chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose #2: Rash with pain; Dose #2:Injection site Pain; Dose #2: red..at the injection site; Dose #2:stiffness at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE URTICARIA (Dose #2: Rash with pain), VACCINATION SITE PAIN (Dose #2:Injection site Pain), VACCINATION SITE ERYTHEMA (Dose #2: red..at the injection site) and VACCINATION SITE INDURATION (Dose #2:stiffness at the injection site) 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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE URTICARIA (Dose #2: Rash with pain), VACCINATION SITE PAIN (Dose #2:Injection site Pain), VACCINATION SITE ERYTHEMA (Dose #2: red..at the injection site) and VACCINATION SITE INDURATION (Dose #2:stiffness at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Dose #2: Rash with pain), VACCINATION SITE PAIN (Dose #2:Injection site Pain), VACCINATION SITE ERYTHEMA (Dose #2: red.at the injection site) and VACCINATION SITE INDURATION (Dose #2:stiffness at the injection site) outcome was unknown.      Treatment of events was not reported. Concomitant medication use was not provided by the reporter.
I would be standing up and had to sit down because my heart started to race and was bedridden for a week (Pots Syndrome). I'm in the process of trying to get diagnosis on it to find out correlation between the two to find out if it was due to the vaccine because my health started going downhill shortly after receiving my vaccination. I have been going to a couple of Cardiologists so far and am mentioning the correlation with the vaccination to see what they are saying and it is still an ongoing investigation. My heart rate increases drastically when I stand up and goes down rapidly when I sit down within 30 seconds.
Patient received flu vaccine in thigh on Thursday,   11/8/07, around 3pm.  Friday afternoon, 11/9, he complained that his "feet were itchy".  Saturday morning 11/10 he awoke with fever (101.6 F) headache, and HIVES all over his thighs, calves, ankles, and feet. We were out of town  called our pediatrician who advised giving him oral Benedryl and taking him to an acute care center.  We did so.  Patient responded to the Benedryl (hives began to fade) and Tylenol for headache and fever.  Felt bad for the day.  Hives faded in two days.
Information has been received from a registered nurse concerning a 5 year old white female with a drug allergy/reaction to cefaclor (CECLOR) furticarial (also reported as no pre-existing allergies, birth defects, or medical conditions) who on 27, Jan 1993 at 3: 00 PM was vaccinated IM in her right arm with a second dose of hepatitis B virus vaccine rHBsAg (yeast), 0.5 mL. There was no illness at the time of vaccination. There was no concomitant therapy. On 28, Jan 1993 the patient developed a fever of 103 degrees Fahrenheit and felt "achey". She was too weak to walk. Medical intervention for the events included acetaminophen (TYLENOL) and bedrest The symptoms improved over a couple of days and she recovered. She did not experience a reaction to her first dose of hepatitis B virus vaccine rHBsAg (yeast), and subsequently she did not complete the series. Follow-up information indicated that on 26, Jan 1993 at 3:00 PM, the patient experienced a fever of 103 degrees, aches, congestion and was unable to walk. The patient recovered on 30, Jan 1993. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations.
Tachycardia, palpitations, chills. BP 182/114 (pulse 121), O2 sat 98%. F/u BP 179/108. Given Benadryl 50 mg PO, ASA 325 mg.
Mother called on 1/3/03 stating that the infant had quit breathing the day before and had to be resussitated and was in the hopsital.  Doctor treating infant indicated it may have been casued by immunizations.
Information has been received from a 69-year-old male with an allergy to penicillin, prostate cancer that was treated with external beam radiation therapy in January and February of 2007 and seed implants on 15-Mar-2007, and has had "about 4 bouts with shingles over the last 2 or 3 years," who on 01-JUN-2007 was vaccinated with a 0.65 milliliter dose of Zostavax (Oka/Merck).  Concomitant therapy included ezetimibe (+) simvastatin (MSD), COREG and BENICAR.  The patient was on acyclovir therapy but discontinued about "48 hours before receiving the vaccine."  On approximately 29-JUN-2007, "about 28 days after vaccination," the patient developed shingles with "skin eruptions around eye and the base of the spine."  The patient did not "resume acyclovir therapy again until the shingles surfaced again".  Unspecified medical attention was sought.  The outcome is reported as recovering.  No product quality complaint was involved.  Additional information has been requested.
PATIENT'S MOTHER CALLED MY OFFICE TO SET  UP AN APPOINTMENT. DURING THIS CALL, THE MOTHER INFORMED ME THAT WHEN the patient WAS WITH HER FATHER LAST WEEKEND HE "allegedly" TOOK HER TO A pharmacy AND LIED TO THE PHARMACIST ABOUT HER BIRTHDAY SO SHE COULD GET A COVID VACCINE SO HE COULD GO ON VACATION.  PARENTS ARE DIVORCED AND MOM HAS SOLE CUSTODY AND FATHER IS NOT ALLOWED TO MAKE MEDICAL DECISIONS WITHOUT HER CONSENT. HE ALSO LIED TO THE PHARMACIST AGAIN WHEN THEY WERE CONFIRMING THE BIRTHDAY AND FALSIFIED MEDICAL DOCUMENTS TO MAKE IT APPEAR THAT the patient WAS ELIGIBLE FOR THE PFIZER COVID VACCINE.
Nattative:  Patient received Twinrix (hepatitis A/B combination) vaccine on 10/4/2019. Two weeks later on 10/18/2019, patient was seen again by same provider and clinic with skin eruption on his lower abdomen and back for 1.5 days. He started to feel itchy while riding his motorcycle, and then started to notice hives to the areas mentioned above. He did not have any signs or symptoms of angioedema (tongue swelling, throat closure, respiratory difficulties), but also felt his face was flushed and the hives were noted on the 10/18/2019 face-to-face visit. Symptoms:  UrticariaPruritus & Skin erruption and flushing Treatment:  METHYLPREDNISOLONE 4 MG Other Take as directed on package instructions ,CALCIPOTRIENE 0.005% BID Apply to affected area on skin
soreness and red bump at injection site; I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site; I have fatigue, soreness and red bump at injection site; The armpit feels tender and raw; I have fatigue; The armpit feels sore/ soreness; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue) and VACCINATION SITE PAIN (The armpit feels sore/ soreness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue), VACCINATION SITE PAIN (The armpit feels sore/ soreness) and INJECTION SITE ERYTHEMA (soreness and red bump at injection site   ). At the time of the report, AXILLARY MASS (I felt swelling under my left armpit, feels like a cushion is there/ red bump at injection site), PAIN (I have fatigue, soreness and red bump at injection site), TENDERNESS (The armpit feels tender and raw), FATIGUE (I have fatigue), VACCINATION SITE PAIN (The armpit feels sore/ soreness) and INJECTION SITE ERYTHEMA (soreness and red bump at injection site   ) outcome was unknown.        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 treatment and concomitant drugs was provided
Pt. had 18 mo WCC 3/28/11 - given FLUVAX #2. Developed high fever to 104.8 with decreased appetite, emesis x 1, diarrhea x 5 on 3/29/11. Fever lasted through 4/1/11. No sequelae - doing well now.
Limited mobility in Right shoulder difficulty getting dressed, bathing, brushing teeth, doing hair shoulder pops. Prednisone, antibiotics, cortisone shots, pain and physical therapy.
pt recvd vax & was found to have a pos Hep B surface antigen (confirmed by neutralization) 3 days following w/1st dose of Engerix-B; Md felt that this finding was coincidental did not exp any clinical sx;
SCHOOL NURSE CALLED CLINIC THIS AM, 10-01-08. NURSE STATES PT C/O TENDERNESS IN RA. SCHOOL NURSE DESCRIBES REDNESS AND SWELLING NOTED. SCHOOL NURSE STATES SHE HAS ADMINISTERED ACETAMINOPHEN AND HAS APPLIED AN ICE PACK.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number patients of unknown age and gender. The reporter stated that doses of vaccines PNEUMOVAX 23 (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had been informed of any adverse effects. It was unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Extreme radiating shoulder pain, unable to lift or use the left arm.  Injection was given in the acromion process joint instead of deltoid muscle.  Dr. see on 9/24/13 for arm pain prescribed corticosteroids.  Will be going back due to no improvement in the impingement syndrome.
Several varicella lesions at site of vaccine administration. Left thigh with swelling but no significant tenderness.
I sat in the facility for the 15 minutes or so required,  then in about 1/2 hour later I had like a had time breathing, something like labored and my vision was very blurry for about 30 minutes or so, I went back to work and a co worker asked if I was ok, she said my eyes looked weird  and within the hour I was seeing fine again, was very tired but that I thought was normal,.
This spontaneous report as received from a medical assistant refers to a 4 month old female patient. The patient had no medical conditions, her concomitant medications, and past drug history were unknown. The medical assistant reported that the patient started ROTATEQ oral solution (dose unknown) on an unspecified date at two months of age (approximately in February 2014). On 30-APR-2014, the patient received her second dose of ROTATEQ oral solution (dose unknown) lot # H020560, expiration date: 18-APR-2014. No laboratory data was provided. As of 30-APR-2014, it was unknown if the patient continued to take ROTATEQ. The medical assistant reported that the patient was fine when she left their office and that they were going to contact the patient's mother and keep in tough with her to monitor the patient. Additional information has been requested.
No symptoms or adverse effects reported; 3 patients received unspecified dose of ROTATEQ that was improperly stored.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-MAY-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660958, expiration date 23-MAR-2021 (strength, dose and route of administration not provided) for prophylaxis. Administered dose of vaccine was stored in temperature of 46.9 degrees Fahrenheit (F) for 1 hour. Data logger was involved. There were no previous excursions reported. No symptoms or adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003741: US-009507513-2005USA008179:
I have yet to get my period and I?ve always been on time since it began. Other women have also told me they experienced pain or no period after as well
diverticulitis; perforated colon; it caused an abdominal infection and inflammation; she is still having a little bit of pain in her abdomen/she was in a lot of pain but is mostly better; This is a spontaneous report from a contactable consumer (pateint) via a Pfizer-sponsored program COVAX Support. A 40-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in right arm on 17Mar2021 10:00 (Lot number was not reported) as single dose for covid-19 immunisation. The patient and concomitant medications were not reported. The patient experienced diverticulitis, perforated colon, abdominal infection and inflammation on 30Mar2021; she is still having a little bit of pain in her abdomen/she was in a lot of pain but is mostly better on an unspecified date. The patient was hospitalized for diverticulitis, perforated colon, abdominal infection and inflammation from 30Mar2021 to 01Apr2021. The all events were resulted in Emergency Room and Physician Office. Patient was due for second dose of Pfizer BioNTech Covid vaccine tomorrow (08Apr2021) but was hopitalized last week for diverticulitis and a perforated colon. She was released from the hospital last Thursday and is currently taking Metronidazole 500mg three times a day and ciprofloxacin 500mg1 tablet by mouth every 12 hours. At her follow up today (07Apr2021) the doctor was unsure of a recommendation. She lost her vaccination card. She mentioned that she will be having the 2nd dose tomorrow 08Apr2021 and she wants to know if possible since she doesn't have the card. She mentioned that she got hospitalized last week and she is under medication due to abdominal infection and she is taking antibiotics until next 2 weeks. She was in the hospital for diverticulitis and a perforated colon two nights last week and was pumped with a ton of antibiotics and is currently on antibiotics. It caused an abdominal infection and inflammation and she received five bags of antibiotics and was sent home with two different antibiotics, one for 2 weeks and one for 3 weeks. She is essentially from tomorrow to two weeks on antibiotics and didn't know if it would be an issue with getting the vaccine. She asked her family physician and he said he would probably wait because there is a chance it would counteract with the vaccine. Caller states her daughter lost her vaccination card and asks if this is going to be an issue as long as she goes to the same place she went to get her second shot, states this must have happened to other people. During that time at the hospital she had a total of five bags of antibiotics. She was still having a little bit of pain in her abdomen and probably why she was on antibiotics for two weeks. She was in a lot of pain but is mostly better. About the treatment, patient stated she was on morphine while in the hospital and they did a CT scan with dye. Patient stated all her blood work came back healthy. The outcome of the event abdominal pain was recovering, other events was unknown.  Information on the lot/batch number has been requested.
2 month old patient received one dose of Gardasil 9; This spontaneous report was received from a physician concerning a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 31-MAR-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45t 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular for prophylaxis (strengh, anatomical location, lor number and expiration date were unknown) (product use issue).  At the reporting time, the patient's outcome was unknown.
Initial unsolicited report received from a consumer on 17-APR-2017. This case involves a female patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (manufacturer unknown, batch number, dose, dose in series, expiration date, route and site of administration not reported), on an unspecified date. The patient had a medical history of a pre-cancerous condition that involves her esophagus that is now stable and depression and being bi-polar and is also losing weight due to breaking out after eating. It was reported that the patient has been using Xyzal (generic version) in the past couple of months for respiratory allergic conditions. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had redness in the face and itching all over. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old female patient with no history and no previous illness was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 672547/1745AA) on 17-APR-2012. There was no concomitant therapy. On 17-APR-2012, the patient was noticed edema and tingling of "pins and needles" of right arm. On 18-APR-2012 ("the following day") the symptoms had changed to include numbness of the entire right hand and loss of strength and sensation. The patient had a neurology appointment without definitive findings on 18-APR-2012, followed by an ultrasound and MRI significant for a blood clot, and details were not known at this time. She was treated and seen at Medical Center. As of this point, the patient had not recovered. The original reporting source was not provided. No further information is available.
SORE ARM; This spontaneous report received from a patient concerned a male 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 not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-546523.
No additional AE's; A medical assistant reported that an improperly stored PROQUAD vaccine was administered.  No additional AE's and no PQC's were reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 13-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number U022729, expiration date  16-JAN-2023 (dose and route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.
Patient presented to the pharmacy for a booster covid vaccine.  Said she had Pfizer before and would get Moderna.  Presented vaccine card with first dose on 12/17/2020 and second dose on 1/7/2021.  Also said aloud her last dose was 1/7.  Administered 0.25ml of Moderna vaccine. Pulled up the Immunization Registry and noted that there was already a 3rd dose listed on 9/24/21 at a Pharmacy. Called the patient to verify that she had received a vaccine at Pharmacy.  She said yes a long time ago in September or something but it's been 5 months.  Counseled the patient that she had received a 4th dose that she shouldn't have but that she would be fine.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th January 2023) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: A reporter called to ask for information about the administration of an expired Havrix dose to a patient. The reporter asked for safety information. The reporter did not provide patient and vaccine (lot number) information. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered with expired dose of Havrix, which led to expired vaccine used.
Spasms/odd jerky movements, created possible allergy to cow and pork. Taken to ER due to fear of seizure, EEG was normal. Refuses breast milk when beef or pork is ingested and screams in pain immediately afterward, also has the same spasms/jerky movement. patient continues to have spasms immediately after breastmilk containing pork and beef.
I flew on 9/23/22 and was shopping with my son on 9/25 when I felt light headed.  Upon sitting down I began to feel tightness in my left chest and down my arm. I thought I was having a heart attack.  My son drove me to emergency room which was about 10 minutes away.  They admitted me immediately  after some tests told me I had a mild ischemic stroke.  I was given the stroke medication and went to ICU for 24 hr. monitoring.  I then was transported to Hospital for further tests and monitoring.