chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a rash at the injection site; black dot at the site; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of injection site rash in a female patient who received Men B NVS (Bexsero) (batch number J52PN) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site rash (Verbatim: developed a rash at the injection site) and injection site discoloration (Verbatim: black dot at the site). The outcome of the injection site rash was resolved and the outcome of the injection site discoloration was not resolved.   It was unknown if the reporter considered the injection site rash and injection site discoloration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site rash and injection site discoloration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 24-OCT-2023 The reporter stated patient administered the Men B vaccine and developed rash at the injection site. The patient went to urgent care as it was getting bigger on the skin. The reporter stated it was now healed. The patient still had a black dot at the site. The reporter consented to follow up.
Extremely bad headache, exhausted, running a temperature of 99.5 (normal temp. 97.6). Advil did not help symptoms
This is a spontaneous report received from a contactable reporter(s) (Physician). A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant) with onset Oct2021, outcome "recovering", described as "Pulmonary embolism"; MIGRAINE (non-serious) with onset 01Oct2021, outcome "recovering", described as "New daily persistent headache, with migrainous features beginning on day of vaccination". The events "pulmonary embolism" and "new daily persistent headache, with migrainous features beginning on day of vaccination" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, migraine. The treatment received for the adverse event included anticoagulation and headache medication. Clinical Course: The patient had no known allergies. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the Pulmonary embolism cannot be excluded. 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.
Patient initially contacted her PMD on 5/13/2021 that she "felt anemic" (which she has struggled with in the past), we got a CBC on 5/17/2021 which showed severe pancytopenia: WBC 1.7, hgb 5.0, plt 10.  Referred that night to Hospital.  Bone marrow aspiration on 5/19/2021 confirmed severe aplastic anemia.  Since then she has had an on-going work up including a genetics evaluation that was non-contributory.  She has had a second opinion at another hospital that confirmed the diagnosis, and treatment plan, which was Bone Marrow Transplant if donor available, or immune therapy if no donor found.
Vesicular rash to right shoulder blade, with burning, itching, and pain. Clinically resembles shingles.
Call from grandparent on 10/7/03 am-child ran high fever last noc- temp relieved by Tylenol-taken to ER last noc-told child had "fembine." Parent call Dr and hospital. May consider taking to local pediatrician.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and PA DOH, decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
After receiving vaccination, I started experiencing intermittent bouts of anxiety, rapid heart rate, sleeplessness and "dark thoughts." This symptoms began approximately a week after the vaccination. I have no history of any of these conditions.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Light headed, dizzy, vison issues, drop in blood pressure
Information has been received from an 81 year old male with a history of prostate cancer and no allergies who on 23-JUL-2007 was vaccinated IM with a first dose of ZOSTAVAX.  Concomitant therapy included hypertension medication (unspecified).  In July 2007, after vaccination the patient had PSA test and reported that it had dropped.  On 30-OCT-2007 it was 0.8 and before vaccination the PSA test value was 2.2.  The patient had contacted his dermatologist and neurologist.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Initial and follow up information has been received from a physician concerning an 81 year old male with a history of prostate cancer, hereditary neuropathy. hypertension and no drug reactions or allergies who on 23-JUL-2007 at 10:00, was vaccinated subcutaneously (also reported as IM) into the left arm with a second dose (also reported as first dose) of ZOSTAVAX (Merck) (Lot#656395/0290U). concomitant therapy included hypertension medication (unspecified). The physician reported that two weeks after receiving the ZOSTAVAX (Merck), the PSA levels were elevated. PSA levels are an follows: 01 JAN 2007 (0.2), 07 AUG 2007 (2.1), 29 AUG 2007 (1.4), 04 SEP 2007 (0.6) and 30 OCT 2007 (0.8). The consumer had reported that after receiving ZOSTAVAX (Merk) "his PSA test dropped". There was no illness at the time of vaccination. Medical attention was sought. The patient contacted 4 neurologist and dermatologist. At the time of report the outcome was not reported. A product quality complaint was not involved. Additional information is not expected.
Right deltoid with increased swelling, redness, warm to touch, no tenderness, no fever. Symptoms happened 24 hrs post vaccine. Tx: benadryl, motrin, cold compresses
12 year old immunized with Pfizer (Orange, 5-11). Parent informed; patient had no adverse effects
NARRATIVE: Headache, Rash, & Urticaria Pruritus. Itchy pain, headache.
Initial misuse report received from health care professional on 24 October 2013. The cases were received on 21 March 2014 at GPV. A 74-year-old patient received a dose of FLUZONE ID. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
The morning after her second dose of the Pfizer covid vaccine, Patient woke up very dizzy and, on standing, passed out. She fell over, almost losing consciousness, three more times that morning.  From that point on, Patient was "dizzy" or lightheaded daily. She had been an avid athlete, playing soccer at least three times per week and teaching swim lessons 4 times a week. She began to have to sit out at soccer practice and to have to leave the field during soccer games. Her dizziness was worse with exertion. She was treated zealously for assumed dehydration, but it did not help. She continued to be more and more dizzy until in January she had to quit her job teaching swim lessons because she would get dizzy in the pool where she was watching young kids. She is home schooled and only attends school twice a week, but she did miss school at least 6 times from dizziness (and more due to heart surgery but I am not counting that). Patient stopped playing soccer completely  in November due to her symptoms.  In the quest to try to find out what was wrong, her pediatrician, (since retired), found a first degree AV block on her EKG. She was referred to cardiology where she was diagnosed with a 17mm atrial septal defect. Her cardiologist, thought this could be causing the dizziness. The ASD was repaired on 3/2/22 with open heart surgery. Patient felt less dizzy for a day or two while in the hospital, but unfortunately after a week it was clear that the symptoms had not gone away. After further testing (blood pressure tests, holter monitor) she was diagnosed by Dr. with POTS/Disautonomia. Dr. said this could have been caused by her COVID vaccine, especially condsidering the timing of onset and never having symptoms before the vaccine. Dr said disautonomia was a possible side effect of the vaccines. At this time, a year after the vaccine, Patient is still suffering with debilitating dizziness and light-headedness not associated with dehydration. She is still unable to play soccer or to work, or can't tolerate heat and humidity well. This has been very difficult for her.  With her concurrent heart condition, we have been to Emergency Room and many doctors trying to tease out what is going on with her.
Started not feeling well, then some headache. Could not sleep well and woke up with congestion, body pain, headache. Woke up in the morning and had chills. During the day I continued feeling headache and general discomfort and tiredness.  I got an Advil and It is helping so far. I am still in the middle of this process. Nothing I cannot tolerate. I know I have a very sensitive immune system that reacts to any minimal aggression. to my system. I trust J&J and I want to provide this information to help with the statistics.
SWELLING AND REDNESS OVER UPPER ARM AND SHOULDER AROUND INJECTION SITE.
Tachycardia that started about 40 minutes after vaccine that lasted for 8.5 hrs  Consulted with  my primary card doctor . EKG was done . Treated by hydrating and resting in bed  Resolved after about 81/2 hrs
Vaccine given at 9:30am : around 5pm. I became dizzy and repeatedly felt that I was passing out/ tingling of hands feet and face. Next day started dizziness: all these mentioned continued for four days. Very tired. Slept a lot : pulse 103 to 113.
Pt states she noticed the site of Varicella #2 itchy with redness and warm to the touch the day after injection. Pt states she has not scratched the site and now it is painful and she avoids touching the site.
GOT AN EXPIRED DOSE OF THE VACCINE; LEFT OUT OF THE REFRIGERATOR LONGER THAN THE 6 HOURS AFTER IT WAS PUNCTURED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has no medical history. patient has healthy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 05-JUN-2021, the subject experienced got an expired dose of the vaccine. On 05-JUN-2021, the subject experienced left out of the refrigerator longer than the 6 hours after it was punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left out of the refrigerator longer than the 6 hours after it was punctured and got an expired dose of the vaccine was not reported. This report was non-serious.
Rash / near the injection site that resolved; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced raised rash. On an unknown date, the outcome of the raised rash was recovered/resolved.   It was unknown if the reporter considered the raised rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix and developed a rash on right arm near the injection site that resolved, and she described the rash as raised but it did not itch. The reporter consented to follow up. No other information given by the patient. For tolerances of 2nd dose, refer case US2021AMR070842, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070842:Same reporter.
Muscle weakness through out body, right hand/Arm numb, tingling headaches, left knee pain
Diarrhea started Sunday 1/10, lasting until 1/12, involving mild to moderate cramping, lethargy A week to the day after vaccine administration (1/13) Itching, swelling, discoloration, heat (size of an egg)  at injection site started in the afternoon and continues, though seems to be lessening in severity
4/10 at night -  lightheaded, fever, chills, sweating, headaches -- > took Tylenol  4/11 in morning- fever, headaches, dizziness, severe dehydration, fainting/passing out -- > taken to ER after passing out, treated with saline, other fluids, and rest
This spontaneous report as received from a nurse practitioner, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 21-JAN-2015, unspecified number of patients were vaccinated with improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse experience had been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from an office manager concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot# and expiration date were unknown) orally for prophylaxis, which had a temperature excursion 27°F for 10 minutes and 28°F for 14 hours. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009058: US-009507513-1702USA008645: US-009507513-1702USA009057.
Pt received her Moderna COVID-19 Vaccine at 2:50 pm on 1/25/2021. Pt tolerated administration well and was monitored for 15 minutes inside the agency. She was accompanied by her son. When exiting the building at approximately 3:15pm,  pt  continued walking off of the side walk into the flower bed. She then was noticed by son to have confused and jumbled speech. Staff from The Agency and EMS was on the scene immediately after this was observed and 911 was called for EMS. Son reports this is not her baseline.
SEVERE HIVES HEAD FACE BODY HANDS ARMS, SWOLLEN LIPS TAKE TO EMERGENCY ROOM IV WAS GIVEN STEROIDS BENEDRYL AND PEPCID
Vaccine was found to be expired as of 8-31-21. Contacted State Health. They then followed up with Moderna. Received confirmation from Moderna that vaccine given was still considered viable. No adverse outcomes noted.
Pt. stated, "I felt dizzy and I had a headache 3 minutes after getting vaccinated."  O2Sat 99%, HR 98, R 16.  Pt. is alert and orientedx3.  Pt. stated, "I feel much better now at 10:42am.  Pt. is afraid of needles and did not have breakfast.  At 10:49am pt. stated, "I feel ok now, I'm ready to go home."  At 10:50am pt. went home with wife.
Vaccinated on 09/30/05 At 2 PM.  On 10/13/05 at approximately 1 AM, patient began itching all over body, especially on his stomach.  Itching persisted until he fell asleep.  Itching continued in the morning.  Lesions are bumps (like "mosquito bites").  Bumps are on back, head, legs and under knees.  Total of 12 bumps on body.  Patient itched until lesions were painful.  No fever, but did experience muscle aches.  Treatment included Benadryl allergy tablets and Benadryl cream.
Approximately 22 hrs after administration of influenza vaccine, status epileptic generalized, then walk in local facility. Child had brief febrile seizure previously at 10 mos, did not have fever at time of seizure but developed one later in the day,
Per mom, pt has a lump about 2 inches in diameter at injection site and there is a rash on her left arm spanning from left elbow up to her face, nose, chin & neck area, and she has a headache.  Mom has been applying topical cortisone, given her loratine orally, apply ice packs and given oral ibuprofen.  Mom says it is not getting worse, but still very uncomfortable at this point.
Rapid Heartbeat, heightened blood pressure, dizzy, faintness within minutes of vaccine. Thereafter tiredness, lightheaded, dizzy, easily out of breath, chills, hot flashes, pain in different joints at different times, headache, extremely painful arm all lasting 12 days. Covid arm from day 7-11.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (Pfizer/BionTech COVID-19 Vaccine), dose 1 via an unspecified route of administration administered in left arm on 02Mar2021 13:00 (Lot Number: EN6203) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included dupilumab (DUPIXENT) taken for asthma and eczema from Oct2019 to Feb2021. The patient experienced diarrhea on 03Mar2021. The seriousness of event was medically significant. Event required visit test: physical office. No treatment received. No prior vaccinations within 4 week. The outcome of event was recovered on 20Mar2021.  No follow-up attempts are needed. No further information is expected.
first evening very painful shoulder -- at point of injectcion.  next morning: ZERO mobillity in my shoulder and could not move left arm.  now, six days later: shoulder is still hurting and mobility is limiited in my left arm to 40 degrees of movement. but painful. and very very weak.  the injection seemed to be very high on my shoulder/muscle area compared to first shot.  first shot had no or limited shoulder pain.  this time, I am in quite a bit of shoulder pain and again, have very very liimited arm movement.  it is like a partial tear of my rotator cuff, which I had in the other shoulder a few years ago.  very weak shoulder, very limited abilitiy to move my arm.
FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's medical history, drug abuse or illicit drug usage, alcohol consumption, smoking were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown gender and ages. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were inadvertently administered with ROTATEQ (lot # L033693, expiry date: 31-MAY-2017) that had been improperly stored at a temperature of 34.5 F for 5 hours. The outcome of the excursion was reported as supported. No adverse effects were reported. The outcome of the events was unknown. Additional information had been requested.
Severe stomach pain on left side where cancer is. Pain was so bad, I had to take a morphine pill. Hadn't had to take one for over a year due to cancer. Fever of 102 and bad headache and aches and pains. Slept for about 2 days. This was my first shot so i am not risking taking the second shot. Already had covid.
this morning, I don't feel good; feeling a tightness of the throat and chest; feeling a tightness of the throat and chest; feels like having an asthma attack; headache; Injection site is hard and hot to touch; Injection site is hard and hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (feels like having an asthma attack), VACCINATION SITE WARMTH (Injection site is hard and hot to touch), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest) and CHEST DISCOMFORT (feeling a tightness of the throat and chest) in a 75-year-old female 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 was provided.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA), SALBUTAMOL (ALBUTEROL HFA), METOPROLOL, ATORVASTATIN, COLECALCIFEROL (VIT D [COLECALCIFEROL]), LORATADINE (CLARITIN [LORATADINE]), CYANOCOBALAMIN (VIT B 12), TIMOLOL and LATANOPROST for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hard and hot to touch) and VACCINATION SITE INDURATION (Injection site is hard and hot to touch). On 27-Feb-2021, the patient experienced ASTHMA (feels like having an asthma attack), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest), CHEST DISCOMFORT (feeling a tightness of the throat and chest) and HEADACHE (headache). At the time of the report, ASTHMA (feels like having an asthma attack), VACCINATION SITE WARMTH (Injection site is hard and hot to touch), FEELING ABNORMAL (this morning, I don't feel good), OROPHARYNGEAL DISCOMFORT (feeling a tightness of the throat and chest), CHEST DISCOMFORT (feeling a tightness of the throat and chest), VACCINATION SITE INDURATION (Injection site is hard and hot to touch) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication was provided by the reporter. Patient had recovered after 1 week. Patient's allergist had suggested her to take some inhalers before taking 2nd shot,  which she did.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Outcome of the adverse event added
My arm hurt immediately after receiving the TDAP vaccination, which was expected, but the pain continues to this day nearly one month later. The pain is in my left shoulder and continues down my left arm, stopping at the elbow. It is noticeable throughout the entire day and causes problems for me when I try to sleep; I have problems falling asleep and often wake up in the middle of the night. I have just started my first week of graduate school and am extremely concerned at the difficulties this pain is causing me, especially in my inability to receive adequate rest.