chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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 concomitant drug details were reported. No treatment details were reported.
This spontaneous report as received from a physician, as part of a marketing research program refers to 11-17 year old male patient. The patient had no concurrent condition. On an unknown date the patient was vaccinated with his first dose of GARDASIL 9 (dose and route were not reported). There was no concomitant therapy. The reporter stated that patients faint in response to GARDASIL 9, boys faint more frequently than girls. On an unknown date 1 out of 60 girls fainted. After fainting the kids sit still until their "color comes back" and then they leave the Pediatrician office. The outcome of faint was reported as recovering. The event did not prevent administration of second and third dose of GARDASIL 9. The reporter considered faint to be related to GARDASIL 9. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
loses sense of smell again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: EW0181) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NOVOLIN 70/30 (ongoing); PRESERVISION AREDS 2 (ongoing). Vaccination history included: comirnaty (DOSE 1; Lot number: EN6198 in the left upper arm), administration date: 20Feb2021, when the patient was 83-year-old, for COVID-19 immunisation, reaction(s): "affected my sense of smell"; comirnaty (Lot number: ER2613; in left arm), administration date: 31Mar2021, when the patient was 83-year-old, for COVID-19 immunisation, reaction(s): "affected my sense of smell". The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "loses sense of smell again".  Additional information: The patient received Pfizer's COVID-19 vaccine for each of the injections made available to the public. The first injection, and each of the following, thereafter affected sense of smell. The patient states that if this continues, he will never smell again. This is frustrating for him as most foods have no flavor except for the taste on his tongue. The pleasure of eating a good meal is lost. Every vaccine he has received, he has a loss of smell and gets a little better and gets next dose or booster vaccine and loses sense of smell again. Just got latest Pfizer Covid vaccine and it happened again. He cannot identify any smells and can tell difference between some foods but not what they are; it makes a big difference on what he enjoys. The first time noticed the loss of smell was after the first two initial vaccinations he got a month apart. He remembers it was after the 2nd dose is when he realized what was going on. It has stayed about the same, it got a little better and when he got the next booster shot it went back. That happens each time he gets booster shot. He doesn't know how to explain improvement, he can tell a little difference between fruit or maple syrup but not the flavors for example. If he has a hot cup coffee in front of him, he can't smell it. But it tastes different, something there but doesn't know what it is. they only mentioned to primary care doctor and see him end of this month and will mention again. States when they see doctor on 29th this month and will talk to him about this again. Going to ask once again for recommendation or referral to ENT. Prior Vaccinations (within 4 weeks): no.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384676 same patient, same product/event, different doses;US-PFIZER INC-202300367705 same patient, same product/event, different doses;
pt presented w/mild bilateral eye irritation & lid swelling 5 hrs post immun;
Severe pain in entire body including joints and muscles along with severe nerve pain which is a severe burning pain in all extremities (arms and legs)and including low back, both hips, hands and fingers and ankles and feet.  It started the same day of the vaccine and it has been 2 and a half weeks and it is still very severe and debilitating. Also with muscle fatigue.  I had experienced severe lethargy until I was put on medication.  My doctor first put me on prescription dose of Ibuprofen (2400mg over 24 hours) after a week and a half of being on Tylenol with no relief.  After four days of Ibuprofen and it tearing up my stomach and having to go on medication for my stomach (Pepsid 40mg with Mylanta) I was still having severe unrelenting pain. My doctor then put me Prednisone 40mg taper. I am on day four of Prednisone and still having severe pain.
Patient received Moderna Covid-19 vaccine at the age of 17; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at the age of 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at the age of 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at the age of 17) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of Inappropriate age at vaccine administered, for mRNA-1273, lot #: unknown,  with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate age at vaccine administered, for mRNA-1273, lot #: unknown,  with no associated AEs.
Itchy rash covering body when I woke up the morning of 10/24/09, I took 50mg Benadryl and it went away. At 08:00pm full body rash again, took 50mg Benadryl, 125mg methylprednisone and rash was gone by 02:00am 10/25/09. Woke 10/25/09 at 09:00am and rash started to come back and by noon it was all over my body again. Continued to take Benadryl every 4 hrs and rash never cleared. 10/26/09 went to internal medicine MD and prescribed Xyzal and Prednisone taper for 10 days. After taking 60mg prednisone and Xyzal rash is gone. With rash the only other symptom I experienced was left upper quadrant abdominal pain. No difficulty breathing, nausea, vomiting, diarrhea, fevers, sore throats, or upper respiratory sx. I have had flu vaccines in the past and have never been allergic to eggs.
This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. On 17-AUG-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 13-AUG-2013, the patient was vaccinated with the second dose GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. No concomitant therapy was reported. No known adverse effects were reported. Additional information has been requested.
First shot: 09/22/21: (At different pharmacy):  Intermittent nonexertional nonpleuritis 2/10 Left sided chest pain started roughly 9 hrs after vaccine shot and lasted for roughly 20 hours  Second Shot: 10/21/21 (At pharmacy address provided) : Irregularly irregular heart rate, excessive perspiration, dizziness, confusion first noted roughly 17 hrs after the vaccine shot. Highest heart rate noted was around 135 (not sure exact number). I have a picture of heart rate 128 noted on my pulse ox. There was vasospasm (pain) in different areas of body but no chest pain. Headaches were persistent occasionally generalized but often point ice-pick like headaches. Irregular heart rate worsened with mild exertion like climbing one flight of stairs (Absence of any cardiac personal or family history). When symptoms persisted for 5 days after second shot, I decided to take anti-inflammatories. I took two doses of Ibuprofen. I also took Curcumin (One of natural anti-inflammatories well studied and published). Taking anti-inflammatories for 3 days helped to reduce heart rate irregularities. My heart rate now (Day 17 post second shot) varies between 80-95 beats per minute (my baseline heart rate prior to vaccine was in 60s). I did not have ice-pick headache for last few days. However, generalized mild headache is often noted (last one yesterday evening).  Not sure if I fully recovered from adverse event as my baseline heart rate prior to vaccine first shot was in 60s. Now my Heart rate varies between 80-90s on day 17 after second vaccine shot.
The patient felt dizzy and lightheaded a few minutes after receiving the vaccine.  She proceeded to fall to the ground but remained talking and did not lose full consciousness.  The paramedics arrived to monitor her further.
On the day of my 2nd vaccination, I developed chills and felt slightly queasy. I woke the next morning with the same symptoms plus a headache. After being up several minutes, I suddenly had a syncopal episode and fell against an antique trunk I use for a coffee table, hitting my face. There was no explanation for the fainting other than the Moderna shot. I have had no symptoms since then other than the injuries I sustained from the fall. I saw a dentist the same day and have an appointment with my PA on Monday, April 12.  I was encouraged to report this incident by family members since it was more than mild flu- like symptoms.
The Moderna Vaccine was given to a 16 year old instead of the Pfizer Vaccine. No symptoms occurred during observation.
Patient began to exhibit mild symptoms (malaise, low grade fever, headache, myalgia) that persisted and became worse by day 4 post vaccine. Then with worsening headache, fever >101 and oral ulcerations that persisted/became worse through 4/19 when he was seen again. Seen in ED on date of first visit at clinic 4/16/21. Extensive testing with elevated protein CSF. Otherwise unremarkable. Seen again 4/19/21 in clinic setting, fever improved but headache present and ulcerations worse. CHF w/u showed no viral or bacterial meningitis or encephalitis.
Lethargic; Difficulty sleeping; Shivering; Fever; Body aches; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced lethargy. In December 2019, the patient experienced shivering, fever, general body pain, headache, nausea and difficulty sleeping. On an unknown date, the outcome of the shivering, fever, general body pain, headache, nausea, difficulty sleeping and lethargy were unknown.   It was unknown if the reporter considered the shivering, fever, general body pain, headache, nausea, difficulty sleeping and lethargy to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that she received her first dose of Shingrix vaccine and experienced shivering, fever, body ache, headache, and nausea. The patient was not able to sleep at night and was feeling lethargic. The patient did not consent to follow up.
I started having gradual pain in the joint in my right thumb that became very severe. I couldn?t pick up a cup without it hurting. I went into the doctor, and they x-rayed the thumb and found arthritis that haven?t been there before. They also found tendonitis and prescribed prednisone. They recommend me to splint it, ice it, and warm compress. I still wear the splint, but it is a little better. I tried not to wear the splint one day and it got worse, so I keep it on.
Pt. arrived to pharmacy on 8/4/18 and stated that her left arm was still hurting after 2 weeks of receiving vaccine. She stated that she can't move her arm much and that she's taken TYLENOL and iced her arm to alleviate pain. Pt. also stated that she would be visiting the doctors office to get her left arm checked out because it was hard to lift her arm. She also stated she'd used ICY HOT to try and alleviate her pain. I explained to the patient that the soreness usually goes away after about a week and instructed her to get her arm checked out if she still felt uncomfortable.
dizzy; I'm tired of being sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "I'm tired of being sick"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizzy". The events "dizzy" and "i'm tired of being sick" required physician office visit. Additional information: the patient received the vaccine 23 months ago and was dizzy every day, so had been to to 9 doctors they all said they didn't know.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a mild case of chickenpox with 100 body lesions, high fever, fussiness and trouble sleeping. The pt was treated with Benadryl, calamine, camphor, and Aveeno bath.
COMPLAINTS OF FEVER OF 102.0 FOR 2 DAYS AND VOMITING
Itching and hives over face, neck and arms.  No difficulty breathing. Diphenhydramine 50 mg IM administered in EC.  Prescriptions given for Benadryl oral, Hydrocortisone cream 1%.  Told to report to primary care provider in morning.  Primary care provider has referred to allergist to see if causative agent could be determined and obtain guidance for series completion.
pt recvd vax; baby had no congenital anomalies but was born w/ a broken clavicle;
Patient fainted, fell off exam table and hit head, then had tonic-clonic seizure lasting approximately 10 seconds. Post seizure exam showed stable vital signs and neurologic state with the exception of reporting feeling tired postictally.
The pt states that after receiving the 4th dose of Anthrax, she got sick on the 27th of May and saw an MD because she had a head cold with vomiting. Pt also states that at the end of July, she got sick with a sore throat and was seen by an MD on the 30th of July and also on the 1st and 2nd of August. The pt was treated with Steroids and an IV. At the end of August she noticed rash like spots above her left eye, left arm, and also torso area. The pt states that on August 11, a large rash progressed on her right upper thigh, both arms, and also the back of her neck. The MD ordered tests and told the pt to use cortizone cream and Benadryl. On September 3, the pt states she had a bladder infection along with diarrhea.  Follow up on 12/27/2000: "Patient has not recovered from adverse event.  Has been diagnosed with Gottate psoriasis.  Am currently DNIF (duty not including flying) until fully recovered.  "
2-5-09 mother reports fever 102 degrees -onset evening after immunizations. 3" redness at site of PENTACEL (L) upper thigh- warm to touch.
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) 0.5 ML once, administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Patient is experiencing pain, primarily at the injection site and the arm is puffy or slightly swollen.  Patient is experiencing no itching, redness, or temperature at the area.  The pain is primarily at night and bedtime keeping the patient awake at night.  During the day, the pain is low or absent.  Patient has been taking Tylenol periodically for pain and will switch to ibuprofen to see if that helps more.  I, the pharmacist, recommended that she visit the doctor to check the area and see if there are any problems.
This spontaneous report was received from an approximately 61 year old female patient regarding herself. Current conditions of the patient included thyroid problems (unspecified), high cholesterol, atrial fibrillation (AFIB) and depression. There were no drug reactions or allergies. On 04-NOV-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date unspecified), intramuscularly. Concomitant therapies included levothyroxine sodium, simvastatin, and venlafaxine hydrochloride. On 04-NOV-2013, within 2 hours of vaccination, her arm started hurting from her shoulder to her elbow. It ached like a bad tooth and she had an egg sized lump at the injection site. The following day (on 05-NOV-2013), the arm was still hurt but at the time of report (06-NOV-2013), the hurt was a lot less. Her concern was that the egg sized lump had moved from the injection site to her inner arm closer to the elbow. The patient sought medical attention (talked to the pharmacist). No treatment was given and no lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for PNEUMOVAX23. Additional information has been requested.
The vaccination was given and before the pharmacist could return to the pharmacy the patient passed out. The patient appeared very pale and disoriented.  While the patient was sitting in the chair being assessed by the pharmacist, he passed out a second time, and 911 was called.  EMT's evaluated the patient and the patient's mother requested no further service from the pharamcy or EMT and walked out of the pharmacy with the patient.
dizziness, impeded spacial awareness displayed by bumping into walls, chairs, desks ect over 2 days after vaccination
Sat a, (10/04) patient began to note swelling at injection site (now resolving), then sun she noted lesions (fluid-filled vesicles) cropping up on her legs, arms, back, buttocks, lip, scalp (one to there in each area), mildly pruritic, then sun evening she complained of fever, headache, body aches, stiff neck, improved today.  Is recovering.
I awoke with a heart rate of 155 BPM, and BP of 131/81 (upper left arm) and the need to urinate. Over the next 40 minutes I needed to urinate 6 additional times, and my heart rate peaked out at 195 BPM, and BP of 139/84. My blood oxygen never went below 95. My hands and feet were extremely cold, but normal in color. After approximately an hour after I recorded the peak heart rate, my rate was 138 BPM. By about 8:45 AM, I was very close to mo normal heart rate and BP. I had no other notable symptoms other than the expected soreness at the injection site and a very slight headache.
pt recvd vax;urticarial wheals 24 hrs after vax;DPH given;to MD 18nov in eve;rept 21nov,swelling in legs from knees down,face;lt side of abdo swollen & tenderness to touch;to MD & dx of schoelein henoch purpura;rx DPH & apap;no dtp per MD
First shot I experienced being lightheaded and I thought I was going to pass out. I stayed for an extra 30 minutes. I felt mild flu like symptoms but still went to work the next night. The second shot my arm hurt much more and I had a low grade fever and chills, same thing with my booster. I still got Covid-19 and was diagnosed positive on 12/28.
rt knee became very swollen, red, warm to the touch & painful sx resolved in about 3 1/2hr;
11/3 Large hives appeared on abdomen, back about 8 hours after receiving H1N1 vaccine (shot). Pruritus. About 18 hours after vaccine-Temp 102 degrees x 2 days, chills, myalgia severe, headache. No cough, rhinorrhea.
I had my second dose of Moderna COVID19 vaccine (lot #030M20A) on 2/10/2021.   Around mid-May I began experiencing foot pain.  On 6/21/21 I was diagnosed with a stress fracture of my right foot (not history of high impact or strenuous activity).  On 7/5/21 I broke the little toe of my left foot with a relatively minor trauma, banging it against the ambulation device I was using for my stress fracture.  A follow up x-ray on 7/20/21, after being non-weight bearing for 4 weeks, showed no change - it is not healing.  Then on 8/10/21 I sustained a significant fracture in the little finger of my left hand when it caught in the shirt sleeve of my husband's swim shirt and he spun to avoid something suddenly.
Headache across forehead(6 hours), ear ringing/sensitivity, joint pain (especially knees-2 days), fatigue(3 days), muscle soreness(1 day), constipation (2 days)
2 DAYS AFTER VACCINE PT STARTED HAVING HEADACHE. WITHIN THE NEXT 7 DAYS, SHE SEVERE PAIN DOWN IN HER ELBOW. NO PAIN AT INJECTION SITE.
Localized itching and tenderness to site on 11/6 also erythema at injection site.
Redness and swelling at injection site on right arm and traveling redness/swelling on arm.  Fever, pain, redness, with worsening pain, headache.