chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was received on 06 October 2010 from a healthcare professional. A 15 year old female received on 04 October 2010 a left deltoid intramuscular injection of FLUZONE (lot number UT3580CA). Within 24 hours on 05 October 2010, the patient experienced redness and swelling from the top of the shoulder down to the elbow and around the left arm. The arm was warm to touch. The patient had no illness at the time of the vaccination, received no other vaccinations within 4 weeks and had no reactions following prior vaccinations. She had no pre-existing medical conditions, no allergies and no concomitant medications. The patient was seen at an urgent care facility. There was "no respiratory involvement." The treatment included steroids NOS. As of this report the patient had not recovered. Follow-up information received from a health care professional on 17 December 2010. From the following new information received, this case was upgraded to serious. Per the reporter, the patient was seen in their office on 06 October 2010 and diagnosed with cellulitis involving the left arm that spread from the injection site. The patient was treated with a 3 days course of ROCEPHIN injections and then a 10 day course of oral Cephalexin. Recovery status was not updated by the reported. Documents held by sender: None.
2d dose: Covid19(Pfizer-BioNTech), Lot EL1283given by injection, Left Arm, Feb 3, 2021, 3 PM. Pt walking stamina declined over the next week. Prior to second dose, she could walk about 1.25 miles; afterward her stamina declined to a few blocks distance. On Friday, Feb 12, Pt collapsed after bath. Saturday, Feb 13, 2021, Pt did not get up. Began episodically screaming in pain. Ambulance to Hospital. Admitted and given emergency pericardial window to address pericardial effusion. Pt was discharged Feb 19, 2021, diagnosed with 1:Cardiac tamponade; 2:Hypotension; 3:Sepsis; 4:Acute kidney injury. Slowly Pt recovered some ability to walk but as of June 11, 2021 her distance has not exceeded 0.25 mile.
"Hives" approx. 50 cents size on both arms & back started 6 days after Immunoglobulins injection per mom's report, Fever 101.3 rectally when seen @ hospital on 10/04/02 & mom was told labs WNL but was reaction to IG, Taken to another hospital ER 10/15/02 with c/o right lower leg/ankle swelling & again told related to IG per mom, Hives resolving 10/07/ 02,  No treatment received at either ER visit.
Rash appeared on chest, itchy.  Within 24 hrs it began to blister. Rash is still present 5 days later. Seeping, blister.  Chills/sweating. I will go from uncontrollably shaking to a fever.  This cycle repeats every 5-6 hrs. This has been on-going for 5 days now.  I am unable to care for my infant as I am too weak to walk without feeling like I will pass out.  Extreme body aches, my bones and joints are painful to move.
Information has been received from a registered nurse concerning a 6-year-old female who on 30-AUG-2002 was vaccinated subcutaneous with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 643117/0502M). On 10-DEC-2007 the patient developed a rash with less than 50 lesions, no fever. The patient sought medical attention via a phone call. No diagnostic labs were performed. On 22-JAN-2008, the patient recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008.  Information has been received from a registered nurse concerning a 6-year-old female who on 30-AUG-2002 was vaccinated subcutaneous in the right arm with a first 0.5 ml dose of VARIVAX (Merck) (lot # 643117/0502M).  On 10-DEC-2007 the patient developed a rash with less than 50 lesions, no fever.  The patient sought medical attention via a phone call.   No diagnostic labs were performed.  On 22-JAN-2008, the patient recovered.  A product quality complaint was not involved.  This is one of several reports received from the same source.  Additional information is not expected.
Patient came to pharmacy on October 27, 2021 to get his second dose of pfizer.  He received his second dose around his appointment time, about 3:30PM.  Later that evening, the pharmacist who administered the dose realized that the pfizer dose she had administered expired at 3:10PM, approximately 20 minutes before the dose was administered.  She contacted her immediate supervisor and informed the patient of the incident.  She was instructed to follow-up with the patient for the next few days and call the manufacturer the following day for further instruction.  Patient is not experiencing any adverse effects from the vaccine.
I had no symptoms. I went for a normal check up on 10/28/2022. They found an irregular heart rhythm, they detected and confirmed atrial flutter. 11/07/20222, I took another ECG and echocardiogram with a specialist. They gave me the option to take medication for the rest of my life or a procedure. I elected the procedure, called ablation which I will be taking in January 2023. I don't feel any symptoms.
Patient noticed a hot sensation immediately after the injection at 11am on 11/08/07.  At 1pm patient noticed increasing soreness and redness at the injection site.  The pain and redness increased through the day and night.  On 11/09/07 the pain, redness and hot sensation was severe and consistent.  She started acetaminophen 1000 mg q 4hr for a total of 4 doses.  11/10/07 symptoms still present and severe.  She made a call to the pharmacist who recommended ice compresses and Tylenol.  She used these q 4hr.  On 11/11/07 symptoms improved slightly and on 11/12/07 symptoms improved & almost absent.
Developed severe headache, nausea, vomiting. Blood pressure 160s/100s on arrival at ER. Required injection of Dilaudid and Phenergan.
Pt admit w/ confusion & found to be COVID+ on 5/29/22. Pt received 1 dose of J&J on 4/10/21. Pt treated with 3 days remdesivir
Dr from mother, reports client had episode of dizziness and blacked out at school. Ambulance took him to hospital. Reports he had mental confusion not knowing who she (mother) was at first. Was discharged same day (yesterday 02/25/09) - couldn't find anything wrong. Mother remembered this am that he had #2 Hep B vaccine 02/13/09. Also he had dizziness last week.
10 am pt. woke up on 12/03/14 with a rash from head to toe mom gave BENADRYL, CLARITIN, ZANTAC 6 pm this evening spoke with mom pt. is doing better.
Had bad sz 24APR91- rx'd @ hosp; Tx inc PB to 5cc;
Pt developed dizziness and palpitation several minutes after vaccination.  She did not pass out. She denies prior similar episodes. HR 100, BP: 110/80, SP02 97%. She improved and symptoms resolved after several minutes. The pt elected to drive home.
Information has been received from an RN concerning a female pt who, post vax, within 24 hours, developed "a hypersensitivity reaction and was seen by a dermatologist who dx'd erythema multiforme, which was confirmed by biopsy." Additional information has been requested. Follow up information from a registered nurse reported that the patient developed the rash on her arms and chest. It was noted that no further vaccinations were administered and that the patient had not had any problems with previous vaccinations. The patient subsequently recovered.
start with arm hurt, and then headache, dizziness. and these symptoms getting worse along with time.  I start to feel cold at night time, but the room temp was 70 which is not cold for me. I started to shiver with cold. my hands and feet were freezing cold. at the same time feel my body is so hot but cold. I started to sweat.  after I feel less dizzy,  I  use an oral thermometer, it was showing 38.5 degrees. I was still boiling hot this morning. and then I took some Tylenol for my body ache and fever.  and then i went back to sleep for 6hrs.
It was reported that a 62 year old female pt received a Fluzone SV 00-01 vaccination in 11/00. Reported ten days after vaccination the pt developed painful spot on index toe on foot. After the first of the year (Jan 2001) the pt developed painful spots on right side of back-possible atypical shingles
This spontaneous report was received from a physician (who is also the patient) via a company representative reporting on himself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unspecified date in 2014 (reported as: "about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 14-JUN-2017 (reported as. "about one week ago"), the patient developed a case of shingles. On an unspecified date, the patient experienced a classic dermatomal rash, from front to back on the right hand side of his body". The patient received treatment with unspecified antiviral medication. The case did not involve cancer or overdose. No product quality complaint was involved. At the time of the report, the outcome of shingles and rash was reported as not recovered. Additional information has been requested.
This spontaneous report was received from a register nurse, refers to an unspecified number of patients, of unknown age and gender. The patients' medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # K026246, expiration date: 28-JAN-2017; lot # L016429, expiration date: 09-AUG-2017; lot # L025737, expiration date: 28-JUL-2017; lot # L014415, expiration date: 25-JUL-2017 (strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
migraine; arm sore; itching; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN IN EXTREMITY (arm sore) and PRURITUS (itching) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (migraine), PAIN IN EXTREMITY (arm sore) and PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), PAIN IN EXTREMITY (arm sore) and PRURITUS (itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Pt's mom had shingles around 6-1-16. Pt had VARICELLA vaccine on 6-8-16. Pt Dx with chickenpox on 6-29-16.
Patient mistakenly received a 3rd dose in a 2 dose series of Shingrix. Patient is now having severe leg cramps and thinks it might be related to the extra dose.
PT SAID BEGAN HAVING NAUSEA THE EVENING AFTER IMMUNIZATIONS AND BEGAN RUNNING A FEVER OF 102 DURING THE NIGHT. SHE CONTINUED TO FEEL VERY NAUSEOUS THE NEXT FEW DAYS.  FEELING A LITTLE BETTER BY TODAY.  SHE ALSO SAID HER RIGHT ARM WAS VERY SORE THAT NIGHT AND BY MORNING IT WAS SWELLED AND REALLY RED DOWN FROM WHERE PNEUMOVAX WAS GIVEN. THE SWELLING HAD GONE DOWN MOSTLY WHEN SHE CAME IN TODAY, BUT THERE WAS STILL SOME REDNESS.
erythema and vesicles at sight of VZ injection approx 12-13 days after injection pt started on keflex and counseled about possibe VZ transmission
Father reported pain and swelling of R leg within 48 hours of injection. Began applying an ointment to area. Symptoms worsened and was taken to ER on 4/2/06. Dx of abscess which was I and D'd. Tx included antibiotics and pain medication. Administering RN reports what appeared as fire ant bite on extremity vaccine administered.
This case was reported by a healthcare professional and described the occurrence of felt like passing out in a 60-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline). On 11 September 2014, the subject received 1st dose of FLUARIX (.5 ml, other, left deltoid). On 11 September 2014, less than one day after vaccination with FLUARIX, the subject experienced felt like passing out, feeling flushed and injection site redness. Her blood pressure was checked 3 times and was elevated. The subject was treated with BENADRYL which helped the redness. At the time of reporting, the events were improved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. This is one of the 2 cases reported by the same reporter for the same vaccine. See case A1089073A for more details.
After about 12 hours severe body aches started , then uncontrollable chills, and nausea. These lasted about 20 hours. Also very painful swollen testicle which lasted about 30 hours.
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The reporter reported about administration of the Moderna COVID-19 vaccine past the published expiry.  The vial was initially stored in the refrigerator on 01-Apr-2022 and vaccine were thawed on the day of administration. The administration was spread out throughout the end of March to the beginning of April.  The dates for vaccine administration were reported as 29-Mar-2022, 30-Mar-2022, 31-Mar-2022, 01-Apr-2022 and 04-Apr-2022. The vial did not undergo any temperature excursions. No treatment medication were provided.
Pt experienced nausea and diarrhea post vaccine, also fever. She reports she has lost 6 to 7 lbs, she also developed induration and tenderness in L3 area. Pt also has nodule at injection site. Pt recovered.
Vesicular lesions, mildly itchy 10-15 papular lesions, scalp, face, trunk, buttock. Diagnose: Post vaccine Varicella.
Total: 48 hrs - muscle aches: Back, neck, hips started a few -> sore under arms, swollen hand hours after shot mild headache knuckles (ached also). (this pm (still painful left hand). Used Tylenol.
It was reported that an 18 year old female pt received a Menomune A/C/Y/W-135 vaccination on 5/26/00. Reportedly, the pt developed migraine headaches, 1 week, post vax. From additional information received on 1-DEC-2000, additional information for the Reporter, Vaccine Administrator and Responsible Physician were received. The patient's recovery status was reported as unknown.
Case number PHEH2013US001917 is an initial spontaneous report from the nurse received on 18 Jan 2013. This report refers to a 20-year-old female patient. It was reported that on 15 Jan 2013, she received only the Men, C, Y, W-135 liquid component of MENVEO (batch number: A10123) intramuscularly without reconstituting it with MenA lyophilized conjugate. No other adverse event was reported following the inadvertent administration. No other information was available.
site of injection still has scab after 3 months, it won't fall off. If I pick it it hurts alot and comes back, shoulder sore
I experienced arm pain with the onset of body chills occurring several hours later after the initial shot. Also experienced a dull headache and muscle pain all over the body that eventually subsided a day after the shot. Also experiencing fatigue.
Server chills, fever all night after shot. Headache, dizzy feeling sick. Eyes hurt. Today bad head ache sweats and exhausted.  Called doctor yesterday. Taking Tylenol. Rest and drinking fluids. Arm hurts
pt recv vax NOV98 & 3hr p/vax pt exp n/v & abd cramps;pt was seen in ER;pt was released from ER w/no dx or causal relationship determined;pt recv 2nd dose w/no sx; This is in follow-up to report(s) previously submitted on 03/01/1999. Information has been received from a registered nurse concerning a 27 year old male who on 17-NOV-1998 was vaccinated with the first dose of RECOMBIVAX HB. Three hours after vaccination, the patient experienced weakness, diarrhea, nausea, vomiting and abdominal cramps. He was seen in the emergency room. The patient was released from the ER with no diagnosis or causal relationship determined. He was vaccinated on 18-DEC-1998 with the second dose with no symptoms. No further information is available.
P/receiving a dose of Td, pt devel a sore, edematous (edema 2+) arm from the shoulder to the elbow, w/massive redness; pt was given enteric coated aspirin & advised to elevate the arm & use warm packs;
Immediately after receipt of the vaccine, I experienced significant arm pain that lasted about three - four days. This was not concerning because I also have arm pain when I receive the flu shot. Nearly a week after the injection, I noticed my arm was warm and I also had a rash that was contained to the upper part of my arm. This lasted about two days and then it became itchy as the rash went away. It was not significant enough to seek medical treatment, although I did report it to employee health as directed and they advised over the counter remedies.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-OCT-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, intramuscularly, lot # M029680, expiration date: 17-JAN-2018 (exact dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 72 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Room was hot for mass H1N1 school clinic. Patient waited in line prior to vaccine. Symptoms were nausea - ice given. Sent to school nurse to lay down. Patient was weak diaphoretic with fading consciousness. Vital signs stable per school nurse. Parents notified and ambulance called as condition did not improve. Ammonia inhalant used. Ambulance arrived around 11:20 am.
Patient received 2nd dose of Moderna vaccine, and as she stood up, she reported feeling dizzy and some tingling in BUE and BLE. Patient had a witnessed-assisted fall to the floor, did not hit her head, regains consciousness quickly with no injury from fall. Initial VS: BP 135/86 HR 97 RR 18 O2 sat 98%. Assisted to WC. Brought to medical bay. Monitored vital signs. Provided H2O. At 5:20 PM Checked final V/S: BP: 127/83 HR 99 RR 19 SaO2 99%. At discharge, patient A&O x4 with no complaint. Patient able to ambulate without assist. Patient discharged home with bf.
The same day I got the shot I fell walking up the stairs. I was not able to get up for a couple of minutes. I was dizzy. It was like 30 hours after the shot that my urine was changing color. I went to the doctor and they told me to go to the hospital. They told me I had a rare form of anemia that was basically like my immune system was attacking itself and killing my blood cells. I had like 14 or 15 blood transfusions. They did a whole bunch of tests. I am still going back to get blood tests because I have the anemia. I am on a steroid called prednisone to treat that. I had to be hospitalized from 9/11/2021 to 9/20/2021.
Became nauseous and started vomiting approximately 20 minutes after the vaccine. She initially refused to go to the emergency room by ambulance. The vomiting continued and she then passed out and became diaphoretic. 911 was called and she was transported to the emergency room. I later spoke with a nurse at the ER and tests were being ran. She said they did not feel it was vaccine related. She did say the doctor said she had a panic attack.
Strong uncontrollable cough, chills, headache, sneezing, sinus congestion and low fever
Patient inadvertently received Covid-19 Moderna bivalent 6 yrs and up instead of the Pfizer Covid-19 6 months thru 4 yrs (maroon cap).  Mother and patient were scheduled to received Covid-19 vaccines. The vaccines were prepared and labeled accordingly. At the time of administration, the medical assistant administered the mother?s vaccine instead of the patient?s vaccine. The medical assistant immediately informed the facility coordinator and the following actions were taken:  1)Provider was made aware of the incident. 2) Moderna manufacturer was contacted.  Per Moderna, the Bivalent dose received by the patient is considered an invalid dose due to its lower strength. It was recommended that the patient is re-vaccinated immediately with Covid-19 Moderna monovalent 6months-5 years. (However, may delay up to 8 weeks to reduce the risk of myocarditis, which is mostly seen in males 12 years and older). 3)CDC was contacted.  4)Mother was made aware. She stated she does not want to vaccinate immediately. Patient has a 15 month WCC scheduled in April and will discuss then since mom wants to administer the Pfizer Covid-19 monovalent vaccine.  Pt was observed for over 1 hour and remained asymptomatic.
UPSET STOMACH; SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021, the patient experienced upset stomach, sore arm, chills, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upset stomach, and chills on 08-AUG-2021, and headache on 07-AUG-2021, and had not recovered from sore arm. This report was non-serious. This case, involving the same patient is linked to 20220531923.
Vasovagal Syncope. Fainting, What seemed like temporary loss of consciousness.
Report A0355827A describes an injection site reaction in a 4 year old female who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. There was no illness at the time of vaccination. On 11/26/2001, the vaccinee received her first injection of Infanrix. On that date, she also received injection of IPOL and MMR. On 11/28/2001, two days post-immunization, she experienced an injection site reaction painful lump the size of a "half dollar." The vaccinee was seen by the physician, who prescribed Duricef 250 mg twice daily. The vaccine provider considered the events to be mild in intensity and related to Infanrix administration. The events resolved on 12/03/2001.
Evening of 7-9-07 had fever, arm hurt, body aches. For next 4 days was lethargic, had chills, blisters inside of mouth.
Maculopapular rash after immunization. Tx BENADRYL. Present x4 days.