chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female, who on 17-APR-2007 was vaccinated with a first dose of Gardasil (lot#656051/0224U). Concomitant suspect vaccinations received on 17-APR-2007 included Varivax and Vaqta (manufacturer unknown). Other concomitant therapy included DTaP (unspecified) (+) tetanus toxoid. Subsequently, after being vaccinated with a first dose of Gardasil (lot#656051/0224U) the patient fainted a few minutes after administration. It was also reported that when the patient was vaccinated with a second dose of Gardasil (lot#657868/0523U), 15 minutes later the patient experienced light headedness, nausea, and a headache. The physician reported that "the patient got well" on the same day that she received the first and second dose. The patient sought unspecified medical attention. No product quality complaint was involved. Additional information has been requested.
No additional AE reported; patient was accidently administered PROQUAD instead of MMR II; that patient was accidently administered PROQUAD at 36 years old; This spontaneous report has been received from a medical assistant to a 36 years old female patient. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.     The patient had lab work done and her titers said that she needed measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On 31-MAY-2022, the patient was accidently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U029322, expiration date 19-MAR-2023) instead (wrong vaccine administered and inappropriate age at vaccine administration). No additional adverse events (AE) reported.
About 8 hours post vaccine, at 2300 as I was going to bed I felt what I would describe as breathing resistance. I would not describe it as chest pain/pressure/tightness or SOB. It was just upper chest resistance to inhalation when lying down for bed. 12/24 started with intermittent gnawing epigastric during the day.  Persisted through the night with gnawing epigastric pain radiating through to my spine, i was unable to sleep due to the pain.  Attempted tums (I do not have GERD), motrin & tylenol however, nothing was helpful.  12/25 & 12/26  same symptoms persisted both day and night 12/27 asymptomatic  12/28 cramping/twisting epigastric pain returned, much more mild
This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX. On 20th February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 20th February 2018, the patient experienced fever. The patient was treated with BENADRYL. On an unknown date, the outcome of the fever, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the fever, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported via live chat. On 20th February 2018, less than a day after receiving SHINGRIX, the patient was feverish at night. The site of injection was red about 2 inches and swollen.
facial drooping/ Right Sided Bell's Palsy/ All the right side of his face is not moving; swollen face; his tongue feeling fat; sore and swollen area behind his left ear on his neck; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of the Pfizer Covid19 Vaccine, (Formulation: Solution for injection, Batch/Lot number were UNKNOWN) via an unspecified route of administration on 13Mar2021 as a single a dose for covid-19 vaccination. Patient medical history included, Right Sided Bell's Palsy. Concomitant medications were unknown.  On 15Mar2021, the patient was sent to the ER. Monday morning after experiencing symptoms the night before and the morning of such as his tongue feeling fat. He was tested for Lyme's disease which came back negative and was diagnosed with Right Sided Bell's Palsy. The patient was discharged that day after 3 hours and was prescribed with prescribed with Prednisone and Valtrex. Up until now, the patient still has symptoms such as numbness, tingling, blurry vision, on and off headaches, a swollen face, facial drooping, his tongue feeling fat, difficulty in swallowing and talking, drooling, and a sore and swollen area behind his left ear on his neck. All the right side of his face was not moving. The patient received physical therapy 3 times as of calling. He was supposed to receive his second dose this Saturday and is contemplating as their doctors have not given them a straight answer. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Patient received Td vaccine on 04/27/07; on 04/28/07 called the doctor's office and complained of swollen nodule at the injection site which progressed to become red and warm to the touch. Patient was recommended to take Benadryl. Patient called doctor's office on 05/01/07 to say that the redness went away and that there was just a slight nodule. Patient was told to call back in one week if the nodule does not completely dissipate.
Woke up about 7 hours after receiving vaccine with violent shaking or shivering almost like a seizure except was alert and oriented and could hold conversation. Every part of body was shaking so hard the whole bed was moving. Lasted about a full hour. Was ready to go to hospital when the shaking died down to flu-like shakes which lasted on and off for the next 24 hours. Felt incredibly sick and exhausted for next three days.
Case number PHEH2014US012925 is an initial spontaneous report received from the pharmacist on 19 Jun 2014. This report refers to a 17 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X12004, expiry date: Oct 2014) on 18 Jun 2014. It was reported that she received partial dose of MENVEO from the Men CYW-135 vial alone and she did not receive Men A lyophilized conjugate. No adverse event reported after the maladministration.
First of all, I do not know the drug company or lot number for this vaccine that was administered. I had the vaccine about 2 pm and around midnight, I woke up with feeling weak, shivering, and chills, which seemed to go a long time. When I woke up in the morning I was very weak and had a very bad headache that was above my eyes, forehead and back of the head and neck area. This lasted all day, along with the continued weakness. I vomited two times, and could not eat, but did drink water. Then I woke up this morning with continued headache and now have a really red rash around my eyes, and on most of my face, neck, and chest. It is now 11:30 am, and finally the headache has gone away, but I still have the rash and am tired.
Pt stated that she had started to feel itchiness on the right side of her jaw, throat and on her tongue just after getting the vaccine.
pt recvd vax & approx 44 to 6 wks later devel a false positive result to a Mantoux skin test;No further details were provided;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by a physician assistant for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
None stated. 7/15/08-records received dor DOS 6/30/08-DX:adverse vaccine reaction. monitored overnight. Presented to ED in afternoon with C/O pale, shaky and not acting normally per parents. Fussy.
ON 1-7-2022 AT BREAKTHROUGH RECOVERY, PATIENT REPORTED SHE HAD NEVER RECEIVED A COVID VACCINE. SHE CONFIRMED 3 TIMES THIS WAS HER FIRST TIME RECEIVING A COVID VACCINE. I EXPLAINED TO HER THAT SHE WOULD BE RECEIVING HER FIRST OF TWO DOSES OF MODERNA. I EXPLAINED MOST COMMON SIDE EFFECTS/DURATION. SHE EXPRESSED UNDERSTANDING AND WAS TOLD SHE SHOULD RECEIVE HER SECOND DOSE IN THE SERIES IN 28 DAYS OR 4 WEEKS. UPON ENTERING VACCINE ADMINISTRATION INFORMATION INTO GRITS, I DISCOVERED SHE WAS FULLY VACCINATED (2 FULL  DOSES + BOOSTER).
CHARLEY HORSE IN CALVES; CLOTHES FELT WET WHEN THEY TOUCH BODY; FEELS WARM/CANNOT FEEL THE COLDNESS; LEGS FEEL FUNNY; MUSCLE ACHES; BURNING SENSATION; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 210 pounds, and height was 67 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-OCT-2021, the patient experienced burning sensation. On an unspecified date, the patient experienced charley horse in calves, clothes felt wet when they touch body, feels warm/cannot feel the coldness, legs feel funny, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation, and the outcome of muscle aches, charley horse in calves, clothes felt wet when they touch body, feels warm/cannot feel the coldness and legs feel funny was not reported. This report was non-serious.
Rash on injected arm, sore lymph nodes, sore throat, muscles achy a week after shot
Left side of face numbness (Bells Palsy) unable to close eye lid, tongue numbness, lip numbness, patient went to ER given Prednisone, antiviral per patient getting better still has some symptoms. Patient delivered 12/19/09.
I immediately felt sharp pain and burning in my arm while being injected. The burning in my arm lasted for about 20 minutes. I got a severe migraine about an hour after the vaccine that lasted for about ten hours.  I broke out in hives all over my body later that night, the same day as the vaccine. I also had intense heartburn. I never get heartburn so this is not normal for me. The following day, I was still having hives and started also having chest pains. I was consistently taking antihistamines to keep the hives under control. On Saturday morning, 2 days after the vaccine, I was still breaking out in hives. My throat also started to swell and I was having a hard time breathing. My heartburn was also getting more severe. I ended up going to urgent care. There I was prescribed 2 stronger antihistamines and prednisone to help with my reaction. I was also given an epi pen.  Later that night, I ended up going to the ER as I was having severe chest pain. I have a history of DVT so I was concerned about blood clots. I had several tests done along with a chest CT scan. Thankfully everything came back clear for blood clots and heart attack. The ER doctor could not explain why I was having chest pain and advised me to monitor it and to come back in if it got worse. The following day, I was still needing antihistamines for hives and difficulty breathing. I woke up in the middle of the night with severe stomach pain and cramping. I had intense vomiting and diarrhea. The diarrhea started to have a lot of blood in it. I went back urgent care and they sent me for a CT scan which showed I now had colitis. The bleeding lasted for about 3 days.
An old injured right ankle I dislocated when I was 20years old  swelled up and I was unable to walk on for three days. It still is very sore.
Pt. recieved vaccine greater than 12 hours after being drawn up. No adverse event. MD contacted pt. declines revaccination.
Pt had a Bivalent Vaccine administered instead of a Monovalent. recommendations by Manufacturer was to administer a Monovalent as soon as possible. Pt returned in the afternoon and had a Pfizer Monovalent administered. Follow up with patient two days after vaccination and reports no symptoms, only arm pain on site of administration.
Fever; Chills; Headache; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 48-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 28Mar2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and cyclobenzaprine (MANUFACTURER UNKNOWN) for unknown indications from unknown start dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 07Mar2021 at 16:45 (at the age of 48-years-old) 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 vaccination. On 29Mar2021 at 15:00 the patient experienced fever, chills, head ache and body aches. Therapeutic measures were taken as a result of adverse events included treatment with Tylenol. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fever, chills and body aches was recovered on an unspecified date in 2021.  No follow-up attempts are possible. information about lot\batch number cannot be obtained.
Guardian requested patient to have an HPV 9 vaccine. Provider ordered vaccine and vaccine was administered. Upon documentation of HPV 9,  it was noted that patient had already received 2 prior HPV 9 vaccines.  Due to patient's age the series was complete with the 2 prior doses and patient did not need the 3rd HPV 9 that was administered.
Pt woke up experiencing: numb bottom lip on right side, right hand numbness, fingers on right hand tingle, and taste altered. Pt presented today 10/30/12 still having numbness in lip and dexterity issues with right hand and finger.
(URGENT) MULTIPLE  - severe, sharp shooting pain up from left side of neck to upper chest. - Lasted 3 weeks and still will come every now and then.  - 2 day neck stiffness (normal)  - complete immune system break down: Lost partial taste in tongue, developed oral thrush that was resistant to diflucan and nystatin.  - 2 day stint with allergies (Sneezing, stuffy nose, no yellow mucus or fever) - Periodic headaches - swelling of tongue - fatigue lasted weeks.  - easily bruising or bleeding under skin after getting minor scratches. Never healed properly (As in disappear)  -glossy watery, red eyes with swollen nasolacrimal duct (inside pink corner of eye. Puffy and red.)
No adverse reaction occured. However Proquad is not licensed for over the age of 12 years.
tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse reported for a 13-year-old female patient (granddaughter) that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on 10Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Caller Retired RN stated in behalf of her 13 year old granddaughter who received the 1st dose of the Pfizer COVID 19 vaccine- She had the 1st dose on 10Sep2021 and tested positive for COVID on 14Sep2021 - He wants to know if they need to have 90 day period wait before taking the 2nd dose - The patient will have her 2nd dose on 01Oct2021 - Caller also had COVID 19 before and he was advised to wait for 90 days before getting the 2nd dose. On 14Sep2021 the patient underwent for SARS-CoV-2 test and it was reported as positive .The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
low potassium levels; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient herself) reported for female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 09Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient took first dose on February 9th and was scheduled for her second dose on March 2nd. she was currently taking potassium for low potassium levels on 22Feb2021 and would like to know if this is alright. The outcome of event was unknown.  Information on the lot/batch number has been requested.
2 days after 5th DTaP/Varivax given, temperature to 103, vomiting, rash on back of neck.
Approximately 12 hours after injection, noticed a small amount of fatigue.  Approximately 20 hours after injection, noticed my left armpit lymph nodes were extremely swollen, muscle aches as well as moderate joint aches, and a moderate headache.
Lethargic on 10/23/09 and 10/24/2009. Body aches that intensified until 10/25/2009. By 10/27/2009 the aches and lethargy had passed.
Patient observed post vaccine for 9-min when she complained of headache. She has a history of migraines. She sat for a few minutes and had some hydration to which headache resolved.
mild fatigue with onset the day after vaccination lasting 3 days mild sore throat with onset the day after vaccination and lasting for 24 hours
Pt recvd MMR vax on 11OCT90; On approx 21OCT90 pt devel a fever, irritability, vomiting, & ataxia, assoc w/falling, difficulty in walking, & lower extremity weakness; @ time of report, pt's sx persisted but had not worsened;
Patient was on our covid vaccine schedule for "Moderna Booster"  Moderna was accidently given, when patient's first two vaccines were Pfizer.  No adverse reactions or side effects were noted from patient.
Information has been received on 19-FEB-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route on or about 27-APR-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, rather the patient to contract a persistent strain of herpes zoster. On or about 03-SEP-2013, the patient was treated by a physician for the onset of a severe, painful vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for treatment of his painful symptoms. As a direct and proximate result of defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  The vial was punctured on 28DEC2021 at 10 PM and administrated on 29DEC2021 at 10:30 AM - 2:55 PM, and used for up to 17 hours post puncture
tightness in lower neck; tingling lips; This case was reported by a pharmacist via call center representative and described the occurrence of tightness of back muscles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2019, the patient received Shingrix. On 7th May 2019, less than a day after receiving Shingrix, the patient experienced tightness of back muscles and tingling lips. On an unknown date, the outcome of the tightness of back muscles and tingling lips were unknown.   It was unknown if the reporter considered the tightness of back muscles and tingling lips to be related to Shingrix.  Additional details were provided as follows: The patient experienced tightness in her lower neck and tingling lips.
Red itchy rash on stomach, and different points along the back (lower back closest to the side of waist, along the bra line and scapula, spots on the breasts and near armpit.  Some areas have clear raised red spots other are a general itchiness under the skin without red marks but looks a little mottled under the skin.  Seems to get worse as day progresses (by 5pm into the evening) and when I get too warm and perspire.  Began on the 17th with just a few spots of rash and progressed the next day, 18th.  Today the 19th my armpits area began to itch more than previous days.  Almost a slight sense of burning which also reminded me of a light case of shingles.  But it does not look the same as shingles.  It has not shown any sign of diminishing even now on my 3rd day.  I took a Benadryl on the 17th and 18th, it did not seem to make much of a change.  The itchiness is  bothersome, but tolerable without the Benadryl.  I have taken  only 25 mg of benadryl each night to alleviate the itching and to hopefully reduce the redness so I can sleep.
Hospitalization: 9/9/2022 - 9/11/2022 Presentation to the ED: generalized weakness and decreased effort tolerance, CONTROLLED FALL TO THE GROUND & INABILITY TO GET UP.  COVID-19 + date: 9/9/22. Treatment: BRONCHODIALATORS. Discharge to: Home or Self Care.
TOOK LAST DOSE OF VIVOTIF TWO DAYS LATE; This spontaneous case report (PVX2019-1813) was received from a caregiver on 15-Jul-2019. It describes a male consumer who "took last dose of Vivotif two days late" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the last dose of Vivotif two days late. The doses were taken on 25-Jun-2019, 27-Jun-2019, 29-Jun-2019, and 03-Jul-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif two days late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif two days late" was considered as not applicable.