chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme tiredness (more than 12 hours sleep) necessary starting on Saturday thru Monday; Extreme tiredness (more than 12 hours sleep) necessary starting on Saturday thru Monday; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 13:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient received the shot on Thursday afternoon. On 06Mar2021 at 07:00, the patient experienced extreme tiredness (more than 12 hours sleep) necessary starting on Saturday thru Monday. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme tiredness (more than 12 hours sleep) necessary starting on Saturday thru Monday was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT AGE <50, AND  HAS ONLY AUTHORIZED SECOND BOOSTERS FOR AGE >50. UPON DISCOVERY,  FOLLOW-UP WITH REHAB FACILITY WHICH PATIENT RESIDES-NO ISSUES REPORTED
tested positive for COVID 2 days later; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported that she received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unknown date, two days later after vaccination, the patient tested positive for COVID-19. The Event took place after use of the product. Symptoms were aches, chills, fever, cough, sore throat, fatigue, headache, loss of taste and smell, nausea, congestion. The Outcome of the events were unknown. Follow-up (31Mar2021) This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to the query. Follow-up (01Apr2021) This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to the query.  Information related to batch/lot number has been requested.
Usage of Bexsero in patients after it was given instead of Menveo.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received Men B NVS (Bexsero) (batch number 8n989, expiry date 31-OCT-2024) for prophylaxis.   On 30-AUG-2023, the patient received Bexsero. On 30-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Usage of Bexsero in patients after it was given instead of Menveo.).  The outcome of the wrong vaccine administered 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: 12-SEP-2023 The reporter was a medical assistant. The reporter wanted to know information about the usage of Bexsero in patient after it was given instead of Menveo. The vaccine administration facility was the same as primary reporter. The reporter reported that, they were intending to administered Menveo and inadvertently administered Bexsero instead of Menveo , which led to wrong vaccine administered. The reporter consented to follow up.
This spontaneous report as received from a nurse refers to a 17 year old female patient. Information regarding patient's medical history, drug reactions and allergies were reported as unknown. On an unknown date the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis whose dose, route, lot number and expiry date were reported as unknown. It was reported that "patient did not have her period the next month". It was unknown if any medical attention was sought. It was unknown if any treatment was given to the patient or any lab diagnostics or studies performed. The outcome of menstruation delayed was reported as unknown. The reporter did not provide the causal relationship with GARDASIL 9. There was no product quality complaint (PQC) involved.
Approximately 2 weeks after receiving the injection site became red, swollen and painful. I was concerned I had a sterile abscess at the injection site but the symptoms resolved after 48 hours. However, this progressed to pain on raising my arm particularly when bent at a 90 degree angle. My right arm dangles due to my radial head excision so my left arm is my only functional arm. In Feb 2019 I asked my orthopedic oncologist to evaluate my arm and he gave me a PT prescription. With the use of US treatments I can now raise my arm with only occasional slight twinges of discomfort but have two distinct points of pain with pressure - 1) the injection site and 2) on the back of my shoulder near my armpit.
Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 61-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had upset stomach. The reporter asked how long would the side effects last.
Developed URI and middle ear infection after receiving flu vaccine  Vaccine was given on 10/7/2019  Developed symptoms 10/10/2019 Still symptomatic on 10/14/2019  Symptoms include: congestion, cough, runny nose, fatigue, sneezing, postnasal drip, fever, laryngitis, headache, increased phlegm, inflammation of ears, sinusitis
This spontaneous report as received from a health professional (nurse) refers to an unspecified number of patients of unknown demographics. Medical history, concurrent conditions and drug reactions/ allergies of these patients were not reported. On an unknown date these patients were vaccinated with improperly stored VARIVAX (Merck). Concomitant therapy was not reported. No adverse effects were reported. This is one of the two reports received from the same source (MARRS # 1507USA005406). Additional information has been requested.
Developed swelling, redness, pain, and itching at the injection site. Symptoms started 8 days after vaccine was administered. Area of redness and swelling increased over the period of 1-2 days and was fully resolved by day 5.
Became extremely unable to soothe, extremely irritable with large swelling in left thigh. Currently gets a high fever every day usually in the evening not associated with teething. Mental confusion and aggressive behavior after 48 hours.
1115 c/o nausea, hives neck, throat, upper arms, upper back; no itching, no resp problems, t98.2; P140-reg; no hives or redness @ inject site; 1130 P100-rash only remains on throat;
CHILLS; MUSCLE ACHES; FEVER; VERY TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. On APR-2021, the subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle aches, fever and very tired was not reported. This report was non-serious.
Pt given flu shot in left deltoid and Pneumovax in right deltoid on 1/26/01. He presents to office with painful left arm and axillary lymphadenopathy.
Diarrhea for 4 hours Chills and Low Body Temperature (below 96 degrees)  for 4 Hours
Patient                                    CHART #: (Privacy) Upon receiving prescreening form and a verbal request to vaccinate this patient for a Moderna booster. The covid card accompanying the prescreen form was written: 1st and 2nd doses Moderna.  This writer initiated inquiry for verification of previous vaccinations and medication review to rule out immunocompromised patient. The vaccination history surmised in the patient?s chart was documented on September 28, 2021 for Pfizer with Lot number FF841, 0.3 ml on the left deltoid by RN at 1025 with charting completed at 1735 on 9/28/21. The covid card was transcribed as September 28, 2021 with Moderna lot # 047C21. One of two things occurred:  1. The initial or prescreening information tool sheet was selected to receive 1st dose Moderna per patient request; therefore, the covid card was completed for Moderna, lot # 047C21A.  The vaccinator took the Moderna for vaccination. Prior to vaccinating the patient  perhaps changed her mind to get a Pfizer and this change of vaccination was not communicated to make the change to Pfizer but was left with that initial information of Moderna.  2. The vaccinator followed through with the initial order of Moderna, 0.5 ml per patient request and per screening tool; vaccinated the patient at 1032 . Charting was completed and signed off at 1937 on  9/30/21  per chart documentation for Pfizer FF841 and NOT Moderna. At this visit, on 3/28/2022, the patient verbalized receiving the Moderna and not the Pfizer.  ?We all got Moderna, my mom and another person and no Pfizer was requested?. The mother?s covid card verified the date, 9/28/21 as her second dose to match the daughters same lot number as first dose Moderna with lot number: 047C21A.  The patient received a booster of Moderna today, 3/28/22 with no reaction.
Weakness, body aches, fast heart beat, heavy feeling in chest, tingling in hands and legs, numbness and dropping on left side of face, confusion.
LT THIGH RED SWOLLEN. BENDRYL 12.5ML 1 TSP EVERY 6 HRS. 80Z. ALLERGIC TO DTAP
Child with mucolipidosis type II, encephalomalacia and developmental delay. Received vaccinea AM 07/08/02, PM of same day, had seizure that reportedly last 15 mins, temp 101 in ER. May need to have an MRI.  Follow uP:  Encephalomalacia. The annual follow up received on 8/4/03 states the pt has some neurological deterioration in the last 1 yr, but this is most likely due to her underlying diagnosis and not the vaccines.
Patient presents to the ED with shortness of breath and cough. Patient was admitted for covid evaluation and treated with remdesivir.
Mom called today (7/17/17) and reports that a rash came up on child and has very fine red bumps that is spread all over body mom also says that a night child runs a fever and gets miserable. Has MD appt on Wednesday (7/19). Rash still present but only has fever at night.
Nearly immediate hives, progrss rapidly to coughing and difficulty breathing. Was given oxygen and Epi, symptoms went away after that.
Increase in size of lymph nodes.  This was detected the day before my second shot based on self exam suggested by my spouse.
2/3 of my upper turned red and itched.  I went to e.r and was told I had cellulitis Given antibiotics and antihistamines
pt recv vax;1-2 days later, devel fever, malaise & cold like synd which MD noted were not serious;
Arm itched 9 days after for about 12 hours; Arm hurt for 48 hours; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via an unspecified route of administration in right arm on 13Mar2021 at 09:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The medical history included eczema. The patient had allergies to penicillin. Concomitant medications included topical steroids, estrogen (MANUFACTURER UNKNOWN) and progesterone (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 14Mar2021 at 21:00, the patient experienced arm hurt (arm injury) for 48 hours and 9 days after on 22Mar2021, the patient arm was itched (itchy) for about 12 hours. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events arm injury was resolved on 16Mar2021 and itchy was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 12-JUN-2015, the patient was vaccinated with improperly stored doses of VAQTA with one of the following lot numbers: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016, (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot numbers K014696, L001445 and L004439 have been verified to be valid lot numbers for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Rt upper arm deltoid area  with mild diffuse deep swelling, tenderness. No skin discoloration.
was tested positive in the rapid test; This is a spontaneous report from contactable physicians. A patient of unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), an unspecified route of administration on an unspecified date at single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tested positive in the rapid test on an unspecified date with outcome of unknown. The physician appreciate knowing that the COVID-19 vaccine could not create false positives. The physician asked if the vaccine cause the positive result? The physician didn't think it was likely.  The information on the batch number has been requested.
No additional AE reported.; HCP reported VARIVAX was administered to patient after a temperature excursion.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 27-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, (valid lot number W008904 [expiration date 15-MAR-2024]) (dose, dose number, strength, vaccination scheme, and route of administration were not provided), administered for prophylaxis, after a temperature excursion of 23 degrees Fahrenheit (F) with a time frame of 2 hours, 17 minutes (product storage error). No previous temperature excursion.  No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013410:same reporter
Patient is only 11 years old and received 0.3ml, which is for ages 12+.  Upon noticing the mistake, we contacted the patient's father. He said that child is feeling fine, and just has a sore arm.
pt recvd vax & 10 min /p dose 2 devel nervousness, palpitaions, rash w/ itchniness on arms, chest & face;
Site was "hot and red to the touch. And arm muscles felt jiggly." X 2 days.
About 1.5 hours after dose administration, patient began to feel lightheaded and weak, unable to stand up.  He then noticed a rash on his forehead, chest, arms and back of neck.  He had no swelling of the lips, tongue or throat.  No shortness of breath or wheezing noted.  VS 157/110, 101, 20, 97.7.  Pulse ox 99% on room air.  No acute distress, but a little anxious.  No oropharyngeal erythema or swelling seen.  Lungs clear to auscultation.  Skin revealed red macular rash on the face.  Other areas had faded.  Benadryl 50mg po given with good effect.  Weak feeling subsided quickly and hives began to fade.  Repeat vitals over 30 minutes were largely unchanged.  He was allowed to go home with instructions to contact his PMD and to use Benadryl 50mg po Q4H PRN.  If he develops any signs/symptoms of anaphylaxis he should call 911.
I noticed my right arm felt stiff and extremely tender. The I pulled up my sleeve, I noticed 2 large red blotches, one on the front of my upper arm (about 1.5 inch radius) and one on the back of my upper arm (about a 2 inch radius). Both were to the left and to the right below the injection site. Both areas were hot to the touch and a bit swollen as well. I should mention that immediately following the injection, I had pain but not really any different form the previous injections.
Pts hands developed severe swelling. Pt got hives and began wheezing approx 30 min following vaccine. Sent to ED. Received Benadryl and Albuterol nebulizer and d/c home.
Patient age at time of shot 34. 02/28/97: 1st Anthrax shot. 03/14/1997: 2nd Anthrax shot. 05/19/97: Local medical inquiry about rash. 07/22/97: Dermatology. 09/19/97: Diagnosis: Scleroderma. 10/15/97, 11/17/97, 12/17/97, 01/07/98: Follow up dermatology. Final results were found to be final stage of Morphia Scleroderma. The rash began within weeks of my first shot of Anthrax. It began with a small red rash and slowly began to darken over time and expand in size. Doctors (PA and surgeons) believed I had bruised myself. After seeing the rash become dark in color and with a feel of leathery skin, I requested referral to see dermatologist. Over several years and personally researching scleroderma, I mentioned to my dermatologist, doctors and PA that I believed the first anthrax shot induced the skin disease. No action was taken to investigate. I also contacted the CDC in NY with no success. In Dec 02, I emailed my doctor with this info in response to a DOD requesting me sign a waiver for anthrax shots and currently with small pox shots. Reviewing my medical records, I find records written and photos taken of affected areas missing. An anthrax follow up report received 10/20/2003 states "unknown long term effects".
CONFIRMED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. Initial information was processed along with additional information was received on 22-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes, asthma, allergies, hypothyroidism, and drug allergy (Omnicef allergy). The patient initially received Moderna covid-19 vaccine (elasomeran) (dose number in series 1) (form of admin and route of admin were not reported, batch number: unknown, expiry: unknown) dose not reported, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient experienced any adverse reaction following vaccination with Moderna covid-19 vaccine (elasomeran) (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 08-MAR-2021 for covid-19 prophylaxis. The product was associated with Off label use (off label dosing frequency) (dose number in series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included cetirizine hydrochloride, ciclesonide, insulin aspart, levothyroxine, lisinopril, and salbutamol sulfate. On an unspecified date in JUL-2022, the patient experienced covid-19 symptoms (dose number in series 2) for which patient was treated with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered from 26-JUL-2022 till 01-AUG-2022 for treatment of covid-19. On 07-AUG-2022, the patient experienced rebound covid-19 symptoms and had covid 19 test positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of off label dosing frequency was not reported. This report was non-serious. This report was associated with product quality complaint: 90000246993. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
After receiving Td injection on left deltoid, pt developed swelling and redness on injection site with maculopapular rash, no tenderness.
Got Shingles shots about a year ago. Today I have shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On 26th November 2021, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shots about a year ago of reporting. At the time of reporting the patient had shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Bullous lesion of feet and extremties, started Sept 6 and as of Oct 24, 2021 still ongoing Slowlly better with topical steroids