chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash appears on bilateral arms about 45 min after injections given.  Benadryl, Claritin and pepcid taken but hives became bigger and more itchy.  Steroid shot given at urgent care  3 days later
This spontaneous report was received from a nurse refers to a 20 year old female patient without drug reactions, allergies and medical history. In 2005 the patient was vaccinated with VARIVAX (Merck) 0.5mL, dose 1, subcutaneously. On 14-JUL-2014 the patient was vaccinated with VARIVAX (Merck) 0.5mL, dose 2, intramuscular. There was no concomitant medication. On 14-JUL-2014 the patient experienced brief stinging sensation at the injection site after administration of her second dose of VARIVAX (Merck). The patient sought medical attention and did not receive any treatment for the adverse event. There were not laboratory diagnostics performed. The outcome of brief stinging sensation at the injection site was reported as recovered/resolved on 14-JUL-2014. Additional information has been requested.
Information has been received from an RN concerning a teething 13 month old Caucasian female with no known allergies and no past medical history who on 2/21/02 was vaccinated with the 1st dose of MMRII (lot 635180/0737L), SC, in the right vastus lateralis. Concomitant therapy that day included the 3rd dose of Hib + Hep-b (lot 634237/0289K), IM, in the right vastus lateralis, the 1st dose of varicella (lot 641151/1181L), SC, in the left vastus lateralis and the 4th dose of DPT, IM, in the left vastus lateralis. It was noted that the vaccinations were administered between 09:30 AM and 11:30 AM. There was no illness at the time of vaccination. On 2/22/02, in the AM, the pt's mother reported to the nurse, that her daughter developed a rash described as non-raised, "blotchy red, with white skin in between". It was noted that the pt was afebrile. The pt sought unspecified medical attention. The rash was completely resolved by the time the pt was seen in the physician's office on 2/25/02. Follow-up information reported that the symptoms resolved in approx. 1 day. No further info is expected.
pt recv vax & 5 hrs later devel a high fever, drowsiness, h/a & muscle aches;
About 1 week after receiving flu shot pt became very sick, went to MD and diagnosed with a severe case of Shingles. Possibly due to flu shot affecting resistance.
C/o numbness tongue, right eye tearing, facial droop, loss of taste, ear pain left side.
This spontaneous prospective pregnancy report was received from a nurse practitioner concerning her approximately 23 year old daughter with no pertinent medical history. Current conditions of the patient included CECLOR allergy and amoxicillin allergy. Approximately on 07-MAY-2013 (reported as on 07-MAY-2013 or 08-MAY-2013), the patient was vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously. There was no concomitant medication. On 13-MAY-2013, the patient discovered that she was pregnant and was followed in an unspecified prenatal clinic. The patient was easily upset. Pregnancy test was performed at home and in clinic. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. Approximately on an unknown date in May 2013, the patient experienced local reaction where injection site was red and the size of a half dollar and painful. The patient did not seek any medical attention. Ice was applied to local reaction. Outcome of the events was unknown. The relatedness for the event was unknown for VARIVAX (Merck). The patient had received an unspecified varicella vaccine at age 4 and had mild case of chicken pox 2 year later that started and ended in one day. Additional information has been requested.
swollen liver/his liver was swelled up; his liver swelled up and was in pain; This spontaneous case was reported by a consumer and describes the occurrence of HEPATOMEGALY (swollen liver/his liver was swelled up) and HEPATIC PAIN (his liver swelled up and was in pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. W2621A) for COVID-19 vaccination.     Concurrent medical conditions included Hepatitis C. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for COPD and Asthma, GABAPENTIN for Nerve pain, MILK THISTLE [SILYBUM MARIANUM], SIMVASTATIN, DUTASTERIDE, TAMSULOSIN, FERROUS GLUCONATE, BACLOFEN, CETIRIZINE and MONTELUKAST for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced HEPATOMEGALY (swollen liver/his liver was swelled up) and HEPATIC PAIN (his liver swelled up and was in pain). At the time of the report, HEPATOMEGALY (swollen liver/his liver was swelled up) and HEPATIC PAIN (his liver swelled up and was in pain) 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.   The patient reported that 2 hours after receiving the vaccine, his liver was swollen and he was in pain for 4-5 days. The patient  reported that the symptoms stopped around the 07JUN2021- 08JUN2021.  The patient  reported that he had liver problems for 10-12 years and  he was diagnosed with Hepatitis C. The patient  was told to quit drinking and had to start taking Milk Thistle.    The patient reported that he had couple of biopsies done and the last one was good. He  reported that his liver function was fine.   No treatment information was provided.
Pt recvd vax & 2 day p/vax devel myalgia, h/a, nausea, dizziness & bilateral swelling in feet; also had weakness in knees & difficulty grasping & holding on to items;
Redness swelling from almost elbow to upper arm. Extreme soreness mild headache. Applied ice packs Tylenol. After 2 weeks still have about a 4-5 inch in diameter red spot and a little swelling
VACCINE GIVEN AT 03:00PM AND PT RETUNRED TO PHARMACY STATING SHE HAD SWELLING IN HER HAND. GAVE THE PT THE OPTION ON BENADRYL AND RECCOMMENDED F/U AT URGENT CARE.
felt unwell; took his oxygen level and it was at 80%; he had swelling; difficulty breathing; tachycardia; allergic reaction; tested Covid-19 positive; blood clots; he got very sick; This is a spontaneous report from a contactable consumer(patient's daughter). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) at the age of 71-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fine and nothing happened until after the vaccine. The patient took the 1st dose on 24Apr2021 and the next day he got very sick, they thought it was just a reaction from the vaccine, then he was swelling said he was not feeling well. The day after the vaccine, the patient was rushed to the emergency room and confined to the ICU. He felt unwell and it got worse and worse, we took his oxygen level and it was at 80%, he had swelling, difficulty breathing and tachycardia. The reporter thought it was an allergic reaction but this morning the patient tested positive for covid, he didn't go out the only time he went out was to get the vaccine. The reporter asked If he didn't know he had covid and got the vaccine, will he get more sick. In the report they found blood clots and the doctors thought it was from the vaccine. He was diagnosed with blood clots and difficulty breathing and he tested Covid-19 positive. Events seriousness criteria reported as hospitalization. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
I felt fine the day of the vaccine.  However the very next day before noon I started feeling very lightheaded and dizzy.  That lightheaded and dizzy feeling has not gone away.  I have never felt this before.
Got flu shot and pneumonia vaccine on Tuesday-- L arm; Started w/ fever on Tuesday night; Noticed some swelling at injection site, redness and pain; Very warm to touch; T 101-103; Last dose of ibuprofen at 1pm today; AM T 102; Has had flu vaccine before w/o issue; No difficulty breathing; On exam, L arm w/ erythema, induration, warmth and tenderness.
PHARMACIST RECEIVED A CALL FROM A NURSE AT HOSPITAL ER TO REPORT PATIENT LOCAL REACTION TO THE VACCINE ON 10/13/17. NURSE STATED THAT PATIENT EXPERIENCE REDNESS AND SWELLING AT THE INJECTION SITE AND IT IS VERY PAINFUL TO TOUCH.
approx 24 hrs p/vax pt felt like was coming down w/flu; on day time woke up w/terrible h/a, eyes were sensitive to light, aching all over, w/fever x 1 wk, head cold w/congestion, no energy, no appetite;
patient requested administration in thigh / he planned to call the patient to schedule administration; patient requested administration in thigh / he planned to call the patient to schedule administration; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and vaccine administered at inappropriate site. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and vaccine administered at inappropriate site were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, they had a patient that only had one arm and he said he did not do well getting vaccines in his only arm. The reporter stated that, the patient requested administration in thigh.  At time of reporting, the Shingrix had not been administered to patient, but the reporter planned to call the patient to schedule administration, which was the circumstance or information capable of leading to medication error and if vaccine administered in thigh region, it would lead to vaccine administration at inappropriate site.
Had tingling in back of head/felt tingling in right bicep; felt shooting pain in left knee replacement; weakness; felt pain in C5 cervical area; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:45 (at the age of 67 years) as dose 1, single for covid-19 immunisation.Medical history included ehlers-danlos syndrome, arthritis, osteoarthritis, Morphine, Prednisone, Cephalexin, Keflex, Cortisone, Sulfa drug hypersensitivity. Concomitant medications included lisinopril, paracetamol (TYLENOL), celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 02Mar2021 15:30 patient experienced tingling in back of head immediately, felt tingling in right bicep where patient had a large rotator tear, felt shooting pain in left knee replacement- felt pain in C5 cervical area- everywhere patient currently having issues patient felt immediate tingling and/or pain. Patient had an Autoimmune disease -Ehlers Danlos and the doctor said patient could get the vaccine with no problem. Once patient left the clinic, stopped at grocery store and felt weakness in lower back and legs but just kept moving. Patient stated It's been 3 hours and having lots of joint pain already. No treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Same lot number as the first one. With this I had a sore shoulder and I had fatigue and I had a fever about 100.5-101. That was not well controlled with Tylenol - still stayed about 100.5. Also had some gastro-intestinal distress - diarrhea. Lasted for about 36 hours. And then my fever went down and I felt pretty good but still experiencing some low grade fatigue and a little congestion which is lingering from first dose. Lingering effects may be from COVID
had the first dose in September 2020 / second dose in December 2020 / doctor said she had shingles/ completed vaccination failure; also had shingles in her eye; doctor said she had shingles; developed swelling and pain on right side of her face; developed swelling and pain on right side of her face; nose and face are numb; The blisters dried up; The blisters dried up, but she still has scars; This case was reported by a consumer via call center representative and described the occurrence of completed vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th May 2021, between 5 and 6 months after receiving Shingrix and between 8 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, facial swelling, facial pain, numbness facial, blister and scar. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles, facial swelling, facial pain, numbness facial, blister and scar were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, facial swelling, facial pain, numbness facial, blister and scar to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix vaccine in left arm in September 2020 and 2nd dose in right arm in December 2020. 3 weeks ago from the day of reporting, the patient developed swelling and pain on right side of her face. Her doctor said that, she had shingles.  The blisters had dried up, but the patient still had scars, her nose and face were numb. The patient also had shingles in her eye and took anti retroviral medication, but had not developed vision problems. The patient was not completely recovered.  The patient could not provide the lot number due to pharmacist writing. This case was considered as completed vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were known at the time of reporting. The reporter consented to follow up.
vision clouded, and it progressed towards the night; This is a spontaneous report from a contactable consumer (patient). A 90-year old female patient (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9261 and Expiration Date 31May2021) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and AFib. The concomitant medications were included apixaban (ELIQUIS) at 5 mg, dofetilide at 250mg, metoprolol at 60 mg for hypertension. Patient mentioned that about 6-7 hours after she received the vaccine on 21Jan2021, her vision clouded, and it progressed towards the night. First it began in right eye and it started it was the time when patient usually retire so she went to bed and when woke up and vision was extremely clouded (both eyes). Patient had the night light on and could not see the night light. She could just see a glow. The morning after, it was gone. She said that she normally has perfect vision and never had this experience before. She says it was not an issue right now since it went away. She wanted to know if she should be concerned and wanted to report this event because it was bothersome and other people might have a similar experience. Not taking second shot if it was going to cause problem; concerned of getting 2nd shot. The outcome of events was recovered on 22Jan2021 without treatment given.  No follow-up attempts are possible. No further information is expected.
She called reporting hives starting yesterday on her chest, this morning it had spread to her neck and face. She is calling her PCP. No throat involvement or difficulty breathing or wwallowing, Advised on when to seek emergency medical intervention.
body aches/body aches and joints persisted for a long time; body aches/body aches and joints persisted for a long time; had nodules in her neck and under her arms for a long time.; had nodules in her neck and under her arms for a long time.; Body aches, headaches, and all kinds of side effects; Was ill for about three months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: 2021, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body aches/body aches and joints persisted for a long time"; NODULE (non-serious), NECK MASS (non-serious) all with onset 2021, outcome "unknown" and all described as "had nodules in her neck and under her arms for a long time."; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Body aches, headaches, and all kinds of side effects"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Was ill for about three months". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller states that she has had 2 of the shots already.  She wanted to get the test before the booster because after the second shot she had nodules in her neck and under her arms for a long time.  She could not have a mammogram for a while.  Her body aches and joints persisted for a long time.  The lot number for bnt162b2 was not provided and will be requested during follow up.
contracted Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (contracted Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced COVID-19 (contracted Covid-19). At the time of the report, COVID-19 (contracted Covid-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated with GARDASIL injection.  Concomitant therapy included MENACTRA.  Subsequently the patient fainted.  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  No further information was provided regarding this adverse experience.  Additional information has been requested.  This is one of several reports from the same source.
Pt broke out with the chicken pox diagnosed by PCP. Spread rapidly throughout her entire body. Very itchy. PCP called in acyclovir to help but was too late. Rx didn't arrive to the pharmacy until 6/12 when patient's condition was subsiding. She did not pick it up.
SUDDEN LOSS OF VISION ACUITY IN LEFT EYE.  LOSS OF ABILITY TO SEE COLOR IN PART OF LEFT EYE. UNABLE TO CORRECT VISION BY LENSES TO BETTER THAN 20/60 VISION.  TREATMENT BEING SOUGHT AT THIS TIME.
Achy sore painful arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD, expiry date 07-DEC-2024) for prophylaxis.   On 01-SEP-2023, the patient received Arexvy (left arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Achy sore painful arm).The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.  It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter stated that a patient received Arexvy in her left arm and developed achy sore and painful arm that had not resolved yet.  The reporter consented to follow up. The case had been linked to US2023133483, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023133483:2nd report
9 month 22D old female presents with c/o Rash for yest woke with rash all over yest AM, spread since.        Flu shot given Friday (11/30), AGE noted 1 wk ago(11/22), Due to have PE Tubes tomorrow. Also, poss. chemical exposure as former trailer had been "bombed" for insects months ago; family went in over this weekend and child was playing on floor.
Per the patient, she reported went home and within hours she states she was vomiting, had diarrhea, felt light headed and was having fevers. She reports she was advised to go to the ER. Per ER note, Pt was instructed to continue drinking fluids, and given 500 ml of saline.
A Moderna Covid-19 vaccine was administered beyond the use date. Moving forward we have clearly labeled all vaccine boxes to represent expiration date. Also, have spoke with staff to pay closer attention to these details so this incident does not occur in the future.
AFTER  MY 1ST COVID VACCINE I WAS COMPLETELY FINE THE REST OF THAT DAY. WHEN I WOKE UP AT 6A THE NEXT MORNING I COULDN'T STAND OR LIFT MY HEAD WITHOUT GOING PALE AND PASSING OUT. THAT SIDE EFFECT LASTED FOR ABOUT 10 HOURS. DURING THAT TIME I HAD THE WORST BODY ACHES AND CHILLS I'VE EVER EXPERIENCED ALONG WITH A HEADACHE. THOSE SIDE EFFECTS LASTED FOR 4 DAYS AND FATIGUE LASTED FOR ANOTHER 3 DAYS. AFTER I THOUGHT I HAD RECOVERED FROM THE VACCINE I NOTICED MY BLOOD SUGAR KEPT DROPPING AND I COULD NOT REGULATE MY BLOOD SUGAR FOR 5 MORE DAYS.  AFTER MY 2ND COVID VACCINE, AGAIN, I WAS FINE THE REST OF THAT DAY. I WOKE UP AT 3A TO USE THE BATHROOM AND THE FAINTING STARTED AGAIN LIKE WITH THE 1ST VACCINE. THAT SIDE EFFECT LASTED FOR ABOUT 10 HOURS. AGAIN, I HAD THE WORST BODY ACHES AND CHILLS BUT NO HEADACHE THIS TIME. THE BODY ACHES, CHILLS, AND FATIGUE LASTED ABOUT 24-36 HOURS AND I DID NOT HAVE THE LOW BLOOD SUGAR ISSUE AS LAST TIME.