chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster; Pain at the injection site; Really very sore arm, it is still sore; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 10:00 (Lot number: FH8027) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE-1), for COVID-19 immunization; Bnt162b2 (DOSE-2), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 10:00, outcome "unknown", described as "booster"; INJECTION SITE PAIN (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Pain at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Really very sore arm, it is still sore"; NAUSEA (non-serious) with onset 06Dec2021, outcome "recovered" (Dec2021), described as "Nausea". Therapeutic measures were not taken as a result of injection site pain, pain in extremity, nausea.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
developed sx including sore throat, congestion, fatigue on 7/7/22, tested positive for covid on binax rapid antigen test 7/11/2022
first 36 hours had 10 episodes of heart trying to go into tachycardia, 1 episode of heart fluttering for about 5 seconds, 3 episodes of a sharp pain shooting across my left chest  first 72 hours had slightly sore arm at injection site
Pt. states Monday 3/7/16 started to feel ill. By Wed 3/9 she broke out in welts from top of shoulders to hips (bright red large welts). Used CORTAID on Thursday and Friday they were almost gone. States it knocked out her immune system. Also caused break out of herpes zoster. Was diagnosed with giardia.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated that, too many of his/her acquaintances got shingles after the vaccination. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
T104 & irritable, tempra would not dec temp; Mom called MD's office; F/U 9JUL91 mom states pt doing fine;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable Consumer. The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: er8733), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 026L21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Oral allergy syndrome" (unspecified if ongoing). Concomitant medication included: PANTOPRAZOLE. Patient received Paxlovid from 15Aug2022 to 19Aug2022 for treatment of COVID-19 in 2022. Outcome of the events was unknown.
Patient to Emergency Department on 10/10/08. He was admitted for cellulitis and placed in ICU under airborn precautions.  The local health department was contacted the following day.  Hospital advised that it was likely a "robust take" and not cellulitis and recommended to discontinue the antibiotic. 11/3/08-records received for DOS 10/09-10/10/08-presented to ED with erythema, swelling and streaking which began 4 days prior. Fever 2 days ago and increased pain. DC: local necrotic reaction to small pox vaccine. Fever chills. Cellulitis at the injection site. Papules noted around cellulitis area with lymphangitic streaking to axilla.  Follow-up: No additional information is available.
started getting light headed, then got dizzy, hot flash, sat down rubbed eyes and for next 10 minutes could not see, vision gradually returned to normal about an hour later, light headed and dizziness continued for next 3 hours about 4:30 light headedness and dizziness subsided, felt very weak in the neck and shoulder the rest of the night (was with fellow teacher at school and with friend at home)
Fever 102 9/12 to 9/14. Papular rash throughout body 9/15 - 9/18. 9/19 rash improving but not sore.
Vaccine was administered to an ineligible patient during an off-site immunization clinic. Patient was contacted to ensure no adverse events and patient's PCP was contacted to inform of incorrect vaccination given. Patient is 49 years old and does not meet the minimum age requirement of 50 years old to receive this vaccine.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline.  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756548A, A0756550A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) :  AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
it is warm to touch.; very itchy and comes and goes; Rsh at the injection site which spread to her entire upper arm; pink to red area on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it is warm to touch.), RASH PRURITIC (very itchy and comes and goes), VACCINATION SITE RASH (Rsh at the injection site which spread to her entire upper arm) and VACCINATION SITE ERYTHEMA (pink to red area on upper arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE WARMTH (it is warm to touch.), RASH PRURITIC (very itchy and comes and goes), VACCINATION SITE RASH (Rsh at the injection site which spread to her entire upper arm) and VACCINATION SITE ERYTHEMA (pink to red area on upper arm). The patient was treated with CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (it is warm to touch.), RASH PRURITIC (very itchy and comes and goes), VACCINATION SITE RASH (Rsh at the injection site which spread to her entire upper arm) and VACCINATION SITE ERYTHEMA (pink to red area on upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient tried cool compress which helped. Treatment included Benadryl and used a topical cortisone cream per doctor recommendation.
This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, and adult patient was vaccinated with a dose of PROQUAD (dose, route of administration, lot#, expiration date were not reported) for prophylaxis. The vaccine was reconstituted with a sterile diluent (lot# and expiration date were not reported). No adverse effects were reported.
Left arm so heavy, sore, and good for nothing. Slight fever,  skin hurts, totally out of commission. I feel awful, definitely makes me want to think long and hard about second dose.
pt recv inj as was ready to leave pt fainted & hit head;slow to respond-pulse faint;1 eye dilated transported to clinic;sutures to forehead;doing well by 5PM;
Patient was diagnosed with acute leukemia within 6  weeks of receiving first and 2 week of receiving second Covid Vaccine.  I do NOT think vaccine caused the leukemia, but am reporting it in view of timing of her having received the vaccine and being diagnosed.
Both shots resulted in a rash that started 8 days after my injection , both started on my right thigh and spread to my chest to my feet.  Treated both treated with Prednisone 40 mg seven days .
Constant crying, crying starting at 10:00 AM and continuing throughout afternoon. Patient came back to office approx. 3:30 PM to have doctor to check out. Patient had no other related problems besides constant crying.
Started out as general ache, progressed to fire like pain in the muscles, generalized swelling, joint pain/swelling, low grade temperature, headache, diaphoretic.
I had a runny nose, sneezing and I could tell I was warm & I had a bad cough. I had 2 nights of a bad cough & 2 mornings of a sore throat. I went to the urgent care and got prescription for Z-PAK and nasal spray. I tested positive for COVID19.
Patient was feeling extremely fatigued after the vaccine. Patient also was shivering and said she felt cold. Her blood pressure was 107/78. Her mental state did not seem far from normal. She was taken home by her son.
Immediately when the shot was given, I experienced no pain or other adverse event. That evening my upper left arm and shoulder started to become sore and moving my arm in certain directions resulted in sharp pain. Overnight I took acetaminophen for the pain. The next few days my arm improved, but three or four days later I still had limited range of motion. Lifting my arm out to the side, checking my watch, or reaching forward to use a keyboard all resulted in sharp pain. Moving my left arm with my right arm felt fine.  After a week I slowly improved; I had range of motion mostly back but my shoulder still felt uncomfortable. On 4/30 I relapsed and again experienced the limited range of motion as experienced right after the shot -- again I was unable to do something as simple as lifting my arm to check my watch without pain. My primary care doctor recommended ibuprofen and physical therapy. The ibuprofen had no effect, and physical therapy didn't have immediate effects. I again started to recover but mid-May I had a second relapse; like the prior relapse I had the same limited range of motion.  In mid-May I started a series of appointments with a Physical Medicine and Rehabilitation specialist. After blood work, an MRI arthrogram, and electromyography, I was diagnosed with an injury to the left axillary nerve, potentially consistent with Parsonage-Turner syndrome. The electromyography identified instability in the left teres minor and left deltoid. The specialist prescribed three days of methylprednisolone followed by daily gabapentin which I am still taking.  As of this filing I continue to work with a physical therapist where we have some progress restoring stability in the shoulder. The gabapentin has generally helped with reducing pain. Most day to day activities are done with little or no pain. My most recent visit with the PN&R specialist still identified weakness in some muscles and expects full recovery to take the rest of the year. I was previously advised to get my second dose only after I had a full recovery, but with the recent rise of cases the advice is now to get a second dose but consider avoiding Moderna to reduce the risk of a second injury. I have not yet received a second dose.
Her allergist had her receive a Prevnar 13 shot. Her allergies decreased substantially; Her allergist had her receive a Prevnar 13 shot. Her allergies decreased substantially; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization.  Medical history included allergies (sinus).  The patient's concomitant medications were not reported. The patient's allergist had her received the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) shot. The patient's allergies decreased substantially on an unspecified date. The outcome of the event was not reported.  No follow-up attempts are possible; information about batch number cannot be obtained.
pt says that she felt a little run down but got better.  About a week later she noticed a red spot on her breast.  Within an hour the rash spread across her chest.  She saw her PCP 5/5/21 and was diagnosed w/ Shingles.  he prescribed Valtrex and prednisone.  She is also using Calamine lotion.
At 12 mo WCC concerns raised about intermittent gagging and clearing of throat - advised to monitor. Returned on 4/16/18 for update of imms as delayed/alternate schedule. Facial changes with gagging and excess salvation increased in frequency 5/3-5/5 prompting ED visit on 5/5/19. EEG (+) for focal seizures while inpatient.
Patient called Occ Health Office on 1/21 and was advised to be seen by HCP given the length of time that had passed since she received the vaccine.  She was seen in urgent care.  Notes from that encounter states, "...presents for swollen lymph nodes x 3 days, received second covid vaccine on 1/13/21 and had dental procedure that day, just finished bactrim. Physical exam as above; non-toxic, well-appearing, afebrile in NAD. Cervical adenopathy present along with L>R inguinal lymphadenopathy, bilateral inguinal lymphadenopathy. She has received the second covid vaccination and this seems consistent with post vaccination adenopathy. No dental abscess/infection or evidence of tonsillar exudates to suggest strep pharyngitis. Upon discussion with ED staff physician, she reports she has been working excessively and feels fatigued. She was encouraged to take the day off of work today and was given a work note. Encouraged PCP follow up to ensure improvement in symptoms.  The ER research team was contacted and will chart review and follow up regarding adenopathy after second covid vaccine. Reviewed return to ED precautions. In ED labs were drawn, EE was given Ibuprofen and advised to follow up with PCP is symptoms persist or worsen.
Varicella vaccine breakthrough. Diagnosed with Varicella on 2-28-07.
This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M021124, expiration date 02-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No symptoms were reported. Product quality complaint was not involved. The administered dose of VAQTA was stored in the temperature of 32 degrees Fahrenheit for 15 minutes and in the temperature of 31 degrees Fahrenheit for 15 minutes. The reporter did not know why the temperature excursions occurred. There were no previous and no further temperature excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012794: US-009507513-1608USA012916: US-009507513-1608USA012908:
Fever; diarrhea; headache; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 12:00 (Lot number: Ew0177) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medical history: anxiety. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0177, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19May2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "Fever"; DIARRHOEA (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "diarrhea"; HEADACHE (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "headache"; CHILLS (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset 19May2021 22:45, outcome "recovered" (2021), described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, diarrhoea, headache, chills, pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19. The patient was not tested with COVID-19 since the vaccination.  Follow-Up (08Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included VALSARTAN (DIOVAN) and OXITRIPTAN (5 HTP [OXITRIPTAN]) for an unknown indication.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported.  The Vertigo that patient had was gone within 2 and half weeks. It could be a condition due to DM. The vaccine is working perfectly.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up received on 21-Sep-2021 contains significant info. event outcome for vertigo reported as resolved.
first two shots were Pfizer/third dose as Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 07-Jan-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna). On 06-Feb-2021, INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
due to product leaking and patient not receiving full dose with no adverse event reported; Initial information received  on 13-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who due to product leaking and patient not receiving full dose with no adverse event reported while receiving diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 13V (CRM197) (PREVNAR 13), rotavirus vaccine live reassort oral 5V (Rotateq) and hepatitis B vaccine (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 06-Mar-2023, the patient received a dose 1 at 0.5 mL dose of suspect diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (lot number: UJ807AAA; expiry date: 08-Oct-2023) via intramuscular route in the left thigh for immunisation.  On 06-Mar-2023, due to product leaking and patient not receiving full dose with no adverse event reported (incorrect dose administered) (latency: same day) following the administration of diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  It was reported as there is a discrepancy between nurse and parent, nurse reports full administration but the parent reports product leaking and patient not receiving full dose. No details on amount or where the leaking occurred due to full administration reported from staff.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Information has been received regarding a case in litigation from a physician concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown).  Subsequently the patient experienced an allergy to the vaccine.  At the time of this report, the patient's outcome was unknown.  No further information is available.
Severe Body / joint pain, fever, chills, headache, vomiting,  elevated BP,