chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT PRESENT FOR 2ND PFIZER VACCINE, 3 MINUTES AFTER RECEIVING  THE VACCINE  PATIENT EXPERINCED SYNCOPE.  PT WAS PLACED  ON HER BACK AND FEET ELEVATED.  PT REGAINED CONSCIOUSNESS AFTER ABOUT A SECOND. PT REPORTED NOT HAVING ANYTHING TO EAT OR DRINK BEFORE APPOINTMENT. BLOOD PRESSURE WAS TAKEN  (200/105) AND SHE WAS GIVEN A BOTTLE OF ORANGE JUICE. AMBULANCE ARRIVED IN LESS THAN 10 MINUTES. PT WAS TAKEN TO THE EMERGENY ROOM.
Pt recvd 3 dose of Hep B vax & 3 minutes p/inject pt exp numbness in extremities, hot flashes & SOB; tx DPH;
Pt given Rotateq vaccine PO 10/02/06. Pt diagnosed with intussusception 10/08/06 and had surgical reduction 10/09/2006.  11/16/06 Received medical records from hospital which reveal patient had history of 3 days of vomiting & 1 day of blood tinged stool prior to admission on 10/9/06.  Afebrile. Air enema success only at ileocecal valve & was taken to OR for reduction of intussusception.  Developed post op ileus which resolved & progressed to stable status.  D/C to home on 10/12.  D/C Dx: S/P intussusception, surgically resolved./ss
10/7/14 - WCC with imm. given. Foster mother called 10/20/2014 stating patient developed a rash on 10/18, described as fine sm. red bumps on her torso and buttocks. Noted that area (R) lateral thigh where varicella immunization given 10/7 was bright red at this time.
This spontaneous report was received from a nurse practitioner (also reported as "nurse prescriber") via a field representative, concerning an anonymous patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), for prophylaxis. Then, after GARDASIL 9 administration, the patient experienced chronic pain and increased of vaginal bleeding (dates unspecified); and finally was diagnosed with polycystic ovary disease. No product quality complaint (PQC) was involved. The outcome of the polycystic ovary disease was not reported. The causal relationship between the polycystic ovary disease and the GARDASIL 9 was not provided.
Redness, bumps, minor burning pain limited to forehead and chin.  Pt washed hair and applied lotion to mitigate the minor burning sensation.  Pt advised he noticed onset at about 6 hours post injection on same day, Saturday, January 2, 2021.  As of this date, burning and bumps have dissipated and redness is only minor.  Photos from Sunday evening, Jan 3, 2021 and Tuesday evening, Jan 5, 2021 showing progression of symptoms, are available upon request.
This spontaneous report as received from a medical assistant refers to a 49 year old female patient. On 22-SEP-2014 (reported as today), the patient was vaccinated with an expired dose of RECOMBIVAX HB (dose number not reported) lot # J014312, expiration date 07-SEP-2014, 1 ml dose, intramuscular injection the right arm. No adverse effects were reported. No product quality complaint (PQC) involved. Additional information is not expected as no consent for contact was given.
I have had a persistent headache since 1/29/2021. I have been taking Ibuprofen which helps a little, headache still present.  I also had neuropathy in my legs that lasted until 2/2/2021.
pt recv vax 16MAY96 & 23MAY96 pt exp low grade fever 99 & a little rash around the diaper area, face, & legs;f/u stated that this was not an unusual side effect or rxn to the vax;
PT received the Pfizer booster vaccine and flu vaccine , PT described feeling light headed and dizzy about 4 minutes after the vaccine administration, Pt crossed his legs to help ease his symptoms as this has worked in the past. PT vasovagal and regained consciousness about 5 seconds later. Pt states that he felt like he just went to sleep. Pt was provided water at his request. Pt admitted to not eating before receiving the vaccination. Pt stated that he felt fine about 2 minutes after regaining consciousness and waited 30 minutes before leaving the clinic.
I took my daughter, who was 13 at the time, to the pediatrician to get her "vaccines for middle school". I don't know the exact dates, but if I need to, I can get request her files. Once there, the doctor insisted that she get the new GARDASIL shots as well. She had me feeling that if I didn't, I wouldn't be a good mother, etc. Anyway, within a month of getting the shots, my daughter, began to have stomach issues that she never had before. It took me quite a while to connect it with the GARDASIL shots, but I can't think of anything else that it might be. We went to 3 different pediatricians, an allergist, 2 different gynecologists, and a gastroenterologist. All testing came up that she was ok, yet she had constant gastrointestinal issues (especially but not only whenever she ate), extreme fatigue, and migraines. She eats very healthy (has no choice since almost everything including healthy food makes her sick). After reading about the side effects that some girls are having after the shots, it appears that short of the paralysis (thank God), she has so many of what I am reading about. When confronting the doctors about whether it could be or not, they refuse to commit an answer to me. I begged them to stop pushing the shots on all of their patients fearing that someone else will respond the way my daughter has. She is 22 now and has been trying to live with her health issues, but she should not have to because people are making money off of families like mine. I refused to allow my son or younger daughter to get the shots after that and they are in good health. No one in my family has the same issues that my daughter does. I'm at my wits end and don't know what to do or how to help her. I feel as if everyone has given up on her. It's breaking my heart. I feel breaking my heart. I feel powerless. It tried to contact the maker of the drug, Merck, but I couldn't find a place to place my claim and since there are no doctors that will say anything negative about GARDASIL (I cant understand why), they made me feel like I was on the wrong track. But I don't feel as if I am so I'm starting here.
Client sated that within a few minutes of receiving vaccines, she started itching-mostly in face, but also in nose and eyes.
Patient received second dose of Pfizer on June 11th, 2021 and a rash appeared on entire posterior side of back. Patient stated he wanted to come back to Center to get it checked out. Patient also stated that he has a past medical history of hypertension and hyperlipidemia. EMS was called and vitals were taken. EMS advised patient to go to ED and patient complied. BP: 163/108. HR: 86.
Pain, redness, swelling at injection site, 103 fever, chills, aches
EE stated received annual flu vaccine and about 1 hr later her face began to sting/burn and was flushed. Took Benadryl 25 mg at that time.  The next day, had eval itching was reported 1 hr after the flu vaccine across cheeks and chin no forehead involvement. No throat swelling or tongue enlg. Denies any other systemic symptoms.  Impression from ARNP Angioedema-likely from influenza injection, dut to timing onset. Continue Benadryl 25mg po qhs add Claritin 10mg 1 po q am until erythema resolved.  EE was also instructed to follow up with her PCP, since she has been told in the past she needed allergy testing. Strongly recommended she accomplish this prior to next years flu season.  EE denies allergies with history and physical.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 13-JAN-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 32F (0 Celsius) for 104 hours; also there were reported temperature of 27F (-2.7 Celsius) for 1728 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Case number PHEH2015US000667 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 52-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 26 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen instead thought it was thermometer malfunction. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided.
Extreme swelling and pain first evening in upper arm progressing into bicep overnight.  Second day becoming hot and red. Second night into morning, swelling and redness into elbow area.  Had pre-scheduled appointment with oncologist on morning of 2/11/22.  Diagnosed as cellulitis and prescribed Cephalexin 500 mg capsule 1-4x a day.  Went to pick up prescription at same pharmacy where vaccine was administered and was told to report on CDC website.
A lot of pain, in her muscles; Muscle pain symptoms had worsened after the 1st dose; sciatic nerve pain; back pain; 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. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "back surgeries" (unspecified if ongoing), notes: history of 2 back surgeries. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "A lot of pain, in her muscles"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Muscle pain symptoms had worsened after the 1st dose"; SCIATICA (non-serious), outcome "unknown", described as "sciatic nerve pain"; BACK PAIN (non-serious), outcome "unknown", described as "back pain". The events "a lot of pain, in her muscles", "muscle pain symptoms had worsened after the 1st dose", "sciatic nerve pain" and "back pain" were evaluated at the emergency room visit.  Additional information: Patient reported that her muscle pain symptoms have worsened after the 1st dose that she was taken to the emergency room twice. Patient was worried since she was due for her 2nd dose today and has gotten better, but still experiencing back pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Administrator and refers to a 12 months old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 19-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
I'm painful ear ache right ear lasting three days so far; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Jul2021, patient experienced painful earache in right ear, lasting three days so far. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided. On an unknown date, VARIVAX was improperly stored (product storage error). Temperature was 1.1 Celsius degree (C). Time frame was 1 hour and 49 minutes. Previous temperature excursion did not occur. On 25-APR-2023, the patient was vaccinated with VARIVAX (0.5 milliliter (ml), lot# W024335 has been verified to be a valid lot number, expiration date was reported as 31-JUL-2024, but upon internal validation established as 01-AUG-2024, anatomical location was not provided) subcutaneously for prophylaxis after temperature excursion. No additional adverse event (AE) reported (no adverse event).
Presented to office on 1/9/09 c/o "rash".  10 days post vaccination hospital + eruption consistent with H. ZOSTER RT TIV Denmatine treated with ACYCLOVIR 800 mg.
got the shingles after I got the shot / suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got the shingles after he or she got the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Off-cycle menstruation.   Period came 2 weeks early.   Normally on cycle and very reliable, never had off cycle menstruation previously.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.  It was reported that expired vaccine were given as booster shot to patient. The vaccines were stored in freezer and took out one to two vial and placed in fridge each day as needed.
Strong immune response resulting in triggering ITP, platelet count fell from stable to 22.  Also, elevated liver functions.  Addtionally, 10 days following Dose 1 and Dose 2 an inflammatory flare in the colon.  Inflammatory response may also have resulted in inflammation of eyelids and chronic dry eye disease ie. Blepharitis.
Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient experienced symptoms a day after receiving the vaccine. She went to work and did not feel well. She went home and was unresponsive, her neighbor found her and she was taken to the hospital. At the hospital she was told she had 7 seizure events. She was monitored in the hospital for 2 days. She still does not feel back to normal. Patient stated that she does not get routine vaccinations and is HIV positive.
Pt recvd 3 doses of Engerix-B vax & 2OCT91 found to be a non-seroconverter;
SkinRash, Rash & ErythemaMultiform Narrative:  employee reports skin rash at injection site erythema spreading to entire left upper arm. no itching or swelling. reports taking antihistamine (Claritin) q day, 1% hydrocortizone BID, and applying ice PRN. skin rash improving with treatment.
Lump (nodule, knot, lump) developed Day 15 post-vaccination at MMR injection site. Right arm, subcutaneous. Lump became tender on Day 15 and has continued to grow daily. Day 18 lump throbbing. Roughly 1" in diameter.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 (route, dose and frequency not reported, lot # L033707, expiration date 18-MAY-2017). The total cumulative temperature excursion was reported as 117 minutes in high temperature (49.1 Fahrenheit) and 225 minutes in low temperature (34.1 Fahrenheit) (the total cumulative time in high and low temperature was reported as 342 minutes). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had stepped on a rusty nail on 5/24-had MD order for Td-NO tetanus x40yrs due to prior reaction-Td given within 1 hour experienced trouble breathing, asthma sx's- tightening in throat-had went to Dr office-was given ephinephrine and Decadron IM-watched for 4 hrs-given Zyrtec po x 4 days. 5/27/2004 PHN called pt-experienced sx's x 4-5 hours only improved on 5/25/04 PM
1990: Within one month of the vaccine on 8/21/90 pt changed from a happy baby to a very unhappy baby. He stopped nursing during this time. Rashes started on and off. At 9 months he became very aggressive, angry, nothing pleased him. Having major tantrums. Behavior problems very severe. His doctor continued to tell me that this was not abnormal behavior. 1993: Heart murmur diagnosed. 1994: Vomiting began. Later diagnosed as cyclic vomiting syndrome as no other cause could be found at the time. 1996: Diagnosed with ADHD. Started medications. 2000: Diagnosed with Asbergers syndrome (High functioning autism). 2003: Diagnosed with mercury (thimerosal) poisoning. This is the cause for all of pt's above listed problems. He is currently undergoing chelation therapy.  The medical record received on 4/5/04 states hypertension and kidney dysfunction. Information from Annual Follow-up report states that behavioral problems continues, ADHA problems, mercury continue levels are at 4 times normal levels, amino acid levels in hair are low due to mercury. Patient continues at this time with chelation therapy and nutrition replacement.
Patient noted recurrence of ulcerative colitis symptoms within 2 days of receiving vaccination. Had been nearly one year without symptoms now with 15 bloody diarrhea stools per day.
Both vaccines appeared to have been given subcutaneously as they were not near the patient's deltoid. Vaccines were re-administered. Patient appeared satisified with resolution.
Admitted to hospital 12/21/06 for syncope 1 day after pneumovax injection. Noted to have pain right arm around injection site and erythema and swelling of entire right upper arm extending to elbow area. Syncope likely related to pain in arm. Possible cellulitis right upper arm.  2/2/07 Received medical records from hospital which reveal patient experienced syncopal episode & fall at home w/laceration to back of head.  Right arm where received pneumovax noted to be very tender & painful, very large area of erythema on RUE & low grade fever of 100.  Admitted 12/21-12/22/06.  Tx w/antibiotics & d/c to close f/u. FINAL DX: syncopal episode w/fall; right upper arm erythema & swelling likely vaccine reaction to pneumovax, possible early cellulitis; & HTN.
103 fever; nausea; mouth watering; body aches; chills; difficulty focusing; headache; nerve pain; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: Er8732), via an unspecified route of administration, administered in left arm on 31Mar2021 at 17:00 (age at vaccination was 35-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included HSV2 (Herpes simplex virus 2). The patient's concomitant medications included ibuprofen from an unspecified date and unknown indication. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: En6206), via an unspecified route of administration, administered in left arm on 10Mar2021 at 17:00 (age at vaccination was 35-year-old) as dose 1, single for COVID-19 immunization and experienced left arm swelling; numbness of left arm, neck, and lower left quarter of face; and extreme lethargy. The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 01Apr2021, the patient experienced nausea, mouth watering, body aches, chills, and difficulty focusing; all at 06:00, and 103 fever on 17:00 while headache and nerve pain on Apr2021. It was further reported that 18 hours later from vaccination the nausea has become extreme and 24 hours later from vaccination, 103 fever was experienced. Also, after taking both of ibuprofen and paracetamol (TYLENOL), headache and nerve pain was experienced. Therapeutic measures were taken as a result of the events (nausea, mouth watering, body aches, chills, difficulty focusing and 103 fever) included treatment with paracetamol while no treatment for other events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L043703, expiration date 03-NOV-2017, lot # M007277, expiration date 09-FEB-2018, lot # reported as M017347, expiration date 06-APR-2018 and lot # L041457, expiration date 22-OCT-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of M-M-R II were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.