chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, refers to 4 year-old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications includes sterile diluent. On 14-JUL-2017, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018, albumin status: rHa) (Incorrect product storage) (dosing regimen and frequency unknown) for prophylaxis. It was reported that the vaccine was reconstituted with properly a stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. A Digital data logger was involved. The outcome of events was unknown. This is one of 11 reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001467: US-009507513-1708USA001338:
Unsure when issue started - noticed on 03/13/21.  Reaction is an (approximate) four inch, oval-shaped rash around injection site on left arm.  Somewhat warm to touch, somewhat achy, slightly swollen.
Swelling, rash around injection area, approximately 2.5 inch circle, and itching.  Red rash area still visible on 02/28/2021 and still itches part of the time.
Later in evening, patient developed rash on cheeks and then hives. Had  intermitant hives x 24-36.
slight fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 11:20 (Lot number: EN6202) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes", start date: 1990 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single at 10:00 , Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EL9269), administration date: 05Feb2021, when the patient was 71 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 27Feb2021, outcome "recovered", described as "slight fatigue". Therapeutic measures were not taken as a result of fatigue. Additional information: Prior Vaccinations (within 4 weeks) was reported as none.  No follow-up attempts are possible. No further information is expected.
Pt states she has been having diarrhea with 7/10 abdominal cramping and decreased appetite since getting second dose
cancer; Initial information was received on 22-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient's son or daughter) via social media.  This case involves an unknown age male patient who experienced cancer (neoplasm malignant) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed serious cancer (neoplasm malignant) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  It was unknown if an autopsy was done. The cause of death was reported as neoplasm malignant.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns an unknown age male patient who had neoplasm malignant and died, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. It was unknown if an autopsy was done. Further information regarding patient's past medical condition, previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cancer
Information has been received from a registered nurse concerning a 69 year old male patient who on 06-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 667913/1021Z). On 06-DEC-2010 the patient experienced an adverse reaction at the injection site and a fever. The injection site was warm, reddened and swollen with an area of induration 6 cm in diameter. His temperature was 99.4. The patient reported the event to a physician's office. The doctor prescribed a steroid and an antibiotic. At the time of reporting, the patient did not recover from the adverse events. Additional information has been requested.
Information has been received from a physician concerning a 77 yr old caucasian female pt with diabetes mellitus, hypertension, hyperlipidemia, palpitations, cataracts, xerosis, and no known drug allergies who on 01/16/2002 at 1300 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent intramuscularly in the left deltoid (lot number 641116/1160L). On 01/17/2002, at 1430, the pt developed a local reaction which occurred "8 cm below the injection site" and was characterized by pain, swelling, erythema, and warmth. The pt was treated with celecoxib (Celebrax) 200mg daily for 5 days. Subsequently, the pt recovered. No additional information is expected.
Patient reported that starting night of vaccine, 1/6/2022, she noted left arm pain and swelling of left ring finger both of which have increased in severity since that day. Has taken Tylenol OTC without improvement. Notable decrease in ROM in left arm/shoulder.
102 fever, swollen lymph nodes underarm ( side of injection), tenderness of swollen area.    Skin rash
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history included herpes zoster rashes on the back. As a result, the patient started concomitant therapy acyclovir on 23-FEB-2015 to prevent future herpes zoster rashes. On 22-MAY-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot# and expiration date were unknown) subcutaneously. The pharmacist stated that the vial (the one used) had been leaking, product quality complaint (PQC) involved. The patient received her last dose of acyclovir on 23-MAY-2015. On an unknown date in 2015 the patient experienced shingles-like rash after receiving ZOSTAVAX. The outcome of shingles-like rash was unknown. Additional information has been requested.
Had vaccines 5/23, at site of Varicella vaccine pt started with redness at injection site, worse today area marked, call if erythema spreads outside of marked area. Cephalexin BID for 10 days.
During the blinded phase of the study the subject received 3 doses of the study vax. Upon unblinding at the end of the study, the subject was found to have received placebo, and therefore was eligible to received 3 doses of the open-label vax, per protocol. The subject received a first dose of Lymerix at 16:20.  At 17:20 one hour post vax, he had developed a severe frontal headache. The subject was seen in the ER at approximately 17:45, and began to experience rigors. He was observed in the ER for 2 hours, after which time all symptoms had subsided. The investigator reported the headache and rigors serious due to significant hazard, contraindication, side effect or precaution, and probably related to treatment with study vax. The subject's mother confirmed that he had not used his Maxair inhaler between the time of vaccination and the onset of the headache/rigors.
This was my booster.  I had swelling in my left arm for 3 days, fever, body ache and headache
Patient had redness, swelling and pain shortly after receiving Tdap vaccine, redness and swelling worsened the next day and had fevers up to 103.7. Was given 1 gram of ROCEPHIN in office and Rx for KEFLEX x 10 days.
Varicella - Information has been received from a healthcare professional concerning 15 students ranging in ages from kindergarten to third grade who at unknown dates were vaccinated with a dose of varicella virus vaccine live (Site unknown).  The reporter stated that in April 2000 a total of 19 students from one school including those that were vaccinated, had developed chicken pox.  An undetermined number students sought unspecified medical attention.  Also reported were 3 students from another school who werre vaccinated and experienced similiar events (wases 00042153).  follow up information receive on 31 may 2000 from a public heatlh administration woman indicated that by the time they got the report of the varicella outbreaks, the information was 3 weeks old and she does not have any additional information.  No further information is available.
April 17 (night) to April 18, 2021: fever (99.6-100F), severe headache, chills, body ache, fatigue April 19: no more fever, minor headache and body ache, mild chills and fatigue, minor light headedness April 20 to 22: symptoms gradually reduce April 23 evening: developed severe dizziness and nausea April 24: level of dizziness and nausea reduced April 25: severe dizziness returned accompanied with fatigue and mild headache. Sometimes accompanied with nausea April 26 and 27: dizziness persists, sometimes severe and accompanied with nausea and headache. Still feel fatigue. Rest or lying down seems to reduce the dizziness while sitting up or standing makes it worse.  Eating and sleeping are not affected, although somewhat lack of appetite. Blood pressure is normal (self checked),  No fever, no numbness on limbs, no shortness of breath
Instant itching Localized reaction at injection site Left deltoid red dened area size of golf ball with a raised center. EMS Medic responded with Diphenhydramine 50mg Intramuscular Right Deltoid 1315 . Local EMS at site Patient declined transport to local hospital for evaluation. At 1333 patient left building. accompanied by spouse. Advised of anaphylaxis reactions to observe for and to seek medical attention immediately. Advised patient to seek counsel from her Primary MD for second vaccine.
Rash developed 3-4 days ago (approx.) no fever. Few vesicles on trunk & upper extremities.
Second dose 47 days past first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose 47 days past first dose) in a 27-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose 47 days past first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose 47 days past first dose) had resolved.        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.   Relevant concomitant medications were not provided. Treatment information was not provided.
A patient was given an expired ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00589040) and transmitted to Sanofi on 05-May-2021.  This case involves a 15 month old male patient who received 0.5 ml dose of expired suspect HIB (PRP/T) VACCINE [ACT-HIB] vaccine (lot number: UJ178AAB; expiry date: 04-May-2021) via unknown route in the right thigh for prophylactic vaccination on 05-May-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot number and expiry date: not reported) for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) (lot number and expiry date: not reported) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter wanted to know if they should revaccinate the patient.  At the time of report, no adverse event was reported.  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 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.
Light pain at the injection site, the next morning when I woke up I was exhausted. I had a good night's rest (I slept for about 7 hours) but was just very very tired. I got up, walked and fed my dog  around 9am then when I got back I went back to bed for a few hours, I think I got up around 12pm. I tried to clean my apartment but was too tired to do much so, around 2:30 in the afternoon I laid down again and took a 3 hour nap. When I got up it was around 5:30, I felt a bit better and was able to stay awake until around 8:30. Then I went to sleep for the day. I got up early on Sunday morning because I had to be somewhere for some work. I worked from about 9am-12pm, got home and was still exhausted. That feeling like when you're dragging and just lethargic. So when I got home I laid down to watch some TV, I ended up falling to sleep around 1:30/2 and took another three hour nap. When I woke up around 5/5:30 I felt much better and was able to continue my day. I don't usually take long naps like that so I'm pretty sure it was a result of the vaccine. I also noticed that I had a very light tension headache on Saturday afternoon and also on Sunday afternoon.
Soreness in arm for 17 days and counting. Feeling even more tired or exhausted. Enlarged and painful lymph nodes on the left of my neck. Feeling of pain in my left breast.
Pt. states that after receiving the 3rd Booster of Phizer 10/28/2021, started experiencing symptoms 10/30/2021 of fatigue, achy (lasting 24hrs)  a rash on the left cheek and muscle ache on the left side of bottom. No noted Primary visit/communications. Still continuing to experience symptoms.
headache; soreness; discomfort; tingling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), DISCOMFORT (discomfort), PARAESTHESIA (tingling) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B or 03AZ1B) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (soreness), DISCOMFORT (discomfort), PARAESTHESIA (tingling) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (soreness), DISCOMFORT (discomfort), PARAESTHESIA (tingling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include some exercise (walk) which helped her reducing symptoms.
DIFFICULY BREATHING, CHEST TIGHTNESS, 25 MG OF BENADRYL GIVEN IN LEFT DELTOID. 0.5CC epi given 1:1000 sc left inferior arm.
Patient was due for a Dtap and was given a TDAP instead. This was the patients 4 dose. Parents have been notified of this.
pt recv vax JUL98 & devel sterile abscess lt thigh @ site of inj, required incision & drainage;
This spontaneous report as received from a registered pharmacist refers to a 63 year old female patient with penicillin allergy who on 04-JUN-2013, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). The pharmacist reported that on 05-JUN-2013, the patient came into the pharmacy complaining of significant pain, redness and swelling (almost down to the elbow) on the arm where she received the vaccination. No treatment was given for the experience. At the time of the report, the patient outcome was unknown. The relatedness for significant pain, redness and swelling (almost down to the elbow) and ZOSTAVAX was unknown. Additional information has been requested.
left deltoid (inject site): Erythema (4 1/4 x 4 3/4 in size).  Non tender, itch.
Raised, itchy rash directly underneath injection spot.  Started applying  hydrocortisone.
Large golf ball size painful knot under skin on right arm by injection site. Accute painful inflammation in arm, neck, all over back for over 3 days. Right shoulder felt out of socket after a week, still inflamed. Doctor prescribed Naproxen 500 mg. 2 x day for the pain. Took 3-4 days for inflammation to calm down and another few days before Chiropractor could adjust shoulder back to almost normal. All due to the extreme inflammation from the vaccine and the fact that I had >600 antibodies at the time, which I reported to the nurse practioner before the injection. She said it wouldn't matter at all. I found out different much later.
Patient's left arm is swollen and red in an area about 9" long and 5-6" wide starting a little above the injection site and going down her arm. The area is also firm and feverish to the touch. Parents do not want to bring the daughter in to be seen by a physician.
Narrative:  85yo male patient died inpatient on 1/31/2022. Death was caused by: complications from recent cardiac arrest. Pt had received one covid vaccine (J&J) on 3/10/2021 from nonfacility site. This death is not related to the covid vaccine.
accidentally given a third dose of Shingrix; arm pain; swollen area on arm; Nausea; fatigue; HEADACHE; MUSCLE ACHE; red swollen area on arm, redness from the 3rd dose; This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (also experienced arm pain, headache, muscle ache and redness after receiving 1st dose in left arm on 12th October 2021, refer case US2022AMR060911). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In March 2022, the patient received the 3rd dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain, erythema of extremities and extra dose administered. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain and erythema of extremities were recovered/resolved and the outcome of the extra dose administered was unknown.   The reporter considered the injection site pain, injection site swelling, nausea, fatigue, headache, muscle pain and erythema of extremities to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR060910, US2022AMR060911   Additional Information: GSK Receipt Date: 02-Apr-2022 and 06-Apr-2022 Reporter's comment: The case was self-reported by the patient. In January 2022 (the patient thought around the 20th of month), the patient received 2nd dose in left arm and experienced nausea, arm pain, headache, muscle ache and redness which lasted about 2.5 days.  Last week from reporting date, the patient accidently given a third dose of Shingrix in left arm. The patient stated side effects from the Shingrix vaccine were rough compared to other vaccines. The patient had pretty significant side effects nausea, fatigue, headache, muscle ache, red swollen area on arm and arm pain. In addition, patient had redness from the third dose of Shingrix that went from the injection site travelling down and wrapping around her arm. The side effects from all three doses were similar, but side effects from third dose were more intense and lasted longer (about a week). The reporter consented to follow up with health care professional (pharmacy) Additional Supportive Information: The patient accidently given a third dose of Shingrix, which led to extra dose administered.  For tolerance of 2nd dose refer case US2022AMR060910. This case was 1 of 3 cases reported by same reporter for same patient for different dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060910:same reporter US-GLAXOSMITHKLINE-US2022AMR060911:same reporter
Local soreness/tenderness around injection site; Brief fatigue; Unable to get our second dose;  First dose was 23 April; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get our second dose;  First dose was 23 April), VACCINATION SITE PAIN (Local soreness/tenderness around injection site) and FATIGUE (Brief fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to get our second dose;  First dose was 23 April). On an unknown date, the patient experienced VACCINATION SITE PAIN (Local soreness/tenderness around injection site) and FATIGUE (Brief fatigue). On 13-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Unable to get our second dose;  First dose was 23 April) had resolved. At the time of the report, VACCINATION SITE PAIN (Local soreness/tenderness around injection site) and FATIGUE (Brief fatigue) outcome was unknown.            Patient has stated that they were received their first dose on 23 April and unable to got their second dose and  they have got opportunity to get their second dose on 14 may and also stated that should they plan for third dose. The only reactions that can be noted after dose 1 were Local soreness or tenderness around injection site and Brief fatigue less than 24 hours. No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Additional information was received on 29-JUL-2021, New events were added
Diffuse fine maculopapular pink rash no urticaria rash from head to toe.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: After patient was vaccinated she went to wait with her mother in the car (vaccinator did not specifiy to wait in the store). Patients mother came to alert us that the patient was not feeling well. I went to the car with the clinic nurse to check in on the patient. She was responsive however was feeling faint/dizzy/nauseas. Vitals were within normal limits however EMT was called by mother. Patient started to feel better and went home. Patient reports feeling fine now.
Pt vaccinated with MMR developed pain in elbow & weakness of arm. Unable to fully flex or extend limb. Aches 24 hrs a day.  Still has deep joint pain.
Had redness & swelling, warm to touch in (L) leg. Gave 1/2 g ROCEPHIN IM (R) hip.