chrisvoncsefalvay/vaers-outcomes huggingface dataset:
101.5 Fever, chills, headache, lower back pain on April 25,2021. Received Covid Rapid test on 4/25/21 - Result was negative. Was advised to follow-up with Primary Care Doctor. Went to Primary Care FNP on 4/26/21 and was given blood test and scheduled CT ABD/PELVIS W/O IV No Oral Con (Stone Protocol)
Patient received 3 vaccines on 10/16/16; Spikevax, RSV, and High Dose Flu.  The Spikevax and RSV werer given on the left arm.  Patient reported extreme soreness in the left arm and having to go to physical therapy for it.
Lost taste and smell; Lost taste and smell; A bad headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste and smell), ANOSMIA (Lost taste and smell) and HEADACHE (A bad headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (A bad headache). On 11-Feb-2021, the patient experienced AGEUSIA (Lost taste and smell) and ANOSMIA (Lost taste and smell). On 11-Feb-2021, HEADACHE (A bad headache) had resolved. At the time of the report, AGEUSIA (Lost taste and smell) and ANOSMIA (Lost taste and smell) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test negative: Negative.   No relevant concomitant medications were reported.  No treatment.
Sunday 11/2/14 went to ER-pain in entire body esp. knees, shoulders, neck and entire body was burning "like on fire". 11/4/14 went to MD's office burning in knees especially at night.
Rash diagnose as SHINGLES by MD (on 2/29/2016) treated with Valcyclovir.
her right arm is aching in the shoulder and under her arm is sore; it feels like the muscle or something is hurting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration at the age of 50-year-old at arm right on 06Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she received the first dose of the Pfizer COVID vaccine on 06Apr2021 in her right arm. The patient stated her right arm was aching in the shoulder and under her arm was sore in Apr2021. The patient would like to know if there was anything she can take for the pain. The patient would like to know if she can take extra strength Tylenol. Due to long hold, e-transmitting. Caller states okay to contact later for more information. The patient took a COVID shot 06Apr2021. Her arm was sore and it felt like the muscle or something was hurting in Apr2021. She was wondering what she can take for it. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a nurse via call center representative and described the occurrence of watery diarrhea in a 4-month-old female patient who received ROTARIX lyophilized formulation (batch number G9HA5, expiry date 17th October 2019) for prophylaxis. On 10th September 2018 02:55, the patient received ROTARIX lyophilized formulation (oral) 1 ml. In September 2018, 1 day after receiving ROTARIX lyophilized formulation, the patient experienced watery diarrhea (serious criteria GSK medically significant). On 19th September 2018, the patient experienced rotavirus test positive. On an unknown date, the outcome of the watery diarrhea and rotavirus test positive were unknown. It was unknown if the reporter considered the watery diarrhea and rotavirus test positive to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: On 11 September 2018, the day after receiving ROTARIX vaccine, the patient developed watery diarrhea. On 17th September 2018, the patient was seen at healthcare professional (HCP) office for diarrhea. Nine days after receiving ROTARIX lyophilized formulation, the stool test was performed and came back positive for the Rotavirus. The batch number reported for ROTARIX Lyophilised formulation G9HAS, did not exist and was updated to G9HA5, as per sales data sheet.
This spontaneous report was received from a certificated medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with a dose of improperly stored PNEUMOVAX 23 (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 17-OCT-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # N016089, expiration date 22-NOV-2019 (also reported as 22-NOV-2018), therapy type RHA for prophylaxis. No adverse effects were reported. The PROQUAD underwent a temperature excursion of -14 to -10 degrees Celsius for 96 minutes. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA002685: US-009507513-1801USA002686: US-009507513-1801USA002315:
Pt called pharmacy on 11/8/15 to report bruising around injection site. Bruising started 3 inches down from left shoulder bone and is 2 inches in diameter. Pt reports taking NSAIDs and aspirin daily.
received covid vaccine Monday morning. became sick with body aches, joint pain, sweating early Tuesday morning. called out sick for Tuesday shift 11am-7pm.
Pt. developed jaw and throat tightness, nausea, rapid heart beat and difficulty breathing approximately 20 minutes after receiving Tdap immunization and Mantoux test. 911 responded and transported her to the local ED where she was given Benadryl, a steroid, and Zantac. An EKG was normal. She was discharged with Rx for Benadryl, Prednisone and Allegra.
Patient was given Janssen vaccine dose when he was returned to pharmacy to get his 2nd Moderna Vaccine after 28 days. pt is not having any Major side effects. He is doing well. Pt had body ache and joint pain for about a day after shot.
2 adverse effects 1. Vertigo beginning in January 2022. Have never experienced it prior 2. Intense, sometimes debilitating pain at injection site beginning towards end of Feb 2022
5 continuous days of injection site swelling, lethargy, loss of appetite, visual disturbances, severe headache/body ache, testicluar swelling and tenderness, and high grade fever of 105 that began in evenings and lasted through the night.
A fter 3 days started running high fever. about 5 days the shoulder and elbow pain started  .Sensitive to cold air . was given a band for carpal tunnel . Band did not help . Made pain worse.
crying more than 3hr w/o stiffness-occurred w/in 24hr;tx w/APAP
ACHY JOINTS; HEADACHE; VERY TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced achy joints, headache, and very tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, achy joints and very tired was not reported. This report was non-serious.
Extreme muscle aches in shoulders, upper arms, across chest, thighs.  Prednisone prescribed. Follow up with rheumatologist, treating for Polymyalgia rumatica
An attorney reported that a child received Orimune, Tripedia, MMRII, ActHIB, Recombivax HB, hep B vaccine, Varivax vaccines and Tuberculin PPD betweent he time period of two weeks after birth to 11/06/1998. It is alleged that, as a result of exposure to these vaccines, the child experienced thimerosal-induced mercury poisoning. *F/Up report on 10/7/02: It is also alleged that he suffers from the toxic neurological effects of mercury poisoning.* Mercury poisoning is considered medically important.
Vomiting, diarrhea, body aches on 03/16/2021 Death on 03/18/21  Cause: ruptured myocardial infarction
Client sitting in chair while vaccines administered within 2-3 minutes, while still sitting, client rolled his eyes back, stiffened arms and fell back in chair. Unresponsive to name for 10-15 seconds. Skin pale and diaphoretic. Continued to sit in chair, placed head down, cold pack to back of neck, drank juice. Returned to normal within few minutes.
6h after Shingrix #2 onset fever 102'F, chills, Myalgias. The following day cough, sore throat.
Pt developed a fever of 103.7 two days after vaccine administered, this was her 3rd dosage.
First dose incorrectly entered by Walgreens. We think dose was entered on wrong patient. First dose given at our clinic 4/3/21
Fever, chills, nausea, pain at injection site, soreness around injection site, body aches
Significant local itching followed by total body itching for 72 hours without rash except at the site of injection. Local itching came within a few hours and lasted several days.
No additional AE reported; patient received a dose of PROQUAD intramuscularly (IM) instead of the subcutaneously (SC); HCP was instructed to administer another dose of PROQUAD to the same patient subcutaneously; This spontaneous report has been received from medical assistant concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions or allergies, and concomitant medications were not provided.   On 25-JAN-2023, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human Albumin recombinant Human albumin) (rHA) (PROQUAD) 0.5 mL once (lot number W007748 has been verified to be valid, expiration date reported and established as 04-SEP-2023).  The patient was vaccinated intramuscularly (IM) instead of subcutaneously (SC) (Incorrect route of product administration), and medical assistant was instructed to administer another dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) SC to the patient (Extra dose administered), the reporter did not specify if both doses of Measles, Mumps, Rubella and Varicella (Okaa-Merck) Virus Vaccine Live (PROQUAD) had the same lot number and expiration date. The reporter refused to answer questions to further clarify the adverse events. No additional adverse events were reported (No adverse event).  This case was classified as non-valid report due to lack of patient identifiers.  Follow-up information has been received from a vaccine provider on 27-FEB-2023.  The patient was female of 12-months. Her birth weight was 4505 Kg. Historical vaccines included 3 previous doses of PVC13. On 25-JAN-2023, she received two doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human Albumin Recombinant Human albumin) (rHA) (PROQUAD) under direction of medical assistant (noted that re-vaccination was necessary) as previously reported, both doses were given with product of the same lot number W007748 with expiration date 04-SEP-2023 in the right thigh. On the same date, she also was vaccinated with hepatitis A Vaccine, inactivated (VAQTA) IM in left vastus lateral (LVL) (lot number reported as: W017344) and "PVC13" (lot number FF7356, expiration date 30-APR-2024) IM on the LVL. All given by a health care professional at a private doctor's office or hospital by private funds. Subsequently, the were aware of both errors, and the patient's mother was advice of precautions. Patient did no experienced any adverse effect. This report has been previously reported to doctor and manufacturer.
Just a sore arm; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9266; expiration date: May2021), on 18Feb2021 at 09:30 AM (at the age of 21-years-old) at 1st dose, single, administered in left arm, for COVID-19 immunisation. Medical history included Crohns disease, depression, anxiety, seasonal allergies. The patient was not pregnant. The patient had no known allergies, no COVID prior vaccination and no COVID tested post vaccination. Other medications in two weeks included adalimumab (HUMIRA), gabapentin, escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D). No other vaccine was received in four weeks. The patient experienced just a sore arm on 18Feb2021 at 10:30 AM. No treatment was received for the event. The patient was recovering from the event.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Pneumonia/flu like symptoms s/p receiving FLUMIST. Vaccine given approx 23rd September w/ onset of symptoms 28th September 2010. Hospitalized on 28 Sept 2010/ICU x18 days.
Patient is a 18 y.o. female who presents for evaluation of multiple complaints. The first being headache that began around 1230 today. Headache is located in the occipital region and radiates frontally. It is constant. She cannot identify aggravating or alleviating factors. She has not taken anything for the pain today. She has a history of migraines. She has a also experiencing perioral and upper extremity numbness and tingling and generalized weakness. She is tachycardic at 143 and states she does not normally have an elevated heart rate. She feels flushed but is afebrile. Denies neck pain or stiffness.  She complains of lower abdominal pain and nausea. Denies vomiting or diarrhea. Denies dysuria, polyuria or hematuria. Denies vaginal discharge or pregnancy concerns. She does take oral contraceptive pills. Last menstrual period was this past Friday. Denies lower extremity swelling, tobacco use, recent trauma, surgery, travel or prolonged periods of immobilization. Mom tells me that she received the meningococcal B vaccine yesterday.
1.  face rash that later turned into acne. had to see md. was diagnosed with rosacea. was given rx's. 2. irregular heart beat. went to er, was refereed to cardiologist. diagnosed with pvc. still going through different tests.
Got the vaccine in left arm on 12/31, sat for 15 minutes for observation. After leaving and driving home, started feeling worse pain in left arm and numbness around the left ear and left cheek.   Went back, they examined and observed for another hour, then released. It went away and returned; has been intermittent since.   Left V2/3 distribution
hearing loss in the left ear; diagnosed with covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS UNILATERAL (hearing loss in the left ear) in an 83-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced COVID-19 (diagnosed with covid). In July 2023, the patient experienced DEAFNESS UNILATERAL (hearing loss in the left ear) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. In August 2023, DEAFNESS UNILATERAL (hearing loss in the left ear) had resolved. At the time of the report, COVID-19 (diagnosed with covid) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had hearing loss in the left ear 2 weeks after covid diagnosis but came back 3 weeks later. Company comment This spontaneous case concerns an 83-year-old male patient with no medical history reported, who experienced the unexpected, serious (medically significant), event of deafness unilateral and the non-serious event of COVID-19, in the context of a dose of SPIKEVAX NOS. The vaccination date was not provided, thus, exact latency between vaccination and onset of the events could not be assessed. It was reported that the patient had hearing loss in the left ear 2 weeks after COVID-19 diagnosis, but came back 3 weeks later. He was treated with Paxlovid. No further clinical information was provided for review. The events deafness unilateral and COVID-19 could be associated with each other. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-742650, US-MODERNATX, INC.-MOD-2023-742692 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742650: US-MODERNATX, INC.-MOD-2023-742692:Same reporter, Different Patient
Immediate and severe pain on administration of flu shot.  The pharmacist gave it at the tip top of my shoulder, right over the bone, instead of down in the thick part of the muscle.  Over the next 3 weeks, pain did not get better.  Now have constant pain in the joint.  It gets worse on use of the shoulder. The spot of administration is still very tender to the touch as well. My doctor's office says to wait, it will get better.  That was over 3 weeks ago.  I am losing hope.
Discharge Provider:  Primary Care Provider:  Admission Date: 5/7/2022 Discharge Date: May 12, 2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] Type 2 myocardial infarction [I21.A1] Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] COVID-19 virus infection [U07.1]   HOSPITAL COURSE:   This is an 80-year-old female patient who presented with a 5 day history of cough and progressive shortness of breath which escalated on the morning of admission.  At home she had pulse oximetry reading that were severely low, along with profound tachypnea and severe coughing paroxysms.  Her daughter called EMS immediately and EMS found her pulse oximetry reading to be 50% on increase in her supplemental oxygen.  They placed her on BIPAP because of the severity of her dyspnea and her pulse oximetry readings and brought her to ED.  The patient's BIPAP was maintained with an FiO2 of 100%.  She was given Solumedrol and Nebulizer treatments.  She tested + for COVID.  She is vaccinated and has received a booster.  She had an elevated D dimer which prompted a CTA of the thorax that revealed bilateral interstitial pneumonia, ? Consolidative process, previous lobectomies from lung adenocarcinoma, and bronchial inflammation, but no pulmonary embolism.   She was admitted and treated with oxygen therapy after weaning off of BiPAP, IV Solu-Medrol, systemic antibiotics with doxycycline and Rocephin, as well as meter dose inhalers with albuterol, Symbicort, and Spiriva.  She was also treated with 5 days of remdesivir intravenously.   By discharge she was feeling back to her usual level of function, with a pulse oximetry in the upper 90s on 1 L of oxygen.  She does use oxygen at home more on a p.r.n. basis.  She was felt to be stable for discharge with the following changes in her medications.
Shoulder pain-intermittent pain to fingers. Patient reported that the pain started after her flu shot.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: pt fainted but woke up immediately after and was responsive and aware -Mild, Additional Details: pt fainted and hit her head, woke up 30 seconds after and was responsive and aware of what happened and surroundings. she hit her head on the wall corner when she fainted but claimed to be okay. we called 911 and she refused treatment when they arrived. her mom picked her up and she went home.
Vaccines were given at the well child exam on 6/5/2023. Mother of the child called our office on 6/6/2023 after receiving a call from the school informing her child was having issues moving the right side of her face. We scheduled an appointment for child to be seen at our office the same day. Child was examined and she seemed to be paralyzed on the right side of her face. Her right eye was blinking slowly and she couldn't smile on the right side. She didn't have any numbness and she was walking well. She did seem to have a hard time hearing. No fever or other illness. She was started on a low dose steroid for one week and then she will lower the dose for the week after. A referral was generated for both Neurology and Ear, Nose and Throat.
PHARMACIST GAVE PATIENT THE SECOND DOSE WHICH IS LESS THAN 21 DAYS APART.
Pt seen for shots on 2/20/13. Mother noticed that left arm red and swollen and tender to touch on 2/22/13. Patient was seen by provider on 2/22/13. No fever, child able to move arm and no problem. KEFLEX 150 mg po tid x 7 days prescribed. Patient reassessed on 2/26/13. Doing well. Area of left arm, no swelling, no redness, no warmth, no fever. From of shoulder and arm.
Information has been received from a physician, via a company representative, concerning a patient who on an unspecified date was vaccinated (route unknown) with dose of pneumococcal 23v polysaccharide vaccine (Lot # 649697/1038P).  "Within the last 2 months", the patient developed "redness and swelling of the arm where the injection was given". Subsequently, on an unspecified date, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Acute DVT in left LE. Patient presented to ED on 3/22/21. She had 2 day h/o leg discomfort and leg was taught and painful on the day she went to the ED. Study was limited due to pt lack of cooperation. Lovenox started.
Fully vaccinated with two doses of Moderna. Tested positive for COVID 19 on 01/23/2022. Admitted to hospital on 01/23/2022. Expired on 02/10/2022 while still hospitalized.
swelling, spreading redness extending from injection site with treatment of Benadryl x 2 - dx of cellulitis, tx with higher dose of Benadryl and steroid Rx
No trouble with the shot itself, just felt tired, headache, but then I got COVID-19 in October, I had fever, a little cough, lasted for 5 days, they put me in Paxlovid. I took the entire dose, I felt good. but on the 3rd day I got COVID-19again, I was sicker this time than before, a since then, I have fatigue that is progressivity worst, dizzy, I have brain fogs, nausea. I can't concentrate, the extreme fatigue stops me from doing things, occasionally, shortness of breath, I can't exercise. The doctor sends me for stress test, which I could not do. Since then, I have seeing doctors to see the reason why I am tired, but results come normal.