chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Same day as when patient received the 2nd vaccine, she was overcome with generalized fatigue and nausea.  By the 4th day, her legs would not hold her when she tried to stand getting out of bed.  She was nauseous to the point of not being able to eat or drink.  Infact, she did not have the strength or desire to eat or drink.  By the 5th day post vaccine (02/20/21), I took her to the Emergency room because she was so fatigued, she just slept, and couldn't stay awake to eat or drink.  She was able to get to the car with a walker, but that was the last time she walked.  After time at hospital and then Skilled nursing, she passed away on 03/21/21.  She never regained the ability to toilet herself, eat on her own, failed to eat and drink, and eventually was put on hospice because she lost 30 pounds over the month from failure to eat or drink, even though I was there or the nurse was there to feed her every meal, and try to get her to take fluids.  Her fatigue was just overwhelming. When she first arrived at the emergency room, she: ? Presented with 2 days of weakness and AMS; fever, nausea  and generalized fatigue ? Word finding difficulty; without stroke or acute abnormal on CT or MRI; according to the Hospital
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-JUL-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 64 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
health decline; postural orthostatic tachycardia syndrome; This spontaneous report was received from a consumer (patient's mother) via other (journalist) through social media refers to a 12-year old female patient. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, dosing schedule, route, lot # and expiration date were not reported) for cancer prevention. On an unknown date, patient experienced health decline (general physical health deterioration) and postural orthostatic tachycardia syndrome (POTS). The consumer reported that her child was very active that she had swam before she could walk. The patient reported that she would scare her mom as she sank to the bottom and just stared at her. She proudly reported that she would kick herself back up and take a breath and would go back down to the water. After vaccination, she could walk but getting up to do something has been a challenge. The consumer concerned about her daughter and described what was going on with her. She added that her daughter's heart rate was one thing that she did not have enough blood volume or blood pressure to push back up to the brain like it was supposed to go. She also added that her child did not show any signs of before being vaccinated. The patient was treated with florinef. No product quality complaint was reported. The outcome of general physical health deterioration and postural orthostatic tachycardia syndrome was unknown. The reporter considered the events to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2002USA002380:
The patient was mistakenly given the moderna primary dose for pediatric patients, as the bottle is still labeled "for booster dose only", but was supposed to get the moderna bivalent booster. The patient was informed of the mistake and did not have any adverse reactions. She received the correct moderna bivalent booster dose on 12/23/2022
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On unknown date, the patient was scheduled to be vaccinated with RECOMBIVAX HB intramuscular (lot # M033220 and expiration date 31-MAY-2018, dose was not provided). The nurse practitioner reported that on that day pressure in a vial of RECOMBIVAX HB was irregular upon withdrawing the vaccine into syringe causing medication to spray from the vial. As result the patient missed a dose. No adverse effects were reported. Product quality complaint was filed. Additional information has been requested.
Patient received PEDIARIX (DTap, Hep B and IPOL combo) and IPV vaccine. Patient did not need the dose of Hepatitis B as he had 3rd dose on 3/14/2017 and received a dose of IPV in PEDIARIX as well as separate dose.
12/12/21 fever 101.5 with nasal congestion. 12/13/21 rash noted left lateral thigh and left mid-back. erythematous area with central papule, pinpoint vesicular site. 12/14/21 fever 101.7 with two additional similar sites right facial cheek and mid-forhead.
She recalls feeling more pain than she usually in/around the influenza vaccine site (left deltoid, centrally).  Then, she states she began to notice bruising and increased pain in the days that following her being vaccinated for influenza.  Approximately 2 weeks after her initial vaccination date, she was still noticing pain in/around the vaccine site, but she also felt lumps in her left deltoid which she had never noticed before.  A little more than one month post-vaccine, she continues to experience pain in her left deltoid.  On examination, her left deltoid exhibits a small, round area of what appears to be ecchymosis.  The surrounding area is tender and nodular to touch.
headache; dry hacking cough; running nose; repeated sneezing; Rapid heartbeat; body ache's; This is a spontaneous report from a contactable consumer (patient, self-reported). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 25Feb2021 at 07:15 AM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included HIV+, chronic bronchitis, asthma, and arrhythmia. It was unknown if the patient had known allergies. The patient received unspecified medications in two weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 26Feb2021 at 02:30 PM, approx 20 hrs later, she started with a headache and a dry hacking cough, developed a running nose then repeated sneezing. She also had rapid heartbeat and body ache's at about 24 hrs. Symptoms continued through Saturday and Sunday. She felt better today (Monday 01Mar2021) but body aches were returning around 3:30 pm still had a headache and it had never gone away. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
PATIENT STARTED HAVING  A SEIZURE after 10 MINUTES VACCINE. HE BECAME CLAMMY AND WET TO THE TOUCH. B/P 66/45 P. 60  EMERGENCY CALLED AND DR. RESPONED- B/P 61/41 P.  76   --PATIENT VINITED GREEN BILE nd second seizure. EMS CALLED AND EVALUTED.   BLOOD SUGAR NOTED TO BE 99.   TRANSPORTED AT 2;25
12.17.20  around 2:00pm, my stomach started cramping, I had diarrhea, started cramping up really bad, got home and had diarrhea episode 5-9:00pm. Body felt hot, i did not have a thermometer to check my temp. Woke up around  6 am, and had another cramp and diarrhea episode, and had one every other hour.  Today, 12/18/2020 from 10am -3:30, I have not ate anything. Last episode has been at 11:00am. I am scared to eat and I am still experiencing cramps.  I have the feeling of nausea that comes and goes. I had to miss work due to the events of my illness.
Shingles.  Treated with single course of valacylovir.  Pain persisting for several weeks, but is now diminishing.
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient received expired FLUMIST QUADRIVALENT. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Incredible chills; body aches; A spontaneous report was received from a patient concerning a 72-year-old, female patient,who received Moderna's COVID-19 vaccine (mRNA-1273) experienced body aches, chills.    The patient's medical history, was not provided by the reporter. Concomitant medications reported included levothyoroxine sodium    On 10-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010M20A) I(route of administration npt provided), (injection site unknown) for prophylaxis of COVID-19 infection.       On 10-FEB-2021, prior to receiving mRNA-1273, the patient had some intense body aches for about 36 hours i.e., upto on 12-FEB-2021.On 22-FEB-2021 at morning 2.00 AM he  woke up with incredible chills and body aches and on 28-FEB-2021 he got more side effects. Treatment for the events included Acetamanipohen. lab report results  were not provided.    Action taken with mRNA-1273 in response to the events was not applicable.    The out come of events Body aches, chills were not recovered or resolved
318 patients received dose from vials beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The date of refrigeration was reported to be on 19-Aug-2021.   Treatment information was not provided.
Immediate feeling of mild nausea after receiving the vaccine  When going to bed a more intense feeling of nausea and mild body pain  Next morning, the same feeling a nausea, a more intense body pain and a slight fever  Around 10 AM the next morning - a VERY intense headache and high fever (~102) with intense nausea and body pain that almost resulted in a trip to the hospital  Rested and got fluids throughout the rest of the day and fever began to break around 5 PM. After this ate dinner and was asleep by 7 PM.  Next morning felt better and had no remaining side effects.
Some hair loss after 1st injection. 2nd injection extreme hair loss visible scalp on crown, front edges and rear. No regrowth as yet.
This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a female patient who received MENVEO. On 7th May 2012, the patient received MENVEO. On an unknown date, unknown after receiving MENVEO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningitis were unknown. It was unknown if the reporter considered the vaccination failure and meningitis to be related to MENVEO. Additional details were provided as follows: The health care professional called in to find out the effectiveness of MENVEO. The health care professional stated the patient received the vaccine and was in the hospital at the reporting time with suspected meningitis. It was stated that there had been no lab work returned and the patient had not yet been diagnosed with meningitis. The vaccine administration facility was not known by the health care professional who reported the adverse event. This case was considered as suspected vaccination failure, since the time to onset and confirmation of sero type were unknown.
Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a two-months-old male patient who was vaccinated with a dose of PENTACEL lot C5573AA (ACT-HIB part) via intramuscular route in right thigh on 27-Dec-2018. The patient received ACT HIB from the PENTACEL and not the DTaP/IPV (lot number: C5427BA). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not reported. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; PREVNAR for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. It is an actual medication error case due to wrong solution used in drug reconstitution and inappropriate reconstitution technique. It was reported that patient received ACT-HIB 0.5ml from the PENTACEL carton and diluted it with sterile water instead of the 0.4 % NaCl. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Severe chills and fever began around 9pm. Recovered overnight after a full night's rest. No major signs or symptoms the next morning/day.
Temp max 102 degrees. Neck and back pain. Soreness of whole arm- Arm where Td was received.
passed out in facility 11-21-20 at 12:33pm- was told Monday 11/23-2020 by company
ENG. An area of densified tissue has appeared on the left arm around the spot of the vaccination shot. On the surface of the skin, the periphery of that area has a shape of an uneven interrupted pink line. That pink line resembles a distorted ellipse of 5-6 cm x 3-4 cm. The inside area of the "ellipse" is also pink but of lesser intensity than the borderline. The surface of that area has a noticeably higher temperature than the corresponding area on the right arm. The overall temperature of the body is normal.
15 minutes after administration patient complained of a scratchy throat and cough. No overt signs of swelling.
Fainted, legs and arms went numb and my hands froze, felt almost like a stroke. Was ok after about 30 minutes,,was just very tired rest of day
Sore arm, heavy to lift still Bruising by left knee started 8/7 No taste Migraines worsened and in new location O2 levels were lower than usual. Pulse rates extremely high at times Coughing SOB
within 24 hours of having the first booster, I experienced general tightness throughout chest area, developed fever and chills - took 1600mg acetaminophin ,,,went to bed and fever went away within 2 hours and I felt better ( I am an NP - didnt feel I was having a heart attack but wont take any more vaccines after this   no radiating pain or shortness of breath
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Since unknown dates improperly stored doses of GARDASIL, VAQTA (adult doses), RECOMBIVAX HB and ROTATEQ were administered to unspecified patients. no adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Body aches, chills, dry cough, severe pain in the hip, severe pain in the arm where injected, fever, generally achy flu like symptoms with severe hip joint pain in my left hip.
pt recvd flu vax & exp pain, w/o swelling, a limited ROM, which has persisted 13 days p/inject; pain has waxed & waned; pt recovered;
10 patients received second dose beyond the use date (30 days on refrigeration); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received second dose beyond the use date (30 days on refrigeration)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received second dose beyond the use date (30 days on refrigeration)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received second dose beyond the use date (30 days on refrigeration)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.   This case was linked to MOD-2021-354415, MOD-2021-354436.
Fatigue, muscle aches, chills, fever, nausea, diahrea, vomiting
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-SEP-2013, the patient was vaccinated with PROQUAD (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the right upper chest) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 01-Mar-2021, the patient experienced RASH (Rash on the right upper chest). At the time of the report, RASH (Rash on the right upper chest) outcome was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: NNI -Reporter reported
fine for first few hours then some swelling at shot site the need to lay down hit and I as out for 35 hours.  Ended with flu like symptoms.  Had covid in Dec 2020 with a 5 day hospital stay.  The 35 hours was unnatural and mentally fuzzy.  Very concerned about a second shot.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because her facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patient. Reporter confirmed that patients had administered doses while the temperature excursion assessment was ongoing.   This case was linked to MOD-2022-501575 (Patient Link).
Breakthrough case admission after 2 vaccines Moderna 1/18/21 Lot# 02BL20A;  Moderna 2/15/21 Lot# 028L20A
Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional via phone. This case involves a 4 months old male patient received 0.5 ml expired PENTACEL (frequency once, batch number C5391AB, expiry date 24-JUN-2018) in right thigh on 16 July 2018. Concomitant medication included PREVENAR and Rotavirus. It was a case of actual medication error due to expired vaccine used. ER/Dr visit and date16 July 2018 (also reported as 16 July 1988). It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.