chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse referring to a unspecified number of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M048200 with expiration date 07-DEC-2018 and Lot# N004628 with expiration date 08-FEB-2019, for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F during a time frame of 5 hours and 50 minutes, which was detected by the data logger. There was a previous temperature excursion of 6°F to 14°F for 40 minutes. No adverse effects were reported.
PATIENT NOTICED SORENESS AT THE SITE OF INJECTION THE EVENING SHE RECIEVED THE VACCINE.  THE MORNING AFTER SHE RECIEVED THE VACCINE SHE NOTED A 2 INCH PINK/RED AREA THAT WAS PAINFUL AND WARM TO THE TOUCH.
Intense waves of deja vu, feeling of dread, feeling like panic attack. No history of anxiety disorder.
Vaccine administered to left deltoid area 8/27/04 in the right thigh around 4:30 PM. Next day, red, tender, indurated area around injection site. Fever 102.7F 8/29/04.
Received vaccine 12/18/07 - 12/20/07 noticed red area dime size.  12/21/07 - area increased to golf ball size.  Red, no fever or neurological changes.  Kept bandaged on at night.
10/15/2012 flu vaccine given 11/03/2012 I noticed problems with my face while at a  football game with my kids.  Facial drooping and excess watery eye.  After googling and calling a doctor and realizing that it was not a stroke (arms and legs fine), determined that it was probably Bell?s Palsy.  This was 19 days after the flu vaccine injection.  No stress noted at time.  After talking to others, it was noted that they noticed some drooping up to 3 days before I did.  Was prescribed steroid and valtrex.  On 11/6/2012 I went in to see because of stress and difficulty doing my job due to the Bell?s Palsy.  He prescribed Xanax and wrote a work excuse.
I developed Staph infection. It started on my lower left leg. I developed Staph infection. I woke up the next morning and it was significantly worse, so I went to the hospital. I was hospitalized and kept there for 4 days. I didn't run a fever at all, but I was very fatigued. They had me on two different antibiotics, but I am unable to recall the medication name. They had me on several medications actually, but I just can't recall the names of them. I still have some scarring, but the wound itself has healed.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 30-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N023024 with expiration date 23-AUG-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Information was received on 14-JUL-2017 from a pharmacist regarding an unspecified patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 14-JUL-2017, an unspecified nurse inadvertently administered an expired dose of ZOSTAVAX (lot # M018453, exp 28-JUN-2017) (dose, route, site of administration not reported) to an unspecified patient. No adverse effects reported. The outcome of the event was unknown. The pharmacist reported that the ZOSTAVAX was stored at the appropriate storage condition specified in the product label through the date of administration. No additional information was provided. Additional information has been requested.
raised injection site; a little itchy injection site; broken up rash 2'x3'' about size of 2 eggs; Not feeling as good as normal until; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Not feeling as good as normal until) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Allergy (allergic to Latex, PCN).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (Not feeling as good as normal until). On 15-Jan-2021, FATIGUE (Not feeling as good as normal until) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Excessive vaginal bleeding started occuring my first menstrual cycle after getting vaccinated. After a concerning amount over the span of the day, I called my OBGYN for guidance and was recommended to go to the ER.
This case is linked to case number 2013-00780 (same reporter after MENACTRA). This case is created from source document of case number 2013-00780. Initial report received from healthcare professional on 03 May 2013. This case is non-valid as adverse event description is missing. A 12 (years/months was not specified) male patient, whose medical history was not reported and had no concomitant medication, received a first dose of MENACTRA vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. Patients 11-year-old sister had received an intramuscular dose of MENACTRA vaccine (batch number- U4291AA, dose number were not reported) in left deltoid and ADACEL vaccine (batch number - U4384AA, dose number-not reported) in left deltoid, both on 10 January 2013. Patients sister developed urticaria on 11 January 2013, i.e. one day after vaccination. It was reported that on an unspecified date of August 2004, after receiving MENACTRA vaccine, the patient experienced unspecified adverse event. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Pt seen following Guillain-Barré syndrome with hx of temporal association of OPV according to ph. Pt was diagnosed with Guillain-Barré syndrome in April 1996. He was in excellent health until 2-3 weeks prior to the event he experienced a "stomach virus." One week prior to the event he notes that he received an oral polio vaccination. In April after participating in a marathon training event, he noted tingling and numbness of his hands and feet with difficulty walking. He was evaluated at a base health station where he was treated with Nuprin. The following day "while running across the street" he collapsed with complete paralysis of his legs. He was subsequently transported to hospital where he was admitted to the neurological intensive care unit. He was treated with IV gammaglobulin for several days. Despite his numbness initially progressing to include his tongue, he experienced no respiratory compromise and was discharged in no acute distress. Approximately two weeks after his discharge he had a recurrence of his numbness with concomitant swallowing difficulty. Over the next several months he was treated with IV gammaglobulin on an outpatient basis. A diagnosis of chronic relapsing-inflammatory demyelinating polyneuropathy was considered and he continued on IV gammaglobulin until 7/23/96.
6/19:  Sore arm, achy muscles, difficulty sleeping.  6/20:  Woke up with severe headache, achy muscles, sore arm, upset stomach, very little appetite.   Later in the day, started getting rash on torso.  Listless.  6/21:  Rash was bright red and covered entire torso, still achy muscles, sore arm, still no appetite, listless.  6/22:  Rash still bright red in morning, expanded to both upper arms overnight.  By evening (after using Benedryl), rash subsiding some, appetite returning.  Arm still sore, achy muscles.  6/23:  Rash subsided considerably, still some rash on upper chest and upper arms.  Very itchy back and lower torso.  Pain in arm subsided as did achy muscles.  6/24:  First day without rash, still some itchiness on back, arm & muscles no longer hurt.  First day I've been able to do anything.
MMR given 5/10/06. Pt brought in 5/15/06 with report of severe hives on following day, Thursday, Friday and Saturday. Provider Dx: Delayed hypersensitivity to MMR. Event unreported, found during chart reviews.
Initial injection site resulted in hard knot, about size of a quarter.  Days afterwards, knot did not go away, but the soreness did. Now, 25 days out, the area has a red rash ring grown to the size of my fist, with a red edge surrounding it. The knot doesn't feel as prominent as before. No fever, no other side effects....just a growing red rash.
Vaccine Thursday afternoon 2/2/23 Sx started on Friday 2/3/23 - starting mid day By evening really noticing it  Started with fast heart rate Swelling in throat, face and lips No difficulty swallowing or breathing Could see the swelling though in her lips and neck Could feel her glands were swollen + Stomach cramping No vomiting or diarrhea No hives or rash No wheezing or SOB Temp was lower than normal  Took Benadryl x 6 doses total. Symptoms have resolved.  No other changes - no new meds or foods No recent illness in month prior  Got pretty sick with second dose of shingles vaccine - not sure if this was the same thing though Similar reaction to an infusion last April - no rxn to subq form of med though No reaction to flu or COVID vaccine No reaction to prior doses of TDAP.
-Patient received Fluarix Flu shot 9/5/2020. -Then came in 10/28/2020 for his second Shingrix and was given Shingrix (2nd) dose and Fluad H.D. Flushot
Information has been received from a medical assistant concerning a female patient greater than 65 years of age who was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine.  It was reported that no other vaccinations were given with the pneumococcal 23v polysaccharide vaccine.  The patient was reported as generally healthy with "no major health problems".  Subsequently, the patient experienced injection site cellulitis which lasted at the most for 3 days.  The patient recovered from the injection site cellulitis.  No further information is available.
6APR94 pt was spraying insecticide in garden & face was exposed to the spray; that day pt devel maculopapular rash which was primarily on lt cheek; also exp itching on face; face felt as if it were burning; rash was only on face;
Patient is 79-year-old female with complex medical history notably immunosuppressed secondary to myeloproliferative disease, CAD status with aortic valve (bioprosthetic). She was admitted with acute hypoxic respiratory failure meeting sepsis criteria in setting of Covid-19 pneumonia. She received aggressive treatment with Remdesivir, Empiric antibiotics, Baricitinib, Decadron and had multiple consults from specialists. Despite treatments, she developed bilateral spontaneous pneumothoraxes and required Emergent Right chest tube. Right lung subsequently with no air movement and one frank bleeding with concern for on pneumothorax. Repeat chest x-ray revealed stable bilateral infiltrates with increasing right pneumothorax use and continued left pneumothorax with subcutaneous emphysema the base of the Right neck. During this time, patient became unresponsive. After family discussion, patient was transitioned to comfort care. She died at 12/27/2021 1929 from Sepsis due to Covid-19 with Bilateral Pneumothorax, Pneumonia and Acute Hypoxic Respiratory Failure in setting of Immunocompromise due to Myeloproliferative Disease/Cancer.
Light pink splotchy rather than red itchy, tender to touch - gave BENADRYL/IBU.
This spontaneous unconfirmed report as received from a consumer refers to unspecified number of children patients of unknown age and gender. On unknown dates, the patients were vaccinated with MMR II (dose, route, therapy type, lot# and expiration date were not reported). The reporter stated that she had heard some cases from "other people" about their children having "negative result" from receiving MMR II (dates unspecified). The reporter stated that those cases had been already reported to unspecified pediatricians. The outcome of the event was unknown. The relatedness between the event and MMR II was not reported. Additional information is not expected, because there was no contact details provided.
Case is a soldier who was vaccinated at medical center with vaccinia and antrax vacccines.  Presented to Hospital Emergency Room on 2/21/2011 complaining of blisters around vaccination site.  Patient initally evaluated by Dr who reportedly called CDC and discussed the case with a representative CDC.  I talked to Dr, Infectious Disease attending at Hospital today.  Patient was and remains afebrile and nontoxic.  There is a large blister at the innoculation site with a few scattered vessicles ~2-3 inches from the innoculation site.  No other involvemnt.  Apparently, patient did get a tatoo placed above the innoculation site after he was vaccinate.  Dr. feels that patient has some cellulites and he is being treated with iv antibiotics but anticipates the patients discharge tomorrow on oral antibiotics.
36 hrs after 1st dose of pills head flicking side to side every few mins. Then slowly progressed to nodding up and down and flicking sometimes every thirty seconds but usually every 5 to 10 seconds. No other symptoms or adverse reaction. Doesn't do it while sleeping.
Adult received Engerix 10mcg; Adult received Engerix 10mcg; This non-serious case was reported by a nurse via sales rep and described the occurrence of accidental underdose in a 61-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Previously administered products included Engerix Adult (received 1st dose of Engerix 20 mcg in January 2023).   In FEB-2023, the patient received the 2nd dose of Engerix B pediatric 10 mcg/mg. In FEB-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Adult received Engerix 10mcg) and adult use of a child product (Verbatim: Adult received Engerix 10mcg). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 At the time of second dose inadvertently administered pediatric dose with 10 mcg. The reporter informed that the error not due to packaging or labeling of GSK product but on human error and way in which they label and stored their vaccines. They had plan corrective action to avoid errors in future. The reporter understands that dose 2 did not count and would be repeated at today's (reporting day) visit and would complete the schedule.  The reporter consented to follow up. The adult patient received pediatric dose of Engerix B, which led to accidental underdose and adult use of a child product.
adhesive capsulitis of the left shoulder began around the time of the vaccine injections Treated with physical therapy and Cortisone shot. Recovering but still have symptoms as of 9/30/2021
Full on covid.  This also happened after my first dose.  I felt totally fine before the vaccine.
Intense pain upon injection not felt with any other form of vaccine. Pain in arm continued to get worse throughout the day. Unable to lift my arm very far without pain. Worse than any other injection recieved in the past. Pain throught the night-causing lack of sleep. Severe pain for about 24 hours or so then completely gone. My muscle in my arm then felt tight as if there was inflammation of some sort or an injury to the muscle. Upon lifting my arm it felt as if my arm was pulling back. No pain during this action but more of a weakness. No relief from anti inflammatory medicaiton or ice. Sensation in arm noted to be gone on 01/09/2021.
kidney issues/ Is that possibly his kidney?; cold; numbness of left upper arm/He also had numbness in his arm.; lower back pain/but started hurting again.; difficulty walking/He was also unable to walk the first week.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 13May2021 at 14:00 (Lot Number: EW0176) (at the age of 50-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 administered in left arm on 21Apr2021 (lot number: ER8731) for COVID-19 Immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. Illness at time of vaccination was reported as none. On 13May2021, the patient complaints of lower back pain, difficulty walking, and numbness of left upper arm. The patient was wondering how the pain can be resolved. The patient was asking and wanted to know if he was having kidney issues due to his lower back pain. On reply Pfizer did not provide any recommendations regarding the management or treatment of potential adverse events. The patient was advised healthcare provider was in the best position to provide appropriate action to take as healthcare provider was most familiar with medical condition, clinical history and treatment and any relevant information to specific case. He had lower back pain. He didn't know that this was a side effect at the time. The pain was in in his left lower back, and he was also unable to walk the first week. After receiving the second dose the patient started to feel something but didn't know exactly what it was. A few days ago, he found that it was cold be a side effect. He also had numbness in his arm. For that he requested that he receive the vaccine in his left arm. He had numbness for 2-3 days that he remembered. It did not bother him after 7 days. He took Advil or Ibuprofen. He has not gone for treatment. He thought it was something else. He went back to where he received the vaccine. They were unable to tell him anything. Outcome of the event for difficulty walking/He was also unable to walk the first week was recovered on 15May2021, for numbness of left upper arm/He also had numbness in his arm was recovered on an unknown date in 2021, for lower back pain/but started hurting again was not recovered, while unknown for rest of the events.
Approximately 14 days after shot, pt found marble size tender spot on right arm.  Saw PCP on 08/01/03, instructed to take Ibuprofen and apply heat to site.  PCP diagnosis sterile abscess at injection site.  Took augmentin for 7 days 08/12/03.  Swelling has gone down.  Recovered well.
stated that she had dry skin; stated that she had flaky skin; stated that she had burning skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (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: DRY SKIN (non-serious), outcome "unknown", described as "stated that she had dry skin"; SKIN EXFOLIATION (non-serious), outcome "unknown", described as "stated that she had flaky skin"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "stated that she had burning skin".  Additional information: Attempted transfer from agent has a consumer who stated after second dose of Pfizer Covid 19 vaccine that she had dry, flaky burning skin. Stated that she missed her booster dose today and was informed to call her site. Wanted to know why she needed a booster shot if she had such a bad reaction. Medical Information (MI): Were any medical questions addressed by this program forwarded/referred to Medical information?: Yes: Customer and/or medical inquiry forwarded or referred to MI.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.