chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible itching; swelling of face, eyes, lip; Huge hives/hives turn to deep purple marks on skin; swelling of face, eyes, lip; swelling of face, eyes, lip; Huge hives/hives turn to deep purple marks on skin; severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip) and LIP SWELLING (swelling of face, eyes, lip) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031914) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu on 25-Oct-2023. Past adverse reactions to the above products included No adverse event with flu. Concurrent medical conditions included Multiple myeloma and Orthostatic hypotension.    On 25-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 05-Nov-2023, the patient experienced PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip), LIP SWELLING (swelling of face, eyes, lip), URTICARIA (Huge hives/hives turn to deep purple marks on skin) and ARTHRALGIA (severe joint pain). The patient was treated with PREDNISONE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE at an unspecified dose and frequency; MORPHINE at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip), LIP SWELLING (swelling of face, eyes, lip), URTICARIA (Huge hives/hives turn to deep purple marks on skin) and ARTHRALGIA (severe joint pain) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. On first ER visit: Prednisone, benedryl, famododine, IV fluids, second ER visit Morphine, Torodol, Benedryl, famodidine, decadron, IV fluids and sent home on 60 mg of prednisone, 25 mg hydroxizine, 40 mg famododine.
Shaking from being cold.   Chills, left ear pain, nausea, very tired and rundown fir 3 days afterwards.  Couldn?t eat for / days afterwards.  Bad dry cough still persists now 2 weeks later.      Took Tylenol  nothing helps the dry cough
Patient was suppose to get a dose of VAQTA and was given RECOMBIV AX HB; This spontaneous report was received from a registered nurse and refers to a 15-month-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 27-AUG-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 0.5 milliliter, via subcutaneous (reported as SUB Q) route (lot# 4CL44 upon internal review was established as invalid for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date was reported as 24-JAN-2022) (dose number, anatomical location of administration were not reported) for prophylaxis. The patient was suppose to receive a dose of hepatitis A Vaccine, Inactivated (VAQTA).
24 hours of chills, severe body aches, nausea, flare up of RA, fatigue
severly ill; fever; achy; flu like symptoms; severe weakness; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 03Feb2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On 04feb2021 the day after vaccination the patient became severly ill including 14.7F fever, achy, flu like symptoms, severe weakness. He was treated with Tylenol but didn't respond. He did not go to the hospital. He called to see if he should receive the second dose scheduled for the 25Feb2021. Therapeutic measures were taken for the events. Outcome of the events was unknown.
A nurse reported that an 85 year old male received his 2nd dose of Pnu-Imune 23 on 4/3/01. Within 48 hours, he developed an injection site reaction characterized by redness and swelling which extended to his elbow. The pt was treated "symptomatically" and he recovered. No further information was available at the date of this report. MANUFACTURER'S COMMENT: This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 470592. See related HQ9390306APR2001. FOLLOW-UP information was received from the nurse on 07/13/01. The reporter indicated that the patient was unable to sleep for two night due to discomfort.the reporter noted that a third patient from this facility developed an injection site reaction following receipt of Pnu-imune 23, lot number 470-592. See related case HQ3493419JUL2001.
Hives on breast, under arms. Uticaria, swollen sides purple dots on sides. itchyness
Redness and itching at injection site. "Nickel Sized" . No treatment or further Sx
Hot to touch. Swollen raised 1/4 inch area 2 1/2-3" around.
Redness, swelling, joint stiffness, myalgia, pain in shoulder/wrist/elbow joints.
Case number PHEH2013US025374 is an initial spontaneous report received from a nurse on 06 DEC 2013. This report refers to a patient of unknown age and gender. This patient was given only Men A component of MENVEO (batch number: unknown) intramuscularly, reconstituted with sterile water instead of Men CYW component on an undetermined date. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
extreme and constant joint pain in both hands  (New, not experienced before shots) slight fever (normal is 97.3)  98.5 neuropathy spots on legs and hands excelled heart rate headache
Patient has a lot of pain in arm and was unable to move it freely. Patient went to see MD and he gave her a CORTISONE shot in her arm to help loosen it up. Patient said she started to feel a little better but is still in pain.
Patient became very fussy during the evening and then continued to cry every 30-45 mins in his sleep every night for the next 5 nights.  During the day, he was fussy and didn't smile, I couldn't put him down.  He was clinging to me, when I did put him down. He just cried and fussed until I picked him back up. He is typically a very good natured baby, he had a double ear infection and never ran a fever a couple months back.... he even ruptured the ear drum and never acted sick. I just happened to notice stuff in his ear and immediately took him to doctors and he was sick.  No clue how long he was that way.  He never cries and always sleeps 12 hrs a night without waking up.  I know something was not right.... took him back to docs on Saturday and CBC showed viral infection.  I asked about this being related to the vaccine. I was told that they had never seen this kind of reaction so not likely. On 3/17/2015, he was still not feeling well, them woke up from his nap at 6:30pm with 102.5 fever and I immediately took him to ER.  He was tested for flu, strep, rsv..  urine sample taken and chest Xray.  All negative.  He had small red dots on chest and doc at ER said just viral and follow up with regular doc.  Finally, patient slept that night from 2am til 11:30am.  He was asleep on me, so I called his doc after we woke up.  No appts available, which was yesterday.  He was finally seen by them again today.  CBC and strep and mono test.  CBC still shows viral infection and strep and mono are negative. Most red dots are gone now.  Low grade fever intermittent since it spiked on 3/17/15. He is not as fussy, but still not his unusually good natured happy self.  He still won't let me put him down most times.
78 y/o woman from home with BMI of 28, history of hypertension, T2DM ( a1c of 8.5 as of 12/12), HLP, CAD/MI s/p PCI/stent, and glaucoma, who presented on 12/11 with worsening shortness of breath admitted for acute exertional hypoxemic respiratory failure due to covid-19 pneumonia.    Hospital course:    COVID Pneumonia, Acute hypoxemic Respiratory failure: Symptom onset on 11/30, COVID positive on 12/7. Last fever unknown. CTA on admission no PE, could not rule out subsegmental PE, Ground glass and patchy consolidation bilateral upper, mid and lower lung regions, left greater than right. She completed 10 days of decadron on 12/19 and 5 days of remdesivir on 12/14. She was on RA at rest and hypoxic to 84% on RA which improved by the time she completed steroids. She is hypoxic to 87-88% with ambulation and only requires 1-2L. She was on lovenox 40 mg SQ daily got DVT PPx. She is being discharged on home O2 1-2L on ambulation to keep O2 above 92%.    Poorly controlled T2DM: now off decadron. Resume PTA metformin.    History of HTN/HLP: continue PTA asa and lovastatin. On reduced dose PTA blood pressure meds of MTP 50 mg bid ( 100 mg bid) amlodipine 5 mg daily ( 10 mg daily) and lisinopril 10 mg daily (PTA prinzide 40), please adjust as blood pressure increases.    History of glaucoma: continue PTA eye drops   Primary Procedures:      Secondary Procedures: CTA chest    Reason for Hospital Admission (Admitting Diagnosis):  Covid pneumonia and hypoxemic respiratory failure.
After 1 week of receiving vaccine patient experienced fatigue, headaches, lymphadenopathy, liable blood pressure - both hypertension and hypotension, 1 episode of syncope due to hypotension, nausea, joint pain, muscle aches, brain fog, numbness and tingling to bilateral upper and lower extremities, decreased libido. Symptoms have been constant and unchanged/not improving x 6 weeks.
This spontaneous reports as received from a nurse refers to an unspecified number of patients. In 2015 (reported as K010325, expiration date reported as 10-MAY-2016, batch/lot # K007244, expiration date 16-MAR-2016, batch/lot # reported as L000434, expiration date reported as 10-JUL-2016 that had been exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested. Additional information has been requested.
body aches; headache; nausea; vomiting; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "laryngitis" (unspecified if ongoing), notes: for about a month and the patient was seeking treatment. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 01Mar2021, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 01Mar2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 01Mar2021, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset 01Mar2021, outcome "unknown", described as "vomiting".  Additional information: The patient wanted to know if it's "normal" for side effects to begin almost a week after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has experienced redness, and continued warmth and swelling since vaccination has been given. Patient just reported to this office today (01/30/18). Patient away at school. Advised to seek treatment at Student Health.
My ears began to itch towards the end of February or early March 2023. My right ear itches about three times more than the left. I went to the walk-in clinic on March 30th. The itch occurs on the inner ear area, and I use water drops or cotton ball to help. There was a physical exam of my ear, and nothing was found. The prescription I was given for Flonase was over the counter. I was advised to take my allergy medication. Neither of those worked and I went back using the salt-water solution to help. I have an ENT appointment on April 20, 2023. At this time, I have not felt pain and there has not been any discharge.
Patient received a 2nd dose of Moderna. Moderna is not approved for patients under 18.
CLIENT VACCINATED ON TUESDAY. ON WEDNESDAY CLIENT NOTICED SOME SLIGHT NUMBNESS IN THE LEFT ARM, ARMPIT AREA, SIDE OF THE BREAST. ON THURSDAY MORNING CLIENT REPORTS "VERY NUMB", SLIGHTLY PAINFUL AND TENDER. NO CHANGE IN PHYSICAL APPEARANCE BUT DOES FEELS SWOLLEN BY THE TOUCH. LEFT HAND WAS SWOLLEN IN JOINTS, AND WAS TENDER. CLIENTS REPORTS SOME ARTHRITIS. IMPROVEMENT OF ARM THE NEXT DAY. CLIENT WILL SEEK MEDICAL ADVICE IF SYMPTOMS WORSEN OR DO NOT IMPROVE. RECOMMENDED TO SPEAK WITH ONCOLOGIST TO SEE IF OTHER CLIENTS WITH BREAST CANCER AND HX OF DOUBLE MASTECTOMY HAVE NOTICED ANY REPORTS IN OTHER PATIENTS.
Patient was hyperventilating, shaking and she said her arm was tingling, called EMS they checked her vitals was okay when they arrived probably 10 min later and patient refused to go to the hospital
Information has been received from a physician concerning a 4 month old male who on unspecified dates were vaccinated with ROTATEQ vaccine live (human-bovine) at his 2 month and 4 month check up visits. It was noted that at the two month check up visit the patient vomited and was re-dosed. It was also noted that at the four month visit the patient received another dose of ROTATEQ vaccine live (human-bovine) and vomited again, but was not re-dosed. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. No further information is available.
On Monday evening 06/24 pt "felt hot" and had unconsolable crying all evening and most of day on Tuesday 06/25. Came to the county today for business and brought him by to be checked. Temp 106 rectally upon arrival. Motrin given in one hour, temp had decreased to 101.
herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 15-APR-2009, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a medical clinic by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, the patient was treated by a physician for herpes zoster. As a direct and proximate result of patient's use of the Zoster Vaccine Live(ZOSTAVAX) vaccine, patient would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (on unspecified dates), physician care, monitoring, treatment, medications, and supplies. At the time of report, the patient was not recovered from herpes zoster. The reporter considered the adverse events to be related to Zoster Vaccine Live(ZOSTAVAX).
Fever, chills, headache, severe body aches, very swollen arm and redness in vaccinated arm
Fluzone HD administered to 4 year-old boy, no AE; Fluzone HD administered to 4 year-old boy, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a health-care professional (nurse) via phone.  This case is linked with 2019SA307288.   This case involves a 4-years male patient, who was vaccinated with a dose of INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE), (Batch number: UJ287AA and expiration date: 28-MAY-2020 at a dose of 0.5 ml via Intramuscular in Left Vastus Lateralis on 01-Nov-2019.  The patient medical history and concomitant medications were not reported.  It was the case of inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021. No treatment medication was reported.
This spontaneous report was received from a 71 year old female patient refers to herself. In fall 2011 the patient was vaccinated with ZOSTAVAX injection (dose unknown) for prevention for shingles. Concomitant therapies included baby aspirin and amlodipine besylate, CADUET. In early July 2013, patient began experiencing intense pain that prompted a Physician visit. The cause of pain was undetermined initially until the Shingles rash presented about one week later. This rash was concentrated on the left side torso area and extended onto abdomen and back. The patient was treated with sulfamethoxazole, BACTRIM, pain pills including PERCOCET and TYLENOL with codeine. At time of call the patient reported that her condition had improved and only residual tiredness remained (the patient was recovering). Additional information has been requested.
Dizzy, shakiness, and lightheaded... at 4:28pm. Full body flush, body tingling, heart racing, chest tightness, nose/lips/tongue started burning and feeling numb... all at 4:38pm. Benadryl taken at 4:55pm. Symptoms lessened... except chest tightness, burning in face/tongue, shakiness/dizziness remained.... 5:03 pm. Rest of symptoms have gone away. 5:10pm. Current time during this form is 5:22pm and patient feels fine and completely okay now. Just tired.
Patient developed mild fever on Wednesday 7/28/04. T 99.8-100 degrees. Developed hives on Thursday 7/29/04 involving chest, shoulders, back of neck, under arms. Left arm reddened and slightly swollen.
I tested positive for Covid 19 on October 17, 2022 my symptoms are headaches, mild sinus congestion, sneezing.
After vaccines were administered the patient was given a juice box and escorted to front lobby to wait 10-15 before leaving the clinic. I noticed 14 mins after given the vaccine she was grabbing her throat and drooling from her mouth. She stated that " I don't feel right" and then said "Iam dizzy" she appeared to have troubles swallowing. She was quickly escorted back to exam room where she went unresponsive. B/p 70/62 P 98 R 9 O2 sat 68. EPI pen was administered and 911 called. Patient was transported to Local ER .
Patient presented to get a Moderna COVID booster. The patient should have been given the bivalent Moderna booster, but was administered the monovalent Moderna booster. According to CDC guidelines, the dose should generally should not be repeated, but the patient is able to get the bivalent booster after two months if she desires.
nausea, tightness in chest. No SOB or tightness in throat. pt reported chills/shivering. Temp 99.0F was given oxygen at 2L. symptoms subsided within 20 minutes after close monitoring
Muscle aches and pains, 11/05/09 vomiting & diarrhea 11/06/09 headache.
Client reported feeling dizzy within a few minutes of vaccination. Her face flushed and she had a rash on her arms. Vitals remained stable. EMS was called, however client refused transport. Clients symptoms resolved without treatment.
rash and swelling at site-warm to touch-slight itch-size of rash was 4inches by 6 inches. Rash occurred 10 days after vaccination date
I experienced dizziness on 4/5-4/6 and then ringing in my ears on April 6 for over an hour that evening,  and it has continued ever since. It comes and goes at various times throughout the day and evening.
Pain in my chest ,swollen throat, light headed, dizzy, shortness of breath. sick for a week steroids, fluids
The pt's right arm was swollen and red and she was given Keflex antibiotics.