chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm is swollen; left arm is red; left arm is little hard; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Left arm is swollen), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE INDURATION (left arm is little hard) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Left arm is swollen), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE INDURATION (left arm is little hard). At the time of the report, VACCINATION SITE SWELLING (Left arm is swollen), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE INDURATION (left arm is little hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided.
Drug dose administration interval too long; Injection site whelp; This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose in September 2018 and experienced a slight shingles outbreak).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site wheal and drug dose administration interval too long. On an unknown date, the outcome of the injection site wheal was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix in August 2019, which led to lengthening of vaccination schedule. The patient experienced a 3 inch whelp on her arm at site of injection that has improved but not completely resolved after 3 weeks. The patient consented to follow up. This case has been linked with case US2019159147, reported by the same reporter.
An 88 year old female patient, received "Tetanus and Diphtheria Toxoid Adsorbed for adult use" vaccination on 06/21/01, for a cat bite which became infected. Four days after receiving the injection, she developed a red, swollen, hot area at the injection site. She reported it to her doctor who recommended putting cold compresses on it for relief. Three days later she entered the ER with vomiting, diarrhea, achy joints, fatigue, sour taste, and inability to swallow. She was evaluated and sent home with a diagnosis of viral gastroenteritis. Three days later she was admitted into the hospital. She was severely dehydrated and with all of the previous symptoms. She spent nine days in ICU where, after performing numerous test, the attending staff failed to make a diagnosis. She was fed through TPN because of her inability to swallow. In addition, she had fluid built up around her heart and lungs. She improved slightly and was released from ICU and admitted into a nursing care facility. The patient was readmitted to the hospital 08/14, with a high fever (105 C) and a staph infection for  which she is currently being treated. Also diagnosed with atrial fibrillation and constipation.
Rupture of appendix; Hasn't yet received their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of ruptured appendix in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced ruptured appendix (serious criteria hospitalization and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the ruptured appendix and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the ruptured appendix to be related to Shingrix.  Additional case details were reported as follows: In 2018, the patient experienced a rupture of appendix. The patient spend 4 days in the hospital. Till the time of reporting the patient did not receive the 2nd dose of vaccine, which led to incomplete course of vaccination.  The batch number and expiration date were not available since the first dose of Shingrix was administered on a different facility. The pharmacist did not have date of hospitalization for the patient. The reporter consented to follow up.
I experienced  after my second dose vaccine, swelling of my right clavicle, had an ultrasound.  My ultrasound demonstrated no lymphedema or lymphadenopathy and I have to follow up in one month.
Child received vaccines at 16:00 on 08/02/04. At approximately 12:00am 08/03/04, child developed fever, chills, general body aches, dizziness, and nausea. Signs and symptoms continued 08/03/04-he vomited x1 at 8:00am on 08/03/04.
Shoulder soreness, day after shot. Arm soreness and painful for over two weeks with severe pain and arm mobility pain began after three and diagnosis of SIRVA, shoulder injury related to vaccination administration four weeks after vaccination.
This case was reported by a nurse via sales rep and described the occurrence of vomiting in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to BEXSERO. Additional information reported as follows: The age at vaccination was not reported. The 2 female patients received BEXSERO vaccine and experienced the vomiting. This case has been linked with US2018GSK133107, reported by same reporter.
Dizziness, Myalgia, Fever, Sore arm, feeling of heaviness in head Narrative: One day of work missed on 01-19-2021
Severe inflammation of lumbar spine - had been symptom free for 14 years.; This is a spontaneous report from a contactable consumer (patient).    A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 15:00 (Lot Number: EN6203) as single dose (at the age of 71 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included known allergies: Penicillin. Concomitant medications included unspecified drugs. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318) on 04Feb2021 03:00PM in the left arm (at the age of 71 years old) for COVID-19 immunisation.  On 27Feb2021, the patient experienced severe inflammation of lumbar spine - had been symptom free for 14 years. The outcome of the event was not recovered. The events required a visit to the physician's office. Therapeutic measures were taken as a result of the event included Corticosteroid Epidural Injection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
01/12/22 presents to ED for "ventricular tachycardia". PMHx of "CAD, DM2, hypothyroidism"
Information has been received from a physician and a medical assistant concerning a 13 month old female with no medical history, no known allergies and no illness at the time of vaccination.  On 01/13/2003 she was vaccinated in the right leg with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 642702/0350M).  There were no concomitant medications.  On 01/22/2003 the patient developed a rash on her trunk and face.  ON 01/23/2003 she presented to the physician's office "with vaccinia-measles induced by MMR post vaccine."  The physician reported that this case was not just a rash but that it was "vaccinia--a measles-like infection that occurs after vaccination accompanied by fever, malaise, rash and coryza."  On 01/28/2003 the rash was gone and the patient was considered recovered.  The physician said he has not seen this type of reaction in years and suspects that the vaccine might have been too virulent.  The physician requested an investigation into that lot number.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was reported that two other patients received the same vaccine and also developed a measles-like infection (WAES # 0301USA03088) and (WAES # 0302USA00199).  Additional information is not expected.
Case number PHEH2014US024288, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up received from nurse on 21JAN2015. This report refers to a 16 years old male patient. His medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. He was vaccinated with FLURVIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly into the right deltoid at a dose of 0.5 ml on 05NOV2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 21JAN2015: updated site of vaccination and reporter comment.
Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 08-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 661443/0528X) 0.5 mL subcutaneously and a dose of MMRII (lot # 656864/0412U).  Concomitant vaccination included a dose of PREVNAR.  On 08-SEP-2008 the patient was diagnosed with erythema multiforme.  The patient had lesions on the face, neck, upper back and chest.  At time of reporting, the patient was recovering.  No labs or diagnostic studies were performed.  The patient sought medical attention with an office visit.  Additional information has been requested.
Morbilliform rash 7 days after vaccination 3 MMR Rxn
Developed fever to 104 degrees on the morning after vaccination and had a grand mal seizure that lasted about 1 minute followed by generalized tremors that lasted about 10-15 minutes and resolved with administration of rectal Diastat 5mg.  Tremors resolved within 5 minutes.  Temp treated with Ibuprofen 600mg and cool sponge bath.  Temp down to 101 within one hour and afebrile after 8 hours.  Temp did not recur.   Normal postictal mental status.  Somewhat lethargic for a day or two then gradual return to baseline cognitive and physical functioning over 10 days.   Wilmer has had this type of seizure with high fever in the past.
Received OPV/DTP vax & next day developed hives. Low grade fever, child looks fine otherwise.
Got TDAP injection on 3/23.  COVID vaccine given earlier that 14 day interval recommended by ACIP/CDC for non-emergent situations.
patient got a dose from a vial punctured more than 12 hours before; slight fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  concomitant medication provided by the reporter. no treatment information provided by the reporter
pt recvd flu vax & devel redness, swelling, warmth & pruritus @ the inject site;
headaches; runny nose; red, teary and painful eyes; red, teary and painful eyes; red, teary and painful eyes; She woke up with pain and swollen red watery eyes; This is a spontaneous report from a contactable consumer (patient, self-reported). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 27Jan2021 at 12:00 o'clock noon, as a single dose for COVID-19 immunization at local hospital. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she was administered with the first dose of the vaccine yesterday. On 27Jan2021, at night, around 7 pm and after that her eyes started getting red and the headache started, and also had a runny nose, red, teary and painful eyes. After midnight, either being 27Jan2021 or 28Jan2021, she had very huge pain in both eyes and swelling as well as the wateriness in the eyes. It wasn't tolerable and so she started having Tylenol. She woke up with pain and swollen red watery eyes. She started having eye drops and that helped but she was still having pain. Her headache went away last night when she slept. She did not have positive COVID test or Antibody test before the vaccine. She did not have any issues with vaccines in the past. Outcome of the event headache was recovered on an unknown date. Outcome of the event runny nose was unknown and for all other events, it was not recovered.  Follow-up attempts are completed. No further information is expected.
Initial report was received from a health care professional on 09 March 2011. A 48 year-old female patient with a past medical history of vertigo, hypertension (HTN) and an allergy to Darvocet-N-100, had received on 03 March 2011 at 3:15 pm the following vaccines: a right deltoid intramuscular injection of ADACEL, lot number U3872BA (sanofi pasteur Ltd. lot number C3827); a right deltoid intramuscular injection of IPOL, lot number E0330 and a first dose left deltoid intramuscular injection of PNEUMOVAX 23, Merck lot number 1021Z and 10 hours later on 04 March 2011 at 1:15 am, experienced a 101 fever, chills, nausea, vomiting and lightheadedness. The lightheadedness and nausea continued for six days. According to the reporter, the patient had received one dose of IPOL as a child and (illegible) as a child of ADACEL. Treatments were not reported. Concomitant medication was LISINOPRIL 30 mg daily. Relevant diagnostic tests/laboratory findings, other vaccines within four weeks prior to suspect vaccine, illness at the time of vaccination and adverse event following prior vaccination were reported as none. No further information was available at the time of the report. The patient's outcome was reported as recovered (date not reported). Follow-up information was received from a health care professional on 20 April 2011. The patient was not evaluated by a physician. She was prescribed Phenergan suppositories for the nausea. She had not received ADACEL previously but had received DECAVAC on 22 August 2005. The patient's outcome was reported as fully recovered on 03 April 2011. Documents held by sender: none.
This spontaneous report as received from an administrator refers to a patients of unknown age and gender who on an unknown date, were vaccinated with VAQTA (dose and route not provided). The reporter stated an unspecified number of patients may have received doses of VAQTA (dose in series unspecified) that were exposed to 25 F for up to 5 days (120 hours) (not supported). No adverse effects reported. Administrator stated she has no patient details at this time. No further information provided. The outcome of incorrect product storage was unknown. This is one of several reports from same source.
Swollen veins in legs that caused pain. My doctor said they were not blood clots but they felt like blood clots.
2.5" diameter circle of redness/pain/hardness around injection site. Warm to touch. Started 1 day after 2nd dose of Moderna vaccine. Did not have it with the first dose. Still there 2 days later.
Right arm was so painful. Never experienced such a reaction as I take flu shots every year. By the evening my entire right arm hung at my side and I couldn't raise it above waist level. 2nd day it was even worse.....so painful. I attribute this to HD Flu vaccine I took for the first time.
My mouth has broken out with lesions consistent with lichen planus. My mouth burns when consuming certain foods and toothpastes. This condition has lasted for at least 3 months and is not getting better.
The patient stated that the day of his PREVNAR 13 vaccination on 6/5/15 he started to note some pain in his right deltoid. He denies any redness, warmth or swelling. He states that he has constant pain in the deltoid with some radiation into his forearm which has since subsided. When I get up in the night it hurts a lot, it hurts to just let it hang. This is new and different for him. No other changes in activity just prior to his shot. He finds that taking Tramadol will help with the pain but he doesn't like to take it too often. The pain is worst at night when he is sleeping and in the morning when he first wakes up.
She now has a head cold and wants to know if it's safe to get the 2nd dose or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "She now has a head cold and wants to know if it's safe to get the 2nd dose or not".  Additional information: Patient was supposed to get her 2nd dose tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, Headache, HYPERtension,  tingling down left arm  Narrative: Tingling down left arm   Other Relevant History:
After receiving 1st GARDASIL Vaccine Shot patient suffered collapse of platelet counts 3 weeks after vaccine. She was admitted in Emergency Room near her. She was diagnosed with Acute ITP and had platelet count levels of 3K. This happened exactly 3 weeks after shot. Patient does not have any abnormal medical history and is currently being treated with steroid treatment to increase platelet levels. ER Hemotology at Hospital is treating patient.
No adverse effects were reported in the patient; The patient received a dose of PROQUAD via ntramuscular route; This spontaneous report was received from a medical assistant, concerning a 4-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 02-OCT-2019, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), via intramuscular instead of subcutaneous (incorrect route of product administration), for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). No adverse effects were reported in the patient.
Shot hurt. Arm was sore during the day. Hurt when I rolled over in bed Woke up with it sore and swollen. Hurt to try and hit golf club so didn?t play golf Cannot straighten arm straight up Hurts when I touch it. Feeling fine otherwise.  Happy I received the shot.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced HERPES ZOSTER (shingles). The patient was treated with CHLORAMPHENICOL (ANTIBIOTIC [CHLORAMPHENICOL]) for Shingles, at an unspecified dose and frequency.   At the time of the report, HERPES ZOSTER (shingles) had not resolved. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications were not provided.
t105 2-3 days p/vax lasting <1 hr, relieved w/tepid bath & oral fluids, but recurring;
2 SMALL HIVES ON BACK/SIDE - SOME DISTANCE AWAY FROM INJECTION SITE.  PT. TOOK BENADRYL BY MOUTH AND TOPICALLY AND ISSUES RESOLVED WITH NO FURTHER BREAKOUTS.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patient of unknown age and gender. The nurse reported that the vaccine GARDASIL underwent a temperature excursion, then on an unknown date unspecified amount of patients were vaccinated with this GARDASIL (dose 0.5 ml, lot number and expiration date not reported) intramuscular. There was no concomitant medication reported. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
Fever 105 for 2 days after DTaP and IPV and Comvax and Prevnar (2nd set) rash broke out on 3rd day, has mild pharyngitis.