chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was trying to protect myself from getting the shingles. My insurance offered a free ZOSTAVAX inj. so I got one on 9-16-16 at 10:23AM. Within 1 day I broke out with full blown shingles. I suffered for 3 weeks w/painful blister under my arm and back and chest. Still scabs and pain.
Large egg shaped welt appeared at injection site. Rash was itching and red. Pharmacist recommended antihistamine therapy and Hydrocortisone cream.
Pfizer-BioNTech COVID-19   Vaccine  Symptom started a few minutes after the vaccine, around 1:50pm, and lasted until approximately 5:30pm. Symptoms: ear or head pressure. Felt like when driving from a height altitude to a lower one, and the fast change of heights causes the ears to get plugged with a feeling of great pressure.
Pt reported having extreme redness and swelling at the injection site. She also had a fever and the injection site felt warm to the touch. She reported that the area was hard and felt like there were a few nodules near injection site. The "hardness" and nodules resolved within 48 hours but the redness remained for 2+days. She said it was hard to move her arm up and down for about 48 hours and she experienced some tingling in her fingers. She took ADVIL and TYLENOL and the fever resolved within 48 hours. It is still painful for her to move her arm but she does have full range of motion. She did not take any BENADRYL initially but was going to start BENADRYL today since it was still red near injection site.
Left arm red, hot to touch, growing boil. My son reports pain in whole arm when raised.  Runny nose and cough. Drowsy.
I have extreme anxiety that will not go away! I cannot sleep and it wont go away. I feel like someone turned a knob up on my anxiety level. I have the flu shot every year and I have never reacted. This is extreme for me. I also have a low grade fever and chills. This all started on the 23rd of Oct and it is still going on today (Nov. 1st). I am fixing to see my doctor for it. My aunt got the same exact flu shot and she is having the same side effects.
Information has been received from a physician concerning an 18 month old male patient with possible asthma and a history of bronchitis who on 22-JUN-2010 was vaccinated with the first dose of VAQTA (lot#667261/0261Z). On 22-JUN-2010 the patient developed a body rash. On 23-JUN-2010, the patient presented to the physician's office and was prescribed ORAPRED for the rash as well as BENADRYL. The patient made a return visit on 02-JUL-2010 for a separate unknown reason, however his issue with the body rash had resolved. Additional information has been requested.
pt recv vax; hard knot 1-2 days p/ inject; large red area surrounding site (9x10cm); Itching around area x several days; pain;
Invalid doses delivered to 4 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid doses delivered to 4 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid doses delivered to 4 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid doses delivered to 4 patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Left side of face swelled; Cough; Cold; Migraine; Chills; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), SWELLING FACE (Left side of face swelled), COUGH (Cough), NASOPHARYNGITIS (Cold) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating), COUGH (Cough), NASOPHARYNGITIS (Cold), CHILLS (Chills) and MIGRAINE (Migraine). On 03-Sep-2021, the patient experienced SWELLING FACE (Left side of face swelled). On 06-Sep-2021, MIGRAINE (Migraine) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), SWELLING FACE (Left side of face swelled), COUGH (Cough), NASOPHARYNGITIS (Cold) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter denied pregnancy  No concomitant medications reported.  No treatment information was reported by reporter.
10 daya after receiving Moderna vaccine:  60 year old right handed woman with migraine + chronic headaches, nephrolithiasis, who presented to the hospital with expressive aphasia and right facial weakness and was found to have at least to distal left MCA occlusions for which she received IV tPA.  MRI brain shows a small left frontal cortical acute ischemic stroke.  Post tPA ICU course has been notable for angioedema of the tongue now improved. TTE showed PFO. LDL 111, new diagnosis HLD.
I had a fever for 2-3 days and vomited six times over the first day. My blood sugar was in the 400s for two days. I still can?t walk without being dizzy and can barely eat. I have a large srash on my arm. My period started again about a week after my normal period.
On April 12th, she began to notice increasing pain around the right shoulder blade, this rated around to the front of the chest over the next few days.  On April 15th, she noted a rash developing in this region.  She sought evaluation / treatment in the Emergency Department on April 17th, where the vesicular rash was felt to be consistent with shingles.
Occurred 4/12/2023 at approximately 2:15 PM. Administered pt's vaccines in left arm as ordered by provider. Patient tolerated vaccines without any issue. Pt was seated beside his mother as I completed his sibling's finger stick for a capillary lead. As I was collecting blood from sibling's finger, pt got up and walked behind me out of my sightline. Mom reported that pt became very pale, passed out, and hit his head. Patient was laid on exam table and provider was notified and came to room to assess patient. Providers examined patient, patient was provided drink and snack, and remained in office for 15 minutes following initial assessment. On reassessment, patient was feeling much better and had stabilized. Patient was cleared to leave office and provided instructions on signs and symptoms to monitor for and when to seek care.
Pfizer 3/3/21, 3/24/21. Positive on 8/5/22
At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes.  I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.
she already took second vaccine two weeks ago approx. and just had a little of general malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01), administration date: 07Jul2021, for Covid-19 Immunization. The following information was reported: MALAISE (non-serious) with onset Jul2021, outcome "unknown", described as "she already took second vaccine two weeks ago approx. and just had a little of general malaise".  Additional information: It was reported that Caller got the 1st dose of the Pfizer COVID-19 vaccine in on 07Jul2021 where her daughter lives and does not have a schedule for her 2nd dose yet. She was told from people in that she was not allowed to get the 2nd dose and she was confused. Also indicates she already took second vaccine two weeks ago approx. and just had a little of general malaise. Also indicates she already took second vaccine two weeks ago approx. and just had a little of general malaise. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 1st dose of vaccine on 12/31/20 @ 1332.  On 1/14/21 @ 0800, patient reported to Employee Health Nurse that she awoke with a rash around the injection site.  She described the rash as a circular rash around the injection site, with a smaller circle nearly on the injection site.
The patient had a big flare up of Lupus.  She had a little flare up after the 1st dose of the Moderna shot, but after the 2nd dose she has had a larger flare up requiring 2 courses of prednison to help with the flare up.  It has taken about 1 month for the flare ups to be controlled for both doses of the vaccine.  She is feeling better now after getting 2 rounds of prednisone.
NEEDLE RETRACTED AFTER IN ARM  MOST FLUID FELL ON PATIENT ARM. LESS THAN 50% VOLUME ADMINISTERED. PT. REDOSED W/O FURTHER ISSUE
Went to ER on 01/25, diagnosed with Bell's Palsy. Patient was having pain in jaw and terrible headaches.
8 days after my first round my injection site became swollen. I didn?t have any swelling prior. The swollen area is itchy and painful to the touch.
pounding headache,/ bowel issues for 24 hours/ naesous / body aches especially / the lower to middle back pounding for 3.5 days./dehydration
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with five improperly stored doses of ROTATEQ (lot # M031650, expiration date 16-MAR-2018) for prophylaxis (dose and route of administration were not reported). The vaccine was stored between 32°Fahrenheit and 36°Fahrenheit for 40 minutes. There were no previous temperature excursions. No adverse effects were reported. Temperature excursion information was obtained from a digital data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002833: US-009507513-1702USA008690.
46 y/o male presented with palpitation cough weakness. NO fever/CPV/D. NO COVID Exposure. vaccinated.
Case number PHEH2014US025086, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 42-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1455701) intramuscularly at a dose of 0.5 ml on 10 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
The swelling in the upper left arm eventually came down (after 2 weeks), but resulted in a symptom similar to frozen shoulder (from the back of the shoulder down to the elbow.) Cannot raise the left arm and has not healed after 5+ weeks post vaccination.
fatigue and aching/chills mid afternoon the day of the injection, 101.6 degree fever that evening reduced to 99.2 degrees by next morning, headache developing during the evening and lasting through the night, nausea and sporadic stomach and abdominal pain occurring the following morning which recurred for several days, diarrhea and rectal bleeding culminating in clotting 3 days after immunization and scaring me enough to see my nurse practitioner the next day
bloody and mucus stools; bloody and mucus stools; This spontaneous report was received from a physician and refers to a 8-week-old (discrepant information, also reported as 4-month-old) male patient. The patient was delivered via cesarean section however it was challenging to take him out during the process. When the baby was finally delivered, he was dark blue and only had a heart beat. The patient stayed after birth in the neonatal intensive care unit. He had a significant medical history including birth asphyxia, brain damage and seizures. Concomitant therapies were not reported.  On 14-JUN-2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #U037808, expiration date: 26-MAR-2023 (both confirmed to be valid), administered orally for prophylaxis (strength was not provided).  On 15-JUN-2022, also reported as 1 day after the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient experienced bloody and mucus stools (haematochezia). The patient was seen by a pediatric gastroenterologist and no treatment was given. The patent was observed and on 17-JUN-2022, the patient recovered from the events.  The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown.  Upon internal review, the event bloody and mucus stools (haematochezia) was determined to be medically significant.
Bilateral knee pain. Right hip pain. Lower back pain. Neck pain. Right elbow pain left thumb pain. Right wrist pain. Right ankle pain (All previous injuries at these sites in the past)  Tested, rest, stretching, Advil, Tylenol, colchicine, prednisone.  Improved up to 4 hours then returned up until filling vaers today
Patient went down to floor shortly after receiving immunization and complained of dizziness, weakness, face numb and tingly. Patient monitored and when feeling better was sat in a chair. Started feeling anxious again and was laid back down.  Patient was feeling better and sat back down in a chair. Reported numbness in face and tongue but was alert and conversating with friend. After 8 minutes, patient reported feeling better and denied any symptoms.
I had the shot and then I got the shingles/Suspected vaccination failure; Got the 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: 29-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and then got the shingles. The reporter stated that, it was strange. 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 possible as no contact details were available.
Four hours post DTaP vaccination cried more intensely than I had ever heard him cry before.  As he was screaming his body was tense and his arms were raised and stiff.  I tried to nurse but he would not feed.  His temp was normal.  He looked distant and it seemed that he was in intense pain.  His chin was shaking and his arms appeared to jerk simultaneously a few times, similar to Moro reflex.  He screamed for less than 1/2 hour during which time we gave him Infant Tylenol.  He soon calmed down and fell in and out of a restless sleep for a couple hours after which he was back to himself.  His reaction was very acute, but intense.
A physician reported that a 25 year old female received an injection of Pnu-Imune 23 vaccine on 2/24/00 and subsequently, developed a "severe" injections site reaction. The reporter state the injection site "is swollen, red, black and there is muscle atrophy".
an itchy rash; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 12Mar2021 16:00 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was Reported that, Patient stated, got her first dose of the vaccine last Friday, 12Mar, at 4 p.m. (Pfizer). had developed an itchy rash on my upper body that surfaced overnight on Monday and not concerned about it at all but haven't seen anything out there about this being a reaction. Treating it by applying moisturizer. My doctor recommended that I report the rash to Pfizer for your information collection. The patient experienced an itchy rash on 15Mar2021 with outcome of unknown.  Therapeutic measures were taken moisturizer as a result of an itchy rash (rash pruritic).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given Gardasil in error. Patient was to receive Meningococcal vaccine. The Provider asked MA to administer Meningococcal the MA heard Gardasil and administered Gardasil to patient. Patient completed 2 dose series of Gardasil at 12 years old. Pt now has had 3 doses of Gardasil. Reviewed by Medical Director . Pt has not experienced any adverse reaction. No further work up needed.  Education and policy and workflow updates have been updated to prevent this from happening again in the future.
Patient received the Moderna vaccine on 2/2/21 and 3/2/21 so was fully vaccinated when they tested positive for COVID-19 on 9/16/21.
My arm at the injection site got real sore and was  tired for about 24hrs and all subsided within 12-14 hrs after.  And on 1/10 I begin sneezing and got really congested so per my job protocol I had to take a COVID test so on 1/13 the PCR test showed I was positive for COVID
Varicella Information has been received from a physician concerning a 12 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Within the last 6 months" the patient developed a breakthrough case of varicella. Unspecified medical attention was sought. Treatment included either ibuprofen (Motrin) or acetaminophen (Tylenol). No laboratory diagnostic tests were performed. There was not product quality complaint involved. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-DEC-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. Upon being vaccinated, the patient experienced a pain and burning sensation throughout her arms and fingertips. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster and severe complications. Several days post-inoculation, the patient broke out in a painful vesicular outbreak. On or about 08-AUG-2016, the patient was admitted to the hospital for symptoms of a blistering rash and severe illness, which was diagnosed as severe herpes zoster, or shingles. The patient was hospitalized for a period of three days for the severity of her symptoms. She was prescribed valacyclovir and gabapentin for management of her painful symptoms and chronic pain. She suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX, 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 ZOSTAVAX did not prevent shingles and the painful vesicular outbreak/persistent strain of herpes zoster was unknown. The outcome of herpes zoster and severe complications/shingles is not recovered. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 08-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
This spontaneous report as received from consumer's wife regarding her husband of unknown age. The patient's concurrent condition included allergy to penicillin. On 09-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose/frequency: 1 single shot) intramuscularly. Concomitant medications were unspecified by reporter. On an unknown date in January 2015, the patient's muscle at the injected arm was sore. No treatment was given for the event. Action taken with ZOSTAVAX was not reported. The outcome of the event was reported as not recovered/not resolved. The causal relationship between event and ZOSTAVAX was unknown. No further information was reported. This case# 1501USA008040 is linked to the case # 1501USA008948 via same reporter link. Additional information has been requested.
Swollen lymph nodes around collarbone and neck developed day two of second dose, they are still swollen and painful 4/5/2021. Very ill with high fever, dizziness for 5 days after second shot.
Shortness of breath, tired, elevated blood pressure, no appetite, upset stomach, nausiated, blood blister in groin area. soreness in groin area, overall feel bad.
pt presents with copd exacerbation, hypoxia, and covid. pt treated with steriod and breathing treatments.  pt discharged home
HYPOTENSION CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 12/13/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Mom came for 4 months immunizations and reported that after pt received his 2 month immunizations 2 days later she noticed his right leg had lost a roll line and that he was not bearing an equal amount of weight on that leg.