chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Induration; Redness/erythema; Heat; Swelling; This spontaneous case was reported by a health care professional and describes the occurrence of INDURATION (Induration), ERYTHEMA (Redness/erythema), INJECTION SITE WARMTH (Heat) and SWELLING (Swelling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INDURATION (Induration), ERYTHEMA (Redness/erythema), INJECTION SITE WARMTH (Heat) and SWELLING (Swelling). At the time of the report, INDURATION (Induration), ERYTHEMA (Redness/erythema), INJECTION SITE WARMTH (Heat) and SWELLING (Swelling) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: unknown (Low) low grade temperature.     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 information was not provided.  Concomitant product was unknown  by the reporter.  Patient gave consent to safety for follow-up.
shingles; This is a spontaneous report from Pfizer sponsored program. The consumer (patient's husband) reported for his wife.   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. The patient received the second shot of vaccine and couple of days later she experienced shingles on an unspecified date. She visited a doctor one or two days after shingles showed up. Therapeutic measures were taken, and the patient was treated with unspecified medicines. The outcome of the event was recovered after few days.  Information on Lot/Batch number has been requested.
Severe headache with vomiting 1 1/2 hr after vaccines. Then "foggy" and unsteady for 2 days. Day 3 getting better.
Patient tested positive for COVID-19 on 9/20/2021;  patient has symptoms of chills, headache, coughing, body aches, loss of smell
Deep itch at vaccine site.  Used alcohol wipe and small knot in arm. The itch is a annoying bug bit sensation almost 24 hours now
Patient report pain in the left arm that is still ongoing after months of being vaccinated. She reports unable to bend her arm behind her back on raising her arm up.
no adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25).    Concomitant product use was not provided by the reporter.  It was reported that on 25-May-2023, 20 patients who were over 65 years old was administered with 0.25 ml Moderna bivalent vaccine instead of 0.5 ml. All these patients had their monovalent and a previous booster dose of bivalent vaccine.  Treatment information was not provided.  This case contains information about patient 8th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Master case  (Elderly Patient no 1)
Felt fatigued but 7 pm Sunday night. Woke up the next day feeling extremely fatigued, aches, excessive sweating and nauseated. I feel fine the day after so it only lasted on day
First dose 20-JUL-2017, Second dose 05-JUN-2019, Third dose 14-DEC-2020.; 19 yr old female received a smaller volume ofGARDASIL 9, it was  administered 0.4 mL out of 0.5 mL to patient.; The patient "gets kind of fainty.; The patient fainted at the time she received her 2nd dose; This spontaneous report was received from a  medical assistant referring to a 19 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On  20- JUL-2017 and on 05-JUN-2019, the patient was vaccinated with her first and second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.         On 05-JUN-2019, the patient fainted (syncope) at the time she received her 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Subsequently, on 14-DEC-2020 (reported as "today"), the patient was vaccinated with her third dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The medical assistant reported that she administered 0.4 mL out of 0.5 mL to patient, she inquiring about validity of dosage. Additionally, she reported that the patient got kind of fainty (dizziness) after vaccination.   At the time of the report, the outcome of syncope and dizziness was unknown. The reporter did not mention the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Patient was very nervous prior to vaccination, and immediately after the injection, she developed vasovagal reaction.  It took her at least 30 minutes to recover, but was stable and went home with spouse.
Mom returned to clinic 1 day post vaccination reporting child had developed a fever ranging from 103 to 105.  Not excessivily fussy, no high pitched cry, normal appetite. Tylenol at 6:30 am, temp in clinic 2 hours later was 100.9.  Blood test revealed an elevated white count.
Styes in both eyes. Treated with hot compresses. Still active after 9 days
After the Gardasil shot in my left arm, I had a lot of pain for about 7-10 with a lump that eventually went away. About 1 month later, while in the shower washing, I noticed anytime I went over the injection area on my left arm, it was tender. After the shower, I immediately noticed a lump again, and the pain has been consistent for the last 4 days. It is red where the lump is, and today I noticed some slight aching  in my upper arm and shoulder area. This is new and not constant.
None - Came thru flu vaccine clinic and given the 0.5ml dose instead of the 0.25ml dose.
Office manager calling to report that a dose of MMR II was administered 5 days after its labeled expiration date. Administration date: 10/26/2023, expiration date: 10/21/2023. Caller confirmed the product has never experienced a temperature excursion; This spontaneous report was received from the office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot # U033041, expiration date:21-OCT-2023, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis.   It was reported that a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) was administered 5 days after its labeled expiration date. Caller confirmed the product has never experienced a temperature excursion (expired product administered).
Body aches, fever, pain that radiated up right arm from injection site to ear and jaw, stiff neck, vertigo, headache.
I received the Moderna vaccine on 5/28/21. No reactions on the first day. Day 2 I noted the small red swollen area, extreme pain radiated from my shoulder to my wrist. The next day it had tripled in size and was hot to the touch and pain continued as well as a little itchiness. Also noted a large marble size knot. Followed up with the pharmacist who checked the area on 6/1/21. He advised the redness was pretty much gone but the heat was still there as was the marble sized knot, the outline of the "rash"  and the soreness. Today, marking a week after injection, the large marble is now a small marble knot, still slightly sore to the touch but not unbearable. Still slightly itchy.
Swelling from top of left shoulder to the neck after second shot; Itching left arm injection site after second shot; Weird reaction after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Weird reaction after second shot), SWELLING (Swelling from top of left shoulder to the neck after second shot) and VACCINATION SITE PRURITUS (Itching left arm injection site after second shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029M19A and 007M20X) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Weird reaction after second shot). On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching left arm injection site after second shot). On 04-Mar-2021, the patient experienced SWELLING (Swelling from top of left shoulder to the neck after second shot). On 06-Apr-2021, VACCINATION COMPLICATION (Weird reaction after second shot), SWELLING (Swelling from top of left shoulder to the neck after second shot) and VACCINATION SITE PRURITUS (Itching left arm injection site after second shot) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to (Patient Link).
Started Friday night with 3 raised red hives at injection site which next day progressed to welts, itching encompassing whole L upper arm from axilla to elbow
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 5/20/2022 -- RECURRENCE OF SAME SYMPTOMS
Doctor notes: Progress Notes, MD at 6/28/2021 3:30 PM Chief complaint: Neurologic problem.HPI:6/28/21Consult at request of Dr. 47 y/o man. JJ vaccine 4/6/21. Flew to Syracuse to get vaccine (friend is a pilot). Next AM had fever, flu-like symptoms which lasted 4.5 days. 1-2 days after vaccine developed vertigo. Vertigo occurred while lying down in bed and on getting up from bed. While walking lurched to either side. Couldn't stand on one foot. Turning over in bed with lifting head also caused it. Episodes subsided 1 min after stopped moving. Did not have vertigo while upright. Did not have double vision. No change in chronic tinnitus on L. No change in hearing. No change in speech, swallowing. No confusion. No facial numbness. No limb weakness or numbness. No new HA.  Was taking Advil PM for fever, etc.  Had covid test and Ab test a few weeks before vaccine.   Vertigo lasted 4 - 5 days. On 4/18, after it ended, went on a date, had 2 drinks over course of 7 hours. 2 days later, on 4/20/21 again felt ill with temperature and vertigo, which persisted for another 5 days. Saw his acupuncturist Dr.  and vertigo resolved after acupuncture treatment. Continued to have fatigue for several more weeks. Saw Dr. 5/13/21, dx BPPV.   Sees functional medicine doctor. Lost 35 lb with diet. Started on B12  Data:3/12/21: covid ab neg5/13/21: covid ab neg PMH/PSH: Strabismus surgery 2002; psoriasis Social History: No substance abuse. Employment - business consultant; musicianFamily History: No neurologic illnessMedications: Vit d 500 daily; b12 1000 daily; topicals Allergies: Dust; shrimp; cocoa PE:General: NAD.  MS: Oriented to person, place and time. Recent and remote memory intact. Attention and concentration normal. Normal fund of knowledge. Language - no evidence of aphasia or dysarthria.    CN: VA grossly normal. VFF. PERRL. EOMI, no nystagmus. PP intact b/l V1-V3. Face symmetric. Hearing grossly intact. Palate elevates symmetrically. Shoulder shrug 5/5 b/l. Tongue midline.Motor: 5/5 x 4. Tone normal. No tremor or other abnormal movements. No drift. Sensory: PP intact x 4.    Coord: FTN normal.DTR: Arms 1; KJs 1; AJs 2. Plantars: flexorGait: Narrow base. Normal heel, toe. Tandem slightly difficult. No Romberg. Impression:Positional vertigo and imbalance in setting of flu-like illness after Johnson and Johnson flu vaccine received 4/6/21.  Symptoms currently resolved. MRI Brain/IAC and MRV head ordered to r/o CVA, venous sinus thrombosis.  Covid PCR and Ab sent today. I will message with test results.  FU PRN I personally spent a total of 60 minutes face-to-face and non-face-to-face time reviewing the patient's chart and documenting in the record. This total time was performed before, during, and after the visit on the same service date. 6/28/2021 3:30 PM1 sst tube, 1 viral swab sent to nyp lab
About 12 hours after shot, had fever, chills, stomach pain, nausea, severe headache.
Patient presented to the vaccination site on 11/08/21. The client notified RN that a week after his second dose of the COVID Pfizer vaccine on 2/13/21 client reported having a pulsating on and off headache for 6 months. Client stated that he did not go to PCP regarding symptoms. Client stated that he is not currently experiencing symptoms and he hasn't experienced the pulsating on and off headache for 3 months. RN took clients vital signs at 1840. BP: 135/79, HR: 71 and O2: 98%. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer booster dose. Approval to proceed with COVID vaccine Pfizer booster dose was obtained from medical consult team, Vaccine Operations Lead, RN via text message. Client received COVID vaccine Pfizer booster dose Lot# FF8839 on 11/08/2021.The client did not report any symptoms during the 15 minute observation period. RN educated client on worsening signs and symptoms of receiving booster Pfizer COVID vaccine and when to seek EMS, urgent care, or go to the ED. Client verbalized understanding. The client left the vaccination site at 1920 unassisted and with a steady gait.
This spontaneous report as received from a 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 VAQTA (Lot# M003011, expiration date: 15-NOV-2017, dose, frequency and route were not reported) that were improperly stored at 31.3 Fahrenheit for 124 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever blister on top lip; Swollen arm; throwing up; Diarrhea; tired; swelling and redness, it is really itchy.; swelling and redness, it is really itchy.; She has been putting ice on the arm and as soon as she takes it off it gets warm and hot again.; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: EN6208), Solution for injection, via an unspecified route of administration, administered in Arm Left on 13Mar2021 14:00 (at the age of 81-year-old) as single dose for covid-19 immunisation. Medical history included diabetes, high cholesterol, blood pressure high, breast cancer and lymph nodes removed. he patient's concomitant medications were not reported. Family medical history was reported as none. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: EL9266), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Feb2021 (at the age of 81-year-old) as single dose for covid-19 immunisation. On 14Mar2021, the patient experienced swollen arm, throwing up, diarrhea, on 16Mar2021, fever blister on top lip, on an unspecified date in Mar2021, tired, swelling and redness, it is really itchy, she has been putting ice on the arm and as soon as she takes it off it gets warm and hot again. The patient did not have any reactions from the first dose, but she got the second dose on Saturday 13Mar2021. Sunday afternoon, her arm was swollen, she was tired, throwing up, and had diarrhea. On Tuesday the patient had a fever blister on her top lip. Patent had been putting ice on her arm to help with the swelling and redness, it was really itchy. She was unable to put her dentures in because she was throwing up. Her stomach still feels like it was not good. She was fine as far as she can tell with the diarrhea. She had been putting Abreva on her fever blister on her top lip. She got both doses in her left arm because she had lymph nodes removed from her right arm because of breast cancer. Therapeutic measures were taken as a result of swollen arm, fever blister on top lip, swelling and redness, it is really itchy, swelling and redness, it is really itchy. Patient did not visit emergency room or physician office due to adverse events. No relevant test was performed. The outcome of event swollen arm, fever blister on top lip was not recovered and outcome of all other events was unknown.   No follow-up attempts are possible. No further information is expected.
COVID-19 infection with cough, shortness of breath, hypoxia 1 day after vaccination. Elevated liver enzymes with AST peaked at 2231 U/L and ALT peaked at 1330 U/L in addition to acute kidney injury
Redness, warmth, slight pain at the injection site which spread down the length of her arm and included bruising. Pain didn't last long (less than 1 day). Warmth lasted approximately 1 1/2 days, bruising lasted approx. 1 1/2 weeks. She went to ER and was told it was just a bad bruise.
Information has been received from a physician concerning a 9-year-old black male with no pertinent medical history or allergies who on 18-JAN-1999 (previously reported as 08-JAN-1999) was vaccinated with a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) a second subcutaneous dose of on 19-JUL-2007 (lot# 657752/0780U) administered in the right arm (there was conflicting information regarding which dose lot # 657752/0780U refers to). On 29-JUL-2007 the patient's mom noticed an itching rash and lesions on scalp and torso. On 30-JUL-2007 the patient was brought to the physician's office and it was noted that the child had lesions on his scalp, face, trunk (front of chest), back, both arms and legs (chickenpox). There was no cough, cold, runny nose or fever. No diagnostic labs were performed. The physician also noted that the patient's sister who is eleven years old had experienced a chicken pox rash (also described as shingles like) three days ago on 27-JUL-2007. The shingles like rash was described as vesicular papular lesions in different stages of evolution, positive scalp, neck, ears, chest, abdomen and buttocks with swelling and erythema. She is currently on her way to recovery with the majority of the lesions scabbing over. At the time of the report the patient's status was unknown. The patient did not return for follow-up visit. No product quality complaint was involved. Additional information has been requested.
PATIENT REPORTED TINGLING AROUND LIPS 3 DAYS AFTER AND SOME PAIN, SAID SHE FELT LIKE SHE HAD SOME TIGHTNESS IN HER CHEST AS WELL.  HAD ITCHING THAT SUBSIDED WITH TAKING SOME BENADRYL
Moderna COVID-19 Vaccine EUA Patient describes reaction as an arthus reaction - redness, warmth, itching and soreness in an area below where her vaccine was given, 10 days post vaccination.
Information has been received from a Doctor of Pharmacy concerning a 63 year old female patient with sulfa allergy and high blood pressure who on 23-MAY-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose not provided) (lot # 670816/0693AA, expiration date). The pharmacist reported that the patient developed a raised area at the injection site spreading 1.5 inches, soreness and itching after vaccination with ZOSTAVAX (Merck). Onset dates not provided. At the time of the report, the patient had not recovered from the events. The patient contacted the pharmacist. Follow up information has been received from the pharmacist concerning the patient with no illness at time of vaccination and no drug reactions or allergies (previously reported as sulfa allergy and high blood pressure), who on 23-MAY-2012 at 14:00, was vaccinated with a first dose of ZOSTAVAX (Merck) (dose not provided) subcutaneously in the upper left arm. The pharmacist reported that on 24-MAY-2012, the patient experienced swelling, itching, redness, pain and rash. There were no Lab diagnosis/studies performed. At the time of the report, the patient's outcome regarding redness, swelling, itching and rash was unknown. Follow-up information has been received from the pharmacist concerning female patient with none of pre-existing medical conditions. It was reported that on 24-MAY-2012, the patient experienced redness, swelling, looked like a "rash" at the injection site. It was also reported that the patient thought she was getting shingles. At the time of report the patient's outcome regarding to redness, swelling, looked like a "rash" at the injection site, "thought she was getting shingles" was recovered (date unspecified). The relatedness for the patient's events was not provided for ZOSTAVAX. Additional information is not expected.
Pt referred from clinic for Hep-B Series and had shot #1 on 10/20/00 PM. One hour later, she had difficulty breathing, a wheezing noise in her chest, pain in her left chest and down her left arm. She also had dizziness for 2 1/2 days. The pt sought no medical care. Has no medical insurance. Did not report until today. This has resulted in the pt refusing Hep-B dose 2 and 3.
Severe pain and loss of movement in right arm, swelling in shoulder, ongoing since 11/17/2016. Ice and rest, pain medication, not working.