chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 27 year old female patient who on 03-JAN-2011 was accidentally vaccinated with a 0.1 mg dose of PNEUMOVAX 23 (lot number 666025/0932Z, expiration date: 18-JUL-2011) in the left forearm instead of a tuberculosis (TB) test. The patient's relevant medical history, concomitant medications and past drug history were unknown. On 03-JAN-2011, after the patient got the PNEUMOVAX 23, she got a reaction around the site, redness, swelling and itching. It was unknown if there was any relevant laboratory data. As of 03-JAN-2011 she would not be getting any more PNEUMOVAX 23 and she had redness, swelling and itching on her forearm. At the time of this report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Information has been received from a medical assistant and medical records, concerning a 27 year-old, female who on 03-JAN-2011 was accidentally administered PNEUMOVAX 23, 0.1 ml, in the left forearm, instead of TUBERSOL for an tuberculosis (TB) test. The patient returned to the office 1 - 2 hours later with redness and severe swelling at injection site. She was treated with BENADRYL, 50 mg, intramuscularly (IM), and SOLUMEDROL 125 mg, IM. The patient was sent to a hospital for chest x-ray that was negative. Went to after hours clinic with increased swelling and pain. She was informed to continue BENADRYL. The redness subsided, but there was more swelling. The patient applied ice packs and, within two days, the signs and symptoms were gone. No continuing effects. On 05-JAN-2011, the patient recovered. All medical records will be available upon request. Additional information has been requested.
Arthralgia & Rash Narrative:  Rash - limited to left cheek and neck (resolved in 3 hours)
patient admitted for COVID post vaccination. patient was negative multiple times since his original COVID contraction date of 09/15/2020. Negative tests recorded 12/29/20 and 03/31/21. Patient positive on 4/3/21 and 4/4/21.
Nurse drew up a covid 19 vaccine for pt but the vial used was punctured greater than 12 hours prior to administration. Pt was contacted, and informed pt, reported sore arm, fatigue and nausea x2 days-now resolved, no other side effects. Provider informed.
12/23/22, at around 6 PM his son returned from the grocery store and found him unresponsive.  Paramedics found him with room air sats in the 70s and a temperature of 101.  In the ED he met sepsis criteria and was positive for influenza and a urinary tract infection.  He was admitted to the hospitalist service and remains admitted on oxygen at this time.
large red knot at injection site that was extremely hot and itching.    spiked fever of 103.9 and it bounced up to 104.9 and down to 102.5 over the period of 1145 pm Friday evening until Sunday morning around 10am.   entire body was itching to point I was scratching  red marks to attempt to stop it.   Throat was swelling could not swallow solids.   Entire body ached and was extremely weak with spells of uncontrol able shaking.
The patient experienced a fever shortly after the vaccines were administered. The patient began vomiting during the night through 11/01/2001, with the worst day being 10/31/2001. The patient's fever continued through 11/02/2001. The patient has a history of fever reaction with prior DTaP's. The mother states this reaction was the most severe.
pt states she had flu like symptoms and then experienced extreme fatigue. She had pressure and burning in her chest and left side of her head that lasted a couple of hours.  She contacted her PCP.  She has her taking natural supplements.  She has difficulty focusing. She now gets exhausted after physical exercise.  She had to work from home for a while but ended up having to go back to work where she has a hard time making it through the day because she is completely exhausted.  She had her BP checked at work on 4/30/21 which it is was 160/110 and was told to get medical treatment so she went to a local medical center.  She had blood test and EKG.  She was monitored until her BP was back to normal.  She was discharged to FU w/ PCP.  On 5/3/21 she went to her PCP.  She was told to document her BP readings.  Her BP has been around 140/90.  She has been referred to a cardiologist and her appt is on 5/7/21  w/Cardiologist.   She had blood test on 4/27/2021.  Her antibodies level was greater than 20.
Rec'd call from patient 12/8/08 who relates that she rec'd flu shot 10/15/08 and shot was given in left deltoid. She experienced typical pain at time shot was given and (3) days later experienced a cramping aching pain. Arm was warm to touch for 2-3 days. She went to her MD on 11/21/08 who prescribed medication for inflammation and nerve pain. Relates arm is still painful and radiates to fingers.
I contracted Covid about three weeks after my Pfizer booster injection; booster injection; I was previously vaccinated with the Moderna vaccine; I was previously vaccinated with the Moderna vaccine.; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 18:00 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "arthritic knees/hips" (unspecified if ongoing); "arthritic knees/hips" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ADVAIR; BENICAR; IBUPROFEN. Vaccination history included: Moderna covid-19 vaccine (First Dose), for Covid-19 immunization; Moderna covid-19 vaccine (Second Dose), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster injection"; OFF LABEL USE (non-serious) with onset 15Nov2021, outcome "unknown", described as "I was previously vaccinated with the Moderna vaccine"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Nov2021, outcome "unknown", described as "I was previously vaccinated with the Moderna vaccine."; COVID-19 (non-serious) with onset 28Nov2021, outcome "recovered", described as "I contracted Covid about three weeks after my Pfizer booster injection". The event "i contracted covid about three weeks after my Pfizer booster injection" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19.   Additional information: Not an adverse reaction in terms of allergies, but I contracted Covid about three weeks after my Pfizer booster injection. I was previously vaccinated with the Moderna vaccine. The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient was not diagnosed with covid prior vaccination. The patient was tested for covid-19 post vaccination by nasal swab on 01Dec2021 and resulted positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
On day of 2nd vaccination,  2/11/21, severe momentary dizziness about an hour after then no reaction until 2/13/21.  Approximately, 8P on 2/13/21, found blood in urine that lasted approximately 3 days.  Towards the end of the episode, saw very small blood clots.  Went to my clinic .  Urine sample confirmed blood in urine, CT Scan showed no abnormalities of kidneys, and Cystoscopy with a Urologist showed bladder to be normal.  Have no history of kidney stones, kidney disease or cancer.  As of today's date, 4/08/21, no further episode.  Lab worked showed no abnormalities.
After receiving the vaccine, I had a sore arm. The next day I felt extremely drowsy. I would sleep for 4hrs wake for 2hrs and then need a nap again. This became a cycle. This was unusual because after the first vaccine, I only experienced common and minor side effect like aches and mild fever etc. The week after the vaccine, I began to have migraines with extreme pain, nausea and dizziness. These symptoms all became increasingly worse. I hadn't had a seizure since 2005, and in January, following the vaccine, I had one. My neurologist cannot determine the cause of this nor the migraines. My usual medication for my migraines do not work anymore. I have had to quit my job because I am a fall risk. I also must use a can to move around now to maintain my center of gravity.
Mother presented to office with child reported that Varicella was given 2/26/09.  Papular rash appeared on child 3/8/09.  No fever was noted.  Child was given Benadryl on 3/9/09.  Greater than 50 papules were noted on trunk of body, stomach, back and upper legs.
The site of injection has about a 3" diameter red raised bump, hurts to touch and feels very hot, all my joints in my body ache, headache, very tired, hurts when I move my eyes around. Have chills periodically.  This started around 5 this morning and appears to be getting worse as the day is progressing.  Almost feels like when you come down with the flu. I had shot given the day before around 3:00 pm 2-MAY-21
PATIENT REPORTED BODY ACHES, HEADACHE, NAUSEA AND THREE EPISODES OF VOMITING. HE WAS TREATED WITH IV FLUIDS, ZOFRAN, AND TYLENOL AND REPORTED SIGNIFICANT IMPROVEMENT IN SYMPTOMS.
it makes everything swollen like my nose, teeth and everything; Not able to sleep; I have severe arthritis that deform the fingers; No circulation in my hands.My hands are swollen; If I lay down on bed, feel pain within few seconds and get out of bed and put my hands down like on standing position hanging down; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I have severe arthritis" (unspecified if ongoing), notes: I have severe arthritis that deform the fingers. The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "it makes everything swollen like my nose, teeth and everything"; INSOMNIA (non-serious), outcome "unknown", described as "Not able to sleep"; ARTHRITIS (non-serious), outcome "unknown", described as "I have severe arthritis that deform the fingers"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "No circulation in my hands.My hands are swollen"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "If I lay down on bed, feel pain within few seconds and get out of bed and put my hands down like on standing position hanging down". The events "it makes everything swollen like my nose, teeth and everything", "not able to sleep", "i have severe arthritis that deform the fingers", "no circulation in my hands.my hands are swollen" and "if i lay down on bed, feel pain within few seconds and get out of bed and put my hands down like on standing position hanging down" were evaluated at the physician office visit.  Additional Information: Patient stated that she had first dose Pfizer Covid Vaccine and it triggered everything that she had gone medically, it triggered all of that at her body, she was not able to sleep, and she had to run to her Primary Doctor. She had severe arthritis that deform the fingers, she reported vaccine made everything swollen like her nose, teeth, and everything. She basically had no circulation in her hands and hands are so swollen that if she had to lay down on bed, she felt pain within few seconds and she like to get out of the bed and put her hands down like on standing position hanging down." Patient stated that Pfizer shot triggered her body to attack her own immune system, so now she will  not supposed to take second vaccine (dose) shot."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RN administered Pfizer 0.2ml pediatric dose to a 12-Year-old client. The client should have received 0.3 Pfizer adult dose. The nurse verified this was the dose given. Education provided to the staff.
Have a rash were i got the shot; Med Info Agent:  Have a rash were i got the shot does happen  often.
Less than 15 mins after having the shot, I had passed out. This was Wednesday. On Sunday morning I got the worst headache I have ever had. Acetaminophen  didn't do anything to alleviate the pain. It was debilitating. Took Motrin, 2-200 mgs. finally got some relief. The pain lasted the rest of the day. Monday it came back just after lunch. Pooped more Motrin, better. Tuesday just before dinner it came back. More Motrin. That was the last of that headache, just very worn out, tired the rest of the week.
PT RECIEIVED VACCINE NO ISSUES AFTER EXAM COMPLETED BY NP, LAB WENT TO STICK PT AND COULD NOT ABTAIN BLOOD DRAW. PT GOT UP TO LEAVE WALKED FROM EXAM ROOM TO LOBBY AND FAINTED.
Information has been received from a physician concerning a female who was vaccinated with an unspecified dose of Gardasil (lot number unspecified).  Subsequently, the next day, the patient experienced vaginal bleeding.  No further information provided.  The physician requested not to be contacted.  No further information available.
I experienced chest pain after my vaccine. I received the vaccine on 04/02/2021 and passed out the next day, 17 hours later. I passed out, hit my head and tweaked my right hip. The result was got a concussion. I went to ER, and I had a hip replacement. It was very hard to know what the symptom of hitting my head and hitting my hip.
Event: Slight increase in temperature (99.1 C), Chills/sweating, headache, lethargy. Treatment: Ibuprofen (4 x tabs).
Information has been received from a registered nurse (RN) concerning a child who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live )human-bovine). The RN reported that the child became quite ill the day after being vaccinated as they experienced vomiting, diarrhea and fever. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
1/22/21 - red, swollen, painful injection site.   About 2 x 4" in size.  It starting resolving approx. 48 hrs later. 1/22/21 - Strong feeling of sickness, nausea, aches  (No fever, chills joint pain, headache or vomiting) 1/23/21 - Extreme Body Aches, fatigue -  couldn't work 1/24/21 - Strong (but not Extreme) Body Aches, fatigue - couldn't work.    1/25/21 - Feeling back to normal.
Fever (101F), body aches, joint pain, headache, left upper abdominal pain (under base of ribs) all lasting apx 16hrs. Then the next 24 hrs just mild HA and some body aches.
Thirty minutes after receiving vaccine, developed white, thick, exudate from corners of both eyes, itching of eye lids and whole face, and minor swelling of eye lids.  No other skin problems, no leisons or blotching on face, neck, or body.  On 12/4/09, saw her optometrist who diagnoses bacterial infection.  Perscribed Ofloxacin 2 drops in each eye every 4 hrs.  Dischage from eyes resolved on 12/5/09 but minor itching of eye lids and face continued.  On 12/9/09, itching increased in eye lids & face and has burning in eyes.  Called optometrist again.  He advised her to report as possible reaction to H1N1 Vaccine.  To return to optometrist on 12/10/09.  No other symptoms or side effects.  No difficulty breathing.  No further skin problems.  No lesions or hives.
Loss of consciousness; Fear of injection; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and FEAR OF INJECTION (Fear of injection). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and FEAR OF INJECTION (Fear of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was ok during her vaccine. Only after I finished the shot she passed out. We called 911 to make sure she was o.k. even though she said not to call.    It was unknown if the patient received any corrective treatment and concomitant medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Yesterday, 1/28/20, Eight days after receiving injection, my arm presented swelling, itching, and burning sensation.  Today, 1/29/20, was not better and rash developed on my abdomen.  Went to clinic.. She said it was my body reacting to the vaccination.  I did not have any unusual side effects other than a sore arm for 2 days post injection. Just showed up 8 days later.  Doctor suggested I report to CDC for data reasons.  She prescribed Claritin 2 X per day, and Prednisone if needed for pain.  Did not feel this should deter me from getting second dose on 02/18/2020.
Case number PHEH2016US027904, is an initial spontaneous report received from a health care professional on 25 Oct 2016. This report refers to a patient of an unknown age and unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient received one single dose of FLUVIRIN (lot number: 1620101, 1620201, 1620301) at a dose of 0.5 ml intramuscularly on 24 Oct 2016. No adverse event was reported following this medication error (incorrect product storage).
Presented to office with rash - Began on chest spreads to arms -8/27/ rash began.
Initially developed left arm erythema and rash at the site of the vaccine and subsequently developed feeling of being unwell, low grade fever, chills and viral resp symptoms.
Patient complained of low grade fever, swelling and redness around the injection site (about 1 inch), painful arm that migrate to her back and elbow.
ABOUT 1 MINUTE AFTER ADMINISTRATION, THE PATIENT BEGAN TO GET LIGHTHEADED, COLD, CLAMMY, COLD SWEATS, AND BP DROPPED TO 66/48 . WE CALLED 911. I NEVER OBSERVED THE PATIENT LOSE CONSCIOUSNESS. HE PUT HIS HEAD DOWN ON OUR SMALL TABLE IN THE IMZ BOOTH. HE WAS TALKING AND KNEW WHERE HE WAS AT.  WE THEN LOWERED THE PATIENT TO THE FLOOR FOR SAFETY REASONS BECAUSE HE STATED HE STILL WASN'T FEELING WELL. BEFORE THE AMBULANCE ARRIVED THE PATIENT WAS ALREADY FEELING BETTER AND BP WAS 129/78 WITH PULSE 82. THE PATIENT WALKED OUT ON HIS OWN POWER.
BROKE OUT IN FINE RED RASH,ALL OVER BODY, INCLUDING FACE. RASH NOT NECESSARILY HEAVIER AROUND INJECTION SITE. RASH STARTED ALITTLE LATER THE SAME DAY AS VACCINATION --- CONTINUED FOR NEXT 36 TO 48 HRS. NO DIFFICULTY BREATHING OR ANY OTHER S/S. SG
Woke in middle of night with aches and chills. Pain at injection site. Fever up to 100.7 Symptoms lasted for 20 hours.
Pt recvd 1st dose Hep B vax 28JAN91 & day of vax exp abd cramps; 02FEB91 dizziness & ear pain; 15FEB91 flu-like sx, joint pain, muscle pain, lower back pain; 11MAR91 recvd 2nd dose exp pain @ inject site, twitching of rt eyelid, nausea;
a 11-year-old patient for which Tdap was ordered inadvertently received Infanrix vaccine/No AE; Initial information was received on 16-Jul-2020 regarding an unsolicited valid non-serious case received from a consumer or other non-health professional (Clinic Manager).   This case involves a 11-year-old patient for which DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [Tdap] (produced by unknown manufacturer) was ordered, but on an unknown date, inadvertently the patient received a dose of suspect DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] (not produced by Sanofi Pasteur) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  It was a case of an actual medication error due to wrong vaccine administered.  It was also reported that, Infanrix was intended for infants and not indicated for this age (for 11 year old patient).   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
had her first shot / in January 2020 / not yet received her second shot.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient did not want to answer any further questions. The reporter did not consent to follow up.
BODY PAIN, SWEATING, SHIVERING, CHILLS, HEADACHE, STOMACH ACHE.  STARTED ABOUT 9:00 PM ON THE NIGHT OF THE VACCINATION,   GOT BETTER AFTER TAKING IBUPROFEN THE NEXT MORNING.
Right neck muscle spasm, occurred when in class at school and turned around, then felt acute neck pain. Treated with heat, cervical collar, and low dose diazepam. Seen within hours after spasm first started.
pt sister states pt has sore, red & swollen rt arm;redness started evening of 16DEC which is the day pt recv vax;states area warm to touch & pt c/o soreness & not moving arm;not taking any anti-inflammatory meds ie APAP, advil, Ibuprofen;
Started the evening of the injection with a temp. of at least 101 - lasted for approximately 48 hours.  Injection site started to swell and resulted in a rash from shoulder to elbow that lasted for one week.