chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IPOL was administered after the excursion with no adverse event; IPOL being administered post excursion with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who was administered Ipol post excursion with no reported adverse event, while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 16-Jul-2022, the patient received a  dose of suspect IPV (VERO) lot U1A452M at a dose of 0.5ml once via intramuscular route in the left thigh for immunization.  On an unknown date, the reporter stated that the vaccine Ipol had temperature excursion with no adverse event (product storage error).  On 16-Jul-2022, the patient developed a non-serious event of Ipol being administered post excursion with no reported adverse event (poor quality product administered)same day following the administration of IPV (VERO).  Action taken :not applicable.  Outcome: unknown for both events   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 the guidelines. 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 cranky, inconsolable, crying; no sleep x 2 days; fitful; sore, hard, red lump on rt x 3 days; t102.6;
Roughly 4 minutes after receiving 2nd Hep. B immunization, patient dropped to the floor from a standing position. Patient eyes open, unresponsive, and upper body started to have a rhythmic jerking movement. Patient appeared to hold breath for 5 seconds while jerking occurred. Seizure like activity lasted about 7 seconds and then stopped. Patient then resumed consciousness, sat up and became oriented. Pediatrician called. Paramedics called. Orthostatic were performed. Unsteady on feet it appeared when walked to exam room. In exam room nauseated & small emesis. Patient taken to ER via ambulance.
exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KN5VR, expiry date 16th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The pharmacist called due to their discovery that the patient was inadvertently administered on 16th September 2021 the vaccine that was in the temperature excursion, which led to incorrect storage of drug. The pharmacist was informed that the vaccine should be discarded due to exposure to freezing temperature 31.5 degree Fahrenheit for 13 hours. The reporter did not consent to follow up. This was 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter
Left CVA - headache, weakness, numbness, speech slurring, left face asymmetry.
Pt was seen for 15 month WCC on 9/16. Pt received Dtap and Hib vaccines. About 36 hours later on 9/17, pt awoke from sleep, mom noted swelling of his entire face, pt put his arm to his chest, his eyes rolled back and he had whole body shaking for 30 seconds. Pt was unresponsive during the episode and was sleepy for 30 minutes afterwards. Pt was evaluated in the ER. Pt's temp was 100.2 in the ER, pt received motrin, was diagnosed with simple febrile seizure, and instructed to follow up with PCP. Per mom, pt did not have a fever at home prior to seizure, pt did not feel warm during event, and pt did not receive any anti-pyretic at home. Pt did not have any associated nasal drainage/congestion, ear pain, vomiting, diarrhea, or rash around the time of the event.
Pressure/sensation in throat and chest, lightheaded. Was instructed to wait until I felt better, which was 45 minutes later. Given orange juice and attention. Back muscular pain later in day. Headache and chills episode following day.
Received dose on 5/17/2021,  on 5/19/2021 pm patient said she had a small, hot, hard red spot on front mid arm (inj was given on upper left center deltoid). She came in on 5/20/2021 with a larger pinkish/red area that she said was not as hot and did not have a hard bump. She took benadryl on 5/19/2021 evening before bed.  Advised patient to use a cold compress on warm area and continue benadryl.  Along with instructions to contact physician if area became worse.
facial symptoms; Bell's Palsy.; headache; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 25Mar2021 10:30 AM (Lot Number: ER8733) at the same age as single dose for COVID-19 immunisation. Medical history included Herpes (although no symptoms or outbreaks for 20+ years). Concomitant medications included estradiol (ESTROGEN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 04Mar2021 11.30am (Lot Number: EN6206) as single dose for COVID-19 immunisation. The patient experienced Bell's Palsy and first had headache on 12Apr2021, first facial symptoms appeared on 16Apr2021. The adverse event result in: Doctor or other healthcare professional office/clinic visit. Treatment was received for the events including Prednisone and anti-viral. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant. Outcome of the events was recovering.
Post flu vaccine pt c/o right leg numbness pt was left in observation for 15 min. Pt had dizziness, headaches after 15 min patient stated his leg was feeling better by the time the patient was discharged, patient stated the numbness had gone away.
Information has been received from a physician concerning a 6 month old female who was vaccinated with a first dose of RotaTeq vaccine on a unspecified date. On 12-APR-2007, the patient was vaccinated with a second dose of RotaTeq vaccine. On 11-JUN-2007, the patient was vaccinated with a third dose of RotaTeq vaccine (lot# 657046/0504U). On 12-JUN-2007, the patient experienced bad diarrhea that was persistent for 2 or 3 days. Subsequently, the patient recovered 3 days after vaccination with the third dose of RotaTeq vaccine. It was reported that the patient's mother called the physician's office for medical attention. No product quality complaint was involved. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of fever in a 17-year-old female patient who received Bexsero for prophylaxis. On 22nd June 2018, the patient received the 1st dose of Bexsero. In June 2018, less than a week after receiving Bexsero, the patient experienced back pain, photophobia, headache and muscle pain. On 22nd June 2018, the patient experienced fever. On 24th June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the back pain, photophobia, headache and muscle pain were unknown. It was unknown if the reporter considered the fever, back pain, photophobia, headache and muscle pain to be related to Bexsero. Additional details were provided as follows: The patient was 17.5 years old at the time of the event onset. The patient had a PPD skin test on 22nd June 2018. Latency of fever was less than a day. On 22nd, 23rd and 24th June 2018, the patient experienced fever that finally resolved on 24th June 2018. The patient also complained about throbbing on the front of her head, back pain, pain when moving her head and photophobia. The patient visited her physician on 29th June 2018 for the headache, photophobia, back muscle pain and tenderness on her back. The sales representative did not have any details on whether events were still continuing or resolved. It was reported that, sales representative was having an MSL following up with the physician.
Arm Pain, Can?t Lift To Dress, Can?t Lift Anything, Shoulder Pops, for 2 weeks
Developed a severe headache worst I have ever had and it lasted 7 days before going away. This started about 4 or 5 days after my vaccine. Didn't go to the Doctor because I thought it was just allergies
7cm x 3cm area on lt deltoid, swollen, red,  & painful;
Given undiluted 2nd dose of pediatric series vaccine. No reported adverse events at this time.
TD shot 2 days ago has red/painful area to L upper arm lateral side. Tender and arm, no pustules, 6 cm diameter erythemic warm patch L arm.
The night of the day I received the shoot, I noticed a redness to my face along with a burning sensation. The next day (Oct 23) the redness had extended to my arms and the burning had intensified spreading to my ears. I went to the emergency room where the doctor concluded it was a reaction to the vaccine. He was going to administer a steroid but decided not to, wanting to avoid anymore "adverse reactions". Today (Oct 24) I woke with the rash (or hives) spreading to the rest of my body.
PT C/O OF FEVER 103,BODY ACHES,SOB,STIFFNESS IN JOINTS AND DIZZINES, SWOLLEN GLANDS
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-046007.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021 contains non-significant information.
pediatric dose / was given to a 40 year old adult; pediatric dose / was given to a 40 year old adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number LM992, expiry date 13th December 2022) for prophylaxis.   On 30th July 2021, the patient received Engerix B pediatric 10 ug. On 30th July 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
Pt recvd MMR vax on 30AUG91 13 days later had t104; screamed 8 hrs; no rash then OK; Not seen by MD;
Dizziness began 21 min after vaccines given. Pt lay down on exam table, B/P 110/76, color good, not cyanotic, pt. shaky, claimed to see "spots". All sx gone after 30 min.
pt recv vax 18JAN noted to become irritable-tx w/APAP 130PM & 10PM;next morning pt was very difficult to arouse-would awaken for short periods;would take feedings but would remain unawake,eyes closed;less alert,diminished eye contact
Frontal headache onset 6 days ago. Reports she developed the headache and a fever (T-max 103 °F) after she received her first COVID vaccine 6 days ago. She says she last had the fever yesterday (7/25). She admits to associated symptoms of abdominal pain, dizziness, vomiting (2 episodes yesterday), and sore throat.
I had normal vaccine reactions that lasted for two days including significant body aches, unable to lift left arm without significant pain, and chills. The very unusual symptom was all TEN fingers  (i.e. both hands) from the last joint to the finger tip went numb for 2 hours from 11:50 am to 1:50 pm. And then the numbness was gone. The numbness felt like the kind you get if you were outside on a below freezing day and let your finger tips go numb in the cold. However, I tried many techniques to try and get my fingers to stop being numb and nothing worked. The numbness resolved on its own after 2 hours.
Vestibular migraine; vertical/constant dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (vertical/constant dizziness) and VESTIBULAR MIGRAINE (Vestibular migraine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (vertical/constant dizziness). On an unknown date, the patient experienced VESTIBULAR MIGRAINE (Vestibular migraine). The patient was treated with VENLAFAXINE for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (vertical/constant dizziness) had not resolved and VESTIBULAR MIGRAINE (Vestibular migraine) outcome was unknown.            No relevant concomitant medications were reported.  The patient reported that she had constant dizziness for 7months.
This spontaneous report was received from a back office lead and refers to a 52-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (1 ml, left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. The patient was vaccinated on three separate times with a dose of RECOMBIVAX HB (dose, route of administration, lot #, expiration date and therapy type were unknown), on 10-MAR-2016, followed by 11-APR-2016 and finally on 02-MAY-2016, respectively. However, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Redness, swelling, tenderness at site of infection that extended from the shoulder to the elbow with swollen lymph nodes in the axilla and a mild fever.
Patient presented to the ER initially at facility with stroke-like symptoms, CT perfusion study showed acute infarction with a large ischemic penumbra, patient was transferred to another facility on 12.20.21 for a mechanical thrombectomy. Patient was diagnosed with a left MCA ischemic stroke, suspected from uncontrolled DM and hypercoagulable state from Covid-19. On 1/1/22, patient returned to ICU after being hypotensive, hypoxic and went into PEA arrest. CT showed development of a R MCA stroke. TTE with evidence of an LV thrombus. Family transitioned patient to comfort care
We arrived on 02/10/2021 to give second doses to residents at Medical Resort . Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.
pt recv vax 25APR96 & pt sat down in a chair & arms started shaking & then passed out;the episode lasted a matter of seconds;w/in min pt had fully recovered;
Employee came back to employee health 1.5 hours after the vaccination complaining of severe dizziness and chest heaviness.  No shortness of breath, wheezing or signs of airway restrictions.  No nausea or vomiting. No redness or bruising at injection site.  Blood pressure taken was 150/88.  Heart rate was 120.  Employee taken to facility Emergency Department  by wheelchair.
Fever of 101; chills; joint pain; Headache; nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache) and NAUSEA (nausea) in a 66-year-old male patient 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Pyrexia: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
Swollen hard area 18mm x 28mm developed at site of ADACEL injection (Left deltoid) given 11-5-2008. Area very painful to touch with reported shooting pain down arm when arm flexed, first tightened. Reported "burning" pain extending into hand if tries to lift a heavy object.
pt devel a high pitch cry w/in 6 hrs of immun; lasted throughout the noc; fever 103 ax was irritable;
The patient should have received Pfizer dose #1. Multiple attempts have been made to reach this patient via phone about this vaccine error.  No return phone call from this patient and patient has not reported any adverse reactions to receiving this dose.
Patient had chills and fever accompanied by tachycardia with heart rate in the 130's
Given R upper lat leg - VARIVAX - 4 d ago. Redness- serpentigenous.
Pt's mother reports pt had swelling to left deltoid and rash to left arm two days after getting his shot on 06/10/02. Pt complained of pain to left arm that night. Mom also reports pt had difficulty breathing that night as well. Swelling and rash persisted to left arm for 10 days. Fever of 100 tat night mom used cold compresses. Pt continues to have large knot to left arm.
day following vax pt a seizure & lost consciousness for approx 30 seconds. no treatment
Right ear felt like it was plugged with ear wax on February 20, 2021.   Administered 5 drops of Murine Ear Wax Removal Ear Drops twice per day on February 21, 2021.  Right ear was very painful on February 22, 2021 AM.  The pain kept getting progressively worse.  Took two 325mg of Tylenol in the evening.  Pain abated, but ear feels like it is suffering from a residual cold.
Nov 28 7 am - fatigue, chills, body ache. Recorded temp around 11 am at 100.1
muscle tenderness; stiffness in his upper shoulder and the neck; stiff neck and shoulder; local light pain; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL9261, expiration date: unknown), via an unspecified route of administration in the left arm on 21Jan2021at 12:50 as a SINGLE DOSE for COVID-19 immunization. Medical history included back pain and arthritis. Concomitant medications include propafenone taking for more 5 year still ongoing for indication atrial fibrillation and dutasteride taking for a year and half still ongoing for indication prostate. No history of all previous immunization with Pfizer vaccine and no prior vaccination in four weeks. On 21Jan2021, received first dose of the vaccine about 2 and a half weeks ago. He stated, it went fine but the day after, on 22jan2021 had some muscle tenderness (local light pain) and stiff neck and shoulder developed that was pretty mild but it was still going. It's about 2 and a half weeks now. In the morning it was maybe a tad more stiff mostly on left arm, it improved some when walking around and with exercising so he doesn't have to take medication. He stated, when you don't move it doesn't hurt, it's when you move the neck muscle that it was sore but not much at all. At his age you have back pain and a little arthritis. It was strange that it started the day of or day after. He stated he did report just a bit of local pain but only when you touch the area and a very mild muscle pain, but it has continued and he doesn't know if it was related. He asked if this was related to the vaccine and how long this typically lasts. Mentioned he has had this pain before but he feels that he has avoided exercise or yoga or anything that would cause it now. he does have arthritis in his back. He was scheduled to receive the second dose of the vaccine on 11Feb2021. He didn't receive any treatment for the events. The clinical outcome of the events was still unsure if he had this before vaccine or not and its persisting.The outcome of all events were not recovered.
On 07/15/2003 client took 1st dose of oral Typhoid-vivotif Berna 30 minutes later she experienced nausea, vomiting, and diarrhea.  It is unknown if client had fever.  By 07/17/2003 client reported nausea and lack of appetite.  No other symptoms.  07/18/2003 client reported having a "cold" and she felt the Vivotif Berna had "lowered my immune system".  07/22/2003 client reports "getting over a cold".  No other doses taken.
Pressure and pain on my right side of neck radiating to armpit.  Pain in the injection site. Sometimes can't turn my head. This is still occurring two weeks after vaccination.   I have tried heat, Aleve and resting.
Gave vaccine, patient left then returned a few min later with cough, congestion, audible wheezing, and redness on skin. Reassessed patient and gave BENADRYL/ORAPRED. Patient was taken to hospital EMS. Sent to ER for observation.