chrisvoncsefalvay/vaers-outcomes huggingface dataset:
normal pain in arm after the vaccine; lower back and down there is in pain; walking is difficult.; feel something weird after the vaccine; my legs bothered me after the vaccine; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (normal pain in arm after the vaccine), BACK PAIN (lower back and down there is in pain), GAIT DISTURBANCE (walking is difficult.), FEELING ABNORMAL (feel something weird after the vaccine) and PAIN IN EXTREMITY (my legs bothered me after the vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (normal pain in arm after the vaccine), BACK PAIN (lower back and down there is in pain), GAIT DISTURBANCE (walking is difficult.), FEELING ABNORMAL (feel something weird after the vaccine), PAIN IN EXTREMITY (my legs bothered me after the vaccine) and HEADACHE (headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (normal pain in arm after the vaccine), BACK PAIN (lower back and down there is in pain), GAIT DISTURBANCE (walking is difficult.), FEELING ABNORMAL (feel something weird after the vaccine), PAIN IN EXTREMITY (my legs bothered me after the vaccine) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was provided.   This case was linked to MOD-2021-213975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information received which contains dose 2 events.
So the first adverse event was shingles, and that was maybe a week or two after the second vaccine, I just don't know because I did not keep track of it all. The second thing was pain in the right shoulder and like terrible nerve pain going up my neck and down underneath my right armpit and also tingling up the right and back of my head - just burning, aching and made it hard to breath at times. I saw the DR at ER on 6/19/2021 and saw a sports medicine DR on 6/22/2021.
Information has been received from a physician via a field employee referring to a female patient of unknown age who was not pregnant. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not reported. On an unknown date the patient was vaccinated with GARDASIL (strength, dosage, dose number and frequency unspecified), intramuscularly. On an unknown date the patient developed an unspecified seizure disorder after she received the unspecified number of doses of GARDASIL. The patient's mother told the physician the patient had been consulting with an unspecified neurologist regarding the patient's seizure disorders, but she did not specified whether the neurologist had officially confirmed the diagnoses. The outcome of the event was reported as not recovered/not resolved. Causality was not reported. Upon internal review, the event of seizure disorder was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVD A COVID-19 VACCINE.
sore throat; sinus congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and SINUS CONGESTION (sinus congestion) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and SINUS CONGESTION (sinus congestion). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Sore throat and Sinus congestion, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and SINUS CONGESTION (sinus congestion) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative covid-19 tests and negative (Negative) Negative covid-19 tests.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   For the past 2 weeks patient has had a sore throat and sinus congestion that has started to get better. No relevant concomitant medications were reported.
weakness, SOB, Abdominal cramps, nausea and vomiting starting 5/28/2021.  admitted to the hospital required breathing assistance. tested positive for COVID-19 06/03/2021,  died 7/18/2021
Patient came to the pharmacy and complained that she experienced a rash and pain 4 days after getting PREVNAR 13 shot. The pharmacist on duty suggested to see her doctor, but she did not want to go to her doctor. She wants to take something over the counter. Therefore, the pharmacist suggested taking BENADRYL. She experienced some relief from the itching, but believes the medication is still causing a reaction and pain.
I developed moderate to severe tinnitus ringing in the ears 12 -16 hours  after my second dose of an mRNA vaccine.  It has  gotten slightly better in what is was, eight months since I was immunized.
got bad pneumonia p/2nd dose in series;shot in MAY94;was bronchial virus going around & got sick;went to MD;had to be hospitalized;had relapse, hospitalized again;pt exp anxiety & angina;
Pt was in office for a well check visit.  MD ordered ActHIB and Varicella and MA gave Gardisil HPV instead of the HIB by mistake.  Pt did not have any reaction as on 1:30pm when we called after noticing the mistake.
Received flu shot Thurs afternoon and by Friday there was a bright red patch covering 75% of outer arm starting about an inch below injection site. By Saturday pm the entire upper arm was swollen, red, and warm down to the elbow. We outlined in Sharpie. By Sunday am it had spread outside the marking so brought him to Urgent Care and was prescribed antibiotic for cellulitis.
Information has been received from a registered nurse concerning a 17 month old female who on 26Feb2004 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that on 10Mar2004 the mother called the physician's office and stated that her daughter had developed a mild case of chickenpox. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Left upper arm swollen, tender muscle from injection site down 1/3 of lateral arm (upper). Swelling well defined in muscle. No erythema. No skin changes. No fever. Pain with motion left arm. Onset of symptoms within a couple of hours post-injection. Treated with Prednisone 20 mg oral.
Fever of 102.7 F with 2 inch red circle with swelling. Baby cranky. Same size today. Gave Tylenol fever decreased to 101.7. Advised ice pack continue Tylenol, call pmd.
2  days after receiving 2nd Moderna along with flu shot patient have developed intermittent E; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (2  days after receiving 2nd Moderna along with flu shot patient have developed intermittent E) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (2  days after receiving 2nd Moderna along with flu shot patient have developed intermittent E). At the time of the report, VACCINATION COMPLICATION (2  days after receiving 2nd Moderna along with flu shot patient have developed intermittent E) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got flu shot along with second dose of Moderna vaccine. No treatment was reported by the reporter.
3/26 10pm Chest pain/tightness in chest.  4/11 6am Cough, congestion and sore throat.  4/14 12pm 2nd shot Persistent cough to present.
Prolonged vertigo, sense of dizziness, nausea and BP drops with feeling of passing out.
Immediately after vaccine, pt experienced dyspnea & lower back pain pt used her own Xoprenex inhaler. 9/1 was contacted and pt was fanned to give her fresh air. Vitals were monitored too pt refused to go to hosp.
pt received 2 doses same day Narrative: Unknow if any symptoms yet. Pt received 2 COVID doses on same day. First one at 9:13 am and second at 9:33 am
Information has been received from a consumer concerning her 8 years old daughter with no pertinent medical history and no known allergies who"years ago" "as a young child" was vaccinated with VARIVAX (Merck) (dose number lot number not reported, site unknown). In approximately 2006, when her daughter was 8 years old a growth appeared on her arm. It was not known at this time if this was where the vaccine was administered. The area was reddish, not dark but with a distinctive color. The growth was removed in the doctor's office and abnormal cancer cells were found. No chemotherapy or treatment required. The area has fully healed with scar present. The mother was questioning the use of fetal cells in the vaccine as the cause of the growth. Upon internal review, cancer was determined to be an other important medical event. No further information is available.
Mild swelling of lower left eyelid; 1. Pain at injection site (sore upper arm) - immediate onset; This is a spontaneous report from a contactable consumer, the patient.  A 49-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0176), via an unspecified route of administration, in arm left on 03May2021 18:15 (age at vaccination 49 years) as dose 1, single for covid-19 immunisation. Medical history included allergy to latex, benadryl, wellbutrin. The patient did not have Covid prior vaccination. No other vaccine was taken in four weeks. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC); ibuprofen; colecalciferol (VIT D); melatonin since an unknown date. The patient experienced Pain at injection site (sore upper arm) - immediate onset on 03May2021 at 18:15 and mild swelling of lower left eyelid beginning approximately 3.5 hours after injection on 03May2021 at 21:45 and lasting about an hour. No treatment was taken for the events. The patient was not tested for Covid post vaccination. The outcome of the event pain at injection site was recovering and for mild swelling of lower left eyelid was recovered on 03May2021.  No follow-up attempts are possible. No further information is expected.
Patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, redness, and swelling at injection site. This lasted 3 days, similar symptoms of when patient had COVID.
had the shots have them now/suspected vaccination failure; internal shingles; miserable pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shots have them now/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: internal shingles) and pain (Verbatim: miserable pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The reporter asked that anyone could tell him/her if they had shingles internally. The patient had the shingles shots. The patient had shingles now, internal shingles. The patient did not even know that was even possible but it was. The patient had shingles for 3 months now and it was the most miserable pain he/she ever had in his/her life and he/she had a lot of pain and surgeries. The patient had been reading where some of you had gotten shingles multiple times. The reporter stated that he/she lost his/her ever loving mind if he/she got these again.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Severe left lower quadrant abdominal pain/his pain is worse; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN LOWER (Severe left lower quadrant abdominal pain/his pain is worse) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. UJ901AB) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced ABDOMINAL PAIN LOWER (Severe left lower quadrant abdominal pain/his pain is worse). The patient was treated with ACETAMINOPHEN for Lower abdominal pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN LOWER (Severe left lower quadrant abdominal pain/his pain is worse) had not resolved.            No concomitant medications were provided.  It was reported that patient had received 4 doses of the Moderna COVID-19 vaccines by intramuscular injection on 20-FEB-2021 (lot number unknown, expiration date unknown), 19-MAR-2021 (lot number unknown,expiration date unknown), 26-NOV-2021 (lot number 012H21B, expiration date unknown).  The lot number of dose 4 was reported as 061F22A.  It was reported that patient had taken 2 acetaminophen and was able to sleep through the night.
Left arm is swollen, red, and warm to touch. Patient was advised to put cool compresses on the swollen area and to take MOTRIN. Patient was also seen at the PCP's office she works for & was dx with cellulitis, was started on CIPRO & steroid dose pack. She was advised to avoid any additional pneumonia shots.
Pfizer COVID Vaccine EUA: Rash, Serum Sickness, Febrile Illness. Patient received Pfizer Vaccines on 12/22/2021 and 1/21/2022. Presented to ED 1/28/2022 with complaints of pain in palms and soles x24 hours, with burning sensation, and rash on palms, soles, and over bilateral knees. Febrile on presentation with AST = 106, ALT = 173, Alkaline Phosphatase ALP = 305, Total Bili = 2.2, CRP 14.9 (Increased to 25.4 on 1/31). C3 Complement = 168, C4 Complement = 13.4, WBC 14.8 on 1/29 and 21.3 on 1/31, Hepatitis panel negative, HIV negative, RSV negative, Respiratory viral panel all negative, syphilis negative, typhus negative, Neisseria and chlamydial negative. Symptoms resolved with steroids, discharged home hospital day 4 on steroids.
Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via Agency number: 00812470.  This case is linked to cases 2021SA343449, 2021SA343828 and 2021SA343988 (same reporter).  This case involves a 13 year-old male patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant vaccines given to patient.  On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Injection; lot number: UJ769AC, expiry date: 30-Jun-2022, frequency/ drug interval dosage: once, strength: standard) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events).  It was reported "Caller reported last night a family of four who are all under the age of 65 were giving the FLUZONE HIGH DOSE VACCINE. Caller reported there are no adverse events at this time but wanted to make sure there was nothing to expect and what they should do from here."  Emergency room/ Doctor visit on 13-Oct-2021. Product used: Used and Still using product: No.  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 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.
On day 2 arm had redness and swelling but this was gone by day 3. Things went back to normal and patient concluded VSafe 7 day reporting. On day 8 the site began getting extremely itching and has swollen for three days and now has redness and rash on site of injection and is extremely warm to touch and itchy. Patient hasn?t reported to doctor yet as unknown whether this side effect is expected or whether it warrants doctor visit but patient wants adverse event to be known.  Patient doesn?t consider this adverse to be severe yet but somewhere between minor and moderate adverse reaction.
Fever, chills, muscle ache, fatigue, cough, congestion, sore throat, chest congestion, headache starting on September 3rd at approximately 0330 hrs.
After receiving the COVID-19 vaccine, I was diagnosed with Gestational Diabetes through the 1- and 3-hour glucose testing. My estimated due date is 7/13/2021.
Left arm has marked area of erythema (10x12cm), warm to touch and is bordered by 2 area of ecchymosis (approx 2x4cm) pt is not on anti coagulants.
This is a spontaneous report from a contactable consumer. A 72-year-old female patient received PREVNAR 13 (Lot # L93594; Expiration Date Jan2017) via an unspecified route of administration on 22Oct2015 at 0.5 ml single. Medical history included lung cancer from Mar2013 to 08Nov2014 (she had had radiation and chemo for a year and a half after diagnosis), chronic obstructive pulmonary disease (COPD) from Mar2013 and ongoing, emphysema from Mar2013 and ongoing, ongoing colitis since about 20-25 years ago and under control. The patient was on oxygen at the time of this report as she was a lung cancer survivor. Concomitant medications, all ongoing, included APRISO (caplets) at 0.375 mg once daily for colitis, clonazepam (manufacturer unknown) at 0.5 mg once daily to settle her down, SYNTHROID at 0.075 mg once daily for thyroid, SPIRIVA daily for emphysema, ADVAIR daily for emphysema, PROAIR as needed for emphysema. The patient experienced cough in Oct2015, and low grade fever, rib sore and throat sore on an unspecified date in 2015. The admission to hospital in Oct2015 was involved for cough, throat sore and rib sore. The patient had a bad cough about a week after getting PREVNAR 13. The cough got so bad she couldn't talk sometimes. She had had a bronchitis like cough that made her ribs sore and her throat sore. She also had a low grade fever with the cough. She then called her pulmonary specialist and he gave her nitrates and started her on prednisone (manufacturer unknown), both for cough. The cough had started getting to the point it was not so bad. She no longer coughed for 20 minutes at a time. No treatment was received for throat sore and rib sore. The patient was still experiencing cough, throat sore and rib sore. The outcome of low grade fever was unknown. Follow-up (30Dec2015): New information reported from a contactable consumer includes: PREVNAR 13 details (vaccination date, Lot # and Exp Date), concomitant details (ongoing), events details (seriousness, treatment and outcome).
when pushing the dose in the vaccine seeped out of the syringe at the hub; when pushing the dose in the vaccine seeped out of the syringe at the hub; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (when pushing the dose in the vaccine seeped out of the syringe at the hub) and UNDERDOSE (when pushing the dose in the vaccine seeped out of the syringe at the hub) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (when pushing the dose in the vaccine seeped out of the syringe at the hub) and UNDERDOSE (when pushing the dose in the vaccine seeped out of the syringe at the hub). At the time of the report, DEVICE CONNECTION ISSUE (when pushing the dose in the vaccine seeped out of the syringe at the hub) and UNDERDOSE (when pushing the dose in the vaccine seeped out of the syringe at the hub) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  concomitant and treatment medication information was reported.    This case was linked to MOD-2021-098598 (Patient Link).