chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. On 07-JAN-2015, the patients were vaccinated with M-M-R II inj (strength, dose and route were not reported) (lot # K005431 and expiration date 15-APR-2016) which were exposed to an unsupported temperature excursion. No adverse effect was reported. No product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Just started today, thought I had bug bites, until I started to get red blothes all over my body and itch
LIGHT HEADED; SLEPT ALL DAY; NAUSEA; LOSS OF TASTE TO RIGHT SIDE OF MOUTH ONLY; 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 past medical history included cardiac arrest, hypertension, chronic obstructive pulmonary disease, and heart condition, and concurrent conditions included penicillin allergy, codeine allergy, demerol allergy, and secor allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced light headed. On 16-MAR-2021, the subject experienced slept all day. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced loss of taste to right side of mouth only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept all day, and nausea on 17-MAR-2021, was recovering from light headed, and had not recovered from loss of taste to right side of mouth only. This report was non-serious.
Brother holding baby while watching TV. Mom took baby, tried to wake baby, unable to wake the baby. Opened up one eye then closed. Lasted 10 minutes until she arrived at the hospital ER.
Major fatigue  (can't awaken), Mass confusion (doesn't know what she is doing. Not eating or drinking. Can't get dressed.)
Site: Pain at Injection Site-Severe, Systemic: numbness in right side of face and lips-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Left elbow hurts.  Like I slept on it funny but it won't go away.
Per a clinic provider's email sent on 9/1/2022: "The monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient, seen in office on 9/2/2022, received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer). This was in error as patients are now only supposed to receive the bivalent booster per email. Patient due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent COVID-19 boosters until receipt of the bivalent booster doses. This was overlooked, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.
Very sore arm rash on arm hot arm, chills and fever nausea dry heaves  , diarrhea , very very weak whole body hurts and hurts to walk.  This will not go away, It has been weeks it is affecting my life
This spontaneous report as received from a registered nurse and refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-NOV-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 35 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
The injection arm was sore within 1 hr of vaccination. The soreness was then spread to the shoulder, then in the middle of night, I was awaken with whole body muscle aches that similar to flu. The next day, the aches were subsided but I felt tired and sleepy with sore arm the entire day. I went to sleep early and lasted for 11 hrs  (something that is unusual for me).
Acute CVA with Multiple small Infarcts to left Pariaetal and occipitral area  Admitted to Medical Center  Admit 02/19/2021,  DC 02/22/2021
Patient received his vaccine at 12:15 PM. Around 1:10PM he stated he started to feel "fuzzy" and "euphoric" almost. He was dazed and said he just felt off. When he stood up, he fell down and felt very dizzy.  We were doing a vaccine clinic at his place of employment that day so I was still on site and he came back into the room I was stationed around 1:30pm. He said he felt ok, was talking, breathing fine, just felt a little "off." He had white spots all over his left arm and some on his right.   None were raised, red, or itchy. His left hand was red/purple in color. I gave 50mg of diphenhydramine and he stated about 10 minutes later he felt better.  I observed him for approximately another hour. He was walking around, talking fine and stated he felt normal when he left. He still had some slight discoloration on his left arm.
Acute, severe, transient substernal chest pain. Pain lasted 30-45 minutes at a time. Pt. had EKG changes consistent with pericarditis and elevated troponin. Coronary arteries were clear on Left heart catheterization, but patient had EF of 40-45%  One recurrence of pain 17 hours after initial onset, otherwise asymptomatic.  EKG, TTE, and Cardiac MRI concerning for myopericarditis.
13 year old patient presented to the pharmacy with his mother to get needed back to school immunizations. Pt received Adacel (Tdap) and Menactra (meningitis) vaccines. Tdap administered to patient in R arm without issue. Pt requested meningitis to be administered in R arm as well. Upon administration of meningitis vaccine Pt immediately went limp. Mother initially thought PT was joking with her, Pharmacist recognized signs of syncope, summoned technician to help respond and retrieve ammonia and epi pen from the immunization supply cart. the patient remained unresponsive and the technician was instructed to call 911. The pharmacist utilized 1 ammonia smelling salt and the patient became partially responsive. EMS arrived shortly thereafter to evaluate the patient. Pt was evaluated by EMS and released into his mothers care after approx. 30 minutes.
Patient called into to clinic on 07/09/2021 stating that she had a reaction to the Yellow Fever vaccine, which she received last week on 07/01/2021. However patient received both typhoid and yellow fever on the same day, at the same time, in the same arm. It is unclear as to which vaccine is causing the reaction. Patient states the she has an area of 1.5 X 3 inches of skin at the injection site that is red, raised and itchy, and still growing. She denied N,V, headaches or blurry vision. She was directed to see her health care provider for all other concerns. RN
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.      No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.  Patient did not reported any adverse event.  No treatment medications were provided.
improperly stored administered PROQUAD; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 17-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) rHA (Lot # T013540 with expiration date on 17-OCT-2021; dosage regimen and route of administration not reported) for prophylaxis. The administered vaccine underwent a temperature excursion from 6 degree farenheit (F) to 14 F (average 11.7 F) during 25 minutes (no previous temperature excursions). The call was performed by data logger.
Swelling and redness at site of injection. 5cm by 4 cm in size, no tenderness, less then 24 hours after injection. treatment is motrin and benedryl.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 21-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006064:
Upper arm pain and limited range of motion. Achy constant pain. I wasn't able to sleep on left side, still can't without discomfort. Occasionally travels down to elbow.
3 days fever 103.7; numerous vesicles over body grouped on upper arm; redness; Varicella reaction. Duricef 125mg bid X 10d.
This spontaneous report as received from nurse refers to a patient of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the unspecified patients were vaccinated with PROQUAD (merck) (dose, lot#, not reported). No concomitant medications reported. The nurse reported that since 01-JUL-2014, unspecified patients may have been administered with PROQUAD (merck), that were not stored properly. No adverse effects reported. This is one of the several report received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Pt reported reaction at approx. 16:00 on 4/12/01. She had pain, edema, erythema and itching at left deltoid injection site. Area of edema measured and area of erythema measured. Benadryl 25mg given at 16:30 and 10 capsules of same for home administration.
Radiating pain from the right neck, shoulder and arm that spread to the left side. Tingling sensation in fingers, along with pain. Taken to ED, labs and imaging were done that were inconclusive. Tingling and numbness spreading to feet and legs, but however patient was discharged even in worsening condition with no answers, and told to make an appointment with a neurologist the following week. After being brought home, the numbness spread and patient could not support her weight and would lose balance. Ambulance called and taken back to the same facility. Admitted under observation initially, the following day, a lumbar puncture was completed, at the request from our daughter (who is a nurse) to the doctors, that showed elevated protein in the CSF. It was concluded that patient showed clinical signs of Guillian-Barre Syndrome and was subsequently started on IVIG therapy. Her condition worsened and she was upgraded to progressive care and then the neuro ICU when numbness had spread to her face. A central line was placed and patient was started on plasmapheresis. Patient showed loss of feeling and function in her arms and legs, swelling in her face that did not allow her to speak or eat properly. 3 more rounds of IVIG were done after plasmapheresis was completed. Patient was stabilized and transferred to the rehabilitation hospital for rehab and therapy.
Dose was administered to an unapproved age group. 0.25mL was dosed inadvertently for a 2nd dose. Also discovered pt had received the 1st dose of Moderna as well 3 weeks prior.
Post Menopausal Spotting Oct 1, Dec 24 and Jan 28th for a few days each time along with symptoms of period such as back pain, cramping, and bloating.  First episode occurred 2 weeks after 3rd dose.    This was first symptoms of a cycle after goin 450+ days of no cycle or symptoms.
Rt knee tenderness followed by accumulation of fluid in bursa; W/2nd dose of vax Aspiration of rt knee bursa done revealed Candida Parapsilosis; Also had tenderness & swelling of the bursa;
On Tuesday went to work and at around 1:30 she told her boss that she was not feeling good.  Felt achy in her body, her arm was hurting and was not feeling like herself.  She went home, sat on the sofa and drank something and went to sleep and felt drained, and slept for 4 hours.  She then woke up with runny nose, low grade temp, and felt really weak.  The next day, 1/6/21 her body ached bad.  She slept a lot that day and drank a lot of water, didn't eat and just felt really sick.  Then on Saturday evening, she looked at her leg and felt cold chills and her leg was hot.  She looked at her leg and had an area that was like a red dot, and she then realized that her leg was about to be inflamed.  She went to bed, woke up and her entire leg was blotchy red, swollen and hot.  She then called her family and around 12:00 on Monday 1/11/21.  She went to the hospital, and they treated her like she had COVID, isolated her and was negative.  Sent her to vascular and did not have a blood clot in her leg, and told her she had an cellulitis flair, and she started being treated with IV antibiotics.  Was in the hospital for 5 days.  She was discharged and went home after infectious disease team told her to go home with a nurse on IV antibiotics.  She came home on 1/15/21, and was off the IV antibiotics on 1/22/21.   She has been home and unable to work.  She is going to therapy for her legs.  They changed her hypertension medications, and put back on her antibiotics last week as they told her that the swelling was not going down.  Her kidney function is low and told today, 2/9/21 that she is concerned about her kidney function.  She is to have more labs drawn on Monday, 2/15/21.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PARTIAL EPILEPSY EPILEPSY, UNSPECIFIED TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
This report describes myasthenia gravis in a 44 year old male who received Lymerix. Following the onset of myasthenia gravis, the pt developed plaques on his knees and elbows that were "suggestive of psoriasis". The pt was referred to a dermatologist. This was not reported as an adverse event due to vaccine administration, but was found during the course of review of the pt's medical records. Therefore, it is not listed as an adverse event. The pt received his 1st and 2nd injections of Lymerix in 4/99 and 5/99. An unspecified time, post vax, he awoke with left eye ptosis. He placed a patch over his right eye in an unsuccessful attempt to strengthen his left eyelid. The ptosis persisted when he received his 3rd Lymerix on 4/20/00. He was referred to aneuro-ophthalmologist. The pt was seen on 8/23/00 and the physician wrote that the pt "states that 1 year ago, he woke up and noted left eye ptosis. He notes that with fatigue the lid droop is accentuated. He did try to place a patch over the right eye in order to strengthen his left eyelid but this was to no avail. He has had no generalized fatigue. However, he has had occasional burning sensation down both legs with exercise. He has had no complaints of SOB, dysphagia or double vision. He noticed that the left eyelid twitches at times. He received a Lyme vaccination in 4/99 and 5/99, just before the onset of his ptosis." On physical exam, "he did demonstrate mild curtaining and a positive lid twitch sign. There was dermatochalsis noted bilaterally. An ice pack test was carried out and also showed improvement of the ptosis". The physician's impression was "At this time we need to exclude myasthenia gravis". The pt was seen by the neuro-ophthalmologist on 4/17/01 and he wrote "The vaccinee returns today for follow-up of his myasthenia gravis. He was lost to follow-up for several months. He has undergone a single fiber EMG which does suggest a presence of a neuromuscular defect. He had had no other new neurologic signs or symptoms including no dysarthria, dysphagia, weakness or SOB. He is currently asymptomatic from a myasthenic point of view." On exam, "He continues to have a mild left ptosis and slight eyelid retraction on the right. Motility was full". The physician recommended a CT of the chest to rule out thymoma and thyroid function testing.
On February 13, 2023, I noticed a tickle in the back of my throat. I didn't feel flushed. I have a lot of allergies. When I woke up the next day, I felt a little achy. I felt like I had an upper respiratory infection, but I didn't feel that bad. I tested myself for COVID-19 test at home. The result was positive. My temperature was normal. I called my doctor. They said he would call me back. I could breathe fine. I didn't have a cough. I kind of felt achy and tired. I rested most of the day and ate chicken noodle soup. I drank plenty of fluids and took Tylenol. My temperature was about 100-degrees that afternoon. Around 09:00AM Wednesday morning, my doctor called. He called in a prescription for Paxlovid. In the meantime, I contacted my heart doctor to make sure I could take the Paxlovid. They called back Thursday morning, and I started the Paxlovid that day. I isolated. The first day I was starting to feel better. The next day, I didn't really have any symptoms. I took the Paxlovid for the full five days. My last dose was the next Monday. I took another COVID-19 test on February 21, 2023. The result was positive again. I isolated for another five days. I went to the hospital for a COVID-19 test. I didn't have any symptoms and felt fine. I finally tested negative for COVID-19 on February 27, 2023.
Patient currently admitted at (3) days inpatient stay starting at 11/23/2021. PT 56 y.o. male  who presents to hospital with shortness of breath.  Patient is presently vaccinated against COVID in May of this year.  He states approximately 2-3 days ago he began having worsening cough shortness of breath and fatigue.  Denies any GI complaints.  He has been using his oxygen around the clock; normally only uses 3 L at night.  Because of worsening shortness of breath he presented to the emergency department for evaluation.  Oxygen saturations on room air were in the 70s.  He is currently saturating 94% with 4 L of oxygen.  Chest x-ray showed bilateral infiltrates and COVID testing was positive.  He had significant wheezing; he did get steroids but did not get bronchodilators.  D-dimer was negative.  Because of his worsening hypoxemia and respiratory distress he was referred to the hospital for further evaluation and care.   Acute respiratory failure with hypoxia Assessment & Plan Patient uses 3 L of oxygen at nighttime only Concurrently saturating 94% on 4 L Plan incentive spirometry, flutter, proning as tolerated Check blood gases to rule out hypercapnia   COPD with acute exacerbation Assessment & Plan Patient with history of severe disease based on PFTs Uses trilogy at home Suspect exacerbation worsened due to underlying COVID Aggressive respiratory hygiene steroids and bronchodilators Strongly encouraged smoking cessation   * Pneumonia due to COVID-19 virus Assessment & Plan Patient with symptom onset 11/21 Worsening shortness of breath cough and hypoxia Chest x-ray showing bilateral infiltrates Vaccinated in April and May of 2021 COVID positive 11/23 Plan admission, steroids, remdesivir, and aggressive supportive respiratory care   Hypertension Assessment & Plan Blood pressure is currently stable     Obesity Assessment & Plan Body mass index 47.6
consumer reports that wife exp difficulty breathing, stiffiness, swelling of lt knee & ankle, feeling of tiredness & listlessness, neck pain & pleurisy of lt side approx 3 days p/vax; required office visit; treated w/cortisone;
chronic spontaneous urticaria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: CHRONIC SPONTANEOUS URTICARIA (non-serious) with onset 12Nov2022, outcome "unknown".  Additional information: It was reported that was just speaking to an agent and got disconnected.  She was reporting an adverse reaction she has had since 12Nov2022 since she took Pfizer booster shot. Clarified product as Pfizer Covid Booster Shot. The reaction was that she has been suffering from hives since she took booster. She was doing search on internet. She did a search and she came across something about a guy this happened to. It comes and go and it was long term urticaria which was hives. They called it chronic spontaneous urticaria after the covid19 vaccine. It was an article and it sounded classic to what she is going through. Caller declines report for the guy that had long term urticaria. She only has the website. It was through.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.