chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; patient was inadvertently administered an expired dose of MMR II; This spontaneous report was received from a nurse and a vaccine provider referring to a 31-year-old male patient. Concomitant vaccines included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) and varicella virus vaccine live (oka/merck) (VARIVAX). The patient's current conditions included gout, vitamin d deficiency, hepatitis c and vitamin b12 deficiency. The patient's illness at time of vaccination was reported as none.   On 30-MAR-2023, the patient came in to his appointment for immunizations and was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (0.5 ml (full dose), lot # T013727, expiration date 21-APR-2022; strength was not reported) intramuscularly in the left deltoid for prophylaxis (expired product administered). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was later discovered to have been expired. The operator of vaccine was a trained health professional. The remained expired vials were disposed. No prescription drug treatment for the experience required. The patient agreed to return in 4 weeks to have another measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine since dose was invalid due to expiration. The patient had no complaints. No adverse effects were reported.
I had the typical local reaction for the first 3 days following the injection:  redness, soreness, swelling at injection site, occasional itchiness and occasional burning, warm to touch.  It was resolved by the 4th day.  Then on the 8th day, I felt a little itchy and itched the site gently.  Three tiny hives appeared and became a moderate-sized red swollen area by the evening with mild pain and some burning.  The 9th day it was very red, moderate-to-large sized, some burning, warm to touch.  The 10th day, today, it doesn't look angry anymore, is no longer warm to touch, looks like it's resolving but still some swelling that feels like it goes around my upper arm.  I had it checked by an NP today and she thinks it's all related to the injection being administered lower than my deltoid, instead went into the subcutaneous/fat area.  So we will watch it but she doesn't think it's infected or any reason to not take the 2nd dose when it's time.
Patient called to express concern about soreness in  her left arm, a little below where the COVID vaccine was given 2 days prior. Patient was concerned because she was having some difficulty lifting the arm due to the soreness and they fact that she did not have soreness with the other 3 COVID vaccines. There is no redness reported. She is currently using over-the-counter extra strength Tylenol to help with the pain and was advised to continue icing her arm and contact her doctor if symptoms do not resolve in 5-7 days.
Rapid mixed heart rhythm. Ambulance called. Rhythm resolved it self, but irregular beats have continued to occur 5 days out. Thinking seems to be just slightly off. Cardiologist was seen, ekg taken. Patient given a prescription of flecainide to take if another event is to occur.
Got up during the night ;headache; sore arm' sore leg both on the same side as the injection site; extremely unsteady on feet. In AM extremely unsteady ; difficulty eating due to severe tremors. As the day progressed; became disorientated; confused. Needed assistance with everything. Could not walk without assist. Not aware of date or day or where he was. Went to ER per direction of the Clinic to rule out CVA due to symptoms. Blood work; urinalysis and CT of the head done- all negative. MD in the ER felt that it was related to the Covid vaccine that had been administered the day before. Slept almost entire day of 4/2/21.Walking better 4/2/21. He had absolutely no recollection of what had occurred the day before 4/1/21. Did not know he went to the ER or what occurred there.
No additional adverse effect reported; that patient was administered an expired dose of MMR; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender.   No information regarding the patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant therapies was provided.  On 20-APR-2020, the patient was vaccinated with  an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, albumin status (rHA), live (M-M-R II) (dose, route of administration, vaccination scheme and  anatomical site of vaccination, were not reported); lot number R011219, expiration date 17-APR-2020) as prophylaxis.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). No additional adverse effects were reported.
Information has been received on 14-JUL-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The medical assistant reported that on an unknown date an unspecified patient was administered an improperly stored VARIVAX lot # M037642 expiration 01-SEP-2018, subcutaneous for prophylaxis reconstituted with correctly stored sterile diluent (STERILE DILUENT) lot # M035268 expiration 19-APR-2019. No adverse effects were reported. The vaccine was stored at a temperature of 15.8 degrees Fahrenheit for the time frame of 234 hours. There was no previous temperature excursion. The call was made due to a data logger.  Additional information has been requested.
Myalgia, Arthralgia, extreme fatigue/ brain fog, flushing/ swelling Narrative:
Information has been received from a nurse practitioner concerning a 24 year old female patient with Hyperlipidemia, polycystitis ovarian syndrome and penicillin allergy who on 31-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (lot# 654702/0011U), intramuscularly. Concomitant therapy included cholestyramine resin, atorvastatin calcium (Lipitor) and drospireneone + ethinyl estradiol (Yasmin). On 11-FEB-2007, the patient developed a maculopapular rash on her torso and bilateral upper extremities. The patient was evaluated at an urgent care facility and was prescribed a Prednisone pack. At the time of the report the patient was considered to be not recovered. Unspecified medical attention was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow-up information has been received from a nurse practitioner concerning a 24 year old female with hyperlipidemia, Polycystic ovarian syndrome, ovarian cyst and penicillin allergy who on 31-JAN-2007 was vaccinated with a first dose of GARDASIL, (lot # 654702/0011U), in left deltoid intramuscularly. Concomitant therapy included cholestyramine resin, LIPITOR and YASMIN. On 11-FEB-2007, the patient developed a maculopapular rash on her torso, chest, and bilateral upper extremities. The patient was evaluated at an urgent care facility and was prescribed a prednisone pack, tapered dose. As of 14-MAR-2007 the patient's outcome was unknown. Additional information is not expected.
One week after the vaccine (1/13/21) I had a Prolia shot; the first one. About 2 weeks after the first vaccine I began to be dizzy, nauseous and had diarrhea.  Eventually a brain MRI showed an inflamed meninges and numerous test were done, including MRI, CT and lumbar puncture but there has been no answer.  It has been suggested I had the Prolia  shot too soon after the first vaccine but no one can give me an answer.  I am still suffering from dizziness and minor nausea.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported for two patients. This is the second of the 2 patients. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm on an unspecified date at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced significant swelling in the arm from injection site in the upper deltoid down toward the elbow. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016526195 same reporter/ drug/ AE, different patient.
intestinal cramps in the large intestine that has been persistent for over 2 months that gets worse when I eat; debilitating pain; lost 20 lbs; This is a spontaneous report from contactable consumer (patient) via the Regulatory Authority. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left on 08Apr2021 13:30 (lot numbers: EW0150 also reported as EN6205; expiry date: unknown) at the age of 51-years-old, as dose 1, single, for COVID-19 immunisation. Medical history included reactive arthritis from food poisoning. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. Concomitant medications included ibuprofen, acetaminophen, and gabapentin, and more (unspecified). On 24Apr2021, the patient experienced intestinal cramps in the large intestine that has been persistent for over 2 months that gets worse when he eats. It manifests in the corners of the intestine and can cause debilitating pain. He had a weekend of "normal" reactions then intestines started cramping 2 weeks after that. He had lost 20 lbs since April and shows no signs of slowing down. The patient did not receive treatment for the events. The events resulted in: Doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. Outcome of the event lost 20 lbs was unknown, while for the other events was not recovered.
no additional adverse effect reported; patient was administered a dose both PROQUAD and VARIVAX on the same day; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were not provided.     On 01-JUN-2017, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously in the left arm (dose, frequency, lot/batch # and expiration date not reported) as prophylaxis.   On 19-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the left arm (dose and frequency not reported; lot # S017239, expiration date 01-DEC-2020). On the same date, she was also vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) in the right arm (dose and frequency not reported; lot # S002874, expiration date 29-JAN-2021). Both vaccines were administered subcutaneously as prophylaxis. No additional adverse effect was reported.
Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On 20th September 2021, the patient received Menveo. On 20th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter
REC'D SHOT IN MORNING LUD&BY NOON HE BEGAN WITH FLU-LIKE SXS, INCLUDING STOMACH ISSUES, FEVER 101, CHILLS, NIGHT SWEAT & RUBBERY LEGS. NEXT DAY HIS INCISION AREA FROM HIS RIGHT HIP REPLACEMENT (BUTTOCK/HIP) FROM NOVEMBER 5, 2020 WAS BLACK & BLUE, THEN PURPLE & BLUE & ITCHY. RASH LASTED ABOUT 3 DAYS. STILL PINK "LOOKS SUNBURNED" HIS WIFE STATED. "BURNING SENSATION IF TOUCHED" ADVISED HIM TO CONTACT HIS PCP. HE WAS ADVISED TO NOT GET THE 2ND COVID VACCINE BY HIS PCP. HE FEELS GOOD NOW EXCEPT FOR THAT "SUNBURNED LOOK" & "TOUCHY". HE WILL F/U WITH THE DOCTOR WHO DID HIS HIP SURGERY. HE WILL ALSO GET A LETTER FROM HIS PCP RECOMMENDING THAT HE NOT GET THE 2ND COVID VACCINE-FOR HIS RECORDS
Warmth and tingling that started in the injection site (right deltoid) that ran down the arm and to the hand a couple minutes after injection. Warmth and tingling in moderate intensity lasted about 20 minutes and decreased with increased arm movement but lasted the first 24 hours with mild aches in the same arm. An enlarged and painful lymph node occurred in the armpit of the same arm two days later and lasted (although decreasingly) for at least the next 5 days.
like I need to lie down; little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (like I need to lie down) and NAUSEA (little nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 025021A, 007B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced FEELING ABNORMAL (like I need to lie down) and NAUSEA (little nauseous). At the time of the report, FEELING ABNORMAL (like I need to lie down) and NAUSEA (little nauseous) outcome was unknown.            No concomitant medications were reported. About 1 hour after receiving the shot she started to feel a little nauseous, and like she needed to lie down. Patient stated that she had not taken any medications or treatments to try and help with this feeling.  No treatment medications were reported
Information regarding PREVNAR was received from a healthcare professional regarding a 2-year-old female patient who developed general septicemia and streptococcal pneumonia. The patient received the fourth dose in Dec-2006. Healthy child. Product was administered in Dec-2006. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 05-Dec-2007 the patient was hospitalized with general septicemia and streptococcal pneumonia (drug ineffective). The patient was treated with unspecified IV antibiotics; hospital discharge was tentative for 12-Dec-2007. The patient has not yet recovered. Blood culture (results: positive) and chest x-ray (results: pneumonia) were done in Dec-2007. No additional information was available at the time of this report.
Pain at injection sites, swollen lymph node in right armpit lasting several days. Extreme tiredness.
Right arm sore Monday night 9/25 said on Tues and Wed just sore, no redness, sore to move arm around.
administration of vaccine that was reconstituted with wrong diluent with no reported adverse event; Initial information received  on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case is linked to cases 2022SA502558 and 2022SA489108.   This case involves a 17 years old male patient who was administered with Yellow Fever Vaccine - YF-VAX] that was reconstituted with wrong diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Typhoid Vaccine (Typhoid) for Prophylactic vaccination; and Rabies Vaccine (Imovax) for Prophylactic vaccination.  On 18-Nov-2022, the patient received 0.5 ml Total (Dose 1) of suspect Yellow Fever Vaccine - Solution for injection that was reconstituted with wrong diluent with no reported adverse event (product preparation error) (latency: same day) (lot number UJ412AB) (Expiry date: 22-Nov-2025) via subcutaneous route in the right arm for prophylactic vaccination.  It was reported She also provided information for the 4 patients who received the vaccine, She confirmed that each patient was contacted and none of them had safety issues nor side effects reported. Patients declined revaccination despite knowledge that the vaccine was invalid.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax; 6 dys after vax; pt devel rash that was dx as viral exanthum;
No concerns noted after the injection. Mom informed today of the of medication error. She denies concerns or side effects from the immunization.
pain in arm; injection site hot to the touch; injection site has a little welt; injection site arm is swollen; injection site red; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No additional information.
Initial unsolicited report received from a consumer on 25 September 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose, site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not provided. On an unspecified date, following the vaccination, the patient experienced a side effect (no other details were provided). Lab data and concomitant medications were not provided. The outcome of the event was not reported. List of documents held by sender: none.
Headache, UrticariaPruritus & Diarrhea SEVERE ITCHING 1/31-2/1/21
Chills, I was freezing for a few hours. I don?t ever get cold.  Headache and nausea. Pain at injection area.
After getting my 1st shot in the series on 12/29/20 at 8:20am. I waited 15 mins in a chair and felt fine.so they let me go. But when I started walking to my car I started to feel lightheaded. As I got to work which is only 5 mins away from the vaccination site. I started to feel even more lightheaded at 9:00am. So my coworkers told me to lay down.  At which point,  I started to feel even more dizzy, nauseous, and weak.  That is when I went to the bathroom because I felt like I was going to throw up. Work got involved and helped me back down to Employee Health to be evaluated.  From there they check my blood pressure which was 120/70 and asked if I ate anything this morning, which I did not. But I never eat in the morning and have never had this happen.  So they gave me a muffin and orange juice. Which did help a little. But after an hour of being at employee health, I still felt lightheaded, dizzy, nauseous, tired, and weak.  My mother picked me up and drove me home. I proceeded to feel that way most of the afternoon and evening. Plus slept most of the day. But I noticed I also developed a headache and a very stiff sore left arm where I got the injection at. Today 12/30/20 I feel mostly tired, nauseous, and still have a very sore arm.
I was getting ready for bed on 03/24/2021 and right above my elbow I developed an itch and severe redness that spread to the other arm. It was itchy and I called my daughter who brought Benadryl. It cleared in about 4 hours. I spoke to a telehealth doctor overnight and they were unsure if my reaction was to the Humira or the vaccine (I took Humira the same day as the vaccine). I called my PCP and my rheumatologist the next morning, I saw the rheumatologist at some point after this event and was given an EpiPen for safety and told to not take the Humira the same day as the next vaccine. Also, was instructed to sit for 30 min after the next vaccine.
Red rash appeared near injection site about 10 days after injection. Triangle shaped, about 6 or 7 inches at the peak, 3 or 4 inches wide. Itching, no pain.
Information has been received from a consumer referring to her daughter, a female teenager of unknown age. There was no medical history or concurrent condition reported. On 16-OCT-2014 the patient was vaccinated with the first dose of GARDASIL (dose, lot# and route were unknown). After administration, on an unknown date in 2014, the patient experienced multiple adverse events including headache, fatigue, muscle aches and pains, extreme changes in her vision, stomach pains, memory and speech problems, fevers, vomiting and diarrhea. The headaches and muscle pain were constant and other events developed "about every two months". On 05-JAN-2015, the patient was administered the second dose of the vaccine, after which the adverse experiences increased in frequency, occurring every month. Then the patient was administered her third dose of the vaccine on 10-SEP-2015 and was now sick all of the time. The reporter gave permission to contact her by phone. Additional information has been requested.
60 minutes after receiving the vaccine the patient became very dizzy and was unable to walk. After a couple of hours dizziness lessened and patient was able to ambulate.
Information has been received from a registered nurse concerning a 26 year old female with no medical history or allergies, who on 04-JAN-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. On 04-JAN-2007 the patient felt dizzy and had a sensation of hands being pressed down on her head. No other symptoms were noted. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The symptoms lasted about 15 to 20 minutes and then resolved. No product quality complaint was involved. Additional information has been requested.