chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Paresthesia/pain at injection site x6 weeks following administration of flu shot. Shot given at outside facility (local Pharmacy, address uncertain). Pt reported to our facility for follow up when symptoms did not improve. Pain and paresthesia started within 24hrs of administration and are still present today.  Concern for possible injection in triceps rather than deltoid, but this is uncertain.
This infant developed fever after receiving vaccinations yesterday. The fever came on this morning, and she seemed somewhat fussy. A little later in the morning, grandmother noticed baby grunting, appearing to be shaking or shivering, and seeming not to be as responsive as normal. This lasted for about 5 minutes, and then she seemed to be more like her normal self. Paramedics were called, and recommended that the infant be seen. She has not had: Paleness, inconsolable crying, or cyanosis. Fever - 103 degrees. Fluid intake - good. Exposure history - positive for gastroenteritis affecting the mother (History from mother.
Patient noticed muscle pain in right arm in December a few months after vaccinations. OTC medications and chiropractic therapies could not alleviate bothersome pain.
within 15 seconds of vaccination patient became diaphoretic and alerted vaccinator to this.  she adjusted in her seat.  Patient was assured of being secure in her seat and became unresponsive.  Vaccinator held her hands and observed twitching motion of arms and hands, as well as sudden and very significantly dilated pupils.  The patient then became fully responsive and Alert and oriented to person, place, time and event though was unaware of exact circumstances.  The whole course lasted less than 30 seconds.
This spontaneous report as received from an other health professional refers to unspecified number of patients unknown age and gender. On unknown dates, the patients were vaccinated with M-M-R II (recombinant human albumin (rHA)) lot # M044351, expiration date 04-NOV-2018. Concomitant therapies included sterile diluent. On an unknown date, the patients experienced incorrect product storage and no adverse event. Additional information has been requested. Sender's Comments: US-009507513-1708USA012441: US-009507513-1708USA012440.
Chills, fatigue, weak, headache at 2:15 am on Oct 12. Shot was received 4:15 pm on Oct 11. Weakness & headache continued for 18 hrs. Took ex-strength TYLENOL for 18 hrs, every 4 hrs. Recovered.
Pt sat in Dad's lap for shots, did not cry. After shots dad stood up and help pt stand. Pt upon rising started collapsing and turning white. Dad picked pt back into his lap. Pt eyes rolled back but did not go completely unconscious. Pt's skin was cold and clammy. PO2 decreased <90%. O2 started via face mask. Within 10 minutes PO2 up to 99-100%. Pt took sip of soda and then slowly sat up. Within 20 min of episode pt was walking on own and talking, color pink. Phone call to home 24 hr later, pt is completely recovered, playing no problems. DX. syncope episode s/p vaccination. R/o seizure d/o.
About one week after the shot I noticed a red spot on my ankle. I suffer from eczema which is usually not bad. The spot on my right ankle is about 6 cm by 3cm large. The wound site does not itch. The wound site started to flair up in a bright red and the skin broke in several areas after a couple of days. The wound has scabs which I have been moisturizing and keeping clean. The scabs are slowly falling off.  The scabs are thick beige/brown in color and the area is still inflamed. Very slow healing.
Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for 5 days was seen by doctor who did covid test came back negative. After 5 days flu like symptoms some what resolved but leg pain continued. Hard to walk and painful. Seen doctors 2 more times when they finally did bloodwork and sent her for admission to hospital. They have done Bloodwork, MRI's and they are all coming back normal but still have leg pain, cant bend toes or touch leg. Been out of work since.
Developed muscle pain in left leg. No swelling, tenderness, or visible signs of issue. Other symptoms from vaccine have resolved, but this area is still sore. States it feels like a pulled muscle. Patient was advised to seek medical care if symptoms have not resolved soon.
Vaccinee rec'd 3 doses Engerix-B 23MAY90, 22JUN90 & on an unspecified date for an indication of "sexual contact." P/3rd dose, vaccinee was a non responder.
patient came in on 10/4/19-reported red swollen area of arm around half circumference of arm.  are was about size of her hand. injection site had black and blue small area.  patient said was warm to touch, and occasionally it was itchy.  she came in because her dermatologist examined her.  she said she didn't think it got worse symptoms since injection. she will monitor , use cold compresses, and see doctor possibly / if gets worse.
Pt went to the ED on 03/19/21-03/20/21 a week after first vaccine.She was seen at Clinic 04/08/21  Patient states that on the day after her 1st immunization last month she had developed fever chills along with nausea and loose stool which progressively got worse.  She went to the Emergency Room and received IV fluids. Patient presents today to get her 2nd vaccination. Per MD patient may experience worsening GI symptoms with her 2nd vaccination.MD recommended patient receive second dose.
Hypertension,  tremors, muscle twitching, brain fog, anxiety,  large muscle weakness arms and legs, inflammations to pubic region with tendonitis both hips (confirmed with MRI), elevated C-Reactive Protein, feeling of having adrenaline surges,  constipation, fatigue, tinnitus right ear,  joint pain
get some pain after the vaccine/here is normally a slight soreness.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (get some pain after the vaccine/here is normally a slight soreness.) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN (get some pain after the vaccine/here is normally a slight soreness.). At the time of the report, PAIN (get some pain after the vaccine/here is normally a slight soreness.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had a booster shot a few minutes ago. Every now and then patient get some pain after the vaccine. Patient queried that if patient could take treatment medication Tylenol or Advil. Treatment information was not provided.   Reporter did not allow further contact
CMA inadvertently administered a Moderna vaccine instead of a Pfizer vaccine to a 14 year old female.
This case was reported by a consumer via call center representative and described the occurrence of numbness in feet in a 77-year-old male patient who received SHINGRIX for prevention. Concurrent medical conditions included blood pressure, sciatica (low levels of sciatica pain for about a month now) and nerve pain. Concomitant products included evolocumab (Repatha), timolol and tafluprost (Zioptan).  On 7th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th June 2018, less than a day after receiving SHINGRIX, the patient experienced numbness in feet, difficulty sleeping, nerve pain and condition aggravated. On an unknown date, the outcome of the numbness in feet was unchanged and the outcome of the difficulty sleeping was unknown and the outcome of the nerve pain and condition aggravated were recovering/resolving. It was unknown if the reporter considered the numbness in feet, difficulty sleeping, nerve pain and condition aggravated to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medications included anticoagulant medication and blood pressure medication. At 10:00, the patient received SHINGRIX on the left arm. The patient's nerve pain became more noticeable on the last night. The patient had trouble to fall asleep last night as well. The patient also stated that, last night he experienced numbness in his right foot and calf in the lower part of his legs. His nerve pain had decreased a little and the numbness was still unchanged on the date of reporting compared to the last night. The patient denied permission to contact their physician. The patient had followed up with his healthcare provider and had scheduled for an MRI, along with an appointment with his neurologist.
Bad menstrual cramping  and light bleeding even though I have an IUD and haven?t had my period in nearly 3 months.  Cramping started two days after receiving the vaccine and today the bleeding started.
STOMACH UPSET; DID NOT TAKE LAST DOSE OF VIVOTIF; This spontaneous case (PVX2019-1039) was received from another healthcare professional on 29-Apr-2019. It describes a female consumer who experienced stomach upset, after the administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. She also "did not take the last dose of Vivotif".  Case report: The consumer took three doses of Vivotif. She experienced stomach upset after taking of each dose. She did not take last dose due to stomach upset.  The consumer had no medical history.  Concomitant medication at the time of event included birth control pill.  Action taken with Vivotif with respect to the event stomach upset was vaccine discontinued while with respect to the event "did not take the last dose of Vivotif" was not applicable.  The consumer had recovered from the event stomach upset while with the event "did not take the last dose of Vivotif" was unknown.  Company's Comment: In this case, it was reported that the consumer experienced stomach upset, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach upset is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.The causality of the event "did not take the last dose of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach upset, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach upset is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.The causality of the event "did not take the last dose of Vivotif" was considered as not applicable.
all fingers on left hand were vibrating for maybe 2-3 minutes, my husband wasn't able to feel any vibration, but in close visual observation, he could see slight vibration.  I massaged my hand and fingers and shook my hand until it finally stopped.
21/2-3 hours after injections, Patient experienced extreme swelling, itching, redness and her arm felt hot. Swelling continued into the next day and she had swelling past her elbow. She applied hydrocortisone and ice. Injection was on 11/10/2018. She went to her Doctor on 11/12/18 and received a prednisone taper prescription over 8 days. She saw her Doctor again on 11/14/18 and told her to stop prednisone on 11/15 rather than 11/20 since her condition had improved back to normal. On 11/12 she was also instructed by Doctor to take aspirin.
vaccines were exposed at minus 1.25 degree Celsius and administered to patient after excursion, No AE; Initial information received on 03-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case is linked to cases 2020SA203233, 2020SA203126, 2020SA203423, 2020SA202350, 2020SA202831, 2020SA202832, 2020SA203422 and 2020SA207050 via same reporter.  This case involves a 11 years old female patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and 0.5 mL dose of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was exposed at minus 1.25 degree Celsius (batch number and expiry date not reported) via unknown route (in the left arm and site not reported for Adacel) on 31-Jul-2020 for prophylactic vaccination(product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degrees Celsius.  No adverse event was reported at the time of reporting.  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 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.  There will be no information available on the batch number for this case.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 11-AUG-2015 the patient was vaccinated with a dose of improperly stored VAQTA (0.5 ml, lot # J002347, expiration date 04-SEP-2015, dose in series was not reported) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
09/09/22 presents to ED for "abnormal labs, shortness of breath". PMHx of ", cardiac arrest, anoxic brain injury"
Vaccine administered on 3-20-09 in AM.  By afternoon tips of fingers hurt.  Played basketball after school.  Noticed tips of fingers had blisters.  Some bleeding.  Tips of fingers were blue.
Client received second dose of Pfizer vaccine @ 2:45pm.  Client reported feeling chest tightness and palpations, trembling and then numbness of right arm and hand, shortness of breath @ 3:23 pm.  Client states she has been having "palpitations and difficulty breathing when walking distances for 1 week now", has not followed up with primary care because she is working on her med-care.  Client also reports feeling nervous and anxious prior to receiving second dose of COVID vaccine today.  Vital signs:  blood pressure 165/100, pulse 80, respirations 12 @ 3:23pm.  Client is able to talk and answer questions, no labored breathing noted.  Vital signs @ 3:34 pm;  blood pressure 155/95, pulse 80, respirations 12.  Client reports that symptoms have lessened but continue.  Client denies any medical history, no medication and no allergies.  Client reports no symptoms with first dose of COVID vaccine.  At 3:45 pm RN makes client aware that will call EMS, client refuses, states "I have been dealing with these symptoms for a week now and do not want to have ambulance check me out, I would like to go home."  RN instructs client to dial 911 if symptoms worsen at  home.  At 3:49pm, client leaves against medical advice, her son is with her.  Client able to walk with steady gait.
Greater than 35 days since the first Moderna covid-19 vaccine dose; sore throat; sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the first Moderna covid-19 vaccine dose), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore injection site arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the first Moderna covid-19 vaccine dose), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore injection site arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the first Moderna covid-19 vaccine dose) had resolved and OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains non-significant information.
4x5cm diameter erythemic, warm to touch area; lt upper arm pinpoint center noted to be slightly harder than the outer area;
Tachycardia, facial flushing, hoarseness, chest tightness occurred within minutes after injection.  Prednisone IM given approx 10-15 minutes after start of symptoms.  Zyrtec 20mg PO and Benadryl 50mg PO given at the same time.  Symptoms did not worsen, but tachycardia and hoarseness improved over 20-30 minutes.  Involuntary twitching began approx two hours after incident and continued at times of rest for two weeks.  I would get a sensation prior to the twitching and I was not able to control it.  Twitching stopped but continue to have the sensation at times of rest.  I have unusual allergic reactions since first Moderna vaccine reaction in 2021.  Most recent developed diplacusis after drinking camomile lavender tea.  I develop facial flushing and facial burning when exposed to certain scents/fragrances, foods, drink, topical lotions, etc.
Caller tested positive for covid 19; mild cold symptoms; This is a spontaneous report from a contactable consumer (patient himself). A male patient of (age: 63, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration on 19Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID-19 on 25Feb2021. The patient stated that he had mild cold symptoms the day he got the shot on 19Feb2021. Second dose of vaccine was due in two weeks. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Big red square at the site of the injection; Injection site was swollen and was terribly itchy; Injection site was terribly itchy; Pain at the injection site; A spontaneous report (United States) was received from a consumer concerning herself ,a 72-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at the injection site, big red square at the site of the injection, injection site was swollen and was terribly itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023LwA) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the pain at the injection site.  On 23 Jan 2021, the patient experienced big red square at the site of the injection, injection site was swollen and was terribly itchy.  Treatment details included Ice, Advil, Benadryl.  Action taken with mRNA-1273 in response to the events was unknown.   On 26 Jan 2021 the outcome of big red square at the site of the injection, injection site swollen was resolved.  The outcome of pain at the injection site was unknown and for injection site was terribly itchy was not recovered.; 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.
This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown ages and genders. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M043582 for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to sterile diluent and VARIVAX. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA011729.
pt recvd vax & 12 days post pt devel a mild rash w/30 vesicles total;no further details were provided
Felt weird agt 15min end time of observation.  Needed to take a deep breath.  Got up: lost footing/stumbled.  Feels weird, very tired.
Sore arm within hours of vaccination (mid-day Thu 30 May through the night of Saturday 1 Jun 2019) Overnight: chills, light-headedness (lasting through the evening of Fri 31 May 2019) Second night: heavy night sweats (lasting through the night of Sunday 2 Jun 2019)
Patient is a 4.5 year old male. He received his first pfizer pediatric dose by accident. Mom was made aware and was told patient is okay and has no reaction. She understands that he can come in after he turns 5 years old for the 2nd pfizer dose.
I experienced extreme fatigue, nausea, almost fainted. I never experience any of these reactions to any other vaccine. I could not go to work. I also had light headiness which I could not stand for too long. I spoke with a HCP through telephone.
Crying for hours in the evening after shot, 2 days later followed a fever. Day 5, shaking and vomiting.   The last DTAP vaccine he had the same reaction as well with vomiting and shaking.
7 PM began having headache, vomiting, eyes began itching and swelling. Took 2 BENADRYL and went to bed. Eyes remained slightly swollen and itchy in the morning but resolved throughout the day.
I developed a cough, headache, fever, and body aches a couple of days ago after the Christmas holidays. I took an at-home COVID-19 on 12/27/2022 which came back positive right after. I contacted my physician assistant's at my doctor's office who prescribed me PAXLOVID to take twice a day. As of now, my symptoms are stable and not so much pain since taking the prescription; my fever has gone and my body aches are slowly diminishing.
Arm pain, headache, diarrhea, agitated insomnia, fatigue. Resolved in 72 hrs.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Around 20 hours after injection, had body aches in lower back, hips, glutes, and thighs. It lasted about 9 hours.  Pain, swelling, redness, and warm  and hard to the touch around injection site.
I have a huge lump on the right side of my neck that I can feel. They did a biopsy but couldn't find it. They did an ultrasound and found other things in my neck. My neck is sore and stiff and thats how I was able to find the lump.