chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a female patient of unknown age referring to herself. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, lot #, dose and route unknown). There was no concomitant medication reported. On an unknown date the patient experienced side effects from ZOSTAVAX. She had a large round painful bump with a rash at the vaccine site. She did say it was the size of a silver dollar coin. The outcome of the events was unknown. Additional information has been requested.
Dizziness, Nausea started within 5 minutes of vaccine.  Paramedics onsite checked vitals, oxygen levels good, pulse good, however BP was 200/120.  Normal BP for patient is 145/85.
16 days p/vax 13FEB98 pt exp fever 102, rash red blanching macules head & trunk;3MAR98 rash more-no fever;
Shortness of breath, admitted to Emergency Room, No Fever or Coughing, X-Ray taken, showed involvement of left lung, diagnosis: pheumonia of lower left lung, treatment Amoxycillin.
The patient patient received her second dose of GARDASIL 9 2-3 months late; no adverse event; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unspecified date, the female patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 2-3 months late and the pharmacist would like to know when to administer the third dose. No adverse events were reported.
Hives/Itching in arms and neck. Still present today 01/30/2017. Taking OTC Benadryl at night. Has improved since 1/26/17.
GOT COVID; This spontaneous report received from a consumer concerned multiple patients. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious.
patient under 65 was accidentally administered the Fluzone HD Quadrivalent with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 61 years old female patient who was under 65 and accidentally administered the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included elasomeran (Moderna COVID-19 vaccine) for COVID-19 immunisation.  On 05-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (lot UJ926AA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 05-Oct-2022 the patient under 65 was accidentally administered the fluzone hd quadrivalent with no reported adverse event (product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
unbalance movement; couldn't walk straight which leads to pitching in to the wall; Buzzing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Buzzing in ears), BALANCE DISORDER (unbalance movement) and GAIT DISTURBANCE (couldn't walk straight which leads to pitching in to the wall) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event and Head injury (Patient had head injury when she was 23 years old and also had one in 2010).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TINNITUS (Buzzing in ears). On 18-Mar-2021, the patient experienced BALANCE DISORDER (unbalance movement) and GAIT DISTURBANCE (couldn't walk straight which leads to pitching in to the wall). At the time of the report, TINNITUS (Buzzing in ears), BALANCE DISORDER (unbalance movement) and GAIT DISTURBANCE (couldn't walk straight which leads to pitching in to the wall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Responses: Monday, when I was at work for my second shift, I almost passed out more than four to five times. I left early. I had to rest in the car for ten minutes, before I felt safe to drive home which is ten minutes away. Even so, I had to pull over on the way home for a few minutes to rest, again. Also, I could not bend over without starting to fall. Each day, from Friday to Tuesday, I slept about sixteen hours to recover along with necessary several hour naps during the day. Until today, I was unable to do dishes without dropping them. I also got blurred vision in the evening. Pain: On Thursday, I got a vaccine on my right upper arm. My arm burned after the shot which I assume is normal. On Thursday night, I could not move my arm especially my upper arm without pain. Thorough out the evening I got short two to three burning sensations in my arm. On Friday to Saturday, I could not move my upper arm away from my body without 8 out of 10 sore pain along with touching anything like a couch or lay on my upper arm without 6 out of 10 sore pain. On Monday, I had hard time working at my waitressing job, I lifted some heavy objects that caused my arm to be in extreme pain 9 out of 10 sore pain which caused me to be unable to work my second shift. Today Wednesday August 8, 2018; I am feeling better, I was able to modify a yoga 10 minute exercise before my shift in the morning. At work, I only used my left arm. In the afternoon, I am starting to be able to use my right arm again, do dishes and laundry at home, with just 3 out of 10 sore pain.
Same day after getting the shot I developed chills. I came home from work and I took a shower and went to bed. Next day I woke up with nausea and headache. Later that day I had a nose bleed. The following day I was so weak, tired and dark urine. 12/24 I developed a fever of 101.0. I called my MD and made an appointment for 12/28 but I did not see her. I took Benadryl and Tylenol. 12/25 I woke and I felt better.
lethargic; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (lethargic) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 23-Apr-2021.    On 23-May-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 LETHARGY (lethargic). At the time of the report, LETHARGY (lethargic) 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.
This spontaneous report was received from a registered pharmacist concerning a 69 year old female patient with no pertinent medical history. Current conditions of the patient included penicillin allergy, cephalosporins (unspecified) allergy and MACRODANTIN allergy. On 23-AUG-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date reported as H012577 and 28-SEP-2013 respectively), subcutaneously. There were no concomitant medications. On 24-AUG-2013, the patient developed redness, swelling, warmth, periodic itchiness and 2 to 3 dots/bumps in an area about the size of a baseball around the injection site. The patient sought medical attention (came to pharmacy). No lab tests were performed. No treatment was given. However, the pharmacist informed the patient that if the symptoms become bothersome then to use a hydrocortisone cream (manufacturer unknown) for the itchiness and a cool wash cloth for the warmth, redness and swelling. VZVIP packed was faxed. The patient was not recovered from all the adverse events at the time of reporting. The relatedness for all the adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Fever of 100.4; Aches; "Enlarged (swelling) of what I presume was the lymph gland below my left armpit extending over to my left breast"; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 25Mar2021 at 13:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and an allergy to "probably penicillin". Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included losartan potassium (LOSARTIN), rosuvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and sodium phosphate dibasic, sodium phosphate monobasic (VISICOL). The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 27Mar2021 at 19:00, the patient experienced a fever of 100.4, aches, enlarged (swelling) of what the patient presumed was the lymph gland below her left armpit extending over to her left breast. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 100.4, aches and enlarged (swelling) of what the patient presumed was the lymph gland below her left armpit extending over to her left breast was resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Day 8 swollen, raised and red at injection  site.  Warm to the touch.
Suspected breath holding spell.  Doubt related.  Nurse follow up on 06/16/04 states: "ADD: Cerebral palsy."  Nurse follow up on 06/25/04 states: "No new information."
Patient received combination MMRV instead of MMR and was also given stand-alone varicella, resulting in double dose of varicella being administered. Mom states patient seemed to be more irritable than usual after vaccine administration, and the injection site was redder and more swollen than with other vaccines previously administered. Mom did not feel the need to initiate follow up care based on patient reaction and side effects resolved on their own.
aches; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), CHILLS (chills) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 130M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), CHILLS (chills) and FATIGUE (tiredness). At the time of the report, PAIN (aches), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.
Patient fainted and regained consciousness within a minute. He was taken to an exam room and stayed until he felt well enough to leave.
No other AEs reported; Patient received VARIVAX less than 28 days after MMRII; This spontaneous report was received from a nurse concerning a 33 year old patient. Information regarding the patient's  medical history, concurrent conditions and concomitant medications was not reported.   On 18-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T013727 was determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 21-APR-2022) (strength, dose, route of administration and anatomical location were not provided).  On 25-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration) for prophylaxis (lot number U002399 was determined to be valid for varicella virus vaccine live (oka/merck), expiration date reported and establish as 22-JAN-2023) (strength, dose, route of administration and anatomical location were not provided).  No adverse event reported.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N001528 with expiry date: 13-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
After the administration of the vaccine the patient was instructed to wait in the sitting area until cleared to leave. Before 15 minutes elapsed the  patient reported symptoms of itchy and clammy skin. He also reported having an itchy throat. Theses reactions took place 10 minutes after the vaccine was administered. I gave the patient 37.5mg  of Benadryl liquid. The patient reported feeling a little better. Due to the need to followup up with a physician I escorted the patient to the student health center where he was seen by a NP. At the health center vitals were taken (O2 sat was at 97, BP slightly elevated, Throat not swollen but red), solu-medrol was given, and a nasal cannula was utilized. The patient was stable before I left the health center. EMS was not called.
Patient was given the incorrect vaccine. Needed Pfizer Bivalent booster for ages 5-11 yrs, but was given Pfizer Monovalent booster ages 5-11 yrs.
I received the two-part shingrix shot on 1/15/19 and 5/29/19. After the first shot I had soreness for a couple of weeks, which lessened somewhat, but I periodically had pain in that arm until and including the time of the second shot. The initial pain with the second shot was worse, and it got better within three days, but I still have pain in my left arm. It is a dull, achy pain most of the time, but it gets worse when I am NOT using that arm and when I lie down at night. Tylenol helps, and I have used some topical ointments which help somewhat, but the dull, achy pain is there most of the time.
Shortly after receiving shot in left shoulder, I began to feel sensitivity/tingling in left jaw.  A few minutes later, the left side of my face felt heavy/full/numb/tingling.  This persisted throughout the remainder of the day along with feeling woozy and having a bad headache.  Headache and wooziness were gone by next day but left facial heaviness, fullness, numbness and tingling persisted and is still present today.  Not as bad today but still under left eye, along left jaw and mouth, and parts of left cheek.   Had teledoc visit with doctor the evening of the shot and he diagnosed as Bell's Palsy.
Subsequent to receiving vax, the pt developed warmth at the injection site. No further information was available at the date of this report.
DIARHEA DIZZINESS-FELL 5 TIMES CHILLS SHAKING DIDNT GET MEDICAL HELP
Tingling lips, low grade fever, elevated blood pressure, shortness of breath, tight chest, coughing, headache, mucus in eyes, red face, severe body aches, hoarseness.
MMR shot caused severe allergic reaction and extreme high fever of 105 degrees. Baby had permanent damage. Took too long to get fever down. Had reaction in Dr office. This was a happy baby, after shot was overly fussy, high fever, rash and became chronicly angry. Suffered liver damage. 60 Day Follow-up Information 16-MAY-2006: Physically yes. Mentally NO. This was a happy child. Now he is ANGRY. Easily upset, depressed. He is smart but has difficulty with reading. Why wasn't I informed of the RISKS BEFORE he was given shots? It should be a requirement to be educated on vaccines BEFORE the child is given any - say during pregnancy. Follow-up: He has liver damage, and his brain was affected. We hope he will learn to be happy. Even though some thing we did to his body without his permission (the shots) have caused permanent damage.
On 2/17/22 patient received vaccine that expired on 2/12/22.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Cutaneous skin reaction on chest and thighs yellow and purple color
Pt developed coughing , vomiting one time , abdominal pain and wheezing
Information has been received from an investigator via agency concerning a patient who was enrolled in a study. On an unspecified date, the patient was vaccinated with MMR II and PNEUMOVAX 23 vaccine. This report was part of a post-marketing surveillance program. Subsequently the patient experienced edema/swelling/induration and fever. The patient outcomes were not provided. The reporting investigator felt that the patient's fever was possibly related to the MMR II and the PNEUMOVAX 23 vaccine. The investigator considered the edema, swelling and induration to be definitely related to the PNEUMOVAX 23 and not related to the MMR II vaccine. Edema/swelling/induration and fever were considered to be other important medical events. No further information is available.
Headache, Myalgia, Fever, fever & chills lasting 1.5 days; bad headache and felt bad
Burning itchy rash on arms/legs and vomiting. Patient got medical attention at the urgent care and was prescribed oral steroids' which cleared up her rash
Erythematous papule on trunk and extremities; rash with red bumps; itchiness; scab; This case was reported by a consumer via other manufacturer and described the occurrence of red rash in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 29th March 2019, the patient received Boostrix. On an unknown date, less than a month after receiving Boostrix, the patient experienced red rash, papular rash, pruritus and scab. The patient was treated with ambiguous medication nos (Campho Phenique (Nos)). On an unknown date, the outcome of the red rash, papular rash, pruritus and scab were not recovered/not resolved.   It was unknown if the reporter considered the red rash, papular rash, pruritus and scab to be related to Boostrix.  Additional details were provided as follows: The patient's age was not reported. The patient received Boostrix during the normal course of business. In the afternoon, when the patient was at home, she started to present rash with red bumps and itchiness on her legs. Then patient's mother noticed it was up to her thighs when she was in dancing class.  They applied Campho Phenique which helped a little.  Three days later the same rash also appeared on her arms and trunk.  Since then it was still there and not going away.  The reporter stated, nobody else at their home had anything similar events.  Upon examination, it was confirmed as erythematous papules on trunk and extremities, some with scab on top. No additional information was provided.  Permission was given to follow up with the reporter.
Redness, heat, welts & pain in her left arm extending to elbow and into chest, shoulder & neck.
I developed symptoms on 29Dec2020 and test obtained on 30Dec2020. My results are back today and I'm positive.; I developed symptoms on 29Dec2020 and test obtained on 30Dec2020. My results are back today and I'm positive.; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for himself. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 16Dec2020 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient tested positive for coronavirus on 30Dec2020. It was reported that the patient obtained his first Pfizer vaccine dose on 16Dec2020. The patient reported that he was a physician assistant and worked in a dedicated COVID patient care area. The patient developed symptoms on 29Dec2020, and a test was obtained on 30Dec2020. The patient's results were back "today" and he was positive. The patient was scheduled for his second dose of the vaccine on 06Jan2021. He reported that he would cancel that because he would still be in his 10-day isolation period. Given those circumstances, the patient inquired as to "when would be the most ideal time to obtain my second dose of the vaccine? When should I take my second dose of the vaccine if I contracted COVID after receiving the first dose?" The clinical outcome of the event "I developed symptoms on 29Dec2020, and test obtained on 30Dec2020. My results are back today and I'm positive" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on a compatible temporal asociation, a causal relationship between event "patient developed symptoms on 29Dec2020 and test obtained on 30Dec2020. was positive" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
Patient was admitted to observation level of care on 12-18 with dyspnea and cough. Patient tested positive for covid on 12-18.
Four months after vaccination on May 31, 2021, mysteriously got Vestibular Neuritis disorder.  Had extreme vertigo and went to ER. Have seen ENT doctor and currently seeing neurologist and PT for vestibular disorders.  Have been lightheaded since May 31st.  Not sure if it is vaccine related but wanted to report it.