chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose Sep 2022, 2nd 7Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 38-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 7th October 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 Information: GSK Receipt Date: 05-Dec-2022 The pharmacist called and reported that the patient was administered a second dose of the Havrix vaccine 1 month after receiving the first one. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. This case is 2 of 2. Additional supportive information: The patient received 2nd dose of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. This case is linked to the case US2022181959, reported by the same reporter.; Sender's Comments:  US-GSK-US2022181959:Same reporter
Headache, neck pain, fatigue, dizziness, lightheadedness, stomach pain. Started the day after the shot, currently experiencing symptoms.
patient was administered expired Daptacel in her left thigh with no reported adverse event; Initial information received on 05-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 years old female patient where patient was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] in her left thigh with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and polio vaccine for Prophylactic vaccination.  On 28-Jun-2023, the patient received 0.5 ml (TOTAL) dose 5 of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (batch number- C5893AA and expiration date- 21-Jun-2023)  via unknown route in the left thigh (strength: not provided) for Immunisation.  On 28-Jun-2023 the patient was administered expired daptacel in her left thigh with no reported adverse event (expired product administered) (latency- same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Vaccine that had expired June 21,2023 was accidentally administered to 5 patients. Product used : Used Still using product : No  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 recvd vax, seen for weight loss; was vomiting; had type I diabetes;
Itchy rash developed from mid spine to front of breast bone around one side of the body.  Patient went to the Doctor and got a prescription for gabapentin and topical lidocaine.
I have a lot of muscle aches and fatigue since receiving my vaccine. I have joint pain and sometimes I get sharp pain in my left arm where I got the vaccine. I also got some tightening of my chest and will have it checked since I did have a heart attack in 2019. I also had body aches and also have sweats. I'm having complete physical in couple of weeks.
Information has been received from a consumer concerning her mother who was on 04-Oct-2007 vaccinated with a dose of Zostavax.  On 04-Oct-2007 the patient developed injection site redness.  The patient's injection site redness persisted.  It was unknown if medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  No further information is available.
Client had onset of symptoms within hour of vaccine c/o lt hand swelling. Injection site sore 1st evening. Next day 6/1/05 developed knot at site of injection. C/O fatigue, napped, took Advil through out day. 6/16/05 knot at site of injection larger. c/o achiness on left side of body, shoulder, elbow, hip, knee. 6/17/05 symptoms resolving. 6/22/05 follow up symptoms gone.
CHRONIC FATIGUE, FEVER, FLU-LIKE SYMPTOMS ONGOING FOR 6+ WEEKS PER PATIENT
Guardian stated to MA and DR that pt had not yet received a single dose of covid vaccines in the past- interested in receiving them today. At the end of the visit the M went in to the exam room, took 2 patient identifiers, proceeded to document vaccines due for each patient (covid 1st dose and HPV). After both vaccines were give to the patient and handed a vaccine card for covid, guardian then stated pt had already received two doses of covid Pfizer vaccine at a local store (1st dose in January, 2nd dose in February) and provided Ma with Vaccine cards proving that they had already been fully vaccinated.  Pt record in state registry for first two doses was under alternate name and not found until after administration.  Patient too young for booster dose.
Shot given 2-8-2021 Symptoms started 2-10-2021 Body Aches  Chills Fever 100.4 Fatigue
SEVERE VERTIGO; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-DEC-2021, the patient experienced severe vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe vertigo. This report was non-serious.
pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating; Developed right leg muscle cramps; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) and MUSCLE SPASMS (Developed right leg muscle cramps) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) (seriousness criterion hospitalization) and MUSCLE SPASMS (Developed right leg muscle cramps) (seriousness criterion hospitalization). The patient was hospitalized on 02-May-2021 due to MUSCLE SPASMS and PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) and MUSCLE SPASMS (Developed right leg muscle cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Ultrasound scan: (normal) studies were ok. On 02-May-2021, X-ray: ok (normal) studies were ok.         On the evening of 01-May-2021, the patient states he developed cramps and pain in his right leg, which continued to get worse. The patient stated The patient states that the hospital gave him medications to help the pain, and he left the hospital. The patient  took the medicine and it eased for a while, but keeps recurring. The patient stated that he then went to another hospital due to the persistent pain, where he was admitted for observation. The pain is in the back of right leg, up into the thigh. Treatment included pain medicine, Tylenol, Ibuprofen, nerve tablets, and a muscle relaxer. The doctors were trying to find out what the pain was from.  The action taken with mRNA-1273 in response to the event was not applicable.  Company comment Based on the current available information and temporal association between the use of the product  and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product  and the start date of the events, a causal relationship cannot be excluded.
Per ER chart: "42 year old female here tonight for treatment of allergic reaction to vaccination from earlier today. States she received a hep B vaccine around 1530 today.  Around 1730, noticed that she was really hot and didn't feel right.  Approx 10 minutes to arrival noticed rash to face and chest and noticed shortness of breath/difficulty breathing.  She isn't sure about associated throat or tongue swelling, just states something doesn't feel right.  Denies any nausea/vomiting.  Does report feeling a bit lightheaded.  Denies any other changes to her regimen- no new foods, medications, etc.  States the only thing that is new is her Hep B vaccine.." Treated with epi 0.3 mg IM, solumedrol 125 mg IV, benadryl 50 mg IV, pepcid 20 mg IV.
About an hour after I received the Moderna vaccine, the left side of the face felt warm and being to tingle.  My left ear, my left cheek and my lower lip to the midline felt like pins and needles.  It began to get more numb and I had a lot of difficulty eating my lunch because I started to bite my lip because it was so numb.  I then took 50 mg of Benedryl in  Tablet form.  Within 45minutes the numbness dissipated and has not returned.  I have no weakness or drooping.  The numbness has not returned.  My left arm was really sore for 3 days but is no longer painful.
Baseball size knot and redness at injection site, pain radiating down arms and fingers, blisters on arm and side of torso.
Patient is 76-year-old female with chronic chronic interstitial lung disease, chronic hypoxic respiratory failure on 3 L nasal cannula at baseline who presents to the ER complaining of increased cough over the past 2 weeks a mostly nonproductive.  History per limited records and patient's daughter who is present.  Patient presents to the ER due to of cough is noted above for denies headache, currently short of breath, no chest pain, nausea vomiting diarrhea she has not been on recent antibiotics.  She has had COVID vaccine series he has had 2 doses and unaware of any COVID positive contacts      DISCHARGE:     Patient is a pleasant 76 year old female with history of ILD on
Approx 12:25pm, patient received Pfizer Covid vaccine, assessed by RN at 12:26pm, 12:30pm patient complained of throat tightness, 12:31 patient complained of voice being raspy.  Radial HR 120, pupils equal and reactive.  Denies nausea.  No hives/rash noted.  At that time, patient admitted to previously being diagnosed with Paradoxal Reactions to Medications, Anxiety and Depression.  Patient takes Zoloft and Elavil, and admits to being anxious. 12:40-12:43pm patient states that she is feeling SOA,  throat tightness, dizziness.  Respiration unlabored, however patient admits to becoming more anxious.  Patient red faced, HR 130's.  12:44pm Epinephrine 0.1mg/0.15mg/0.3mg auto injector given IM to right outer thigh.  Patient tolerated well. EMS called at 12:45pm.  EMS arrived to assess patient at 12:53pm.  Patient walked into ambulance.  Patient did not require O2.  No hives noted.  Denies nausea.  Patient transported to ER per protocol for evaluation.
Reported after 15 minutes face became hot and flushed and then spread to arms and neck.  Denies any difficulty breathing or ever having any problems with any other immunizations.  Observed for at least 15 minutes and no difficulty breathing and redness cleared from arms. Face began to blanch out. Attempted to call her PMD and he was out of office already. Advised to take Benadryl and if no better or if had any difficulty breathing to seek emergency treatment.
Within 18 hours developed explosive diarrhea and rash covering lower back to mid thigh including entire genital area. Also started running fever near 102 deg F
about 5 pm: took pt to vaccine room to administer vaccine about 5:05 (2-3 minutes after vaccine administration): Pt gets up from seat in waiting room to come to consultation window with symptoms of "light-headedness".  Advised him to remain seated for the full 15 minutes. On his way back he collapsed. Called 911, while on the phone with them the pt sat  upright and was responsive. Kept him where he fell until EMS arrived.
She began with an earache and dizziness. Pain got so severe that she could no longer take it. Went to the doctor which she was put on pain medications. Went to ER on 1/6 and on 1/7 went to her PCP. Still in severe pain.
Patient began with redness at site of injection then develooed one hive. Call placed to MD. By the time returned to patient, patient had hives throughout body. Patient taken to ER, given Benedryl and is still receiving Benedryl. Patient at home hives x1 on arm at site with redness.
headache; nausea; shivers; cold; fever; fatigue; myalgia; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, nausea, shivers, cold, fever, fatigue and myalgia. On an unknown date, the outcome of the headache, nausea, shivers, cold, fever, fatigue and myalgia were unknown.   It was unknown if the reporter considered the headache, nausea, shivers, cold, fever, fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 101 degree F.  No additional information was provided.
Patient received a sub-optimal COVID-19 vaccine due to a storage and handling error. Vaccine was stored in a regular freezer prior to being refrigerated and then administered. The local authority requested that a VAERS form be submitted for this patient.
PATIENT STATES HE HAS HAD PAIN , LOSS OF MUSCLE AND NUMBNESS IN HIS LEFT ARM THAT WORKS DOWN TO HIS RING AND PINKY FINGER UPON RAISING HAND TO FACE SINCE RECEIVING THE SHOT.  HE SAYS THERE HAS  NOT BEEN ANY IMPROVEMENT WITH ADDITION OF STEROID PACK AND IBUPROFEN 800MG AND GABAPENTIN (MEDICATIONS WERE TRIED AS SEPARATE THERAPIES NOT AT THE SAME TIME) 3 DAYS OF THERAPY WITH HOT AND COLD
Cellulitis in left arm from the injection site in a wide band down to my elbow, soreness in entire left shoulder, including my upper left back and left armpit. This started on Friday and has lasted for a week. Fever (99.5) on Saturday only. Headache and dizziness on Saturday - Monday.
Baby became excessively fussy, crying and screaming, 1.5 hours after administration of PENTACEL, PREVNAR 13 and ROTATEQ. Leg in which PENTACEL was given is very tender to touch and painful to movement.
Around 6pm after arriving home, started feeling nauseated, and threw up, with severe headaches, body aches and severe chills.  Could not get warm even putting on extra clothing, standing in front of our fireplace, and had chills all night.  Had my husband take me to Urgent Care, the next day, January 16, 2021.  They tested me for Covid and  flue.  Negative.  Still shivering , they gave me an IV.  No temperature.  Gave me Tylenol and went home to recover.  Had the second vaccine shot  on February 5, 2021 and no reaction, except for a slight sore arm.
Pentacel administered accidentally. Patient was ordered to receive DTAP, was due for DTAP.  No adverse outcomes. Patient has already had 3 doses of Dtap-Hib-IPV, most recent dose was 03/02/23. Patient has only had one dose of Hib-PRP-T and it was administered 06/07/23.
vomiting started after vaccine no fever for 2 days-soft stools tarry oral hydration done at hosp with Pedialyte 1/7/08-records received for DOS 12/23/07-Presented to ED with cardiac arrest. The patient was found by family in cardiac arrest, unresponsive, abdomen distended. Vomiting day before. 3/28/08-COD:Complications of a small bowel obstruction. Extensive small bowel adhesions involving the spleen, pancreas, stomach, liver and large bowel. Exucdate in patchy distribution over the surface of the small bowel, liver and retroperitoneal fat. Small bowel luminal narrowing and serosal congestion and hemorrhage. Bilateral cystic dilation of kidneys and ureters.
Flu like symptoms (general body ache--very sore arm)  12 gours after second dose was given
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Patient did not inform us that she had received a third dose in August 2021. She was administered 0.5ml instead of the recommended 0.25ml for immunocompromised patient booster.
Note: pt received vaccine 9/11 but did not report any adverse event to me until she returned from a trip 9/30 and emailed me.  According to her email, she had "red itchy hives all over my body, my throat was itchy and I felt generally weird all over.  Benadryl took care of it eventually."  She said the hives occurred within two hours of the vaccine, and resolved completely within 4 hours of taking diphenhydramine.  she has received previous flu vaccines without incident.  all of the equipment we used is latex free.
I went to hospital on 04Feb2021 and was diagnosed with TIA.; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810, expiry date not reported) as SINGLE DOSE for covid-19 immunization. Medical history included atrial fibrillation (Afib), high blood pressure, pacemaker, type 2 diabetes and high cholesterol. Concomitant medications included apixaban (ELIQUIS), metformin (METFORMIN), levothyroxine sodium (SYNTHROID) and valsartan (VALSARTAN). The patient reported "I went to hospital on 04feb2021 and was diagnosed with tia. (transient ischaemic attack)" on 04Feb2021. The patient was hospitalized for the event from 04Feb2021 to an unknown date. The patient received first dose of BNT162B2 on 14Jan2021 First dose (lot number EL3248, vaccine location= Left arm). Therapeutic measures were taken which was reported as AE treatment Jardiance. Outcome of the event was recovered.
pt recv vax 22OCT96 or 23OCT96;pt devel vomiting & diarrhea w/o fever 48hr p/vax;10NOV96 pt exp n/v & 1 loose bowel movement;
The patient received the H1 mist and seasonal injection. Upon receiving the seasonal injection the patient passed out. The medical staff provided an ammonia smelling vial and she regained consciousness. EMS was called and evaluated the patient. The parent informed the staff the patient had not eaten breakfast. The parent declined transport to the hosptial.
Information has been received from a physician concerning a 19 year old female patient, sexually active for less than 1 year, who in December 2006 was vaccinated with a first dose of GARDASIL. A papanicolaou smear (PAP) test was done on the same day as the vaccination and the results showed cervical intraepithelial neoplasia (CIN) 2 or 3. After her second injection with GARDASIL vaccine (yeast) she required conization due to the rapid development of CIN. Human Papillomavirus (HPV) types were unknown. The physician felt that rapid development of CIN was an other important medical event. Additional information has been requested.
Fatigue, headache, muscle pain, chills, joint pain lymphadenopathy dizziness, nausea
patient states that she had severe dizziness a week after receiving the vaccine that lasted several days. she contacted her doctor and they diagnosed it as vertigo, but could not be sure whether it was related to the vaccine or just a coincidence
9/19/06 In the evening patient had fever or felt bad. 9/20/06 am hives on face and body, no trouble breathing.  9/20/06 at 2:36 pm given BENADRYL 25 mg by mouth every 6-8 hours as needed.
vague stippled itchy erythematous rash at site of influenza vaccination - brand of vaccine is unknown.
3/14/16 - Received MMRV. 3/15/16 - Mom noted red, hot to touch, tender to touch, hard area approximately 4-5" long and 2.5" wide on upper (L) arm. MOTRIN and ALLEGTA given. 3/17/16 - Examined in office oval area 4 x 3" light pink in color non tender, not indurated, hot.
Case number PHEH2016US023279 is an initial spontaneous report received from nurse on 09 Sep 2016. This report refers to 60 year old female patient. Past medical history and concomitant medications was not reported. The patient was vaccinated with single dose FLUVIRIN (batch number: 168705) at a dose of 0.5 ml intramuscular on 06 Sep 2016. It was reported that, patient received FLUVIRIN in the gluteal muscle and patient had no any problem. Not any adverse event was followed after (wrong route of administration).
initial lightheadedness, anxiety, shortness of breath within first 15 minutes then after 30 minutes light erythematous maculopapular rash on face and arms (no hives) headache, nausea and vomiting tachycardia 130 O2 remained 98-99%  Treatment: Zofran 4 mg ODT and 25 mg Diphenhydramine Symptoms improved/resolved over30 minutes -- continued observation for 2 hours  Home with family member driving  Diphenhydramine 25 mg prn instructions reviewed.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose VARIVAX, dose, route and frequency unknown. On 11-DEC-2013, the patient was vaccinated with improperly stored VARIVAX lot # H018451, dose number 2. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves male patient who gets violently ill, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) 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 not reported via unknown route. The patient developed a non-serious gets violently ill, has even had a couple ambulance rides (malaise) following the administration of INFLUENZA VACCINE. Patient had even had a couple ambulance rides. (Other relevant tests included No lab test.) Final diagnosis was gets violently ill, has even had a couple ambulance rides. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for gets violently ill, has even had a couple ambulance rides.