chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4yr old patient came in with mom requesting child immunizations. After reviewing. child vaccination record she was eligible to receive Hepatitis A, HIB, Polio, PCV15, MMR and Varicella. Mother agreed for patient to receive all the vaccines. I went ahead to dilute the HIB vaccine and administered to patient. Patient was observed for 15 minutes, and no adverse reaction was noted. At the end of the day while counting the vaccines it was discovered that the HIB diluent was still in the box and that's when I realized the vaccine was mixed with the wrong diluent, sterile water was used instead of sodium chloride 0.4%.  Provider was informed, and patient's mom was called. Mom mentioned that child was not having reaction.
Bruise started day of administration. 12 days later, 6/27/19, pt began experiencing strong signs of fever with vomiting - bruise is still present though diminishing and not painful. Recommended to treat fever symptoms with Tylenol, illness is possible but not likely due to reaction to vaccine because of time span.
Information has been received from a male physician who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the physician experienced a varicella like rash. Unspecified  medical attention was sought. He recovered from on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Left arm pain, muscle weakness, dizziness, seizure-like activity with staring spell and inability to speak or move for a few minutes.  Happened again 10/15/2013 at about 9am at facility.  I was seen by NP who described it as "looking Luke a seizure" and is referring me to a  neurologist. I remember feeling hot and light-headed, then fainted, cried and my body felt like it was jerking.
Patient was sitting in chair, then slumped down, stating she could not see about 5 minutes after the vaccine.  She then became unresponsive for about a minute.   After laying her down and elevating her feet she began to feel better.  Patient's respiration and pulse remained normal throughout
Increasing muscle weakness. MRI brain EMG/NCS MRI C spine, lumbar puncture plasmapheresis started 10-28-10. Dx Guillain-Barre Syndrome.
pt recvd vax in approx 1990 & the pt had a poss allergy to Neomycin component of the vax; No further details were provided;
Mother called with complaint of a rash that appeared within 2 days after immunizations around the site of the immunizations.  The rash is approx 1 1/2- 2 inches around the injection site.  The rash has continued in same area but is not going away which is why the mother called.  She states it does not appear to be itchy and it is not a blister or pimple-like in appearance.
The patient said that he is now only able to walk with the assistance of a walker. His doctor is unable to find the cause. The only thing they can think of is that it is because of his Shingrix vaccine. Before the vaccination, he was able to walk with out a walker.
On night of vaccine around 9:30  p.m. chills cramps in both legs and both feet. Day after vaccine body ache and fatigue.
Information has been received from a physician concerning a 12 month old male patient who on 13-JAN-2010 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot# 665417/1129Y). It was reported that the next day (on 14-JAN-2010) the patient's mother called the physician to inform him that her son had some bumps on his torso. When the physician finally saw the patient on 19-JAN-2010, he diagnosed it as chickenpox. The patient also mentioned that he got the vaccine from a fellow physician and transported it from one floor to another and was not sure on the storage of the vaccine at a previous location. At the time of reporting, the patient did not recover from these events. The patient's brother's information has been captured in WAES# 1001USA02540. Additional information has been requested.
Vaccine was at room temperature for>6 hours at time of administration. Headache and very tired
Area of influenza vaccine site became raised and red area grew to 3 inches by 6 inches over three days.  Itchy and sore.  No treatment administered.
I seem to still be experiencing symptoms; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (I seem to still be experiencing symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (I seem to still be experiencing symptoms). At the time of the report, VACCINATION COMPLICATION (I seem to still be experiencing symptoms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient had the Moderna Booster 13 days ago and the patient seem to still be experiencing symptoms.  No treatment information was provided.
woke up in sweats; fever; headache; This case was reported by a consumer via interactive digital media and described the occurrence of sweating in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced sweating, fever and headache. On an unknown date, the outcome of the sweating, fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the sweating, fever and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix and the patient woke up in sweats, fever and headache.  The reporter asked if duration of resolution of these symptoms.
Six days after vaccination she developed a round red circle around injection site. Site is itchy and warm to touch. No other symptoms are apparent.
pt recvd vax; devel rt facial palsy (Bell's Palsy); onset was 29jan95;
Patient contacted pharmacy complaining of a red, swollen, painful rash 6 inches wide around the vaccine injection site.
side effects in her ear and throat; side effects in her ear and throat; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISORDER (side effects in her ear and throat) and OROPHARYNGEAL DISCOMFORT (side effects in her ear and throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISORDER (side effects in her ear and throat) and OROPHARYNGEAL DISCOMFORT (side effects in her ear and throat). At the time of the report, EAR DISORDER (side effects in her ear and throat) and OROPHARYNGEAL DISCOMFORT (side effects in her ear and throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported
36 hours after he got the MENACTRA he developed achy legs and fever of 104.9 at home and 103.9 in the ER. No local reactions to injection site. Laboratory tests done and given IV fluids in the ER. Patient sent home after 2 1/2 hours in the ER.
I felt a tingling to the tip of my tongue.  I did not affect my speech or breathing. I saw a nurse practitioner while waiting for my side effect to wear off, and she told me to take Benadryl.
Per Nursing Staff- patient died within 24 hours of receiving the vaccine. patient has hospice. Please contact  director of nursing for more details.
This spontaneous report as received from a physician refers to a 14 months old female patient. The patient was vaccinated with a dose of M-M-R II (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The physician reported that on an unspecified date "about 10 days" after vaccination, the patient developed idiopathic thrombocytopenic purpura. The patient was taken to the emergency room and admitted to the hospital. It was unknown how long the patient was hospitalized. The outcome of idiopathic thrombocytopenic purpura was reported as recovered/resolved. The relatedness for idiopathic thrombocytopenic purpura was unknown for M-M-R II. Additional information is not expected.
This is a spontaneous report from a contactable nurse for a patient enrolled in a Pfizer-sponsored program; this report regards an event part of the medical history of the patient. A currently 24-year-old female patient received a single dose of PREVNAR 13 on an unspecified date for immunisation and INVEGA SUSTENNA, BACTRIM, CIPRODEX, MIRALAX and sulfa, all via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication. The patient's concomitant medications were not reported. The patient experienced drug allergy to PREVNAR 13, INVEGA SUSTENNA, BACTRIM, CIPRODEX, MIRALAX  and sulfa on an unspecified date with outcome of unknown. The action taken in response to the event for INVEGA SUSTENNA, BACTRIM, CIPRODEX, MIRALAX and sulfa was unknown.
felt bad for about a day; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her pharmacist told her that she herself had the Shingrix shot and felt bad for about a day afterwards and then it resolved. No further details were provided. The reporter did not consent to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Patient felt lightheaded, nauseated, diaphoretic. Placed in recliner, drank apple juice, felt better Monitored for 20 minutes History of vasovagal episodes with blood draws/injections Patient left feeling better, girlfriend drove him home
Given KINRIX & MMR in (L) deltoid & left sub-q (respectively) on 10/4/11, on 10/6/11 presents to clinic with localized swelling, redness. Low grade fever, 99 degrees-100 degrees.
Information has been received from a consumer concerning a friend's male child who at 12 month of age was vaccinated with MMRII. Subsequently, 1 week later, there were noticeable changes in the child's behavior. Between the ages of 18 and 24 months, the child was dx'd with autism, which the friend feels is related to vaccination with the MMRII. Unspecified medical attention was sought. Upon internal review, autism was considered an "Other Important Medical Event". Additional information has been requested.
No additional adverse events were reported; Patient received VARIVAX and PROQUAD together; This spontaneous report was received from a registered nurse referring to a 21-month-old, patient of unknown gender, whose medical history, concurrent conditions, and concomitant therapies were not provided.  On 31-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, dose reported as 1 dose, administered for prophylaxis (lot number: u024220, has been verified to be a valid lot number, and expiration date: 04-AUG-2023; exact dose, vaccination scheme frequency, route of administration, and anatomical location were not provided); it was administered together with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, for prophylaxis (exact dose, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) (overdose).   No additional adverse events were reported.
Fever to 105, shaking in afternoon that 5-12-15 after fast fever rise.
Information has been received from a physician via a company employee referring to a 15 year old male patient. The patient did not have any pertinent medical history. His drug reactions or allergies were unknown. Concomitant therapy included MENACTRA. On 16-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (strength and dose unknown, frequency was reported as 3 doses, intramuscular). The patient lay down to rest for about 10 -15 minutes and when he got up to leave he passed out. The patient did not seek medical attention or receive treatment for the event. No lab tests were performed. The outcome of the event was reported as resolved (unspecified date in August 2016). The reporter did not provide the causality assessment. Additional information has been requested.
Welts, red raised itchy - on a right arm and neck & back.  9-30-11 - spread all over body, arms, legs, big splotches. She took pictures. Still red 1 week later swelling down.
Patient received her second covid vaccine 1/19/21. Patient returned within the hour of receiving the vaccine concerned that the vaccine was given incorrectly . After consultation with pharmacy, nursing and company it was recommended the patient   would need to have the second dose  repeated. The patient returned 1/22/21  and received a repeat second covid vaccine.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses (RECOMBIVAX HB) (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Difficulty swallowing, slight fever, rash at shot location, coated tongue, runny nose, body aches. Missed 2 days of work, and sick thru the weekend.
8/25/21 - body ache in shoulders 10pm, Intense headache began.  Tension was around the entire hairline.  I had to hold my head all night.  08/26/21 - Headache/tension continued.  1 caplet Tylenol taken at 0445.  No relief.  No appetite.  Drank lots of water to stay hydrated.  Body aches continued.  Slight nausea.  Headache/tension eye strain.Slept more.  7pm took walk and was exhausted after walk.  Went to bed early.  Headache/tension persisted.  Took Tylenol.  08/27/21 - Headache/tension/eye strain - continued.  Intensity changed throughout the day.  When laying down at night, metallic ringing in ears, heartbeat in head, head tension continued, "carbonation fizzes" sensation from occipital area of head down neck.  This remained the same for five weeks.
she ordered a vaccine and the pharmacist didn't make it clear that it had to go in the refrigerator so it was at room temperature for a couple of days; Initial information was received on 09-Dec-2021 regarding an unsolicited valid non-serious case from a consumer / non healthcare professional via Agency (under reference 00891725).  This case involves an unknown age female patient who was administered with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] of which she ordered a vaccine and the pharmacist didn't make it clear that it had to go in the refrigerator so it was at room temperature for a couple of days (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual case of medication error due to incorrect product storage.  It was reported that she ordered a vaccine and the pharmacist didn't make it clear that it had to go in the refrigerator so it was at room temperature for a couple of days in a really cool house that always has the air conditioning running and her doctor asked her to call the company to see if we think it is still ok to use. She wants to know if she has side effects does that mean it is working.  At the time of report, no adverse event was reported.  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.  There will be no information on batch number for this case.
Felt "hot & dizzy", looked flushed, BP: 133/90, HR: 67. Cool cloth to forehead, 16 oz ice water consumed. Symptoms resolved by 2:35pm.
This spontaneous report as received from a medical assistant refers to 4 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 18-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA004609:
The evening of my 2nd vaccine, I had a 103 fever that lasted 2 days. I treated this with Tylenol. Since then, I have experienced fatigue. 2 weeks later I woke up about midnight to shooting pains down both arms. This lasted about 5 minutes and then stopped. I didn't think anything of it at the time or linked it to the vaccine. Since that first time I have had that experience 3 more times in the middle of the night. I also have noticed vision changes in my left eye. As of now my fatigue has gotten better, but I am not back to my normal energy level.
I was administered the Moderna booster on the evening of December 16. I woke up December 27 covered in hives (which I have never experienced before). By Tuesday evening my hives were unbearable, and I could feel them in my throat, so I admitted myself to the ER on the morning of December 29. I was kept in the ER for a few hours and given an IV of Prednisone and Benadryl until my hives had settled. I was sent home with a steroid prescription and no none cause or understanding of the hives. I have dealt with urticaria as well as dermatographia every day since their onset, December 27. I am confident that I am experiencing a delayed adverse reaction to the booster.
Within 5 minutes of vaccine felt woosey. Within 35 minutes felt mild numbness tingling in lips. Within 40 minutes of vaccine felt back pain, then neck pain.  The neck pain intensified throughout day to a full blown stiff neck. My neck continuted to hurt mostly the first day, but day 2 as well, by day 3 it had dissipated. I felt "weird" in my spine hours after the vaccine can only describe it to feeling like I took a medication that did not agree with my system. Had asthma flare 8 hours after vaccine. The first night I felt hot all night, feverish, seemed to break the feaver in middle of night around 2 am but continued for next day having on/off fevering, feeling hot. By day 3 I felt mostly recovered and good.
Was fine after getting the shot walked out got to car went down looked like seizure then stopped breathing/no hart beat did CPR police/ems came took over got him back took to hospital.
fever; body aches; This is a spontaneous report from a contactable other health care professional (patient himself) via medical information team. A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 18Feb2021, the patient developed fever and body aches and getting a coronavirus test. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as K008885, with expiration date 20-SEP-2015, dose 0.65 ml, subcutaneously, which had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.