chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days after, fever 102 which lasted 3 days. Then rash broke out on day after fever resolved.
Case number PHEH2011US01257 is an initial spontaneous report received from health care professional on 08 Aug 2011. This case refers to an adolescent male patient. He was vaccinated with MENVEO (batch number: X10053) intramuscularly on 04 Aug 2011. But, the patient was inadvertently administered only the Men CYM-135 liquid conjugate vaccine component. He did not receive the Men A lyophilized conjugate vaccine component. No adverse reaction had occurred following this drug administration error.
2 doses of FLUZONE HIGH DOSE QUADRIVALENT to a patient 20 minutes apart with no reported adverse event; Initial information received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 71 years old female patient who took 2 doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] 20 minutes apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Dec-2022, the patient received 1st 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ932AD) via intramuscular route in the left deltoid and received 2nd 0.7 ml dose of the same vaccine via intramuscular route in the right deltoid for Immunization.  On an unknown date the patient administered 2 doses of fluzone high dose quadrivalent to a patient 20 minutes apart with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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 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.
Immunocompromised patient received J+J as D1 on 05/12/2021. Received Moderna 0.25ml as D2 as indicated in this report on 11/9/21.  Identified on 04/01/2022 when patient came in for third COVID vaccine - received Moderna 0.25ml on 4/1/22 as additional booster.
Day 1 & 2 irritability and depression  Day  3 nausea, fever, chills & diarrhea - really felt bad, but no vomiting. Was able to eat. Day 4 (today) fever, chills and diarrhea - feel a little better than yesterday. Still able to eat ok. I have not contacted my healthcare provider about these symptoms because it is the weekend. If I still have symptoms on Monday, I will call him. In the meantime I?m taking Tylenol for the fever and drinking water to stay hydrated.
Breakthrough COVID on 1/5/2022.  Mostly GI symptoms, continuing through today, 4/19/2022.  Diagnosed through endoscopy with chronic gastritis.
Severe muscle pain in right arm since booster on 9/30. Tried rest, heat, cold pack, NSAIDS, pain relief gels (arnica and biofreeze), and medical massage. Medical provider prescribed Meloxicam on 1/4/23.
Thyroid or throat area was pounding; Thyroid or throat area is pounding; legs swelled up so bad; Heart rate very low; circulation issues; Felt like having a stroke; Dizzy; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Pitting in left leg, which was pale and had veins showing; Struggling to breathe/can't breathe; Weak; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 04May2021 12:00 (Batch/Lot Number: EL9269), as dose 1, single, at age 22 years old, for COVID-19 immunization, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease, Ehlers-Danlos syndrome, and Raynaud's disease, all from unknown dates, not reported if ongoing or not. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination (unspecified concomitant medications). On 07May2021 (also reported as "around day 3 or day 4"), the patient started to get dizzy. On the same day, 07May2021, the patient felt like have a stroke because she could not make thoughts. She had pitting in left leg (also reported as "pitting in left left", pending clarification), which was pale and had veins showing, and she was struggling to breathe and was weak. On 09May2021 (also reported as "about day 5"), her heart rate was very low and she noticed circulation issues. On 11May2021 (also reported as "day 7"), her legs swelled up so bad. On 14May2021 (also reported as "day 10"), the patient's thyroid or throat area was pounding. The events resulted to emergency room and physician's office visits. Treatment for the events included turmeric and aspirin which the patient took every day, multiple times a day. Blood work on an unspecified date mostly came back normal. The patient reported the events were better in two weeks. Her physician advised her to skip the second dose. However, the patient received the second dose out of "fear of missing out" on 25May2021 12:00 (Batch/Lot Number: EW0178) in the left arm. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Pain on left upper extremity 3 days post Pneumococcal vaccine. Erythema 3 inches below site of injection, warm to touch, mildly swollen. Diphenhydramine HCL 25mg tab, take 50mg PO every 6hrs PRN.
Positive COVID-19  Note: Documentation shows that while this was the second shot in the COVID-19 series, it was given 9 months after the first shot. The first shot was also Pfizer.
Pt admit to hospital with COVID pna s/p 4 doses of Moderna vaccine (1/21/21, 2/9/21, 9/5/21, & 10/5/21). Of note, he had been on prolonged course of prednisone since 8/28/21
Lump under right arm-site slight red & slightly warm to touch. Amoxicillin given orally.
No voice; Really sick; Fever; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on 05Apr2021 at 16:00 (at the age of 41-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included asthma and hypothyroidism and COVID-19 on 31Oct2020 and unknown if ongoing. Patient received unspecified medications (concomitant medications) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (unknow result). It was reported that after receiving the dose of vaccine she was really sick with fever and sore throat on day 1 and 2 (on 08Apr2021 at 23:00). Day 3 sore throat was worse and woke up day 4 (on 09Apr2021) and had no voice. It was unknown if the patient received any treatment. On 31Oct2020, the patient underwent lab tests and procedures which included PCR Covid test (nasal swab) which was positive on 31Oct2020. The reporter assessed the events as non-serious. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
R thigh 14cm round indurated erythematous area at injection site-hot to touch T-97 deg ax.
MILD BACK PAIN; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse or illicit drug usage were found.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced mild back pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild back pain. This report was non-serious.
Information has been received from a pharmacist concerning a "young child" of unknown age. No relevant medical condition or concomitant medication was reported. On an unknown date, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot#, expiration date, strength, route, dose and frequency were not reported) (inappropriate schedule of drug administration0. No adverse effect was reported. Additional information is not expected due to the pharmacist was unable to be reached for follow-up information.
itching from head to waist off and on.constant itching from head to waist.worsened itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching from head to waist off and on.constant itching from head to waist.worsened itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BD1A) for COVID-19 vaccination.     Concomitant products included Aller-Tec pill once daily                                      Allergy pill, OMEPRAZOLE, ATENOLOL, ESCITALOPRAM, ROSUVASTATIN and TRAMADOL for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRURITUS (itching from head to waist off and on.constant itching from head to waist.worsened itching). Not Provided      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.
AT 1433, patient complained of left side facial swelling. We closely watched the patient for 15 more minutes. At 1449,  patient told staff that he was feeling well enough to return home. He was advised to go to the Emergency Room if any symptoms returned.
Information has been received from a company representative concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil 0.5 mL.  Concomitant therapy included MENACTRA at the same office visit.  On an unspecified date the patient became dizzy.  Medical attention was sought.  The representative mentioned that she did not know how long the patient was dizzy or if the dizziness has resolved.  She stated that there was no injury associated with the incident.  No additional information was available.  Additional information has been requested.
Patient ( 4/12/1958) presented to vaccination site on 12/01/2021. The client notified RN and other RN that she received two doses of Pfizer vaccine on 4/9/2021 and 4/30/21. Client requested to receive Moderna booster instead of Pfizer booster. Client reports that she experienced vomiting upon receiving first dose of Pfizer vaccine. Client reports experiencing diarrhea upon receiving second dose of vaccine. Both symptoms lasted one day. At three weeks post vaccination client followed up with primary care provider where thyroid labs where drawn. Client reports that TSH levels were elevated and primary care provider prescribed levothyroxine. In July/August the client developed a diverticulitis flare up. The client has a history of diverticulitis 5 years ago. Client denies any other significant medical history, no allergies, no previous history of a reaction to a vaccine. RN and RN submitted a medical consult via text message to Vaccine Operations Leads requesting to proceed with the COVID vaccine Moderna booster. Per CDC guidance, approval to proceed with Moderna booster was obtained from medical consult team via text message, Vaccine Operations Lead. Client received COVID vaccine booster Moderna Lot 027H21B. Client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek care. The client left the vaccination site in no apparent distress and unassisted.
Patient returned to clinic 2+ hours post vaccination stating that he had generalized itching and a rash developing on his chest and bilateral arms.
Patient reports dizziness for 24 hours post vaccine and a hot flash, nausea and upset stomach that night
This patient had a TD given in her right deltoid on 01/26/01. On 01/27/01, the next day, the patient complained of redness and pain to the site. Presented 01/29/01 with swollen, red area on the left site 70 mm x 80 mm. Per the doctor the patient was allergic to the vaccine.
Fatigue, Dizziness, Chills followed by fever of 100.9 degrees F.
Back pain; no comfortable position; spread out like fingers from spine, mostly of left side creeping toward flank. No treatment available until Monday when my dr office opens. Believe it is reactivation of Shingles. No rash hx for chicken pox nor shingles, but terrible nerve pain that did not cross mid-line.
Left eye drooping and heaviness which impaired vision for 5 days. Of note, I received Dysport injections to the forehead and crows feet area 12 days before receiving Pfizer vaccine. No eyelid drooping or heaviness had occurred within those 12 days after Dysport and prior to receiving the vaccine. The very next day after receiving Pfizer vaccine, eyelid dropping started. Concern is for interaction between Pfizer vaccine and Dysport especially because the eyelid drooping only lasted for a limited time (5 days).
A report was received from a consumer on 12/10/03 concerning a 9 year old male vaccinee who received Fluvirin on 10/11/03 and developed hives and a huge rash all over his body. On 10/11/03 the vaccinee received Fluvirin and developed hives and a huge rash all over his body. The patient was treated with diphenhydramine. The vaccinee recovered from the rash on 10/14/03. Update 2/10/04: Further information was received from a health care professional on 2/10/04 indicating that the vaccinee was administered Fluvirin at church and the on call doctor was contacted regarding the vaccinees rash. The vaccinee was seen in the office on 10/30/03. There was insufficient information to determine the reporter's causality assessment. No follow up pending, all information received.
3 days post vax pt had edematous, extremely tender, reddened lt testicle; Seen by hlth dept; Impression was intermittent torsion, vs mild epididymitis, but cannot r/o MMR related;
ON 7/6/18: LEFT ARM WAS SWOLLEN AND PAINFUL. TOOK ADVIL 200MG 3 TIMES A DAY FOR 1 DAY AND SWELLING DECREASED BUT PAIN STILL PERSISTED. HAD SHARP PAIN WHEN LIFT UP LEFT ARM. HAD TO HOLD ON ARM TO PUT PUT IT DOWN DUE TO PAIN. HAD NUMBNESS IN LEFT FINGERS. ON 8/10/18, PT HAD A VISIT WITH DR. COMPLAINED ABOUT THE PAIN AND NUMBNESS DUE TO THE THE SIDE EFECTS OF THE SHINGRIX SHOT. PER DR, PAIN GENERALLY SHOULD GO AWAY BUT LETS COME BACK TO OFFICE IN NOVEMBER TO REEVALUATE AND GO TO PHARMACY TO INFORM WHAT HAD HAPPENED. ON 9/6/18, PT INFORMED US AT STORE ABOUT ADVERSE REACTIONS, THEREFORE; WE ARE SUBMITTING THIS FORM.
Right thigh redness, swelling, induration. Advised - Tylenol and cold compressions.
Patient was administered Bivalent and previously was administered in another location on 10/19/22.
Having a reaction to the vaccine; Second shot was giving to lowbetween her shoulder and elbowand got reddish and was hot to the touch; Second shot was giving to lowbetween her shoulder and elbowand got reddish; Arm got very sore; Patient went to get the second booster and got .05ml instead of .25ml; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Having a reaction to the vaccine), VACCINATION SITE WARMTH (Second shot was giving to lowbetween her shoulder and elbowand got reddish and was hot to the touch), PAIN IN EXTREMITY (Arm got very sore), VACCINATION SITE ERYTHEMA (Second shot was giving to lowbetween her shoulder and elbowand got reddish) and ACCIDENTAL UNDERDOSE (Patient went to get the second booster and got .05ml instead of .25ml) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .05 milliliter. On 14-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient went to get the second booster and got .05ml instead of .25ml). On 15-Apr-2022, the patient experienced PAIN IN EXTREMITY (Arm got very sore). On an unknown date, the patient experienced IMMUNISATION REACTION (Having a reaction to the vaccine), VACCINATION SITE WARMTH (Second shot was giving to lowbetween her shoulder and elbowand got reddish and was hot to the touch) and VACCINATION SITE ERYTHEMA (Second shot was giving to lowbetween her shoulder and elbowand got reddish). At the time of the report, IMMUNISATION REACTION (Having a reaction to the vaccine), VACCINATION SITE WARMTH (Second shot was giving to lowbetween her shoulder and elbowand got reddish and was hot to the touch), PAIN IN EXTREMITY (Arm got very sore), VACCINATION SITE ERYTHEMA (Second shot was giving to lowbetween her shoulder and elbowand got reddish) and ACCIDENTAL UNDERDOSE (Patient went to get the second booster and got .05ml instead of .25ml) outcome was unknown.            No concomitant medications were reported. It was reported that the patient went to get the second booster, and got 0.05ml instead of 0.25ml, because there were negligence when they were processing the syringes. And 45 minutes later the patient was asked to go back to the clinic and get a 2ml doses to complete dosages of a booster. After the second booster the patient noticed the second shot was giving to low between shoulder and elbow and got reddish, had to go to the emergency room, because patient's friend thought it was infected, and was hot to the touch. Doctor said patient was having a reaction to the vaccine, and that the immune system was working.  Patient stated that with all the Moderna covid19 vaccines her arm got really sore. No treatment information was reported.   Reporter did not allow further contact
Red bumps like bug bites or mosquito bites.  Wet itchy for days on multiple body parts like stomach neck and upper back. Day 6 since they appeared and still itchy red and unsightly.  Also cramping on right side like a bruised rib feeling coupled with difficulty to take a deep breath. Lasted several days and still not fully resolved.
He struck his head and in the emergency department was found to have a subdural hematoma.  He was admitted to the ICU initially as he came intubated and sedated from an outside institution.  He was successfully extubated within 2 days of admission and was transferred to a hospitalist service.  He required an NG tube for nutrition as he was very somnolent and unable to maintain good oral nutrition.  Unfortunately, despite optimal medical care, the patient never really showed consistent signs of improvement in terms of his cognition and mental status.  Finally, after discussion with family on 12/14/2021, the decision was made to transition to a completely comfort focused approach of care. Patient dies on 12/16/2021. Hospital admission and death within 6 weeks of receiving the COVID vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 11-SEP-2011, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. The female patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 09-MAY-2016, she was treated by a physician at an unspecified facility for a vesicular outbreak on her face with ocular interference, which was diagnosed as herpes zoster eye disease. The patient has been prescribed acyclovir, oxycodone, and gabapentin for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, vesicular outbreak on her face with ocular interference, which was diagnosed as herpes zoster eye disease was determined to be medically significant. Additional information has been requested.
feeling shaky about an hour after vaccination; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (feeling shaky about an hour after vaccination) and VACCINATION SITE PAIN (Sore arm at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced NERVOUSNESS (feeling shaky about an hour after vaccination) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, NERVOUSNESS (feeling shaky about an hour after vaccination) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
received vaccine 4/5 developed bpv sx 4/6 with dizziness, nausea, tinnitus, headaches
5/28-10 - Mom calling asking if fever typical after immuns. Then on 5/29 child seen in ER with prolonged seizure and stopped breathing. Intubated for a brief period of time. Airlifted out.
Pt called Rx dept to ask about the "red hard egg" at the injection site. She did report that it was less red today than yesterday. She did not report a fever.
Day after receiving third GARDASIL 9 had (L) arm soreness, fever, chills, headache.
On Day 8, injection site is swollen, red, warm, and itchy. No symptoms before today except a bit of fatigue yesterday.
Stiffness/tightness of the hand. Inability to relax hands.  Faint feeling.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 21-NOV-2016, the patient was vaccinated with improperly stored M-M-R II (lot # L036853, expiration date 24-SEP-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature was 52 Fahrenheit degree for 17 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010695: US-009507513-1612USA010696: