chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 71 year old female with diabetes who "about a year ago" was vaccinated with a "single dose" of ZOSTAVAX (Merck). Recently ("about 12 days ago") the patient started experiencing pain across the ribcage area (that feels like post-herpetic pain) which after 4 days moved to the back of the patient's body. The physician stated that there are no lesions or redness however still diagnosed it as shingles and prescribed medications for treatment of shingles (names and manufacturer unspecified). The patient received unspecified medical attention. At the time of the reporting, the patient had not recovered. Additional information has been requested.
0.3mL of vaccine was drawn out of J&J vial instead of Pfizer vial and administered in error.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a female with allergies who on unspecified dates was vaccinated with two doses of GARDASIL (lot # not reported).  The consumer reported that "I'm having a fever and some swelling around the face but I think it maybe just my allergies".  The consumer also reported that "I will have my third dose of GARDASIL next week".  No further information was provided.  Additional information is not expected.
MASSIVE LYMPH NODE SWELLING ON NECK FOR 6 STRAIGHT WEEKS; TINGLING IN LEGS AS IF THEY WOULD FALL ASLEEP, COULDN'T EVEN WORK OUT FOR 2 STRAIGHT WEEKS; FREAKING OUT; HIGH FEVER 12 HOURS AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient worked out routinely.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced massive lymph node swelling on neck for 6 straight weeks. On APR-2021, the subject experienced tingling in legs as if they would fall asleep, couldn't even work out for 2 straight weeks. On APR-2021, the subject experienced freaking out. On APR-2021, the subject experienced high fever 12 hours after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever 12 hours after vaccination, massive lymph node swelling on neck for 6 straight weeks, tingling in legs as if they would fall asleep, couldn't even work out for 2 straight weeks and freaking out was not reported. This report was non-serious.
Day of vaccines: Extreme headache, blurry vision, loss of muscle control, fever, chills and extreme loss of bladder control (could barely make it to bathroom) Day after vaccines: chills, slight fever, no energy, and no appetite
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B221A and advised vaccine maintained activity necessary to protect against covid 19 at time of administration. Also patient did not call in to report adverse event.  This is administrative error without adverse event.
Patient diagnosed Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung on 05-06-2021. As well as: oxygen saturation 95%, blood pressure 95/62 Pulse 89 BMI 18.31Respiration 18 Weight 135 Height 6' on 5-6-2021
She received Moderna vaccine on her first dose but is only 17 and Moderna is currently only approved for 18 and over.  We then gave her Moderna for her second dose as told to do so to finish the series.
p/vax pt exp severe vomiting; D; h/a; malaise; fever
No additional AE reported; Customer called for a temperature excursion; This spontaneous report has been received from a medical assistant and refers to a 15-month-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 10-DEC-2022, a varicella virus vaccine live (oka/merck) (VARIVAX) that suffered a temperature excursion (Product storage error) (lot number W018828 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and established as 14-JUN-2024) was administered intramuscularly to a patient for prophylaxis (dose, strength was not provided).; Sender's Comments:  US-009507513-2303USA002114:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot# reported as N1046004, expiration date: 18-NOV-2018 (dose and route of administration were not reported) or lot#M049127, expiration date: 15-DEC-2018 and/or an improperly stored dose of PROQUAD lot# N013864, expiration date: 31-OCT-2018 or lot# N001490, expiration date 12-JUL-2018 (dose and route of administration were not reported). The vaccines were stored in the temperature of 13.4 degrees Fahrenheit for 1 hour. Digital Data Logger was involved. There was no previous temperature excursion. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA000520: US-009507513-1711USA000521: US-009507513-1710USA002215.
Child complained of not being able to swollow.  Symptoms occured after vaccination with H1N1 intranasal vaccine.  Child in no accute distress alert,oriented and could speak.  10:40 Am was given Benadryl liquid 12 ml per protocol.  10:45 pulse 80, resp 15 easy non labored, 10:50 pulse 74 resp 20 breathing easy and unlabored.  Stated felling al little better but still having a hard time swollowing.  No swelling of lips or tongue, breathing easy, conblains of no throat soreness but feeling like a "lump".  11:05 pulse 76. Client talking and in no acute distress breathing easy.  Child discharged to parent at aproximately 11:15 am.
suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient 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 Information: GSK Receipt Date: 08-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that he/she got the newest shot and still got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.
Neuromuscular weakness with hypotonia. Pain on right leg.  Follow up: Diagnosed with GBS; pain in left leg.
p/vax pt exp nausea; burning sensation on cheeks; entire body turned beet red; felt hot; MD tx w/anti-histamine & recovered
Chest pain 2 days after 2nd dose of vaccine, elevated Troponin 10.2 which continues to downtrend, now down to 1.29 (during hospital day 2). EKG on admission with borderline ST abnormality in lead V1, subsequent EKGs were NSR. Echo showed normal function.  EBC, CMV, Enterovirus PCR sent (pending). Blood, Urine, Throat Culture negative to date.  Chest pain treated with Ibuprofen. She received no other treatments.
pt recv vax 16JUN97 & 24JUN97 pt exp a large rxn that extended to the pt elbow;A cellulitis was suspected & pt was treated w/unspecified ATB;
08/28/2019 At 1140am got a call from patient's mother who said that she is concerned about her son's right arm since he got vaccines on the 26th. Mom reports to this nurse that patient's arm is very swollen, area is dark red and hot to touch. Mom states that patient is not feeling well today and that she had to pick him up from school d/t his symptoms. Mom says that he's having issues not being able to move his arm d/t the swelling and redness. Asked mom if patient had a fever which mom stated she has not taken it so she was unsure. This nurse also asked if he had vomited today? Mom said no but feels very sick to his stomach. Mom said that that she is going to take patient to the ER. Mom said that she is not going to their PCP office because of an unknown issue at the office.
This spontaneous report as received from a nurse via a company representative refers to a 15 or 16 year old female patient. On an unknown date the patient was vaccinated with GARDASIL dose 1. No concomitant medications were reported. On an unknown date the patient was vaccinated with dose 2 of GARDASIL. The nurse reported that the patient experienced pelvic pain  on an unknown date some time after receiving dose 2 of GARDASIL. The patient sought medical attention and visited the physician who treated the patient with unspecified medication for an unknown diagnosis. The outcome of pelvic pain is unknown. Additional information has been requested.
No additional Ae's and no PQC's were reported.; An expired dose of VARIVAX that was administered to a patient on 6/2/2022.; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 02-JUN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) , lot #T010313, expiration date 24-MAR-2022 (strength, dose, anatomical location, and route of administration were not provided) used as directed to prevent varicella infection (expired product administered). No additional adverse events were reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-OCT-2012, the patient was inoculated with the ZOSTAVAX vaccine at a Health Department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-OCT-2015, the patient was treated at a county health center for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and TRAMADOL for management of her painful symptoms and chronic pain. As a direct and proximate result of 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. Additional information has been requested.
Patient showed up to clinic with Dr's note saying she has allergies but that she should get the COVID 19 Vaccine.  Prior to administration, patient appeared anxious and states "I shouldn't have had mayo...I'm allergic to eggs." appx 5 min later, patient appears flushed and c/o chest tightness. Was moved into room to lay down and Dr was brought in along with a total of 3 RNs, 1 EMT-1, etc. MD prescribed 50mg Benadryl IM and patient was sent to hospital via local ambulance.   During event, patients BP was elevated, HR 120s, SPO2 96% on 1L O2. Patient was able to speak in full sentences and lung sounds were clear bilaterally.
No adverse event.  Reporting clinical deviation only.  Patient was 49YO and not immunocompromised.  Received Moderna Booster #2 earlier than current CDC regulatory age of 50YO.  Patient reported only standard side effects day after.  Otherwise, reports as being OK.
Swelling softball size on muscle on arm pain/redness/warm, (Injection site reaction ZOSTAVAX). Back of left tricep. Patient treated for cellulitis post reaction).
After getting Shringrix vaccine on 2/14/20. She noticed palpitation & dizziness that evening. She grabbed a towel holder in bathroom to get steady or break her fall. She did not fall. (Unsure if episode since she has dizziness anyways or secondary to vaccine), but also had localized redness & tenderness on injection site that is gradually getting better, but still red, painful & warm today. She also noticed gum swelling & sore throat (unsure if related to vaccine)
Severe onset back pain on right side. Went to hospital and was prescribed flexeril and naproxxen. Pain persisted through all last week. Work sent me to medical center "I work there" for a follow up. I reported my back pain and also tingling slight loss of feeling in my right leg. Was informed that it's a 50/50. That you've either strained your back "when I didn't do that" or you had a adverse reaction to the vaccine. Was then prescribed gamapentin along with the flexeril and naproxxen. My back is still out of sorts and is starting to hurt more towards lower center of spine.
2nd dose Pfizer shot administered at 9:37am.  Pt was noticed to be really out of it near the front of the store.  No previous history of allergic reactions and no issues with 1st dose.  Patient said head was hurting bad and throat felt weird.  Her eyes were rolling back in her head and she was in and out of responsiveness.  Ice pack was given at 10:07am, EMS was called, at 10:10am bp 129/101 pulse 89, ems arrived on scene at 10:15am and took patient to the hospital.
4 hrs. after PNEUMOVAX injection she developed significant diaphoresis and weakness as well as inability to raise her L arm very well.
Case reference number 1998027650-1, is a clinical trial report from study 217744/027, a phase III multicenter, randomized, controlled primary vaccination study to assess the lot-to-lot consistency of the production method of Biologicals DTaP-HBV-IPV and Hib conjugate vaccines when mixed extemporaneously and given in a single injection and compared to commercially available vaccines in healthy infants. this case refers to a 3 month old male pt. The subject received a dose of DtaP, Hep B, Hib and IPV vaccines on 11/10/1998. One day after vaccines were given, on 11/10/1998, the child's mother called to say the subject had experienced a possible local reaction to the vaccine. The mother stated the injection sites on the left leg were swollen with a small amount of pus coming from the sites. The subject was evaluated at the physician's office. No fever, gastrointestinal complaints, pain and loss of appetite was seen. Three distinct circular scabs were seen with surrounding vesicles, which were confluent with underlying ecchymosis through most of the left anterior thigh. The physician ruled out that the subject was immunocompromised, and he was treated with Elocon ointment. The vaccination course was stopped. The subject recovered from the event on 12/09/1998. The investigator reported the event was serious and probably related to study vaccine and also associated with a reaction to immnizations. Local reactions to vaccines is a serious and listed event adequately reflected in the investigator's brochure.
Numbness, tingling, pins and needles in hands and feet that progressed up the body.  Severe burning pain in legs and difficulty walking.  Shooting pain all over body.  Rapid weightloss (12 lbs in 14 days).  Symptoms began over 12 hours after vaccine administered.  They were slight and progressed over 3 weeks until it reached the worst, then started to slightly improve over several weeks.  Neurologist diagnosed as Acute Demyelinating Polyneuropathy, or Guillain Barre Syndrome
This spontaneous retrospective pregnancy report as received from a Nurse Practitioner refers to a female patient of unknown age. On 11-DEC-2014, the patient was vaccinated with a dose of  VARIVAX (Merck) while she was pregnant (dosage, route, lot # not provided). Patient's last menstrual period (LMP) was in 2014 and the estimated date of delivery (EDD) was in 2015 (exact dates unknown). On an unknown date, in December 2014, the patient miscarried, while she was approximately 8 to 12 weeks pregnant (I trimester). The patient sought unspecified medical attention. The outcome of pregnancy was reported as abortion spontaneous. Foetus demographics and outcome were unknown. The outcome of miscarriage was unknown. Relatedness between the event of VARIVAX (Merck) was not specified. Upon internal review, the event of miscarriage was considered to be medically significant. Additional information is not expected as there was no consent to contact physician.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Diagnosed with vitiligo in a small area in back, two spots developed within 2 days of second dose.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, within 2 days of second dose, the patient developed two spots and was diagnosed with vitiligo in a small area in the back. The patient had no family history nor any other prior indications. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with steroid and topical medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diagnosed with vitiligo in a small area in back was not recovered at the time of this report.
numbness/ tingling in both hands, started 6:50 pm (20 minutes after vaccination) resolved by 7:02 pm.
Very weak, worn out, tired, achy, fever lasted about 3 days, used ibuprofen, rested, couldn't go to work, no medical attention.
I have been experiencing much much heavier bleeding than normal since I've gotten my period at the age of 11!! I am 20 years old and have NEVER had an irregular period even when I started taking birth control (age 16) .  I am experiencing excruciating pain with my cramps much worse than the past 9 years.... And I'm bleeding for longer periods of time. October I bled for almost the entire month, and this month I've already started a second period cycle and it is not DUE for another 15 days! Ever since I received the second dose of the  Pfizer vaccination, I have been experiencing symptoms a woman should NOT have to go through.  I am in pain constantly bleeding and just miserable about this effect.
Information has been received form a health professional concerning a female who on 12, Feb 2007 was vaccinated with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # "Y1050-2"). Concomitant therapy included prednisolone Na phosphate (ORAPRED). On "08, Jan 2004" the patient had a documented case of chickenpox. Unspecified medial attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sore for couple days but never got better. Patient went to doctor on 12/12/19 could not lift arm, + left arm pressure dr felt nerve could be irritated gave her naproxen/gabapentin - she called us today
12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For the next 11 hours i had chills, severe body aches, a headache and spiked a fever to 101. The following day after ~12 hrs of symptoms I began to improve slightly and all that remained was a severe headache and body aches. Now, I am about 32 hours in to the adverse event and I still have a headache and sore arm/shoulders but other symptoms have resolved.
Increase in seizures (baseline seizure disorder), partial seizures lasting 3 hours, spontaneously resolved.
Same as the first shot, however, the adverse effects started shortly after the 2nd shot (within 2 hours after 2nd shot, vs 12 hours after the 1st shot). The symptoms are as follows: Severe headache, severe fatigue and muscle ache, shortness of breath and mild dizziness.  Muscle pain is more noticeable at joints (knees, shoulder cuffs, ankles).  I probably couldn't walk more than 2 blocks before having to sit down and catch my breath. I probably can't stand for more than 5 minutes,  and most definitely not in a shape to be able to work (office /engineering). It is hard to pin point, but I would probably say my mind is foggy and not as sharp. However I can quantify this.  The above symptoms lasted 5 days after the first shot, however,  it took up to 14 days before I recovered from general fatigue.   As for second dose, I am filling this form 5 hours post injection.  Considering the severity and early onset of symptoms (compared to 1st dose) I can predict uneasy days to follow.  Note, I am 178cm, and 76Kgs and do not have health issues. My pain tolerance is much higher than an average person.
11/10/21 presents to EC ED for "weakness and fatigue". PMH "heart transplant recipient, diabetes type 2, HTN, CAD s/p PCI, CHF, pulmonary embolism on Xarelto and COVID + on 11/01/21"
I thought my lopes were tingling immediately, but thought it may just be psychological. Several hours later, my arms and hands were tingling and numb, followed by some chest pains momentarily. Eight hires after the shot, I got up to use the restroom, in distress of the tingling and numbness. I was sitting on the toilet and seem to be going in and out of consciousness. I stood up, washed my hands... and woke up on the bathroom floor. I had clearly passed out, hit my head and lost some time.
Felt a pain/burning sensation when wiping after urinating on 2/28. Assumed it was an abrasion associated with shaving. When still occuring on 3/02, I used a mirror to check the area and discovered a single, white, blister-looking lesion on my labia minora (right side). The lymph nodes under the arm on my left side (injection site) and in my right groin are still swollen and have been since 2/28.