chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a nurse via consumer from other company Pfizer (under the reference number: 2017382866) on 30-Oct-2017. This case involves a female patient (age not reported), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced anaphylaxis. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Upon internal review the case was considered as serious because of important medical event: anaphylaxis. Documents held by sender: none. Sender's Comments: The patient experienced anaphylaxis post vaccination with Flu vaccine (MFR UNK). No information regarding the time to onset has been reported. No information regarding product lot or brand name has been reported. Additional information regarding latency, product lot or brand name must be obtained. Alternate etiologies along with patient's immunological and allergic history should be assessed. Based upon reported information the role of the vaccine cannot be assessed.
arm pain, painful rash that is streak down arm about 4 inches from injection site, body aches, chill, headache, hives on neck and chest that resolved within an hour
Patient signed up to get vaccine and stated was 16 years old, Nurse asked if 16 or older, patient said yes. Patient does not turn 16 until October. Nurse realized this after injection was complete and the dose was being documented.
Information has been received from a physician concerning a 16 year old female who on 11-SEP-2008, was vaccinated with her first dose of GARDASIL. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 12-SEP-2008, the day after vaccination the patient experienced fever, sore throat and headache. The parent of patient called office. At the time of reporting, patient's fever, sore throat and headache persisted. Patient will be seen in the office today. Additional information has been requested.
Information has been received from a health professional concerning a female (age Unknown), who on 02-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 02-NOV-2007 the patient developed a large lump on her arm at the injection site. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Inadvertently gave Moderna to 16 year old Mother relates had cold like symptoms, and fatigue but was well on day 3
Pt had not received any flu vaccine in last 10 years.  decided to get one this year.  pt got shot on sat 10/10.  she called the next fri 10/16 to explain she had experienced adverse effects (mild throat swelling, tongue swelling, tiredness) with about 24 hours of shot.  Her symptoms while sounding concerning began to resolve and slowly improved over the next couple days.  she did not seek any emergency care.  Her dr would not return messages left, as of our conversation on friday 10/16.  When we talked on Fri, she was concerned about her symptoms, but had improved and was not upset.  I reassured her she had received the correct flu vaccination, and encouraged her to continue to reach out to her dr for any further guidance.
Severe chills, fever, body aches, syncope, sharp pain, intermittent L side of back, fatigue.
Localized erythema and induration to right tricep, approximately 130mm in diameter. Does not extend below the elbow. No systemic symptoms.
Blood in stool, emesis, lethargy noted over 16hr time course. Appeared pale, tachycardia at office. Barium enema and reduced intussusception.
On 6/15/23, the patient returned for his second dose MPV vaccine.  Upon assessing the patient, he told the RN that he had received his first shot (on 5/18/2023) via IM route in the left deltoid.  He reported that after vaccination on 5/18, he had fatigue, body aches and a perceived fever.  No other side effects were given.  The site where he received the vaccine was WNL, without pain or any evidence of injury.  Second dose was administered SQ per CDC guidelines.
Information has been received from a physician concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  Subsequently the patient had aches and pains.  The patient sought unspecified medical attention.  Additional information has been requested.
Inconsolable crying persisting for several hrs, recurred twice in first 2 days; t100 R;
1 day p/vax pt devel fever of 102 & an inj site rxn w/redness, swelling & pain @ the site;seen by MD;WBC 15,900;blood cult negative;
11 months after dose 3 of COVID-19 vaccination started getting a sore throat and felt sick. Took a COVID-19 test, two days in a row and they were negative.  By the third day Oxygen levels started dropping; Took another Home COVID-19 test and it was positive; Was having a hard time breathing and went to the ER. Was examined and when Oxygen levels became normal he was released.
Short term extreme muscle pain for 5 days post injection.  Loss of muscular endurance since injection.  Continues long term.  Long term fatigue.
After getting second dose: fever 38C, vomit (1 time) and diarrhea, swollen glands in the vaccinated arm, cutaneous eruption by the stomach and back. This eruptions is after the second dose at the time of menstruation (on regular basis because it coincided with the second dose) They prescribed an antihistamine and it went away.
No adverse event, incorrect strength of Covid19 vaccine given, reported to, NP.  Directed to have parent bring back child to get vaccinated with correct strength of Covid19 vaccine.  I called parent over the phone, no answer; left voicemail message for parent to call me back.
Pt called health system call ceneter on 5/18/2021 and verified pt with 2 identifiers. Pt stated pt got 1st covid vaccine Pfizer @9:25am  5/14/2021 at Pharmacy and pt got chest pain(mild chest pain), mild SOB, abdominal cramping(last 2 days), fatigue since next day from vaccination. Noted pt has hx of seizure 2 years ago and taking medication for seizure. Pt also said upper back pain and pt had mild fever next day from vaccination. Noted no known allergies. Instructed pt to call 911 or go to ED d/t pt shows 3 emergency s/sx of covid vaccine side effects. Pt is educated covid vaccine side effects.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot# M007728, expiry 21-MAR-2018; M011840, expiry 01-FEB-2018; L043214, expiry 30-AUG-2017; L027282, expiry 21-SEP-2017; L013429, expiry 21-JUL-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Shot given at mass vaccine clinic.  Nurse gave shot in very upper portion of left arm close to shoulder.  Needle (retractable) kicked back after vaccine.  In couple of days I have a huge bruise about the size of a whole dollar (coin)  Bruise stayed for 2-3 weeks. Then the upper arm was starting to hurt. Movement is sore when having to put on a coat, blouse, or seatbelt. Still bothering only taken Advil.
Student  became lightheaded and dizzy after the vaccine and passed out while sitting in the chair and fell off chair landing face first onto the floor. PA to the students side immediately and student was breathing but not alert.  Student aroused easily but 9-1-1 was called as a precaution due to student hitting head. Student was observed but was not transported via EMS. No meds were given and he was able to ambulate out to the clinic without issues after the episode.
swelling, bruising, tenderness for more than 4 wks p/vax;
Patient received Covid19 (Moderna) at 11:00am on January 25, 2021. Patient reports that she experienced fatigue, headache, chills, body aches and pain at he injection site 7 hours after receiving the vaccine. 24 hours after receiving the vaccination, Patient reports experiencing redness at the injection site along with itchiness and welts.
This spontaneous report as received from an office manager to a patient of unknown age. After VARIVAX (Merck) (reported lot#J006109, expiration date 21-May-2015) underwent an unsupported temperature excursion, it was administered to the patient on 12-JUL-2013. (Dose, route, indication not reported). No adverse event was reported. this is one of the several reports received from the same source. Additional information has been requested.
Red rash three inches in diameter and growing. ER Doctor prescribed Benadryl . After one day still growing in size on the arm at the injection site.
On January 14th around ~6:30pm I was getting the 2nd Covid Moderna booster vaccine. This vaccine was administered by pharmacy. I was told to take my arm out of my sleeve (instead of rolling it up) because he needed the vaccine to be higher up on my arm. The second he administed the vaccine, I felt a sensation that I never felt before receiving any vaccine, almost as if something bursted. I put my arm back in my sleeve and he told me to go sit in the waiting chairs to the left of the pharmacy and he would "check on me" after 15 minutes. About about 3-4 minutes after I sat down in a chair, I began to feel felt a warm flush, sweatiness, palpitations, and extreme nausea and passed out. I woke up on the floor laying on top of my jacket, wondering where I was and had no idea if i hit my head. I sit up and am very dizzy and have someone from the pharmacy (unclear who) behind the desk ask me what had just happened. I responded "I have no idea I think I just fainted". Maybe 2-3 minutes after this I fainted again for a shorter amount of time. I woke up very sweaty and in chronic distress with no one attempting to come out from around the desk to help me. Not once was anyone above me when I woke up on the ground. I remember a customer raising her voice at the pharmacist saying "does it look as if she is ok? she looks horrible help her!". I was very foggy and begged for water. I was given water and kept asking "what should I do","can I lay down, i need to lay down", "please help me this never happens to me I'm scared" and he not once came around the counter and denied helping me lay down, I was alone. I was told that there is a hospital 2 blocks down and is "a short walk" even though I was extremely dizzy, pale, and about to pass out. I then had to repeatedly ask the pharm to please call for help because I am going to pass out. EMT came and took my vitals, I asked for another cup of water from the pharm behind the counter and as EMT was taking my finger sticks, I passed out again(3x). I woke up without the water I asked for and no one watching me from the pharmacy again. I was then taken to the ED.  I was pale white going in there and shivering. I was in the ED for ~5 hours. The Doctor told me the pharmacist administered the vaccine in the wrong location, it was too high up and not in the deltoid muscle correctly at all. He said this could pose concern for blood clots and potentially injured my tissue. I have a referral to see  Sports Facility for OT for this injury. I have experienced numbness in days after the vaccine, from my arm down to my hand. It hurts to the touch.
On 9/28/00, the pt complained of chest heaviness and swelling. Mom noted that ears were reddened but did not think they were swollen. Pt slept most of the day and was a little congested that evening. Mom noted she had not felt well on 9/27. She does not was her son to stop the Hep B series. Concern was that the pt had a similar reaction to bee stings.
14 year old was given a moderna shot by mistake; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old was given a moderna shot by mistake) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old was given a moderna shot by mistake). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old was given a moderna shot by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.
FEVER, NECK STIFFNESS, MALAISE,HEADACHE ONE DAY AFTER VACCINATION, ADMITTED TO HOSPITAL, DIAGNOSED WITH ASEPTIC MENINGITIS. SPENT 4 DAYS IN PEDS UNITS, DISCHARGED IN STABLE CONDITION. 9/11/07 Reviewed hospital medical records which reveal patient experienced lethargy, fatigue, fever, decreased appetite, epigastric pain HA & neck stiffness.  Admitted 8/12-8/15/07.  Tx w/IV antibioticsContinued w/intermittent fever while hospitalized. Symptoms otherwise improved & was d/c to home on no additional antibiotics.  FINAL DX: Aseptic meningitis, likely viral; GERD
Client received flu vaccine on 12/09/03 in left arm. States shot given in back of arm-tricep area-not deltoid.  On 12/10/2003 noted vax site was tender with red, raised, hard area, hot to touch.  No drainage, no streaking.  Referred to ER.  Told area infected.  Prescription for antibiotic, but did not take.  Symptoms resolved by 12/15/03.
I woke up the morning after the vaccine and it felt like someone was stabbing my head. Whenever I went to stand the pain would increase. My eight year old daughter called my mom and my mom left work to come to the house.. my mom reports that I was lethargic like. My husband ended up taking me to the arm because the pressure in my head was unbearable. He had to help me get in the car because I was unsteady on my feet. I went to the ER and they gave me medication. They sent me home on a few day supply.
Arm swelled to 3x normal size and bright red and hot at injection site, left shoulder, down to elbow crease. It has stayed this way but began traveling down my arm. I took BENADRYL on the nights of 11/9/2017 thru today's date. The swelling has decreased but is still present, the redness persists, but the heat has lessened a lot. Currently, my arm is still red from the injection site to my forearm.
Patient now has Guillaine-Barre Syndrome. Symptoms started on Nov. 28th, 2021 with numbness and tingling in fingers and feet. By noon the next day he couldn't walk. He became mostly paralyzed. He's been in the hospital for over a month now. He received IVIG treatments and plasma exchange treatments. He is in inpatient rehab now.
On 3/23/2021 at 9pm my injection site started itching furiously and I noticed that there was a painful, red, raised lesion where I received my vaccination. Right after I got the vaccine, my site was numb and stayed bruised for a week, but the bruise, while noted, wasn?t anything alarming or worth reporting. However, the delayed itchy, red skin lesion I thought should be reported to you since it is known as a rare skin reaction that may not be as rare as it is being released in the news in people with a known history eczema.
Janssen Covid-19 vaccine was administered to an individual that was not yet 18 years of age in error.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On 30-DEC-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, lot # M035148, expiration date 25-OCT-2017, subcutaneously for prophylaxis, which was exposed to a temperature excursion of 13F for 1.5 hours. It was reported that the vaccine had a previous temperature excursion of 14F for 1.5 hours. The reporter stated that the temperature excursion was detected by a data logger. No adverse effects were reported. This is one of several report from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA004734:
I started feeling funny not long after the shot. I had some pain in my eyebrow area. I was so exhausted that I started crying, and my legs and arms were very heavy and it was  hard to move them. In my left hand going up all the way to my shoulder, starting with my fingers, they went numb. It tingled so bad that it hurt. Then, it started in my legs. This happened on all 3 doses, but on this dose, I also had shooting pains in my lower back area and it is still happening to this day.
Reaction began with in 4 hours - had resness, itchiness, swelling, severe edema, slight pain, swelling to elbow, seen next day.  Advice:elavation, rest, advil, and benadryl.  Totally resolved on 10/24/99.
In addition to the expected reaction I had heard about:   Mild fever, chills, fatigue, headache and body aches, I also experienced a rapid heart rate.  I went to bed around 7pm and was awoken by a rapid/ strong heart beat.  I went to the ER where I was evaluated, hydrated and then released.  The attributed the heart rate to the vaccine.  Sometime over the course of the overnight, my heart rate returned to normal.
Hives, itching, sensitive skin, ~12 days after booster. Used topical anti-itch cream
red and sore right arm with a burning sensation also feels firm as swollen. I have neuropathy in my right side thigh and it seems to hurt constantly now.
Patient reports that she "felt fine" upon leaving health dept. but shortly afterward developed itchiness in her lower arms, dizziness, nausea. Patient called nurse line at facility and was told to go to ER. Seen at ER, treated with IV BENADRYL and 2 Epinephrine injections. Patient reports reaction started roughly 30 minutes after the injection.
Not from med. believe injection done too deep. Nerve damage/irritation-arm numbness like asleep when at computer or various angles-4-5 x a day-slowly improving-still active. Injection site still notable if pressed-nerve pain.
Menstrual cycle - increased cramping, heavier than normal bleeding; Menstrual cycle - increased cramping, heavier than normal bleeding; Menstrual cycle - increased cramping, heavier than normal bleeding; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 15:00 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown: False, Previous dose lot unknown: True, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion, Previous dose administration date: 14Apr2021, Previous dose administration time: 03:00 PM, Previous dose number: 2, Previous dose Vaccine location: Left arm), administration date: 14Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Menstrual cycle - increased cramping", "heavier than normal bleeding"; Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer, Previous dose brand unknown: False,, Previous dose lot unknown: True,, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Previous dose administration date: 31Mar2021, Previous dose administration time: 03:00 PM, Previous dose number: 1, Previous dose Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Menstrual cycle - increased cramping", "heavier than normal bleeding". The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster"; MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "recovering" and all described as "Menstrual cycle - increased cramping, heavier than normal bleeding". Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, heavy menstrual bleeding.  Additional information: It was reported that, the patient had no Known allergies. No other vaccine in four weeks. No other mediation in two weeks. No covid prior vaccination. No covid tested post vaccination. Facility type vaccine: Hospital. The patient did not receive any treatment for the adverse event.   The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recv vax 26FEB96 & w/in 1hr hr pt felt diaphoretic, sweaty & weak;no further details were provided;
Patient had temp to 103 (2 hr) post vaccination associated with febrile seizure simple approximately 2-3 minutes.
fever of 99.9F; patient received expired Rotateq; This spontaneous report was received from an office manager and refers to a patient of unknowage and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported. The patient's concomitant vaccines included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 7v (crm197) (PREVNAR) and hepatitis b vaccine rhbsag (yeast) (ENGERIX-B).  On 20-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, orally, for prophylaxis, (lot # 1660999 was verified to be valid, expiration date reported and established as 03-MAY-2021).  On 21-MAY-2021 (reported as a day after the vaccination), the patient's family sought medical attention and called to the office to inform that the patient developed fever of 99.9 Fahrenheit degrees. It was unknown if there was any treatment given for the adverse event. The healthcare provided told the patient's family to call back if the fever did not go down. Since they did not call back, the office manager though that on an unspecified date in May 2021 the patient did recover from the fever.   The causality assessment between the event of fever and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.