chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at injection site; nausea; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number LA5RC, expiry date 22nd May 2021) for prophylaxis.   On 1st February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd February 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, nausea and flu like symptoms. On 4th February 2019, the outcome of the injection site pain was recovered/resolved. On 6th April 2019, the outcome of the nausea and flu like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nausea and flu like symptoms to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced pain on his left deltoid after receiving the Shingrix vaccine into the left deltoid. The patient experienced nausea and flu like symptoms for 63 days. For tolerance to the 2nd dose of Shingrix, refer case US2019GSK086420. There was a discrepancy in the reported outcomes in XML and the ones autoloaded in the Argus, however, outcome captured as per Argus.
pt complained of sore, swelled arm.  she also had vomiting and diarrhea today. suggested ice pack for arm and tylenol or ibuprofen for swelling/pain, forced hydration for other symptoms.
Pt presents to urgent care clinic complaining of itchy allergic rash consistent with appearance of hives on B/L knees & B/L forearms. This is approximately 2 weeks after received 2nd dose of COVID-19 pfizer vaccine from a different facility. Duration of symptoms: 1 day. Symptoms began on 05/04/21. Pt is to be treated with medrol dose pack, topical triamcinolone & oral hydroxyzine. Pt has been advised to return to office if symptoms persist or follow up with Dermatology.
Myocarditis with symptom onset one day after receiving second dose of COVID Pfizer vaccine
My left armpits is inching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (My left armpits is inching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (My left armpits is inching). At the time of the report, PRURITUS (My left armpits is inching) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow up contains no new information.
Pt had prolonged generalized sz about 15 hrs p/DTP was febrile @ hosp pt also had fever 40 hrs p/inject; had bronchospasm; suspect viral illness assoc fever & febrile sz;
shingles itching pain rash on left side under breast and up to armpit. Started -5/15/2021 home treatment
Mostly the local skin reaction: harden at injection site, 4 inches in diameter. By third day it was gone, some itching, flu like systems, hurt all over. I felt like I was fighting something half. Headache and neck pain. I may have taken ibuprofen when my neck hurt.
Patient presented to the ED and was subsequently hospitalized with toxic encephalopathy within 6 weeks of receiving COVID vaccination.
36 hours after, on 4/21/21, I started feeling tired and ran a low fever and diarrhea until 4/23/21 . Starting 48 hours after, I started having significant loud tinnitus in my right ear that lasted until 4/27/21. I also had a uveitis flare after each dose of this vaccine.
Flushed; Body aches; Red rashy spot; Fatigued; The site on my left arm got to a baseball size; Headaches; Felt like I would throw up; Ended up fainting/ went down for a second time; Diarrhea; Light headed; Discombobulated; A spontaneous report was received from a 58 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, flushed, fatigued, had body aches and headaches.   The patient's medical history included high blood pressure. Relevant concomitant medications included unknown blood pressure medication.    On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, around three, the patient experienced diarrhea, she thought it was food poisoning. While on the "pot" with diarrhea she felt that she would throw up. She mentioned that she became lightheaded but did not throw up and ended up fainting. She fell off the pot and decided to lay down in her bed. She got lightheaded again and went down for a second time. She stated she had a difficult time getting up; she crawled to the bed. When she attempted to stand up, she could feel she was lightheaded again. The patient mentioned that maybe she was down 45 minutes before getting to lay on her bed. She felt discombobulated. She felt very clumsy when trying to dial her sister's number; she left a message on the machine and was struggling to get her words together. The site on her left arm got to a baseball size, and in the middle was a red rashy spot.  On Friday evening, 26 Jan 2021, the patient stated she started feeling better. She mentioned that she was flushed, fatigued and had body aches. The patient stated she hasn't tried any treatments but took paracetamol for headaches and tried to rest.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, diarrhea, felt that she would throw up, light headed, fainted, discombobulated, site on her left arm got to a baseball size, and in the middle was a red rashy spot, were resolving. The outcome of the events, headaches, flushed, fatigued and body aches, were unknown.; Reporter's Comments: This case concerns a 58 year old female patient with medical history of high blood pressure, who experienced a serious unexpected event of Syncope and NS unexpected events of diarrhea, nausea, dizziness, confusional state, injection site swelling, rash erythematous, flushing , fatigue, pain and headache. The events occurred approximately 8 days after first dose of the study medication administration. she only took paracetamol for headaches and tried to rest without any other treatment.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient mom reports patients eyes rolled back into head and she slumped in her seat for 20 seconds during her first 15 minutes of observation. Mom brought patient to me for assessment. When patient presented to me, patient was alert and vitals were normal. I asked patient to remain seated for 15 more minutes of observation.  Mom did say patient exhibited this behavior once before at the eye doctor.  I informed mom to please check with patients doctor for follow up. Patient exhibited some mental disability and thats is why the mother is involved. I dont believe patient is capable of taking care of herself.
On 11/21/2003 had 2 immunizations.  See below.  1-2 hrs after immunizations, family noted "prickly heat appearing" rash on back, chest, under right eye, and right upper arm.  Hands from wrist down.  bilaterally red.  No respiratory distress.  Grandfather gave 2 Benadryl at bedtime.  On weekends works at local restaurant scrubbing dirty dishes.  Wore no gloves used mild detergent with dish washing.  When got off work Saturday.  Hands from wrist down were solid red bilaterally; right upper arm reddened, dry.  Lotion was applied which "burned".  Benadryl was given by grandfather.  11/23/03: Client worked, he did wear gloves.  Hands from wrist down had slight bilateral pitting edema, were sore and red.  He reported lotions and Vaseline "burned" when applied.  No respiratory problems, no muscle aching, no fever or weakness noted.  Benadryl was given at HS by grandfather.  11/24/03; Grandfather and patient into public health to report the above.  Patient has no rash on back, has a few pinpoint scattered rashes on abdomen, wrists, and hands bilaterally.  He had dry, rough, red and chapped skin with dried white cracks in skin.  No edema noted.  No rash or redness at injection sites.  Arms pale with mottling blue veins visible under skin.  Patient states his arms have never appeared this way before.  Outer right lower leg appears to have rough skin.  No itching.  He continues to have "burning" of skin when lotion is applied and has some soreness under right armpit.  Grandfather states the rash is drying out.  PHN instructed regarding the importance of going to ER if respiratory problems occur. 11/25/03: TC to patient and grandfather.  Rash on hands is "drying".  Olive oil is being applied with relief.  No new foods or new hand soap or laundry detergents.  Above information reported.
Pt received shots stayed in office for appx 20mins after. Pt left and returned about 45 mins later. Eyes black, face swollen, hard to breathe and sweaty. Took Pts vital signs he was stable and called for ambulance to pick Pt up and take to ER.
Emergency room 1/28/21 HPI Patient is a 66 y.o. female who presents with complaints of left hip pain reports is moderate severe sharp ongoing over the past few days and aggressive worse reports symptoms is moderate
This 12 yo received two vaccines (TDAP & MCV 4) in left arm administered by Medical Assistant on 11-1-10. Pt developed redness & swelling (local cellulitis) of Lt arm, 11/4/10.
erythema, pruritic, swelling, rash, discomfort, pain when articulating shoulder joint
Swollen and painful arm. 9 days post shot had ring around injection shot with itchiness
Skin cancer; Allergy to vaccine; MARKETING PROGRAME NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4237721-00 (AbbVie).  A female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN CANCER (medically significant), outcome "recovering", described as "Skin cancer"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergy to vaccine". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of skin cancer.  Clinical information: On unknown dates, the patient experienced skin cancer on face and leg and might be allergic to the covid-19 boosters. The patient developed skin cancer after starting on HUMIRA. In 2021, she had a surgery on her face to remove the area with cancer. On Jul2021, she had a second surgery on the skin on her leg. She suspected that she might be allergic to the ingredients of covid-19 boosters. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of the event skin cancer and allergy to vaccine with the suspect product BNT162B2 and adalimumab was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  As per Licensee opinion: The event of skin cancer on face and leg is not assessable for adalimumab. There is no reasonable possibility that the event of might be allergic to the covid-19 boosters is related to humira (adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the event skin cancer , allergy to vaccine with 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
No symptoms reported.  Called state ASAP after pneumococcal given.  Reported no harm to infant , watch for local reaction at site.  Mother notified will return for Prevnar after 6 months.
RECVD SECOND VAX ON 3/8/90. YHE NEXT DAY ONSET OF SYPTOMS:TEMP 99.8,SORE THROAT,SWELLING IN THROAT,FLY SYMPTOMS,BREATHING DIFFS,COUGH. NO TREATMENT PRESCRIBED.SYMPTOMS REMAINED 13-MAR-90.
Delayed large local reaction. Large--four inch diameter "oval" area with "tendrils" extending beyond. Raised, red, hard, very itchy, stinging, with very small areas of dark red around the center. Started day after vaccination and got worse for two days. Then faded over next five days.
Initial information received on 17-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves a 5 years old male patient who came to receive to DTAP but mistakenly given PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No Concomitant medication received. On 07-Jul-2017, patient received 0.5 ml single dose of PENTACEL (lot: C5456AA) via intramuscular route in left leg. It was also a case of actual medication error due to wrong vaccine administered as patient received PENTACEL instead of DTAP and extra dose administered as received extra dose of ACT-HIB. It was not reported if adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Patient received Pfizer Bivalent vaccine as the first vaccine in the primary series in error. Patient had not received any COVID vaccine and was given the Booster.
New onset of Tinnitus. Unknown if related to vaccine or not, but reporting it due to it being a symptom after receiving booster.
Extreme pain at injection site, unable to lift arm for 8 hrs, pain deminising after 8 hrs.
A  spontaneous non-serious report of administration of expired product was received from a certified medical assistant in a physician's office concerning a child of unknown age and gender. On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during flu season resulting in some medication errors that occurred shortly after teh product expired. Additional information was received on 09-Apr-2009 that included the results of root cause investigation for the medication error.
Left arm reddened and swollen area approximately 3-4 inches width; very sore. Recommended warm compresses, Tylenol or Advil.
itching at the injection site; vomiting; fatigue; Soreness; Slight headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (Soreness) and HEADACHE (Slight headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (Soreness) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (Soreness) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Mom states child began to lose appetite the evening of immunizations.  He had a fever of 103 F.  Tylenol and Motrin were given with resolution of the fever, but the child remained lethargic and with no appetite.  No pain evident.  On the morning of 10/21; the child vomited a couple times.  He continues to be lethargic with no appetite, but with no fever and no signs of pain.
My face broke out into an itchy rash and my cheeks felt like they were burning similar to sunburn. I went to the doctor a week or so later. I was tested for lupus which I did not have. I was diagnosed with rosacea and prescribed Minocycline 100mg capsules 2x per day to treat the condition. Medication helped resolve the issue.
Arm is swollen. Patient reports size of 2 hard boiled eggs. Tender & painful.
(Td) placed 08-03-07 in (R) deltoid; pt. came to office 08-07-07 c/o (R) arm sore with "huge red area" has 3" to 4" (approx 8cmx10cm) erythema with 1.5 cm diam. firm, tender. SQ nodule centrally at site of injection. Pt. refused 50 mg for Keflex; seen again 08-10-07 with decreased erythema 6x6cm, decreased tender.
Pain down (L) arm into wrist and fingers - Pain started 2-3 days after shot.
Diagnosed and tested positive for COVID-19. Severe body aches, chest pain, difficulty breathing, night sweats, chills, fever, dizziness, vertigo
ACHY; MILD FEVER; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced achy, mild fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever, achy and tired was not reported. This report was non-serious.
Developed a Mondor's cord in the left breast on the same side as the shot as well as swollen lymph nodes in the left armpit. After palpation, doctor ordered a diagnostic mammogram and ultrasound to confirm the suspected thrombophlebitis diagnosis. Given topical NSAID for a month. Ultrasound repeated and cord and node swelling had resolved.
Shortly after being administered the HEP B vaccine on 4/8/17, the day he was born and was 2-3 weeks premature. He developed sleep apnea and stopped breathing in his sleep many times.
First dose received at 14 years old and second dose received at 17 years old/Pharmacist confirmed patient received dose 1 at age 13 and dose 2 at age 17; Caller did not provide any additional AE information at this time/No additional AE/PQC reported at time of call; This spontaneous report was received from a pharmacist concerning a 17 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On an unknown date  (reported as when the patient was 13 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).         On an unknown date (reported as when the patient was 17 years old), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  No adverse event reported.
throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.