chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to an unknown number of patients of unknown gender and age. The patients' concurrent condition and medical history were not reported. On unknown dates, an unknown number of patients were vaccinated with improperly stored PROQUAD (dose and route unknown, lot # N004629, expiration date 07-AUG-2018) for prophylaxis. It was unknown if the sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. The vaccine was improperly stored at 6 to 14 degrees Fahrenheit for 51 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 3 hours. The phone call was a result of the data logger. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA000676: US-009507513-1709USA009052.
Arm swollen, hot, red and itch. It happened about 12 hrs after vaccine, then went away and started back up again today 3/22/21. No other symptoms
On Dec. 8th, child had inconsolable crying, paleness, constipation, bloody stools, vomiting. Diagnosed with intussusception on 12/10/10.
Extreme fussiness, behaving very ill and abnormal. I expected this to go away anf it never did. Patient has acted very out of character and began screaming or crying unconsolably frequently. This has been a nightmare. Her sleeping patterns have also been significantly affected. Almost three weeks later she suddenly acquired a fever of 101-103 for over twenty four hours. After that period (in which I was told to keep her home for monitoring) we resolved to get her to the doctor the following morning. Over this time she slept in our bed with us and was vlosely monitored. The following morning her temperature had dropped so we did not end up going into the doctor. However, hours later after the doctor's offices had closed her fever returned, lasted about 4 more hours, and finally subsided for good. Then about four or five days later (tonight; almost a full month since vaccination) my daughter developed visible bumps that had the appearance of chickenpox all over her torso. When I saw this I recalled prior odd behavior that in hindsight was obviously her rubbing against things to scratch herself...so I am inferring she is also itchy. And still highly irritable, unconsolable fits (not in her character), extreme lethargy and desire to sleep, decreased appetite, and abnormal bowel movements ranging from constipation to mild diarrhea.
The patient was 4 years of age.  He was given the vaccine for the 5-12s years old His father was notified of the error. No report of adverse reaction wass made to the clinic
Adult Td was given instead of Flu vaccine. No reaction noted by Mom after 3 days.
High pitched screaming started ~45' with shots, continued X 45' Pt slept X 48' then cycle repeated X 5 days
PATIENT HAD RECEIVED INFLUENZA VACCINE EARLIER IN THE DAY BY HIS PERSONAL PHYSICIAN & RECEIVED MENINGOCOCCAL VACCINE AT PUBLIC HEALTH DEPT LATER IN THE DAY ON 1/7/2008. AT 3 A.M. ON 1/9/2008, PATIENT HAD REDNESS & ITCHING OF FACE; SWELLING OF FACE, HANDS & TONGUE.  ACCORDING TO PHYSICIAN'S REPRESENTATIVE, PATIENT WAS SEEN ON 1/9/2008 IN LATE A.M. AND DIAGNOSED WITH A REACTION TO EITHER THE FLU VACCINE OR THE MENINGOCOCCAL VACCINE.  PATIENT GIVEN MEDROL (METHYLPREDNISOLONE 4 MG) DOSE PACK.  AS OF 11:30 AM 1/10/2008, PATIENT'S SYMPTOMS HAVE DIMINISHED, BUT NOT COMPLETELY RESOLVED (ACCORDING TO PATIENT'S PARENTS).
Light headedness; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Latex allergy (blisters , hives, loss of voice), Fragrance sensitivity (loss of voice , tingling tongue), Allergy to chemicals (loss of voice, heart rate increased, tingling tongue, pain in jaws) and Allergy to vaccine (pneumonia vaccine causes Fever of 103. Chills. Aching. Weakness. Swelling. Not able to get into any clothes. ) on 31-Oct-2018. Concomitant products included AMLODIPINE for Hypertension.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 02-Feb-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) HIGH.         This case was linked to MOD-2021-173466 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: ADEDD MEDICAL HISTORY AND SECOND DOSE INFORMATIONS
Initial report received from a healthcare professional on 22 October 2012. A 31-year-old pregnant female patient, whose medical history was unknown and concomitant medications were not reported, received an intradermal dose of FLUZONE ID (Lot number UT4470AA) in the left deltoid area on 04 October 2012. The last menstrual period was unknown. The patient's estimated date of delivery was reported as 01 May 2013. On 4 October 2012, same day after vaccination, the patient experienced left arm site sore, painful to move and had difficulty in sleeping. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 22 October 2012, the patient's outcome was not recovered. Documents held by sender: none.
Shingles, I?m on day 4, treatment is anti viral med and nerve pain med. I have a large patch of painful itchy bumps under my left shoulder blade and it is spreading to my left side and under my left breast. It burns on the skin and internally feels like someone is squeezing my kidney and spine.
Symptoms included fever (max >101F), extreme distress (crying/screaming), irritability, appetite loss, unusual tiredness, weakness, drowsiness, somnolence, confusion, extreme mood change (stopped smiling), vomiting, hallucinations, red/irritated eyes, runny nose, cough, slight bloody nose, tachycardia, unsteady gait, white spot inside mouth, back pain. Physician-ordered treatment for acute symptoms was rest and fluids (plus NSAID if fever causing distress). Acute symptoms peaked on 07/09 and 07/10 and then gradually resolved over about 1.5 weeks -- except for the back pain, which the patient never had mentioned previously but has mentioned almost daily ever since (current date: 09/02/2014). As of 08/29/2014, patient is being medicated for slow/incomplete stool transit in large intestine (found upon x-ray 08/25) in hopes that will help the back pain.
on the 8th day after my first injection my arm started to ache and got very hot and swollen, not really red or rashy, but really hot and achy.  Not a huge deal, but I think the data is important to you. Today is day nine, still hot rashy and swelling has gone down.
Patient felt faint around 5 min after vaccination. He was sweaty, pale, and dizzy. He was given water, peanuts, and a fan. . Patient laid flat on the ground for 15-20min and began felling better. He left on his own shortly after that.
Weakness that started shortly after receiving 2nd dose moderna. Usually able to walk 3 miles daily. Also able to run with her dog. Now barely able to get out of bed. Feeling unbalanced. Weakness bilateral hips with jerky gait. Weak BLE. Neurologically intact. CMS intact.
Throat closing up, nausea, vomiting, anxiety, loss of appetite, migraines, body ache, muscle weakness,
SIGNIFICANT REACTION/NEGATIVE REACTIONS; This spontaneous report received from a patient via a company representative concerned a 62 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient was in great health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced significant reaction/negative reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of significant reaction/negative reactions was not reported. This report was non-serious.
reddened are L upper arm BENADRYL 25mg q  6 pm. DURIAF 500/s  1 tsp BID X 10days MOTRIN q 6 hours.
No adverse reaction reported; The vaccine went onto the patient's mother's pants; she could not confirm whether this meant some of the vaccine went onto the patient's mother's skin also; This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported.    On 13-MAY-2019,  the patient's children was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), subcutaneously (lot # R036581, expiration date 17-DEC-2020) (dose not reported)  for prophylaxis.  The vaccine was reconstituted with sterile diluent (lot # S008565, expiration date 09-AUG-2021).      The patient "pulled away" during administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) and as a result, the vaccine went onto the patient's mother's pants; medical assistant could not confirm whether this meant some of the vaccine went onto the patient's mother's skin also. No adverse reaction was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA009408:Original Case : 1905USA009408
p/vax pt noticed reddened area in AM 10/22/99;230PM 10/22/99 saw provider pt states felt some anxiousness;7x3cm local rxn & jitteriness 1hr p/vax;had to use asthma inhaler;soreness;local redness;
The patient was observed to be lethargic on 1/29/21 at 1515. BP-80/50, P-75, RR-27, T-100.1. He was given a bolus of  NS 150 mlx2. and Rocephin 1 gram IM.
Booster; 6 patients received the Pfizer COVID-19 vaccine adult formulation (purple cap)- booster dose past the expiry date; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Dec2021 10:00 (Lot number: FE3592, Expiration Date: 03Dec2021) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: Unknown, Expiry: Unknown, NDC: Unknown), administration date: 05Feb2021, when the patient was 74 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: Unknown, Expiry: Unknown, NDC: Unknown), administration date: 25Feb2021, when the patient was 74 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 10:00, outcome "unknown", described as "Booster"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 10Dec2021 10:00, outcome "unknown", described as "6 patients received the Pfizer COVID-19 vaccine adult formulation (purple cap)- booster dose past the expiry date".  Additional Information: This report is for patient 1 of 6. Patient received the vaccine on 10Dec2021 as a booster dose; expiration date was 03Dec2021. A contactable other Hcp reported similar events for six patients. This is 1st of 6 reports. This other HCP reported for a patient stated 6 doses of the booster Pfizer Covid vaccine was given out of expiration date, for the purple The patient did not visit Emergency Room or Physician Office. The patient was not hospitalized. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None, prior vaccinations: None, Patient's Medical History, Family Medical History Relevant, Relevant Tests: none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101806366 same reporter/drug/AE with different patient.;US-PFIZER INC-202101806368 same reporter/drug/AE with different patient;US-PFIZER INC-202101806367 same reporter/drug/AE with different patient;US-PFIZER INC-202101806369 same reporter/drug/AE with different patient;US-PFIZER INC-202101806370 same reporter/drug/AE with different patient
On the 26th I woke up with pain behind my right eye/eyebrow. I had a headache there all day, and the pain hurt worse when I moved my right eye.  On the 27th the headache was gone, but  it still hurt to move my right eye. I took ibuprofen and scheduled an appointment to see my primary care doctor.  On the 28th, the eye pain had improved some, and my doctor said my eye looked fine. She said it could possibly be some facial swelling behind the eye. She said I can wait a week to see if it is still bothering me and then follow up with my eye doctor. In the meantime she recommended ibuprofen/Tylenol for the pain.  I was still worried, and having headaches so on the 29th I saw my eye doctor. She also said my eyes looked fine, but to follow up if the eye pain gets worse again, or if I notice any visual changes. I am still currently taking Tylenol/ibuprofen today for the headaches, and the lingering eye discomfort.
pt recv vax 9SEP96 & 12SEp96 pt devel gen urticaria;pt was taken to MD 25SEP96 & was referred to a dermatologist;the 24 antigen test was performed, which determined the pt had an allergy to thimerosal;
Severe leg pain (inability to stand for longer than a minute). Extreme fatigue. Facial numbness. Loss of taste.
About 10 min after injection I began to feel dizzy, then had 1 faint wheeze at the base of my chest, I became nauseous, then developed rapid palpitations.  I BP was checked about 10 min later and I was hypertensive SBP 180s.  By the HR was down to about 90 bpm and I felt the palpitations begin to decrease.  I was feeling better by about 10 min later and went home.  I also had itchiness of the L hand for about 1 hr afterwards.
First 12 hours- slight tiredness, 24 hours- extreme tiredness; Hard to focus when 'I'm' most tired; Pain at injection site; Chills; Anxiousness; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 11:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and allergy to fresh apples and fresh cherries. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 13:00, for first 12 hours the patient experienced slight tiredness and 24 hours extreme tiredness, hard to focus when the patient was most tired, pain at injection site, chills and anxiousness. 48 hours the patient had slight pain at injection site, tiredness and anxiousness. 72 hours (also reported as currently), the patient experienced tiredness and anxiousness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events first 12 hours slight tiredness, 24 hours extreme tiredness, hard to focus when most tired, pain at injection site, chills and anxiousness was not resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I did not put shot and pain together, so unsure of date and time of onset. Just know that within a couple of weeks of flu shot, which was administered really really high--almost at top of left shoulder---started having much pain and limited range of motion in high shoulder area. I can't cross arms as if to take a shirt off---raising left arm over head, etc. quite painful.
Pt received hep b #3 at school on 04/02/2002. No complaints by client till 04/04/2002 at school. Approx. 4cm hard area around injection site and red area 1 1/2-2" down upper arm. "Red bruised look" per mom. To PMD on 04/04/2002, was recommended symphors with ice and Advil. On 04/05/2002 arm looked much better, still red and swollen but "almost gone."
Fatigue, fever, shortness of breath, left sided chest pain. Major pulmonary embolism and right femora vein DVT. Required emergency admission morning of 6/21/2021, EKOS treatment with TPA, 3 night hospital stay so far.
using improper technique and administered in tendon; using improper technique and administered in tendon; frozen shoulder; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose brand name unknown=COVID19 Vaccine, is bivalent=False, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose number=1), for COVID-19 immunization; Bnt162b2 (prev dose brand name unknown=COVID19 Vaccine, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=2), for COVID-19 immunization. The following information was reported: PERIARTHRITIS (non-serious) with onset Dec2021, outcome "recovered", described as "frozen shoulder"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown" and all described as "using improper technique and administered in tendon". Therapeutic measures were not taken as a result of periarthritis.  Additional information: MD reports that vaccine was administered by pharmacist in grocery store using improper technique and administered in tendon. MD also states that primary care has seen in an increase in frozen shoulder d/t improper administration technique of covid vaccines. Other vaccine received in four weeks and other medications in two weeks reported as unknown. Covid prior to vaccination and covid tested post vaccination reported as unknown. Known allergies and other medical history reported as unknown.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Headache, body aches, chills  4/8 Nausea, vomiting, diarrhea.  4/9
pt recv vax; awoke & cried; did not stop crying for 4 1/2 hr; no fever; apap given; no local rxn;
Moderna COVID-19 Vaccine EUA Swelling, Redness/Discoloration, and Itchiness on the injection site about 5-6 days after receiving the vaccine Within 48 hours of receiving the vaccine: Migraines, Queasiness, and bit of brain fog // Went away after the 48 hours
Received Pfizer dose for patients 12 and up. Should have received dose for children between 5-11 years of age. Consenting parent made aware of what happened. No s/s of distress noted.
administered half the dose of Pentacel only the diluent was administered, with no reported adverse event; Initial information received on 26-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 4 months old female patient who was administered half the dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(VERO)/ HIB(PRP/T) vaccine [Pentacel (Vero)] only the diluent was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and rotavirus vaccine live reassort ORAL 5V (Rotateq) for Prophylactic vaccination.  On 26-Jul-2023, the patient received 0.5 mL dose 2 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB (PRP/T) vaccine, Suspension for injection (batch number: UJ877AA) (expiry date unknown) via intramuscular route in the right vastus lateralis for Immunization, half the dose of pentacel only the diluent was administered, with no reported adverse event (product preparation error) (same day latency).  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event administered half the dose of pentacel only the diluent was administered, with no reported adverse event.  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 the 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.
ischemic stroke (cerabellar)  * I realize this is not a recognized side-effect, but I am also not a believer in coincidence. Prior to receiving the vaccine,  I was in excellent health, physically active (long walks, and gym 3-4 days/week), normal BMI, and excellent cholesterol numbers. BP had been "borderline high" for several years, but 3 different doctors agreed that no medical treatment was needed - just stay physically active and reduce fat and sodium in diet, which I did. I am retired with no financial worries, so stress is not a factor. Stroke occurred 5.5 weeks after receiving second Moderna vaccine.
No adverse events; a patient who was administered the first dose of ROTATEQ on 6/18/2019 and the second dose of ROTATEQ on 9/4/2019; This spontaneous report was received from a registered nurse referring to a 4 month old patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 18-JUN-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose, lot number and expiration date were not reported) for prophylaxis. On 04-SEP-2019, the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient orally, with lot number S010046 and expiration date on 08-NOV-2020 (dose was not reported) for prophylaxis (inappropriate schedule of product administration). No adverse events.