chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately following immunizations we were walked out of room by nurse to the front desk to schedule a follow up appointment. With in 1-2 minutes of standing at the desk I heard a loud bang! I turned around to see what it was and my daughter was laying flat on her back, her eyes were rolling and she was seizuring. My daughter fainted while standing, fell back and slammed her head off the tile floor. She was unresponsive and very confused.  911 was called and she was taken by ambulance to the hospital. My daughter did indeed have a concussion. Since the fall she is experiencing severe headaches and neck pain started today.
Influenza Vaccine, Quadrivalent Split Virus Preserv Free >/=6 MOS is the vaccine I had. Swelling, redness, pain, warmth and itching at injection site. Pain in lymph area of underarm and left breast. Feeling sick to stomach and feeling feverish.
when I received my second shot I was totally unaware that I was pregnant. Here I am over a month ago 2 months pregnant. I went to my ob and he did bloodwork. I already had a baby in the past and I knew I was very healthy. little did I know my tests would come back abnormal. My dr told me that I have antibodies for polyglandular autoimmune syndrome. I was so shocked and no extremely worried. I never had this before. I have read that some people have gotten this from the vaccine. I wanted to tell you people so that maybe you can make it know as a side effect. bc I know I got this from this vaccine.
11/18/22 presents to ED for "altered mental status""increased cough". PMHx of "ischemic cardiomyopathy status post AICD placement, DVT/PE on Eliquis, previous strokes"
Complained of numbness around mouth, approximately 2 minutes after flu shot was administered. Exhibited difficulty talking. Pulse 100, BP 152/90. Pt also complained of very dry mouth, Was given Benadryl 50 mg IM and transported to ER by family members.
took off the band aid it was soaked in blood; the site of injection was black; A spontaneous report (United States) was received from a consumer concerning herself, who is a 61-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events when she took off the band aid it was soaked in blood, the site of injection was black .  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced the events when she took off the band aid it was soaked in blood and the site of injection was black. The site of injection has remained black since then. She has not used anything to alleviate the symptoms. The black spot is gradually fading.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events when she took off the band aid it was soaked in blood, the site of injection was black was resolving.
Radiation "recall" from radiation I had from breast cancer (DCIS) on Oct. 23, 2000. Very rare said my doctor and an oncologist friend.....also had flu, chills for about 24 hrs.  The "Sunburn"  radiation lasted about 4/5 days....Mr. Dr. suggested I take antihistamine which I did.
about 2 weeks after vaccine was administered father noticed a 4cm in diameter erythematous region around site of injection of HepA & Varicella vaccines (right thigh).  Went to ED on this sunday and was started on Clindamycin which seemed to help redness per dad.  I saw patient in Peds Clinic on April 17th.  3-4cm erythematous region in diameter.  Two 3mm papules (appeared clear fluid filled) in the central region as well as a 8mm region also in the center that was bluish-purple color.  Whole 3-4cm area felt indurated.  No fluctulance.
No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (9.37 C) for 2 hours and 30 minutes; (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-APR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016061, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: 9.37 degree Celsius for 2 hours and 30 minutes; -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Fussy 25FEB w/sweating & fever (no temp taken); 27FEB pt @ sitter started persistent unconsolable crying @ 3PM lasted until 28FEB 5AM; 28FEB t100.2 PM; 29FEB-1MAR slept almost continuously, harder to arouse than usual, had to wake for feed;
A company representative reported that a female infant received her second dose of Prevnar. At the age of 6 months, she developed streptococcal bacteremia and was hospitalized. Follow-up info was received from the physician on 05/20/2002. The infant, who had a medical history of mixed gonadal dysgenesis, received her second dose of Prevnar and doses of Comvax, IPV and Infanrix vaccines on 12/17/2001 at age 4 months. When she was 6 months old, a blood culture was performed which was positive for streptococcus. She subsequently recovered.
HIVES, ITCHING, REDNESS, BURNING SENSATION, WELTS. APPEARS/ OCCURS IN RANDOM PLACES ALL OVER BODY. STARTED ABOUT 12 DAYS AFTER THE BOOSTER AND HAS NOT GONE AWAY. I TAKE ZYRTEC TO CONTROL, BUT AS SOON AS THE ZYRTEC WEARS OFF, IT COMES BACK.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 16-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Red, swollen, hot to touch, 3-4 inches down arm, painful to touch. Area marked with a marker.
20 minutes of palor & poorly responsive awake but dysconjugate eye movement; no stiffness, twitching;
Vaccines received on Thursday 7/28/22,  on Sunday 7/31 numbness and tingling in both legs.
Five minutes after administration of vaccine, patient began experiencing itching and feeling of chest tightness. Patient was administered EpiPen 0.3mg. Patient vitals were stable, O2 fluctuating. Patient appeared flush and airway movement somewhat decreased. With monitoring, for about 45 minutes to an hour, patient stabilized and was dismissed without incident. This is patient's first pregnancy. Patient's due date is 9/13/2022.
Information has been received from a health professional concerning a pt who was vaccinated with MMRII and subsequently, the pt experienced an anaphylactic reaction. No further information was available. Upon internal review, anaphylactic reaction was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states: Information has been received from a health professional concerning a 5 year old Caucasian male pt who, on 5/1/01, at 13:00, was vaccinated in the right arm with a 2nd dose of MMRII (lot 0168L-invalid lot). The pt returned to the office about 1/2 hour, after the injection, complaining of wheezing and covered with hives, consistent with an anaphylactic reaction. The pt was treated with albuterol nebulizer, antihistamines and epinephrine. It was noted that the pt recovered on 5/1/01. Upon internal review, anaphylactic reaction was considered to be an "Other Important Medical Event". Additional information has been requested.
Lost of appetite; Fatigue; mild headache; Chills; Nausea; Tested positive for COVID-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination), DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu on 25-Jan-2021. Concurrent medical conditions included Blood pressure high, Cholesterol and Prostate ablation. Concomitant products included LISINOPRIL for Blood pressure high, PRAVASTATIN for Cholesterol, POLYCARBOPHIL CALCIUM (FIBER LAXATIVE) for Laxative supportive care, TAMSULOSIN for Prostate ablation, OMEPRAZOLE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination). On an unknown date, the patient experienced DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination) outcome was unknown and DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, COVID-19: Positive. On 25-Jan-2021, Influenza: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No additional AE details were provided; A medical assistant is calling in to report an AE for a patient who received their first dose of MMR-II and VARIVAX 7 days too early.; This spontaneous report has been received from a medical assistant, referring to a 11-month-old female patient.  The patient's concurrent conditions, medical history, and concomitant medications were not provided.  On 26-OCT-2022 the patient was vaccinated 7 days too early with their first dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R-II) 0.5 milliliter subcutaneously (lot number W009104 has been verified to be a valid lot number, expiry date 04-DEC-2023) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter subcutaneously(lot number W017551 has been verified to be a valid lot number, expiry date 06-JAN-2024) (strength, frequency, and anatomical location were not reported) indicated as prophylaxis (inappropriate schedule of product administration). The reporter states that the patient turns 12 months old on 01-NOV-2022 and that was when she should have received her first doses.  No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA009819:
4DEC 830PM pt noted rash on trunk & down legs;5DEC rash looked more like hives & spread to face;rx denies pruritus but c/o mild pain;by 6DEC hives persist so will be seeing MD this afternoon;
This case was reported by a physician and described the occurrence of the flu like symptoms in a 22-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allodynia, chronic proteinuria, hypertension, post herpetic neuralgia and Wegener's granulomatosis. Concurrent medications included ADDERALL, Lisinopril, NORVASC, Gabapentin, LEXAPRO, Trazodone, PHENERGAN, SEROQUEL, ROBAXIN and Antibiotic (unknown). On 29 September 2009 the subject received 1st dose of FLUARIX (.5 ml, left arm). Within 24 hours after vaccination with FLUARIX, the subject experienced mild flu like symptoms. The next day the subject experienced a low grade fever. On an unspecified date in October 2009, one week prior to the time of reporting, the subject developed sinusitis. The subject experienced a fever with the sinus infection. The physician considered the flu like symptoms, low grade fever, sinusitis and fever were disabling. At the time of reporting the flu like symptoms were resolved, low grade fever and fever was unresolved, and sinusitis was improved. The physician considered the flu like symptoms, low grade fever, sinusitis and fever were possibly related to vaccination with FLUARIX. The physician reported that the subject was given FLUARIX and within 24 hours experienced mild flu like symptoms. A low grade fever 100.3 manifested and resolved after three days but returned. About two weeks after vaccination, the subject was treated with antibiotics for sinusitis which she developed one week prior to the time of reporting. Fever was present again with the sinus infection. The physician was going to see the subject on 20 October 2009. The physician noted that the subject had improved, but still reported a low grade fever of 99.4.
7/2/09 1500.  Received call from pts mother stating that child began with red, raised, maculopapular rash covering entire body approx. 30 min post receiving vaccine.  No resp. distress, fever, or itching noted.  Instructed to contact pts. private MD for further F/U & discussed s/s of anaphylaxis.  Physician instructed to give BENADRYL & F/U if necessary.
Injection given at 5:00 P.M. on 1/16/15. Also given injection of ROCEPHIN and Rx - AUGMENTIN. About 11:00 pm I was awakened by urge to vomit. experienced projectile vomiting. On 1/17/15 awoke with 3" band of swelling at injection site. Violent coughing episode. Swelling continues to date. Joint ache, mostly in neck. Popping noise with movement of spine, knees. Earache in right ear. Several episodes of coughing.
severe headache, 102 degree fever, abdominal pain, leg pain and sharp chest pain that occurred over night and then again in the afternoon on July 23.
Having pretty bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Having pretty bad headaches) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Having pretty bad headaches). At the time of the report, HEADACHE (Having pretty bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 25 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: NSAIDs" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
NAUSEA, ABDOMINAL PAIN, INCREASED PULSE, FATIGUE, FEELING HOT.
receiving expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Rota (Rotarix lyophilized formulation) (batch number 3A333, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 27th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 27-Jul-2022 Reporter's comment: The nurse practitioner reported that on the day of reporting a patient received an expired dose of Rotarix. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Rotarix, which led to expired vaccine used.
Triple Hit Diffuse Large B cell Lymphoma; Diffuse Large B cell Lymphoma; Pneumonitis; tested for COVID antibodies, had no antibodies; This case was reported by a consumer via call center representative and described the occurrence of triple hit lymphoma in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included rituximab (Rituxan) for triple hit lymphoma and diffuse large b-cell lymphoma and TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   On 7th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Rituxan at an unknown dose and frequency and COVID-19 VACCINE PFIZER. In January 2022, less than 2 months after receiving Shingrix, the patient experienced covid-19 antibody test negative. On an unknown date, the patient experienced triple hit lymphoma (serious criteria GSK medically significant), diffuse large b-cell lymphoma (serious criteria GSK medically significant) and pneumonitis. The patient was treated with cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone. The action taken with Rituxan was unknown. On an unknown date, the outcome of the triple hit lymphoma, diffuse large b-cell lymphoma, pneumonitis and covid-19 antibody test negative were unknown.   It was unknown if the reporter considered the triple hit lymphoma, diffuse large b-cell lymphoma, pneumonitis and covid-19 antibody test negative to be related to Shingrix.  Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comment: The case was reported by the patient. Last year from reporting, he/she was diagnosed with triple hit diffuse large B cell lymphoma.  The patient went through 6 rounds of chemo, 1 R-CHOP (an immuno-chemotherapy regimen consisting of Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Vincristine and Prednisone) and 2 through 6. The patient was tested in January 2022 for Covid antibodies after 3 injection of the Pfizer vaccine.  They found that, the patient had no antibodies for Covid, likely due to the Rituxan in the chemotherapy treatment. After round 4, completed on 11th May 2022, the patient developed pneumonitis, possibly related to the Rituxan in the chemotherapy treatment. The Rituxan was not used in the final two rounds of chemotherapy. Less than a month after receiving Shingrix,the patient experienced triple hit lymphoma and diffuse large b-cell lymphoma. Between 5 and 6 months after receiving Shingrix, the patient experienced pneumonitis. The patient was due for his/her second shot of Shingrix. The reporter wanted to know that, Rituxan interfere with the Shingrix vaccine. Unfortunately, there was no drug interaction (Rituxan prevented Shingrix from working) section listed in the package insert. It was unknown if the reporter considered the b-cell lymphoma, pneumonitis and covid-19 antibody test negative to be related to Covid-19 vaccine Pfizer.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 6-month-old male patient who received DTaP. On an unknown date, the patient received DTaP vaccine. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to DTaP vaccine. Additional details were provided as follows: The mother of the patient reported that her son received DTaP vaccine when he was 6 months old and he had a reaction. The patient's mother was not sure what he was vaccinated with. So, they held off on getting him any other vaccine, but he was 4 years old at the time of reporting and they are trying to get him caught up on vaccines for school. They went to the doctor a day before reporting date and the patient was vaccinated with KINRIX (see case US2016139353).
Loss of appetite within 24 hours of receiving the vaccine. Fever spike within 48 hours. Fever reaching 104+ during the night 3 nights in a row. No other symptoms showing she has contacted a virus and none of my other 3 kids have contacted any virus from her so I know it is from the vaccines.
Developed low grade fever day 1 post injection which continued into day 2. Then developed severe watery diarrhea, headache, and body aches on day 2 post injection which continued for approximately 36 hours before subsiding. Used Ibuprofen, Tylenol, and Imodium for treatment of symptoms.
On 10-7-15 pt received a immunization at hospital. Patient came into her PCP on 12-1-15 because her left deltoid has been sore since she received the influenza immunization vaccine.
Reporting administration error as per Agency. We contacted Pfizer for expiration dates. Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from then.