chrisvoncsefalvay/vaers-outcomes huggingface dataset:
According to the nurse, a 13 years old patient was administered the first dose of PROQUAD; Information has been received from a registered nurse referring to a 13-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 09-JAN-2020, the 13-year-old patient was administered the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD) with sterile diluent for prophylaxis (dose and route of administration were not reported) lot number S021619 and expiration date 09-JAN-2021.
Narrative:  PATIENT RECEIVED ONE DOSE OF COVID VACCINE. PMH INCLUDES Parkinson Disease, mixed dementia, CVA with left sided hemiparesis, dysphagia, dysarthria. PATIENT WAS ACTIVELY DYING AND REQUIRED TRANSFER TO HOSPICE. NO OTHER CONCERNS RELATED TO DEATH OF PATIENT. REPORTING PER INSTRUCTIONS.
Information has been received from a licensed practical nurse concerning a 17 year old female with a history of penicillin allergy and drug hypersensitivity who in August 2007, was vaccinated with the first dose and on 24-OCT-2007 was vaccinated with the second dose of GARDASIL (lot #'s not reported). On 22-MAY-2008 the patient was vaccinated with the third dose of GARDASIL (lot# not reported). Subsequently the patient experienced inappropriate schedule of vaccine administered. Concomitant therapy included hormonal contraceptives (unspecified). The patient also told the nurse that when receiving the previous injections, she experienced a moment of pain st the injection site. Some residual pain was present the next day. The patient's injection site discomfort resolved. Then sought unspecified medical attention in the physician's office. No additional information is available at this time. Additional information has been requested.
In December of 2021, at my annual visit with my primary care physician, they noticed that my liver enzyme levels had gone up. Since then, they have not gone down. My cholesterol levels were also up and I have been controlling that with medication but they are still high.
On evening of 5/13/08, started running a temperature (101) and started breaking out with a rash. On 5/15/08, went to doctor. Culture taken. Diagnosed with chicken pox. Put on Tylenol and Valtrex (first for 5 days and then for an additional 7 days.
I started with a very bad headache akin to a migraine, it developed into a 100-101 degree F about 12 hours after the shot which also included aches all over the body and nausea. The headache and fever had mostly subsided 40 hours later, but I'm still a bit nauseous  over 52 hours since the shot.
Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th September 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 14 Jul 2023 The pharmacist had a patient who received the first dose of Shingrix back and stated the patient just showed up for a second dose. The reporter asked if any guidance? The reporter did not consent to follow-up. Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccine
pt recv DTP/HIB #1, OPV #1 & hepatitis B #2;pt was given DTP/HIB #1, OPV #1 & was given HIB vax instead of Hep B so was doubled dosed w/hemophilus influenza B vax;no adverse effects noted;f/u w/pt mom next day no problems;
It was reported that the pt is "covered by pox" according to the mother. Additionally, it was noted that on 2/5/00, the pt was febrile. Unspecified medical attention was sought. Additional information has been requested.
Pt presents for s/e after 2nd dose COVID 19 pfizer vaccine today, about 1-2 hours prior to office visit. She called over to the medical staff because her right side of mouth became tingly, and her right eye hurt about 5 minutes after vaccine. The episode lasted about 10-15 minutes per Patient, and did not loose consciousness  She brings in a rhythm strip with only BP- she denies having EKG. BR 218/94 and HR 63 @1224, and 195/99 HR 64 @ 1228. They called EMS, and pt declined to go.  She denies any CP, SOB, no slurred speech or sudden weakness during the episode. Denies swelling of face or lips, no dysphagia. No meds administered at clinic. Pt has not taken any additional medications today.
6/5/07 - C/O slight nausea.  6/7/07 - C/O cough, sore throat, achy, temp 98.8 refused ER. 6/8/07 - C/O short of breath and weakness. Seen in ER, Chest X-ray and labs  - normal. 6/11/07 - C/O nausea, dizzy, weakness, headache, temp over 100. Referred to personal physician.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient with unknown age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 29-NOV-2012 the patient was prescribed and administered with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions by a healthcare provider. On an unspecified date (reported as subsequent to patient's inoculation), the patient was treated by a doctor for shingles. It was claimed that as a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered as not recovered. The causality was assessed as related by the lawyer.
Leg pain, heavy and achy; shortness of breath while just walking down the hall; something in my throat - bump or lump, like a blister
Vaccine initially stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 009C21A and 009C21A) for COVID-19 prophylaxis.     The patient's past medical history included Carpal tunnel syndrome on 13-Nov-2015. Concurrent medical conditions included Hyperlipidemia since 21-Jan-2022, Hypertension since 21-Jan-2022, Impaired fasting glucose since 03-Jan-2022 and Impotence since 07-Nov-2013. Concomitant products included AMLODIPINE from 21-Jan-2022 to an unknown date for Hypertension.   On 27-Jul-2021 at 10:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Aug-2021 at 9:44 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Jul-2022 at 8:26 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo temperature excursions. The patient did not report any adverse events. 6 patients on 05-Jul-2022, 6 patients on 06-Jul-2022, and 3 patients on 07-Jul-022. No treatment medication were reported.   This case was linked to MOD-2022-607866 (Patient Link).
On 2/6, I noticed my left elbow was itching and had hives on it. The hives subsided a little after a while, and I forgot about them. I woke up on 2/7, I had large, lesion-like hives on the area where the thighs join the buttocks. I found more hives and was itching on both elbows. By the evening of 2/7, my wrists, my ankles, and the back of my knees were covered with itchy hives and welts. The rashes on the ankles and the backs of the knees were noticeably swollen and painful. It was uncomfortable to bend my legs and ankles. On 2/8, I called my doctor and she had me come in. One of my feet was uncomfortable to walk on, because it was so swollen and painful. At this point, most of my joints ached. The doctor gave me Benadryl and told me to call her if it got worse. A blood panel was taken, and it said my inflammation markers were really high. At 6:30 that night, I had a fever, and one foot was so swollen I could barely walk. The doctor sent me to the ER. I was examined. An ultrasound was done to ensure I didn't have blood clots, which I did not. Based on the blood tests and the doctor's observations, they concluded I had serum sickness caused by the vaccine. They gave me a triple dose of steroids and sent me home with 4 more days' supply of steroids. I was told I needed to follow up with an allergist. By the next morning, I had much relief. I was able to put weight on my foot and the inflammation in all my joints was significantly reduced. I saw an allergist on 2/10. She also concluded I had serum sickness and she kept me on the steroids I was already prescribed, plus she gave Allegra for the mornings and Zyrtec for nights. That was for a week. The second week, she had me take Allegra daily for a week. By that point, I felt totally back to normal.
Nausea/vomiting/diarrhea/dizziness x 3 days.
Sore arm at injection site. Chills, headache, and fever of 100-101F. .. on third day of fever
Patient was given a TDaP instead of a DTaP. Called public health and spoke w/them. She stated that since it's her 4th series, she will not need an additional vaccine. Dr. spoke w/father and understood. Nursing supervisor, was notified as well.
Nothing debilitating like she experienced with at least one of the first two vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 70's received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Nothing debilitating like she experienced with at least one of the first two vaccines".  Additional information: Caller received her first Pfizer Covid 19 Vaccine in Feb & her second Pfizer Covid 19 Vaccine in Mar. She received the Pfizer Coivd 19 Vaccine Booster on Sat, 11Dec2021. Caller reported that she was fully functional, wasnt tired. Nothing debilitating like she experienced with at least one of the first two vaccines.   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 physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Fell once; wobbly legs; felt like throwing up; Tenderness on left arm; Nausea; little fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell once), MUSCULAR WEAKNESS (wobbly legs), MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm) and NAUSEA (Nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm), NAUSEA (Nausea) and PYREXIA (little fever). On 23-Feb-2021, the patient experienced FALL (Fell once) and MUSCULAR WEAKNESS (wobbly legs). On 22-Feb-2021, MALAISE (felt like throwing up), VACCINATION SITE PAIN (Tenderness on left arm), NAUSEA (Nausea) and PYREXIA (little fever) had resolved. At the time of the report, FALL (Fell once) and MUSCULAR WEAKNESS (wobbly legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-024626 (Patient Link).
patient was found to be weaker than normal today prompting her to call 911. There was no reported fever, diarrhea, SOB or any other symptoms noted. Per wife, the patient is homebound and has visiting physicians. She stated the patient had the J&J vaccine on 3/29/21. In the ED, labs were unremarkable, no Covid markers available, CXR noted possible early pneumonia, sats were 95% on RA with no SOB noted. UA pending. CT brain neg. Rapid Covid noted as positive prompting request for admission.
Upper left arm swollen and reddened.  Increasing redness in past 3 days. Pain with Motrin. No red streaking noted from site. No drainage.
Chills; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0ZA21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CHILLS (Chills). On 10-Mar-2021 at 5:00 AM, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included natural pills.  Treatment information was was not provided.
Parent reported swelling on 10/7/01. Pt was seen in office on 10/8/01 and was found to have blanchable, red macule which was large over injection site with generalized swelling of middle of right thigh. No treatment was given.
General feeling of being weak, light sensitive, and in a fog persisted 11/30-12/02; Chest pain felt mainly in the sternum area and racing heart rate despite being relaxed started at 11pm 11/29 and lasted in decreasing strength to 3am; only treatment taken was relaxing and drinking fluids, although chest pain was self monitored in case it was deemed hospital worthy
The same day that the person was vaccinated he started feeling dizzy and had difficulty breathing.  He was hospitalized from February 5 to February 23.  Patient died in the hospital on February 23, 2021
syringe leaked out and was given another shot, not of 0.5mL in the other arm; syringe leaked out and was given another shot, not of 0.5mL in the other arm; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a leaky syringe and was given another injection (not of 0.5mL) in the other arm.  The patient's medical history was not provided.  Concomitant medications were not provided.  On 29 Jan 2021, the patient received his dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  The patient states that while the vaccine was being administered, the syringe leaked out.  He was given another shot, not of 0.5mL in the other arm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event of  experienced a leaky syringe and was given another injection (not of 0.5mL) in the other arm were considered resolved.; Reporter's Comments: This case concerns a male patient of unknown age who received his dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection and while the vaccine was being administered, the syringe leaked out.  He was given another shot, not of 0.5mL in the other arm. There were no reported adverse events after the vaccine was administered in this case of syringe issue and incorrect dose administered.
pt exp mild anaphylactic rxn rapid heart beat-diff breathing lasting approx 3min then subsiding;
Very tired.  Achy  body  & very cold.  Lasted around 18-24 hours
give a Bexsero and it expired 3 days ago; This case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero. On 3rd August 2021, the patient started Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and unknown after starting Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The reporter stated that they had a nurse just gave a Bexsero vaccine and it expired the end of July, 3 days before date of reporting. The reporter's doctor would like to know if this was considered invalid. Additional Supportive Information: The patient was administered with Bexsero vaccine, which was already expired, which led to expired vaccine used. The follow-up would not possible as no contact details were available. This case has been linked with the case US2022AMR115313, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR115313:Same reporter
Chills; Body aches/ Pain; Vomiting; Diarrhea; cramping; arm pain/ leg pain; leg pain, could not walk; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) (batch number 4c493, expiry date 20th March 2023) for prophylaxis.   Previously administered products included Flu vaccine (received dose on an unknown date), Moderna (received 3 doses on unknown dates) and Zostavax (received dose on an unknown date).   On 6th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In November 2021, less than a day after receiving Shingrix, the patient experienced chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk. On 7th November 2021 16:00, the outcome of the chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk were recovered/resolved.   It was unknown if the reporter considered the chills, general body pain, vomiting, diarrhea, cramp, pain in arm and unable to walk to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received her 1st dose of Shingrix intramuscularly into her left deltoid at her pharmacy at around 12-1pm in the afternoon.  At 2am the next morning, she woke up with chills, body aches, vomiting, diarrhea, and cramping.  She also reported she experienced arm pain and leg pain that was so bad she could not walk.  By 4pm on 7th November 2021, she reported that all of these symptoms had resolved. The caller reported her reactions to her PCP and her doctor told her she should not get the 2nd dose of the Shingrix. The caller reported that her past vaccination history (dates unknown) included Zostavax, 3 doses of Moderna, and the flu vaccine and she has never had any reactions like she experienced after taking the initial Shingrix vaccine. The reporter consented to follow up.
rule out cancer.; vitamin deficiencies; This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Mar2021 as dose1, single for covid-19 immunization. Medical history included having health issues of dizzy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced rule out cancer and vitamin deficiencies. She stated she was having health issues of dizzy and passing out before receiving the vaccine and her HCP told her to skip the second dose until they were done running tests on her to rule out cancer. Now she is wanting to get the second vaccination but states no one will let her get it now due to missing the second dose. She is asking if she will need to start over or can we tell her what to do to get the second dose. The outcome of all events was unknown.  Information about Lot/Batch number has been requested.
My mom lhad been up walking around for maybe an hour or so.  She then laid down across the bed & when I looked at her, she was drenched with sweat, then she started hacking, almost like she was choking or couldn't breathe.  She also started mumbling & called on Jesus.  I tried sitting her up, her eyes then rolled back in her head, then this very gold colored stuff started coming out of her mouth (which scared me to death).  Her body was so limp, she slid on the floor.  I wiped her mouth & also put a cold rag on her  forehead to try to cool her down.  I dialed 911 & continued talking to her.  She started to respond to me & along with my help we were able to sit her back on the bed.  EMS arrived, took her vitals.