chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 06 October 2009 from a health care professional. A 17-year-old female patient, who has asthma and no prior obstetrical history or allergies, had received a 0.5 mL intramuscular right deltoid injection of ADACEL (lot number C3248AA); a 0.5 mL intramuscular right deltoid injection of MENACTRA (lot number U2686AA); and an intramuscular left deltoid injection of GARDASIL (manufacturer Merck, lot number 1446U) on 24 August 2009. The patient was taking PYRIDOXINE for nausea (etiology not reported) at the time of this report; however the reporter indicated the patient had not experienced any adverse events since being vaccinated on 24 August 2009. The patient denied being sexually active at the time of the vaccinations, but was subsequently found to be pregnant with a last menstrual period date of 19 August 2009. Expected date of delivery was not reported. The patient has denied any smoking, alcohol use, or recreational drug use during this pregnancy. The recovery status for the event of nausea was not reported. Follow-up information received 30 October 2009 from a health care professional who provided contact information for the obstetrician overseeing the patient's care. No additional information was provided, and the patient's recovery status was not reported. Follow-up information received 14 December 2009 from a health care professional. The patient's last menstrual period was 18 August 2009. Estimated date of delivery is 25 May 2010. An ultrasound on 05 November 2009 was normal. Prenatal labs on 19 November 2009 were within normal limits. The reporter indicated that the patient was a healthy 17-year-old who had not experienced any adverse events. Follow-up information received from a physician on 27 September 2010. The patient delivered a single live male baby on 18 May 2010 at 39 weeks gestation via Cesarean section. The baby weighed 3 Kg (also reported as 87 3/4?) and his Apgar scores were 7 at one minute and 9 at five minutes. The baby had no congenital anomalies. All prenatal testing was normal. There were no complications of pregnancy and or labor and delivery. Per the reporter, the patient did not experience any adverse events. The patient recovered from the nausea (date not reported). Follow-up information was received from a physician on 22 October 2010. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. The patient was reported to have had pre-eclampsia. The cesarean section was performed due to the "failure on descent" of the fetal head. No further information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: None.
Client had varicella like rash (approximately 30 lesions) 20 days after vaccination, 1 on 12/07/2005.  Diagnosed with chickenpox at ER on 12/27/2005.
Initial soreness inj site as was informed as potential. No erythema, edema, induration, bruising or signs of infection. Continued pain which has increased becoming constant and worse with arm use.
4-5hr p/vax pt cried all evening & noc;would fall asleep & awaken screaming, t100, APAP given 3x;
Had a seizure after getting their vaccine; This is a spontaneous report from a non-contactable other HCP. A patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), UNKNOWN, SINGLE for covid-19 immunisation. The patient had a seizure getting vaccine. The patient reportedly had a known seizure problem. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt recvd vax 25OCT95 & started to feel uncomfortable about 2hrs p/shots;arm was sore (lt arm swollen from middle to elbow, reddened, warm to touch) yesterday had fever, aches;took APAP; had no relief;
Had IZ on 4-9-09 04-11-09 2/3 of upper thigh around injection site - was red, swollen and child refused to walk. Was not itchy. Was given BENDARYL in ER without any change. Was sent home with antibiotics (KEFLEX and SEPTRA) - Seen again 4-13-09 and much improved.
This case is one of a cluster of two patients who experienced adverse events following administration of FLUZONE, lot number UH476AB. The events for the other patient were captured in case 2011-09913. Initial report was received on 12 October 2011 from a patient. A 58-year-old male patient had received on 08 October 2011 an intramuscular injection in left deltoid of FLUZONE. On 11 October 2011, the patient experienced fever, diarrhea, generalized body aches and pains which came on sudden. No further information was available at the time of the report. The patient's outcome was reported as unknown. Follow-up information was received from a healthcare professional on 30 January 2012. Verbatim: "Upon future exploration we found that other people we know (work with/associate) were hit with the same symptoms in the month before and since October they did not have a flu shot, so we tend to believe that our illness was not related to the shot, but the intestinal bug that has been prevalent. Ours just coincidentally occurred following the flu shot". The patient outcome was reported as recovered/resolved on 13 November 2011. Documents held by sender: none.
2 hours after vaccination my left arm from elbow to mid neck was extremely sore. Took Tylenol and used ice pack. I was very fatigued. Woke up with chills. The arm soreness and fatigue continued for 3 days. Soreness in left breast and under arm began 3 days after vaccination and I developed a sore throat on upper palate to the back of my throat which continues through today, day 6. Yesterday evening, day 5, I developed a large cold sore below my left lower lip. Still fatigued.
Shingles diagnosed at local Urgent Care on 6/25/2019.  Rash and blisters on upper left chest just next to injection site.
Afib, right hand freezes up, increase medication and started Xarelto. Will later get a pacemaker to offset Afib
AFIB, 3 trips to ER due to shortness of breath.  Amiodarone Hydrochloride for heart, Eliquis for blood thinner.
Information has been received from two physicians concerning a 5 year old male who on 18-APR-2007 was vaccinated with a dose of ProQuad and a dose of Varivax  on the same day. It was reported that the patient received ProQuad instead of MMRII. Unspecified medical attention was sought. No symptoms were noted. It was reported that this was a nursing error and not related to the vaccine. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Seizures several times throughout the day; This case was reported by a consumer via call center representative and described the occurrence of seizure in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   On 9th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season and Havrix. On 13th September 2019, 4 days after receiving Fluarix Quadrivalent 2019-2020 season and Havrix, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was not recovered/not resolved.   It was unknown if the reporter considered the seizure to be related to Fluarix Quadrivalent 2019-2020 season and Havrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Fluarix and Havrix, four days later she started having seizures several times throughout the day. On 17th September 2019, her Pediatrician refers her to a Pediatric Neurologist. She visited an emergency room (ER) on 18th September 2019, where she received no treatment or test but an appointment for next day to see the Neurologist. On 19th September 2019, she finally visited the Neurologist, she had no medication just an appointment for an EEG on 22nd October 2019. The patient's symptoms get worsened every day.
Urticarial rxn, no arthralgias, bitten on 10AUG91 tx 6SEP91, 8SEP91; given DPH & 1 course of Cortisone;
On Jan 29th I started experiencing burning hands, hives and rashes multiple times a day. Im not positive it is linked but I have never experienced hives or rashes before. It is ongoing now for over 5 weeks.
I gave the patient a Pfizer COVID-19 vaccine after confirming the patient had not received any previous doses of the vaccine verbally and from the consent form. After processing the vaccine, I could see that they had already gotten a Moderna COVID-19 vaccine from another pharmacy on 4/20/21.  The patient denies getting the Moderna vaccine.
Erythema, warmth, edema to (L) Humerus 7cm x 11cm.
After my vaccine, I have a head pressure or headache everyday. I have been to my family doctor, I had my 2 discs removed but didn't help. I am now seeing a neurologist and ear and nose and throat doctor to figure out what's going on my headaches.
Pain and swelling at injection site. Pt couldn't lift arm over 90'. Very painful and weak for 3 days.
face was swollen as well as her head, tongue and eyes which were shut closed; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 1-month-old female patient who received Hepatitis B vaccine for prophylaxis.   On 17th August 2020, the patient received Hepatitis B vaccine. On 17th August 2020 21:30, less than a day after receiving Hepatitis B vaccine, the patient experienced facial swelling (serious criteria hospitalization). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Hepatitis B vaccine.  Additional details were reported as follows: The patient received 2nd dose of a Hep B vaccine on monday, 17th August 2020 but the patient's mother was unsure if it was Engerix.B and about 9:30 that evening, her husband noticed the left side of the baby's face was swollen as well as her head, tongue and eyes which were shut closed.  The patient was hospitalized thinking it was an allergic reaction.  She was given Benadryl which reduced the swelling.  However, the hospital ruled out an allergic reaction because her entire face wasn't swollen.  She was admitted to the hospital for testing and remains there at the time of reporting.  She was started on an antibiotic in case it was an infection but later her blood work indicated there was no infection.  The reporter did not consent to follow-up.
Patient came in this evening from visit with her doctor with a prednisone dospak, 6 day... loratadine tabs and a albuterol inhaler.  Stated  her right side of her face went numb and her right eye began to swell.  also stated her skin was blotchy all over and later in the evening (3/31)  had very labored breathing.
pt recvd 4 doses of Engerix-B; tested weakly pos in JAN92 & in APR92 titer was 0;
pt recv vax 18NOV92 & the same day exp allergies, learning difficulties & stopped talking; no further info provided
had fever; had chills; had myalgia; only the bilateral hip pain did not not go away after 2nd dose; This case was reported by a pharmacist and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received the 1st dose of Shingrix. On 9th December 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, myalgia and pain in hip. On an unknown date, the outcome of the fever, chills, myalgia and pain in hip were recovered/resolved.   It was unknown if the reporter considered the fever, chills, myalgia and pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that they developed fever, chills, myalgias and bilateral hip pain. For the tolerability of 2nd dose, refer case US2020AMR063465 reported for same patient.
Was fine after shot @ 10:00 am, then became very fussy @ 13:45pm. On Tylenol every 3 hours. Doing well since 05:00 am 7/14/06. Did do Tylenol every 3 hours during night.
Pt received first dose and within minutes stated she had a burning sensation from the site of injection up neck to her lower hairline.  Pt did not have swelling/shortness of breath, etc.  Pt was given Benadryl 25mg, water, crackers, and cool compress. Symptoms resolved within about 30 minutes.
Felt dizzy, faint, and hot after 2nd vaccine.   Nurse sat with her until she felt better.    5/14/21, she had an acute ischemic stroke.  Many tests ran during 4 day hospital stay including CT scan, MRI, several blood tests, echocardiogram, TEE heart test.  Discovered vegetation in heart that they decided must have broken off and caused the stroke that killed about a third of the right side of her brain and there was one time spot on the left side of her brain.  Had loss of strength and mobility in upper left side of body (mainly left hand and left side of face).   Discharge papers gave diagnosis of acute ischemic stroke and Libman Sacks endocarditis.   Blood tests have shown that there was no infection that caused problems.   Have been unable to determine cause.
This spontaneous report was received from a registered nurse refers to a patient of unknown demography. On an unknown date, an unspecified number of patients were administered the second dose in the GARDASIL series more than 2 months after the first dose of GARDASIL (0.5 ml) intramuscular. No adverse event was reported by the reporter. Additional information has been requested.
Right thigh swelling, pain and itching, started evening of administration. Seen in clinic next day - started BENADRYL, cool compress. Increased next day and started prednisone.
My period came a week early and had super painful cramps. I never get cramps and my period has always been at the same time frame between 1-2 days.
cried 2 1/2-3 hrs (3P-6P), occasionally high-pitched, not consolable; was also very gassy; no fever noted was crabby afterwards, but fine the following day; used APAP;
Arm became numb and painful. Had pain in arm and surrounding lymph glands and could not raise arm. Symptoms lasted 2-3 days.
Experienced appendicitis 3 weeks post first vaccine dose.  Treatment was an emergency appendectomy about 6 hours after diagnosis.
Case number PHEH2014US007525 is an initial spontaneous report received from a nurse on 14 Apr 2014. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He inadvertently received an intramuscular dose of MenA lyophilized powder component of MENVEO (batch number: M13059) mixed with MENACTRA (batch number: not reported) on 14 Apr 2014 and did not receive the MenCYW-135 liquid conjugate. The reporter stated that they pulled out a MENVEO powder and MENACTRA since it was accidentally placed in the box with the MENVEO liquid components. The reporter stated that she was sure that maladministration occurred.  No revaccination occurred till the time of reporting.
Infant received 2mo immunizations 1/18/12 at 115pm at health department, later in day lethargic. Mom unable to wake infant, calls Dr nurse sends to ER at 5pm. ER examines child and sends home with normal exam. Mom calls 1100am 1/19/12 same s/s. Infant ate only 2oz formula since 12 1/18/12. Sent infant back to ER for exam and evaluation.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (172086).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. He had to get monoclonal antibodies. Told he has to wait three months until he can get his COVID-19 vaccine booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200695911 Same product and event, different patient
Patient contacted the clinic 12/27/2018 and reports developed widespread rash all over body with itching and body aches. This was around 2 weeks after her vaccines were administered. Denied any resp symptoms. Pt was taking BENADRYL for symptoms with no improvement. Pt was advised to continue with antihistamine as needed and advised could follow up with PCP if no improvement and reviewed ER precautions. Verified with nurse practitioner at clinic that this can be a side effect of both MMR and varicella and is listed on the VIS. Pt was notified. Called patient 1/2/2019 for follow up. She reported that the symptoms completely resolved in around 2 days and currently having no symptoms.
Skin rash bilaterally from knees to ankles, flat, red BB size without itchiness, lasting 3 weeks.  Second MMR given 1/4/12 rash started sooner and was from hips to ankles with same symptoms.  No other systemic symptoms.
Patient became pale and unresponsive which was followed by generalized seizure activity (tonic-clonic jerking movements) with apnea, urinary incontinence. Event followed by brief postictal period with apparent full recovery
Arm was a little itchy after the shot; Redness in the same are as the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm was a little itchy after the shot) and INJECTION SITE ERYTHEMA (Redness in the same are as the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (Arm was a little itchy after the shot) and INJECTION SITE ERYTHEMA (Redness in the same are as the injection site). At the time of the report, PRURITUS (Arm was a little itchy after the shot) and INJECTION SITE ERYTHEMA (Redness in the same are as the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-Significant follow-up
Two patients received first dose Pfizer Covid Vaccine, second dose expired Moderna Vaccine; 2 patients received 1st dose of Moderna that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received first dose Pfizer Covid Vaccine, second dose expired Moderna Vaccine) and EXPIRED PRODUCT ADMINISTERED (2 patients received 1st dose of Moderna that was expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received first dose Pfizer Covid Vaccine, second dose expired Moderna Vaccine) and EXPIRED PRODUCT ADMINISTERED (2 patients received 1st dose of Moderna that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received first dose Pfizer Covid Vaccine, second dose expired Moderna Vaccine) and EXPIRED PRODUCT ADMINISTERED (2 patients received 1st dose of Moderna that was expired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment information was not provided.
The patient was seen in the ED on 9/21/23 with weakness, cough, shortness of breath, generalized weakness, fever, and chills over the past few days. Generalized weakness has been worsening and it became difficult for the patient to get up and ambulate or take care of himself. A COVID PCR test resulted positive in the ED. Ultimately, the patient was admitted 9/21/23 - 9/25/23. During admission, the patient received supported cares for his symptoms. Discharge diagnoses included COVID-19 infection, among other diagnoses. Of note, the patient has received the primary COVID vaccine series and two boosters.
Fever; Chills; Body aches; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-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 22Apr2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and thyroidectomy. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN). Past medical history included penicillin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 15:45 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 23Apr2021 at 10:00, the patient experienced fever, chills, body aches, dizziness and nausea. On 23Apr2021 at 10:00, the body temperature was reported as 102 degrees Fahrenheit. The clinical outcome of the events fever, chills, body aches, dizziness and nausea were recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients (reported as approximately 50) of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since 24-OCT-2016 (it was also the date of the temperature excursion), the patients were subcutaneously vaccinated with the improperly stored doses of VARIVAX (for prophylaxis; lot # M030138 with expiration date 15-JUN-2018, lot # L049532 with expiration date 08-DEC-2017 and lot # M014916 with expiration date 25-MAR-2018; dose was not reported). No adverse effects were noted. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014016.
dizziness and vertigo with   change of position,    improving with use of meclizine
Patient noticed discoloration of skin on both the arms on 9/8/14. Feel sore in arms.