chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 01-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 01-MAR-2013 at 9:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 16.50 hours (also reported as 10 hours at -1). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Spotty rash began 4-19 which did include a fever up to 102. Started on antihistamines and/or lotion for itch comfort.
This spontaneous report has been received from a 76 year old male patient and refers to himself. The patient had no drug reactions/allergies. There was no concomitant therapy. In May 2013 (reported as "two years ago"), the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (route of administration, lot#, expiration date not reported). On an unspecified date (reported as a few months ago) the patient had stents put. On 03-MAY-2015 (reported as "about ten days ago, May third or fourth"), the patient began feeling pain on "his head". The patient went to the doctor and was told he had shingles (the shingles rash was located on his head and ear) and his sore was throat. Approximately in May 2015, the patient had had headache for "six days, but it was letting up" at the time of the report. No lab diagnostics studies were performed and the patient was treated for adverse events with valacyclovir 500 mg and prednisone (manufacturer unknown). The outcome of shingles rash located on his head and ear, sore throat and stents put in was not reported. The patient sought medical attention. The relatedness between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
I have a squamous cell carcinoma the size of a grape on my left hand below my thumb, by the palm of my hand; I got my booster shot two weeks ago; I got my booster shot two weeks ago; I got a big welt on my arm.; It was sore for 1.5 weeks; swelling; I get some deep pain in my shoulder under my clavicle and sharp pain in my hip; I get some deep pain in my shoulder under my clavicle and sharp pain in my hip; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the third dose of BNT162B2 via an unspecified route of administration in Sep2021 at the age of 78-year-old as single dose for COVID-19 immunization. Medical history included squamous cell carcinoma on leg in 2019 and on hand in 2016 and malignant neoplasm of central portion of right female breast. Concomitant medication included palbociclib (IBRANCE) for malignant neoplasm of central portion of right female breast. The patient previously received the second dose and the first dose of BNT162B2 both via an unspecified route of administration on an unspecified date at the age of 78-year-old as single dose for COVID-19 immunization. Patient stated "I've been losing track of days" and "I got my booster shot two weeks ago and I got a big welt on my arm. It was sore for 1.5 weeks". Patient stated "Ibrance is a miracle drug" and "it caught it when my cancer marker was 2400 and got it down in a year". Patient stated "On 10Sep my cancer marker was 110 and the month before it was 107". Patient stated "I am not swelling as much anymore" and "I get some deep pain in my shoulder under my clavicle and sharp pain in my hip". Patient stated "I have a squamous cell carcinoma the size of a grape on my left hand below my thumb, by the palm of my hand". Patient stated "I have to have it removed on 14Oct". Patient stated "I had squamous cell carcinoma on my leg in 2019 and on my hand in 2016". Patient stated "I had to have a CT scan on my body" and "I have to have a bone scan". The outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Tenderness in arm; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in left arm on 27Jul2021 at 15:00 (at the age of 28-years old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID) and fish oil (OMEGA 3) pills; both for unknown indications from an unknown start date. The patient previously received minocycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in Jul2021, the patient experienced tenderness in arm. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tenderness in arm was unknown at the time of this report.
Fridge temp out of range 1-9-17. No adverse reaction. Re-vax recommended by clinic.
Since getting both doses of the Moderna ( I got the second one on 4/22/21) my cycles have been irregular not only with when they appear but also the length of them. I had my baby and when I started my cycles up again in October my periods had been on a routine- starting on the second of each month and lasting 6 days and all that changed once I got the vaccine. Nothing else in my life has changed but that.
Within the 5 minutes of the Pfizer vaccine 2nd dose, my son said he felt tired. He was sitting down, I asked him if he was okay, he said "Yes" Then after 3 more minutes total of 8 minutes after the vaccine dose he got up and walked towards me and said he felt like throwing up and he passed out. The pharmacy staff came and gave him fluids and crackers. He was taken to the hospital Emergency room.
Throat feels numb and SOB P-64 R-20 116/76 Transported No EPI given at time
Itching, sore throat, hives, first feet turned red then whole body, head ache, chills later, heat pouring off his body. 50mg Benadryl PO, then Shot of Benadryl from Urgent care doctor.
ErythemaMultiform  TENDERNESS AT INJECTION SITE  Narrative:  RECOMENDED PO BENEDRYL AND ICE
This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 23rd December 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The nurse reported that a 4 month old patient inadvertently received a dose of Kinrix which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Vagal reaction.  Patient was diaphoretic, altered, hypotensive, bradycardic and oxygen sats were in the low 90's.  Patient was responsive but not answering questions appropriately.  911 was activated by myself and Ambulance responded.  They evaluated the patient who's vital signs improved and patient signed a refusal to be transported to the emergency room.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Advil for fever   Reporter did not allow further contact
This case was reported by a healthcare professional and described the occurrence of needle stick injury in a 12-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR II (non-gsk); Merck; unknown; unknown given on 8 March 2010; PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on 8 March 2010; VARIVAX (non-gsk); Merck; unknown; unknown given on 8 March 2010. On 8 March 2010 the subject received unspecified dose of HAVRIX (.5 ml, unknown, left thigh). On 8 March 2010, at the time of the vaccination with HAVRIX, the subject experienced needle stick injury and pharmaceutical product complaint. The sales representative reported the needles that the healthcare professional was using do not seem to lock on the syringe very well, it was detaching from the syringe while the needle was in the subject's leg. The healthcare professional clarified the needle detached from the syringe while in the subject's leg. "The office was not using a Leur-Lok needle; they were using a regular needle. Nothing adverse resulted and the provider administered a different syringe of HAVRIX; the office had already discarded the syringe". On 8 March 2010, the needle stick injury was resolved. Quality Assurance (QA) results were received on 16 March 2010, who considered the complaint as not verified and suspected that this complaint was probably due to a mishandle by the customer. Follow-up information was received on 23 March 2010 via healthcare professional who reported the events were associated with erroneous administration in which the needle may or may not have been locked into the syringe and/or the TipLock on the syringe may have been defective and unable to hold needle correctly.
RECEIVED PHONE CALL TODAY 12/17 FROM RN ON MV UNIT SC08, RN STATED THE PT AND MOM WERE AT THE WENDY'S LOCATION TO RECEIVE HIS SECOND DOSE OF MODERNA.  THE RN NOTICED THE PT WAS UNDER THE RECOMMENDED AGE TO RECEIVE THE MODERNA VACCINE.  INSTRUCTED THE MOM OF THE PT WE FOLLOW THE CDC GUIDELINES FOR VACCINE ADMINISTRATION AND AT THIS TIME THE CDC HAS NOT APPROVED FOR ANYONE UNDER THE AGE OF 18 YEARS OF AGE TO RECEIVE A MODERNA VACCINE.  THE PT HAD NO ISSUES WHEN HE RECEIVED THE FIRST DOSE WHICH IS WHY HE WANTED THE SECOND DOSE.  RN OFFERED TO GIVE THE PT A PFIZER VACCINE HOWEVER, THEY REFUSED AT THIS TIME.
This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered GARDASIL (lot # K010574, expiration date: 18-APR-2017, dose, frequency and route were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. complained of mild itchiness to her throat approximately 14 minutes after receiving her Pfizer COVID19 vaccine. Stated that the itchiness was relieved after drinking water. Requested Benadryl. Upon assessment, no further c/o itchiness, no shortness of breath or respiratory distress. Once RN arrived with injectable Benadryl pt requested oral Benadryl which wasn't available so she declined the injection stating that she will take some PO Benadryl when she gets home. Pt. left the site ambulating without difficulty.
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 16th May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site itching and pruritus. The patient was treated with triamcinolone acetonide, SCALPICIN, prednisone and steroid shot (nos). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site itching and pruritus were unknown. It was unknown if the reporter considered the injection site itching and pruritus to be related to SHINGRIX. Additional details were provided as follows: The itching was intensified at the same points on body and in scalp. The patient realized that effects were tied directly to the shingles vaccine. The dermatologist prescribed Prednisone and that also gave temporary relief during the time the medication was taken but the side effects returned after taking this medication. It had been a little over 5 months since my initial shot and I had experienced no decrease in effects whatsoever. The patient had experienced an adverse reaction to any sort of inoculation. The patient would greatly appreciate any suggestions to overcome these unpleasant and annoying side effects.
Given hepatitis B vaccine at approx 0945, told to wait in waiting room x15 mins.  At 0955 c/o reporting itching of face, chest, arm, diff with swallowing, returned pt to pt room vs taken.  Seen by Dr.  Adm. Benadryl liquid 50mg p.o. at 1000.  At 1020 feeling better.  At 1040 released to return to Institute.
sore arm; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Onset of fever on 6/27/01 in the AM. Dx'd as viral syndrome vs possible reaction to MMR. No treatment except fluids and Tylenol. Did not return to clinic until 7/5/01 with resolution of previous symptoms.
On 10/6/09, this employee received her "Seasonal" Flu shot (FLUVIRIN, Novartis, lot# 98439P1, exp date 6/30/2010) she reported to the me on 10/7/09 that an hour after receiving the vaccine, her face broke out in an rash - no other symptoms - she took Benadryl at night only and HC cream on face. Reported to acting med doctor. Rec Benadryl after or see prescription steroid shot- reported to risk management.
This prospective pregnancy report was received from a registered nurse referring to a 17 year old female patient. The patient's medical history, concurrent condition, drug and allergy history were not reported. The patient's last menstruation period was on 07-APR-2017. On 28-APR-2017, the patient was vaccinated with GARDASIL 9 lot # M0367059, expiration date 06-MAR-2019 (strength, dose, route of administration were not provided) for prophylaxis. The patient's concomitant medication was not reported. The reporter states that the patient had a positive pregnancy test on 15-MAY-2017 (first trimester of exposure), the estimated date of conception (EDC) was on 21-APR-2017, and the estimated date of delivery was on 12-JAN-2018. The pregnancy outcome was not reported. Adverse events were not reported. Additional information has been requested.
My gland is extremely swollen and hard in my neck under my jaw. My gums are super sensitive and hurt.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history and current conditions were not reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Sep-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Soreness, stiffness, limited mobility in arm and shoulder. Feels like joint and muscle pain. It got a little better after a week and is now getting worse. I have tried anti pain and anti inflammatory meds, ice, hot and cold compress.  Nothing helps.
Every joint in my body is hurting started in my pinky, I'm freezing cold down to the bones. Every muscle in my body hurts, feeling very weak and lightheaded, feel dehydrated even though I have drank a few liters of water without voiding much, body in so much pain hard to walk or move.
Mother states that child had a small area under bandaid that was red, warm to touch on 11/09/2010.  The following day the right thigh (location of injection) was swollen, red, and hot to touch.  Patient states that area was itchy.  They came to clinic on 11/11/2010 and area was 8cm across and 6 3/4 cm from top to bottom.  They did not use any type of over the counter treatment. Our treatment was Benadryl elixir and cool compresses with a follow up visit on 11/12/2010 to access if the area had grown or decreased in size.
Pain w/in hours. Flu vaccine given in Distal (R) Deltoid. Developed marked pain in deltoid/scapula and pain radiating into hand with subsequent numbness weakness as noted.
On 4/3/00, the pt developed a generalized raised, red, hot, itchy rash. She sought medical attention and was diagnosed with urticaria. The pt was treated with prednisone and cetirizine. At the time of the report, the pt's symptoms persisted and she felt as if she was on "fire". Follow-up information received on 5/17/00 from the consumer who is a medical assistant indicated that on 4/2/00 she woke up with raised itchy welts all over her body. She stated that her whole body was covered and felt like "it was on fire". she received therapy with "medications" from a physician. She indicated that she also experienced joint pain and lightheadedness and her legs swelled. The reporter stated that after 3 days she recovered. No further information is available.
Seizure on 6-1-2007--anticonvulsant, and seizures 6-8-2007 4/14/08-records received for DOS 7/1/07-seen after 3 short lived episodes of jerking right leg. Alert no loss of consciousnes. Neuro exam, slight head lag when pulled to sitting position. Observed rhythmic movements of right lower extremity, mostly flexion and extension at knee. Impression: Focal seizure.  Follow-up: This patient is seeing another Dr - I have no follow-up information.
Information has been received from a registered nurse concerning his physician who "back a few years ago" was vaccinated PNEUMOVAX 23. Subsequently the physician experienced same reaction as the nurse has experienced. The nurse reported that on 20-SEP-2010 at 11:00 AM he was vaccinated subcutaneously in his right arm with 0.5 ml PNEUMOVAX 23 (lot# 665707/1407Y). On the same day, a few hours later, his right arm was very stiff, painful, swollen and warm to the touch. He stated "it was almost like I had compartment syndrome". He stated he saw his physician this morning. He was advised to take two ibuprofen and apply ice. He stated his swelling went down 30% in the morning of 21-SEP-2010. There was no laboratory test performed. At the time of the report, his muscle was edematous and hard. At the time of this report, the physician's status was not reported. This is one of several reports received from the same source. Additional information has been requested.
Patient stated that she had a scratchy throat, breathing problem . Patient stated scratchiness getting better. Advised to stop on the way home to take Benadryl.
3cm x 4cm size erythema, positive for blanching and induration. No tenderness.
pt c/o itching @ shot site 5min p/arm assessed;pt c/o feeling faint;pt assisted to another room to sit down;pt diaphoretic, pale, altered resp status, non comprehensive epi given;c/o nausea;shaky;no idea why in another room;
Itching in mouth, back of throat, head, face, neck arms, shoulders approx 30 mins to  1 hour after  Light headedness shortly after shot Body ache, joint pain started few hours after shot Terrible headache on 2nd day Intense joint pain especially knees 3rd day after Nothing other than the light headedness has stopped.
On 6/28/2022 we were traveling home and I started having symptoms that I thought were allergies. runny nose; cough; itchy runny eyes; then slight fever. Over the next few days it got worse. My fever increased; I felt sick to my stomach and very fatigue. ON the 6/30/2022 I took a COVID-19 at home test and it was positive. We stopped at the urgent care. They took x-ray of my lungs; checked my kidneys; and prescribed me Paxlovid and Benzonatate. Most of my symptoms went away after a few days. However, I still have a cough and feel weak.
Presented to ED w/SOB; admitted for COVID-19 pna; tx w/O2, steroids, remdesivir; pt weaned to RA on discharge; tx to SNF for strengthening & rehab