chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Arm was warm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Arm was warm) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE WARMTH (Arm was warm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event NOS, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event NOS, at a dose of topical cream. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Arm was warm) and FATIGUE (Fatigue) outcome was unknown.            Treatment drugs also includes antihistamine allergy pill and arnica gel.   This case was linked to MOD-2021-395748, MOD-2021-395768 (Patient Link).
FLUZONE Sanofi Pasteur administered into (R) deltoid within 5 mins the individual experienced intermittent hand and arm tremors for 24 hours.
Systemic: covid symptoms/pneumonia-Medium, Additional Details: claims after each shot had cold symptoms and pneumonia. hospital felt it was covid symptoms but they tested her and she was negative.
Hear attack - 2 blood clots in rear heart arteries requiring an operation to remove them an insertion of a stint.
Area on upper right arm just below the injection site became red and itchy about 1 week after receiving vaccine.  The area at the bottom is slightly raised.
13JUN96 rash & low grade fever-(normal) but drainage from the nose & a cough;called MD they prescribed amoxicillin & rynatan & BDC;23JUN96 fever 102.9;APAP given q 4hr;then on 24JUN96 fever 102.3 called MD CXR taken dx pneumonia
This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9262) dose 1 via an unspecified route of administration on left arm on 26Jan2021 at single dose for covid-19 immunization. Time the vaccination was around noon. No prior vaccinations within 4 weeks. Medical history included ongoing blood pressure high. Concomitant medications included metoprolol 50mg once a day taken blood pressure from an unspecified start date ongoing. On 27Jan2021, Wednesday he started to feel pain in his arm which he knew was normal. But now he started to feel his temperature rise and usually takes his temperature every day as he works with the fire department. On 28Jan2021, Thursday he started to notice the rise in temperature. Then it was kind of within normal, but it was 98.4. However, this morning when he took his temperature it was 100 degrees. His usual temperature was between 97-98 degrees. He also had a cough last night and did not had the cough this morning. More, or less the main thing bothering him is the temperature. He has taken some Tylenol 500mg. He stated he does not know if he should be taking Tylenol. He was drinking more tea, coffee, and juice. The pain in his left arm was not immediate and was delayed. He does not know what time it started, but it was early in the day. He was coughing last night but he was not doing it on a consistent basis. Later he was doing it all day but did not know what time it started. He said as pretty much has subsided, no additional details provided. The patient underwent lab test which included body temperature resulted as 98.4 on 28Jan2021 and on 29Jan2021, body temperature resulted as 100. The clinical outcome of the event pain in arm and cough was recovering and the clinical outcome of the event rise in temperature was unknown.  Follow-up attempts are completed. No further information is expected.
A nurse reported that a 65 year old female received an injection of Pnu-Imune 23 and Fluzone (Aventis Pasteur Inc.) vaccines on 11/13/00. Within 24 hours of vaccine administration, the patient developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration were not reported. This is 1 of 2 patients from this facility who experienced an adverse reaction following receipt of Pnu-Imune 23 lot 469-133.
Rabies Dose # 1 7/5/11 then after Dose # 2 on 7/12/11 developed fever 101 degrees after 12 hours with swelling in upper (L) arm with swelling under armpit. Took ALEVE & resolved after 2 days.
pt recv vax & 3 to 4 days p/vax exp hives;pt saw MD & was treated w/Zyrtec & epi 10;pt was seen @ office on 27JAN97 @ which time still had hives;
8hrs after vaccination started itching all over and moments after that shivering, then shaking very strongly. Got high fever. Shakin lasted for over 2hrs at which point I took 2 Tylenols. After 20min the shaking decreased. The shaking came back about 1.5hrs later. At that point I took 2 ibuprofens. The shaking went away. The entire following day had mild fever. have been tired physically for a week now after receiving the vaccine. Lost sense of smell and taste on the 3rd day after vaccination. It has since slowly improved. Botox injection sites (received Botox injection for migraine on March 4, 2 days before the J&J vaccine) are still slightly red a week after the vaccine. My facial skin is breaking out also. Vaginal yeast infection started 4 days after receiving the vaccination. I feel slower than usual in my thinking processes since the vaccination.
Information has been received from a company representative and a physician concerning a 5 year old white female who on 07/10/1997 was vaccinated with varicella virus vaccine live 0.5 cc SC in the left thigh. On 10/31/01 (also reported as 10/29/01) the pt developed 18 vesicular lesions over her back and chest. The lesions were described as pinpoint papular, vesicular and "scabbed over" over his back and right upper abdomen. The pt was seen by the physician on 10/31/01 and she was diagnosed with chicken pox. She had a low grade fever of 99.3 degrees F. She also had sinusitis with thick yellowish post-nasal discharge. It was reported at the time of vaccination that she had an inflamed pharynx which was "proof of an URI". It was reported that the pt recovered. Additional information is not expected.
Neurological symptoms: Twitching left eyelid for 8 hours. Followed by tingling in both hands and feet for about 8 hours. Followed by slight uncontrolled muscle cramps in both hands and forearms. Followed by worsening muscle cramps in both hands, forearms and more tingling in both feet - starting to drop things when trying to move objects from one place to another. This was going on for 2 weeks then starting to get better, but not disappearing completely. After second dose of vaccine 04/16/2021 the muscle cramps increased again and are still present after 2 weeks, but not so bad as after the first dose of vaccine.
Slight chills in the afternoon - Lasted 2-4 hours. Began at 4:30 pm. No fever Extreme fatigue - Lasted 12-18 hours. Began at 4:30 pm Difficulty Sleeping - body aches and hot flashes. Also had odd dreams of trying to solve a problem related to the vaccine.
Received the vaccination on 1/4/21 and then yesterday on 1/12/21; I woke up and felt my right upper arm was very itchy and then throughout the day it got worse at the injection site.  The site is sore, painful, tender, swelling and hard knot and extremely itchy.  Today 1/13/21, I feel some soreness in my lymph nodes under my right arm pit.  The injection site looks a little better and the knot is not as pronounced as the day before.
2 hrs after vaccination severe shoulder pain, various cortisone shot etc. Pain and range of motion difficulties to present day.
No further AE's reported; Administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 31-JAN-2022, the patient vaccinated with improperly stored  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error)  oral liquid, lot number 1742463, expiration date 20-SEP-2022, administered orally for prophylaxis (vaccination scheme, and anatomical location of vaccination were not reported). The vaccine was stored for the time frame of 9 hours 2 minutes in the temperature of following: above 47 degree F (80.8F) for 6 hours, above 47 degree F(61.9F) for 1 hour 10 minutes, above 47 degree F (53.2F) for 1 hour 15 minutes, above 47 degree F (51.8F) for 37 minutes. There was no previous temperature excursion.  No product quality complaint (PQC) and no further adverse event (AEs) (no adverse event) was reported.
I had vaccination 4/02/2022. On 10/04/2022 I had all day near syncope. I messaged my Neurologist and told what medication I am on. The Dr. stated I needed to go to the Emergency Room but it was too late. I have been under a lot of stress. It resolved by the next day.
MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193302, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).  This case involves 17 years old male patient who was vaccinated with 0.5 ml first booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 06-Jun-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.   List of document held by sender: none.
covid_test_result=Positive; 1st dose, 01Mar2021; 2nd dose, 19Mar2021; covid_test_result=Positive; Cough; runny nose; heavy eyes; muscle aches; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 intramuscular on 19Mar2021 (Batch/Lot Number: EN6207) as DOSE  2, SINGLE and dose 1 intramuscular on 01Mar2021 (Age at vaccination: 54 years), (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On an unspecified date the patient experienced covid test result=positive, on 13Aug2021 covid test result=positive (medically significant), on 12Aug2021 Cough, runny nose, muscle aches, headache, heavy eyes. 1st dose, 01mar2021; 2nd dose, 19mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Aug2021. Patient did not received treatment for the events. Outcome of the events drug ineffective and inappropriate schedule of product administration was unknown. While other events was recovering.  Follow-up attempts are completed. No further information is expected.
Child developed fever of 101 F. Left arm from shoulder to elbow became very swollen, red, hot, skin blistered around site of DTaP injection 3 days after vaccination continued to have temp of 102-103 mom in contact with physician and alternating Tylenol and Ibuprofen for fever and swelling. As of 8/11 skin blisters have dried up. Arm is still hard and discolored but today is first day child has not complained about her arm hurting. 8/13 TC arm swelling has resolved. Child doing fine.
mouth tingling  Tx: none, Resolved  1/27 -> 2nd dose received s problem
I started feeling groggy after the shot, which seemed normal. By Sunday afternoon, i felt foggy and off like i was in a brain fog. And, Monday, I started feeling vertigo and like I was rocking with a headache. By Wednesday, i was worried because it was impacting my day to day so i went to urgent care. They told me to go to the emergency room, which i did on  Thursday. They did a cat scan, which was clear, tested me for COVID ( negative) and ran bloodwork. I am planning to go to the ENT doctor on Monday, but still feel off and am concerned about getting the second shot next week. My second dose is scheduled for Thursday, March 25th. I have never had vertigo before and I just feel off all day and it started after my vaccine.
RASH ALL OVER THE BODY UPPER AND LOWER EXTREMITIES. PAIN PT WENT TO THE HOSPITAL AND SHE WAS PRESCRIBED BENADRIL AND PREDNISONE. FULL RECOVERY AFTER  2 WEEKS.
BODY IN PAINING; I FEEL COLD; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 29-JUL-2021, the patient experienced body in paining. On 29-JUL-2021, the patient experienced I feel cold. On 29-JUL-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, I feel cold and body in paining was not reported. This report was non-serious.
5 minutes after patient received the vaccine,  he was suddenly sweating and dizzy.  We called the ambulance which came in about 5 minutes.  Meanwhile we gave the patient a glass of water and  a cold ice pack on the back of the neck.  He said that he did not have anything to eat this morning. He refused to go to the hospital and said that he was feeling a lot better, he was going back to work .
covid vaccine breakthrough   dose 1   2/28/21    025A21A dose 2   3/21/21    045A21A
p/ recv vax approx 3yr later pt devel a rash w/less than 50 pox
She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy clinic. We pretreated her with cetirizine but did not test her to PEG. She developed significant distress, nausea and cough 2-3 minutes after receiving the vaccine. There was no hypotension, wheezing noted. She was treated promptly with epinephrine 0.3 mg. Within five minutes she started to feel better aside from adverse effects from Epi. Left arm and shoulder pain. No significant shortness of breath. She had a large amount of clothing on so were unable to fully see skin but no visible rash. She was transferred to the emergency department.
This case was reported by a pharmacist via a representative and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On 6 October 2006 the subject received unspecified dose of Fluarix intramuscularly in the right arm. The lot number and expiration date were not known. At an unspecified time after vaccination with Fluarix, the subject experienced rash on the right arm, face and chest. The subject also reported a stinging sensation. At the time of reporting the outcome of the events was unspecified. No additional information was available.
17 year old given 2nd dose of Moderna COVID-19 vaccine. No physical adverse event.
Information has been received from a physician concerning a 16 year old female who on 10/3/06 was vaccinated with 0.5ml of HPV. On 10/4/06, the pt developed muscle aches, fever and shortness of breath. The pt went to the ER. It was unknown if the pt was hospitalized. At the time of this report, the outcome of the event was unknown. The physician considered the events to be serious as other important medical events (OMIC). Additional information has been requested.
The patient complains of tingling in the left arm from elbow to wrist following injection.  She was place under additional observation for 15 min.  The patient has no medical problems, takes no meds, and she is not allergic to any meds.  Following the additional observation subject stated the symptoms were no longer present.  The patient was released at this point.
rashes appeared on 20AUG95 fr chest, then disappeared p/mom applied Calamine lotion & DPH cream; rash spread to back & arms w/o any fever; when rash got worse mom called clinic & took to to ER 24AUG95; MD prescribed DPH;
father states pt seen by MD on 27APR94; dx infection rt arm @ inject site of DTAP; red spot larger than 1/2 dollar; rx ATB to be given x 5 days;
constant pain from hand to neck in left arm; pain in vaccination arm; constant pain from hand to neck in left arm; difficulty raising arm and moving head; difficulty raising arm and moving head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (constant pain from hand to neck in left arm), VACCINATION SITE PAIN (pain in vaccination arm; constant pain from hand to neck in left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising arm and moving head) and MUSCULOSKELETAL STIFFNESS (difficulty raising arm and moving head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 002821A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced NECK PAIN (constant pain from hand to neck in left arm), VACCINATION SITE PAIN (pain in vaccination arm; constant pain from hand to neck in left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising arm and moving head) and MUSCULOSKELETAL STIFFNESS (difficulty raising arm and moving head). On 16-Apr-2021, NECK PAIN (constant pain from hand to neck in left arm), VACCINATION SITE PAIN (pain in vaccination arm; constant pain from hand to neck in left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising arm and moving head) and MUSCULOSKELETAL STIFFNESS (difficulty raising arm and moving head) had resolved. Not Provided          Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Completed ADR Form, updated information includes: patient demographic details, action taken, event outcome date, second dose information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Further information has been requested.
No additional AE/PQC reported at time of call; Patient received a dose of PNEUMOVAX23 on 6/6/2022 with a labeled expiry of 5/26/2022.; This spontaneous report has been received from a registered pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 06-JUN-2022, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T033369, and labeled expiration date 26-MAY-2022, for prophylaxis (Expired product administered) (Route of administration and anatomical location were not reported). It was reported that no temperature excursions were involved, and no additional adverse events were reported (No adverse event).
Freaked out mentally.  Thought that my mom and aunt were trying to kill me and was yelling for help continuously.  Couldn't breathe and 2 hours after that still had heartrate of 100 +.  Lasted 4 hours+.  Took an albuterol treatment.
vomiting & pain in abd went to hosp;vomited Friday night, Saturday AM stopped 5AM Monday;fever 100;
It started as chills, then turned into involuntary shakes (whole body). Next, my hands and feet became very cold. My fingers turned white, and my nail beds turned blue/purple from the cold. Next, the fever started. The chills and shakes stopped, but the fever came on very quickly. My neck and face broke out in hives. The fever got up to 103.9 F. I took Benadryl and Tylenol to combat the hives and fever. Both worked. The fever broke during the night. All reactions had subsided by the morning of 10/29/21.
Odd taste in mouth,  heart racing, sweating. Next day developed tinnitus and pain in right ear/eye. Fatigue and brain fog. Severed headache. Felt like stabbing pain in head.  Saw ENT 6 days later. Was prescribed steroids and ear drops. Have hearing loss in right ear and tinnitus
Pt vaccinated with DTP/OPV cried inconsolably for 5 hrs.
Local soreness at R/shoulder that became decreased in strength to R/arm over period of 1 week, then had decreased fine motor skills/dexterity/writing to R/hand. Had chest pain in first 24 hrs. to R/chest.
I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain on my upper left arm and the next day the pain went to my armpit, back and forth from my upper left arm to my armpit and this went on for at least 5 days.  On 01/02/21, 15 days after I notice red bumps on my upper left arm and as days went on red bumps show in my armpit, left back, and chest. The pain went from sharp to burning. On 01/06/21 I got the 2nd dose of the vaccine and I told the injection person about the red bumps. I told him that they look like hives. He spoke with the medical doctor about it and doctor said it was ok for me to get the 2nd dose of the vaccine. They think it was a delayed reaction.  They have me monitored for 30 mins after the 2nd dose of the injection before I leave the site. I still have pain and red bumps so I went to see my primary doctor on 01/07/21.  The doctor said that I have shingles. I told him that I never had shingles before and he said maybe the vaccine trigger it. He prescribed me some medications for the shingles.  I don?t know if the vaccine trigger the shingles or just coincidence but I want to report this maybe someone might have the same experience. Thank you.
Pt devel fever in the afternoon p/the vax; pt was seen @ hosp dx sinusitis & put on ATB;