chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cycle was extremely light; "my" PMS symptoms of back aches and cramps were nothing compared to what "I "usually have; This is a spontaneous report from a contactable healthcare professional, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 23Apr2021 at 15:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder (ADD), depression and migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), fluticasone propionate (FLONASE) and topiramate (TOPAMAX); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date at 12:45 as a single dose for COVID-19 immunisation. On 23Apr2021 at 18:00, the patient experienced menstrual cycle that was extremely light and premenstrual syndrome (PMS) symptoms of back aches and cramps were nothing compared to what patient usually had. 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 menstrual cycle was extremely light was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Pt is 1 of 8 pts who were tested 6 months p/completion of 3 dose series of Engerix-B & did not convert;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-SEP-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 20-MAR-2022) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. Age at time of vaccination 48 years old. No concomitant medications were reported.  On 18-JUN-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220537683, 20220537683, 20220537688, 20220538146, 20220538149, 20220538210, 20220538292, 20220538297, 20220538347, 20220538379, 20220538316, 20220537341, 20220539045, 20220538425 and 20220538428.
Pt received 5 immunizations as required for school. Five minutes after administration, the pt became pale and diaphoretic and said he felt slightly dizzy.  Pt was assisted from his chair to an exam table in an adjacent room, placed in serm recombent position with legs elevated.  His vital signs were monitored and he drank 6oz juice and 6oz H2O.  Pt was monitored for 30 minutes.  Until his color returned, and no diaphoresis and no complaints of dizziness.  Pt was escorted from exam room to the lobby w/his guardian.  Supervisor was notified when event occurred.
Wrong route. Gave intramuscular instead of subcutaneous at 11:02 am 10/17 22.  No adverse reaction observed.
Right deltoid area swollen to size of an egg. Ached up into neck area. Took Motrin that night. Sore for couple of days. Swelling lasted couple of days. Down to completely normal by 10 days.
Rash that developed about 2 inches around injection site and persisted for 3 days, is now resolving. No other adverse effects/complications.
some of the vaccine came out during injecting the dose of Pentacel with no reported adverse event; Initial information received on 29-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who experienced some of the vaccine came out during injecting the dose of Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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) for Immunisation.  On 29-Jun-2023, the patient received dose of 0.5 ml dose 1 of standard strength of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection (lot: UJ858AA) via intramuscular route in the left leg upper thigh for Immunization and some of the vaccine came out during injecting the dose with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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 guidelines. 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.
PULMONARY EMBOLISM, UNSPECIFIED. 1/16/2021 THYROID GOITER
pt recvd vax & according to mom eyes rolled back & was unresponsive; for 10 secs;
Swelling - red arm - numb vaccination site - numb upper arm - pain in arm - loss of feeling hand and wrist - constant needles feeling in arm and hand.
Immunizations were given at the incorrect injection site. They were given too high and to far to the outer thigh, almost over the greater trochanter. Patient developed fever of 101.3F same day, crying inconsolably, and unable to bear weight on left leg. Injection site swollen and red. MOTRIN was given. Patient seen in ER same day.
This spontaneous report as received from a nurse refers to a 10 months 7 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
She had an allergy from latex and gums are swollen; lips were tiny bit swollen; latex allergy; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A week after patient was vaccinated, she had an allergy from latex and gums were swollen on Dec2020. She said it was mild and her question was if she can still take the second dose of the Covid vaccine this week. She have an allergy to Latex but its a very mild one, her lips were tiny bit swollen and gums were a little swollen on Dec2020. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Information has been received from a registered nurse concerning three siblings who were vaccinated with varicella vaccine. The registered nurse reported that the three siblings broke out in a milder form of chicken pox than their brother. The registered nurse also reported on the three sibling's brother who experienced an event following vaccination with varicella vaccine. Further info has been requested.
Moderate to severe swelling of the left subclavicular lymph node and armpit lymph node. Swelling impacted range of motion. The areas were tender to touch and motion. Swelling lasted 3 days.
Nauseous, hot, cold, and headaches.  Site tender, but no rash or anything.
Janssen COVID-19 Vaccine EUA  headache, fever, chills, nausea
localized reaction at injection site.  began 5 days after injection.  redness, tenderness, warmth, itching, swelling approx. size 3inx3in. worsening over the 3 days prior to eval.  Treated for cellulitis and vaccine reaction with Keflex, Pepcid and zyrtec, cool compresses
It was Pfizer SARSCOV2 VAC, EWO172 8-31-21 per the vaccination card.  This was my 2nd vaccine.  My 1st vaccine only had a sore arm at shot for 24 hours.  2nd vaccine started with a really sore spot at the shot area (lasted 48 hours).  Then I felt very fatigued and went to bed at 6 pm.  I woke up every time that I rolled onto the arm that had the shot (left side).  I switched between cold and hot all day (4/28/21) like a fever, felt very fatigued all day and went to bed at 6 pm. Then woke up around 2 am (4/29/21) with diarreah  and nausea.  Did not vomit.  Had Diarreah again for that morning but good now (4/29/21) at 4 pm.
c/o sore arm, & dark red part of arm between elbow & shoulder;red area hot to touch;pt did not take temp but did not think ran a temp;redness & soreness lasted 5 days starting 12hrs p/shot given;also had a blotchy rash on trunk;itchy-welt
10-28-11 Influenza vaccine administered approximately 1030-11am. TC from patient at 355pm reporting hives on abdomen & slight SOB. Referred to ER. ER - lip & throat swelling & above s/s. TX: steroid injection, ZYRTEC, BENADRYL; observed x 3hrs. & discharged.
itching here or there; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching here or there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching here or there). At the time of the report, PRURITUS (itching here or there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided.  Reporters daughter  just had a bit of itching here or there.   No treatment medication details was provided.   This case was linked to MOD-2022-476307 (Patient Link).
Headache, temp up to 102.4 for three days, loose stool, frequent urination, loss of appetite, mild hallucination, inability to urinate, pain during urination
nausea, stomach pain, vomiting, fever, body aches, headache. Vomiting in night. Other symptoms all night and following day
Patient reports arm swelling to twice its normal size as well as arm turning scarlet red and hot (to touch). Patient required ER visit and was treated with Antihistamines, according to patient. Patient returned to pharmacy days later to report what occured. Arm still showed large bruising around bicep. Patient reports none of the swelling or bruising occured at actual injection site.
Initial report was received on 07 May 2012 from another manufacturer national service center (service request number 1-5116970150), who received the report from a consumer, who is also the patient's parent. A female patient who was a "four to five month-old" infant at the time of the event (date of birth not report) with an unreported past medical history had received a first dose of "DTAP" vaccine (manufacturer, lot number, route, site and date of administration were not reported) and an unspecified amount of time later, lost of use of her legs, could not stand, was throwing up and experienced a rash all over. No further information was provided at the time of the report. The patient did not die, no further outcome was reported. Documents held by sender: none.
This spontaneous report as received from a nurse practitioner via company representative refers to a 61 year old female patient. The patient's concurrent conditions, pertinent medical history and concomitant medications were not reported. On 29-MAR-2016, the patient was vaccinated with ZOSTAVAX. On an unknown date in 2016 (reported as a couple of days after vaccination), she felt "pins and needles as well as numbness" over unspecified portion of her body. On 30-APR-2016, she was seen in emergency room and was diagnosed with "paresthesia and a possible reaction to ZOSTAVAX". She was not hospitalized. At the time of reporting unspecified "labs were good" and the patient was still "feeling weird body feeling" (not recovered). The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
patient received flublock quad 2020-21 on morning of 9/28/20. he called later that afternoon with confusing speech saying the shot made him talk funny. i asked him what did he mean by talk funny? He said he didn't know how to describe it but it was making him talk funny. He was talking in incomplete sentences. I told him  that wasn't a normal reaction to a flu shot, thinking something else was wrong with him. I asked him if he felt his mouth, tongue or throat swelling and he said it could be. I told him I was asking because he would have to go to emergency care if so. He was still talking strange and said he was going to the emergency room. I told him to call us back after going to ER. I called him before closing that day, he didm't answer. I called following day:first time no answer, left voicemail.The second time he answered the phone and said he was busy driving and would call me back to explain what happened. He never called before I left for the day. I left his info for other rph in case he called back. On 10/2/20 on arrival back to work I called him again and was able to speak with him. He  said he's doing well now, but that was a very scary experience and that never happened to him before. he said his face, mouth, lips and hands had swollen and he was itching all over his body. They gave him meds at hospital to reverse the effects but he wasnt sure what they were.
off label use; Booster; Vomiting; This is a non-interventional study report from contactable consumer (patient himself) received via the marketing program by Regulatory Authority. This is a solicited report based on the information received by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4149632-00.  A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported) via an intramuscular route on unspecified date in 2021 (age at the time of vaccination was 77 years old) as Dose 3 (Booster), Single for Covid-19 immunization (reported as Covid-19 vaccination) and upadacitinib (RINVOQ) via oral route from 03Mar2021 to 03Mar2021 for unknown dose taken for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient previously received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via intramuscular route on 03Mar2021 (age at the time of vaccination was 77 years old) as Dose 1, Single and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via intramuscular route on 20Apr2021 (age at the time of vaccination was 77 years old) as Dose 2, Single, both doses for Covid-19 immunization. On unknown date in 2021, the patient had experienced vomiting after he had booster shot. Action taken with upadacitinib (RINVOQ) was reported as unknown. The outcome of the event vomiting was unknown.  The reporter's assessment of the causal relationship of vomiting with Rinvoq (Upadacitinib) was not provided.  The reporter's assessment of the causal relationship of vomiting with the suspect bnt162b2 was reported as Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events immunisation, off label use, vomiting and the suspect drug "BNT162B2" cannot be completely excluded.
After receiving the vaccine, patient called an a few hours later and said he was experiencing 10/10 pain. On 12/12/2020, patient comes into the pharmacy to say that his pain was horrible and he had to take some codeine tablets and the pain was radiating to his shoulder.
Severe Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 24Apr2021 at 10:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones.  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 included paracetamol (TYLENOL) and salicylamide/ caffeine/ acetylsalicylic acid (EXCEDRIN); both for an unknown indication from an unknown dates and unknown if ongoing. The patient previously took ciprofloxacin (CIPRO) and levofloxacin (LEVAQUIN) for an unknown indication on an unknown dates and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN8730) via an unspecified route of administration in the left arm on 03Apr2021 at10:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 11:45, the patient experienced severe headache. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient was given a 0.5 ml pediatric dose of Hepatitis A vaccine by human error. RN administered a second 0.5 ml pediatric Hepatitis A vaccine dose.
Patient called and reported that approximately 48 hours after receiving the influenza vaccine, he developed hives on his left arm that traveled up his neck to his face.
At the time of my vaccine I was 8 weeks and 5 days pregnant.  A few days after my vaccine, I went to hospital 05-09-2021 with pain on my abdomen, and the pain migrated down more, like I had a blockage from being dehydrated.   At the hospital they did an ultrasound and MRI and performed lab work.  My abdomen was fine by the next day.  My EDD: 12-10-2021.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB lot number was L045117 and expiration date of 06-OCT-2018(strength, route of administration and dose were not reported) which was stored at 49 Fahrenheit Degree for 8 hours and 9 Fahrenheit for 39 hours and 20 minutes. Then, the vaccines were back in range. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Fever, faced flushed, joint aches, esp between rt hip and need, started in thigh muscle but by next day moved to nerve.  Made it hard to walk had to take pain meds to be able to walk.  Still having problems today. Went to a massage therapy session.  Nurse said it was prob. just a coincidence.
Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 05Feb2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, fibromyalgia, sleep apnea. The patient was not diagnosed with COVID prior to the vaccination. The patient had no known allergies. Concomitant medications included hydrochlorothiazide/valsartan, celecoxib, duloxetine. There were no other vaccines administered within 4 weeks of the vaccination. On 06Feb2021 at 06:00, the morning after the vaccination, the patient experienced chills, headache, and muscle aches. The patient was treated for the events with 600 mg of ibuprofen and the symptoms subsided. Since the vaccination, the patient was not tested for COVID. The clinical outcome of chills, headache, and muscle aches was resolving.  Information on the lot/batch number has been requested.
Information has been received from a physician, via a company representative, concerning a 25 year old female patient, who on 10-DEC-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot # nor reported). There was no concomitant medication. On the same day, the patient developed a lump at the injection site. At then time of this report, the outcome of the event was unknown. The patient sought out unspecified medical attention. Additional information has been requested. 04/07/2008 Initial and follow up information has been received from a physician, concerning a 25 year old female patient, an office manager, with a penicillin allergy, who on 10-DEC-2007, at 5:10 pm, was vaccinated in the right deltoid muscle with the first dose, 0.5 ml, of GARDASIL (lot # 657868/0523U). There was no concomitant medication. There was no illness at the time of vaccination. At 11:00 that night, the patient had developed a slight lump at the injection site, that "was a little tender". After approximately 2 weeks, the symptoms had resolved. The patient intended to pursue the second vaccination with GARDASIL. Additional information is not expected.
Pt was nervous before getting shot.  After receiving shot he was in a monitor area.  He raised hand and stated he felt weak.  He was pale and diaphoretic.  Helped him to ground and allowed to rest. Felt better. Pt evaluated by paramedics. VS @ 1107 HR 68, OxSat 99%, BP 96/47.  @1115 Sit in chair.  BP 104/56, HR 70, OxSat 100%.  @ 11:45 Pt ambulated w/o difficulty.  Taking bus home.  Told to call nurse when he arrives home.