chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When the vaccination needle broke the skin the client jumped and then within 30 seconds after the injection was completed the client stated that everything looked blue.  In the next minute the clients pupils dilated and she was not able to respond to verbal commands this lasted approximately 30 seconds.  Blood pressure was checked and client became responsive again.  She then started to diaphoresis and have chills.  Her face had a white pallor during the episode.  Client put her head between her knees and was encouraged to breath normally.  A cold compress was placed on her neck.  After about 10 minutes she started to feel well enough to put her head up.  She was given water to drink and continued with the cold compress.  After approximately 20 minutes the color in her face became pink again and she stopped sweating.  She complained of some stomach cramping but did not vomit during the episode.  She sat for approximately 20 more minutes, blood pressure was checked again and she continued to drink water.  Client was able to leave the clinic on her own accord.
I had a heavy arm and tiredness, a few days after the 15 I developed a low grade fever that lasted about 4 days. Just shortly after that I noticed that my left eye seemed to be very fuzzy and hazy, I couldn't see thru the central portion of my eyes. I'm going for test now. They told me that if it had been both eyes it could've been the vaccine. There's fluid that has accumulated around my optic nerve. There is a leak in my eye they want to check on. They don't know the potential cause.
Patient began to experience local reaction within 24 hours of vaccination at both injection site (left deltoid) but also around left elbow, with erythema, warmth, and swelling. Swelling extended down to left wrist and up to axilla over 48 hours following vaccination and seemed to be worsening, not improving. 36 hours after vaccination, patient also reported abrubpt onset of vertigo while sleeping that did not resolve. Was seen for evaluation of arm swelling and vertigo on 10/10/12.
Blurred vision, red tint to vision, and floaters in R eye that began on 3/12/2021 Eye exams showed a retinal vein occlusion
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions drug reactions or allergies were not reported. On an unknown dates in 2016, the patients were vaccinated with improperly stored ROTATEQ lot number M014318, expiration date 30-SEP-2017, by oral route, (frequency was not provided). No adverse effects were reported. The temperature and time frames were: on 24-AUG-2016, 34 Fahrenheit degrees for 14 hours, and, on 29-AUG-2016, 30 Fahrenheit degrees for 14 hours; there no were no previous excursion and digital data logger was not involved. Product quality complain was not involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Vaccine recipient reported feeling lightheaded and had a tickle in her throat. She reported to then have developed an odd taste in her throat *unable to describe?. The vaccine recipient also developed arm pain and swelling around the injection site. The vaccine recipient was sent to the ED for further observation with no medical intervention needed. They were discharged stable to home. On a follow-up call today 1/4/2021, vaccine recipient reported that symptoms went away and they have recovered. Moderna COVID- 19 Vaccine EUA.
Very sick from the shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick from the shot) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick from the shot). At the time of the report, ILLNESS (Very sick from the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporte
Pt. received aDpt in left deltoid 3-8-05. Pt. returned 3-10-05 to read mantoux test. Pt.'s left deltoid was red, swollen, & warm to the touch. Pt. did not complain of pain or tenderness. Pt. was given Zyrtec, told to use cool compresses & return to our office tomorrow (3-11-05) for follow-up.
Vaccine done at 7pm 8/27 Tingling in upper back from 8 am upon waking up. 6pm had change in vision, static in ears and swaying. I layed him down before he passed out.
This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This case was reported by a other health professional via call center representative and described the occurrence of erythema in a adult patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and pharmaceutical product complaint. On an unknown date, the outcome of the erythema and pharmaceutical product complaint were unknown. The reporter considered the erythema to be probably related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a pharmacy buyer. On 15th September 2015 or after (exact date of administration unknown), the patient received FLUARIX QUADRIVALENT on an unknown arm. The patient experienced localized redness around the injection site and on arm. This is one of the five cases reported by the same reporter (see cases US2015133738, US2015133746, US2015133760 and US2015133773). The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. At the time of reporting, any further details were not known by the reporter.
At 18 hrs after dose, swellen hands and feet. Generlized urticarial lesions. No bruises. Follow up: allergies type whelps-red.  Prescribed Benadryl/coolpacks.  REsolving
Nausea, vomiting, fever, malaise, Shortness of breath with pain on inspiration.
2nd dose: pain in the site of injection, first after 1 hour mild muscle pain and contractions; 2nd dose: pain in the site of injection, first after 1 hour mild muscle pain and contractions; while in bed I have a severe muscle contractions in both legs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EW0172) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "penicillin" (unspecified if ongoing), notes: known allergies penicillin. Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; CALCIUM; MAGNESIUM. Vaccination history included: Bnt162b2 (product: COVID 19 , brand: Pfizer , lot number: ER8134 , lot unknown: False , administration date: 01Apr2021 , administration time: 10:30 AM , vaccine location: Right arm, dose number: 1, 1st dose: pain in the site of injection, mild muscle contractions in one leg (left)), administration date: 01Apr2021, when the patient was 60 years old, for covid 19 immunization, reaction(s): "1st dose: pain in the site of injection", "mild muscle contractions in one leg (left)". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Apr2021 16:00, outcome "recovering", MYALGIA (non-serious) with onset 22Apr2021, outcome "recovering" and all described as "2nd dose: pain in the site of injection, first after 1 hour mild muscle pain and contractions"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset 22Apr2021, outcome "recovered" (23Apr2021), described as "while in bed I have a severe muscle contractions in both legs". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, muscle contractions involuntary.  Additional information: 2nd dose: pain in the site of injection, first after 1 hour mild muscle pain and contractions, after eating I was watching TV, then I decided to rest even thought I was not feeling tire from the vaccine (I was sleeping only 5 or 6 hours only ) it was about after 5 hours from the shot, while in bed I have a severe muscle contractions in both legs. I could not stop it massaging them, still with pain I stood up and decided to ride my bike, I rode about 10 miles total. Why? because when I have the first vaccine I went next day to a doctor's appointment and the pain went away with movement. I rode about 9 miles total. Few Months ago I have muscle contractions but when I started taking magnesium went away. When I have them after the 1st dose I thought it was the cold weather but then I was not having them until I have the second dose. It was an excruciating pain that I have never experienced before.  No follow-up attempts are possible. No further information is expected.
hot flashes, tightness on throat an chest. high blood pressure, severpain from wast down, lower back pain, headache
Localized redness, warmth, and swelling to injection site. Subjective malaise, dizziness, low grade fever.  Symptoms beginning evening of vaccine. Plan for rest, fluids, NSAIDs, cool compresses to site.
Sx of cough on 07Mar then COVID positive test on 09Mar2023; Sx of cough on 07Mar then COVID positive test on 09Mar2023; Moderna, Dose Number: 1, 2, 3 / Pfizer, Dose Number: 4; This is a spontaneous report received from a non-contactable reporter (nurse).  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 36 years intramuscular for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 as dose 1, single (Lot number: 011J20A), on 01Feb2021 as dose 2, single (Lot number: 028L20A) and on 05Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown", described as "Moderna, Dose Number: 1, 2, 3 / Pfizer, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Mar2023, outcome "recovering" and all described as "Sx of cough on 07Mar then COVID positive test on 09Mar2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Mar2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient has no COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for events drug ineffective, COVID-19, and interchange of vaccine product. This case will be reassessed upon receipt of additional information.
Pt getting up from exam table fell forward, brushed head on wall and was caught by staff. Laid down, vitals stable, woke up and was able to drink fluids. She remained dizzy x 1 week. Head CT negative, TSH low 0.3 (nl 0.4-4.0), CBC wnl.
pt recv vax 17MAR98 & w/in 24hr of vax pt exp rash consistent w/erythema multiforme, not involving the mucous membranes;tx w/prelone w/improvement noted;
Right thigh - macular rash and cellulitis. Patient was seen by provider and was prescribed Benadryl and Motrin to be given four times/day. Patient will return to clinic 8/11/06 for re-evaluation.
Per History and physical on 1/11/22: "Patient is a 85 y.o. male w/ hx lewy body dementia, cad (prior cabg), ischemic cardiomyopathy/chronic SHF, prior NSVtach and Parox afib (tikoxyn and eliquis) w/ bi-v pacemaker (downgraded from defibrillator last year due to worsening dementia) who lives at friendship at assisted living. Apparently diagnosed w/ covid 19 on 1/8/22 and has since had increased confusion, not taking his medications so brought to ED for evaluation where had normal oxygen saturations, mildly elevated troponins (but flat, not rising) and was admitted to hospitalist service for further workup and evaluation in light of his confusion. Initial d-dimer normal, tsh normal, procalcitonin normal, normal wbc count. Troponin 0.3, repeat 0.2), probnp normal. U/a negative. Ct head negative. cxr no acute process (stable mild chronic interstitial changes)   Encephalopathy, metabolic (due to acute covid 19 viral infectoin) Lewy body dementia"
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On 04-APR-2013, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On 05-APR-2013, the patient developed pain at the injection site during administration and was still present when the patient left the office. The outcome of the event was unknown. Additional information has been requested.
Started to feel better,better balance on her leg,leg are stronger,can raise her arm,able to move her arm; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Started to feel better,better balance on her leg,leg are stronger,can raise her arm,able to move her arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (for 40 years).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Started to feel better,better balance on her leg,leg are stronger,can raise her arm,able to move her arm). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Started to feel better,better balance on her leg,leg are stronger,can raise her arm,able to move her arm) outcome was unknown.            Concomitant medications included MS medication.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Body aches; Chills; Nausea; Fever; Injection site pain; Major night sweats/  Woke up 4 time and had to change clothes throughout the night due to being Soaked in own sweat.; Major night sweats/  Woke up 4 time and had to change clothes throughout the night due to being Soaked in own sweat.; The patient received third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 01Nov2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar II and penicillin allergy. The patient was diagnosed with COVID-19, prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC) and lamotrigine (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 29-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Apr2021 at 10:00 (at the age of 29-years-old); as single dose for COVID-19 immunisation. On 02Nov2021, the patient experienced body aches, chills, nausea, fever, injection site pain and major night sweats. The patient woke up 4 times and had to change clothes throughout the night due to being soaked in own sweat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, chills, nausea, fever, injection site pain, major night sweats woke up 4 times and had to change clothes throughout the night due to being soaked in own sweat were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age or gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient were vaccinated with doses of VAQTA (dose, frequency, route of administration, injection anatomical location, lot# and expiry date were not reported), which were improperly stored. There were no concomitant or co-suspect therapies reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Inappropriate Covid vaccine was inadvertantly administered.  Janssen Covid vaccine was administered, previous dose was Pfizer. Client was informed.  Supervisor was immediately informed. Client was contacted 10/6/2021 and stated at that time she was doing ok
Several hours after Zostavax administration, patient developed pain, redness, swelling and itching at vaccine administration site.  That night she developed chills and temperature of 101.4.  Two days later with increased swelling (measured today at 11 X 10 cm area of induration, warmth, and erythema), temperature 99.2 F oral, and continued chills.
It was beyond the 42 days window between the first and 2nd; Soreness at the site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jun2021 (Lot number: EW0196) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing), notes: So, with that she has cancer (Intent: History); "chemotherapy", start date: 2021, stop date: 2021. Concomitant medication(s) included: ENFORTUMAB VEDOTIN taken for chemotherapy. Vaccination history included: Bnt162b2 (dose 1, single, Anatomical site: Left Arm), administration date: 06Apr2021, when the patient was 53 years old, for COVID-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Jun2021, outcome "unknown", described as "It was beyond the 42 days window between the first and 2nd"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Soreness at the site of injection".  The reporter is calling on behalf of her mom,who received her Pfizer BioNtech covid vaccine back in April first dose, then started on her chemotherapy (the week she was supposed to get the 2nd shot). They didnt know how she was going to react because the chemotherapy was experimental so at the end of April they stated nothing happened so they instructed her to get the covid vaccine. She received her 2nd dose in June. It was beyond the 42 days window between the first and 2nd and the reporter was told if patient missed that window they need to start again. Reporter added, The only thing that happened was the soreness at the site of injection but nothing out of the ordinary. No fever or nothing. She has cancer (Intent: History) so she has been going through chemotherapy between that time that's why there was such a delay (Further clarification was unknown) because her oncologist wasn't sure and don't wanted to take the chance for her to take the second dose with starting of her chemotherapy  Follow-up attempts are completed. No further information is expected.
Covid19 breakthrough.  1st vaccine received on 10/02/2021.  52 y/o with PMHx of Type 2 Diabetes presents to ED with AMS and Hyperglycemia.  Family states pt has been acting bizarre, is repeating herself and blood sugars have been running in the 300's.  Pt admits to not taking her medicine for the last month.  Pt afebrile and O2 sat on room air 100%.  Pt states she tested positive for Covid 2 weeks ago at work but the result on phone indicates a negative test result per MD note.  Admitted for management of blood glucose and psych eval.
A non-serious spontaneous report of administration of expired product was received from a father/consumer concerning a four-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 28-Mar-2010. On 08-May-2010, the patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
seen @ hosp onset earche 26OCT dx Bell's palsy;28OCT to MD for confirmation dx- progressive rt side weakness droopy, rt lip, unable to close;
Pt recvd 3 doses of Engerix-B ID & got neg titer result; will revax pt;
Significant fatigue, fever of 100 degrees fahrenheit, soreness at injection site on upper arm.
I had a very severe reaction with my first dose.  I had the worst pains and feeling of muscle weakness in my joints and muscles.  It was unlike anything I have every experienced.  Every joint hurt from head to toe.  It lasted days.  My second vaccine was more of the same, but to a lesser effect.  The last several days I have been experiencing strong pain, achy ness  and the muscle weakness in my elbows through my hands.  I have also felt the same ache in my shoulders and knees the last several days as well.  But the arm one is significant.  It is hard to hold anything for a long period of time.  NSAIDs do not seem to make much of a difference at all.  I don?t know if it?s related but it?s the only other time I have felt this way before.  I did nothing physical to warrant my issues.  I just figured I would report this in case I am not alone.