chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a office manager refers to patients of unspecified demographics. Reporter stated that doses of improperly stored RECOMBIVAX HB 2.5/0.5 (unites unspecified) (lot number, expiry date unspecified) were administered to unspecified patients on unspecified dates. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
arm got so swollen went to ER twice; broke out in rash in both arms and front of chest; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm got so swollen went to ER twice) and RASH (broke out in rash in both arms and front of chest) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma and Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced RASH (broke out in rash in both arms and front of chest). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm got so swollen went to ER twice). The patient was treated with MUPIROCIN at an unspecified dose and frequency. In 2021, RASH (broke out in rash in both arms and front of chest) had resolved. At the time of the report, PERIPHERAL SWELLING (arm got so swollen went to ER twice) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included pill for cholesterol.  Patient never had any problem with the first dose. After 2nd moderna dose patient had broke out in rash in both arms and front of chest and arm got so swollen went to emergency room twice. Given with steroid and it was a small dose for 6 days and went back (to emergency room) and got another dose for 12 days because rash did not get better. Patient noticed rash about 2 weeks after second dose lasted for 3 months. Patient stated she really should not be on steroid cause as she has glaucoma (previously diagnosed). It was stated that they told patient at the eye place she should not be on any steroid but without them her could not get rid of rash, it was horrible.  Treatment information reported as went to a dermatologist gave her all kinds of stuff and mupirocin mixed with lotion cetaphil on arms
muscle pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reports a patient experienced muscle pain after getting the first Shingrix vaccination. The reporter was consented to follow up. The pharmacist stated she was calling from home and did not have other details about the product (lot number, expiration date), or patient details at the time of the initial report. This case has been linked with US2019AMR177866 having same patient (dose 2).
This spontaneous report was received from a female patient of unknown age. Current conditions of the patient included DEMEROL allergy, Neosporin allergy (derma manifestation), penicillin allergy and sulfa drugs allergy. The medical history included multiple cases of shingles since 2003. Approximately on an unknown date in 2006 (reported as 2006 or 2007), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included ATARAX (50 milligrams) (manufacturer unspecified). Approximately on an unknown date in 2006 (reported as between four and six months following the vaccination in 2006 or 2007), the patient broke out in another case of shingles. She reported that she had experienced between five and seven outbreaks of shingles between her first case and the case she was experiencing at the time of report. Since on an unknown date, she also suffers greatly from post-herpetic syndrome, experiencing pain from prior cases of shingles. The blisters, which had first occurred only on one side of her body seemed to be extending around her waist at the time of report. She described the pain as a biting mosquito-like sensation. She added that, because there was nothing stating that a prior case of shingles was a contraindication to receiving ZOTAVAX, the physician felt that it may or may not help her, but would probably not hurt her. It was unspecified if the patient sought any medical attention. The patient was treated with VALTREX (1 gram, three times daily for seven days). It was unspecified if any lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Hot, itchy, red rash. Went into AFIB a few hours later and had difficulty breathing. Rash has lasted five days now. The AFIB and difficulty breathing lasted the rest of the day. I seem to be slowly recovering.
The patient had not had any issue/No additional AE; Customer called to report that a patient was admin a expired dose of GARDASIL 9.  Caller did not have any other information at time of call.  No PQC.  Caller reported that the patient had not had any issues. LOT: Unknown by reporter EXP: Unknown by r; This non-valid spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, medical history, concomitant medications, drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot #, expiration date, dose, route of administration, anatomical location not provided) for prophylaxis (expired product administered). It was reported that the patient did not have any issue.   This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the pharmacist on 30-SEP-2022. The patient was female in her 20s. On 27-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, prefilled syringe, lot # 1659422, expiration date 04-SEP-2022. No additional adverse event was reported (no adverse event).
No additional AE reported.; Medical assistant reports patient was accidently administered an expired dose of VAQTA on Nov 15, 2022. Product expired on Nov 11, 2022. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC r; This spontaneous report was received from an other health professional (Medical assistant) and referred to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 15-NOV-2022, the patient was accidently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (once, lot #U031911, expiration date: 11-NOV-2022, dose, strength, anatomical location and route of administration were not provided) administered for prophylaxis (Expired product administered). Product had no prior temperature excursions. No further information provided. No additional adverse event (AE) reported (No adverse event).
Patient was administered Immunizations by nurse and within a couple of minutes patient became pale, faint and sick to his stomach. Nurse assisted patient with a cool wash cloth and fan and two nurses assisted patient from chair to exam table with legs elevated.  Patient stated he did not have lunch today.  Mother present during fainting episode and support provided and monitored for 25 minutes prior to going home.
Redness, swelling, and warmth on L arm near shot started next morning; treating with cephalexin 500 mg QID x 10 days
PHYSICAL SIDE EFFECTS; EMOTIONAL SIDE EFFECTS; MENTAL SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) 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 patient experienced physical side effects, emotional side effects, and mental side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the physical side effects, emotional side effects and mental side effects was not reported. This report was non-serious.
7 y/o child recieved a Kinrix vaccine which is specified for 4-6 years. Parent states child had no adverse reaction at all. No concerns at this time.
Headache; fatigue; vaccine exposure during pregnancy; Sore arm after second dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), PAIN IN EXTREMITY (Sore arm after second dose), HEADACHE (Headache) and FATIGUE (fatigue) in a 30-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (Sore arm after second dose). On 13-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. On 13-Mar-2021, FATIGUE (fatigue) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY (Sore arm after second dose) had resolved. On 15-Mar-2021, HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Oct-2020, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. On 11 Oct 2020 patient had positive pregnancy test. The estimated date of conception was 22 Sep 2020.    This case was linked to MOD-2021-048144, US-MODERNATX, INC.-MOD-2021-048144 (Patient Link).
Pt states that she received vaccine and subsequently developed Guillain Barre Syndrome. A female reported that she received an injection of Flu Shield (1999-00 Formula) and subsequently developed Guillain Barre Syndrome.  As of 22-FEB-2000, no further information was available.  This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA.
NUMBNESS FROM TOP OF SHOULDER INTO CHEST ALONG THE COLLAR BONE ON SAME SIDE OF INJECTION; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gastrointestinal issues, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced numbness from top of shoulder into chest along the collar bone on same side of injection. The action taken with covid-19 vaccine was not applicable. The patient was recovering from numbness from top of shoulder into chest along the collar bone on same side of injection. This report was non-serious.
Client received COVID vaccine Pfizer (Lot# EW0187 expiration 07/15/21) at 1316. Client was sitting in the vaccination chair at 1320 when RN noticed Client was pale and fatigued. RN asked for help by a neighboring Ancillary, but RN and Ancillary responded at 1322. RN, RN, and Ancillary aided Client to zero-gravity chair. Student Nurse notified PHN, PHN, and PHN at 1326. At 1327, vital signs are blood pressure 116/60, heart rate 60, oxygen saturation 96%. Client reports being nausea at the start of intervention, but reports nausea been resolved, vision is non-blurry, slight headache, and feels dizzy. Client was offered water and accepted. Client reports a history of fainting, deaf in the left ear, and allergies to sulfa. Client's mother is present at the time of adverse effect. At 1331, vital signs are blood pressure 122/62, heart rate 63, oxygen saturation 98%. Client reports headache has improved, no nausea, no blurred vision, and dizziness has improved. PHN gave Client and the client's mother education on common adverse effects of COVID vaccine and ED precautions. At 1336, vital signs are blood pressure 118/62, heart rate 73, oxygen saturation 96%. Client reports no new symptoms, skin tone has returned to appropriate coloration related to ethnicity. Client remains in the zero-gravity chair drinking water. At 1341, vital signs are blood pressure 112/64, heart rate 66, oxygen saturation 99%. Client reports all symptoms had resolved. At 1346, vital signs are blood pressure 110/60, heart rate 68, oxygen saturation 97%. Client reports no complaints. At 1356, vital signs are blood pressure 112/62, heart rate 65, oxygen saturation 96%. Client reports no complaints. Client stood up with no complaints and left facility at 1357 and was accompanied by his family.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. On an unspecified date the multiple unspecified patients were administered a dose of RECOMBIVAX HB (lot # unspecified) (dose, route, frequency and location unspecified) that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
After my second and third dose, I experienced extreme fatigue, body aches and headache. It started a few hours after the injection and lasted for about 24-36 hours straight. I was unable to work or do anything really except lay in bed and wait for it to go away.
With dose #2 Pfizer I previously reported: Since I woke from an afternoon nap, I can hardly hear and there is intense ringing in my ears (right worse than left). My injection was at 11:23AM and I woke up with this at 5:20PM. I have no cold or sinus symptoms and never have ear problems. These issues are currently still happening. Dose #3 Within 24 hours would have been the start of fatigue, feeling just wiped out, I feel like I never bounced back. Within the week or 2 weeks after vaccine I had a tenderness in my body aches, throat, headaches, extreme fatigue and brain fogginess, I could not do anything but go to bed, I felt so sick, but not sick. By week 2 I was able to get up but had to go lay down and a month later when I went to see my doctor, I was still the same. I saw my doctor on 12/20/2021. She was concerned with a possible thyroiditis or autoimmune condition. Extreme fatigue, headaches, brain fog, it has continued to get better though today, but I am just not well. Body aches have subsided. Headaches are daily nonstop. I have had to take Tylenol every 6 hours, I still have muscle fatigue, it's hard to lift arms and legs, it feels like I went on a hike or lifted weights, but I have not done anything. I have had blood in my urine detected 05/27/2022. We thought I may have had a UTI, but there was no infection, going to recheck in a month. Currently, I am down to trace amounts of blood in my urine. Abdominal CT scan, negative other than visible cholesterol on my aorta. Blood work came back normal. Both PCP, and ENT suggested holding off on the 2nd booster.
Information has been received from a physician assistant concerning a female patient with a history of loop electrosurgical excision procedure (LEEP) in 2005 who on unspecified dates was vaccinated with the series of GARDASIL. On unknown date, the patient had a PAP (Papanicolaou) smear test that showed that the HPV positive was at high risk. At the time of the report, the patient's outcome was unknown. Follow-up information has been received a registered nurse concerning a 26 year old female patient with no pre-existing allergies, birth defects, medical conditions and a history of loop electrosurgical excision procedure (LEEP) and COLPO CIN who on 18-AUG-2006, 09-MAR-2007 and 07-SEP-2007 was vaccinated with the first dose (lot# 653650/0696F), second dose (lot# 654741/0013U) and third dose (lot# 654539/0742U) of GARDASIL in her thigh, respectively. Subsequently, the patient had recurrence of HPV after being vaccinated. On 16-NOV-2009, the patient had abnormal PAP (Papanicolaou) cervical Intraepithelial neoplasia (CIN) I & II after she completed all 3 doses of GARDASIL which required treatment in 2010. In April 2010, the patient underwent colposcopy + loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN). This is one of several reports from the same source. Additional information has been requested.
eye pain; pains; chills; nausea; fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.    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 06-Mar-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 started NYSTATIN (STATIN [NYSTATIN]) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle aches). On 07-Mar-2021, EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle aches) had resolved.            Action taken with mRNA-1273 in response to the drug was not applicable. No treatment was reported for the events.
Day 2 shaking nauseated dRymouth ha 3 swEating Lymph NodEs swollEn dizzy wEak 4 Low back bEiNg RippEd out feeliNg hollow 5 distEnded chest paiN coughing pRoductive wEak InsidE mouth fEEls Raw 6-13 bloatEd distended nauseatEd wEak
PER MEDICAL RECORDS PATIENT PRESENTED TO ER VIA EMS REPORTING INTERMITTENT CHEST PAIN, FEELING LIKE HIS HEART WAS STOPPING.
IBS flare up; 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. Other Case identifier(s): US-PFIZER INC-2021766601 (Pfizer).  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 24May2021 (Lot number: EW0191) at the age of 63 years as dose 2, single for covid-19 immunization. Relevant medical history included: "IBS" (unspecified if ongoing), notes: Verbatim: IBS; "Acid reflux" (unspecified if ongoing), notes: Verbatim: Acid reflux (esophageal); "headaches" (unspecified if ongoing); "diarrhea" (unspecified if ongoing). Concomitant medication(s) included: LINZESS; FOLIC ACID; B COMPLEX (B50); VITAMIN D [ERGOCALCIFEROL]. Past drug history included: Aleve, reaction(s): "acid reflux worse". Vaccination history included: Bnt162b2 (First dose, Batch/lot number: EW0168, Dosage text: Unknown dosage; first dose; upper left arm), administration date: 03May2021, for COVID-19 immunization, reaction(s): "IBS flare up". The following information was reported: IRRITABLE BOWEL SYNDROME (non-serious) with onset May2021, outcome "not recovered", described as "IBS flare up".  Additional information: The stated that IBS and has been pretty good about controlling his flare ups. The patient stated he had IBS flare ups 3-4 days after the first dose of the vaccine. The second vaccine was 3 weeks ago and the caller is getting another IBS flare up. The caller has not had any changes to his diet or stress levels.  Follow-up attempts are completed. No further information is expected.
Reported muscle twitching 24h. after received vaccine. progressed to L side, hip and outer thigh, 3 days after vaccine- sharp pain and muscle twitching to L neck. By 10/7/14- Pt is asymptomatic. No treatment received.
Breakthrough COVID-19 case with symptom onset 8/22/2021: Shortness of breath/difficulty breathing. Hospitalization 8/27/2021-9/4/2021  with shortness of breath.
Patient reported a splotchy itchy rash on right arm about 8x4 inches when asked to see other arm to compare he showed another rash 2X2 over both deltoid regions. Given hydrocortisone 1% topically told to use 3-4 times daily over areas and Loratadine 10mg to take 1 daily. Follow up performed 11/3/23 patient was less itchy but both rashes were still prevalent.
Congestion; Lost of smell and taste; Lost of smell and taste; This is a spontaneous report from a contactable Other-HCP. This male Other-HCP reported for himself that: A Male patient of unspecified age received first dose of BNT162B2 (COMIRNAT, solution for Injection, lot number and Expiration date was not reported) via an unspecified route of administration on 09Jan2021 as first dose, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On 09Jan2021 the patient received first dose of the vaccine and Today he is scheduled to get the second dose, but he had a congestion and loss of smell and taste but no fever (98.5 degree F) though. He wanted to know if he should go to get the vaccine or maybe some other day. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): 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 have been completed and no further information is expected.
my arm has been in pain ever since,my doctor is sending me to a nerologist, thinks there is nerve damage. I am up alot at night with pain. something happened with my shot,never happened before