chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inconsolable Crying, Change in Sleep/Wake Cycle, Constant Rubbing motion with hands, Hand and arm Jerking, disturbance in eating pattern.
Child completed 3 doses GARDASIL, last one given 07-24-14 and again yesterday 09-22-14.
Lower calf pain. Really tight and painful. Happened with dose 2 as well. With dose 2 is started 12 hours post shot. Did not resolve for weeks. Had ultrasound  and doctors apts in regard to the issue. After 5-6 weeks it went away. Dose 3 12 hours post leg pain same exact spot. Only left leg opposite vaccine arm. Sharp deep soreness and pain in calf below knee. Exact same side effect as dose 2.
Arm was sore after initial injection-but soreness increased and our first sighting of swollen redness was this morning-2-8-2021. NO fevers-just sore and swelling-about 3" by 3" and reddish in color-currently no itching or signs of rash.
Left armpit lymph node sore, soreness in left rib cage, and swelling on left side all the way down to hip.
Patient presented for wellness check, was due for Pentacil  and Vaqta.  Clinical Team member administered Adacel instead Vaqta. No related signs and symptoms reported. Even after 7 days. Verified with Poision Control Toxicologist, no indication for concern unless symptoms present.
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant drugs were not reported.  It was reported that patient received 0.25 mL of bivalent booster dose instead of 0.5 mL and stated that reporter called the CDC and were instructed to go ahead and administer the other half of the dose on the same day.  Treatment medications were not provided.  This case was reported for the adult patient 4.
Heart palpitation, racing heart beat, gas in the chest making her feel as though she has to  burp
Adult Pfizer dose administered to child 1 month prior to 12th birthdate. No adverse effects noted.
5 days after second injection site arm began to show red splotches, and hives developed on neck. Patient has red penny sized  scar from first Moderna injection.
Pt recvd 3 doses of Engerix-B & was found to be a non-responder; recvd 4th & 5th dose of Engerix-B & was again found to be a non-responder;
Started with hives on 1/30,  still with hives 2/6. went to my primary care on 2/3 and was given a prednisone taper
Pt vaccinated and immediately felt, hot, sweaty, faint. Hx of having similar reaction to vaccines in the past. No medical problems. No medications. Ate a "snack" this AM. Drank fluids this AM. Pt wheeled without incident to triage area. Feeling a little better after drinking 16 oz water. Appears A & O X 3, no distress, diaphoretic, skin warm and moist to touch Mood and affect normal  Initial vitals 10:30 am - P78 PO2 95% RA BP 113/62  Repeat vitals  1040 am P71 PO2  97% BP 104/56 Repeat vitals 1046 am P76 PO2 97% BP 100/57 Repeat vitals 1048 am P76 BP 102/61 Reports feeling better after water and Gatorade.   Pt advised hydration. Advised immediate medical attention should symptoms persist or worsen Hypotension , Hypotension
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the unspecified patients were vaccinated with an improperly stored doses ROTATEQ, orally (which had a lot # of K022992 and an expiration date of 30-JUN-2016; however, dose and dosage number were not reported). However, no symptoms were reported. The vaccines experienced the following temperature excursion: not less than 32 F for 107 hours. This is one of several reports received from the same reporter. Additional information has been requested.
first dose she was fine, just tired; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as DOSE 1, SINGLE for Covid-19 immunisation. The patient concomitant medications were not reported. Patient medical history reported as Spinal stenosis, Penicillin allergy, Clindamycin allergy. Patient previously received chicken pox shot and reported pneumonia, flu shot, Fluzone. She has had an MRI and X-rays. After the first dose she was fine, just tired and that after the second dose, she was very tired but was fine for quite awhile. She never got the chicken pox when she was younger and she got the chicken pox shot and got pneumonia. She inquired how do you to see genetics. She found out a blood test to see if she might have an autoimmune system situation. Patient reported that she took the flu shot, the Fluzone one without the egg. She had her second dose of the Covid-19 vaccine on 03Mar2021. She had her first dose 3 weeks prior to that, as scheduled. Patient reported that the MRI showed that she has stenosis but nothing happening there. She reported that she also had X-rays done. The outcome of event was unknown.   Information on the lot/batch number has been requested.
pt recvd vax 130PM on 6OCT92 @ 830PM pt had seizure w/fever 105.7; hospitalized for 2 days poss co-existing ear infection;
blisters came and went / middle of the of back with blisters then blisters jumped to my front and big painful; jabbing, burning pain / blisters jumped to my front and big painful/am in a world of pain/left purple marks that are sore to touch; burning pain / woke up on fire ?? just the area that was affected by the Shingles; Prescription meds only made my hands, legs and feet swell painfully; Neuropathy; Got the shingles shot years ago / Got shingles 9 weeks ago; Suspected vaccination failure; This case was reported by a consumer via interactive digital media(Facebook) and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included COVID 19 VACCINE MODERNA for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID 19 VACCINE MODERNA. In April 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), blister, pain, burning sensation and peripheral swelling. The patient was treated with non-drug therapy (Ice Pack (No Medication)), gabapentin and pregabalin (Lyrica). On an unknown date, the outcome of the vaccination failure, shingles, blister, pain, burning sensation and peripheral swelling were unknown and the outcome of the neuropathy was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, blister, pain, burning sensation and peripheral swelling to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix year ago and got shingles 9 weeks ago, blisters came and went but jabbing, burning, pain still here. The prescription medicine only made hands, leg and feet swell painfully. The patient broke out on the middle of the of back with blisters then blisters jumped to front and big painful ones.  The blind had dried up and gone but left purple marks that are sore to touch 3-4 days after Moderna vaccination was this a coincidence. Neuropathy seem to be subsiding, then it was time for 2nd Moderna vaccine.  The doctor said it would be fine.  Got vaccine and next day the patient woke up on fire just the area that was affected by the Shingles.  The patient was using ice pack and taking 5-6 mg of gabapentin and that day do anything. At the time of reporting on 100 mg Lyrica 3 times a day, nothing, but does make a little dizzy. It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, blister, pain, burning sensation and peripheral swelling to be related to COVID 19 VACCINE MODERNA.
feel 1000% better for her bones; feel 1000% better for her bones; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown,single for covid-19 immunisation. Relevant medical history included: "COVID shot made her feel 1000% better for her bones" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "feel 1000% better for her bones"   Additional Information:Attempted transfer from Withheld with Pfizer who reports that the other party just hung up.it helped her tremendously, better than another medication she said she was taking. Agent doesn't know what the other medication was. Agent reports caller said it was short and didn't last.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diluent was given today but not the medicine/no AE; This was dose was number two in the series for the patient,it should have been the third/no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00397592) on 17-Dec-2020.  This case involves a 6-month-old patient of unknown gender who was given second dose of diluent part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] but not the medicine 0.5 ml once (5 dosage packs vial) (Pentacel lot number UJ337AAA and expiry date 05-Jul-2021) (ActHIB Lot UJ337AA, ActHIB Expiry. date: 05-Jul-2021), (DTaP-IPV Lot U6842BA, expiry date 05-Jul-2021) via intramuscular route on left thigh for prophylactic vaccination. (Product preparation error) (Incorrect dose administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and INFLUENZA VACCINE.  It was an actual medication error case due to Active ingredient not added to diluent and Incorrect dose administered. (same day latency)   It was reported that the patient had got diluent which was given on 17-Dec-2020 (reported as today) but not the medicine.  It was asked if sterile water could be used as the diluent and they got one blue (DTaP-IPV component) and they thought that was the diluent so then another blue (DTaP-IPV component) mixed with the green (ActHIB component) was given and this was dose was number two in the series for the patient. It should have been the third.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 17:40 (Lot number: EP7534) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Non-Hodgkin's lymphoma" (unspecified if ongoing), notes: States that she has been in remission for 6 years, was diagnosed 6 1/2 years ago. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 26Mar2021 12:00, outcome "not recovered", described as "swollen lymph nodes". Additional information: Patient would like to know whether their side effects were related to the covid vaccine. Patient would like to know whether their side effects to the covid vaccine could possibly occur after the 1st and 2nd doses are received and would like to know whether the side at which they experience side effects to the covid vaccine matters and how prevalent this can be. Patient received her 1st dose of the Pfizer covid vaccine 1.5 weeks ago. She experienced swollen lymph nodes on the side of her neck, on the same side where she received the covid vaccine. Patient would like to know how long their side effect of swollen lymph nodes to the covid vaccine might last. She wanted to know if this is a common side effect and the prevalence of it. The event did not require visit to emergency room and physician office and patient mentioned that she will possibly be going for an evaluation. There were no prior vaccinations (within 4 weeks) and no relevant family medical history.  No follow-up attempts are possible. No further information is expected.
Had MCV4 vaccine on 8Dec 09; that same day began feeling sick- felt hot, feverish, swollen neck glands, red/swollen/tender deltoid at injection site. Area red + swollen 5 inches in diameter. Rx: TYELENOL/MOTRIN cool compression.
DIZZINES AND FLU LIKE SYMPTOMS THAT SUBSIDED AFTER 24 HOURS. BUT BLURRED VISION WAS SEVERE AND WAS STILL A PROBLEM 3 DAYS AFTER VACCINATION.
Within an hour after receiving Fluzone patient experienced numbness of her left hand...tingling in her lower arm and worse towards the hand.
Contracted the COVID virus after being fully vaccinated. I went in to hospital and had the antibiotic infusion on 09/15/2021.
Warm sensation in right hip / Feels like someone pressing very warm iron to right buttock.; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 22Apr2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse, sickle cell disease and iodine allergy. 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. Concomitant medications were not reported. The patient previously took codeine phosphate (CODEIN) and sulfur (MANUFACTURER UNKNOWN); both for unknown indication on an unknown date and experienced drug allergy. On 22Apr2021 at 11:30, the patient experienced warm sensation in right hip that began half an hour after vaccination. The sensation was intermittent throughout day, worse at night and felt like someone pressing very warm iron to the right buttock. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event warm sensation in right hip was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt developed SOB on the same day of receiving vaccine and she was admitted to the hospital for Pulmonary embolism, elevated troponin, AKI
Pt c/o pain and swelling in left upper arm with vertigo and weakness started evening of the day of the injection lasted throughout next day 06/19/02. Pt feeling much better today 06/20/02.
Pt devel shingles approx 30 days p/receiving Influenza vax;
ACHY; SLEPT 12 HOURS; SPLITTING MIGRAINE; TINGLING 2 FOREFINGERS AND THUMB; NUMB/PINS AND NEEDLES IN LEFT THUMB; This spontaneous report received from a patient concerned a 41 year old White, non Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included: smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient had no drug abuse or illicit drug usage. The patient previously received 2 doses of bnt 162 (Dose number in series was 1) (form of admin, route of admin, and batch number were not reported) dose and therapy start date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with bnt 162 (Pfizer) (Dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-JAN-2022 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 10-JAN-2022, after vaccine, patient slept 12 hours, woke up with splitting migraine, numb/pins and needles in left thumb, tingling 2 forefingers and thumb, and very achy lasted until 12-JAN-2022 (Dose number in series was 2). On 13-JAN-2022, the patient was feeling achy (mild) (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept 12 hours on 10-JAN-2022, and splitting migraine, tingling 2 forefingers and thumb, and numb/pins and needles in left thumb on 12-JAN-2022, and was recovering from achy. This report was non-serious.
severe chills, muscle aches, general malaise, fever starting approx 11 hours after the vaccine and last 4 hours
Information has been received from a registered nurse RN concerning a 42 month old female with no allergies or pertinent medical history who on 20JUL2001 was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 22JAN2004 the patient developed break through chickenpox characterized by 8-10 chickenpox "blobs" with two on her face. It was noted that the patient was afebrile. Unspecified medical attention was sought,but no laboratory/diagnostic tests were performed. At the time of this report, the patient's chickenpox persisted. Additional information has been requested.
Swelling and redness over (L) thigh x 2 days. Received PCV13 and HIB on different legs. + pain over affected area fever x 2 days. Received PCV13 on (L) thigh 6.5 x 6.5 cm.
Irregular menstrual periods following two months. Early period first month after, then period for a day, then disappeared, then full period again 12 days later.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jul2021 15:00 (Lot number: EWO217) at the age of 14 years as dose 1, single and administered in arm left, administration date 18Aug2021 03:00 (Lot number: EWO185) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 11Aug2021 16:00, outcome "not recovered", described as "Irregular menstrual periods following two months. Early period first month after, then period for a day, then disappeared, then full period again 12 days later.". The event "irregular menstrual periods following two months. early period first month after, then period for a day, then disappeared, then full period again 12 days later." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: No other vaccine in four weeks, No Other medications in two weeks, No Covid prior vaccination, No Covid tested post vaccination, No known allergies, No Other medical history.  No follow-up attempts are possible. No further information is expected.
Report  body aches, HA, fever (100.8) and chills started next day post vaccination. Treatment: Tylenol.  Outcome: Mild improvement no interference with ADLs.
headache; sick to stomach; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and ABDOMINAL DISCOMFORT (sick to stomach) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.     On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced HEADACHE (headache) and ABDOMINAL DISCOMFORT (sick to stomach). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and ABDOMINAL DISCOMFORT (sick to stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller didn't wished to get second dose. Concomitant product use was not provided by the reporter.
Heart palpitations, heart flutterings.  Wore a heart monitor for 15 days and these also showed up on the monitor.  They happen at night or if I am taking a nap.
Patient presented to the office with SOB and chest discomfort on 5/11.  She was sent to the ED and diagnosed with BIL DVT and BIL PE
Eruption of itchy rash began 10/04/02, Likely variculuiform
Information has been received from a registered nurse concerning a female infant who on 05-JUN-2008 was vaccinated with a first dose of ROTATEQ greater than 12 weeks of age. There were no adverse symptoms reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/13/2008. Follow-up information has been received from a registered nurse concerning a 13 week old male (previously reported as female). Infant with no known allergies or pertinent medical history who on 05-Jun-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 606427/0280X) at 1:40 PM. The patient had atopic dermatitis at the time of vaccination. There were no adverse symptoms reported. At the time of the report, the patient;s status was unknown. Additional information is not expected.
there was no actual adverse reaction but reporting that this dose was given after the recommended beyond use date of 31 days. It was given on the 32nd day