chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Solitary enlarged lymph node in left posterior cervical chain, approximately 2 cm in diameter, nontender. Enlargement initially felt the morning after receiving the vaccine. The lymph node continued to enlarge for several days and has remained 2 cm (visible bulge) at 7 days post-vaccination. No other cervical or axillary lymphadenopathy. Left arm sore for 24 hours post vaccination. No other swelling, redness, systemic or local reactions.
Recv 3rd vax, remained "orange" for 2 years & significant delays persisted. Shot#1-10/19/92-  fever, intense cry, agitation, lethargic, developmental delays & orange/yellow color. Shot#2 3/34/93- developmental delays, orange color. Annual follow-up received on 02/21/01 provided no additional data.
no additional AEs were reported; an expired VARIVAX dose was given to a patient; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The information about the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 03-FEB-2023, the patient was vaccinated with one dose of expired varicella virus vaccine live (oka/merck) (VARIVAX) lot # U002398, expiry date 22-JAN-2023 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events (AEs) were reported (no adverse event).
Cervical lymphadenopathy; onset 11 days after vaccine, not currently resolved.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # m034799 with expiry date: 01-FEB-2018 (dosing details, route unknown) for prophylaxis. The sterile diluent (lot# and expiration were unknown) used for reconstitution did not undergo a temperature excursion. There was no previous temperature excursion. It was reported that the vaccine was exposed to a temperature range of 47 F to 77 F for a duration of 14 hours 30 Minutes. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is second of the two reported reported from the same reporter.; Sender's Comments: US-009507513-1708USA008952:
sick; lethargic; This is a spontaneous report from a contactable consumer via a company representative. This is the second report for one of two female patients. A female patient received Pfizer COVID-19 Vaccine BNT162B2 on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced sick and feeling lethargic. She did get to a doctor. No Emergency Room visit. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021384123 Same reporter/drug/event, different patient.
15 minutes post immunization patient complained of nausea & dizziness. No loss of consciousness. Observed in office for 30 minutes & discharged.
Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report from a contactable consumer. This consumer reported same events under same suspect product for 10 patients this is 4th of 10 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low estrogen, can't concentrate, can't focus, can't sleep, depressed and had anxiety. The events were reported as non serious. The outcome of the events was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: Linked Report(s) : PFIZER_INC-202101533632.
This spontaneous report was received from a pharmacist, who referred to an 89-year-old male patient. The patient had no drug reactions or allergies. No information regarding the patient's pertinent medical history and concomitant medications was provided. On an unknown date in August 2017, the patient was vaccinated with 1 dose of PREVNAR 13 (dose, route of administration, lot# and expiration date were not reported). On 04-NOV-2017, the patient was vaccinated with 1 dose of PNEUMOVAX 23 injection, intramuscularly (dose, lot# and expiration date were not reported) as a prevention of pneumonia. On the same day, after receiving PNEUMOVAX 23, the patient developed a fever of an unknown temperature. The patient's fever was gone on 05-NOV-2017, therefore the outcome of the event was considered as recovered on that day. No laboratory diagnostics or studies were performed. The patient did not seek medical attention and no treatment was given for the adverse event. The relatedness between the event and the suspect therapies was not reported. The pharmacist considered the event of fever to be disabling, because the patient was bedridden for the rest of the day on 04-NOV-2017.
Infant had severe swelling of (R) thigh- Redness and swelling. Painful to touch. Extreme fussiness.
Onset of malaise was shortly after administration. Headache and nausea set in with worsening malaise over the next 20 minutes. Neck pain (right arm administration).
Patient is having pain in her left arm. she is going to go to the doctor or call the doctor monday to get it seen about.
Information has been received from a consumer via internet blog concerning her 13 year old daughter who was vaccinated with a dose of GARDASIL. According with the patient's mother, the patient was completely disabled for the past year in 2008. The reporter indicated that because of GARDASIL, her daughter was "one less student", "one less active child", "one less in every aspect o her life". The reporter also stated that she spent the last year sitting by her child's bedside wondering if she would "die in her sleep". The reporter also indicated that "this vaccine has cost my daughter a year of her life and tens of thousands in medical bills". The patient sought medical attention through a physician. The patient's outcome is unknown. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available. The patient was being treated in two hospitals.
Pt recv vax on 12/14/98; on 12/20/98 pt exp headaches, blurred vision, loss of appetite, fever, feels badly
generalized skin rash, like hives, very itchy on buttocks, thighs, legs, back, upper arms
After receiving the vaccine, patient started to feel dizzy, nausea, headaches, and neck pain.  @1213: diphenhydramine 50 mg po x1; lot#202906 exp 9/2023 @1216: HR 69 bpm, SO2 99%, BP 120/98 mmHg.  @1227: HR 54, SO2 98%, BP 150/90 mmHg @1238: patient discharged to home.  @1349: Called patient at home, arrived safely.
No adverse event; A patient was administered a half dose of the Bivalent booster instead of the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient was with comorbid conditions.     On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (A patient was administered a half dose of the Bivalent booster instead of the full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (A patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (A patient was administered a half dose of the Bivalent booster instead of the full dose).    No concomitant medication information provided. No treatment information provided.  Reporter asked for the recommendation as patient was given 0.25 of the Bivalent booster. The CDC website says to re-administer the dose.  This case was considered for elderly patient number 2 out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-654604, US-MODERNATX, INC.-MOD-2022-654611, US-MODERNATX, INC.-MOD-2022-654609, US-MODERNATX, INC.-MOD-2022-654610 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654609:Patient 3 US-MODERNATX, INC.-MOD-2022-654611:Patient 5 US-MODERNATX, INC.-MOD-2022-654604:Patient 1 US-MODERNATX, INC.-MOD-2022-654610:Patient 4
Body aches, chills,fever,nausea, arm soreness/redness/swelling
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Weakness-Severe, Additional Details: Vaccine and Epi-pen administered by RN - 618-830-0993
Patient received Rotavirus vaccine on 2/23/2007 and 4/25/07. Patient seen at clinic 6/12/07 with vomiting on and off for 6 hrs. Patient admitted to hospital 6/12/07. Pt diagnosed with intussusception and had corrective surgery 6/13/2007. Pt discharged 6/15/2007.  10/02/2007 Vax record received and data corresponds with what was reported on VAERS form./pc 10/26/2007 D/C Summary received for hospital DOS 6/12-15/2007 for DX Ileoileal and Ileocolic Intussusception.  Infant presented with bilious emesis and blood per rectum.  Barium enema performed which demonstrated IS to the cecum from mid transverse colon but was unsuccessful in reduction.  Repeat BE only partially successful at reduction.  Infant then had a Laparoscopic Reduction of Intussusception and Appendectomy.  Post-operatively the pt developed an marked ileus which resolved on POD #2 when the pt began tolerating po and had a non-bloody BM.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: PATIENT PASSED OUT, HAD SYNCOPE, EMT WAS CALLED AND CAME TO EVALUATE. BP DROPPED BUT CAME BACK. MOM WAS WORRIED.
pt recv vax 24OCT95 & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference
This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) and administered expired product (there was an excursion from the freezer) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient administered expired product (there was an excursion from the freezer). On an unknown date, patient experienced product temperature excursion issue (there was an excursion from the freezer). On Oct 25, 2021, administered expired product (there was an excursion from the freezer) resolved. At the time of the report, product temperature excursion issue (there was an excursion from the freezer) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. There was an excursion from the freezer on Oct 1, 2021. Most recent follow-up information incorporated: On Nov 15, 2021: Patient details received.
Awoke the day after receiving the shot with chattering teeth chills, feverish 101.5 temp, aching all over, extreme headache, light sensitivity,  my face felt like it would explode, sinuses were full and jaw ached and was nauseous. The next day I was better but still had light sensitivity and neck and head pain, no appetite and a bit nauseous. Went to bed that night and woke up drenched in sweat. The next morning my lower back was cover in an itchy rash but otherwise felt alot better. Tired easily that day.
Patient received vaccines on the morning of 8/5/2019 around 9:38. Patient tolerated injections and oral vaccine well. Patients called on call nurse for clinic around 6:45 pm stating that baby had become very fussy, not eating, and vomiting. Mother was advised to take patient to ER. Upon arrival at Peds ER baby was diagnosed with intussusception.
Severe muscle pain at injection site beginning two days after immunization and continuing to date. No edema, redness, or warmth at injection site. Pain continues to interfere with sleep. Some relief with hot packs and pain medication.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium
PT IS A 49 YO/F REPORTING THAT SHE SUDDENLY FEELS TIRED WITH A HEADACHE. PT REPORTS THESE SYMPTOMS STARTED SOON AFTER HER SHOT. PT DOES NOT APPEAR TO BE IN ANY IMMEDIATE DISTRESS, WOB APPEARS NON-LABORED, SKIN IS WARM/DRY/COLOR APPROPRIATE. SHE IS AAOx4, SPEAKING AND ANSWERING QUESTIONS APPROPRIATELY. PT VITALS ARE OBTAINED AND SHE PRESENTS AS HYPERTENSIVE. PT ADVISES THAT SHE HAS BEEN DIAGNOSED WITH ANXIETY AND SHE BELIEVES SHE IS HAVING A MILD PANIC ATTACK. PT IS REASSESSED AND HER BP DECREASES. SHE STATES THAT HER HUSBAND IS COMING TO PICK HER UP FROM THE OBSERVATION AREA. DUE TO PT COMPLAINT OF HEADACHE AND ELEVATED BP, SHE IS ADVISED BY EMS CREW THAT SHE CAN NOT MEDICALLY CLEARED WITHOUT A PHYSICIAN EXAM. SHE IS ADVISED OF REFUSAL PROCEDURE AND POSSIBLE RISKS DUE TO HYPERTENSION. SHE REMAINS AAOx4 AND ADVISES THAT SHE UNDERSTANDS. PT SIGNS A REFUSAL AND HER HUSBAND IS ON SCENE TO PICK HER UP.
Muscle twitch under left eye.  Muscle aches, joint aches - progressing thru body.  Fingers slight swelling, muscle ache back of neck into back of head.  Fatigue in afternoons.  Slight agitation after taking thyroid med in a.m.  Muscle spasm in abdomen for +/- 5 mins on day of vac.
Headache, Fever, Diarrhea, NauseaVomiting, injection site redness/swelling/pain/itching, fatigue Narrative:  Employee reports injection site redness/swelling/pain/itching, fatigue, headaches, chills (x 1 night, 1 week after vaccine), fatigue, and "some" nausea/vomiting/diarrhea. Notes itching was "intense." Also notes more local symptoms began 1 week AFTER vaccine. Reports all symptoms have resolved as of reporting to EOH. Of note, employee has not had a previous reaction to another vaccine, but did experience "severe reaction" when having TB skin test done.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.  It was reported that, the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
54 years old received a Fluzone High-Dose in error/no AE; 54 years old received a Fluzone High-Dose in error/no AE; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 54 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that 54 years old received a Fluzone High-Dose in error/ no AE (product administered to patient of inappropriate age) and (overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation.  On 08-Jan-2020, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ311AA and expiry date: 30-Jun-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, 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.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A male patient of an unspecified age received the 1st dose of TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5ml single dose in Upper deltoid, for immunisation.  Medical history included peripheral swelling and pain in extremity from an unknown date  with other vaccines in the past.  There were no concomitant medications.  The patient experienced severe swelling and pain throughout the patient's (entire) arm within few hours after getting the vaccine on an unspecified date with outcome of recovered. Did not required an emergency room or doctor visit and no treatment was administered.
The first shot I had no reaction to but the second gave me bad reactions including 99-102 temperatures, fatigue, body aches, headache, and joint pain.
Redness and warm to touch no pain (or) hurt per Grandmother. Told grandmother to give TYLENOL/MOTRIN pain plus BENADRYL for redness. Next day all clear per grandmother.
Red,swollen,raised circle/bump at/below injection site-VERY painful & itchy. Dizzy & somewhat nauseous on 1/6/2021.
rash p/vax mom states devel a fine allerg type rash over face & back of arms 2hr p/vax;mom called PMD;mom stated had a bad noc w/a wheezy type cough & breathing problems;mom never took to PMD;
Onset dizziness 24 hours no vomiting.  No findings on physical.  No ataxic gait.
Raised, and has bubbles around it/puffy, watery; Several little pockets of like a flat type of rash/almost like a rash/about one and a half inches long; Bumps around injection site; Sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PUSTULE (Raised, and has bubbles around it/puffy, watery), RASH (Several little pockets of like a flat type of rash/almost like a rash/about one and a half inches long), VACCINATION SITE SWELLING (Bumps around injection site) and MYALGIA (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PUSTULE (Raised, and has bubbles around it/puffy, watery), RASH (Several little pockets of like a flat type of rash/almost like a rash/about one and a half inches long), VACCINATION SITE SWELLING (Bumps around injection site) and MYALGIA (Sore arm). At the time of the report, VACCINATION SITE PUSTULE (Raised, and has bubbles around it/puffy, watery), RASH (Several little pockets of like a flat type of rash/almost like a rash/about one and a half inches long), VACCINATION SITE SWELLING (Bumps around injection site) and MYALGIA (Sore arm) outcome was unknown.            No concomitant medication information was provided.  No treatment medication were provided.   Rash is about one and a half inches long.
All covid symptoms as illness but much more intense then experienced with actual Covid 19 illness.  Headache exploding out of top of head plus out of eyeballs.  Nausea, chills, exhaustion,  sore neck, painful arm , confusion- couldn?t concentrate or keep numbers straight (work =accounting & payroll) , wearing mask is almost suffocating now.  Indigestion, burping.
Information has been received from a health professional concerning a 15 month old female patient, with no previous history of allergies, who on 12/10/98 was vaccinated with a dose of MMR (second generation) (lot # 627849/1009H). Concomitant therapy on 12/10/98 included a dose of haemophilus B conjugate vaccine (manufacturer unknown) (lot # unknown) (also reported as a dose of diphtheria toxoid/pertussis vaccine/teta into the left thigh). On 12/10/98 the patient experienced fever of 105 degrees F. A parent called the office on 12/14/98 to let them know that the child had a fever of 105 degrees F since 12/10/98 and continued on until 12/10/98 and 12/12/98. It was reported that the child went limp and was taken to the emergency room (ER) on 12/12/98. A treatment record from the emergency room was not available. The emergency room physicians reported to the mother that the fever was to be expected. The mother reported no treatment to the practice. As of 12/14/98 the fever persisted. The child was seen at the practice on 12/22/98 with a 1 day history of fever of 104 degrees F, a 3-day history of irritability, a runny nose, and diarrhea. The patient was diagnosed with left otitis and was treated with amoxicillin. The patient's fever was 97.6 degrees F (axillary) at the time of the visit. It was noted that the child had an allergy to cefprozil that was diagnosed on 5/99. It was also noted that the patient's arm became red following vaccination with a dose of diphtheria toxoid/pertussis vaccine/teta and a dose of poliovirus vaccine inactivated on 5/6/03. It was reported that the patient recovered from her experiences. It was reported that the child is now school-aged and the physician will not give the MMR (second generation) vaccination due to the experience that occurred in 1998. It also reported that the physician may have to do allergy testing on the patient. Upon internal review, child went limp and fever of 105 degrees were considered to be important medical events (OMIC). Additional information has been requested.
I received the flu vaccine at about 10:00 AM, and I felt fine that morning. At around 2:00 PM, I started to get leg aches, which became fairly "severe" by around 9:00PM. At 10:00PM, I developed chills which turned into teeth-chattering rigors by 10:30PM. My temp was 101.2 degrees at 10:30PM. Rigors lasted until midnight, & temp climbed to 102.2 degrees F at 1:00AM, but rigors had stopped. At 3:00AM temp had decreased to 101.0 degrees, & I went to sleep. When I woke up at 9:00AM, I was no longer febrile & leg aches were gone. I never had nasal congestion, sore throat, runny nose, GI symptoms, rash, or any sign of an actual bacterial or viral infection. I have never in my 35 years of life experienced such a rapidly rising body temperature with rigors that made my teeth chatter. The only reason I did not go to the ER is because I am a physician!