chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Withing 5 days had a severe episode of insomnia, which she had never experienced in her life. 10 later protruding neck glands, & very painful lymph nodes.  Trouble with simple tasks, could not recall basic piano notes/chords. 26 days later debilitating  insomnia returned and this time lasted nightly for almost 5 weeks. Sleeping very little and saying she "forgot" how to sleep. Didn't matter how tired she was, she would not fall asleep. She was baffled and could not figure out what/why this was happening. She refused to take naps for fear of being even more awake at night.  Sleeping finally improved after much research and giving her anti inflammatories such as Turmeric. However, she continues to have a "racing heart" beat, excessive worry, nervousness which she never had before.
Early the next morning after my 3rd vaccination I lost consciousness and passed out. I had flu like symptoms for the next week. 10 days after my vaccine I started noticing that my face looked strange. A total of 3 weeks (12/11/2021) after the vaccine I developed a weird headache on back of skull. By 12/16/2021 I had trouble eating and my eye wasn't closing. On 12/18/2021 I went to the ER, half of my face was paralyzed. My ER dr referred me to a Neurologist and an Ophthalmologist. I found out that I should see an Optometrist instead of an Ophthalmologist.  From there I was sent to an ENT dr. I'm left with a speech impediment while waiting for my nerves to regenerate I was told that it could take up to a year to heal.
02/08/22 presents to ED for "Altered Mental Status". PMHx of "CKD 3, CVA, HTN, DM"
This spontaneous report was received from a physician refers to a 11 years old male patient. The patient had attention deficit disorder and drug reactions/allergies to penicillin (unspecified)-rash. On 12-JUN-2013 the patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot # H019495, expiry date: 15-AUG-2015), intramuscular at an unspecified location. ON 12-AUG-2013 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot# 0459AE, expiry date: 13-DEC-2014), intramuscular at an unspecified location. Concomitant therapy include ADDERALL tablets. On 14-AUG-2013 the patient developed an itchy rash, over his entire body. BENADRYL was given for event. The patient had sought medical attention by phone call to physician from parent. On an unspecified date the outcome of the event was recovered. No lab diagnostics studies were performed. Additional information has been requested.
This literature report concerns a 74-year-old male patient with left arm swelling, pain and numbness for the last 1 month. His medical history was significant for renal cell cancer (RCC), which was diagnosed 5 years ago. Appropriate staging was performed at that time which was T2N0M0. Because of absence of disseminated disease, nephrectomy was recommended. The patient underwent left sided nephrectomy and was discharged home. Two months before current admission, the patient received a flu shot (manufacturer unknown) in left upper arm and developed left arm swelling, pain and erythema. He was admitted to hospital and treated for cellulitis for 2 days, and then he was discharged home on oral antibiotics. He improved temporarily and then presented again 1 month after discharge (current admission) with similar complaints. On physical examination, the patient had severe edema involving the entire left upper extremity extending from shoulder to the finger tips. There was oozing of serous fluid without any open wounds along with an area of bluish discoloration in left upper arm. On palpation, he had an area of induration on the anterior aspect of left upper arm and palpable left axillary lymph nodes. On vascular examination, distal radial pulses were present. On neurologic examination, he had decreased sensation of the left arm along with complete wrist drop and inability to perform hand grip. Initial laboratory studies showed serum creatinine of 1.63 mg/dL, creatinine kinase 236 units/L, leukocytes count of 13.2 k/uL, hemoglobin of 11.9 g/dL and platelets count of 55 k/uL. Ultrasound of left upper extremity failed to reveal deep venous thrombosis but did show a large hematoma measuring 13.8 x 7 cm. An initial diagnosis of compartment syndrome with wrist drop was made. The patient was taken to the operating room immediately. He underwent open fasciotomy with incision and drainage. A total of 200 mL of serous fluid was drained, and no pockets of abscess or hematoma were found. Histopathological and microbiological specimens from biceps muscle were obtained. Results showed metastatic RCC in the left upper arm of clear cell type. The patient also underwent radiological imaging including computed tomography scan of abdomen that was consistent with developing metastatic lesions in liver. The event outcome was not reported.
Received Hepatitis A vaccine yesterday, and approx. 8 hours later I developed adverse side effects - vomiting, diarrhea, chills, body aches, and cold diaphoresis. I just wanted to report profound side effects. My sister received the same vaccine and had to leave work early for the same symptoms. We both take thyroid medication, not sure if polypharmacy is a researched issue in this case.
This spontaneous report was received from a nurse regarding several patient's of unknown and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified dates in 2016, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route, lot # and expiration date were not reported). VARIVAX doses had been in freezer that had been out of range since 02-JAN-2016 according to the data logger. The temperature excursion was during 4416 hours (184 days). There was no adverse event reported. This is one of two reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a year after receiving SHINGRIX, the patient experienced injection site pain, myalgia and injection site erythema. On an unknown date, the outcome of the injection site pain, myalgia and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, myalgia and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient received her dose of SHINGRIX sometime in the middle of August at her primary care office and experienced redness and pain at the injection site and myalgia throughout the body. The patient said the adverse events lasted about 4 days. The patient got 1st dose of SHINGRIX elsewhere so no other information was provided.
Chills initially.  24 hours after the shot: fever 101, severe body pain, headache, stomach pain, neck and back pain, severe eye burning and body felt to be on fire.  Arm was very swollen and feverish.  This continued 48 hours after the shot.  Saw a doctor at Urgent Care today who diagnosed as a reaction to the shot.
Fast heart rate, massive headache, ringing in my head, body aches, muscle aches, dizzy, hives at the injection site, fever of 101 all day long. Fever stayed at 100 degrees even with tylenol, lethargy and feeling run down, was in bed all day
I was injected in left deltoid and soon thereafter my shoulder started to ache.  It became much worse after 2-3 days and now 10 days later it is still with me - joint pain, inability to raise arm, muscle pain.  I had been injected previously - 1 month ago with same vaccine.  I am in high risk group - dealing with wildlife and feral animals so have had the series many times.  this vaccine was prompted by a feral cat bite.  cat has been quarantined for 16 days and no sign of rabies.
The day following the vaccine, patient developed a headache with right sided head pain, mild photophobia and occasional nausea.  Patient is treated with diphenhydramine, ketorolac, prochlorperazine and IV fluids.  Her headache resolved completely.
I have had a headache after the second shot on March 01st; A few days after, The site were I had the vaccine is still very sort touch. That was 10 days ago; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included dementia early on-set. The patient had no known allergies to medications, food or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO), memantine (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 16:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 16:00, the patient experienced headache after the second shot. On an unknown date in Mar2021, a few days after the site where patient had the vaccine was still very sort touch, that was 10 days ago. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache and site where patient had the vaccine was still very sort touch was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician.  The physician reported that "she heard from a friend that the female patient, who was not the physician's patient, on an unspecified date was vaccinated with a dose of GARDASIL.  Subsequently the patient was unable to move the arm the injection was given.  The physician also reported that the patient had to go to physical therapy".  At the time of reporting, the patient's outcome is unknown.  Attempts to verify the existence of an identifiable patient (and/or reporter, as appropriate) have been unsuccessful.  No further information is available.
moderte dehydration, abd pain, gastritis, PVC's, fever 99.5;
T101 & h/a 28JUL98 x 2 days;took Ibuprofen;sore neck 29JUL98 x 2 days;took Ibuprofen;sl nose bleed 30JUL98;pt saw MD;CBC drawn-no tx recommended;
gradually being short of breath/ huffing and puffing; This is a spontaneous report from a non-contactable consumer (patient's wife). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. About 8 days after the first dose in Jan2021, the patient started noticing gradually being short of breath. He would walk for 50 yards and he would be huffing and puffing which is unusual because he can walk a lot.  It gradually got worse. Outcome of the event was not recovered. Patient received his second dose on 10Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event; the patient was administered a dose of VARIVAX on 12/19/2019, that had been improperly stored; This spontaneous report was received from a office menager and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 19-DEC-2019, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S021926, expiration date 15-JUL-2021 (dose, frequency, route of administration were not provided) reconstituted with properly stored sterile diluent. Administered doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion 1.2 C for 3 hours 9 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse events were reported.
He got his vaccine, and was okay.  The next day was tired, drowsiness and missed a day of work, and was able to work after that.  He        was supposed to get his 2nd vaccine on 5/21/21 and had to go out of town and was going to get it when he got back.  The next day 5/23/21 at 12:00 AM his throat began to swell up and gradually it moved from his throat to his chest area.  He went to the ER on 5/23/21 in Hospital and they looked at his throat, gave him a steroid shot and some antibiotics and sent him home.  The next morning he drove back to home and continued taking the antibiotics that they prescribed and his throat kept swelling more and more.  On Tuesday 5/25 at 1:00 PM he went to the ER and sat there 8 hours without being seen and decided to leave.  The next morning 5/26/21 he went to an UC and they sent him to an ER at Hospital and from there he was sent to another ER by ambulance to have emergency throat surgery.  He had surgery on  5/27/21 at the Hospital where he had an abscess on the inside of his throat that caused his throat to swell.  He had swollen lymph nodes and to release the pressure and fluid in his throat as his neck and chest were swelled up.   He was discharged on 5/31/21.  He is now recovering from the surgery and getting better.  He lost 30# as he was not able to eat and did not have an appetite until he came home and eating a little bit better now.   He goes back to his doctor on 6/15/21 to get the stitches removed from his neck.
6/4/2021 1730  Pt called and stated that he felt fine the day of the 2nd Moderna vaccine, but when he woke up early the next morning, he experienced dizziness and his gait was unsteady.  He went to work and began to feel worse.  His co-workers noticed that he was not completing his paperwork correctly and he struggled doing his daily tasks.  He stated he felt like he was going to pass out and was out of breath.  His supervisor sent him home.  He attempted to drive home and swerved off the road.  He parked his car and got a ride home.  He slept for several hours.  He stated he is feeling better this evening.  Now he has a headache, but does not have dizziness, unsteady gait, or feeling like he will pass out.  I advised him that headache is a possible side effect of the vaccine, but the other symptoms are uncommon.  I asked him to seek medical attention if the symptoms come back.  He voiced understanding.
Cellulitis of Arm, Painful site, swollen tight, hot to touch 1 week after injection. Rx Cephalexin 500mg 1xQID
Vaccination received on 10/12/2010.  Employee reported to Corporate office at 4pm on 10/13/2010 to show the Director of Education the symptoms she was experiencing. Symptoms are as follows:   Swelling, warmth, redness and bruising noted on left deltoid.  Left axillary lymph node and lymph glands in neck bilaterally swollen.   She was sent to our employee health clinic for evaluation.   Results of visit pending.
*Per patient's mom's report* After leaving pharmacy, Pt c/o throat swelling/difficulty swallowing. Within 45 min, angioedema + tongue swelling. Benadryl + prednisone given orally @ home. Dad rushed Pt to ER, IM Epi given, Pt admitted for observation over HS.
swelling, soreness at the injection site; lump at the injection site; syringe issue; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA130001 and 2019SA129987 (same reporter).  This case involves Adult female patient who experienced swelling, soreness at the injection site, lump at the injection site and syringe issue, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB.  On an unknown date, The patient developed a non-serious swelling, soreness at the injection site (vaccination site inflammation) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, The patient developed a non-serious lump at the injection site (vaccination site mass)  following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of syringe issue. . Final diagnosis was syringe issue, lump at the injection site and swelling, soreness at the injection site.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for swelling, soreness at the injection site, as Unknown for lump at the injection site and as Not Applicable for syringe issue.
"I took flu shot on 10/5/2009 and 2 weeks later I came down with a horrible flu." "I took over the counter medications."
Approximately 5 minutes after injection was completed, patient lost consciousness for approximately 10 seconds. Patient awoke startled afterwards. Approximately 3 minutes after that, patient lost consciosness again for approximately 15 seconds. EMS was called and they came approximately 15 minutes later and transported the patient to the Medical Center
administered GARDASIL 9 while pregnant; The patient was suppose to receive a Tdap vaccination; This spontaneous, prospective pregnancy report was received from a physician and refers a 33-year-old, pregnant female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were reported as none.  Date of the patient's last menstrual period (LMP) was calculated as 30-SEP-2021. At the time of the report, pregnancy gestation period was 28 weeks. The pregnancy outcome was pending (unknown fetal outcome). Estimated date of delivery (EDD) was calculated as 07-JUL-2022.  On 14-APR-2022, the patient was incorrectly vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection in the arm (dose, route of administration, lot # and expiration date were not reported) for prophylaxis, while she was supposed to receive a diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) vaccination (wrong vaccine administered).
pt recvd vax; pt devel rash on upper arms at injection sites; pt exp arthralgia & fatigue; abdominal pain & nausea; pt devel arthritis;
Based on information received on 19-Dec-2018, the report previously considered as non-valid became valid as identifiable female patient was present in the Follow up. Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient of unknown age who received vaccine IMOVAX RABIES (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 04-Dec-2018, 07-Dec-2018 and 11-Dec-2018 (schedule as day 0, 3 and 7) which was also involved in cold chain break as vaccines had reached 50 F, for over 72 hours. Patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to product storage error. It was not reported that if the patient experienced any adverse reaction or not. 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. Follow up information received on 19-Dec-2018 from a pharmacist. Case become valid from invalid as identifiable patient was present. List of documents held by sender: none.
A report received from a health professional on 30Oct02, concerning approx 10 vaccinees who inadvertently received last years formulation of Fluvirin. From 28Oct02 to 30Oct02, 20-30 staff members were vaccinated with Fluvirin. After finishing the vaccination, a staff member noticed that one of the used vials was last years vaccine (2001-2002). The vial was discarded, thus the batch number is not available. There was insufficient information to determine the reporters causality assessment. Update 1 27Jan03: A report was received from a health care professional concerning a 57 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date. The vaccinee was subsequently revaccinated with this years influenza vaccination and experienced no adverse reaction. See Ref: PJP200200635, PJP20030049, PJP200300050, PJP200300052, PJP200300053, PJP200300054.
Sore arm; Moderate Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 09:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included Meniere's disease, Hashimoto's disease, and vitiligo. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included calcium (MANUFACTURER UNKNOWN), levothyroxine sodium (LEVOXYL), melatonin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Feb2021 at 16:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient previously took terconazole (TERAZOL) for an unknown indication and experienced fever. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 20:45, the patient experienced moderate headache and sore arm. The patient did not receive treatment for the reported events. The clinical outcome of the events moderate headache and sore arm were recovered on an unspecified date in Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
The day after vaccination, patient syncopized at home. was found down by son.  had respiratory depression, was given narcan, IV fluids, and supplemental oxygen, and slowly became responsive. Urine drug screen negative for opioids.
Information has been received from a registered nurse concerning a patient who in 2006, report as "5 years ago", was vaccinated with 3 dose series of hepatitis B virus vaccine, and on an unspecified date in 2009, bloodwork showed no hepatitis B antibodies. On an unspecified date in 2009 the patient starting a second series of hepatitis B virus vaccine, and finishing in January 2010. On an unspecified date in 2011, the patient's quantitative hepatitis panel done and was negative for hepatitis B antibodies. It was unknown if the patient sought medical attention. At the time of report, the patient's outcome was unknown. No further information is available.