chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness around the injection site; swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen). At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.   Reporter did not allow further contact
1-2 DAYS AFTER VACCINATION PATIENT EXPERIENCED ARM NUMBNESS. TODAY AT 2ND DOSE SHE NOTIFIED US SHE STILL IS EXPERIENCING IT BUT HAS SLIGHTLY IMPROVED IN SENSATION
No information on where vaccine given but patient presented to Hosp. ED 6/24/11 3 hrs after Typhoid vaccine. Complaints of weakness, chills, difficulty breathing & arm heaviness. Observed, given TYLENOL & discharged.
Shingles along the T4 dermatome pathway/red eruption; Burning, stabbing pain in left breast spreading to outer side and al along left upper back; Burning, stabbing pain in left breast spreading to outer side and al along left upper back; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in Arm Left on 01Mar2021 13:15 (Lot Number: EL 3247) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. On 08Mar2021, the patient shingles along the T4 dermatome pathway, one week after vaccine dose. Burning, stabbing pain in left breast spreading to outer side and al along left upper back. Noticed red eruption 2 days ago and went to PCP who diagnosed as shingles. The events resulted in doctor or healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect. The outcome of the events was recovering. The events were treated with Valtrex 1GM TID for 7 days and Prednisone 20 mg 2 tabs once a day for 5 days.  No follow-up attempts are needed. No further information is expected.
Called health system call center to report sxs post vaccination. Seen at urgent care on 5/2/21 for nausea/HA/diarrhea and loss of taste. Pt states that she reportedly had these symptoms the next day after receiving her first dose.  Pt was COVID negative nasal swab 5/2/21. Had previous COVID infection in 11/2020. Pt advised to monitor symptoms and to go to ED if symptoms worsen.
Information has been received from a pharmacist concerning a 79 year old female who on 11-JUN-2007 was vaccinated with a first dose of Zostavax (Oka/Merck) at a physician's office.  There was no illness at the time of vaccination.  On approximately 13-JUN-2007, two days after vaccination the patient developed a rash.  The patient had contacted the physician and he had sent her back into the pharmacy on 18-JUN-2007 to received a MEDROL DOSEPAK.  A product quality complaint was not involved.  No further information is expected.
Diarrhea; Very little appetite; nausea; Headache; chills; Pain in the arm at the injection site; Stomachache; shaking; sweating; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomachache), NAUSEA (nausea), TREMOR (shaking), CHILLS (chills) and HYPERHIDROSIS (sweating) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (NO MEDICAL HISTORY.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache), NAUSEA (nausea), TREMOR (shaking), CHILLS (chills), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (Pain in the arm at the injection site) and HEADACHE (Headache). On 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and DECREASED APPETITE (Very little appetite). At the time of the report, ABDOMINAL PAIN UPPER (Stomachache), NAUSEA (nausea), TREMOR (shaking), CHILLS (chills), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (Pain in the arm at the injection site), HEADACHE (Headache), DIARRHOEA (Diarrhea) and DECREASED APPETITE (Very little appetite) 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 concomitant medications was given. No treatment information was provided.
low grade fever; achiness; slight nausea; chills; UTI; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 71-years-old female patient (non-pregnant)received bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 15:15 (Batch/Lot Number: EN6200, Expiry date was not reported) (at the age of 71-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history was not reported. Concomitant medications included losartan, pantoprazole, nitrofurantoin and vitamin D. Dosing regimen details, Start and stop dates of all concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm left on 27Jan2021 16:00 (Batch/Lot Number: EN5318, Expiry date was not reported) for covid-19 immunization. The patient did not have covid prior to vaccination and has not been tested for covid since vaccination. The patient did not receive any other vaccine within 4 weeks of covid vaccine. On 21Feb2021, the patient experienced urinary tract infection. On 07Mar2021, the patient experienced low grade fever, achiness, slight nausea and chills. It was reported that 1 day after second vaccination the patient experienced low grade fever, achiness, slight nausea, chills for one day ,18 days after second vaccination she again experienced the exact same symptoms for one day. The patient received antibiotics for urinary tract infection and did not receive any treatment for other events. The clinical outcome of urinary tract infection was unknown and other events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
strong headache that was mostly relieved with Tylenol; completely resolved within ~12 hours
PATIENT STATED SHE FELT "VERY OFF AND JUST ALL AROUND BAD" FOR AN ENTIRE DAY THEN FELT FINE AGAIN THE NEXT DAY.
Raised, bumpy, red, swollen rash on both lower forearms and backs of arms and elbows, lower back to buttocks, calves of both legs, back of neck and  back of hands. Occurred day following vaccine and has persisted for over a week so far.
2nd dose of hepatitis b given on 9/30/10, returned to clinic on 10/20/10 with pitting edema to elbow, forearm, and hand
This spontaneous report was received from a medical assistant and refers to a currently 1 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894,expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis and LIQUID PEDVAXHIB lot#R005116, expiration date 28-NOV-2020, lot#R004963, expiration date 21-NOV-2020 (dose and route of administration were not reported). There was no adverse effect reported. It was unknown, which lot# was administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA008636:Original Case : 1809USA008636, US-009507513-1809USA010336:Original Case : 1809USA008636, US-009507513-1809USA010335:Original Case : 1809USA008636, US-009507513-1809USA010334:Original Case : 1809USA008636.
A non-serious spontaneous report of influenza A has been received from a health professional concerning a seven-year-old, subsequent to FLUMIST. The patient had no significant medical history. The patient was not taking any concomitant medications and did not receive any other vaccinations on the day that FLUMIST was administered. The patient received FLUMIST on 25-Oct-2010. On 17-Feb-2011, the patient contracted Influenza A. The outcome for the reported adverse event was resolved. Additional information was received on 09-May-2011 and incorporated in the narrative: reporter information, patient's medical history, concomitant medications and outcome of the event.
Patient states she started having left arm pain the evening after the vaccination and believed this was normal because she was educated about the side effects of the vaccine. However, after 3-4 days of pain, she began to think it was something more serious. She developed arm swelling from her shoulder to above her elbow that required the use of a Methylprednisolone dose pack. She still has limited use of her left arm over a month after vaccine administration and cannot put any pressure on the arm without extreme pain (no sleeping on arm, picking up items, etc.). Patient had an ultrasound of left arm and a small fatty cyst was discovered. It is unknown if this was present before administration, or developed after administration. Patient has also needed muscle relaxers to help with pain. She states she is now having nerve pain shooting into her neck, down to her shoulder and down past her elbow. Patient is going to complete at least 4 sessions of physical therapy to help with pain. The symptoms have not resolved at all since administration and have only progressed, even a month after administration.
Left arm pain, swelling, Itching, since vaccine administration. Symptoms worsened > 2 wks after administration of vaccine. Also with stiff (L) shoulder, neck + radiation of pain down volar surface of left arm to palm
inj site had small red area (less than 1cm) when mom went to work 8AM;when returned home 2PM pt was crying;lt upper arm, hot red, swollen;pt given advil-also prescribed DPH;
ITCHING AT SITE OF INJECTION; OOZING SITE OF INJECTION; DIZZINESS; HIGH BLOOD PRESSURE; NAUSEA; HEADACHES; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced itching at site of injection. On OCT-2021, the patient experienced oozing site of injection. On OCT-2021, the patient experienced dizziness. On OCT-2021, the patient experienced high blood pressure. On OCT-2021, the patient experienced nausea. On OCT-2021, the patient experienced headaches. Laboratory data included: Blood pressure (NR: not provided) high. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching at site of injection, oozing site of injection, nausea, dizziness, headaches, and high blood pressure. This report was non-serious. This case, from the same reporter is linked to 20211014731.
Rash on neck 4:40 Benadryl 25mg PO  Pt denied other symptoms left to go home
This non-valid spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, drug reactions and allergies. The patient concomitant medication included sterile diluent (MRK), which was used to reconstitute the vaccines VARIVAX and PROQUAD. Since 13-FEB-2018, patients were vaccinated with doses of VARIVAX (dose, units, frequency and route not reported) (lot numbers N017395, expiration date: 07-JUN-2019; N026700, expiration date: 20-SEP-2019 and N021722, expiration date: 10-AUG-2019) and patient was also vaccinated with dose of PROQUAD (dose, units, frequency and route not reported) (lot numbers N025926, expiration date: 08-MAR-2019 and N019251. Expiration date: 20-DEC-2018) which were improperly stored at a temperature from 6 (Fahrenheit) F to 14 F (8.4F) for 1 hour 42 minutes. No adverse events were reported. On 01-MAR-2018, reporter contacted in regards to the temperature excursion, no further information was received until the time of report upon conduct evaluation. Reporter stated that there was no previous excursion. Digital data logger was involved. No product quality complaint involved. This is a non-valid case due to lack of patient identifiers.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2007, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated at an urgent care center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
About 5 minutes after leaving had difficulty swallowing. Heart started racing. A few minutes later had sharp constant cough. Throat seemed to swell and still hard to swallow for about 20 minutes.  Started to feel a little relief.  Arrived at destination and took a Benadryl.   All happened very quickly.
This case was reported by a nurse and described the occurrence of anaphylaxis in a 4-year-old male patient who received KINRIX. Co-suspect products included PROQUAD. On an unknown date, the patient received KINRIX at an unknown dose and PROQUAD at an unknown dose. On an unknown date, less than an hour after receiving KINRIX, the patient experienced anaphylaxis (serious criteria GSK medically significant). The patient was treated with EPIPEN. On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to KINRIX. Additional details were provided as follows: The patient required emergency care including EPIPEN administration within minutes of administration of the vaccines. The patient was referred to an allergist, who would like to do further testing, but a dose of KINRIX was needed. The nurse inquired about the allergy clinic for a dose of KINRIX. It was unknown if the reporter considered the anaphylaxis to be related to PROQUAD.
Fever -immediately and still more than 24 hours later despite taking fever reducer.  Temperature going up.  Almost passed out due to rising body temperature and they kept me 30 minutes.
Pt recvd vax & exp myalgia & keratitis; pt exp myalgia & keratitis; pt recvd 3rd dose of Engerix as well as 2 more doses of Recombinant & the sx recurred p/each dose;
Upset stomach/Upset stomach after covid vaccine booster dose; Feeling abnormal/Felt a bit off since covid vaccine booster dose; Fatigue/Fatigue after covid vaccine booster dose; Pain in arm/Arm soreness after covid vaccine booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach/Upset stomach after covid vaccine booster dose), FEELING ABNORMAL (Feeling abnormal/Felt a bit off since covid vaccine booster dose), FATIGUE (Fatigue/Fatigue after covid vaccine booster dose) and PAIN IN EXTREMITY (Pain in arm/Arm soreness after covid vaccine booster dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach/Upset stomach after covid vaccine booster dose), FEELING ABNORMAL (Feeling abnormal/Felt a bit off since covid vaccine booster dose), FATIGUE (Fatigue/Fatigue after covid vaccine booster dose) and PAIN IN EXTREMITY (Pain in arm/Arm soreness after covid vaccine booster dose). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach/Upset stomach after covid vaccine booster dose), FEELING ABNORMAL (Feeling abnormal/Felt a bit off since covid vaccine booster dose), FATIGUE (Fatigue/Fatigue after covid vaccine booster dose) and PAIN IN EXTREMITY (Pain in arm/Arm soreness after covid vaccine booster dose) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2; I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "disable" (unspecified if ongoing), notes: I am disable fixed income dont have money for kit. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2".  Clinical course: Patients symptoms were mild but no tester was stressful due to the onset exposure time and 10-14 days upon results are making patient sicker.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202300036010 same patient/drug, different dose;
This case was reported by a nurse via other manufacturer and described the occurrence of passed out in a female patient who received MENVEO. Co-suspect products included TRUMENBA. In June 2016, the patient received the 1st dose of MENVEO (intramuscular) and the 1st dose of TRUMENBA (intramuscular). In June 2016, several hours after receiving MENVEO, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. In June 2016, the outcome of the passed out and dizziness were recovered/resolved. It was unknown if the reporter considered the passed out and dizziness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a Pfizer Territory Manager and was not provided product information by the reporter. The patient's medical history was unknown. Concomitant medication were unknown by the reporter. On 17th June 2016, the non-GlaxoSmithKline sales representative stated that he was on luncheon at a pediatric office and a nurse and a physician shared adverse events for 4 separate patients who received MENVEO and standard 1st dose of TRUMENBA (non-GSK vaccine). They stated that at least 3 patients also received MENVEO on the same day. The reporting sales representative had limited information regarding patient's details (initials, date of birth, age, height, weight, and ethnicity was unknown) and adverse events. In June 2016, few hours after vaccination with MENVEO and TRUMENBA on the same day, the patient experienced dizziness, lightheadedness and passed out. The patient went to the emergency department. The date of visit to emergency department and the duration of the visit was unknown. In June 2016, the patient underwent blood test and the blood work was fine. Other investigation was unknown. The reporting sales representative did not have reporting nurse's last name. The reporter email and prescribing email was unknown. The National Drug Code (NDC), lot number and expiration date was unknown for both TRUMENBA and MENVEO. The nurse did not have time to provide that product information at the time of reporting. The patient had not received another vaccine due to the 2nd dose was not due at the time of reporting. This case was not associated with product complaint and there was no medical information request. This case has been linked to cases US2016GSK116036, US2016GSK116037 and US2016GSK116038, reported by the same reporter.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with high blood pressure, thyroid disorder, high cholesterol. Patient did not have any drug allergy. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J007211, .65 ml, subcutaneous. No concomitant medications were there. On 15-JAN-2014, 3 days after onset of therapy the patient experienced bumps, redness, itching and swelling at the ZOSTAVAX. The outcome of bumps, redness, itching and swelling at the ZOSTAVAX and injection site is unknown. No laboratory tests were done. Medical attention was sought by consulting pharmacist. The pharmacist advised the patients to stop scratching the area and to apply a cold compress to the area. This case is linked to 1401USA010679 due to same reporter link. Additional information has been requested.
Mom reports (L) upper arm as red & swollen. Warm to touch. Low grade temp.
The patient was given a flu shot, and she said it felt weird. Now over a month later it hurts to lift her arm, and she is in constant pain. She said it felt weird when the shot was given, but she thought it would go away. There's no knot, and her PCP said heat would help - and it does some. But the patient's mobility is severely limited.