chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 16Feb2021 12:00 (lot number: El3247; expiry date: unknown) at the age of 55-years-old, as dose 1, single, for Covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not taking concomitant medications. The vaccine was administered in a workplace clinic. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 17Feb2021 at 08:00, the patient experienced sore arm and fatigue. The patient did not receive treatment for the events. The patient recovered from the events on unspecified date.
Pericarditis approximately one month after second vaccination. Chest pain and shortness of breath. Went to emergency room and was diagnosed with pericarditis. Negative COVID-19 test.
Itchy, burning, painful macular rash that began on chest 7 to 10 days after the vaccine was administered and spread to the entire chest, abdomen,back and inner arms and upper thighs. No fever or other symptoms.  Rash responded well to  the Medrol dosepak and completely subsided 2-3 days after starting the prednisone.  CBC was within normal limits, but osinophil was 9.1% vs the normal range of 0 to 5%, although the number (0.61) was within normal limits.
Approximately 18 hours after the first dose of the vaccine, I experienced the following side effects: sore arm at injection site, moderate headache, fever which fluctuated between 99-101 degrees Fahrenheit, body aches, chills, and fatigue. The headache faded after about 36 hours post-vaccine, but the other symptoms lasted until about 48 hours after the vaccine.
Shot 10/11/16 sore vaccine site day after. Increasingly red second day (10/13) with blisters near injection site. Swelling from shoulder to lower arm. ED visit 10/13 for steroids, antihistamine IV.
pt stated she was nauseous and hot 5 to 10 min after administration.  requested water.  took trash can out and came back to pharmacy to get water for her and her sister said she was out.  went and checked for pulse.  pt had pulse.  her mouth was then jerking and her eyes were open and then started making gurgling noises. checked for pulse and barely felt one.  I administered one dose of epi-pen 0.3 in left thigh and pt became responsive within 1 min. after dose
Information has been received from a consumer concerning her 1 year old daughter with a history of impetigo, cellulitis, contact dermatitis - type rashes several times during 2007, and occasional fevers, who on 30-MAY-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC) (Lot #654070/0071U).  On 10-JUL-2007 the patient was vaccinated with a second dose of PEDVAXHIB (OMPC).  On 27-AUG-2007 the patient was vaccinated with a third dose of PEDVAXHIB (OMPC) (Lot# 655078/1273F).  In the beginning of September 2007, the patient experienced an injection site lump about 1/2 the size of a golf ball.  It was reported that the lump reduced very slowly over the course of two and a half months.  The patient sought unspecified medical attention.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Patient had a reaction to first dose of Moderna. She had a similar reaction to the second dose. patient complained of lightheadedness, headache, shortness of breath and tickling in her throat. Benadry was given. Patient stayed 30 minutes afterwards and reported symptoms were improving including shortness of breath.
vertigo 10 days after 2nd dose; This is a spontaneous report from a contactable consumer reporting for herself  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 01Feb2021 at 13:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history were not reported. The patient received first dose of vaccine on Jan2021 at 10:00 pm, on left arm. Concomitant medications were not reported. On an 11Feb2021, 10 days after 2nd dose the patient experienced vertigo. At the time of the reporting the patient had not yet recovered from the events.   Follow-up attempts completed. No further information expected.
This case was reported by a nurse via sales rep and described the occurrence of Epstein-Barr virus infection in a female patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, 14 days after receiving FLUARIX TETRA, the patient experienced Epstein-Barr virus infection. On an unknown date, the outcome of the Epstein-Barr virus infection was unknown. It was unknown if the reporter considered the Epstein-Barr virus infection to be related to FLUARIX TETRA. Additional information provided as follows: The nurse had two patients in the emergency room at hospital. Amongst them, this patient had Epstein Barr two weeks after FLUARIX. The nurse wondered if this could had been triggered by vaccine. The nurse was agreed to take follow up. This case has been linked with US2017GSK175533, as reported by the same reporter for another patient.
known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws; This is a literature report.  Authors sampled 130 Nursing Home (NH) residents and 95 HCWs 6 months after vaccination who had been previously evaluated 2 weeks following vaccination. Patients were studied from December 2020 to July 2021 from 4 NHs. The HCWs were workers at the buildings and medical center who all had access to the same vaccine at the same time as the residents. All participants received 2 doses of vaccine regardless of prior SARS-CoV-2 infection. Of 225 participants with available 6-month follow-up, 13 (6%) were excluded for presumed or known SARS-CoV-2 infection between the 2-week and 6-month draws. All of these participants were in buildings or workspaces with known outbreaks. Those with presumed infection had an increase in titer greater than 100% at 6 months from the 2 week post-vaccine level in at least 1 of the immune assays. Five participants had known PCR-confirmed diagnoses; the other presumed cases were clinically undetected. Subjects that have been excluded with documented or presumed infection in the 2 week to 6 month interval: 81-year-old male. Reason for exclusion: PCR +ve, Titer rise (Titer rise denotes an increase greater than 100% in either or all of anti-spike, anti-RBD or neutralization titers); Clinical: Symptomatic (Symptomatic denotes subjects with COVID-like symptoms).  An 81 year-old male 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "known PCR-confirmed diagnoses/ known SARS-CoV-2 infection between the 2-week and 6-month draws". The patient underwent the following laboratory tests and procedures: antibody test: titer rise; blood immunoglobulin g: unknown results; fluorescent in situ hybridisation: unknown results; sars-cov-2 antibody test: titer rise; sars-cov-2 test: positive; unknown results.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200314527 Same article/ drug/event and different patient
Redness and swollen right upper arm. Tender to touch. Two days lapse from initial shot sent to ER and given Keflex 500mg QID. Dx: cellulitis.
Flu-like symptoms for 2 days. This started a few hours after vaccine. Long-term side effects started 9/08/2021 with extreme menstrual cramping before, during, and after menstruation. This never happened beforehand, and I think it?s related. I went to an obgyn and they didn?t have much of any information or help.
The first Flumist dose was administered at the clinic to a 6 month old. The product is not recommended in children under 2 years of age.
New diagnosis of diabetes 5 days after receiving vaccine with no past medical of DM and no family history.; This is a spontaneous report from a contactable Nurse (patient). A 31-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EJ1685), via an unspecified route of administration on 18Dec2020 14:00 at arm left at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included asthma and hypertension. The patient had no known drug allergies. Concomitant medication included cetirizine, budesonide, formoterol fumarate (SYMBICORT), escitalopram oxalate (LEXAPRO), montelukast and omalizumab (XOLAIR). No other vaccine in four weeks prior to the COVID vaccine. The patient experienced new diagnosis of diabetes 5 days after receiving vaccine with no past medical of diabetes mellitus and no family history. The event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Adverse event start date was 19Dec2020 06:00 AM. Treatment received included fluid bolus, computerized tomogram (CT) scan and labs. The patient underwent lab tests and procedures which included computerized tomogram and laboratory test with unknown results on Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was recovered with lasting effects.; Sender's Comments: The reported diabetes was unlikely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), considering the latency of the onset of the event.  A possibility that the vaccination unmarked subject's diabetes cannot be completely excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The patient stated that their left arm became very inflamed and red, that their arm was 'bloated' and bigger than usual afterwards.
Severe muscle weakness; unable to stand or walk for about 6 hours. Continued mild muscular weakness and fatigue for about 20 hours afterwards.
11:00AM patient had check up.  Has Asthma, mild cold symptoms, resolving cold.  Flu shot, 1st one ever, reaction with trouble breathing, increased wheezing, cough, vomited.  Oxygen saturation 81 RA, increased to 99 with oxygen.  Treated with Benadryl.  Called 911 to ER via ambulance.
Patient came to the Health Department with his Guardian to receive a Covid-19 booster. Patient received the Pfizer Covid-19 booster 0.3ML in his Right Deltoid. Pt waited in lobby for 15 minutes with no reaction and went home. I was adding the vaccine to the website when I noticed the childs age and that he had already received two Covid-19 shots. I checked my protocol for the booster vaccine and it stated that it has only been approved for 18 years and older. I immediately took the Covid consent to the nursing supervisor and stated what had happened. I then contacted my supervisor to let her know as well.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-SEP-2012, the patient was inoculated with  ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Headache about 3 hours after injection. Nausea 8 hours later. Extreme fatigue about 24 hours later. Pain and swollen lymph node under arm pit at 24 hours last around 72 hours. Vaccinated on right arm
Patient did not have an adverse reaction but was given the diluent to PENTACEL without it being reconstituted.
102.5 °F Fever that went up to 102.8 °F; The syringe with the vaccine in it was dropped on the floor prior to being administered. Clarifies that the cap was on the needle whenever the syringe was dropped; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Apr2021, the syringe with the vaccine in it was dropped on the floor prior to being administered. Clarifies that the cap was on the needle whenever the syringe was dropped. Consumer received second dose of Pfizer-BioNTech COVID-19 Vaccine yesterday 06Apr2021 (first dose was received on 16Mar2021) and wanted to know if her vaccine dose was considered valid: yesterday morning somehow the vaccine, not the vial, the syringe fell to the floor, although she did not see it come off. If it says do not shake it, my question was whether falling down was considered shaking. Dropping the syringe, if they dropped it was that still okay. The Pharmacist said cap was still on and kept on administering it. On an unknown date she had a 102.5 degree F Fever that went up to 102.8 degree F. She had not taken any Tylenol. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Patient CC: Numbness of lips, tingling of throat and thick heavy tongue with difficulty breathing. Vitals were stable, respirations were not labored, and her main complaint was that her tongue and lips felt funny and progessive thickening. Medical officer administered .3 Epi 1:1000SC and 50mg Benadryl deep IM.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 23-JUN-2015, the patient was vaccinated with PROQUAD (Merck) (dose, frequency and route were not reported) (lot # K025760 and expiry date: unknown) which was improperly stored. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
About 24 hrs p/recvd DTP/HBOC pt broke out in a rash over body; no fever t98 R @ ER; rash described as blotchy rings w/outer part darker red than center-raised 1st 2 days then flat on 3rd day & totally gone 4th day; tx meds;
pt recvd MMR vax on 13SEP91 & approx 10 to  15 mins post vax pt devel generalized urticaria & swelling of nose which made it diffiuclt to breath; no bronchospasm;tx w/Vancenase AQ, Epi & DPH;
Adverse event: Patient felt dizzy, nauseated, blurry vision 5 minutes after vaccine administration. Treatment: Patient  was suggested to lay down and  it helped resolve the symptoms.    Juice and crackers were offered to the patient as well.  Patient was feeling better a few minutes after food and rest. Patient was  discharged to POV/Home at 1:25pm.
Pt recvd MMR vax; approx 3-4days p/vax pt devel fever of 102-103F; Tx APAP & the fever resolved; Reporter did not attribute pt's exp to vax w/MMR, while another MD felt the exp was due to vax w/MMR;
pt recvd vax;30 mins later,had sz;arms & legs shaking,body/head moving;face pale;c/o feeling funny & dizzy;BP 180/70;P=104;denies taking any meds;ice bag applied to back of neck due to c/o feeling hot;pt feeling better;P-98;
Treatment of COVID-19; Treatment of COVID-19; Pfizer/BioNTech Dose Number: 3 / Moderna Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6205), on 28Mar2021 as dose 2, single (Lot number: EP7534) and on 14Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18May2022 as dose 4 (booster), single (Lot number: 056M21A) and on 10Oct2022 as dose 5 (booster), single (Lot number: AS7145B) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "reflux" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Known allergies: fentanyl, reaction(s): "Known allergies: Fentanyl"; Known allergies: versed, reaction(s): "Known allergies: Versed". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18May2022, outcome "unknown", described as "Pfizer/BioNTech Dose Number: 3 / Moderna Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: initial positive test; (11Feb2023) negative, notes: tested negative on day 10; (13Feb2023) Positive, notes: retested and was very positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks. On 04Feb2023, patient started treatment with Paxlovid for COVID-19 and stopped on 08Feb2023.
About 1/27/07 head to toe rash and hives edema in legs. Decreased urine output, tired, seen in ER and referred to personal MD on 1-30-07. Dr placed on Benadryl PO and hydrocortisone cream and and review of lab work as ordered by MD.
Headache & NauseaVomiting Narrative:  Pt reported emesis & headache post #2 dose  of covid vaccine. Pt treated with zofran tablet.
within 24 hours of vaccines, my son had low grade fever and crankiness. within 48 hours of vaccines, my son complained on stomach pain/cramps loss of appetite vomited once persistent, high fever up to 104.9 began alternating tylenol/motrin every 3 hours and fever would not go below 103. High fever persistent for 24 hours. Took 24 hrs for fever to break, still administering meds.
On 15AUG2023, it was discovered that a Typhoid vaccine was administered via wrong route on 11AUG2023 as per clinic SOP.  Vaccine was given Subcutaneous on the Pt's left outer aspect arm vice IM per SOP.  As per manufacturer, the preferred route is IM; but SC is also allowed.    The chain of command was notified on the evening of 22AUG2023, and action was immediately taken on the morning of 23AUG2023.  Pt was contacted after a debrief with the Immunization Nurse.  Pt verified the location that the vaccine was given and denies any adverse reactions and has no concerns with the typhoid vaccine at this time.    Additional training has been assigned and further instruction and guidance has been provided.  In order to mitigate this current event and prevent any further issues, a more detailed training will be implemented, and a full review of all competencies will be conducted.  Safety stand-down will occur to discuss the 5 rights of Patient Care.
Mother reported that pt noticed red welts looking like a bug bite the next day (early about noon) starting on leg, over the next day the number of welts grew and child informed mother the next morning (9/3). Welts have spread over both legs, torso, back, both arms, and neck (not face). Welts were described as about quarter size, pink, painful and itchy. Doctor directed her to take Benadryl. Mother reported to us today 9/6 and asked for us to inform the FDA about the side effect/interaction.
This spontaneous report was received from a registered nurse refers to a 6 month old female patient. On 20-OCT-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016) oral. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Vaccine was administered at 1:10pm on 3/31/21. PT stayed in monitoring area for 30 minutes and then went out to the parking lot and states that is when she noticed that she had double vision. At 1:55pm she came back to clinic area and was evaluated by PHN. Vital signs: P-78, R-18, BP-110/70. PT was talking and conversing appropriately, in good spirits, no other s/s other than pain in back of head she states. Laid down for 15 minutes with cold wet cloths on forehead and wrists and then re-evaluated. Continued to have double vision and pain in back of head, she also was talking on phone and sent a text during this time. Reevaluated at 2:30pm after another 15 minutes of laying on the cot.
Incorrect product storage; This spontaneous report was received from a nurse, referring to unspecified number of patients of unknown age, and gender. The patients' pertinent medical history, concurrent conditions, and previously drug reactions or allergies were not reported.   On unspecified dates since January of 2020, an unspecified number of patients were vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection (lot number S021617 has been verified to be valid; expiration date: 09-JAN-2021), and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number S010297 has been verified to be valid; expiration date: 03-APR-2021); both vaccines were administered as prophylaxis (strengths, doses, frequencies, and routes of administration were not reported). It was reported that the sterile diluent used to reconstitute the vaccines was properly stored.  The temperature and time frame were -9 Celsius to 8° Celsius (4.9 Celsius) for 4 hours 45 minutes, without previous temperature excursion. A digital data logger was used.  This is a non-valid case due to lack of patient identifier.