chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot was given in upper right at,. Returned to store twice. I was told to take Advil for inflammation. On the second trip, I was told to use ice. As the pain continued, 9/27/2019, I went to the ER, where they took X-rays. Dr told me that if my arm swells and gets red, return to the ER, which I did on 9/28/2019. They took a CT scan, blood and fluid from my swollen joint. I was given 4 prescriptions and they fitted me with a shoulder sling. Other instruction was to see Dr, orthopedic to be re-checked. On 10/01/2019, had an appointment Dr. He stated that I have Bursitis and gave me a steroid shot. He recommended that I take Tylenol or Aleve for pain and continue with ice as needed. After 2 days, the pain was gone and I am feeling better.
The mother was in with the child for vaccines 3/3/15 and at that time, she reported the child had intussusception with 1st (and only) dose of ROTATEQ 4-1-14. Starting approx. 4/2/14 had temp. which continued to be elevated, fussy, thought maybe spit up blood. Went to ER at hospital - then was transferred to another hospital - 4/7-4/9. Had procedure where air in colonoscope corrected the intussusception. No surgery required.
Pt devel inject site rxn of redness, the size of her hand. Also pain during injection which "really stung".
administered expired Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: The reporter reported that, they inadvertently administered expired Bexsero dose to a patient. The reporter called to inquire to know about how to proceed. The reporter did not consent to follow-up. Additional Supportive Information: The patient was inadvertently administered with expired dose of Bexsero, which led to expired vaccine used.
Brain lesions; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (medically significant), outcome "unknown", described as "Brain lesions". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was  unspecified whether the patients had sought any medical attention. There was no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from a  healthcare processional refers to a 12 months old patient. On 25-JUN-2014 the patient ws vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J013907, expiration date 30-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source.  Additional information has been requested.
HEART SURGERY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: UNKNOWN) dose was not reported, (Dose number in series:1) administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On SEP-2021, the patient experienced heart surgery.(Dose number in series:1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart surgery was not reported. This report was non-serious.
Breakthrough case admission after 4 vaccines Moderna 4/28/21 Lot# 043B21A;  Moderna 6/2/21 Lot# 041C21A;  Moderna 2/9/22 lOt# 033H21A; Moderna 7/28/22 LOt# 051B22A
Patient accidentally intradermally injected with 0.1ml of inactivated IPV rather than 0.1ml of PPD.  No signs/symptoms of any adverse reaction noted. Patient advised to follow up with urgent care or PCP should any signs/symptoms of adverse action occur.
reaction to the Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction to the Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION SITE REACTION (reaction to the Covid-19 vaccine). At the time of the report, VACCINATION SITE REACTION (reaction to the Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT MENTIONED SHE HAS REDNESS AROUND THE BAND-AID AREA AFTER TAKING THE BAND-AID OFF. REDNESS WAS NOT AROUND THE INJECTION SITE, BUT FROM THE BAND-AID BEING ON THE SKIN FOR TOO LONG. PATIENT WAS ADVISED TO TAKE BENADRYL TO REDUCE THE REDNESS.
PATIENTS SISTER NOTIFIED THE PHARMACY TODAY (05-11-2021) THAT PATIENT HAD TO BE HOSPITALIZED 5 HOURS AFTER RECEIVING HIS VACCINE. HE WAS DIAGNOSED WITH A BRAIN STEM STROKE AND HAD TO HAVE HEART SURGERY ALSO WHILE ADMITTED TO THE HOSPITAL
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MALAISE (Laid up for a day or two) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MALAISE (Laid up for a day or two). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MALAISE (Laid up for a day or two) outcome was unknown. No information on concomitant medication was reported. Patient had his primary series and first booster of Moderna. After the 3rd Moderna, he was laid up for a day or two with flu-like symptoms, but they weren't bad. No information on treatment medications was reported.
Patient was pregnant.  Had a viable pregnancy confirmed on 3/17/2021 with a 9wk gestation fetus and + cardiac activity and no abnormalities noted.  Patient returned for prenatal visit on 4/14/21 and was confirmed to have had a miscarriage with no cardiac activity noted and a fetus measuring 12wks 0 days gestation.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/1/2022 -- RECURRENCE OF SAME SYMPTOMS
Abdominal pain, cramping with bowel movements, indigestion, nausea, diarrhea starting 2 days after administration of vaccine. Stool color became tan/pale. Bowel movements initially watery, then very soft. Symptoms improved only mildly with pepto-bismol use for 7 days. Symptoms improved after administration of probiotic.
I started coughing and my cough was not diagnosed until Dr (a Pulmonologist) did a bronchoscopy (in July 2022) and discovered Scarcoidosis. I was put on prednisone and the cough stopped but when I received  the most recent Covid vaccine on December 1st, my coughing returned.
Information has been received from a physician concerning a male approximately in his "early 70's" who at 08:00 (date unspecified) was vaccinated with a single dose of Zostavax (Oka/Merck). Concomitant vaccination administered on that same day at 08:00 included a dose of influenza virus vaccine (unspecified). Subsequently the patient experienced trouble urinating from about 12:00 until 04:00 and then fainted. The patient went to the emergency room and was subsequently admitted to the hospital for an overnight stay. The patient was able to urinate around 04:00 and was noted to be recovering. Medical treatment in the hospital was not specified. There was no product quality complaint. Additional information has been requested.
Fever at 24 hrs, some irritability, No NVD. Exam=WNL Excepting T=101 degrees rectal. Still some fever at 24 hrs.
I began wheezing approximately two days after the vaccine was administered to me and continued wheezing for approximately three months. I have never had breathing issues in the past. On 2/13/2019 I was diagnosed with asthma. I am unsure of the lot number, as I am unclear from the pharmacy receipt as to this. However, I do have the pharmacy receipt which clearly identifies the type of vaccine and date administered.
Information has been received from a registered nurse concerning a 9 year old male with no know medical history or allergies who on 20-MAY-1998 was vaccinated with a subcutaneous dose of varicella virus vaccine live (Oka/Merck) in the right thigh (Lot # "1567G"). Concomitant vaccines administered on the same day included subcutaneous dose of M-M-R II (Lot #625833/0033H) in the left thigh. The patient had no illness at the time of vaccination. On 06-MAY-2007, the patient started itching and on 09-MAY-2007 the patient broke out in lesions with less than or equal to 50 lesions. Subsequently, the patient recovered. Additional information has been requested.
Severe arm pain in the arm injection was given. Pain radiated down arm, across upper blades into neck. No fever at any point. But did have chills and sweats. Severe pain lasted about 6 hours
No adverse event. Patient stated she was here for 2 vaccinations- COVID and flu. We do not have the COVID shot at our facility. Patient said she did not get vaccinations at her doctor's office. Her husband called later that evening stating she did get the flu shot the day prior at her primary care provider's office.
I'm not sure this is entirely vaccine related, but I wanted you to be aware. I occasionally experience unexplained swelling of my lips. It has been investigated by an allergist, but the cause is unknown -- doesn't appear to be a food allergy (no trigger foods identified, and it has never appeared immediately after eating), and may not even be histamine related.     It could be something immune-system related, and my experience this weekend might support that.     I had normal, expected symptoms on Friday evening (chills, headache). Those resolved Saturday. Saturday night, my lower lip swelled dramatically. Swelling spread into the upper lip as well. I have seen this before, but this was one of the more severe instances I have experienced.     Lips remained swollen overnight. When I woke up Sunday morning and went to the restroom, I became suddenly lightheaded and passed out. That's a symptom I have never experienced before. I consulted with my primary care doctor and took it very easy the rest of Sunday. He and I will follow up to further asses what happened. No further light-headedness on Sunday or today. Lips eventually resolved late in the afternoon.     This is all about 72 hours after the vaccine, so I can't be sure it is related, but I do wonder if it is related to having my immune system revved up by the vaccine. I reported it on the CDC check-in app and my primary care physician is noting it on his side as well.
high fever; upset stomach; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Apr-2021, the patient experienced PYREXIA (high fever), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PYREXIA (high fever), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. Not Provided          No treatment medications were provided No concomitant medications were provided
pt recv vax 23JAN97 & 8 days later 30JAN97 pt exp urticaria, arthritis, & perioral & periorbital edema;ER visit was required to treat the events;tx w/IV steroids, solumedrol, atarax, pred & tagamet resulted in alleviation of the sx;
pt had red raised indurated area on rt thigh that reached from inguinal area to knee, where recv vax;
Pt woke at 1am with shakes and temp 106.8. Temp decreased 102.6 to 100.9 in am. Some dyspnea and diff. swallowing. ER in am after calling MD office.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On unknown date the patient was vaccinated with 10-11 doses of (Oka/Merck) VARIVAX (dose, lot # and route of administration were not reported). It was reported that the patient remained negative for titers. The outcome of the event was not recovered/not resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Arm being sore; small red spots and a small dot; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Arm being sore) and VACCINATION SITE ERYTHEMA (small red spots and a small dot ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm being sore) and VACCINATION SITE ERYTHEMA (small red spots and a small dot ). At the time of the report, PAIN IN EXTREMITY (Arm being sore) and VACCINATION SITE ERYTHEMA (small red spots and a small dot ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that got up my knuckles  whether they are from vaccine or spider bites. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Patient premedicated with fexofenadine and famotidine due to previous severe reaction to flu vaccine.  Immediately after receiving covid vaccine, patient began itching and had nausea, vomiting and diarrhea and body aches,  Patient presents to ER on 3/29/2021 due to continuing symptoms,  same as described. Patient is treated with IV fluids and promethazine.  All labs and vital signs are normal.
Can not stand on her own; Light Headed; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Can not stand on her own) and DIZZINESS (Light Headed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 07-May-2021, the patient experienced GAIT INABILITY (Can not stand on her own) and DIZZINESS (Light Headed). At the time of the report, GAIT INABILITY (Can not stand on her own) and DIZZINESS (Light Headed) outcome was unknown.            The patient reported use of concomitant medications but did not provide any details. No treatment information was reported.
TDVax vaccine administered had expired on 4/17/2022.  Patient left with no adverse reaction.  Patient will come back for revaccination.
Arm soreness lasting 3 days, starting 12 hours after inejection. First day was the worst.   Headache, nausea and diarrhea starting 72 hours after infection and lasting 24 hours.
This spontaneous report was received from a nurse refers to 6 unspecified patients of unknown age and gender. Information regarding patients' medical history, current conditions and concomitant medications were not reported. On multiple unknown dates, the patients received improperly stored VARIVAX (lot # N000683, expiry date: 06-JAN-2019) which was reconstitute with properly stored sterile diluent (Manufacturer unknown) via unspecified routes, for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 6-14 degree Fahrenheit (6F) for 36 hours. There were no previous temperature excursions and no digital data logger was reported. No side effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA006125: US-009507513-1708USA006124:
Aggressive nosebleed, left nostril only. No history of nosebleeds without trauma)
Patient went to have labs done for her leukemia checkup 3/24. Patient has had leukemia for many years and has had many blood draws. Patient had blood taken at her appointment and was waiting when the nurse came back out and said her blood had clotted so they needed to redraw her blood. She states this has never happened before and wondered if her blood clotting would have been due to her covid vaccine the week prior. She states the first girl who drew her blood was slower than the second time around when a different nurse drew her blood.
Per pt had "local reaction at injection site 4x6 cm area of redness and was painful to touch." Per pt used topical aloe with relief.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted to Hospital and coded twice before passing away on 3/11/21. Daughter reports that patient began not feeling well and having difficulty breath shortly after receiving his second Pfizer COVID-19 vaccine on 2/26/21. Death occurred at outside facility and suspected cause of death not apparent. Patient was 78 and PMH included chronic hypoxemic respiratory failure, HTN, T2DM, COPD.
Very painful, very red and inflamed, swollen, nauseous, tired. Went away Monday.
July 27. 2021 @1640: unusual chest/back/bilateral arm pain; admitted to ED, EKG normal, troponins elevated, echocardiogram abnormal; showed enlarged left ventricle, troponins reached 0.44 then declined on next two lab draws. transported to another city for heart cath; results showed Takotsubo Cardiomyopathy; will follow up with cardiologist in my home state.
body ache; fever 100.6; Chills; Muscle ache; This is a spontaneous report from a contactable consumer. A 69-year-old Female consumer reported in response to Non-HCP letter sent in cross-referenced case which included that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, in arm left on 09Feb2021 12:45 (at the age of 69-year-old) as single dose for COVID-19 immunization. The patient medical history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, in arm left on 19Jan2021 12:30 as single dose for COVID-19 immunization and experienced headache, chills, fever and muscle ache. Patient concomitant medications were not reported. No other product(s) were taken together with the COVID-19 vaccine. illness at time of vaccination was None.  On 09Feb2021 at 20:00, patient experienced body ache, fever 100.6, chills, muscle ache lasted about 24 hrs. The patient underwent lab tests and procedures which included body temperature: 100.6 on 09Feb2021. Adverse events did not require visit to Emergency room nor Physician Office. Seriousness of the event was reported as non-serious. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Period started 2 days later and lasted for 7 days (it wasn?t due for another 3 weeks)
Mother states client received vaccine on 8/4 and was vomiting and running a fever all night. Mom also states client has numbness and tingling down her face. Nurse instructed mom to take child to see family dr or medical health place. Mom stated taking daughter to urgent care.