chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medications was not reported. On 11-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reported received from the same reporter. Additional information has been requested.
Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EK9231), in right arm, on 25Feb2021 as dose 2, single (Lot number: EL8982), in left arm, on 20Aug2021 as dose 3 (booster), single (Lot number: EW0812), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID 19 Treatment; (unspecified date) Positive, notes: Still spreading 3 days after re-testing positive; (11Jan2023) Positive, notes: Tested positive 6 days after completing 5 day course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.
This spontaneous report as received from a Licensed Practical Nurse refers to a 12 month old male patient. On 30-JUL-2018 the patient was vaccinated with improperly stored VARIVAX lot # R002051 dose 1, subcutaneous in the right thigh for prophylaxis. Other suspect therapies included VAQTA lot # R002086 dose 1, intramuscular in the left thigh; M-M-R II lot # N027782 dose 1, subcutaneous in the left thigh and PREVNAR 13, dose 4 intramuscular in the right thigh from lot # T94425. Concomitant therapies included sterile diluent. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Initial and follow-up information has been received from a certified medical assistant concerning a 14 year old female who on 01-AUG-2007 at 2:00 pm, was vaccinated IM in the left arm with a first dose of Gardasil (lot # 655849/0263U).  Concomitant vaccination in her right arm included a dose of BOOSTRIX.  On 01-AUG-2007 in the evening, the patient experienced swollen lymph nodes in her neck (left side) and it was painful to the touch.  Unspecified medical attention was sought.  The patient's swollen lymph nodes in her neck and painful to the touch persisted.  Additional information is not expected.
After the doctors visit he starting complaining about the area itching then we started seeing swelling. Left arm appears red & swollen. Mom states pt has been scratching the area.
Body aches and Malaise. Took ibuprofen 8/12 continued with body aches and malaise, developed rash on chest and back with low grade fever. 8/13 am increase in rash that remains on chest and back. Body aches, joint pain and malaise. Took Benadryl and Ibuprofen. Rash looks like chickenpox without the pustules. Low grade fever.
Gave patient PEDIARIX and Hep B and Hep B is already a component of PEDARIX. (2 doses).
1 day post injection mild muscle soreness 1 week post injection, muscle soreness at injection site, mild tenderness axillary lymph nodes, mild swelling and redness at injection site
Child fainted and had seizure activity, post vax. The episode lasted about 45 seconds and the child left on his own power.
21 y.o. male with no significant PMHx who received the Johnson and Johnson vaccine 4/10/21 found to have extensive LLE DVT (extending above inguinal ligament).  Pt was transferred to OSF for catheter directed thrombolysis.  He was given 10 mg Eliquis prior to transfer.  Pt reports acute onset of LLE pain the evening of 4/16 with progressive pain over the weekend and development of LLE edema/redness 4/18.  Left leg mildly more edematous than right.  Foot pink/warm, sensorimotor intact.  No skin discoloration.  Pt denies recent surgery, prolonged immobility or known family history of clotting disorders.
c/o throat swelling, tight approx 2-3hr p/immun;pt was taken to hosp assessed & given oral DPH;also exp facial swelling;resp rate 16;heart rate 100; BP 132/82;fullness of the cheeks bilat;
Patient fainted 5 minutes post injection. Pharmacist immediately attended to her and the family, paramedics were called. Paramedics noted blood pressure and assessed patient, family denied hospitalization.
Patient experienced dizziness and lightheadedness after receiving her vaccine, about 5 minutes afterwards. She felt like she could pass out but did not, she stayed alert the whole time. She also felt hot. She also had not eaten since breakfast that morning. She was able to sit for several minutes.  She removed her coat to cool off, and was given some cold water and crackers to help her feel better.  After sitting for over 15 minutes, and drinking the water and eating the crackers, she felt better was able to stand up leave with her father with no issues. She stated that she felt anxious getting the booster shot. Patient is doing fine with no issues.
The night of the vaccine the pt reported chills for 2 days. 3/13/2014 pt contacted clinic to report red raise itchy rash the size of her hand around the vaccine site.
Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore right arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: Mar2021), via an unspecified route of administration on the right arm on 04Jan2021 (between 16:00- 16:15)  at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease about 7-8 years ago. She said she doesn't take medication all the time for the condition. Concomitant medication included azithromycin (Z-PAK), bifidobacterium infantis (ALIGN). Patient had nausea since 06Jan2021. Her sore arm started at around 3:00 AM on 05Jan2021 and lasted only one day. The caller asked if the nausea could be caused by the COVID-19 Vaccine, and if so, should she get the second dose of the COVID-19 vaccine. Reported the nausea is more of an annoyance, and she doesn't feel like she is going to throw up. Her nausea has been persisting since it started on 06Jan2021, but had worsened from 07Jan2021, to 08Jan2021. She said she woke up the morning of 08Jan2021 with a sore throat, and has had an off and on headache since the morning. Outcome of the event sore arm was recovered on 05Jan2021, for the remaining events was not recovered No prior vaccinations within 4 weeks. The reporter considered the event non-serious.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported). The patient developed shingles within two weeks. It was unspecified whether the patient sought for medical attention. The patient was treated with VALTREX and was still having postherpetic neuralgia. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has been requested.
Muscle aches and fatigue beginning 5 hours after the vaccine Headache beginning 7 hours after the vaccine Fever, chills, dizzy 16 hours after the vaccine Night sweats beginning night 2 after injection Red, swollen arm at injection site beginning 2 days after vaccine I'm 54 hours post-injection and still having problems with extreme night sweats, headache, fatigue, dizzy spells, and muscle aches.
1 1/2" x 1 1/2" erythematous indurated raised area surrounding vaccine site. No vesicles, increased warmth.
Patient reported a 2"x 7" long, hard, swollen and hot spot around the vaccine administration site.
pt MD said pt discovered dead by parents on 4FEB93 & that apparently is a SIDS death; MD said that the parents had an apnea monitor @ home but it was not used;
On the day after the vaccine approximately 24 to 36 hours later I started to feel the typical side effects that people report with these vaccines such as chills slight elevation and temperature although not greater than 100.4 so not a fever and the symptoms including body ache or the worse that I had had since my first AstraZeneca vaccine it back in November 2020 which I received as part of the trial I got two Astro Zeneca?s two regular Pfizer?s two regular Moderna's and then this bivalent moderna  approximately 2 1/2 months after my only infection with Covid.   I do not have any true immunocompromised conditions but decided to get the second booster of Moderna due to high risk occupational.  Also bmi 25+. In addition to those usual symptoms I also had a mild sore throat which I thought was strange and test it once for Covid negative on an antigen test although my children were all tested routinely several times around this time and they were all negative. I?ve been developed in severe pain in my left ear approximately four days after the vaccine which as a physician I thought could only be an ear infection acute otitis media given my lack of exposure to water and no prior year history or concerns in the setting of a possible viral URI. I took one dose of Augmentin and then went to urgent care and saw somebody a physician not a mid-level the next day who agreed that it was an ear infection and said they would prescribe a course of Augmentin for me to complete. They wrote otitis externa in the discharge paperwork however so unclear if that was a clerical error or if there?s a misunderstanding of the diagnosis and treatment plan for the condition. Over the next week during which I was taking the Augmentin I started to notice that there was a persistent hearing loss despite an improvement of the pain symptoms and improvement of the slight dysequilibruum. Approximately three days after finishing the antibiotic on Monday the 19th I went to see an ENT about the persistent hearing loss in light of the possible misdiagnosis given at urgent care. I did indeed have some mild hearing loss at the 6000 and 8000 frequencies decibels were 30 or 35. Ent did not see fluid behind tm as possible  cause of persisting loss. Suggestion for possible ssnhl led to rx steroids. Pending mri. Given some studies showing associated with ssnhl in vaccines for covid decided to report.
On 4/10/02, swelling of left upper deltoid, the size of a tennis ball. On 4/11/02, 4" X 2 1/2" area of warmth and pruritic.
Information has been received from a nurse concerning her 24 year old daughter who was vaccinated with a 0.5 ml first dose of GARDASIL. It was reported that the patient experienced a small bump at the injection site area. Subsequently, the bump went away after the a few days. On a specified date the patient was vaccinated with a 0.5 ml second dose of GARDASIL. Subsequently the patient developed a hard bump at the injection site area which was still present. Unspecified medical attention was sought. Additional information has been requested.
H. Flu meningitis - PICU hospitalization -Spinal tap - IV antibiotics - ceftriaxone Seizures - Keppra Subdural fluid collection -MRI Burr Hole drilled - Hospital Iron Deficiency anemia - Packed RBC transfusion
Sudden onset of body aches, fever of 102, sore throat, dizziness, headache, chills, fatigue, lethargy and cough. 3 days alter it hit again symptoms 10x worse, last night nosebleed that took 30 minutes to stop.
Patient admitted to the hospital on 2/22/22 with  symptoms of nausea, vomiting, and fever for 2 weeks. Patient diagnosed with bilateral pneumonia and tested positive for COVID 2 week ago.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA306316 and 2018SA306332 (same reporter). This case involves a 2 months old patient who received expired 0.5 ml dose of vaccine PENTACEL (lot C5439AA and expiration date 29-Oct-2018) via unknown route in the left thigh on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and RHODAVIRUS for Immunization. It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
received vaccine at 7pm and by 11am the next morning my fever was 102.4 (high for me as my normal temp is 97.4) had chills, fatigue, aches, and mostly unusual (reason for report) is pulse-oxygen of 93 for till mid-afternoon when it went back to 96 and then by later evening it was 97 again.  My normal pulse-ox is 97-98.
Swollen deltoid muscle large area. Area is warm erythema and itching. There no pain or knot at the injection site.
Infant patient presented to clinic for second dose of COVID-19 vaccination. A infant-aged Pfizer vaccine was administered by the clinician, but upon  charting, it was observed that the patient had received an infant-aged Moderna vaccine for their first dose. Patient had already left the clinic by the time this error was discovered, but had not presented with any noticeable adverse reactions.
Pt reports feeling a little tired; This is a spontaneous report received from a spontaneous Program. A contactable other healthcare professional and a consumer (patient) reported that a 76-year-old female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), dose 2 via an unspecified route of administration on 17Mar2021 (Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ), via an unspecified route of administration from 10Jan2021, at 5 mg tablet, cyclic for an unspecified indication. The patient previously received the first dose of COVID-19 vaccine on an unspecified date for covid-19 immunization. Patient reported a 1 week pause in tofacitinib citrate treatment as advised after her 2nd COVID vaccine on 17Mar2021. Patient reported feeling "a little tired", but could not be sure if from tofacitinib citrate or recent move back form winter home. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
weird smell/smell you know feels something different/feeling different in regards to taste and smell; a different taste/I can't taste food, food taste like something different/feeling different in regards to taste and smell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 13:00 (Lot number: EW0169) at the age of 41 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IRON; VITAMIN D [VITAMIN D NOS]. The following information was reported: PAROSMIA (non-serious) with onset Apr2021, outcome "unknown", described as "weird smell/smell you know feels something different/feeling different in regards to taste and smell"; TASTE DISORDER (non-serious) with onset Apr2021, outcome "not recovered", described as "a different taste/I can't taste food, food taste like something different/feeling different in regards to taste and smell".  Additional information: It was after the first dose is when the patient started to notice the difference in her taste and smell. When she tried to drink coffee, it smelled weird and so she tried a different coffee and it also smelled weird. She sprayed her perfume and did not like the smell. Even the smell of the food is different than before. Taste is totally different. Tomatoes and cucumbers taste and smell different, along with many other foods. She is asking how long this will last. Prior Vaccinations (within 4 weeks) was none. Events did not cause Emergency Room or Physician Office.   No follow-up attempts are possible. No further information is expected.
On February 7th, I started having severe shortness of breath and pain on the left side of my rib cage. I went to the emergency room and was tested for Covid-19 which was negative. After many hours and tests, I was diagnosed with Bi-Later Pulmonary Embolisms. To say I was shocked was an understatement. I was admitted to the hospital and stayed 4 nights. The many doctors that saw me thought this was caused by Deep Vein Thrombosis. However, I never had any of the symptoms of DVT. The doctors were stumped on how this could of happened.
Administered to 17 year old; A spontaneous report was received from a healthcare facility staff member concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, administered vaccine to a 17 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the healthcare staff member reported the Moderna COVID vaccine was given to a 17 year old patient.  No symptoms or treatments have been reported by the provider.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, gave vaccine to a 17 year old, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 17 year old patient.  The patient's medical history is not provided.  The event occurred on 29 Dec 2020 during administration of the first dose of the mRNA-1273. This report refers to a case of medication error where mRNA-1273  has been administered to the patient of inappropriate age.  There were no reported adverse  reaction associated with this case.
chills; body aches; nausea; Vomiting; coughing; This is a Spontaneous report from a contactable Pharmacist. A contactable Pharmacist reported on behalf of her husband that:  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737), via an unspecified route of administration on 06Apr2021 as dose 2, single. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, body aches, nausea, vomiting, coughing on an unspecified date. caller asked if this was normal. Pharmacist (patient wife) also stated her husband experienced fever and then clarified to state he did not had a fever. She stated that was the patient's 2nd dose of the Pfizer Vaccine and the 1st dose was fine and this 2nd dose was horrible. The outcome of events was unknown.   No Follow-up attempts are needed. No further information is expected.
late evening  of injections date, felt sick at stomach.   early nxxt morning started vomiting thick yellow bile.    felt nausiated all day, "foggy" headache and lack of appetite.    night sweats for 2 nights.   no fever.
Already had all the symptoms; Now he is receiving arm pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Already had all the symptoms) and VACCINATION SITE PAIN (Now he is receiving arm pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Already had all the symptoms) and VACCINATION SITE PAIN (Now he is receiving arm pain at the injection site). At the time of the report, VACCINATION COMPLICATION (Already had all the symptoms) outcome was unknown and VACCINATION SITE PAIN (Now he is receiving arm pain at the injection site) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.
Information has been received from a Medical Assistant (M.A.) concerning a 17 year old female patient who on 28-JUN-2007 was vaccinated with a first dose of Gardasil lot #653736/0868F. The MA reported that on 28-JUN-2007 the patient "passed out, momentarily" after receiving her first dose of Gardasil. The patient was evaluated in the emergency room, and discharged. No other information was available at this time. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.