chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash 2 inches away from the site of injection; red bump around the site of injection; warm to touch; red bump around the site of injection; muscle aches; pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red bump around the site of injection), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at the site of injection) and VACCINATION SITE RASH (rash 2 inches away from the site of injection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and CITALOPRAM for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INJECTION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red bump around the site of injection), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at the site of injection) and INJECTION SITE SWELLING (red bump around the site of injection). On 01-May-2021, the patient experienced VACCINATION SITE RASH (rash 2 inches away from the site of injection). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red bump around the site of injection), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at the site of injection), VACCINATION SITE RASH (rash 2 inches away from the site of injection) and INJECTION SITE SWELLING (red bump around the site of injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Medication includes: Ibuprofen and Tylenol. Action taken with mRNA-1273 in response to the event was not applicable. She received the second dose (Lot: 048B21A, expiration:unknown) on 29APR2021 at 4 PM on her right upper arm. On Friday 30APR2021, she had a red bump around the site of injection that was warm to touch. She also had pain at the site of injection and muscles aches. She took Ibuprofen and Tylenol. On 01MAY2021, she noticed another rash 2 inches away from the site of injection. Patient is currently taking citalopram 40 mg and prenatal vitamin.
Red itchy rash, some burning, first on arms, then progressed everywhere, head, back, legs, scalp.
Some kind of autoimmune response / Doctors / said she has brachial Neuritis; Drop hand of right hand; Lost part of the use of her right hand / Can't open right hand; Pain in / right elbow that traveled to her right forearm / Pain settled in / hand; This case was reported by a consumer via other manufacturer and described the occurrence of brachial neuritis in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 22nd February 2020, refer case US2021AMR082921.).   On 23rd November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 5 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced brachial neuritis, wrist drop, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the brachial neuritis, wrist drop and injected limb mobility decreased were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the brachial neuritis, wrist drop, injected limb mobility decreased and pain in arm to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows:  The reporter was patient's husband. The age at vaccination was not reported.  The patient received flu vaccine in right deltoid and had pain in her right elbow that traveled to her right forearm, about 2 months after that the pain settled in her hand and less than 5 months after receiving Flu vaccine, she had drop hand now in that hand and could not open her right hand but still had full grip strength. The reporter stated that doctors and neurologist had not been able to pin down a firm cause and less than 5 months after receiving Flu vaccine, said she had brachial neuritis. The reporter stated that perhaps it was some kind of autoimmune response to the vaccines. They did all kinds of testing and to ruled out diabetes, rheumatoid, lyme disease, just about everything per caller. The reporter also asked was it possible for his wife to get the vaccine in a different location such as her rear end or thigh. The reporter and his wife had not been able to get any information on if she could get the Covid vaccine and was concerned about her getting the vaccine, did not know if she should get it; or was there some safer way for her to take it. The reporter confirmed his wife had not had any doses of any of the Covid Vaccines thus far and stated they were hoping since these vaccines were newer technology and not dead viruses might be it would be different for his wife. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR082921:Same reporter
A rash started on my left side of the neck on 4-05-2021 and has spread to the other side of my neck by 4-06-2021. It doesn?t itch but it is irritated and becomes uncomfortable if it is messed with like if my seatbelt rubs it.
Extreme pain during and at injection site.  Sore arm.  Next day  (4/18/23) developed a fever of 100, slight nausea, headache, tiredness.  On 4/19/23, temperature fluctuated from 99 to 100 throughout day, headache, tiredness.  But I do slightly feel better today than yesterday.
Pharmacy reported to patient that he was given a full vial of the vaccine instead of one dose. They indicated the error was not diluting it before giving him what they thought was one dose. He reported that it burned when he was injected with the vaccine.
Patient was end stage dialysis last dialysis was on Friday Nov 5th  she refused to go to dialysis on Monday Nov 8th. Patient received vaccine on  11/09/2021 and on 11/10/2021 was unresponsive at 7am sent to ER and expired.
Patient reported to the emergency room from fever and shortness of breath the day after receiving the COVID-19 vaccine. Patient was found to have a UTI and possible sepsis. Unknown if truly related to COVID vaccine.
Can't sleep; Weak; Groggy; Site of injection was very sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't sleep), ASTHENIA (Weak), SOMNOLENCE (Groggy) and VACCINATION SITE PAIN (Site of injection was very sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced INSOMNIA (Can't sleep), ASTHENIA (Weak), SOMNOLENCE (Groggy) and VACCINATION SITE PAIN (Site of injection was very sore). At the time of the report, INSOMNIA (Can't sleep), ASTHENIA (Weak), SOMNOLENCE (Groggy) and VACCINATION SITE PAIN (Site of injection was very sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-181682 (Patient Link).
Pt recvd vax 3JUN95 & 6JUN95 pt exp tremor;follow up from the pts MD indicated that pt exp sz activity;EEG suggested that pt had a long standing undetected abn;
Left acute axillary lymphadenitis, swelling at injection site, mild bi-frontal headache. No fever, body aches or other bodily symptoms noted.
pt recv vax; red area approx 70 mm in length; area warm to touch; round in appearance
On 20 March 2007, he received the booster dose of Hib-MenCY-TT (IM R upper thigh). MMR II (SC L upper arm), VARIVAX (SC R upper arm) and Prevnar (IM L upper thigh). On 03 April 2007, 14 days after the 4th dose of Hib-MenCY-TT, 14 days after the 1st dose of MMR II vaccine, 14 days after the 1st dose of Varivax, 14 days after the 4th dose of Prevnar, 14 days after the unknown dose of Hepatitis B vaccine, this 13-month-old subject developed idiopathic thrombocytopenia purpura. On that day, the subject was hospitalized. Relevant test results included complete blood count : white blood cells (1030 mm3), hemoglobin (11.8 g/dl), hematocrit (34.6%) and platelet count (2300). On review, platelet count was 16000. Subject received immunoglobulin. On 04 April 2007, the subject as discharged. The event improved on an unspecified date. The investigator considered that there was no reasonable possibility that the idiopathic thrombocytopenia purpura may have been caused by Hib-MenCY-TT, Varivax, pneumococcal vaccines but considered the ITP either to be viral associated or associated to MMR II and/or Hepatitis B vaccination.
Fatigue day afterwards; Swollen lymph node in left armpit noticed on secondday after injection; Tender to pressure/ sore if arms reached up above head.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 21Apr2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 the patient experienced, swollen lymph node in left armpit noticed on second day after injection. On an unknown date in Apr2021, the patient experienced tender to pressure, sore if arms reached up above head. On 23Apr2021 at 08:00, the patient experienced fatigue day afterwards. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue day afterwards, swollen lymph node in left armpit noticed on second day after injection. Tender to pressure, sore if arms reached up above head was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt states approx. 24 hours after recieving Yellow Fever vaccine in outer aspect of Left Arm, local erythema and edema was noted approx 40mm in diameter. Pt states he also noted joint aches around the same time and still reports these symptoms. Pt states he is unsure if his joint aches are related to the vaccine.
large local rxn w/in 12hr;malaise, arthralgias, nausea w/in 24hr;eval + skin test reactivity @ 1:100 w/u;
Idiopathic thrombocytopenia purpura onset 3 days p/vax;
4hrs post shot - sore arm with increasing soreness throughout day. 10 hrs post shot - fever, chills, fatigue, joint pain, back pain, overall flu like symptoms. continued for 36 hrs post shot, managed with acetaminophen 1g q6hrs. 48 hrs post shot - ONLY Left cheek  edema, erythema, skin induration on affected area, hot, mild (2/10) pain; no other clinical signs of allergic reaction. Improved after 20 mg zyrtec + 40 mg IM Kenalog. Diagnosed with an allergic reaction, prescribed 6 day course or tapered dosing prednisone. 60 hrs post shot - Left cheek still swollen with involvement of suborbital zone, significantly improved from previous day, very mild erythema, mildly warm to touch, mild (2/10) pain. continued treatment occurring upon submission for this report. Patient has pictures of hourly progression of lesions.
Fever, multiple recordings at home over 2 days, to Tmax 103.5F.  Nothing else, no other symptoms.  Resolved within another 1-2 days.
Developed 3 X 5 cm raised pink macula at site of injection.  Not itchy, is warm, 0 nodes.  Treatment with BENADRYL, ice.  Occurred X 24 hours after vaccine given; also noted to have fever up to 102.6 B Otitis media diagnosed 4/11/10.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 02-Dec-2011. The patient received a repeat dose. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The patient had no late occurring adverse events.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored GARDASIL 9 (lot# R009614, expiration date: 30-NOV-2020, strength, dose, frequency and route were unknown) for prophylaxis. The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
Patient developed shortness of breath upon exertion on 2/16/21 after receiving his second COVID vaccine on 2/12/21. He had an office visit on 3/3/21 with his PCP where he was found to have an elevated d-dimer. He was sent to the ED for a CT-scan that confirmed an acute bilateral pulmonary embolism with large burden of thrombus within the right lung. He was admitted from 3/3 to 3/11. He underwent a pulmonary arterial embolism on 3/5. He was also on a heparin drip while inpatient. He was discharged on Eliquis.
Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. The patient had received 2nd booster. The dates of administration were 03-May-2022, 04-May-2022, 09-May-2022, 11-May-2022, 17-May-2022, and 20-May-2022. No treatment medication reported by reporter.
1/17/19 - chills/shivering - fever 101.3, pain and swelling at site of injection - upper left arm muscle. Went to ER. 1/18/19 - pain in chest near left arm. 1/20 extreme rash and redness with drainage under chin forming crystals on skin if not covered w/gauze. The rash extended from under chin (with swelling) to right ear covering most of chest. Necessary to cover all of effected area w/gauze and secure as best I could w/1 hand. top of left hand and wrist also had severe rash; covering needed there also. Right arm had several spots at inside of elbow, 3 to be exact which also had severe red rash and coverage necessary. 1 small spot above L. eyebrow formed crystal and redness but did not need covering. 3 red spots on stomach did not drain - no covering needed. The redness on the chest was so bright red it resembled a piece of fresh steak being put on the grill. Took pictures to verify and remember for years to come. Blood work at the Emergency Room proved all O.K. The Echo of the heart and Stress test were fine, in fact, the cardiologist assured me I have a strong heart. They never did get to see the "red rash". My granddaughter has had the shingles 3 times on her face and my son has had them once on his face also, so this is what gave me the idea I needed protection. Last Spring I saw an interview with a doctor on TV news regarding the SHINGRIX shots - prompting me to take action. I received shot #1 on 7/17/18 and could not find the second shot until 1/17/19 - exactly 6 months later. I was confined to my home for 2 weeks except for the 3 doctor visits. Have only been out twice since then. No insurance coverage on these vaccines. My cost $332.14 total.
C/O left leg pain & blurred vision from date of injection 7/25/12 to 7/31/12 also c/o numbness & tingling in left leg. No treatment ordered.
Redness, itching swelling, hot to touch surrounding injection site...large lump beneath skin area initially approximate 3 inches x 5 inches, on 051013--area 3 inches x 4 inches.
Woke up the morning after receiving vaccine and had swollen right shoulder/armpit with some edema in armpit. Tender to touch but not painful
3/19/11 - routine screening blood tests showed thrombocytopenic platelet=51,000.
Received expired Fluzone QIV with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician via regulatory authority number: 00814427.  This case involves a 13 years old male patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7108MA and expiry date: 30-Jun-2021 via intramuscular route in unknown administration site prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax;exp redness,swelling at inject site from hip to  knee;md stated pt had injury on affected leg that was unk to him;
I GAVE PATIENT 16 YR OLD VACCINES. MENQUADFI AND TRUMENBA IN THE LEFT ARM AND FLU IN THE RIGHT ARM. PATIENT  SAT IN THE CHAIR FOR ABOUT 5 MINUTES. SHE THEN GOT UP AND SAID THAT SHE FEELS DIZZY AND FAINTED BUT I CAUGHT HER SO THAT SHE DOESN'T GET HURT. I THEN CALLED FOR PA... SHE ATTENDED PATIENT. I ASKED PATIENT IF SHE ATE TODAY AND SHE SAID NO. PA THEN PUT PATIENT INTO ONE OF THE EXAM ROOMS FOR 15 MINUTES. PA THEN CHECKED ON PATIENT BEFIORE SHE WAS ABLE TO GO HOME. `
Per patient the following day she woke up and had 101 degree fever, myalgia, and rash on frontal part of body. Went away after 3 days.
Patient received Pfizer for the 1st, and 2nd doses. Her third immunocompromised dose was accidently given as Moderna. Patient waited her 15 minutes after vaccination with no issues reported, no signs, and no symptoms. Nothing reported after 24 hours of receiving the vaccine.
Vaccine was improperly stored in the Freezer. Pfizer determined vaccine was not viable.
Has had joint pain in the right arm and left knee starting approximately one day after injection. Status had been to MD and he could find nothing abnormal and related pain back to injection.
This case was reported by a consumer and described the occurrence of fever in a male patient who received SHINGRIX. On 12th April 2018, the patient received SHINGRIX. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown. It was unknown if the reporter considered the fever and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on the past Thursday before the date of reporting. A day before reporting, in the afternoon, the patient started to experience bad muscle aches and fever. The patient wondered how long the side effects would last.
She developed an 11 x 14 cm slightly indurated erythematous area on right upper lateral thigh one day after receiving DTaP and MMR injection in that thigh.
Extreme fatigue. Aching all over body. Sore arm. Shivering.
I had the first covid vaccine on 3/20/31, I then found out I was pregnant on 4/2/2021. I recieved the second vaccine on 4/14/21 and at my first scheduled ultrasound on 4/27/21 there was no fetal heartbeat.
Right sided intermittent eye pain, ongoing on a daily basis since June 10, 2021.  Treated with warm compresses, ibuprofen and acetaminophen. Unresolved as of this report.
Patient presented to Medical Treatment Facility on 20June06 with elevated temp of 102.5, body aches and swollen lymph node to L arm pit. Received smallpox vaccination on 9June06. IV fluids NaCl .9% administered. Tylenol 650mg given. Quarters times 24 hours. Temperature decreased to 98.6 one hour after IV administration/Tylenol.