chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came with vaccination worksheet. Registry report was created with the vaccinations on the worksheet.  After the shots needed were given another Registry for the patient was discovered.  The second Registry was found to have all his childhood vaccinations that were given in prior to this process.  Patients mother did not have or disclose the childhood record during the process or when checking in with HD for vaccination.  Mother was notified at the appointment of the extra vaccines that were given on this date and prior to due to no knowledge of his prior vaccination status.  Patient had no adverse signs or symptoms so far.
injection site warmth; injection site hard; The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm  side; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard), VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm  side) and INJECTION SITE ERYTHEMA (injection site red) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20-2A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard), VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm  side) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard) and VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm  side) had resolved and INJECTION SITE ERYTHEMA (injection site red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided.  No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Additional info. VAERS
This was my second dose. I experienced fever (101.9), chills, body aches, slight runny nose, headache, and severe right arm pain - began around 1am on 2-13-21 and continued throughout the day.  On 2-14-21 at around 10:00 am, I got undressed to take a shower and discovered I was covered in a red rash.  It was on all of my body with the exception of my legs and face, though it was along my hairline in the face area.  I contacted the school nurse (received my vaccine through the school system) and she said to go to the doctor.  I went to the Hospital and was prescribed Vistaril.  I was told I may need to take Benadryl before any future COVID boosters that may be needed.  They also told me to log my reaction on this site.  Today, 2-16-21, I am still unusually tired and have only trace amounts of the rash remaining.  My arm is still very, very sore.  I feel the soreness is different than it has ever been with any vaccine I have received - more intense.  My left arm where I received the first dose still feels tender though I did not have any of the other issues with the first dose other than extreme arm pain.  I do have photos of the rash.
Information has been received from a registered nurse concerning a 42 year old female patient who on 11-NOV-2009 was vaccinated in the same arm with PNEUMOVAX 23 and the flu vaccine (manufacturer unknown). The registered nurse reported that the next day, on 12-NOV-2009, the patient called her and stated that she had swelling, pain in the arm and a fever. It was unspecified if lab studies were performed. At the time of the report the patient was recovering. Additional information has been requested.
I have hives and welts on my entire body, including palms of my hands, soles of my feet, in my ears, on my lips, on my eyelids, there isn't a place on my body that hasn't had hives and welts. I am having a hard time breathing. I have to use an albuterol rescue inhaler usually 4-5 times a day in order to open my airways back up.
Information has been received from a health professional concerning a 6 year old female who on 26-JUN-2007 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 657449/0597U). Subsequently, the patient experienced redness. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the Agency t to Agency staff and then to Agency and the staff administering vaccine. Because of this delay, some monovalent vaccine throughout Agency was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Not immunocompromised and received full third dose of 0.5ml; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00F421A, 038K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinsonism.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml). On 19-Oct-2021, OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-358835 (Patient Link).
Last evening (2/2/21) the site where I received the injection on my upper left arm began to itch, redden and grow warm.  I had experienced that symptom immediately following the injection but it had disappeared some days ago.  There is a visible 2? round rash, it?s very itchy, red and warm to the touch.
Tenderness at the injection site; This is a spontaneous report from a contactable consumer (husband). This consumer reported similar events for 2 patients (husband and wife). This is 2nd of 2 reports. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tenderness at the injection site on an unspecified date. Outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021041442 same product/event/reporter, different patient
Started w/ rash, swelling of face & neck, numbness in feet & legs. Swelling of tongue followed with difficulty breathing, sores in mouth, permanent A-Fib, anemia from ulcer caused by excessive medications w/ no appetite. Eventually, diagnosed with COPD & A-Fib & autoimmune disorder, yeast infections, fungus on extremities.
Vaccines given 3/8. 3/10 parent called stated leg red sl. swollen in for appt. Apparent reaction to vaccines given (L) leg Dtap/HIB. Ice area, called next day, doing better. CT 3/13/17.
Patient administered hib vaccine and it was subsequently found to be expired by one day. No S/S of adverse reaction.
patient Received 2nd Dose of Moderna Wed , an Sunday, patient's arm became red, warm to the touch . Diagnosed they pop cellulitis
Shortness of breath and mild chest pain developed April, 2021 which led to ER visit on 5/7/2021.  Throughout treatment and test from May - August listed below in Item #19, was told the following: Left Bundle Branch Block; Systolic Heart Failure; Cardiomyopathy; Myocarditis
Patient's father insisted on child receiving Pfizer COVID-19 monovalent 5-11 vaccine, although due for bivalent booster.
pt recvd Hep B vax 8OCT92 & c/o malaise 9&10OCT; onset of pain under lt breast & under lt arm 10OCT92; sl nauseated; hives noticed on 11&12OCT; referred to MD seen 13OCT92 & considered allergic rxn to vax; t102, n,v; local rxn, lymphadenopa
This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 10th September 2018, refer case US2019GSK054970). On 15th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that she had a consumer that received dose of the SHINGRIX vaccine and stated that the consumer indicated that the only adverse event she experienced was tenderness at the injection site. The field representative was unable to provide any additional information. The reporter did not consent to follow up. This case linked with case US2019052087 and US2019GSK054970, reported by same reporter for the same patient.
This spontaneous report was received from a patient's mother, who was a nurse, and refers to her 9-week-old daughter. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 18-APR-2017, the patient was vaccinated with a dose of ROTATEQ, lot # M040270, orally (exact dose and expiry date were not reported), RECOMBIVAX HB intramuscular injection, lot # reported as M045653 (exact dose and expiry date were not reported), PREVNAR, intramuscularly (exact dose was not reported) and PENTACEL intramuscular injection (exact dose was not reported) as a routine vaccination. Subsequently, on 21-APR-2017, the patient developed bloody mucous diarrhea, which continued for two days and then off and on until 29-APR-2017. No medical attention was sought. The patient did not have any lab diagnostics studies performed and no treatment was given for the event. Causality between the event and suspect therapies was not provided. Product quality complaint was not involved. Upon internal review, the event of bloody mucous diarrhea was considered to be medically significant. Additional information has been requested.
Vaccine administered to patient in wheelchair in back of van.  Pt had been reclined position prior to vaccination but raised to receive the injection.  While speaking to spouse, patient closed eyes and did not respond to husband for a few seconds.  Husband thinks she "passed out".  Patient did respond to nurse immediately.  No further problems.
Pt given IM influenza vaccine. On 11-2-10. Pt was previously vaccinated with nasal vaccine 9-27-10. Therefore pt received 2 influenza vaccines and for this season and 1 influenza vaccine 5-12-10.
Administration deviation only; no adverse event resulted from this deviation.This patient received a mixed series of COVID-19 vaccine (one does of Moderna and one dose of Pfizer-box#4 reflects the date  of the second dose). The decision to administer a mixed series to the patient was due to an "exceptional circumstance" stemming from the unavailability of the first vaccine product (Moderna) at the time the second dose was used.We understand that although CDC provides considerations for a mixed series in exceptional circumstances (such as a vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires reporting:Note second vaccination date is  listed.
Started itching on the neck, spreading all over belly, lower belly, fore arms, wrists, back and lower back and all face. All areas became very swollen, red and hot. My wrists were very swollen and painful to the touch and a swollen nodule on the neck. Started having Benadryl and Atarax at home. After 4 days no improvement started with chest pain and short breath. Went to the ER. Had solumedrol, Benadryl and Pepcid IV. EKG, CBC, BMP, CK and Troponin done.
Patient stated: Developed a rash a couple days after vaccine on the right side and continued to get worse and went to the physician office where he was diagnosed with Shingles.  Dr. ordered Valtrex, Medrol Dos Pak, and Acyclovir cream.
started shaking and jerking like was having convulsions; started shaking and jerking like was having convulsions; started shaking and jerking like was having convulsions; gets a spasm every once in a while; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 04Mar2021 (afternoon about 01:05 or 01:15 PM) at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported they got the vaccine shot (clarified as Covid-19 Vaccine by Pfizer) on 04Mar2021 afternoon about 01:05 or 01:15 and they were fine all day and all evening. On 05Mar2021, about 03:30 AM in the morning, the patient started shaking and jerking like was having convulsions. The patient was shaking so hard they couldn't get out of bed. They didn't know if that was a reaction to the vaccine or something else. It lasted about 15-20 minutes and then it subsided. The patient then gets a spasm every once in a while, for the next half hour and at the time of report it seems go stopped all together. Outcome of the events was recovered on 05Mar2021.   Information about lot/batch number is requested.
Red spots that itch and hurt coming from my right rib under my arm pit to the center below my ribs
Extreme pain head to toe/ constant/12 hour duration , fatigue, lessening pain over next 5 days  pain started 4 hours after shot, extreme pain with movement of innoculated arm
VACCINE ADMINISTERED AFTER THE  31 DAY REFRIDGERATED BEYOND USE DATE BUT BEFORE THE 45 DAY EXCCURSION DATE.
Dose 2 was 48 hours late and dose 3 was 24 hours late/ no AE; Initial information received on 01-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 31 years old male patient who received third dose of RABIES (HDC) VACCINE [IMOVAX RABIES RABIES (HDC) VACCINE lot P1D60 (Expiry date 02-OCT-2020) via intramuscular route in the left deltoid, on 01-Aug-2019 which was 24 hours late.  The patient's other past medical history, medical treatment(s), vaccination(s) and family history were not reported.  The patient was scratched by a monkey in another country.   No other vaccine was given.  It was an actual medication error case due to inappropriate schedule of vaccine administered.  It was reported that while in another country, the patient started his dose 1 and dose 2 of of Imovax. The pharmacist states that Dose 2 was 48 hours late. The patient came home and was 24 hours late for Dose 3.   No AE and No signs of rabies was reported at time of reporting .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Information on the batch number for first and second was requested.  List of documents held by sender- none.
CLIENT PRESENTED TO HEALTH DEPT CLINIC ON 6/2/14 FOR IMMUNIZATIONS, PHN NOTICED SWELLING & BRUISE ON ARM. CLIENT STATED INJURY IS FROM FLU VACCINE RECEIVED ON 3/12/2014.  CLIENT STATED SHE FOLLOWED-UP WITH PHYSICIAN FROM CLINIC 1 WEEK AFTER VACCINATION. PHN OBSERVED BRUISE ON CLIENT'S LEFT ARM OF ABOUT 1-INCH IN DIAMETER AND AREA OF SWELLING 2.5 INCHES X 6 INCHES. CLIENT ALSO REPORTED AREA OF REDNESS AFTER FLU VACCINE RECIEVED, PHN DID NOT OBSERVE REDNESS ON 6/2/14.
Local reaction with swelling, redness and warmth, 48 hours, post vax. Treated with ibuprofen and Benadryl.
Arm swelled up and severe pain right down to wrist including back and right breast. Fever and chills.
Vaccine on Sunday morning. Monday woke feeling unwell, as day progressed, severe chills and freezing cold with body aches. Felt so bad thought Covid had returned. Literally teeth chattering, had to have hot bath to feel warm. Felt the same on Tuesday.   Wednesday chills subsided and started to feel better. My arm was sore and aches for a full week.
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 45-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). On an unspecified date, the subject received erroneously an expired vaccine dose of HAVRIX adult (unknown route and injection site).
Severe headache; moderate fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 at 16:00, the patient experienced severe headache and moderate fatigue. 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 events severe headache and moderate fatigue was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increase of blood pressure; Heart palpitations; Dizziness; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer. This 31-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the right arm on 18Jun2021 at 08:30 PM as single dose for COVID-19 immunisation. The patient medical history included Covid-19 an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop dates were not reported. On 23Jun2021, the patient experienced increase of blood pressure three days after, heart palpitations, dizziness, nausea and diarrhoea. The events lead to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests which showed sars-cov-2 test as positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatments received. No covid tested post vaccination. Device date was reported as 29Jun2021. Outcome was resolving for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
decreased ability to make decisions; Dizziness similar to vertigo;dizziness set in maybe 48 hours after my second dose and worsened over the following week; Dizziness similar to vertigo;dizziness set in maybe 48 hours after my second dose and worsened over the following week; was stimulated by movement, visual changes, and sounds independent of each other; was stimulated by movement, visual changes, and sounds independent of each other; Brain fog; inability to focus my attention; confusion as well as decreased ability to make decisions; Anxiety that was severe/Heightened anxiety levels have remained for almost a week; describe as a severe panic attack; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0179) as single dose for covid-19 immunisation at the age of 34-year-old.  Medical history included ADHD, allergy to Bactrim. She has felt dizziness when had the middle ear suctioned out while having a tympanostomy. The patient previously received the dose 1 administered in Arm Left on 16Apr2021 (Batch/Lot Number: EW0161) as single dose for covid-19 immunisation at the age of 34-year-old. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and sertraline hydrochloride (ZOLOFT). On 09May2021, the patient experienced dizziness that similar to vertigo, that was stimulated by movement, visual changes, and sounds independent of each other. The only time I've felt similar dizziness is when I've had my middle ear suctioned out while having a tympanostomy. The dizziness set in maybe 48 hours after my second dose and worsened over the following week and then started to lessen; also felt brain fog that included inability to focus my attention, switch between tasks effectively, and confusion as well as decreased ability to make decisions. This brain fog has lasted well over a week now but is starting to abate; and also experienced anxiety that was severe. A week after my second dose, I had what I can only describe as a severe panic attack. I have never had one this severe and have not had a panic attack in well over a decade. The panic attack was not preceded by any event that I would characterize as outside the realm of normal levels of stress. Heightened anxiety levels have remained for almost a week now but are slowly dissipating. The outcome of the events was recovering. No treatment received for the events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.