chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After leaving our office she was feeling fine but by the time they got home (about a 10min drive) she seemed dazed, was unable to figure out how to get out of the car; she was responsive but seemed confused about the previous events. Once they got inside mom gave her a popsicle and a blanket on the couch and called our office. She did not have any swelling of the lips or tongue, no resp distress, no rashes. She was responsive to mom but per mom was spacey and not herself. I followed up with mom the next morning and by 5:30p that night patient "snapped out of if" and seemed normal. She ate dinner, went to bed and woke up feeling fine this morning. These are similar symptoms that she exhibited after receiving the first Hepatitis A vaccine at age 3 years and the first MMR vaccine at age 3 years. She has received other vaccines both before and after age three without any adverse reactions.
Fever (Tm 102.5), headache, malaise/fatigue, and body aches along with non-reproducible, non-radiating, left-sided chest pain.
pt recv vax 17JUL98 & 18JUL98 pt exp vigor (shaking) for 4-5hr, fever (unspecified),profuse sweating, neck stiffness & photophobia;18JUL98 3:00 pt devel uncontrollable shaking/rigors lasting 4-5hr, fever, profuse sweating, v, photophobia;
Information has been received from a pharmacist concerning a 72 year old ale with no pertinent medical history and no history of drug reactions or allergies who on 02-JUN-2008 was vaccinated with ZOSTAVAX (Merck). On 03-JUN-2008 the patient experienced itching, a little round pink area at the injection site. At the time of the report, the patient's itching and round pink area at injection site persisted. It was unspecified if the patient sought medical attention. Additional information has been requested. This is one of several reports from the same source.
This spontaneous report as received from a physician via a company representative refers to a 13 year old male patient. In October 2014 the patient was vaccinated with the second dose of GARDASIL (dose, route not reported, lot # reported as K006191 with expiration date 02-FEB-2017) . Concomitant therapies included FLUMIST. The physician reported that the patient (about 6 hours after injection) experienced pain at the injection site and "sort of" a hyperventilating episode on 28-OCT-2014 after being administered the second dose of GARDASIL. MOTRIN and hot compresses on arm were given for the events. The patient had sought medical attention by given medical advice over the phone. Outcome of the events was not reported. Additional information is not expected as the physician did not want to be contacted.
pt had a syncopal episode the morning following her vaccination, n o further episodes.  she is just now reporting it.  work up in progress including labs, MRI, ultrasound
Did not take the fourth dose of Vivotif as per the schedule; A spontaneous report was received from the nurse on 07SEP2022. It described a 39-year-old female patient who "did not take the fourth dose of Vivotif as per the schedule" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took her first three doses of Vivotif correctly (every other day). Reportedly, the patient took her third dose of Vivotif on 02SEP2022 however did not take the fourth dose until 06SEP2022. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer did not take the fourth dose of Vivotif as per the schedule (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer did not take the fourth dose of Vivotif as per the schedule (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Presented with SOB; Acute CHF and COPD exacerbation; Rec'd covid booster 2 days PTA  Labs:  D-dimer 0.59;    TX: Steroids and doxycycline; + covid 10/22 ; back to baseline home O2 at discharge
Insomnia for 3 days.  Made Sinus's were worst Made face around sinus area to swollen Left arm at site was red fever and swollen heart racing
Jerky upper body movements lasting only 3 seconds with temperature of 38.2 C. These jerky movements have decreased in length (now last only a second) but still having multiple episodes per day since onset. Not coinciding with fever (has not had a fever since above stated fever). No staring episodes. No loss of consciousness. Patient seen in office on 2/15/2011 for this issue. Not witnessed by physician. Neurologically stable and appropriate for age.
Started with tingly finger tips and nail beds. Random fingers on the right hand. Then it migrated into the arm. Every time I lean forward, my arm gets tingly. Not sure if it?s vaccine related or an underlying issues. I still have this issue and first does was administered on April 14.
I felt feverish and tired the day after which I expected.  But I never really felt "myself" after, always a bit tired.  Then 8 days later had stomach distress and aches and pains and have so much fatigue it is difficult to work.  I do not have covid, and have not been anywhere to be exposed to anything else.  I also have severe back pain that started after my first shot.
"Moderna COVID-19 Vaccine EUA" --- I had pain in my arm for over 30 hours. this was my first injection. i could not move my arm at all during that time.
Pt seen with vesicular rash on trunk 4/16/09 - rash appeared 4/14/09 on trunk.
Headache, body aches, and fever for 24 hours. Fatigue the following 24 hours.
p/vax pt devel cellulitis;the reporting MD felt that cellulitis was r/t vax;
Fatigue, headache, muscle and joint ache, general malaise, chills, lack of appetite. Pain and slight swelling of injection site. Slept for 36 hours. Treated with 650 mg aspirin every 4 hours. Fully recovered in two days
Patient stated that he got shingles on his face and around the mouth. He went to the MD to get this checked out and the MD advised him to not get the second dose.
08/20/07 VARICELLA VACCINATION GIVEN.08/22/07 PATIENT HAD SHARP PAIN IN RIGHT ARM THAT SHE DESCRIBED AS INSIDE AND FEELING LIKE KNIFE STABBING AS WELL AS ELECTRICITY FLOWING THROUGH HER ARM. NO REDNESS OR FEVER ON SHOT SITE. MOTHER CALLED DR OFFICE, BUT THEY WERE OUT, SPOKE WITH ANOTHER MD'S RN AND WAS TOLD THAT THE VARICELLA VACCINE DOESN'T CAUSE NERVE DAMMAGE, BECAUSE IT IS GIVEN "RIGHT UNDER THE SKIN AND THE THE NEEDLE IS TOO SMALL" WAS INSTRUCTED TO GIVE TYLENOL AND ICE IT, BUT TO CHECK FOR REDNESS OR FEVER AROUND SITE.  ON 08/24/07 THERE WAS A BLISTERED RASH ON RIGHT SHOULDER BLADE THAT WAS IN THE SHAPE OF A PATCH AND APPEARED TO HAVE WATER BLISTERS ON IT.  OVER THE WEEKEND PATIENT'S RIGHT ARM HAD AT LEAST X3 MORE OF THE BLISTERED PATCHES GOING FROM SHOULDER TO WRIST. ON 08/27/07 FATHER CALLED DR OFFICE AGAIN AND WAS TOLD THAT IT WAS A REACTION FROM THE VACCINE WHICH IS COMMON AND TO GIVE TYLENOL NOT IBRUPROFEN. MOTHER CALLED BACK BECAUSE SHE WANTED TO TELL THEM THAT THE RASH WAS BLISTERED AND THAT PATIENT NEEDED TO BE SEEN.  SHE WAS SEEN AND DR AND DR DETERMINED THAT IT WAS SHINGLES CAUSED BY THE VACCINATION.  PATIENT WAS IN EXCRUTIATING PAIN FROM 08/22/07-08/29/07.  SHE HAD A SEVERE HEADACHE AND THE TYLENOL DID NOT APPEAR TO HELP.  DR DID PRESCRIBE TYLENOL 3 WHICH HELPED HER SLEEP AND WITH THE HEADACHE.  THE PAIN HAS SOMEWHAT SUPSIDED AND THE RASH IS IMPROVING.  SHE DID HAVE TO MISS SCHOOL AND THIS WAS THE FIRST WEEK THAT SCHOOL WAS IN SESSION. PATIENT HAS A TWIN SISTER AND A BROTHER THAT HAD THE VACCINATION ON THE SAME DAY, BUT SISTER AND BROTHER DID NOT HAVE A REACTION.
Recurrence of pox lesions 3 mo. post-vax.  Multi-vesicular erythematous lesion about dime-size, 3 cm. from vax site.  Non-painful, no drainage, no systemic symptoms.  Resolving nicely by day 14.
Worsened dizziness (up to 3 days after each shot,) Muscle pain (3-5 days after each shot,) Worsening of weakness (persisting still,) All over body itching - especially of the face (1-3 days after each shot,) Hives of the face (day of each shot,) Severe- but temporary- burning / nerve pain in the feet (few hours the night after first shot only,) Worsening of exhaustion (persisting still,) Signs of hormonal imbalance (persisting still- lab testing to follow,) Cold sweats / chills (1-3 weeks after each shot,) Nausea (persisting still {pt never had nausea before, and this has been the worst / most pervasive side effect},) Brain fog (1-3 weeks after each shot) Pain at injection site (1-3 days after each shot,) Vivid nightmares (1-3 nights after each shot,) Swollen lymph nodes (persisting still,) Sore throat (1-3 days after each shot.)
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: @~1415 HR 63 BP 118/58; @~1430 BP128/92; @~1445 HR 71 BP: 127/87; Pt had gotten up to walk around store (stated she hadn't had an allergic reaction or fainted with a vaccine before), came back within 5 min and stated she was feeling hot, temp was 96.8. I asked pt to sit down and on her way over she fainted; denied hitting her head, only her arm. Responded almost immediately, proceeded to take vitals and monitored.
next dose of Imovax is due over the weekend; Received first Imovax on next day after was bitten by a stray dog/ No AE; Initial information was received on 17-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves adult female patient who was vaccinated with first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on next day after was bitten by a stray dog (inappropriate schedule of vaccine administered) and patient reported that next dose of Imovax is due over the weekend (Product dose omission).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for animal bite and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for prophylactic vaccination on 15-Jan-2019.  On 16-Jan-2020, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number not reported) via unknown route in unknown administration site for post exposure Immunisation (bitten by a stray dog).  The reporter states that on 15-Jan-2020 she was bitten by a stray dog and she went to the ED where she was given Adacel and told that she needed Imovax and Imogam, but it was not available at that ED. The next day on 16-Jan-2020, she went to a different ED and received Imogam and her first Imovax (inappropriate schedule of vaccine administered). Consumer also states that her next dose of Imovax is due over the weekend and there are not any doctors open that day.  It was an actual medication error case due to inappropriate schedule of vaccine administered and Product dose omission .   At a time of reporting no adverse event reported.  Information on the batch number was requested.  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.
A few minutes post vax pt became faint, fell and struck his head in the lobby. Pt had some clonic movements, no urinary or bowel incontinence. Pt awoke alert. Pt was observed for about 30 minutes and sent home.
January 20 received first shot-Moderna 005J20-2A at the hospital.  Arm sore for about a day c. January 22 onward-slight headaches January 26 began having severe chills. These lasted for about 4 days. They were most severe on January 29. Concurrent with chills was the onset of fatigue.  c. January 29-severe pain in hips and shoulders rendering me almost immobile. It was very difficult to get out of bed and to walk. I used a cane for support. Also the onset of diarrhea and loss of appetite. Tried extra strength Tylenol, but it did not help.  Never had a fever, respiratory symptoms, of loss of taste or smell. Had nasal Covid test of February 1 which was negative. Saw Doctor on February 4. He ordered blood tests, one of which was to check potential source of joint pain. The test was negative for that, but showed some lessening of kidney and liver function.  February 8-blood test showed considerable improvement on kidney and liver function. All symptoms except the fatigue have gone away. I did lose about 5 pounds during this reaction period.  The fatigue is improving.
Patient states her vaccine was injecting too high. Immediately after injection she was experiencing discomfort. Later in the evening the discomfort became extremely painful and has not resolved. She cannot move her arm at all.
On the night of the injection an intense headache began that included the back of the head and the neck, the injection site became very sore to the touch, a sleepless night due to a general malaise. In the morning there was intense pain in all the joints which continued, with the headache and a flash feverish feeling. After 24 hours the symptoms were less but prohibitive. Chest congestion started. It's now been 48 hours and the headache and join pain is mostly gone but the injection site has a rash that has spread a few inches down. and there is considerable chest congestion.
9/29/18: Patient's left shoulder and upper arm started getting to red, painful and swollen. 9/30/18: Redness, pain, swelling worsening. Pt felt a large knot on Right deltoid. He says it looked like a large bone was sticking out. Since 9/30, hands started getting achy. Patient states he started feeling very fatigued, dazed, and weak. Unsure if this was related. Since 9/30, Left shoulder and arm were hot to the touch. Patient reports arm and shoulder felt tender and numb in places. He took ibuprofen which gave possible slight relief. Appointment at our office on 10/2/18. Patient's arm was red, swollen, warm to the touch. Doctor started prednisone 40mg by mouth daily for 5 days. CMA 10/5/18
Fever with chills and achy muscles. It started around 10:00 PM and lasted throughout the night. It seemed to break around 3:00 AM. I didn't take my temp so I don't know how high the fever was.
6/20/08 noticed while charting vaccine, TD had been given instead of TDAP that was ordered and expiration date on TD was 3/20/08.  Patient had already left and was going to another doctor's appointment.  Doctor states patient not to be given TDAP on 6/20/08, CDC called on 6/22/08 and patient notified to return on 7/1/08 and will received TDAP.  Arm where shot received was sore.
I could not sleep the night of the vaccination. I was anxious but it only lasted a day.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 104th of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.
From Pharmacy. Pfizer #1 on 09/24/21 @  3 pm. right arm.   Above the  injection site there is a round indented area on the skin., She said that she has never had headache in her life. She has had a headache since the vaccine. " In my frontal Lobe,  it is on & off. " She said that the first day she felt like there was an elephant sitting on her chest, & since then she has been feeling palpitations in her chest. Her  PCP is thru local HCF.  She denied fever or  99% HR 73. For the first 24 hours the site was tender and pink, swollen and it has all since resolved, exception of the  dimple. She said that about an hour after the vaccine she did the magnet to her arm and it was magnetized. She said that about 36 hours after the vaccine the magnet no longer stuck. I advised her to contact her PCP related to the palpitations she is intermittently experiencing. She cried heavily on the phone saying she got the vaccine or she would lose her job. A VAERS will need to be submitted..
Vertigo, dizziness, nystagmus, cerebellum swelling, headache Treatment Neurometabolic Brain-Based Rehabiitation Program Outcome:  Over the course of 6 months of treatment, the symptoms have slowly diminished, but have not subsided,  and have now returned
Patient had Jenssen COVID19 vaccine 4/8/2021 Patient had Pfizer COVID19 vaccine 1/5/2022  Patient had subjective fever, chills, headache and chest pain starting 1/6/2022. Patient hospitalized for myopercarditis at Main Campus from 1/7/2022-1/10/2022.
I had a breakthrough case of Covid, so I've got fatigue, brain fog, trouble sleeping, headache, food did not taste good, congestion and cough, groggy. Loss of smell and taste.
Client is age 12 and received the Pfi zer 5-11 formulation. Multiple safeguards to prevent this type of error were in place, including color-coded wristbands/signs/tablecloths, staff education prior to the clinic and just-in-time training at clinic, only one vaccine type per vaccinator station, and at least 2 points in clinic flow where age and vaccine type are verified. This error was discovered by the family after clinic and also upon record review, and the client's guardian was informed immediately upon discovery on 1/26/2022. Per CDC guidance, the client may receive an age-appropriate dose of Pfizer vaccine in 21 days to complete the vaccine series; this was discussed with the client's guardian. Client's guardian reported that client did not experience any adverse effects after vaccination. This error will be discussed with the vaccine team to identify any adjustments to offsite clinic processes to prevent this type of error in the future.
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: within minute of injection patient passed out, parent and witness said patient had seizure like shaking (I did not personally witness this), became extremely pale and non-responsive for few minutes.  Before shot given Mom informed me patient normally faints and has extreme anxiety and aversion to needles.
pt exp GBS like sx including paralysis from the waist down p/vax;the reporter indicated event was not permanently disabling & the sx resolved in 3 days;
C/O dizziness, diaphoretic, hives, nausea, and headache
Covid positive (RTPCR); Covid positive (RTPCR); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL3248), on 29Mar2021 as dose 2, single (Lot number: EL3248) and on 26Oct2021 as dose 3 (booster), single (Lot number: EN6199) at the age of 39 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "unknown" and all described as "Covid positive (RTPCR)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Headache). On 25-Feb-2021, HEADACHE (Headache) had resolved. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
This is in follow-up to report(s) previously submitted on 5/30/2003. Information has been received from a consumer and follow up information from someone at a physician's office concerning consumer's son, a 25 month old male with fever and a history of a bladder infection at six months of age who on 11/06/2002 was vaccinated subcutaneously on the left with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot # 643500/0633M) (diluent lot # reported to be 0730M). The consumer reported concomitant therapy included acetaminophen (Tylenol) and vitamins (unspecified). The consumer reported that on 11/16/2002 the patient experienced a blank stare in which he would stare straight ahead without blinking or responding to stimuli.  He would then proceed to blink rapidly and press on his eyes. The reporter "suspects that he was experiencing oculogyric crises along with behavioral anomalies." The consumer reported that he also developed a systemic rash consisting of small itchy bumps, fever, chills, and drooling.  Per the consumer, these were not present prior to vaccination.  These symptoms lasted until 12/30/2002.  Unspecified medical attention was sought.  Additional information has been requested. Follow up information received from someone at the physician's office reported that the patient's mother called the physician's office and reported that the patient experienced blinking and questionable drooling one month after receiving the vaccine. The physician office reported that the mother did not bring the child in the physician's office. The consumer reported unspecified medical attention was sought. According to the consumer, these symptoms lasted until 30-DEC-2002. Additional information is not expected.
Was feeling sick and in bed all day on 6/6, could barely walk or talk on 6/7. Collapsed and stopped breathing/ passed away in the middle of the night late 6/7 or early 6/8.