chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift.  She felt this was normal for working the night before and having stayed up to get the vaccine.  After her wait period she went to her car and remembers feeling warm for having to walk in the cold.  Her right side of face became reddish purple and warm.  She sat in car for a few minutes.  As she drove her face started to swell and turn all red.  When she arrived home she had heavy pressure middle of face-nose area.  Her face continued to turn reddish purple with a rash on right side of face and down to her neck.  She felt her sinuses and throat swell with irritation and in throat and wheezing.  Her mom is a nurse and they waited to see if it worsen or got better.  She decided since she could breath she would not go to hospital. After about 5 hours she felt much better.  She continued to have a headache for 4 days.  She had swelling and soreness of left arm for a couple of days.  She continued to go to work.
Lethargy, headache, sore throat, cough, runny nose, achy joints, no energy, couldn?t stay awake
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included duloxetine, gabapentin, omeprazole, perphenazine, Sumatriptan, tramadol, trazodone, ziprasidone, carbidopa plus levodopa and methocarbamol. On 16th April 2018 08:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The pharmacist reported that the patient experienced pain in her arm where she received SHINGRIX.
Severe fast heart beat (tachycardia; several) weakness; about 3:30 to 4 pm. 911 was called I talked to them after few minutes; by that time I felt little better and I refused paramedic to come in.
Stated Burning or stinging at injection site, later in the day weakness in right arm and some swelling in the hand, getting better the next afternoon.
Chest pain, shortness of breath.  Treatment consistent with pericarditis; NSAIDS; Ibuprofen 800 q8; prednisone 500 qd x 5 days
This spontaneous case was reported by another health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature).    No concomitant medications were reported.  I The vial undergo temperature excursion for the first time and patients were involved. Total 40 patients were involved who received Monovalent and Bivalent doses after excursion. No treatment details were reported.
Initial report was received from a consumer on 04 DEC 2009. This patient (18 month old child) was vaccinated with FLUVIRIN (batch no: unknown) on an unknown date. The patient was experienced with fever and flu like illness on 30 NOV 2009. The outcome of the events were reported as fully recovered.
Administered at age 15. At time of administration was not approved for age. No adverse symptoms identified.
Within 6 hours of receiving the shot I developed a headache, became very tired, had a big loose stool, was nauseous, and had mild abdominal cramping.
Shingles; Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about the patient's (pt) concurrent conditions, medical history or concomitant medication.  In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently, the pt was treated for shingles. As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would 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 would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Took nap at noon, would not wake up at 2pm when I tried to wake him by calling his name and rubbing his back (normally he wakes up if I touch the door knob).  I thought he was just very tired and had a babysitter come over while I got my daughter from school.  He woke up at 3:30p, crying, acted lethargic, wouldn't walk, was not happy to see his dad like usual. Had a low grade temp but no fever.  Figured the injection site hurt. At dinner he would not eat, did not look well, would not smile, eyes rolled back and he slumped over. Temp 103.8 and Motrin given. Figured eyes rolling were from being very sleepy.  Slept 6-9p (took temp while he slept at 8p and it was 103.4. Gave more Motrin at 10p and he slept until 7a. At 8am on 1/16/14 temp 102.3, slept 8:15-8:45, then 11-12, at 1p temp 100.4.  Called Dr's office, told them what was going on with child and paper given to me on HiB from CDC said to call MD if moderate or severe reaction occurs but it does not quantify "high fever."  Nurse first said "I'm sure he'll be fine."  Then she asked if I was giving Motrin and Tylenol round the clock since shot, I said how would I know if he had a reaction if I gave him the meds constantly? She said his fever got that high because I let it.  I insisted that it would be covering up a vaccine reaction, and I want it documented and reported, like in the paper they gave me.  She asked me how I took his temp. and said tympanic is not accurate...I explained that room air is not 103.8 so it couldn't be a false high but it could potentially be an even higher temp if she thinks I didn't get it all the way in his ear.  Then I asked for the doctor to call me instead. I explained to the doctor that he was not sick at all before the shot, not one in our house was sick, and he woke up like this hours after the single HiB shot, with no other cold symptoms.  She said he was probably getting sick and since he isn't fully vaccinated we can't be sure what he has.  It is a coincidence.  If the fever is not gone by Friday (would be 72 hours from start) and he does not develop other cold symptoms she would do a straight cath because he is uncircumcised.  He slept 3-5:30pm, then by 4pm on Friday his temp was 99.2.  He never got any cold symptoms and neither did anyone else in the household. He did not eat for 3 days following the injection of HiB and when he started eating again he was very picky and still is.  Previous to that he would eat ANYTHING.
Flublok Quadrivalent vaccine was administered to 13 year old patient, No AE; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case was linked to the case 2020SA279481 (same reporter).  This case involves a 13-years-old male patient who received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2047, expiry date-30-Jun-2021) via an unknown route in left upper arm for prophylactic vaccination on 06-Oct-2020 (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  This was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported that, no other medications or vaccinations were administered at that visit.   At the time of report, no 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 holders 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.
Pt recv vax on 3/26/99; on 3/29/99 pt exp abdomen pain, vomiting, nausea, headache
There was NO adverse event, however the dose was incorrect because it was a pediatric dose given to an adult patient.
Approximately 5 minutes post vaccine administration, patient developed shortness of breath and tightness in throat. She self administered her personal inhaler with no positive response. Epi was given in R thigh per vaccine OBS RN and ED was called. Patient was transported to ER by EMS
Right cerebral superior and inferior acute infarct with hemorrhagic conversion.  No significant sequelae beyond chronic hematoma on 1 month f/u CT and feelings of heaviness and vertigo when moving head quickly or leaning over
Pt keeps getting bad diarrhea after vaccines are given. Received DTAP/Hib #4 on 1/10/02. Received Prevnar #3, IPV #3 and Hep-A #1 on 7/10/02.
Pt denies adverse reaction to 0.5ml instead of 0.3ml dose.
My daughter just had a miscarriage; Maternal exposure during pregnancy; Based on the current case data, this case has been classified as invalid. This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (My daughter just had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (My daughter just had a miscarriage) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (My daughter just had a miscarriage) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication is provided by reporter. No treatment was provided. Company Comment: This is a case of maternal exposure during pregnancy of this female patient, unknown age with no disclosed medical history, who experienced the serious, unexpected event of spontaneous abortion. The patient received the unspecificied dose of vaccine at  unknown weeks of gestation. Spontaneous abortion occurred on unknown date after the unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of maternal exposure during pregnancy of this female patient, unknown age with no disclosed medical history, who experienced the serious, unexpected event of spontaneous abortion. The patient received the unspecificied dose of vaccine at  unknown weeks of gestation. Spontaneous abortion occurred on unknown date after the unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
A serious spontaneous report of bloody nose, and non-serious report of fever of 103, vomiting, irritability, just not feeling well and decreased appetite has been received from a registered nurse/healthcare professional concerning a six-year-old male, subsequent to H1N1, Intranasal. The patient had a deviated septum, neither patient nor family had history of nose bleed. Concomitant medications included oral fluoride tablets, once daily. On 06-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 06-Nov-2009, after receiving H1N1 vaccine, on the same day the patient experienced fever of 103, vomiting, irritability, just not feeling well and decreased appetite. On 07-Nov-2009, the patient started having spontaneous bloody nose. He never had this prior. The bleeds soaked through blankets and had several blood clots in nasal discharge. At the time of reporting the patient has had a bloody nose everyday since 07-Nov-2009, but had become smaller and smaller until they had a totally stopped on 10-Nov-2009. On 11-Nov-2009, the mother reported that her son had been improving daily; that the fever and vomiting resolved on 08-Nov-2009, the decreased appetite resolved on 09-Nov-2009, and that late in the day on 10-Nov-2009 the unwell feeling, and nose bleeding had resolved. She did report that her son was irritability most of the day on 10-Nov-2009, but when he awoke on 11-Nov-2009, he was happy and back to his normal self. The mother reported that she had used only acetaminophen as needed at home during these events. On 17-Nov-2009, the patient was seen by the ENT specialist and all that was found was a deviated septum. The outcome for reported events was recovered. Additional information was received on 17-Dec-2009 and incorporated into the narrative: patient and family history, concomitant medications, outcome of the events was updated.
right arm weakness; loss of sensation intermittently; lightheaded, dizzy; briefly difficult to speak on one occasion; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142, expiry date: unknown), intramuscular on the right arm on 04Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications.  The patient experienced right arm weakness/loss of sensation intermittently lasting <5 minutes on at least 5 occasions on 05Jan2021. Patient also experienced lightheaded, dizzy, and briefly difficult to speak on one occasion on 05Jan2021. The events resulted in an emergency room visit but no treatment was given. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. There were no other vaccine administered within 4 weeks prior to the COVID vaccine.
Tested positive for Covid - 19 on March 24, 2023.  Cough, Sore throat, head ache, fever, tiredness Tested negative with BinaxNow Test on 3/31/2023  Still have coughing , headache and or light-headedness, and sore throat occassionaly during each day.
C/O left upper arm swelling, itching, painful, red, at injection site given on 12/20/2017 increased swelling today.
This infant had a rash on his arms and legs the day after the vaccines. Spread to the trunk and the face. No fever, no vomiting, no joint swelling.
On 12/17/08, patient received DTaP, MMR, and IPV the morning. No problem throughout the day. Morning of 12/18/08, mother noticed fever 101F and hives. No respiratory symptoms or edema.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 03-AUG-2015, a patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # I012036, expiry date: 07-APR-2016) (dose, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm developed large, firm, red, swollen area at injection site.  It was first noticed 7 days post-vaccination and lasted for about 4 days.  The swelling was approximately 3 inches in diameter.
patient missed their second dose of GARDASIL 9; first dose was administered on 2/8/2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 08-FEB-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602284 (verified to be a valid lot number), expiration date reported and established as 26-SEP-2021, for prophylaxis.         On an unknown date, the patient missed their second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse affects were reported.
Information has been received from a mother concerning her daughter, a 23 year old female with no pertinent medical history and no drug reactions or allergies who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL (route not provided). On 21-NOV-2007 the patient received her second dose of GARDASIL (route and lot number not provided) and the third dose of GARDASIL was received on 27-MAR-2008. (Lot number provided with unspecified information corresponds to each patient as below: 659437/1266U; 657736/0389U; 659182/1757U; 656051/0244U; 657617/0384U). Concomitant therapy included an unspecified drug for "birth control". The patient switched from YAZ to the unspecified birth control. The mother reported her daughter's two consecutive pap swears were abnormal. Third pap smears had been scheduled to check patient current status. If their follow up pap smear is abnormal the treatment being discussed/recommended is to freeze the cervix. Laboratory diagnostics studies included a yearly physical in August 2010, results not reported. The patient sought unspecified medical attention. Upon the time of report, the patient was not recovered. Follow up information has been received from a physician concerning a 23 year female who on 25-MAY-2007 was vaccinated in left arm with the first dose of GARDASIL (lot number: 657736/0389U). On 21-NOV-2007 the patient received the second dose of GARDASIL in left arm (Lot number: 659437/1266U) and on 27-MAR-2008 received the third dose of GARDASIL (Lot number: 659182/1757U) in left arm. This is one of several reports received from the same source. Additional information has been requested.
On July 15th, 2021 my Grandma was eating some lunch that I had picked up for her and I returned to cleaning and doing various activities with my toddler. When I came in her room to check on her approximately 2 hours later, her food had hardly been eaten. I noticed something was wrong very quickly as she was unable to hardly speak or move. She was extremely confused and the only word she could seem to say was 'yes' and after trying to walk her to the restroom she was unable to sit down by herself or help herself use the restroom. She was unable to walk and her right side of her body was extremely weak. I had to use her walker to transport her to a different room. Upon calling the Dr's office it was agreed upon to call 911. At approximately between the hours of 3pm-4pm she was transported to the ER by Ambulatory services. She went to Hospital and was kept for a total of 5 days. Through routine medical testing as well as other testing it was found that she also had a urinary tract infection (which was not known at the time), as well as a very small cyst on her brain that the Neurologist was not concerned with, and a blood clot in her neck. She was discharged from the hospital and to continue all of her medication as she had before, except now she is on a blood thinner due to the blood clot. She had issues with her balance while standing in place or walking/moving. She had to use her walker wherever she went or else she wouldn't be able to keep her balance. She also struggles with bladder incontinence and holding in her stool when she needs to go and therefore had to make the full transition to diapers, prior to this medical emergency she had never used diapers and wore women's underwear. She has been seeing Cardiologist and now has a new D.O. for primary care. She was told to follow up with a neurologist on January 2022 to talk about the small cyst on her brain. Besides the bladder incontinence and unable to hold her bodily functions, she has made a full recovery.
Patient received Booster Pfizer at 1400, and drove to lane for observation.   Patient was assessed with a rash to her right shoulder.
almost killed me; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown demographic patient who reported almost killed me (unevaluable event) after receiving INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious almost killed me (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got mine in 1968, almost killed me, and they did it without my parents knowing, it also kept me from having children , so yeah , go get one ya morons , we dont need your offspring running around."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.