chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Quadriceps on both legs are in a lot of pain/generalize muscle soleness in arms and legs; Both thighs feel swollen and tender; Both thighs feel swollen and tender; This is a spontaneous report from a contactable consumer.     A 25-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Oct2021 17:00 (Batch/Lot Number: Ff2590) as single dose for covid-19 immunisation  .  Medical history included covid-19.     There were no concomitant medications.  The patient experienced quadriceps on both legs are in a lot of pain/generalize muscle soleness in arms and legs  (disability, medically significant) on 15Oct2021 15:00 with outcome of not recovered , both thighs feel swollen and tender (disability, medically significant) on 15Oct2021 15:00 with outcome of not recovered.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a currently 12 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Pt experienced extreme panic attack right after vaccination.  Contacted 911, and paramedics were dispatched from Delaware County Memorial Hospital.  Pt alleges he "can't breathe and don't feel right. Never felt like this before."  Epipen was really to be administered.
Pt states that after receiving the 4th Anthrax shot, she had stiffness and cramping throughout her neck, shoulders, right arm and hand and on the right side of her chest. Tenderness and pain throughout the same areas.
Patient called the morning after receiving a Hepatitis B vaccine. First injection in a series of 3 injections. Patient is a new employee. Patient stated she felt well upon leaving the work after a 15 minute waiting period after injection. States that when she got home she ate a meal and a short time later began feeling mildly nauseated. The following morning patient states she felt severely nauseated and was having hot flashes and an upset stomach. Patient denied having any swelling, pain or itching at the injection site and denied having any difficulty breathing or any oropharyngeal swelling.
Severe acute nerve pain, beginning from vaccination site and spreading over the course of several days to shoulders, neck and throat
Shingles Rash; Burning; Shooting pain; Pain under left breast; Left side aches really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Left side aches really bad), BREAST PAIN (Pain under left breast), HERPES ZOSTER (Shingles Rash), BURNING SENSATION (Burning) and PAIN (Shooting pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shingles. Concomitant products included VALACYCLOVIR [VALACICLOVIR], LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE, MULTIVITAMINS [VITAMINS NOS], GLUCOSAMINE and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (Left side aches really bad). On 04-Mar-2021, the patient experienced BREAST PAIN (Pain under left breast). On 08-Mar-2021, the patient experienced HERPES ZOSTER (Shingles Rash), BURNING SENSATION (Burning) and PAIN (Shooting pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Left side aches really bad), BREAST PAIN (Pain under left breast), HERPES ZOSTER (Shingles Rash), BURNING SENSATION (Burning) and PAIN (Shooting pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unspecified date, patient underwent several lab test including mammograms and few other tests which came back fine.  Patient stated she has had shingles before and was prescribed with anti-viral for the rashes.     Reporter did not allow further contact
High fever (104 degrees F) for 36 hours. Leg swelling on vaccination side.
Shingrix was not reconstituted and client only received diluent. She was notified and will come in for a repeat dose.
Rheumatoid arthritis flare up; This is a spontaneous report received from contactable reporter(s) (Other HCP), Program ID.  A 52-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 51 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up". Therapeutic measures were taken as a result of rheumatoid arthritis.  Clinical course: It was reported that the patient reports 14 months ago had COVID booster that caused a rheumatoid arthritis flare up, unknown exact date. patient reports still has not return to their baseline before booster shot. patient reports since starting Xeljanz XR there has been improvement but still sore. doctor is aware. no missed doses reported. Xeljanz XR 11mg tablet by mouth once daily from 29Mar2022 to ongoing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
shingles; This is a spontaneous report from a contactable consumer. A 90-years-old patient of an unspecified gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. Patient would like to report a case of shingles in 90-year-old mother-in-law approximately 30 days after receiving her second dose of the Covid vaccine. There do not seem to be any way to report these kinds of things. She has a terrible case of it and ended up in the hospital for 5 days, was now in her second week of rehab. Felt this was probably underreported, as personally know 3 people who have it following their vaccines. The patient was hospitalized due to events. The outcome of shingles was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Local swelling, urticaria almost immediately after the hep a vaccine was given. It was esxtended at the hep A injection site right deltoid.
Headache, Myalgia, SORENESS AT INJECTION SITE, FATIGUE, CHILLS, MALAISE Narrative:  Other Relevant History:
Patient stated that her arm sore and she could barely lift it. She stated that the injection site was also red, warm to the touch, and swollen. These symptoms appeared about 4 hours after the injection. I called to check up on the patient 10 hours after injection and patient stated arm was not as sore and the swelling had decreased.
I had a sore arm and got tired a little bit. The roof of my mouth felt like I ate a hot pizza about 2 days later. I used ice to sooth it and cough drops. It went away after a week.
arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date at 13:30 as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included simvastatin (SIMVASTATIN) taken for cholesterol, start and stop date were not reported; metformin (METFORMIN) taken for diabetes, start and stop date were not reported. The patient received first dose on Sunday (unspecified date) at 13:30 and on an unknown date, the patient's arm was a little sore. The patient asking about pain relieving medication and also asking about efficacy. He was scheduled for second dose at day 25 and was told to 17-21 days. The outcome of event was unknown.  Information on the lot batch number has been requested  Follow-up attempts are completed. No further information is expected.
muscle fatigue, nausea, vomiting, chills, mild fever lasting for about twelve hours, extreme fatigue for two days  (I assume this was a reaction since i have not been out or in contact with other people, but would side effects be that delayed?)
Pt's daughter reported that on 10/3/05 her mom received pneumococcal vac. around 12:00 noon. R deltoid. Tuesday noted swelling, redness around upper arm, warm to touch mild itching. Swelling extended to above her elbow.
Pt received FLULAVAL QUAD and GARDASIL vaccines at the same time. Pt fainted briefly (< 1 minute) and had tremors. Pt returned to consciousness after about a minute. Paramedics were call and pt evaluated, not taken to ER.
The day after receiving the vaccine, the patient started having some pain behind her ear. She progressively developed more symptoms as the day/days went on. She started having a sore throat, difficulty swallowing and a bad earache. She then later developed numbness on half of her face, her eye drooped and she loss the sense of taste. The Dr. stated she developed Bell's Palsy and believes it should resolve in time.
I started getting symptoms of low grade temp of 101, coughing, chest congestion, and  fatigue. I took an at home COVID-19 test that was positive. I also went to the doctor and had a positive COVID-19 test. I was prescribed an antibiotic then a steroid. Today I am out of isolation period. I still have tiredness and fatigue.
sore left arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6198) via unspecified route of administration in left arm on 27Feb2021 at 01:15 PM as single dose for COVID-19 immunisation. Medical history included glaucoma, diffuse large B-cell lymphoma (DLBCL), thyroid nodules. Concomitant medication included levothyroxine, vitamin D Nos [VITAMIN D], tocopherol (VITAMIN E), curcumin, acetylsalicylic acid (ASA), fenofibrate (NORTRICOL) (medications in two weeks). No other vaccine in four weeks. On 27Feb2021 at 03:00 PM, patient experienced sore left arm. No covid prior vaccination, Patient has not tested COVID post vaccination. The case was considered as nonserious. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
1345 - 03/24/10 patient has rash & erythema to left upper arm with mild pain warm to touch @ injection site. Cool compress applied & given BENADRYL 25 mg IVP x T.
10/25/06 9:30 pm given Fluarix within 5 minutes site started to itch, arms turned blotchy within 20 minutes had hives arms, leg, chest, back.  Face red, no swelling.  No airway problems. Throat scratchy.
My daughter had her MMR shot placed in l upper arm and her diphtheria tetanus pertussis and polio put on her r upper arm.  Reactions as follows- on her r arm after 24 hrs abnormal swelling and tenderness to the size of a peach.  My daughter has a lymphanic malformation from birth and it was not reacting until the day after the MMR where her lymphanic malformation seemed to have a thrombosis reaction and appeared to clot.  Doctor prescribed an aspirin a day and warm packs for the left arm until the thrombosis or clot goes away and cold packs to reduce the discomfort of the r arm swelling.  She also started to react with an all over rash or uncontrollable itchiness which starts in the pm and was prescribed benadryl until discomfort goes away.
Information has been received from a 62 year old male patient who on 08-SEP-2009 was vaccinated with one dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included influenza virus vaccine (unspecified). On 08-SEP-2009 the patient experienced muscle pain in the shoulder and thumb sized red splotches. The patient did not seek for medical attention. At the time of the report, the patient was not recovered. Follow up information received from a physician indicated that he was a male patient with borderline hypertension who on 08-SEP-2009 was vaccinated intramuscularly with his second dose of PNEUMOVAX 23 in his left arm at 15:30. There were no illnesses reported at time of vaccination. Concomitant therapy included AFLURIA (Lot # 06449111A) given intramuscularly in the left arm at 15:30. According to the physician, on 11-SEP-2009 the patient had severe pain in his left shoulder, fever and blotchiness around injection site to elbow. The patient recovered on approximately 14-SEP-2009. No diagnostic tests were performed. This is one of several reports received from the same source. Additional information is not expected.
The delayed adverse events that the patient experienced are nausea, vomiting, diarrhea, weakness, and fatigue.
Patient developed a mild fever and rash the evening of 6/16/2017.  The rash continued and spread for 10 days. All pox scabbed over by day 14. On 07/16/2017 she developed a rash on forehead, face, neck and around her ears following 3 days of elevated temperatures. This rash spread and continued for 1 week.
Woke up from laying on right side with left arm slung over partner. Extreme pain in left shoulder joint & left upper back. Pain & numbness down backside of arm. Numbness & tingling in fingers.
About 2 days after the vaccine, I noticed little red bumps on both arms,  both legs,  neck and shoulder.   The bumps are red and itchy. Then a couple of hours  later, the itch goes away but the tiny bumps are still there.  They did not all show up at the same time. They are the size of a small pimple or a tiny bug bite.  The very first bumps  looks like they are going away but  each day I notice more bumps appear. They are not in clusters like a rash.
PATIENT CAME BACK WITH SWELLING, HEAT, AND REDNESS AROUND INJECTION SITE OF PNEUMOVAX. FLUVIRIN SITE WAS NORMAL SHE ALSO WAS COMPLAINING OF VOMITING UP PHLEGM AND TINGLING LIPS LIKE A COLD SORE COMING ON.  SHE SOUNDED VERY CONGESTED.
Information has been received from a licensed practical nurse concerning a 12 year old female with no known drug allergies who on 16-JUN-2010 at 01:00 PM was vaccinated with the third dose of GARDASIL (Lot #662765/0821Y). Soon after the vaccination, on 17-JUN-2010 the patient experienced flu like symptoms. At this time of reporting, the patient's outcome was unknown. Follow-up information has been received from the licensed practical nurse concerning the 12 year old (also reported as 13 year old) female with birth weight 6 pounds and 11.5 ounces and no sibling who on 30-NOV-2009, 03-MAR-2010 and 16-JUN-2010 was vaccinated intramuscularly with the first (Lot # 663452/0671Y), second (lot # 663452/0671Y) and third (lot # 662765/0821Y) doses of GARDASIL, respectively. No further testing done after flu like symptoms after having third dose of GARDASIL. On an unspecified date, the patient recovered. No further information is available.
I was diagnosed with Covid-19 on 13 March, 2020.  After getting my first injection I was fine all that day. The next I experienced headache and significant aches in my joints along with a general feeling of being ill as has been been reported.  After my second dose the headaches and joint pains began within a few hours.  I also had significant diaherra that lasted most of the day of the shot and into the next morning.  At first I thought the diaherra may have been from cheese I ate the night before but that has never lasted like this.
Dad noticed pt's arm was red, warm to the touch, & had approx. a 3" "blotchy" area. Said the injection site was swollen & raised.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist.  The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot# J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.   Follow up information has been received from the registered nurse who provided patient details. This report refers to a 2 years old child patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a does of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Rash around the injection site; Injection site itches; A spontaneous report ) was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash around the injection site, injection site itches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) rash around the injection site, injection site itches.  Treatment details included dexamethasone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash around the injection site, injection site itches was unknown.
I am a little sore in the arm for about a day. In 12/2022, I was diagnosed with elevated liver enzymes and in 01/2023 I was diagnosed with Type 2 Diabetes. My doctor put me on new medication, and I have changed my diet which has changed my life so much.
PATIENT RECEIVED MODERNA VACCINE AND IS EXPERIENCING ARM SORENESS EVEN AFTER 2 MONTHS OF SECOND DOSE
Initial misuse report received from a healthcare professional on 13 AUGUST 2013. A 6-year-old patient was inadvertently administered ADACEL as fifth dose in DTap series. No adverse event was reported. Documents held by sender: none
Fever & chills throughout the first night, low grade fever (99-101F) returned in the morning. Extreme fatigue and slight nausea day 1, muscle soreness until day 4. Fogginess and headaches persisted throughout the week. Day four had upset stomach.
Fatigue in the afternoon following the vaccine administration.  Fever (101f); body aches, chills, headache upon waking up from sleep at 0100 on 1/22/2021.  Treatment- rest, hydration, Motrin, Tylenol
Painful lump on my scalp; Shivering; Painful lump on my scalp; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced local swelling, shivering and mass. On an unknown date, the outcome of the local swelling, shivering and mass were unknown.   It was unknown if the reporter considered the local swelling, shivering and mass to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient was wondering if a painful lump on scalp that appeared the day after second shot could be related to vaccination.  The patient was also experienced shivering.
Generalized myalgias, stuttering, staring episodes, loss of awareness.  8/25/2008 Hospital D/C Summary received from PCP for DOS 7/11-15/2008 with D/C DX: Nonepileptic form seizures. Muscle spasms. S/P Guillain-Barre Syndrome.  Tobacco abuse.  Pt presented with staring and shaking spells x 4 days.  Pt initially unaware of spells noticed by co-worker. Pt unaware during spells. No post-ictal state. Started on Dilantin.  Pt reported increased head pressure during admission, but no further spells. Pt troubled by muscle spasms, paresthesias and shooting pains which began after Td vax, helped somewhat by Flexeril and Vicodin.
Fever up to 101 for 2 days. Vesicular rash on arms, trunk and legs.
Information has been received from a licensed practical nurse (L.P.N) concerning a currently 68 year old female with hypercholesterolemia, sulfa and codeine drug reactions who on 28-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, subcutaneously, (lot #1411U is an invalid lot number). Concomitant therapy included CRESTOR. On 28-MAR-2011, the patient experienced increased swelling around the area of the injection, it was warm to touch and bothersome. Also, it was reported that the patient had chills and a fever throughout the night a temperature of 100.3. The the patient developed a persistent cough. No lab diagnostics were performed. The patient was told that if the symptoms persist to come into the office. The patient did not seek a medical attention. No treatment was given for the adverse event. At the time of the report, the patient had not recovered. Follow-up information was received from a licensed practical nurse (L.P.N) who stated that the 68 year old (currently 69 year old) female patient with no illness at time of vaccination who on 28-MAR-2011, was vaccinated IM (reported before as SQ) with the second dose of PNEUMOVAX 23 (lot# 667692/1110Z) at 11:50 am. On 28-MAR-2011 by night at 20:00 pm, the patient experienced left upper arm swollen, reddened and warm to touch. The patient also complained of extreme chills and fever. The patient was placed on BENADRYL 25 mg, half a tablet every night and continued half a tablet for 8 hours and continued for the next 24 hours. The chills resolved after several hours on 29-MAR-2011. The patient also did feel some chest tightness, some coughing and there was no shortness of breath. Relevant diagnostic tests were not performed. All symptoms abated in 3 days "on 31-MAR-2011". The patient never sought additional evaluation of treatment. Additional information is not expected.