chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 03-MAR-2014, at 13:15, the 23 year old female patient was vaccinated with the first dose of GARDASIL (lot # H020848, exp. 03-APR-2015) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Red rash that is very itchy; It has spread a bit and it is a skin reaction; It is itchy and warm to the touch; It is itchy and warm to the touch; large red swollen reaction at the injection site; large red swollen reaction at the injection site; swelling in her left side of the lymph node in her mouth and throat; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red rash that is very itchy), SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch) and INJECTION SITE SWELLING (large red swollen reaction at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (had many of her lymph nodes removed on that side).   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH PRURITIC (Red rash that is very itchy), SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch), INJECTION SITE SWELLING (large red swollen reaction at the injection site), INJECTION SITE ERYTHEMA (large red swollen reaction at the injection site) and LYMPHADENOPATHY (swelling in her left side of the lymph node in her mouth and throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Red rash that is very itchy) had resolved and SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch), INJECTION SITE SWELLING (large red swollen reaction at the injection site), INJECTION SITE ERYTHEMA (large red swollen reaction at the injection site) and LYMPHADENOPATHY (swelling in her left side of the lymph node in her mouth and throat) outcome was unknown.            No concomitant medication was reported.  The patient informed everything was fine. Rash disappeared.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Additional information : added patient demographics, medical history, dose start date, additional event(s) On 14-Jul-2021: Follow up received via email contains significant information of outcome of an event (rash)
Developed fever and malaise for 2 days post injection - and another 3 days before feeling "well again".
Severe body aches; headache; nausea; fatigue; severe injection site pain.  Resolved after approx 20 hours.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 15-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient with stomatitis and vaginal mucositis beginning one week after each of her first two Gardasil injections.
Pt received his first dose of Pfizer on 8/11/21 and was schedule for his second dose on 8/25/21.  Pt arrived to the clinical on 8/25/21, and LVN administered the second dose of Pfizer.  The medication administration error occurred as the patient received his second dose 14 days apart instead of 21 days. The patient remained asymptomatic during is observation.  Patient informed of the mistake and advised to monitor for signs and symptoms. Patient denies any symptoms and stated he "felt fine". Provided patient with the Pfizer fact sheet and a contact number.
pt recvd vax; pt cried for 6 hrs inconsolably; pt had inc t of 102 R; was fussy for 72 hrs;
10-16 hours after (4/7): insomnia, confusion due to all-over body pain (myalgias, arthralgias), occasional stabbing abdominal pain and lung/back pain 16-30 hours after (4/7): increasing fever to 3.5 F over normal temperature with continued all-over severe pain including eye pain about 20 hours after (4/7): diarrhea (same thing happened with shot #1 at same timing) 16-50 hours after (4/7-4/8): loss of appetite 24-40 hours after (4/7-4/8): increasing headache with increasing nausea, borderline migraine 24-30 hours after (4/7): rapid (resting) heart rate days 3-5 (4/9-4/11): fatigue, light-headedness days 2-3: pain around injection site radiating up through neck and jaw day 3 onwards (continuing): axillary lymph nodes around injection site sore/tender  The outcome was that I couldn't work for 2 days and couldn't sleep the first night due to all-over pain.
pt recvd vax & devel a possible neurological problem following vax; In f/u nurse reported that pt did not have any info regarding pt w/an adverse react;
01/02/22 presented to ED for "Weakness" "facial numbness ". PMHx of "multiple recent CVA"
recently had eye surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 3 (booster), single (Lot number: GJ3375) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "discomfort in his arm"; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "discomfort in his arm". The following information was reported: EYE OPERATION (medically significant), outcome "unknown", described as "recently had eye surgery".  Clinical course:  As per agent and confirmed by caller, caller is trying to figure out if the Pfizer covid vaccine he received was the vaccine for omicron. Agent provides lot # GJ3375. States someone suggested it wasnt the vaccine for Omicron but he didnt follow up. Caller clarifies details : he received a third dose of Pfizer covid vaccine on 25Oct2022. He thought he was getting the omicron vaccine as he heard on the news that it was available.  States he is in his mid 80s and recently had eye surgery. Caller unable to read information on his vaccination card upon request for information on the card.  Also states he felt no reaction whatsoever after he received the pfizer covid vaccine whereas with the first 2 covid 19 vaccine doses, he experienced discomfort in his arm for several days. States he is confused why he didnt experience any reactions with his last vaccine- he is wondering if he received a placebo.
One week after receiving vaccine I became sick with fever, body aches, and itchy rash on my back
Intense pain in left arm during vaccination. Pain and weakness in left arm started immediately. Loss of mobility in left arm - not able to raise arm past shoulder height.
Pt recv vax on 11/19/98; on 11/20/98 pt exp long red area at vax site, itching of entire body; tx=Benadryl; pt imp 1- 2 wk
SWELLING OF ARM, RED, HOT, PAINFUL, PATCH.  FEVER OF 100-101 DEGREES F FOR ONE NIGHT WITH SEVERE HEADACHE.  GENERAL MALAISE FOR 4 DAYS AFTER SEVERE REACTION.
After receiving the vaccinations, the patient was hospitalized for six days.  The patient's symptoms included vomiting, diarrhea, fever. 5/7/09 - Hosp records received. DOS 1/26/09 to 2/2/09. FINAL DIAGNOSIS: AGE, dehydration Admitted to PICU, multiple episodes of daily emesis and frequent watery stools. Fever. Metabolic acidosis. Possible post-diarrheal lactose intolerance. Physiologic anemia. Gradual improvement. Generally well appearing infant with PE WNL.  To be followed by PMD.  5/20/09 - Addnl hosp records received DOS 1/26/09 to 2/2/09. FINAL DIAGNOSIS: vomiting and diarrhea POST Vaccination: Presented at ED with nausea, vomiting, fever and diarrhea. Dehydrated. Fussy. Low bicarb.
6cm area of swelling & redness w/very dense redness int he central 2cm area around HIB vax; sx noted 13MAR93 1040AM appt; no treatment prescribed;
Pt saw sign for covid vaccine and asked for a covid shot. Pharmacist reiterated COVID shot and said the second dose is on may 27 and she said ok. Later when reporting to registry we discovered the fact that patient  already got both doses of pfizer vaccine. informed doctor (talked to MA and she was going to have doctor call the patient)
Mom noticed low-grade fever later in afternoon of vaccination. Fever was followed by panting spells, and baby would stop breathing for 7 seconds. The apnea occurred a few times. Mom also noted perioral cyanosis with one episode and that the baby's chin and lip turned purple while baby was sleeping. Baby then brought to the ER where the apneic spells did not occur but fever reached 101.9. 4/13/07 Received medical records from hospital which reveal patient experienced apneic spells, fever, panting, perioral cyanosis. Admitted 3/15-3/16/07 for observation & no further episodes noted.  FINAL DX: acute life threatening illness; fever.
Pt recvd 3 doses of Hep B vax & was considered a non-converter; recvd 2 additional vax & still has not responded;
The pt developed left arm redness and induration that was 30 mm x 18 mm length. No fever. Mom states the pt had fever several days ago. The redness has doubled in size since onset. Blisters were noted the day before at the redness site. Mom states it is painful to touch. The child yelled when the site was touched.
sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016BZ1A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included INSULIN, LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE, COLECALCIFEROL (VITAMIN D3), ALLOPURINOL, METOPROLOL, GABAPENTIN and METFORMIN for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 12-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.        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.   Treatment includes Tylenol
She received 1st dose of Moderna COVID19 vaccine on 1/20.  At clinic, around 11:00.  Stayed for 30 minute monitoring.  Around 25 min felt tightness in her neck, slight shortness of breath, chest pain, and dizzy.  Described as mild.  Became somewhat worse.  Stood up and was dizzy.  Took BP, was a little higher than usual.  Had some difficulty standing; was advised to go to ED / did not want to go though.  Took benadryl and zyrtec. 30-40 min later felt much better.  4 hours later took some add'l antihistamine.  Still feeling some chest discomfort intermittently, mild dizzy feeling. She went to ED triage area, appearing as mild at that time (d/n check in though).  Went home.  Felt much better overnight.  (then next 1-2 days had body aches, joint pain etc).  symptoms of dizziness, chest tightness, throat tightness after 1st covid vaccine dose (Moderna).  Derm rec NOT to receive 2nd dose and allergy updated
She had COVID-19 infection on January 5. She received Pfizer vaccine 3.28.2021 - er8733 lot. she was feeling well prior to the vaccine with no seasonal allergy symptoms. No nasal congestion or itchy eyes. No NSAIDs the day of vaccine. Tired 20 minutes later. She woke up 4 hour later with fever 101. Took Tylenol 5-6 hours later. No ocular swelling at that time. had some nausea that evening and some abdominal pain. No muscle pain. Some chest tightness that evening. The next miring was very hot and nauseated and then vomited. Two days later swelling around eyes, not too itchy. Swelling was more severe in April 4. the swelling is slightly improved over the last week. On April 4, antecubutal fossa were itchy and red. lasted 1-2 days. No runny nose, sneezing or itching. Low grade fever lasted 1 hour. fatigue lasted a few days. No muscle or GI symptoms. No NSAIDs, but Tylenol initially. no sore throat. No mucous membrane involvement. No leg swelling. No change in urine output. No joint pain. No headache. No vision change. No bleeding gums. No hives. No enlarged lymph nodes. No SOB. No chest pain. No change in bowel habits. Energy level good. No night sweats. SAR symptoms well controlled. Mild swelling at left arm injection sight that lasted 1 day. swelling is worse in the AM when waking up; both upper and lower eyelids.
Patient felt dizzy and started to sweat. I advise patient to lay down and give him cold compress. I check his blood pressure and it was low . i observe him and call 911. After while he was feeling good and EMS checked and he was doing fine. He left after 45 minutes and he was feeling fine.
Screaming. A nurse reported a pt received Prevnar and IPOL on 3/5/01. The reporter indicated that Prevnar was administered as a split dose. That same day, the infant developed crying and irritability. The crying and irritability resolved in 24 hrs. On 3/7/01 she was screaming for several hrs. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL.
Within several weeks after receiving the Pfizer Booster #1, I began experiencing shoulder pain and radiating/ tingling sensation in my right arm at the site of the vaccination.   Because I was taking Ibuprofen on a regular basis to try to control discomfort, I made appt to see the doctor in Feb. 2022 to discuss intermittent shoulder area pain and tingling/radiating sensation in upper right arm at the site of my booster vaccination and asked if it could be a related to vaccination. MD prescribed muscle relaxant (Cyclobenzaprine 5mg).    Shoulder area discomfort and tingling/radiating sensation continue to today.  I use Ibuprofen and generic naproxen to help with discomfort.  I did not have a reaction when I received Pfizer Covid 1 and 2 vaccinations.  I have not received Booster 2 because of my concern of possible additional side effects.
JOINT PAINS, CHILLS, MALAISE  Narrative: STATES SX LASTED BOUT 30  HOURS. NO FEVER.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored MMR II lot # K016154 and expiration date on 24-SEP-2016, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache; chills; muscle aches; fatigue; hot flashes without fever; rash at injection site.
Myalgia, Arthralgia, Fever, INSOMNIA AND SEVERE CHILLS/RIGORS Narrative:
Patient's last Covid shot, before a booster 11/17/2021, was given to him Feb. 18, 2021.  In June, he complained about pain in his back, in his feet on both legs.  He was taken to the Dr's office  twice in late June due to chronic complaints.  The first time, nothing was discovered.  On 6/23/2021, a Dr. identified the problem and quickly made arrangements to send patient to the emergency hospital near-by.  He was diagnoised with Deep Vein Thrombosis and put on Prodaxa twice a day.  He is still on the Prodaxa because no specific incident seemed to trigger the blood clots in his feet and legs.  After 3 months he is still on Prodaxa because the amount of good it is doing at this time,and its ability to possibly prevent a stroke are about equal.  The Dr. seems to think the incident of blood clots (6/2022) is too far after the second Moderna shot (2/2021) to be linked. But I think there is a possible cause and effect.  He never had a blood clot before!
Parathesia to injection arm. Immediately after the shot arm was warm and tingly. Involuntary muscle twitching noted. On 1/15 chilled pinprick sensation began from fingertips to shoulder. Progressively worsened with pinprick sensations occurring in random location to LUE once per minute. Occasional pinprick sensations noted to RUE, LLE, and RLE occurring approximately once every few hours. Symptoms continue today (1/27) but have not worsened in severity to this date.
On 4-1-21 at 7 PM out of no where I developed what Was determined later as a migraine.  I thought I was having an aneurysm, it was excruciating  !  My BP at home was 180/XX  , we called an ambulance and off to the Er  I went. My BP became elevated to 205/xx
pt recv vax 22JUL97 & 9AUG97 pt devel 9 varicella lesions on trunk & extremities;
This is a spontaneous report from a contactable physician.  A 6 month old male patient received TRUMENBA (Lot Number: T52805, Expiry date: Aug2019, NDC number: 0005-0100-01) intramuscular in the left thigh at 0.5 ml single dose on 02Jan2019 at 09:00 for immunisation. The patient medical history none. The patient had no concomitant medications. The patient previously took PENTACEL (Sanofi, Lot number: UI969AB) IM in the left thigh on 19Dec2018, ROTATEQ (Merck, Lot number: RQ156Q7), oral on 19Dec2018, FLUZONE (Sanofi, Lot number: UT6315RA), IM in the right thigh on 19Dec2018. On 02Jan2019, the patient inadvertently received a dose of TRUMENBA / was given product by mistake. The reporter queried what safety concerns should be on the lookout for. Reporter clarified the patient was scheduled to receive PREVNAR but he ended up not getting it because he was given the TRUMENBA by mistake. Upon follow-up on 23Jan2019, it was reported that patient experienced fever following vaccine: T 101.1 in office/ 102.3 at home. Patient received MOTRIN orally on 03Jan2019 for fever. Follow-up (02Jan2019): New information obtained from a contactable physician includes: Patient's details, event details, date of adverse event, TRUMENBA Lot number and expiry date, no concomitant and medical history. No follow-up attempts are needed. No further information is expected. Follow-up (23Jan2019): New information received from a contactable physician in response to HCP letter includes: suspect drug detail (dose, route, time of vaccination, anatomical location), past drug medications (PENTACEL, ROTATEQ, FLUZONE), new adverse event (fever).
This spontaneous report as received from a pharmacist refers to a 77 year old patient. On 18-FEB-2013 the patient was vaccinated with ZOSTAVAX vial (lot number and expiry date, dose unknown), subcutaneously for unknown indication. It was reported that physician prescribed ZOSTAVAX on two separate occasions over the past year, and the patient received ZOSTAVAX on 18FEB-2013 and 21-DEC-2013. No adverse effect has been reported. It was reported that patient haven't sought medical attention. The outcome of event was unknown. Additional information has been requested.
Swollen/sore armpit area on side of injection (right). Same side arm feels tingly as if having just ?woken up? or as if it?s been held upside down and blood has rushed to it.
Body aches, chills and fever from around 8:30 pm 12/24/20 until around 10:00 am on 12/25/20.  Injection site pain for 3 days. Fatigue for 48 hours after injection.
I started a menstrual cycle 3 weeks/2/20/21 after my first injection, lasted 8 days. 2nd injection on 2/27/21 and had another menstrual cycle on March 24th ended on March 30th and a 3rd cycle started on April 1, 2021 and ended 4/14/21.  I'm 66 years old and my last regular menstrual cycle was when I was 51 yrs old.
Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; very fatigued; Constant headache that only minimizes with ibuprofen; Headache caused sleepless nights; Pressure in my eyes and face; Pressure in my eyes and face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 14:15 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 23Nov2021 14:15, outcome "not recovered" and all described as "Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea."; FATIGUE (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "very fatigued"; HEADACHE (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "Constant headache that only minimizes with ibuprofen"; INSOMNIA (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "Headache caused sleepless nights"; FACIAL DISCOMFORT (non-serious), OCULAR DISCOMFORT (non-serious) all with onset 23Nov2021 14:15, outcome "not recovered" and all described as "Pressure in my eyes and face". Therapeutic measures were not taken as a result of vaccination site pain, neck pain, arthralgia, dizziness, nausea, fatigue, insomnia, facial discomfort, ocular discomfort. Therapeutic measures were taken as a result of headache.  Additional information: No covid prior the vaccination and no covid tested post vaccination. Patient did not have known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.