chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received J&J immunization on 4/12/21. Patient reported common adverse reactions like tiredness and chills on day 1. Patient also reported having bad leg cramps in her calves the night. The following day tiredness and chills had subsided but patient still reported having some leg pain in calves. Patient contacted her PCP who advised her to monitor if pain gets worse, red or warm. Patient states pain has not gotten worse, red or warm but has also not improved. Counseled patient to follow up with PCP as this is not a common adverse reaction of the immunization. Patient will follow-up with outcome.
After patient received both vaccines from LVN, pt started to complain of dizziness and "not feeling well". pt appeared pale. Pt was given water and juice, remained completely alert and oriented with age-appropriate mentation. Pt denied pain, difficulty breathing, rash, or itching.  Pt was able to ambulate from a chair to a gurney where he was observed for another 10 min with parent standing by. Pt reported then that he felt better and parent expressed that she felt comfortable with taking patient home. patient ambulated out of vaccine clinic with a steady gait, accompanied by parent
CHILLS; FEVER; MUSCLE PAIN ALL OVER CAN HARDLY SIT DOWN OR BEND OR USE STAIRS; BODY PAIN ALL OVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. On 06-MAR-2021, the subject experienced body pain all over. On an unspecified date, the subject experienced chills, fever, and muscle pain all over can hardly sit down or bend or use stairs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain all over, and the outcome of chills, fever and muscle pain all over can hardly sit down or bend or use stairs was not reported. This report was non-serious.
My first vaccine was no problem. I barley felt anything. When I got my 2nd injection, I immediately felt a burning sensation in my left shoulder. It felt like fire! My shoulder was very sore for a few days and I wasn?t surprised because that?s normal after a shot or vaccine. I took it easy for about a week but there was still pain but not a soar feeling anymore. There is a sharp electric pain that I feel when doing certain movements with my shoulder. Turning the steering wheel driving causes pain. It has been almost a month since I?ve gotten the injection. I  am getting very concerned about this.  I plan on seeing a doctor as soon as my insurance kicks in for my new job.
Onset of headache, dizziness, shortness of breath.  Eyes became blood shot...all symptoms progressed until ambulance called.
heavy head; muscle aches; Numbness aroundcheeks, face, bottom jawline; Numbness in throat; Tired; swallowing was little tight; Throat area felt tight; Throat area tender; Felt dizziness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. The patient had allergies to pollen (otherwise do not know). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 16:15 (15 min after the shot), the patient experienced dizziness; at 16:30 (30 min after the shot), the patient felt heavy head, muscle aches, numbness around cheeks, face, bottom jawline, throat, felt tired, swallowing was little tight, throat area felt tight and tender (no difficulty in breathing). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for reported events. The clinical outcome of the events felt dizziness, heavy head and muscle aches were recovering at the time of this report; whereas for events numbness around cheeks, face, bottom jawline, numbness in throat, tired, swallowing little tight, throat area felt tight and tender were resolved on 01Apr2021 (5 to 10 and 15 minutes later after the event started).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt complaint of extreme back pain and shortness of breath about 4-5 hours after receiving vax.
Extreme swelling and redness of whole right upper arm for 3 weeks. Hives and welts everyday for several months, stomach shut down for about 3 weeks 1 time and 2 days another -still have hives and welts every 2-3 days. Seen Dr. for stomach (many test) still seeing Dr. for allergic reactions (Dr. swelling arm, red and fever).
Pain, redness (diameter of a baseball), and warmth at the injection site. Chills and achy throughout from the waist down to my legs. Fatigue. Laying down helps a little. Can't stand or sit for more then a short period of time.
parent wanted a 1-year old child to receive a preservative free (without thimerosal) Fluzone Quadrivalent dose but the child was given a dose from the Fluzone Quadrivalent multi-dose vial, no AE; Initial information received on 25-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old patient who received a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AB, expiry date: 30-Jun-2020) via unknown route in unknown administration site for prophylactic vaccination instead of preservative free (without thimerosal) INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered.  At the time of reporting, 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 holders 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.
chills, very nauseous, couldn't sleep, terrible head aches followed by bad stomach pains.  All of this for 24 hours.  Then more stomach pains couldn't eat because of nausea for another 24 hours.  Very tired and weak.  Each day gets a little better
PT Fainted approximately 17 hours post Covid-19 vaccination.  No other health conditions.
PT CALLED AND EXPLAINED SHE WAS FEELING PAIN IN THE ARMS AND BODY ACHES, ALSO FLU LIKE SYMPTONS THAT TRIGGERED HER ASTHMA.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 22-JUN-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis (incorrect product storage). The vaccine was exposure to  temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA008903: US-009507513-1707USA009099: US-009507513-1707USA009101: US-009507513-1707USA009102:
I first gave the flu shot and then the covid shot in the same arm, at an acceptable distance apart. After the second vaccine she passed out of the chair and fell forward onto the floor. She had some seizure-like movements but woke up in less than 30 seconds. Patient states she has no personal or family history of seizures. We let the patient slowly sit up on the floor and then eventually move to the chair while she waited for a family member to come pick her up. She stated she felt fine other than hot and sweaty. Pharmacists recommended she speak to her primary care provider about this incident to see if they would like her to have any follow-up testing. I called the patient later that evening to see how she was doing and she said good. She said she spoke to her primary care provider, and Doctor does not see a need for any follow up testing.
no symptoms from patient. dose of twinrix expired 05/20/2023. provider informed. incident report made. patient informed.
After the 20 minute mark, I felt very nauseated and threw up as well. I got some food and snacks and I was in observation for an hour. I could not drive so I waited for a ride. I slept until 4PM and 1AM and went back to sleep until 9AM the next morning. I felt very weak and nauseated and threw up acid even though I had an empty stomach. I had a headache and fever and slept more. 3 more days passed and I was still feeling awful. 46 hours later, I saw the doctor in my clinic until I got back to normal which they prescribed me Tylenol, 650mg.
Vomiting, fever, diarrhea (lasted 2-3 days), abdominal cramping.
Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies reported. Between 16-DEC-2016 and 12-JAN-2017, the patients were vaccinated with unspecified improperly stored doses of PNEUMOVAX 23 lot number: M035104 with expiration date: 06-MAY-2018 and lot number: M038359 with expiration date: 13-MAY-2018 (strength, dosage schedule, anatomical location and route of administration were not provided), for prophylaxis. On 16-DEC-2016, the administered doses were exposed to a lowest temperature of 29.5°F for 1.5 hours (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006101.
accidentally gave just the adjuvant suspension. Did not mix.; accidentally gave just the adjuvant suspension. Did not mix.; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. Medical associate accidentally gave just the adjuvant suspension to the patient and did not mix it with powder part, which led to inappropriate preparation of medication and inappropriate dose of vaccine administration. The reporter consent to follow up.
5cm by 4cm oval and painful swelling at injection site, raised and red on the surface
Pfizer 3/1/2021 and 3/22/2021. COVID-19 positive on 7/18/2022.
Pt felt dizzy after receiving her 1st Pfizer dose. 2 ice packs were used. Crackers and water was offered. BP at 12:11pm 128/78 Hg/mm, O2 97, HR 81.  Patient was helped down to floor  to lay on yoga mat, pillows and blankets were used. Feet was raised up. After a while she was helped back up to the chair. Pt stated she was very anxious to get the vaccine as she was now required to get the vaccine for her work or lose her job. She had recently lost her spouse and has been working long hours. She didn?t have any breakfast and have been under a lot of stress. BP at 12:30pm 132/80Hg/mm, O2 99, HR 65.  Pt states she feels better now. Recommended to eat before coming to get her 2nd dose and come with a family member. Do let the clinician know of this before getting the 2nd dose.  Patient verbalized understanding. Entire team was present and full PPE in used.
Covid infection after first dose of Moderna vaccine; HCP who told her to wait for 90 days before second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection after first dose of Moderna vaccine) and OFF LABEL USE (HCP who told her to wait for 90 days before second dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid infection after first dose of Moderna vaccine) and OFF LABEL USE (HCP who told her to wait for 90 days before second dose). At the time of the report, COVID-19 (Covid infection after first dose of Moderna vaccine) and OFF LABEL USE (HCP who told her to wait for 90 days before second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.
The patient developed a pruritic rash over her entire body which began shortly after receiving the injection. The patient also complained of puffiness of her eyes a scratchy throat with the sensation of her throat swelling. A physical exam revealed a diffuse urticarial rash over her face, neck and eyelids. The patient was treated with Benadryl and SoluMedrol with resolution of the rash and itching. The patient was discharged with Prednisone.
pt recv vax & devel inj site rxn characterized by a 2.5inch area of swelling, induration & erythema;this is 1 of 6 reports from this facility of inj site rxn p/vax;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history. concomitant medication and drug allergies/reactions were not reported. On 24-JAN-2019, the patient was vaccinated with M-M-R II, subcutaneously (strength, dose, site of administration, lot number and expiry date were not reported) for prophylaxis. On 31-JAN-2019, the patient was vaccinated with VARIVAX subcutaneously (strength, dose, site of administration, lot number and expiry date were not reported) for prophylaxis. No known adverse effects were reported.
Developed a skin reaction below the injection site on arm approximately 2 hours after injection. Skin reddened/developed red dots on arm, and a small welt close to and below the injection site.  Reaction otherwise was not severe, lasted approximately an hour, no antihistamine taken. I had applied ice to my arm beforehand.
Death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was stated that reporter has lost 22 family members in the past 2 years due to covid vaccine. Of this, 2 received with Moderna vaccine and 2 received the Pfizer.  No treatment medications were reported.  This case was for the first of 2 patients reported who died. Company comment- This is a fatal spontaneous case concerning a patient of unknown age and gender with no reported medical history who experienced the serious (death and medically significant), unexpected event of death.  A dose mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It is unknown if an autopsy was performed. It was stated that reporter lost family members in the past 2 years due to Moderna vaccine. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-734472, MOD-2023-734863, US-MODERNATX, INC.-MOD-2023-734538, US-MODERNATX, INC.-MOD-2023-734864 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734472:Invalid case (Patient 1 - MOD-2023-734472) MOD-2023-734863:Patient 3 (Fatal outcome) US-MODERNATX, INC.-MOD-2023-734538:Grandmother's case (Patient 2 - MOD-2023-734538) US-MODERNATX, INC.-MOD-2023-734864:Patient 4 (Fatal - MOD-2023-734864); Reported Cause(s) of Death: Death
Skin very red, hot, 4 inch x4 inch area of erythema and swelling. Skin also bumpy Given oral diphenhydramine, topical ice pack and rest. After 2 hours, area less red and bumps gone, but still swollen.
Varivax given 11/07/2000 Developed Varicella 01/04/2005  MM requested vaccine failure reported.  Currently has Varicella.
Red puffy reaction at site of VARIVAX. Slightly tender. 6x6 cm.
Extreme pain and stiffness in shoulder and upper arm where needle was administered. Not responsive to heat treatments or anti inflammatory drugs.
Bright red, hot site of vaccination, rash chest, neck , itching, at site of rash and ears
Was told to report here by cdc number. Had Covid 5 months ago. Fully vaccinated as of 3/23/2021. Antibody test last week shows negative results for antibodies
Information has been received from a physician concerning a patient who was vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck) and failed to seroconvert. The patient was tested for seropositivity after exposure to the varicella-zoster virus and had a negative titer. No additional information is expected.
General malaise, body ache, fever 38.1 C, mild cough, nasal congestion.
Initial and follow up information has been received from a registered nurse concerning a 4 year old white male with NKDA, no past medical history, and no illness at time of vaccination who on 04/15/1998 was vaccinated in the right thigh with the first dose of varicella virus vaccine live. Concomitant vaccinations on 04/15/1998 included oral poliovirus vaccine. There was no concomitant medications. On 11/07/01, the child developed a fever of 102 degrees F and on 11/08/01 developed chicken pox. It was reported that the child has 5 to 7 vesicles lesions. No other symptoms were reported. Medical attention was sought. The child subsequently recovered from the fever and chicken pox. No further information is expected.
Developed a breakthrough case of COVID-19 on or about Jan 9th after receiving the Moderna booster in November 2021.
No adverse event occurred.  The HIB vaccine was administered 2 days after the expiration date.
Vaccine was injected in left arm near shoulder. It's been 3 weeks and I still feel where injection was and have has throbbing pain in area and down to my elbow. Also will feel pain in shoulder muscle. It's sharp pain when I bend my arm or use neck muscles.
swelling redness to lt deltoid area; warm area; no hardness 4 cm x 6 cm; MD recommended PDH;
My resting heart rate was very low for about 20 minutes. This happened almost immediately after my second dose and I couldn't find anything about low heart rate. I felt better soon and did not tell a pharmacist.
Large red rash, swelling to the size of a golf ball, many small welts surrounding the area, itchy, hot to the touch, severe pain- unable to move arm or carry anything for 2 days. Ibuprofen/acetaminophen and icing the injection site offer little to no relief.
Pt's right arm became slightly raised and red on 04/26/2002. By 04/29/2002 the area increased in size to approximately 3 x 6 inch area of erythema on lateral side of right arm. Pt placed on Keflex 250 mg for 7 days.
Pt experience itching and redness of her skin. Pt was treated with Benadaryl 50mg and asked to wait to be observed an additional 30 minutes before leaving the facility. By the time pt left our facility her itching and redness  had resolved.
This was my first injection of Pfizer COVID vaccination in my left arm.  I woke up next morning with my left hand partially numb.  The thumb and right pointer finger feeling most of the numbness.  The last three fingers had partial to no numbness.  Today (04/24/2021), the numbness is still present.  No pain is present, just the numb feeling.
It has been 3 weeks since I received the flu vaccine (I am unsure which one so listed both above) in my left deltoid. Upon injection it was fairly pain-free, however about an hour following injection the pain, soreness and stiffness increased significantly. I have been self treating with my own conservative therapy (active range of motion, active-assisted range of motion, light isometrics, ice, heat, and naproxen BID). Now that it has been three weeks overall it has not improved and my range of motion has decreased. The symptoms are reflective of possible bursitis, tendonitis of the rotator cuff and impingement. These symptoms are worse in the morning upon awakening. The symptoms are impacting my every day activities and my job. I work as a pediatric physical therapist and am having difficulty lifting children up.
About 15 minutes after receiving shot and having left the shot site. The tip of my tongue was feeling fuzzy, maybe numb.  My face was tingling and I was feeling very shaky.  I had my sister take me to a nearby hospital and we waited in the parking lot just in case my symptoms got worse.  After about 10 minutes or so, the symptoms started to subside and she took me home.
Rash began to appear on day five following first dose. Rash spread over extremities and torso and has continued to date of 6/24/2021.
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, frequency, route and lot # were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.