chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clots in both lungs. Admitted to the hospital with severe pain in chest, trouble breathing, within 5 days of vaccination. Put on blood thinners to help get rid of the clots. Extreme fatigue before admittance to the hospital as well as ongoing extreme fatigue.
Vaccine was administered after the expiration date of 4/28/21.  Pt reports no adverse events.
Meningococcal B (Bexsero) was given instead of HPV vaccine. Provider, Nurse Manager and Parent was informed.
The pt's left arm was swollen from the shoulder to the elbow. Severe erythema and fever was noted in the swollen area. The pt was referred to physician for follow-up and palliative care.
3/31/03 woke with R sided chest pain and R arm pain with numbness. Went to ER for work up. Dx: non-cardiac R sided chest pain, etiology to be determined. Given Vicadin, Motrin, Decadron and Flexeril and discharged. 4/4/03 relieved temporarily and transferred to hospital. Continues to have pain with numbness of ring finger and pinkie. Symptoms continue. The medical record received on 5/27/03 states R sided chest pain, and R arm pain with numbness.
This spontaneous report as received from a pharmacist via company representative refers to a 51 year old patient of unknown gender. The patient's pertinent medical history was not reported. Approximately in September 2015 (reported as last week), the patient was vaccinated with PNEUMOVAX 23 (lot # L007720 and expiry date: unknown, dose and frequency were unknown) and influenza virus vaccine inactivated (unspecified) (reported as flu shot) in the same arm. Approximately in September 2015 (reported as within five days of administration), the patient came back to the pharmacy and stated that he/she experienced arm soreness in the arm where the vaccines were administered. The outcome of the event was unknown. The relatedness of the events with suspect therapies was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
On Saturday, January 23, 2021 I woke up around 5:30 in the morning with itchy hands and feet, after my second dose/ Just as I did with my first dose- Which subsided with Benadryl. However the second dose was given Thursday, January 21. The progressing of the itchy hands and feet lead to my bottom lip swelling excessively large , my tongue begin to swell, my upper lip begin to swell, my lungs begin to burn in my airway begin to tighten. I took two Benadryl and called my family to call 911 and take me to the emergency room. My blood pressure was very low pulse was very high. I had genital pain and swelling, dizziness , nausea vomiting, and extreme body pain. I was given epinephrine, breathing treatments, steroids, Benadryl, and IV fluids. Labs were drawn and my creatinine was high. After about four hours the swelling has gone down and I was able to go home. I have to take steroids for three days, Benadryl for seven , and famotidine.  I have no history of severe allergies, in fact I was tested for food and environmental allergies about a year ago and everything came back negative. I have no history of reacting to any vaccine at any time.
PATIENT C/O VARICELLA LIKE RASH DEVELOPING ON LOWER EXTREMITIES. A WEEK AGO THE RASH BEGAN TO DEVELOPE ON PATIENT'S BACK, ABDOMEN, AND UPPER EXTREMITIES. NO OTHER ADVERSE EVENTS OCCURED.
81 year old male with hx PAF, s/p watchmans, HTN, COPD, current lifelong smoker, bladder ca, ETOH abuse, RBBBB, HLD, hypothyroidsm, presents for a fall, he states he was placing the garbage cans out and lost his footing and was walking backwards and slid on the ground onto his right shoulder. NO syncope or dizziness, no chest pain or changes in breathing, no fever or chills. He is positive COVID 19 in the ED. Otherwise his chest xray is clear, no nausea or other changes in taste or smell or any loose stools. He is vaccinated x 3 with pfizer. Plan to admit to telemetry for arrhtymia monitoring and due to mild tropnin leak. Cardilogist is Hynes. Chest xray is negative for infiltrates or effusion.
Patient complained of redness, itching, and soreness at injection site starting 3 days after vaccination. Patient also complained of headaches. These symptoms resolved by 6/22/15.
SEVERE, BLISTERING RASH ON RIGHT UPPER CHEST, SHOULDER, AND UPPER BACK/SHOULDER BLADE AREA. PT BEGAN NOTICING THE RASH APPOXIMATELY 6 DAYS AFTER RECEIVING VACCINATION. THE RASH HAS PROGRESSIVELY GOTTEN WORSE THIS WEEK AND HE IS EXPERIENCING SHARP, SHOOTING, RADIATING PAIN DOWN HIS RIGHT ARM FROM HIS SHOULDER AREA. RASH APPREANCE IS CONSISTENT WITH PREVIOUS SHINGLES RASHES OBSERVED IN THE PAST AT OUR PHARMACY AND IN COMMON MEDICAL LITERATURE.
Extreme fatigue and pain in all muscle groups.  Fever of 101 degrees.  Extreme tiredness, yet unable to sleep more than about two hours without waking in pain.  Joint pain throughout my body.
Patient presetned 9 days post smallpox vaccine with c/o skin papules an pustules approximately 3mm-5mm in size on trunk of bosy.  Extremeities: Approximate 1.2 cm necrotic papule with central ulceration and 7cmx7cm area of erythema at innoculation site. No evidence of cellulitus or lymphongenic streaking.  Patient discharges without treatement.  Follow up is sx'x increase.
Shingles vaccine - pain in left upper arm and neck unable to lift things. 9/22/16 - 9/27/16. Treatment: Sling, Naproxen, ice and stretches.
Information has been received from a 77 year old female patient with high cholesterol, high blood pressure, allergic to sulfa and a history of shingles who in the spring of 2008, was vaccinated with ZOSTER (Oka/Merck).  Concomitant therapy included NATURES MADE CHOLEST OFF.  A couple of month after the patient experienced little red pimples on her left side that would itch around her hip, her buttocks, her shoulder.  And at one time she had some on her right elbow.  The patient also reported that she put some anti-itching cream on and eventually the little red pimples would dry up and go away, but then eventually they would come back.  The pimples did not blister up, and the patient stated that the pimples she got were nothing like she had when she actually had the shingles.  The patient also reported that while taking NATURES MADE CHOLEST OFF, she experienced heart burn.  At the time of reporting, the adverse events were ongoing.  The patient sought unspecified medical attention.  Additional information has been requested.
pt recvd vax 6MAY94 approx 24 hrs later pt began vomiting; seen by MD 7MAY; pt dehydrated; given oral fluids; vomiting cont, low grade fever devel; blood test revealed elevated liver enzyme levels of approx 700; alkaline phos; level nl;
Within 6-7 hrs, I developed a violent diarrhea, cramps, headache, muscle pain, joint pain and a 4 hour elevation in temperature. My MD saw me Monday. He believed that my reaction came either from the flu shot or a dormant virus which activated due to lowered immune response due to the shot.
Is a 74 y.o. female who presented to the Hospital ED from home on 11/30/2022 with complaint of progressive weakness, increasing shortness of breath, and worsening cough.  Symptoms started on 11/27/2022 and she was diagnosed with SARS-CoV-2 infection on 11/29/2022.   Discharge Diagnosis and Associated Hospital Course     SARS-CoV-2 infection with COVID-19 pneumonia with sepsis Acute exacerbation of asthma Presented with cough, fever, myalgias, shortness of breath, n/v/d, and generalized weakness -Symptom onset: 11/27/2022 -Positive COVID-19: positive at home; prescribed nirmatrelvir-ritonavir on 11/29 -Confirmed COVID-19 testing on admission 11/30/2022  -Vaccination status: Moderna x 4, bivalent x 1 -CXR on admission showed bibasilar opacities secondary to atelectasis versus early infiltrates -Oxygen status: Briefly required low-flow supplemental oxygen at 2 L/min -Dexamethasone: Yes.  Will complete 5 days of dexamethasone -Remdesivir: Yes.  Therapy completed -Inhaled bronchodilator therapy/asthma: Resume tiotropium, montelukast, dupixent and dulera   Abnormal chest x-ray Right phrenic nerve palsy Elevated right diaphram Known history of phrenic nerve injury/palsy with elevated right diaphragm present on current chest imaging likely contributing to abnormal findings -No acute issues   Paroxysmal atrial fibrillation Status post left atrial appendage closure (watchman procedure) Chronically managed with sotalol with less than 1% burden present on holter monitor following left and right atrial ablations in May 2022 status post placement of Watchman device 8/3/2022 on dual anti-platelet therapy as of 11/10/2022 office visit with CHA2DS2-VASc score of 3 -Assessed September 2022 -Continue sotalol and dual anti-platelet therapy; no indication for anticoagulation   Mitral and aortic valve regurgitation  Atrial septal defect  Valvular disease was described in September 2022 as mild while the ASD was reported as large, residual, with left-to-right shunting -No acute issues apparent  Hyponatremia  Hypokalemia Hypomagnesia Mild at 129 on admission improved to 134 presumed secondary to nausea and decreased dietary intake as well as GI losse -Volume replete with IV isotonic crystalloid fluids   Hypertension, essential Lisinopril and spironolactone for held due to low normal blood pressure -Continue to his medications until follow-up with PCP   Hypothyroidism Continue levothyroxine
Persistent pain in left upper arm.  Several weeks after administration and following very vigorous physical exercise sharp exacerbation in pain.
Pt recvd vax 22JUN93 & exp h/a, malaise, induration, sl swelling & redness @ the inject site; pt was nl as of 28JUN93;
Fluzone Quad was ordered, but Tdap was inadvertently given by staff CMA.
swelling in throat and sob after receiving C19 vaccine. Epi x 1 at vax site with relief, required Epi x 1 en route to ED, pt remain stable, no report of urticaria, angioedema or any other complications during transport
COVID-19 +, headache, chills, fatigue, SOB, cough, body aches, sweating, loss of taste and smell. Received MAB infusion on 10/4/2021.
red, itchy rash.; itchy rash./broke out in an itchy rash on his waist, back, shoulders, chest, and neck.; This is a spontaneous report from a contactable consumer, caregiver/wife. An 82-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, Lot Number: EL9263, Expiry Date: Unknown, NDC number: unknown) via an unspecified route of administration on 24Jan2021 at 11:30 on right arm as a single dose (at the age of 82-years) for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE(s) was not provided. Patient used no other products. No vaccines administered on same date of the Pfizer suspect. Patient did not receive any prior vaccinations (within 4 weeks). Caller stated that she was calling on behalf of her husband (name) who received the first dose of Pfizer COVID vaccine on 24Jan2021. Caller stated on 02-03Feb2021 (a week and a half later after receiving the vaccine) her husband developed a red, itchy rash on his waist, back, shoulders, chest, and neck. She said her husband did not have a rash on his arms, legs or face. Patient did not require a visit to emergency room but visited physician office (Primary Care Doctor and Allergist). Reported her husband's allergist did a bunch of allergies testing and all the test results were negative. Her husband's doctor gave her husband a couple of injections. She said she knew one of the medications started with "Dexa", saying the medication was something like Dexatrim. She said she did not know what the other medication's name was. Her husband had taken some over-the-counter Benadryl. She said her husband is no longer taking the Benadryl. She did not have the Benadryl UPC/NDC, Lot, and Expiration Date. Reported her husband was using over-the-counter cream, clarified as Sarna cream. She said the Sarna cream was a white cream and was helping her husband's itch and rash. She said she did not have the Sarna cream with her to provide the UPC/NDC, Lot and Expiration Date. Caller stated her husband is due for his second COVID-19 vaccine and wanted to know if Pfizer recommended her husband get the second COVID-19 Vaccine dose. She reported that her husband's primary care doctor and allergist both recommended her husband not take the second COVID-19 Vaccine dose. Outcome of the events was recovering. Investigation Assessment: Yes.  No further details provided.
Arm pain, not improving Cannot lift arm Chills Fever 100.7 Nauseous
doses were administered post excursion; had a temperature excursion. 9 doses were administered post excursion; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event) in a 5-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion).    Concomitant products were not reported.  It was reported that 9 doses were administrated post temperature excursion. The storage condition at the time of excursion was reported as frozen. The vial belongs to one of the following batch numbers AR9236B: Exp: 22Aug2023, AS1903B: Exp: 14Jun2023, AS7170B: Exp: 09Jun2023 and 216K22A. The maximum or minimum temperature reached was -2 to -18 C. The excursion duration was reported as 2 hours.   Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Follow up-Significant Information received event added and narrative updated.
Pain in leg & sudden increase in neuropathy Blood Pressure abnormally high (over 200) - change in BP medicine has it back to normal Feeling foggy (better now) Decrease in energy level Loss of appetite When I talk, I feel like I'm in a well Off & On tingling in my fingers Face feels puffy & I squint my eyes (comes & goes)
Patient is fully vaccinated.  COVID + on 2/25/2022.  ED visit on 3/13/2022.The patient is a 29-year-old female who presents to the emergency department complaining of a headache for the last 11 days.  She has had some shortness of breath for the last month.  Has a history of asthma, Says she has been somewhat short of breath since having Covid. Chest x-ray unremarkable.  EKG nonischemic.Vital signs were reviewed and found to be within acceptable limits.She was given a migraine cocktail and an albuterol and Atrovent breathing treatment. Pt discharged home.
Injection Site Soreness, Headache, Chills, Body Aches day 1 Narrative:  Other Relevant History:
got real sick with COVID; got real sick with COVID; got real sick with COVID; she wished she could get rid of the ringing in her ears/it is ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200326768 (Pfizer).  A female patient in her 50's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "got real sick with COVID"; TINNITUS (non-serious), outcome "unknown", described as "she wished she could get rid of the ringing in her ears/it is ringing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient suffered from a febrile seizure 10 days after receiving the MMR, DTaP and chicken pox vaccines.
Fever 102.  Shaking. Chills  Aches pain Hot cold sweats.  Weakness
This spontaneous report was received from a licensed practical nurse and refers to a 57-year-old male patient. The patient's concurrent conditions included cerebral palsy, mild bipolar disorder and mild psychosis, as well as allergies to aspirin (manufacturer unknown), ibuprofen, unspecified penicillin, erythromycin, CIPRO, ZANAFLEX and COMPAZINE. On 28-MAR-2017, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly as a general vaccination. His concomitant therapies included HARVONI, CELEXA, ATIVAN and "other unspecified medications". On an unknown date in 2017, reported as "an unspecified time after the vaccination", the patient became agitated and irritable. Subsequently, on 09-MAY-2017, the patient received the second dose of RECOMBIVAX HB injection (exact dose, lot# and expiry date were not reported), intramuscularly. On an unknown date in 2017, the patient could not feed himself (he went from feeding himself every meal to only 30% of the time), was dizzy and weak. On 12-MAY-2017, the reporting nurse could not wake the patient up from bed, he was unresponsive. On the same day, the patient was taken to the emergency room due to the unresponsiveness and inability to be woken up, and subsequently admitted to the hospital due to those events (also reported as "due to an unspecified reason") on the same date. The patient underwent unspecified tests while at the hospital (reported as: "he was thoroughly worked up"; no result was provided) and was discharged on 15-MAY-2017 with no diagnosis, however he was "a little bit better". On unknown dates in 2017, after being discharged from the hospital, the patient experienced seizure-like movements, incontinence, migraines, paresthesia, insomnia, anxiety, tachycardic episodes and neck stiffness. Anxiety was treated with VISTARIL. On an unknown date in 2017, the patient experienced gait disturbance (reported as "went from not needing lateral supports to needing them"). The nurse also reported that the patient's symptoms were intermittent. The outcome of the events was not reported. The relatedness between the events and RECOMBIVAX HB was not reported. The reporter considered the events of "could not feed himself" and gait disturbance ("needing lateral supports") to be disabling. Upon internal review, the events of unresponsiveness and seizure-like movements were determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA008253: US-009507513-1706USA008675.
A mild sore throat started on the evening of 06/04/2022. It was a moderate sore throat on 06/04/2022 and I tested at home because I was going to an event and it was negative. By the evening of 06/04/2022 I started developing body aches malaise. 06/05/2022 the body aches and malaise was worse in the morning, I also tested positive. On 06/06/2022 in the morning I contacted my doctor and have a telehealth visit with him later that afternoon. The symptoms stayed the same body aches and malaise. I had no energy and was very tired. I started taking ibuprofen 800mg 3 times a day which helped control it. I continued with that medication and then on 06/06/2022 in the evening I was prescribed PAXLOVID after my telehealth visit. I took the first dose of PAXLOVID that evening on 06/06/2022. On 06/07/2022 the body aches and malaise was about 75% better. I did have an extreme bitter taste once taking the medication. I did continue and finish the medication of the course of 5 days. By 06/11/2022 I was no long taking ibuprofen and the body aches were completely gone. My energy was still quite low and I was taking naps during the day. From 06/05-06/09 I was sleep through the day on and off in addition to sleeping at night time. It took until about 06/25/2022 for my energy levels to return to normal. I did briefly have some upper respiratory symptoms starting from 06/15-06/21. It was a mild productive cough and mild shortness of breath which was relieved from an albuterol inhaler. It was relieved by 06/21/2022. I also had a annual physical 06/16/2022. Full labs and they all came back normal.
A physician reported the occurrence of an injection site reaction in a 2 month old male who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 4/24/02, the vaccinee received his first injection of Infanrix. On the same date, he received injections of Comvax, Prevnar, and IPOL. On 4/24/02, at an unspecified time post-immunization, the vaccinee developed an injection site reaction characterized by warmth and flushing. The events resolved on 4/24/02.
No adverse symptoms reported- Client pregnant at time of vaccine given. However, client did not report she was pregnant.
Patient states he woke the morning after immunization with initial symptom of feeling paralysis difficulty being able to move any limbs,  aches and pains throughout his whole body, muscle weakness, numbness, headache, dizziness, balance difficulty
Non-Localized rash distal to injection site side; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number J352N, expiry date 11th December 2021) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The physician stated that the patient experienced a non localized rash reaction distal to injection site side after 1st dose of Shingrix. The follow up consent was not granted.