chrisvoncsefalvay/vaers-outcomes huggingface dataset:
both shots, still get shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via SHINGRIX interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster Shingles vaccine for prophylaxis.   Co-suspect products included Herpes zoster Shingles vaccine for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had received both doses of shingles shots but still get the shingles every couple of months. The patient asked why it keeps coming back. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
AM 10FEB94 low grade fever, crabby; 11FEB94 loss appetite; PM 12DEC94 abdominal distension, diarrhea; No treatment, resolved by 15FEB94; no contact w/physician; mom called report in on 14FEB94;
Difficulty Swallowing,  Redness to site, extended to entire arm, itching to site and head.
rash all over my body but this morning it's worst.; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose (Lot EW0150) on 31Mar2021 (last Wednesday) as single dose at left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot EN6207) on 10Mar2021 12:00pm at left arm for COVID-19 immunization. Patient started with some rash all over his body on 04Apr2021 but 05Apr2021 morning it was worst. He didn't think it was food poisoning and just want to make sure these side effects are related to the vaccine before he call his physician. Originating AE Request: REQ-228433. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Fever, fatigue, diarrhea, body aches within 24 hours  Rash at injection site showed up 7 days later and persists at least 9 days later  Chest pains for 3 days following injection
This spontaneous report was received from a nurse refers to a 6 month old infant with unknown gender. No pertinent medical history was reported. On 10-APR-2015, infant was vaccinated with PNEUMOVAX 23 (lot # K020214 and expiration date 25-MAR-2016) in error. No adverse experience observed. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient states pain in shoulder and upper arm severe enough that it inhibits her ability to use arm. Immunization given on 12-22-14 reported to pharmacy on 1-9-15.
Dizziness, accelerated heart rate occurring about 10 minutes after injection. lasted for 2 to 3 minutes then went away
Mother states child had hoarseness, sore throat, very tired, slight fever and a cold for a few days after 1st dose on 12/16/09.
incorrect product storage; This spontaneous report was received from a registered Nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.   On 25-JAN-2021, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) which has a lot # 1688504 and expiration date on 18-NOV-2021 (dose, strength and frequency were not reported) for prophylaxis.    It was reported that the vaccines were exposed to temperature of 13.4 Centigrade range for a time frame of 2 hours and 9 minutes The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
Case number PHEH2014US014193, is an initial spontaneous report received from a healthcare professional on 14 Jul 2014. This report refers to an 11 year old female patient. Past medical history and concomitant medications were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X13067), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component  on 14 Jul 2014. No adverse event was reported following this administration error.
This spontaneous report was received from an unspecified reporter via a company representative, concerning a patient of unknown age and gender. Patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On approximately 2015, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot # and expiration date were not provided). On an unknown date, within a year of the injection, the patient died. The cause of death was unknown. It was unknown whether an autopsy was performed or not. There was no product quality (PQC) involved. The causality was not stated. Upon internal review, the event of death was considered as medically significant. Additional information has been requested.
Tues. 1/8/13 approx. 9:30 am p/t received flu vaccine. Approx. 6:30pm p/t at home screamed of headache at which time she went into seizures. She was rushed to ER for treatment.
Approximately 6 hours post injection patient developed fever and muscle aches - for next five days fever, nausea, malaise, loss of appetite and all over body muscle pain.
15 minutes after receiving the injection in deltoid muscle, there was pain and soreness at the injection site. An hour after injection, pain and soreness at injection site worsened. Activity of left arm was used to help with symptoms. Despite activity (wash dishes, vacuum, lift weights) of left arm, not only did the pain and soreness a the injection site persist, but soreness in the left tricep was experienced.  Pain and soreness in left arm lasted at least 48 hours with the pain and soreness diminishing after that time. Also note: 24 hours after injection, Tylenol was taken to help relief injection symptoms and also menstrual cramping.
Site bleed, stopped, blood pooled under skin. Instructed to massage arm, take BENADRYL if necessary. Returned 10/15/14 wrist on arm was swollen and had radiating pain. Pt. went to emergency room was prescribed IBU 600 mg TQ6-8H prn swelling and pain.
Patient c/o itching and hives that evening and went to bed. Patient states she took a Zyrtec home dose. Patient denies any trouble breathing. Associate states she came to hospital to report the event just in case. Patient states the itching and hives have resolved at this time.
Swelling (approx. size of a nickel-quarter)  was noted at the injection site moments after administration; area had been covered with a latex free bandaid. Patient's BP: 125/90 and HR: 78 Provided patient with 2, 25mg capsules of Benadryl. The patient was observed for approx. 15-20 minutes post reaction. During this time the affected area did not worsen. Before the patient left, the affected area appeared less swollen; however, was warm to the touch.  Counseled patient to follow up with provider if needed, and advised could alternate IBU/APAP (if tolerated) to help reduce fever at site and swelling.  Patient did not report pain.
difficulty walking due to pain from the hips down her entire legs; Developed body aches; Tired; Couldn't lift injected arm; Injection arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Couldn't lift injected arm), PAIN IN EXTREMITY (Injection arm hurt), GAIT DISTURBANCE (difficulty walking due to pain from the hips down her entire legs), FATIGUE (Tired) and MYALGIA (Developed body aches) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia and Drug allergy (Allergy to ACE-Inhibitors.).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MOVEMENT DISORDER (Couldn't lift injected arm) and PAIN IN EXTREMITY (Injection arm hurt). On 22-Mar-2021, the patient experienced FATIGUE (Tired). On 23-Mar-2021, the patient experienced MYALGIA (Developed body aches). On an unknown date, the patient experienced GAIT DISTURBANCE (difficulty walking due to pain from the hips down her entire legs). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (Couldn't lift injected arm), PAIN IN EXTREMITY (Injection arm hurt), GAIT DISTURBANCE (difficulty walking due to pain from the hips down her entire legs) and MYALGIA (Developed body aches) had resolved and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: (normal) x-ray results were normal.         Concomitant medications included high blood pressure and anti-hyperlipidemic meds.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Updated the outcome of the events (movement disorder, pain in arm, myalgia, leg pain) from unknown to recovered. Added the concomitant medications. Added the lab test ( X-ray).
Administration failure - vaccine product leaked from the syringe as dose was being given. Less than half was administered to patient. Due to it being less than half administered, we followed CDC COVID-19 Vaccine Administration Errors and Deviations protocols as outlined (https://www.cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-errors-deviations.pdf) and patient was given dose again.
low grade temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: . The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "low grade temperature". Additional information: My son had a low grade temperature just for a day.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
started breaking out on Tuesday w/red rash itching some; has become worse over pst 16 days; no temp; petechial, hives, macular
Patient had stated he had passed out before because he doesn't like needles. Patient was given a flu shot and a PPD and patient did pass out but then had a seizure. No past history of seizure event. Patient came out of his seizure, was fine, did not require emergency room but we sent him to the emergency room for observation and precaution.
Patient called Sat 10/18/14 to say that she had a large (2-3") area of redness and swelling at the Zostavax injection site but no other symptoms. Advised to take Benadryl and monitor for fever or rash. Waited 24 hours to report...
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. On 04-FEB-2016, the patient was vaccinated with expired dose of VARIVAX (Merck) (lot # J007013, expiry: 05-JUN-2015). No adverse effects were reported. Additional information has been requested.
Administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. It was reported that the vials were not stored in the refrigerator, they directly thaw them  from the freezer before administration. Vial did not undergo temperature excursions. No treatment medications were provided.
Severe vertigo, nausea, paleness, weakness, neck/back/shoulder pain.  Follow-up information received - Pt described as : "within 24 hours"
Large hard welt on thigh 6 in x 3 in. Mom using warm soaks & compresses. Noticed welt on Sat, increased by Sunday & decreasing now. No other sxs.
02/11/2021 Moderate itching to site, Prednisolone 15mg/ 5ml, 30 mg given, received relief 02/12/2021 Moderate arm pain and tenderness, Tylenol 500 mg tablets X 2 given, received relief
stroke-like symptoms/He was told migraine versus TIA; migraine; This is a spontaneous report from a contactable nurse. An unspecified age male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunizaiton. Medical history included TIA. Concomitant medication was not reported. On an unspecified date, the patient experienced stroke-like symptoms/He was told migraine versus TIA. The reporter stated: "I am a cardiac healthcare provider. I had a patient get the Pfizer COVID-19 vaccine.  He indicates that several hours after getting he had stroke-like symptoms and presented to a local ER.  Imaging unremarkable for stroke.  He was told migraine versus TIA.  He does have a history of TIA previously.  He does want to get his 2nd shot, but is concerned.  Whether should he to get or switch to the Moderna.  I honestly do not know what to tell him.  He is high risk." The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event TIA(transient ischemic attack) and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
LEFT THIGH WAS SWOLLEN, RED AND HOT. PT FELT DISCOMFORT AND PRURITUS, LATER ON DEVELOPED A FEVER OF 103.5 F, AND WAS BROUGHT TO CLINIC.
R- arm/neck (R-side) stabbing pain and unable to grip anything with R-hand.  Fingers went numb and tingly.
pt recv vax JUN96 &  9NOV97 pt broke out w/herpes zoster along w/first division of rt trigeminal nerve w/involvement of eyelid;lesions described as painful;
Bright red, firm irritated area on right arm around injection site. Approximately 2 x 2 1/2?.
This child had irritability after the immunization, also sore throat, left ear pain, rash to both arms and legs. On 02/25/01, excessive gas, diarrhea, temp less than or equal to 100 degrees rectally, fatigue, abdominal pain, dysgeusia.
My daughter was receiving her second vaccine about 1230pm  and while administered she immediately told me she felt ?dizzy and nauseous.? We sit down, she is not feeling better and within 3 minutes or so she said she felt? dizzy and feel like I?m going to throw up.? She then starts nodding off and on, not able to keep her eyes open. I waved over for help and by the time volunteers got to her she went limo and passes out. She was taken by wheelchair to medic room and they had her lay down. She came alert and said ?everything went black? and had no memory/recollection or awareness of where she was and how she got to the medic room. We gave her water and I asked for crackers and she felt better and was able to leave around 115pm.  In addition, we saw a teenage male pass out prior to my daughter and was also taken by wheelchair. I spoke with a RN as I was leaving and was told multiple teens had had the same initial reaction today.  She had no reactions or side effects with her first dose.
Pts father states that pt fell at parking lot after left clinic. Pt c/o dizziness noted color pale. Offered apple juice. After that pt said feel better. BP 124/72 HR 77 alert orinted x4. Pt want go home refuse to go ugrent care. Advise to go URGENT CARE if condition gets worsen. Pt left clinic with father.
Mild itchy feeling on opposite of where she rcvd the booster. Several days passed and she still had that itchy feeling.  After scratching she got a series of little bumps. 6 wks later she still has the itch but the little bumps subsided. She is scared to scratch because she doesn't want the bumps to come back.
severe hip pain; could not walk; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 29-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (medically significant), outcome "unknown", described as "severe hip pain"; GAIT INABILITY (medically significant), outcome "unknown", described as "could not walk". The patient experienced severe hip pain, to the point that she could not walk, after Covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ulcerative colitis flare up; abdominal pain; intestinal discomfort; intense pain when having bowel movements; indigestion; tenderness of my abdominal area; fatigue; This case was reported by a consumer and described the occurrence of ulcerative colitis relapse in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis and autoimmune disorder.   On 21st April 2019, the patient received the 1st dose of Shingrix. On 27th April 2019, 6 days after receiving Shingrix, the patient experienced ulcerative colitis relapse (serious criteria GSK medically significant), abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue. On an unknown date, the outcome of the ulcerative colitis relapse was recovered/resolved and the outcome of the abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue were unknown.   It was unknown if the reporter considered the ulcerative colitis relapse, abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue to be related to Shingrix.  Additional information was provided as follows: The patient had history of ulcerative colitis. The patient was concomitantly taking unspecified medication for ulcerative colitis to kept symptoms under control. The patient received the Shingrix and began having abdominal pain and intestinal discomfort. The patient had a flare and previously not had a flare like this for several years.  The patient experienced intense pain when having bowel movements, indigestion, tenderness of my abdominal area, fatigue and other symptoms general to a flared. The patient read that Shingrix was not tested on people with autoimmune diseases and that there was concern that this new adjuvant might cause flares with people with autoimmune diseases. The patient consulted with her physician's and both advised her to get Shingrix vaccine. The reporter would like to know if anyone else with autoimmune diseases have reported similar side effects after getting the Shingrix vaccine. The patient was very concerned about getting the second dose. The reporter would appreciate any information about this.
5/28/2021 Patient started experiencing sharp pain in her left ear. In May patient had stroke symptoms for about 15 mins. Speech was slurred and she could not remember people. In June stabbing pain and left feverish and had a episode of loose stool.
Patient came in for "updated" pfizer covid vaccination booster for child.  The new vaccination is not at this facility yet, the patient received the regular old pfizer covid vaccination.  Patient advised to come back in 2 months for the Omnicron variant
Patient received 2 doses of Moderna vaccine in February/March. On august 3, 2021, the patient came to the pharmacy to receive her second dose of Shingrix. She was given a dose of Pfizer in error.
9/12/02 red, raised areas, itching. 9/16/02 scabbed sores, resolving atypical varicella.
patient called at 145, states she got covid vaccine at 1250.  She describes having dizziness, lightheadedness, and "feeling of overheating" that is continuing.  She stated she had a little dizziness at time of vaccine but it has worsened after leaving.  She is not driving (father is driving).  I asked if there was any trouble breathing and she stated "a little".  I advised to lie down and elevate feet, and remain in cool place.  The patient stated the dizziness was worsening still.  I advised to either go to the Emergency department/urgent care or return to pharmacy for us to monitor her.  She will do one of the above. I spoke to patient about 237 pm, she ended up going to ER for observation, and is currently there being monitored.   spoke to patient today 6/25/21, patient was in ER for a while but has been discharged.  Pt states she was feeling hot for a while then later felt cold (could be because hospitals are cold).  Patient states ER gave her a breathing treatment and something to relax the nerves (not sure of medication).  She still has some dizziness and arm soreness but it has improved significantly since yesterday.
I61.9 - Cerebral parenchymal hemorrhage (CMS/HCC) I61.9 - Nontraumatic intracerebral hemorrhage, unspecified E87.1 - Hypo-osmolality and hyponatremia R29.810 - Facial weakness
4 hrs after vaccination, pt reported fever of 101 degrees, chills, diarrhea, severe headache, and tremors/shaking. The following morning she still had a headache and diarrhea. Everything resolved approx. 16-18 hours after vaccine. She had Fluzone HD last year and reports no adverse events.
Patient complained of "heart racing" after receiving vaccine. HR 131, BP 164/94. Transported to emergency room for evaluation. ER record indicates no cardiac event or arrhythmia. Patient had not been taking prescribed blood pressure medication.
First hives appeared on my lower left forearm that lasted a day, then a Sunburn type rash on my upper arm that wrapped around my arm to my elbow that lasted 17 days, looked like cellulitis