chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate arm pain, traveled to shoulder and neck. Ongoing since October 2010. MRI on neck spine. Three orthopedic visits to no avail. Neurologist visit on March 30, 2010. EMG scheduled.
Patient began to have shooting pain under her left arm that comes and goes.  Vital signs were taken and all with in normal limits.  Patient was observed not intervention or medication given after full 15 min wait time Patient was feeling better and went home.
Rash all over the body that comes and goes; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 86-year-old  This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 10th December 2021) for prophylaxis.   On 3rd August 2020, the patient received the 2nd dose of Shingrix. On 3rd August 2020, less than a day after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: After receiving the Shingrix the patient experienced rash all over her body that comes and goes. The reporter consented to follow up.
ICD 10 L03.113: Cellulitis of right arm and ICD 10 M79.89 Other specified soft tissue disorders. Pt developed pain. redness, swelling, and warmness at site on her right arm in the area of the bicep ( half way between elbow and shoulder) about the size of a fist starting 09/18. Pt went to urgent care 09/19 and was prescribed Augmentin 875mg for 7 days.
No additional adverse events; Administration of expired dose of MMR Il; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 20-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (expired product administered) (lot number# S036663 has been verified to be a valid lot number, expiration date was reported and established as 14-NOV-2021, therapy type: rHA; dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis. The nurse inquired viability information.   No additional adverse events were reported.  This case was considered non-valid due the lack of patient's identifiers.  Follow up information was received from the nurse on 19-JAN-2022. The patient was a 44 years old male. Concurrent conditions included adult-onset Huntington disease (AOHD), bipolar, cervical disc disease, gastrooesophageal reflux disease (GERD), depression, Cannabis use (disorder) and erection disorder. Historical condition included anxiety. Concomitant therapies included pantoprazole and epoprostenol sodium (FLOLAN). There were no other vaccines within 4 weeks prior to administration of the expired vaccine. The medical assistant misread the expiration date on the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) vaccine, and the expired vaccine was given to the patient as first dose subcutaneously on the left upper arm (product administered to patient of inappropriate age). No illness at time of vaccination. No digital data logger was involved.
This is a spontaneous report from a contactable consumer (patient/self-reported). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included flu vaccine; she had previous allergic reaction to flu vaccine on an unknown date. The patient reported she received the first dose of the Pfizer COVID-19 vaccine three weeks ago from today. She stated right after the vaccine, her tongue went numb and was swollen a little. She was tingling a little bit on an unspecified date. She stated the emergency team checked her out and noticed some hives on her neck. They told her to take some Benadryl and she went home. She experienced neurological symptoms for five days after the vaccine at the same time of day. She felt no pain in facial nerve but tingling all over the trigeminal nerve in her face and all over her head in a pattern. She also experienced severe itching of the lymph nodes (from her jawbone to her neck) off and on and in the lymph nodes under her armpit and groin. She had small hives on her lymph nodes and also experienced severe headaches and soreness in her muscles. She had a rash that comes and goes in her midriff area and cheeks. She had a fever over a 24-hour period and her whole body was wet. She would like to know if her symptoms were normal and if she should receive the second dose. She stated she was scheduled for the second dose of the vaccine today, but she did not receive it due to her adverse reactions. She would like to know how long she could put off receiving the second dose. Outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
pt recv vax 24SEP94 & allegedly dx w/GBS on 19OCT94;as a result of GBS pt suffered pain & permanent disability;hosp is presumed, although not documented;this is a serious, labelled event;
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was administered her first dose of GARDASIL (lot# unspecified) 2 years ago in approximately 2011, and the patient had came into the office on 28-AUG-2013 to receive her second dose of GARDASIL (lot# unspecified). No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
Hard and hot lump with redness, itching, and aching around injection site ~2 inches in diameter, with aching going down the arm into the hand.
Fatigue, Chills, Headache, sore arm at injection site.  Took x2 extra strength Tylenol and took a nap. All signs and symptoms relieved by next day
Swelling and redness surrounding the injection site; muscle soreness in arm where the injection was made; severe muscle weakness in legs (could not get up from my sofa).
I had COVID-19 twice this year. It was super fatigue and sore throat. On November 20,2022, I felt the same symptoms of COVID-19. I tested and it was negative. My symptoms of fatigue, sore throat and stuffy nose progressed, and I developed a harsh cough. My sinuses felt pressurized. My ears rang and ached and my eyes and started to get all goopy and pink. I tested with a rapid test again and it was negative. I went to the clinic and was checked out and given antibiotic for the cold and pink eye. I still do have a lingering cough and my throat still hurts. I have not completely healed yet. After getting vaccinated these last two time with the COVID-19 the 3rd dose Pfizer and the 4th dose Moderna, I developed a very large ring like sore on the left arm, it was sore. I did lay in bed thinking I was dying. The arm was on fire, and I felt extremely fatigued. I had to sleep it off.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 03-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
SWALLOWING INJECTION SITE   area spredding down arm  tissue became very hot    fluid  in the upper arm    had much pain when moving arm  took two tylenol  went to bed.    in the morning area of soreness much lower  almost to the elbow.  heat tenderness and redness on upper arm.   pain not as sever      during the day i was able to move shoulder and arm more   next mornimg now friday pain and swelling had gone to mid forearm arm was still very hot  to the touch     returned to the pharmacy and showed arm to the pharmacist she told me to continue with the tylenol and call my primary care doctor
Hives, nausea, severe headache, chest pain. Took ATARAX to stop hives.
Aching in muscle began within an hour; could not raise elbow for about 36 hours. Rapid pulse (120 - 140) began early in the morning after the shot. I did not read the "serious reaction" portion of the "Vaccine Information Statement" until after several days of the rapid pulse. The pulse decreased to 90-100 after two days, and continued to slow down to 80-90, but didn't drop below 80 (my pulse is consistently 60-70). I called the doctor's office on March 5th to report this. The doctor didn't think the event was related to the vaccination.
Pt jerked out of medical assistant's and mothers grasp while being vaccinated. The needle jerked out of patient's arm, scraped the back of medical assistant's thumb, and then back into her arm. The vaccine was squirted outside of the patient, so another dose had to be administered.
p/vax pt exp diff speaking & mouth was distorted;ER visit was required & was treated w/DPH;next day devel a severe tooth ache;seen by dentist who found nothing wrong;sx resolved in approx 2 days;
Continuing redness  - rash - just below the vaccine site; at this point, 19 days after the 1st dose
Approximately 5 minutes post injection, I felt a burning sensation move from my left deltoid, up my shoulder, and across my chest. I experienced burning in my chest for about 10 mins, and then it subsided. About 8 mins after that, I experienced moderate to severe cramping in my lower back and thigh muscles; which completely subsided after 10-15 mins. Two days after the initial injection, the injection site began burning/aching again, with movement up to my shoulder joint. It was to a point where I was tearful and unable to sleep. The following morning it had subsided, and just remains slightly sore.
Generalized hives, angioedema, facial edema. extremity edema. Solu-medrol 125 mg IM, Medrol dose pack, Hydroxyzine, Famotidine, Loratadine
Administered vaccine with a manufacturer expiration of 9/30/22. Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.
10 minutes after flu shot patient feel shortness of breath. Increased HR/BP. Dizziness. EMS came and monitored her vitals, drove her home. EMS says ER not necessary after patient stabilized.
pt recv vax & became violently ill 10min p/vax;26NOV98 pt exp cardiac arrest & hosp w/dx of thrombotic thrombocytopenic purpura & hemolytic uremic synd;
day p/vax pt exp rash under skin @ inject site & back. itching occurred 6 hrs of recv vax. treated w/hydroxyzine.
Fever of 102 to 100.4 since 7/28/22 evening, currently 7/30/22 evening, extreme body aches, joint aches, feel as if skin is on fire, can't  have anything touch skin too painful, chest pain of respiratory type, sharp pain in center of chest with inhalation , Dizziness upon standing,, fatigue, loss of appetite, Nausea. Minimal injection site pain.
Throat and back of tongue swelling, hot flushes in head and face. High blood pressure and pulse.
periodic tingling in Left shoulder radiating into Left chest, scapula and occasionally down left arm 1-1/2 weeks after 1st dose 3/21  Physical Therapy with some relief weakend extremities and hands, increase in amount and intensity of achy and sore muscles and joints get "winded" easily, have to stop and rest between daily chores and activities, feel tired all the time, feel as if aging has progressed faster, have developed some sort of seasonal allergy that OTC antihistamines do not help  (continuous clearing of throat, feels as if there is thick mucous in back of throat) after 2nd dose 4/21 **I can not attest that these are true adverse events, but had none of these things happening until after vaccine ******* **Received 2nd dose of Pfizer vaccine 04/21/21
Information has been received from a consumer concerning a 2 year old female patient who in 12/99 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Subsequently, the patient developed a fever, an upper respiratory infection, and coughing. The reporter indicated that her granddaughter's experiences were caused by thimerosal. "The patient sought unspecified medical attention. Additional information has been requested.
02/18/04: Admitted to ER due to erythema, heat and swelling of right thigh.  Likely immunization reaction but could not be certain it was not a cellulitis.  Child had IPV and MMR in righ tleg- per MD notes.
Started to feel an itching at the site of the injection, as the day wore on it became large ( 5 inch circumference) round , red, hot to the touch and hard. Went from itching to more of a burning sensation. My armpit is sore and continues to be so.  I applied ice, and that has not changed the situation.
A day or two after the vaccine, I felt a constant dull pressure in my chest for roughly 7-10 days. Then it became very on and off with pressure, pulsing/pounding, and pinching feelings in my chest. It doesn?t happen often but at least once a day. About 2 and a half weeks after the shot, it was the worst it?s been; I was kept awake by what felt like my heart pounding against the wall of my chest for 3 hours. It has been worse after intense exercise and when I am laying flat.
My blood pressure spiked. Severe nausea, diarrhea and high blood pressure. Presented to ER two days later. CBC done and need two normal saline while in the ER. Results of blood work was low blood platelets. Was prescribed propranolol and vitamin D. Was also prescribed Xanax but I never took it.
PT CALLED INTO STORER AND SPOKE TO PERSON AND SHE CALLED US SINCE PT GOT VACCINE AT THATLOCATION. PT TOLD PERSON HE HAD NUMBNESS IN HIS THIGH AND CHEST. SHE TOLD PT TO CALL HIS MD
Flu like sympton, chills, body aches, headache, no appetite, no energy.
pt recv vax 8MAY95 & 17MAY95 pt devel 20-30 pox lesions, described by pt's mom as eruptions, scattered over the body; subsequently pt recovered;
This spontaneous report was received from a pharmacist via a company representative refers to a male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The reporter mentioned that the patient have received "more than two doses of PNEUMOVAX 23 (lot unknown by reporter expiry date unknown by reporter) for prophylaxis in their lifetime". The patient had shared with pharmacist that his unspecified primary care administered an annual PNEUMOVAX 23 vaccine to him. The pharmacist additionally stated that she had similar reports from other unspecified asthma patients and cardiac patients. They, too, have received annual PNEUMOVAX 23 vaccinations by their treating physicians. No adverse effects were reported. The patients' outcome and the causality assessment was not provided. This valid case is linked with a non-valid case of multiple unspecified patients #1809USA012845.
flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 11 years old female patient whom influenza quadrivalent recombinant vaccine [Flublok] inadvertently ordered, staff administered to six patients, should have been influenza trival A-B subvirion no preservative vaccine [Fluzone] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  On 04-Jan-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot UJ93AA; strength, formulation, frequency, expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 04-JAN-2023 the flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: on same day).  It is unknown if there were lab data/results available  Action taken : not applicable.  Outcome : Unknown.   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.
I was feeling bad so I took a home test and tested positive on 5/22/2022. I had a virtual visit through a HCP.
This is a spontaneous report from contactable Physician via Pfizer Sales Representative. This Physician reported similar events for 3 patients. This is 3rd of 3 reports. A 16-year-old female patient received TRUMENBA, (lot number: S58879), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at injection site on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2018352636 Same reporter/product, partial same event, different patient.
Nausea, vomiting, muscle and joint aches/pain, chills, fever, diarrhea, headache, arm soreness Started approximately 4:00PM ON 8-16-2021 and ended by midnight 8-17-2021. Treated with ibuprofen and Tylenol.
case number PHEH2014US024327, is an initial spontaneous report received from a nurse on 02 DEC 2014, and with a follow up report received from nurse on 19 JAN 2015. This report refers to a 12 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 14511P, expiry date: MAR 2015) intramuscularly at a dose of 0.5 ml on 05 NOV 2014 into right arm. Nurse reported that PFS of FLUVIRIN was store at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from nurse on 19 JAN 2015. Updated site of vaccination.
Patient's grandmother found him dead in the bathroom 4 to 4:30 hours after his vaccine. She was not aware of him having complaints. He had vomited in the commode -that was the only comment that she had.
pt recvd vax 26JUN95 1130AM & 2 hrs later 130PM pt kept awakening during sleep w/high pitched screaming;mom called family MD who saw pt by 5PM; MD determined that pt was having adverse rxn to pertussis;screaming stopped 7PM;
Fever 103.4; Arm pain; Decay; Cough; Loose stomach.
Patient developed a fever, chills, headache. Fever and chills lasted for 1.5 days, headache persisted for 3 days. He has never had adverse reactions to any childhood vaccines prior to this.
Hard to breathe, exhaustion, high blood pressure.  Afraid I was having another heart attack.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "slow transit constipation" (unspecified if ongoing); "Lyme" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "asthma" (unspecified if ongoing); "EBV" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "slow bowel dysmotility" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: I tested negative on days 3 & 4; (2022) Negative, notes: I tested negative on days 3 & 4; (2022) Positive, notes: 6 days later I tested positive again. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Patient had Paxlovid rebound. Patient had a 5 day course of Paxlovid and asked her Dr. if she could do another course, because she could still feel that the virus was active in her body. Patient tested negative on days 3 & 4 after taking Paxlovid. She still felt terrible and 6 days later she tested positive again for Covid. Patient tested because her congestion came back. Patient had not received any other medication in 2weeks. Patient had received treatment with anti-viral therapy Paxlovid from 18Apr2022 to 22Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I felt fine in the morning of the 20th until around 10:00 am when I began to feel sick to my stomach. I lay down on the couch and to rest until the feeling passed. Instead I began to feel worse, and realized that my vision seemed to be spinning. I had to close my eyes to avoid throwing up. I moved into my bedroom with help from my husband and spent the remainder of the day in bed. If I opened my eyes or got up to use the restroom I was dizzy and the room would tilt. The dizziness stayed all day into the next day. I felt better on Sunday. Then I had my open-heart surgery on that Monday. I felt a lot of dizziness following the surgery and felt that it affected my recovery time.