chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a physician on 16 Sep 2016. This case was linked to 2016SA172869 (same reporter). This case involves a four-year-old male patient who was vaccinated with a fifth dose of Daptacel (batch number: C5101AA, expiry date: 26 Nov 2018, site of administration not reported) intramuscularly on 15 Sep 2016. The patient was also vaccinated with a dose of FLUARIX and a dose of PROQUAD on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not known and illness at time of vaccination was reported as none. Concomitant medications were not provided. On 15 Sep 2016, immediately after vaccinations, the patient had vomiting. Lab data and corrective treatment was not reported. Outcome of event was reported as unknown. List of documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 82-year-old female patient who received BOOSTRIX (batch number FB942, expiry date 3rd December 2017). On 24th January 2016, the patient received BOOSTRIX (intramuscular) .5 ml. In January 2016, 5 days after receiving BOOSTRIX, the patient experienced injection site rash and injection site swelling. On 31st January 2016, the patient experienced injection site redness. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site rash and injection site swelling were recovering/resolving and the outcome of the injection site redness was not recovered/not resolved. The reporter considered the injection site rash, injection site swelling and injection site redness to be related to BOOSTRIX. Additional details were received as follows: In January 2016, 5 to 7 days after receiving BOOSTRIX, the patient experienced rash and swelling at the injection site (left arm). Around 31st January 2016, 7 days after receiving BOOSTRIX, the patient started to experience red streaks on arm. The streaks were described as about one inch long. The reporter stated that, the BENADRYL was helping the patient.
passed away; felt unwell; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 110772.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 05Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 06Jan2021, outcome "fatal", described as "passed away"; MALAISE (non-serious) with onset 05Jan2021, outcome "unknown", described as "felt unwell". The patient date of death was 06Jan2021. The reported cause of death was "passed away". It was not reported if an autopsy was performed.  BNT162B2 is under agreement with Biontech.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
A hour hour after receiving my 3 shot I started to feel fullness in my head and then I felt a tingling in my throat and my voice became foggy. 12:30PM I took a Benadryl tablet myself, 25mg; and then I waited to see if it would fix it. So around 1:00pm, I went to the ER. They checked my vitals and everything was normal. Dr. told me to wait a while to see if my symptoms would go away. I waited about an hour and I was discharged and the Dr. told me to continue to take the Benadryl as needed.
Patient was in 15 min waiting area after her vaccination. She suddenly fell to the floor and began convulsing. 911 was called. Clinic staff provided comfort , basic assessment with vital signs (110/58, 80, 100%RA), and oxygen on standby. Staff agreed convulsions lasted for about 1 minute. Pt began to awake, then promptly vomited clear watery fluid. Staff continued to provide comfort and awaited 1st responders-arrived after about 6min. Pt gradually awoke and was awake alert (AxOx4) by the time the first responders took over care and were interviewing her. Secondary transport (AMR) was called and showed up shortly after, pt was transported to ED for further w/u.
fatigue; headache; sore arm/ pain in arm; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm/ pain in arm".  Additional information: The patient's age was reported as 54 (unit unspecified). The patient stated that she had side effects for 2 days after the 1st dose and then again 11 days after. On day 11, she got a sore arm. She further stated that she had side effects of pain in arm, fatigue, and headache with first "covax" that lasted 2 days and second lasted longer 3 days (not further clarified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
49 year old female with no significant medical history presents to the ED with possible allergic reaction. Patient had to COVID vaccinations at facilitie at 1750 today. She reports lip tingling and tongue swelling, and she was sent to the ED for further evaluation. Patient reports history of reaction to "certain things." She had an "anaphylactic reaction" with a cortisone shot given by orthopedics in her shoulder a few months ago. Patient presented with similar symptoms including tongue swelling and lip swelling. She took a Benadryl and the symptoms resolved. Today symptoms are similar to previous. She was concerned prior to her vaccination about possible allergic reaction, so she took half a 25 mg Benadryl pill prior to vaccination shot. Patient states symptoms have improved. She denies shortness of breath, throat swelling, rash, or other concerns. Allergy to Penicillin and Amoxicillin..
LIGHTHEADED, FAINTNESS, WEAKNESS, NAUSEA, COLAPSING, DIZZINESS, LEG PAIN
Dizziness and a feeling of being off balance, stuffiness in right ear, right lymph node is swollen, neck tension
- Blood Pressure dropped (62/48).  I have a home BP machine and checked through out the day.  This was the lowest but it hovered around here for a while.  - Fever.   Low grade for several day with on and off spikes.  Reached 102.  - weak, light headed, dizzy, nauseous, head felt heavy, joints ache for several day.  Couldn?t walk on my own for 2 days.  Needed someone with me for the first day then a walker for 2 more days.
This spontaneous report was received from the registered nurse regarding a 12 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 14-NOV-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
cold started on Sat 17AUG91, fever 102.4 R; Tuesday rash over entire body; Seen by MD on 17AUG91 & 20AUG91; Given APAP; MD dx as coxsackie virus;
Information has been received from a consumer concerning her 82 year old husband with high blood pressure and no drug reactions. On 13-OCT-2010, the patient was vaccinated with 0.5ml dose of PNEUMOVAX 23. Concomitant therapy included AVELOX "and many other medications". "A week ago" on approximately 31-DEC-2010 the patient "came down with pneumonia". The patent's arms became bright red from the elbow to the shoulder and hot to touch. "One day he could hardly walk." The patient sought unspecified medical attention and was treated with oxygen for his lung. Blood work was performed (result not reported). When the information was reporting, the patient had not recovered (It was also reported as recovering). Follow-up information has been received which reported that the patient was administered at a pharmacy, not the physician's office. No further information is available.
Day after vaccination,swelling in armpit area and burning sensation around armpit area in the same arm of vaccination site, burning sensation spread out a little beyond swollen bump in armpit area. 2 days after vaccination, burning sensation is gone but there is still pulsating pain at times pain is on a lower scale than previous day but pain is comes and goes in comparison to previous day
On January 21, 2021 at the Clinic, an PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the nurse inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The nurse then alerted the APRN, who escalated the situation to the manager. The manager then contacted Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL.  After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them.  Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in an elderly female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported, but it could be 77 or 78 years old. The patient was vaccinated with the dose of SHINGRIX, about 3 weeks before the date of vaccination. When she first received the shot, she stated that her arm "hurt a little bit," but she moved it around and it stopped hurting. Within two days after the patient experienced redness at the injection site that it was the size of baseballs and itching at the injection site. The redness was about 6 inches long and about 3 to 4 inches wide. All the events experienced by the patient lasted for a period of about 10 days. The patient's doctor informed her not to get vaccinated with the 2nd dose. The patient had denied permission to contact their physician. The reporter declined to leave address.
Weak; Tired; Chills; Sweating; Ended up sleeping all day; wakes up dripping wet with sweat; Fever/ Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and PYREXIA (Fever/ Feverish) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-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 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and PYREXIA (Fever/ Feverish). On 04-Dec-2021 at 3:00 AM, the patient experienced CHILLS (Chills). On 05-Dec-2021, the patient experienced ASTHENIA (Weak) and FATIGUE (Tired). At the time of the report, ASTHENIA (Weak), PYREXIA (Fever/ Feverish) and FATIGUE (Tired) had not resolved and HYPERHIDROSIS (Sweating), SOMNOLENCE (Ended up sleeping all day), NIGHT SWEATS (wakes up dripping wet with sweat) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-406703 (Patient Link).
Fever, chills - no treatment, ongoing. Symptoms started approximately 18 hours after vaccine was given.
Information has been received from a physician concerning an adult female patient who "within the last 2 months" in approximately October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 643249/0358M).  Subsequently in approximately October 2002, the patient developed very sore arms, redness and swelling that went from her shoulders down her entire arm.  The patient sought unspecified medical attention and was treated with anti-inflammatory agents (unspecified).  Subsequently, all of the patient's symptoms resolved.  The physician indicated that in his "many, many years" of experience with vaccinations, he had never seen such "an inordinate amount of reports" of "severe reactions" to pneumococcal vaccine 23 polyvalent has he had recently.  He requested a lot check of Lot # 643249/0358M.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The physician also mentioned that 2 other female patients (WAES # 0211USA00016, 0306USA02609) a male patient (WAES # 0211USA00320) had experiences following vaccination with pneumococcal vaccine 23 polyvalent (Lot # 643246/0358M).  Additional information has been requested.
vaccine affect vision; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vaccine affect vision) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (vaccine affect vision). At the time of the report, VISUAL IMPAIRMENT (vaccine affect vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Itchy rash appeared on neck, swelling at injection site and worsened neuropathy.
3/18 - shot given- slight burning and hot feeling pain/ tender in arm 3/19 - body aches/pains manageable with ibuprofen  3/20 - Severe body aches/pains and weakness.  Unable to walk a short distance.  Walking from bedroom to living room felt faint, everything went black and couldn't hear.  Laid on floor until senses came back.  Felt faint upon trying to walk for remainder of day.   102 fever throughout day, down to 101.5 with meds.  So weak needed help sitting up from floor.  Fever broke around 8pm. Then noticed injection site arm was red/blotchy and hot. 3/21 - Still weak and achy but no fever.  Arm still blotchy, hot, itchy and sore/stiff 3/22 - Arm still blotchy, hot, itchy and sore/stiff
I received the seasonal flu shot around 4 p.m.  I woke up the next morning very itchy and developed hives all over my body.  I took Benadryl every 4 hours and used Caladryl.  It lasted for 48 hours.
Patient came in for 2nd vaccination and described swollen first left knuckle shortly after receiving her 1st dose in March. Patient states she received her shot and took a nap and woke up with redness, swelling, and pain in her first left knuckle. Patient spoke with primary care and stated that md is aware and was not concerned as it was not getting worse. Today, the knuckle still looks bigger. Patient states that she feels pain at times but the swelling has gone down since.
loss of control of lower body; neurological disorder; fell a couple of times; Potassium level very low; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONTROL OF LEGS (medically significant), outcome "unknown", described as "loss of control of lower body"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological disorder"; FALL (non-serious), outcome "unknown", described as "fell a couple of times"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Potassium level very low". The patient underwent the following laboratory tests and procedures: blood potassium: very low; scan: nothing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a health professional (licensed practical nurse) refers to an 18 month old female patient. Patients pertinent medical history and drug allergies were not reported. On 04-FEB-2015 the patient was inadvertently administered with two doses of MMR II (lot # J013131, expiration date: 17-OCT-2015). Concomitant medications were not reported. No adverse effects were reported. Outcome of the events were unknown. The reporter considered the event to be not related to MMR II. Additional information has been requested.
SEVERE AND SUDDEN ONSET OF SWELLING OF LYMPH NODE UNDER LEFT ARMPIT AND IN THE LEFT BREAST CAUSING EXTREME DISCOMFORT AND PAIN.   THIS REACTION DID NOT OCCUR WITH FIRST DOSE.
The patient reported a swollen left arm, and swollen lymph nodes in the axillary area. These symptoms lasted 3-4 days according to the patient. The patient saw her primary care provider who told the patient to report her symptoms to the pharmacy.
Had vaccine on Wednesday evening and Friday am had slurred speech and sweating and headache. Patient had urinated on himself while sleeping. Slept all day on Friday.
3/29/21 -one hour after arriving home from getting injection, felt fatigued, took 1 1/2 hour nap, a headache occurred that evening  3/30/21 - All during the early morning hours after midnight, had headache, restlessness, could not sleep, had diarrhea twice and frequent urination. After waking at 10:00 a.m., had severe headache, pain on top of scalp, tender forehead, constant fatigue, chills for three hours, severe stomach cramps and diarrhea for two hours, light headedness throughout the day, slept on and off all day.  While eating dinner that night, realized my tongue felt scalded and sense of taste was decreased, blah.  3/31/21 -Woke up  feeling better, headache was gone, made breakfast, ate and still had decreased taste sensation on tongue.  Continued to shower, dress, wash dishes, then felt fatigued and light headed and more diarrhea after three hours from waking, laid back down and took three hour nap. Took it easy the rest of the day, feeling slight headache and sinus congestion.
Fussy and tired 1-31-12 after shots. 2/1/12 vomiting 2:30AM. No fever or swelling of site. Given vomiting protocol & to call Dr back if pt. worsened.
No additional AE; Patient was administered an expired dose of ROTATEQ; This spontaneous report has been received from a physician referring to a patient of unreported age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies was not reported.  On 31-JAN-2022, the patient was vaccinated with an expired Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally (Lot# was not reported; expiration date reported as 29-JAN-2022) (Expired product administered) as prophylaxis. It was confirmed that, Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) had no temperature excursion.  No additional adverse event (AE) reported. No PQC reported.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergies rash only, who, on an unspecified date, was vaccinated in the right arm with a dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Both parents of the patient reported that she was vaccinated very high up in the deltoid area, almost right at the joint at the top of the arm, almost posterior. The father who is an anesthetist nurse is concerned that this may have been an intraarticular injection. Subsequently, three weeks after the vaccination the patient has experienced increased pain at the injection site, throbbing pain down the arm, and her fingers of the right hand cramp. She is being treated with Motrin over the counter 600mg three times daily. The patient was seen at the doctor's office who states that it may be tissue necrosis, but is unsure. The patient was also seen by the orthopedic office and an A-P Plane X Ray was performed, nothing conclusive. The patient is scheduled for an MRI. The reporter indicated, the patient experienced significant disability or incapacity. At the time of the report, the patient had not recovered. Additional information has been requested.
Three weeks post vaccine I developed severe diffuse abdominal pain sending me to the emergency room. Work up revealed acute appendicitis and I was scheduled for emergency laparoscopic appendectomy the following day.
SWOLLEN AXILLARY LYMPH NODE Narrative:  LYMPH NODE IS DECREASING IN SIZE
4/20/2021 - Increased resting heart rate from 60 to 102 Prescribed -  propranolol to control heart rate  Unable to workout - too high of heart rate Diagnosed Graves? disease - 06/18/2021 Prescribed - methimazole Monitoring?