chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in left arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness in left arm). On 22-Jan-2021, INJECTION SITE PAIN (Soreness in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adverse effect; multiple unspecified patient have received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On 25-JUN-2019, the patient received improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, one dose; lot# N028744, expiration date: 11-MAR-2020; route of administration was not provided). No adverse effects were reported. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored in refrigerator and experienced temperature excursion of 28.2 degrees Fahrenheit (F) (1 cycle) for 19 hours. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005979: US-009507513-1909USA008230: US-009507513-1909USA008228: US-009507513-1909USA008229:
The vaccine was not given in the muscle,  it was in subcutaneous tissue. Saturday morning I noticed the shot area was red and about a quarter sized lump had formed.  By Monday the lump was the size of a tennis ball. It is a tender, hot, red lump that switches between itching and soreness and sometimes does not bother me at all.
Patient received the incorrect formulation of the COVID 19 Moderna Bivalent Vaccine. Patient received the 10ug concentration for infants 6mo to 5 years. No symptoms reported.
abd pain, h/a, low grade fever, pain in both legs;17NOV98 adm to hosp conjunctivitis, both knees & ankles swelling bilat;diff walking;dx myositis & vasculitis;
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4493405-00.  A 74-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), first regimen (Batch/Lot number: unknown) at unk, pre filled pen and second regimen since Feb2021 (Batch/Lot number: unknown) at unk, pre filled pen, all subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 04Jul2022, outcome "unknown" and all described as "COVID". The action taken for risankizumab was unknown.  Additional information: Causality as per reporter was reported as Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red rash  about the size of a half dollar, slightly raised with itching over the vaccine injection site
Caller also stated when her daughter received the vaccine, her daughter's left leg went numb; Nauseous; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient mother) reported for her daughter (patient). This is report 2 of 2. This report is in regard to the reporter's daughter.  A female patient of an unspecified age received bnt162b2 (Pfizer COVID vaccine, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller stated that when her daughter received the vaccine, her daughter's left leg went numb. Caller also stated when her daughter received the vaccine, her daughters left leg went numb. Caller states after her daughter got the second dose, she was nauseous. Caller has heard of that before but has not heard of anybody's left leg going numb. Also stating that was her daughter's business. The outcome of events was unknown.  Information about batch/ lot number has been requested.
The day of the shot I was fine, Friday 10/1.  The very next day, 10/2 at 7am I began throwing up and diarrhea that didn't stop for 3 hours.  I also had a fever of 100.4 along with extreme headache.  My head felt like a watermelon and my eyes felt incredibly heavy/full.  I had to go to the emergency room due to dehydration - that was aroun 10:15 am.  I got an IV with anti-nausea.  My fever of 100.4-100.5 persisted all night into the early morning hours of 10/3.  I also experienced extreme heart pounding late on 10/2 and acute chest pain the evening of 10/3.  I am still experiencing on/off fever and headache
Pain, induration, swelling at injection site. Treatment with local cool compress, OTC antihistamines.
Heart is racing since 2-3 minutes after receiving shot. It continues racing  48 hours after the shot.
Patient seen for autoinoculation on arm and back s/p small pox vaccination three weeks ago. Admitted on 13 Sept 2005. Discharged on 14 Sept 2005. Seen by Dermatalogist day following admission and diagnosed with vaccinia autoinoculation secondary to small pox vaccination. 10/3/05 Review of medical records confirms diagnosis of autoinoculation s/p smallpox vaccine.
This spontaneous report as received from physician assistant refers to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that improperly stored doses of RECOMBIVAX HB (lot number, dose and route unspecified) was administered to unspecified number of patients on unknown dates. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. Product quality issue was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness at injection site; achiness all over; throughout the night developed a fever of 100.9, increased achiness, chills; the next day, fever subsided a little with Tylenol, achiness, fatigue, chills continued
left arm of injection is hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (left arm of injection is hard to touch) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE INDURATION (left arm of injection is hard to touch). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (left arm of injection is hard to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included, pre-diabetes medication, blood thinner, blood pressure medication, vitamins and a heart medication, not otherwise specified.
I have burning during urination. frequent urination with small amounts. I mistook it originally as a UTI, but testing came back negative. I've had multiple repeat incidences since November of 2022. My doctor's preliminary diagnosis Interstitial Cystitis.
About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed headache, dizziness, felt something stuck in throat and difficult to swallow.  Also acid reflux. Sent to ER.  B/P 170/98, still had feeling of difficulty swallowing, headache and acid reflux. Was given Tylenol, Pepcid and Ativan. After several hours B/p was normal and had slight headache when I went home. Following day felt tired and still with headache. Tylenol not helping.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 13-NOV-2013, the patient was vaccinated with PEDVAXHIB (lot number 1310AA expiration date 16-AUG-2013), 0.5 ml, intramuscular. No adverse effect reported. Additional information has been requested.
Pediatric dose was administered instead of the adult dose. The patient is not experiencing any adverse side effects.
Swelling , redness and tenderness in the second DIP joint of the middle and ring finger of my right hand and left hand. Gets worse at night and recedes somewhat during the day. I had mild serious at time of injections. Only using topicals to treat. Had no swelling of joints before vaccine.
A "mass" was found in my left breast during a routine mammogram.   I was scheduled for an ultra-sound where they found something about the size of a grain of rice.  The radiologist said it was a "lymph node" and that I should return in 6 months for a follow-up mammogram.  The affected breast was the left one (same side where I was vaccinated). When I spoke with my doctor, she told me that more of these were being detected in the breast on the same side as the vaccine site.   My first two Moderna doses were in early January and early February of this year so it had been about 8 months out since the last dose.  I have no idea how large the lymph node may have been prior to the mammogram.
Burning sensation at end of urination, increased urgency to urinate beginning on 10/06/2021. Seen and treated at Urgent Care on 10/07/2021. Prescribed cefazolin initially. Culture results indicated resistance to cefazolin. Prescribed ciprofloxacin on 10/09/2021. Resolution began in 24 hours. I completed the 10-day course of medication. Problem resolved.
Patient developed muscle spasms and stiffness diffusely within 15-30 minutes of flu shot injection. Taken to ER by mom.
LETHARGIC; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 02:48 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced lethargic. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, chills, and low grade fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
This regulatory authority case was reported by an other health care professional and describes the occurrence of TOXIC ENCEPHALOPATHY (Toxic encephalopathy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced TOXIC ENCEPHALOPATHY (Toxic encephalopathy) (seriousness criteria hospitalization and medically significant). At the time of the report, TOXIC ENCEPHALOPATHY (Toxic encephalopathy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient presented to the emergency department and was subsequently hospitalized with toxic encephalopathy within 6 weeks of receiving COVID vaccination.   Treatment information was not provided.  Very limited information regarding this event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
A patient was administered an improperly stored VARIVAX; No adverse effects.; This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.   On unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S021926 with expiration date on 15-JUL-2021 (dose, frequency, strength and route of administration were not reported) for prophylaxis.  Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit for 72 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
The day of the injection, my left arm started to hurt, it started out just feeling like a bruise and gradually got worse by that night that it hurt to move it and to touch it.  The next day it gradually stopped hurting and by the afternoon, it was like an ache, and later it didn't hurt.  On 4/1/2021 it was hurting, to touch it it felt like there was a bruise and gradually got worse by 11 pm that night, and hurts to touch and move on 4/2/2021.  My arm to look at has appeared normal looking, no bruises, no rash, no redness.
My arm was sore the next day. Then I felt fine after that. On October 29, 2021, I started to feel symptoms as if I had a UTI. On October 31st I went to see a doctor at Mercy Urgent Care. They diagnosed me with a UTI, and prescribed Nitrofurantoin 100mg 2xday for 5 days. I also picked up an OTC medication that helps with burning and pain when using the bathroom.
pneumonia; fibrotic lung condition; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included prednisone.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant) and pulmonary fibrosis (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia and pulmonary fibrosis were unknown.   It was unknown if the reporter considered the pneumonia and pulmonary fibrosis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received his 1st Shingrix dose in mid-April 2019. The patient's initial diagnosis was pneumonia, but that was under a total re-evaluation now. He might had a fibrotic lung condition. On 28th June 2019, the patient received Prednisone 10 mg 4 for 3 days and progressive fewer pills over the next week. Again, on 5th August 2019, he received the treatment drug again. The pharmacist said that the patient could have 2nd Shingrix dose on 23rd September 2019.
Swelling at injection site; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA281531, 2019SA281763 and 2019SA281764 (same reporter).  This case involves a patient who experienced swelling at injection site (vaccination site swelling), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656KA via unknown route in unknown administration site.  On an unknown date, the patient had swelling at injection site (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site swelling.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site swelling.  List of document held by sender: none.
This spontaneous prospective pregnancy report as received from a Registered Nurse refers to a 26 year old female patient. On 30-JUN-2014 the patient was vaccinated with her first dose of (Oka/Merck) VARIVAX (Lot# unspecified) dose, frequency and location unspecified for prevention of varicella. On an unspecified date in 2014, the patient took a pregnancy test and was found to be pregnant. The patient's estimated due date (EDD) was 03-MAR-2015. LMP (Last Menstrual Period) was 28-MAY-2014 (estimated date) and Date of Conception was 11-JUN-2014 (estimated date). Trimester (s) of exposure were the first. No adverse effects reported. No treatment was given for the event. At the time of this report, the pregnancy outcome was unknown. The reporting nurse did not assessed the seriousness. Additional information has been requested.
hives in left arm are really bad; Big knot in the left arm/knot went down; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives in left arm are really bad) and VACCINATION SITE MASS (Big knot in the left arm/knot went down) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced VACCINATION SITE MASS (Big knot in the left arm/knot went down). On an unknown date, the patient experienced URTICARIA (hives in left arm are really bad). At the time of the report, URTICARIA (hives in left arm are really bad) outcome was unknown and VACCINATION SITE MASS (Big knot in the left arm/knot went down) was resolving.            After the booster dose, patient had a big knot in the left arm that appeared on 30-dec-2021 and it went down on 01-jan-2022 but was still there.  It was reported that concomitant medication included 7 or 8 of them. No treatment medication were reported.   This case was linked to MOD-2022-437506 (Patient Link).
Swollen lymph nodes in neck; This is a spontaneous report from a contactable other HCP. This 37-year-old non pregnant female other HCP (patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No known allergies. No other medical history. On 29Jan2021 patient experienced swollen lymph nodes in neck. The second dose was on 10Feb2021, administration time 01:15 PM, vaccine location Left arm, dose number 2, lot numberen6201. Event resulted in doctor or other healthcare professional office/clinic visit. No covid tested post vaccination. No treatment was received for event. The outcome of event was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
No adverse events at this time. The patient received a double dose of the bivalent Pfizer vaccine. She received her first dose on 9/13/22 and second booster dose on 3/15/23.
Information has been received from a pharmacist concerning a 65 year old male patient. The patient had no relevant medical history, concomitant medications, or past drug history. About a month ago (in April) in 2016, the patient was vaccinated with ZOSTAVAX (dose, route and lot # unknown) for shingles. On 13-MAY-2016, the patient received another dose of ZOSTAVAX 0.5 mL (lot #L040442, Expiration Date 15-JAN-2017) by mistake. The pharmacist reported the patient hadn't had any adverse reactions. It was unknown if any relevant lab work had been done. As of 13-MAY-2016, it was unknown if the patient would continue on the ZOSTAVAX, and the outcome of receiving another dose by mistake was unknown. Additional information has been requested.
I had a sore arm and fatigue starting the day after the injection that lasted 3 days. 1 week after the injection I developed a palpable lump at the injection site that was very tender to touch, a tender and swollen lymph node under the arm that I received the injection, and paresthesia in the arm that I received the injection. These also lasted about 3 days and then resolved spontaneously
pt recvd vax & mom gave apap until 26feb94 then pt began to cry & would stop when apap given; to MD; exam dx w/ stomach virus; cont w/ gas pain & crying; to MD who stated rxn to vax;
9:00 pm - severe chills, nausea, joint pain (every joint), fever 102 and a chemical taste in back of throat.  Felt as if I had been poisoned. By 12:00 noon following day all symptom were gone.
Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 16 year old female with no medical history, and no drug reactions/allergies, who on 09-APR-2008 was vaccinated intramuscularly with her first 0.5ml dose of GARDASIL (lot# 659964/1978U) while pregnant.  It was reported that the patient was "9 weeks pregnant on 22-May-2008" (estimated LMP = 19-Mar-2008).  The patient has no symptoms.  Unspecified medical attention was sought by calling the office.  No further information available.  In follow-up information it was reported that date of last menstrual period was 19-MAR-2008 and the estimated delivery date was 24-DEC-2008.  On 16-JUN-2008 the patient had an elective termination of pregnancy.  It was reported that LMP was 19-MAR-2008, so the patient was approximately 13 weeks.  It was unknown if the products of conception were examined and it was unknown if the fetus is normal.  Upon internal review elective termination was determined to be an other important medical event.  Additional information is not expected.