chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy around injection site; redness around injection site; swelling around injection site; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE SWELLING (swelling around injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL, CHLORTHALIDONE and POTASSIUM CHLORIDE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 12-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE SWELLING (swelling around injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. On 06-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, INJECTION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE SWELLING (swelling around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included ice pack application.
cough, runny nose, tired, sinus congestion, nasal congestion. starting 12/26/21
Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks.  She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath.  They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.
Left arm (where  vaccination shot been done) redness (spot approximate 4 in. diameter) and filling higher temperature than other parts of the body, little stiiness at that area, started 5-6 days after vaccinaton and does not  dissapear after couple days,.
I thought I was getting a cold. I was so tired. I tested positive for COVID-19 on October 02, 2022, and it was positive. I had a telehealth visit with the nurse practitioner. The symptoms I had were that of pneumonia. I physically went to see the doctor on November 13, 2022, and they checked my blood oxygen level which was really low around 88. They had the medical staff personnel to take me to the emergency room in a wheelchair. They did a flu test and I tested positive for the B strain of flu. They admitted me and I was taking TAMIFLU, amoxicillin, and steroids via IV. I was on 2 liters of oxygen and given a generic form of ROBITUSSIN. I was hospitalized for 6 days. When I was discharged, I was prescribed oxygen which I took for about a week and a half. I was placed on a machine to determine how much oxygen I was using at night and if it's within normal levels, they will pick up the oxygen. I was placed in isolation due to the flu virus.
Fever, Diarrhea, NauseaVomiting, Tachycardia, fatigue Narrative: Fever, nausea, fatigue, tachycardia to 162; self treating with acetaminophen and ibuprofen.
mom reports pt w/swollen gland to groin/neck by day 5 p/;fever, glands as big as walnuts in groin, rash chest, groin, visible glands in neck 7JAN;seen by MD; fever as high as 103;hx of allergies;
Starting right after receiving the vaccine, I had pain and swelling at the injection site. Then, I started getting a fast heart rate and they said that was okay. I stayed at the clinic for 30 min after receiving it to be monitored. I went back to work and a few hours later I developed back pain. I have arthritis so i didn't think to much about it at first. However, it got so much worse that it felt like I was in labor (10/10 pain) and I was instructed to go see the doctor. So I went back to the clinic (Dr.) and he gave me Naproxen 250mg to take and I was instructed to take 2 tablets 2x daily. I went home and laid in bed. I got full body sweats and I felt like I had a fever. I have never sweat so bad before. Then, the next day, I was okay after taking the naproxen. Just recently, 06/03/2022 I stayed home because I had a really bad migraine. I took the naproxen, benadryl and the motion sickness medicine and I stayed in bed all day. Since then, I have been having intermittent cluster headaches which I had following the 2nd COVID vaccine (Pfizer). Since I had the Pfizer COVID19 vaccines, I have developed migraines and they have gotten worse with each shot.
This spontaneous report as received from a nurse refers to a 5 year old patient of unknown gender. On 06-FEB-2014 the patient was vaccinated with a dose of MMR II (lot number J003625; expiry date 22-MAR-2015). Strength, dose and route were not reported. The MMR II that was administered to the patient had been exposed to 15.9 C for 5 hours. No adverse effect was reported. No further information was reported. Additional information has been requested.
Flublok Quadrivalent was accidentally administered to 17 year old with no adverse event; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a health professional.  This case is linked with case ID 2019SA291192 (Same reporter).   This case involves a 17-year-old patient of unknown gender who was accidentally administered with dose of QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] (lot number not reported via unknown route in unknown administration site).  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was as actual medication error due to inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Information on the batch number was requested.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. The nurse stated that the patient fainted after administration of GARDASIL. At the time of the report the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Patient's husband reported that pat experienced chills and had a series of red blotches around the site where the injection occurred. Symptoms occurred approx 24 hrs after vaccine.
A few house post vax, the pt complained of myalgias, dizziness, weakness, nausea.
Pt c/o of tingling/numb sensation in left arm following the injection; states it happened with first injection as well.
Fever to 101.4 F, bodyaches, chills, sweats, headache.  Symptoms for 2 days.
My left arm was sore and about 24hrs after the shot , I felt very warm and tired. I took my temperature and it was 100.0. I took a Tylenol around 7pm and went to bed and I was fine around 10:30 pm
Rash both arms; Rash Stomach; itching first day; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash both arms), RASH (Rash Stomach) and RASH PRURITIC (itching first day) in a 56-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 CITALOPRAM for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced RASH PRURITIC (itching first day). On 11-Apr-2021, the patient experienced RASH (Rash both arms) and RASH (Rash Stomach). On 07-Apr-2021, RASH PRURITIC (itching first day) had resolved. At the time of the report, RASH (Rash both arms) and RASH (Rash Stomach) outcome was unknown.        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.
Patient called pharmacy to make aware about 6 months after vaccine administered to report intermittent arm numbness from shoulder to elbow in left arm that started a couple of weeks after receiving the vaccine
Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (like a sunburn) at 2pm. Also felt jittery. Spoke to ER physician and advised to take po Benadryl. Took 2 doses before redness cleared. Jitteriness cleared the next day without Benadryl.
Circular red puritic rash surrounding injection site about 8cm diameter, non-indurated, non-tender lasting about 3 days, onset one week after injection. I reported it to public health the day after onset, but they never called back to get the appropriate information. It resolved with no after effects, but I saw an article today that it was an uncommon reaction ("delayed cutaneous hypersensitivity"), but thought I would report it for your data base. I'd be interested if this should cause any concern regarding the second injection, like getting it in the other arm.
Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss of taste. Day 2 post vaccination only loss of taste, slightly improved.
Large area of swelling, hot to the touch, redness in a patch about 6 inches long and two inches wide on the arm below the vaccination site. Numbness in the right side of the lips three days after the vaccination.  The numbness frightened me as I feared a TIA or return of Bell's palsy.  Went to ER on Feb .7 when the numbness happened.  Was examined by ER physicians, Blood work was completed, CAT scan done, cursory stroke exam completed by a PA and resident.  No diagnosis was made except for adverse reaction to the Moderna vaccine.  I had had COVID symptoms beginning on or about November 30, 2020.  Was not treated by a doctor at that time.  Just seemed like having a common cold.  Have never before had any adverse reaction to any vaccination.
Patient had syncopal episode after receiving vaccine and was unresponsive and hypotensive for 5 mins. Patient improved after rest and juice.
Pt. received flu vaccine to left thigh around 03:40 PM, 8/20/2015. He woke the next morning at 3:00 AM with dry throat, loud breathing, neck and back pain and general body aches. Transported to Emergency Room via EMS. Pt also c/o head pain and vomited x 1. Symptoms completely resolved at ER and pt. discharged home with parents.
On 7/3 I developed a sore throat and runny nose. Symptoms worsened on 7/4 and I tested positive. Reached out to my doctor on 7/4 and received PAXLOVID. After 4 days of medication I felt much better. After day 6 my symptoms returned and gradually lessened over the following 2 weeks.
Patient felt dizzy and fainted moments after receiving the Fluvirin.  Patient came to immediately and rested for a few minutes.  Patient was conscious but no aware of surroundings.  Patient stood back up despite recommendation to stay in horizontal position until paramedics came.  Patient's eyes became very dilated and went unconscious for a second time.  Patient layed waiting for paramedics.  After 10 minutes of rest, patient was coherent and responsive.  No further medical care sought.
One week after second shot on 3/4/2021 severe case of A-Fib, dizzy, loss of balance, lasted 24 hours Follow up with Doctor visit, Echo-Cardi  Possibly related on 7/22/21 second A-Fib event treated in ER - Began Medication Xarelto & Metoprolol Possible Related on 8/15/21 Third A-Fib Event Continuing investigation and medication adjustments.
pt recvd vax & noticed facial drooping, tingling, numbness & flu like symtptoms;
Patient stated his throat was tightening up and that he was having difficulty breathing shortly after (~20 min) receiving the vaccine. Parent stated that the patient has a known allergy to peanuts but was assured that the covid19 vaccine from Pfizer does not contain any peanuts. I checked to make sure the patient didn't have any hives or swelling in any other areas of body and face. Patient was still alert and able to speak but did display some labored breathing. I had an EpiPen ready to administer but first gave him 50 mg of diphenhydramine liquid which he showed difficulty ingesting and continued to monitor while EMS was on their way. When EMS arrived they checked the patient's O2 and it was at normal levels. EMS determined patient was okay and gave the parent the option of taking the patient home or she could have him taken to the ER in an ambulance. Parent decided to take patient home.
arm felt heavy after the second dose; fever of 100.2°F after the second dose; Strong headache after the second dose; Chills; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt heavy after the second dose), PYREXIA (fever of 100.2°F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNKNOWN and UNKNOWN) for COVID-19 vaccination.     Concurrent medical conditions included Cancer in remission and Immunosuppression (Immune system is very low).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced LIMB DISCOMFORT (arm felt heavy after the second dose), PYREXIA (fever of 100.2°F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine). On 22-Feb-2021, PYREXIA (fever of 100.2°F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine) had resolved. On 23-Feb-2021, LIMB DISCOMFORT (arm felt heavy after the second dose) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Arm is hot; Arm is itching at injection site; Arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is hot), INJECTION SITE PRURITUS (Arm is itching at injection site) and VACCINATION SITE SWELLING (Arm is swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm is hot), INJECTION SITE PRURITUS (Arm is itching at injection site) and VACCINATION SITE SWELLING (Arm is swollen). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm is hot), INJECTION SITE PRURITUS (Arm is itching at injection site) and VACCINATION SITE SWELLING (Arm is swollen) outcome was unknown.        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.   No relevant concomitant medications were reported. Other Treatment products include Hydrocortisone cream for an unknown indication.
pt recv vax & become also completely blind in the same eye & pt described it as being 3x worse than a/;
Patient received Menactra vaccine on 8/22/05.  Starting on 9/1/05, patient complaining of fever, headache, and flu-like symptoms.  Parent contacted clinic on 9/12/05 to report symptoms and that patient has gone to the emergency room twice, seen her primary care physician (PCP) twice, had blood work done at PCP's office (unknown what tests or results), and has had two antibiotics prescribed.  Symptoms continuing as of 9/12/05.  Fever on 9/11/05 was 101F.  RN at contacted me to report and document ADR.
Patient felt sick after Shingrix/severe reaction, felt sick; This non-serious case was reported by a physician via call center representative and described the occurrence of feeling unwell in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, less than a day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Patient felt sick after Shingrix/severe reaction, felt sick). The outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter stated about half a day after the administration of first dose of Shingrix, the patient experienced sever reaction, felt sick. The reporter stated the reaction occurred 3 months ago from reporting. Lot number and expiration date was asked but the information was declined. The reporter did not have more information as vaccine was administered at the different facility. The reporter did not consent to follow up.
Approximately 24 hours after receiving first dose of Moderna COVID-19 vaccine, patient experienced redness all over body that lasted for about one hour before it slowly faded away. Patient states he did not experience shortness of breath, rash, hives, itching, or fever. Patient states the only reaction was the color of his skin changed to red and slight increase in body temperature (but not fever). Patient states after about one hour the color of his skin returned to his normal skin tone. Adverse event resolved within one hour and patient has recovered and is currently well.
Swelling of left hand and arm. Treated with Benadryl and Prednisone.
pt recvd vax & devel prolonged abdo pain, fever, diarrhea (2 wks duration), beginning immed p/the vax;
L arm red, swollen and 1/2'' "bubbling.  No fever, SOB, V/D began 48 hrs after vaccination
This case was reported by a consumer via call center representative and described the occurrence of pityriasis rosea in a patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced pityriasis rosea. On an unknown date, the outcome of the pityriasis rosea was unknown. It was unknown if the reporter considered the pityriasis rosea to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The age at vaccination was not reported. The patient received the vaccine in left arm. One week after receiving SHINGRIX, the patient had some kind of pituriasis rosea like eruption on back. The diagnosis was made by a dermatologist and primary care physician.
(Currently occurring) nausea, inability to sleep, loss of appetite, diarrhea, watery stool, stomach cramps, headache, gas, back pain/ache.
Itchy rash formed at injection site 8 days after receiving the injection along with fatigue and overall not feeling well
Pt recv vax on 4/1/99; on 4/13/99 pt exp maculopapular rash-pruritus on head,arms, legs &torso, fever, puffy face, red hands/ ankles; tx=Benadryl
Patient developed large rash and pain in injected arm on 7/27. Presented on 7/28 and could barely move her arm. Followed up with her on 7/30 and she was doing better. She self treated w/ibuprofen, ice, and BENADRYL.
lymphodema that lasted for approximately 3 weeks, only on the side that received the injection. The swelling was large enough that I couldn't comfortably sleep with my arm by my side.
Pfizer 1/5/21, 1/26/21, 9/23/21. Positive on 1/17/22
Caller states she received her Pfizer BTC vaccine Booster dose; The person jabbing me did it really hard and I had large area of redness on my upper right arm, the size of my palm if not bigger; itchiness started; injection site swelling; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received bnt162b2 (COMIRNATY), administration date 22Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Caller states she received her Pfizer BTC vaccine Booster dose"; VACCINATION SITE ERYTHEMA (non-serious) with onset Nov2021, outcome "unknown", described as "The person jabbing me did it really hard and I had large area of redness on my upper right arm, the size of my palm if not bigger"; PRURITUS (non-serious) with onset Nov2021, outcome "unknown", described as "itchiness started"; VACCINATION SITE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "injection site swelling"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arm pain".  Additional information: After several days, the patient had then and now it was still big, but black and blue and still itchy but not as bad. The patient wanted to know if other people had this itchiness. Side effects that have been reported with the vaccine included: non-severe allergic reactions such as itching, injection site redness, injection site swelling and arm pain.   Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Probable cellulitis at the Left deltoid injection site of Tdap vaccine administered 7/15/15.
Tdap 0.5 mL IM R deltoid 5-20-2008.  Edema R deltoid & clavicle & supraclavicular lymphadenopathy R; R pain in deltoid.  Eval done 5-22-2008 & MOTRIN advised by Dr.