink, temp 100.5, no resp distress.  Rxed Benedryl Resolved 10/28/99.
New onset pruritic vesicular rash covering full body except head, palms and soles of feet. Started on 10/21 and resolved with topical OTC hydrocortisone by 11/01.
This spontaneous case was reported by an other healthcare professional, describes the occurrence of product temperature excursion issue (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and poor quality product administered (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022M20A) for COVID-19 immunization. No medical history reported. On Feb 17, 2021, at 10:10 am, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .5 milliliter. On Feb 17, 2021, at 10:10 am, patient experienced poor quality product administered (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, patient experienced product temperature excursion issue (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, product temperature excursion issue (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and poor quality product administered (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Age of patient: 73.36. On Feb 17, 2021, at 09:00 am, the temperature recorded: 22ºF. Vial initially moved to the fridge Feb 11, 2021. Beyond-use-date: Mar 13, 2021. Product moved to clinic: Feb 17, 2021. Vial was in cooler storage and not in frozen storage during high-pace COVID-19 vaccination. Vials only punctured right before administration. Vaccines not frozen at time of administration. It was reported each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1½ hour (approximately), when temperature data logger registered a temperature of 34ºF or 35ºF. Temperature recordings taken using a brand traceable temperature monitor at every hour. This case was linked to MOD-2022-566976 (patient link).
3 hours after second dose, soreness and chills began, about 9pm. Second and third day filled with on and off fevers of 100.2 F and all over aches, very tired. Arm swollen and tender to the touch.  Day 4 fevers and aches stopped but redness, swelling and itchiness at injection site began. Redness and itchiness also occurred 1 week after the first dose too, but itchiness feels worse for this second dose.
infection in the gum of a tooth that she had pulled; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had an infection in the gum of a tooth that she had pulled. She was placed on Clindamycin which she has not taken yet. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Within five minutes, the muscle spasms began in my neck and left upper trap. It spread over the day to both sides of my neck, arms, upper and lower traps, thighs. I have had continuous fatigue. The swelling of arms, hands, legs, abdominal cramps, nausea, diarrhea, bone on bone joint tightness and clicking in my fingers, was all worst the first 4-5 days. In the second 4-5 days, my face and tongue started swelling more. The swelling had gone down in my legs and arms, but it seems to be coming back. The elevated temperature (over 99 daily since April 3rd), blurry vision, and migraines kicked in. The fatigue is persistent. A mild headache is persistent, if I don't have a migraine. I am still sick.
(R) deltoid was sore + neck area is swollen. pt was not eating or drinking. Applied ice + Tylenol given. 7/24/20 Doctor called pts mom pt doing better, visible swelling per pts mom on side injections given. No difficulty swallowing or breathing.
Swelling and discomfort of right foot progressfully worse next 2 days. Saw Podiatrist on 11/07. Diagnosed as either gout or arthritis. Antiinflamatories perscribed.
PATIENT STATES HE STILL HAS SORENESS IN HIS ARM AND CANNOT LIFT IT ABOVE HIS HEAD. HE STATES THAT HE TAKES IBUPROFEN AROUND THE CLOCK TO MANAGE THE PAIN. HE SYAS THE PAIN IS STILL A DAILY OCCURENCE OVER 2 MONTHS AFTER RECEIVING THE IMMUNIZATIONS IN HIS RIGHT ARM. THE IMMUNIZATIONS THAT HE RECEIVED IN THAT ARM WERE ADACEL AND SHINGRIX.
Pt recvd 1st dose of Hep B vax on 21MAY91 & approx 24 hrs post vax pt exp bilateral hip pain that inc in severity; pain disseminated to all joints & lasted 3 days; tx APAP; pt recovered 26MAY91;
Redness swelling, decreased range of motion, pain, hardened subcutaneous tissue: all at site of injection and spreading out from there 6 inches. Treatment with ice, Tylenol, ibuprofen.
6/11 71y.o. female admitted through the EC for altered mental status and new onset seizure. PMH significant for dementia.
very tired; tingling in lips; chest tightening; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening), HEADACHE (slight headache) and FATIGUE (very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening) and HEADACHE (slight headache). On 03-Mar-2021, the patient experienced FATIGUE (very tired). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at a dose of UNK dosage form. On 03-Mar-2021, PARAESTHESIA ORAL (tingling in lips), CHEST DISCOMFORT (chest tightening) and HEADACHE (slight headache) had resolved. On 07-Mar-2021, FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
REceive vaccine on 9-18-2007. Father came in and provided info. Mother gave Tylenol. Child had red and warm area where vaccine was given. Child was given Benadryl with good effect. RN spoke with mom this am, child immediately responded to Benadryl. No redness today or other problems.
Immediately I was not able to lift my arm, which continued for several days. The pain became more intense and unbearable. I also felt tingling and numbness. This has lasted for several weeks. The arm continues to be painful.
Kinrix (Dtap/IPV) given instead of ProQuad (MMRV)
patient complains of wheezing, beginning on 10/4/21. He has had to use his inhaler 2-3 times per day after not having used it for months
local swelling, pain, redness & warmth lt thigh;seen in ER in 24hr;change as cellulitis;tx w/keflex;;
Arthus reaction L deltoid.  Tylenol, Benadryl, cold compress.
Client received vaccines at 1350. Client's skin color normal. Client was engaged with siblings and mother in the room, answering questions appropriately, and moving around the room as normal. RN discussed updated record and client's next appointment with client before dismissing family to leave. Fifteen seconds after family left room, RN hears a heavy impact to the floor. RN leaves clinic room to witness client on floor prone in process of picking herself up from lying to standing fifteen feet from clinic room door. Deep laceration about 0.5" across client's chin observed that was not present before client left clinic room. Client's skin color pale. Client alert and answering mother's and RN's questions appropriately. RN encouraged client to sit down. Gauze and pressure applied to chin laceration by client. Cold water provided to client; client able to sip without issue. Mother stated client has received stitches on chin in the past. After three minutes of sitting, client stated feels well enough to leave. Client denied dizziness and lightheadedness. RN encouraged mother to drive private vehicle closer. RN sat with client on bench inside the entrance of the public building while mother brings vehicle forward. Client told RN that she had not felt well earlier that day, experiencing nausea and "vomited a couple times" that morning. Client stated vomiting had stopped, and she told her mother she felt well enough to receive vaccines. However, client stated she did not eat a lunch before coming to the appointment because of the nausea she experienced that morning. Client stated sipping on water helped her feel better. RN was in the process of encouraging client to eat a snack when she returned home when client became nauseous and vomited water and clear mucous (about 0.5 cup volume). After client vomited, proceeded to drink water; RN advised client to sip water slowly. Mother arrived with vehicle. RN told mother client had vomited. Client stated was feeling better and felt stable to go. RN released client with mother to private vehicle where mother will take client to seek further medical attention for chin laceration.
This medically confirmed spontaneous report (initial receipt: 25-Oct-2012) concerns a 72-year-old female patient, who was administered two doses of AFLURIA injection within 2 weeks time. The first dose was administered on 07-Oct-2012 and the second dose (batch number: P58507) was administered in upper left arm on 22-Oct-2012. No adverse effect was reported.
On day 8 post vaccination a localized raised "blistery" rash developed, 5 days of fever not other symdromes. Recheck on 7/24/14 (day 10 5/10 vaccination) doing well. Rash resolving. Afebrile.
rapid heart rate; lightheadedness; headache; exhaustion; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate), DIZZINESS (lightheadedness), FATIGUE (exhaustion), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetic since an unknown date. Concomitant products included METFORMIN, HYDROXYUREA, TOCOPHEROL (NATOPHEROL [TOCOPHEROL]) and RAMIPRIL for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced FATIGUE (exhaustion) and VACCINATION SITE PAIN (sore arm). On 17-Jan-2021, the patient experienced HEART RATE INCREASED (rapid heart rate), DIZZINESS (lightheadedness) and HEADACHE (headache). On 17-Jan-2021, DIZZINESS (lightheadedness), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache) had resolved. At the time of the report, HEART RATE INCREASED (rapid heart rate) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment included Tylenol.
-Bruise on left arm in area of injection -sore -Not feeling well; fever on 9/8/09
Red spots with rash in the areas - head itching - hives/ rash on ribs, head, shoulders- Benadryl on my regiment of medicines - prescribed triamcinolone acetonide cream apply 3 times daily for 7 days.
A spontaneous report has been received from a 5 year old, male patient, who had been receiving FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on an unknown date. The patient experienced rash which started on 21-OCT-2014, slight fever, blisters on his lips, hands are swollen and scarlet fever. At the time of reporting, the event of rash was ongoing and the outcome of slight fever on his lips, hands and swollen are scarlet fever is unknown. The report was considered to be non-serious.
As soon as the vaccine was administered, I immediately felt a pain as if it was administered incorrectly and yelled out.