chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruising on my legs; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on my legs) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced CONTUSION (bruising on my legs). At the time of the report, CONTUSION (bruising on my legs) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
From 1 to 3 hours  after vaccination : uncontrolled crying. From 1 to 4 hours after the vaccination: weakness in legs and arms, unable to raise legs to walk or no strength in arms, I couldn?t hold objects in hand or close hands. About 3 hours after vaccination: numbness in all face like if under anesthesia, and I could barely been heard when trying to speak, no strength to talk other than single words. First 24 hrs extremely sleepy and lethargic the next day.
vaccinated with an expired dose; patient  vaccinated with Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-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 7th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were 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: 08-JUN-2022 Reporter's Comments: The reporter called to report that the patient was vaccinated with an expired dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The patient received Bexsero at the age of 59 years which was not the recommended age, which led to inappropriate age at vaccine administration. The patient was vaccinated with an expired dose of Bexsero, which led to expired vaccine used.
LETHARGY; SHIVERING; HEADACHE; This spontaneous report received from a patient concerned a 57 year old. 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: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On 01-APR-2021, the subject experienced lethargy. On 01-APR-2021 at around 11:30 , the subject experienced shivering. On 01-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering on APR-2021, and had not recovered from headache, and lethargy. This report was non-serious.
I had my 2nd Moderna shot on 3/29 around 12:50pm. I felt fine until 8:30pm ish that night. Here's the timeline:  8:30pm- Temperature reached to 99.8F  11pm- Temperature stayed around 101F. Headache. I had really bad chills but my head and face were very warm.   12:30am- I put on my T-shirt and Leggings but still felt very cold.   (Restless. Stayed awake all night)  3:00am- My body was really hot like an oven so I took off the T-shirt and leggings. My temperature reached to 104F. Worst headache ever. I had a real feeling that my body broken into piceses.   8am- I got up. I had chills again. Temperature lowered to 101F. Still had headache. Left hand felt dumb.   8pm- Took a nap. Temperature lowered to 98.8F. Headache, Chills all gone.
My last injection was Aug. 4th. On Aug. 7th, started having chest pains and hard to breath; My last injection was Aug. 4th. On Aug. 7th, started having chest pains and hard to breath; On Aug, 8th, when to the ER at (Hospital name) Hospital. The diagnosis was Pleuritic Chest; This is a spontaneous report from a contactable consumer or other non hcp.     A 68-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Right on 04Aug2021 21:00 as dose number unknown, single for covid-19 immunisation. Medical history included and concomitant was not Reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID It was Reported that, my last injection was Aug. 4th. On Aug. 7th, started having chest pains and hard to breath. On Aug 8th, when to the diagnosis was Pleuritic Chest Pain. Never had this before. I wanted to report this because I felt it may be related to the vaccine. on 07Aug2021 10:00 with outcome of unknown. The patient underwent lab tests and procedures which included computerised tomogram: unknown on Ae treatment. Therapeutic measures were taken as a result of my last injection was aug 4th on aug 7th, started having chest pains and hard to breath (chest pain), my last injection was Aug. 4th. on Aug. 7th, started having chest pains and hard to breath (dyspnoea), on aug, 8th, when to the er at (hospital name) hospital. the diagnosis was pleuritic chest (pleuritic pain).  No follow-up attempts are possible. No further information is expected.
pt recv vax 30JUN97 & 21JUL97 pt exp 15-20 chickenpox lesions;pt recovered;
Pt came in today 4/12/21 and notified us that she had a reaction from the COVID-19 vaccine that was administered on Friday 4/9/21 @1334.  Pt stated it happened when she got home after tx.  She had chills, itchyness, loss of balance, blurred vision, and high blood pressure.  Pt stated is lasted till Saturday and took Tylenol to relieve her sx.  Pt is afraid to take the 2nd dose.  I notified Dr. about the situation.  Dr said to let patient know its ok to take the 2nd dose and to give Benadryl and Tylenol with the 2nd dose.  And to reassure pt that the reactions are normal.  I notified the patient and is ok with taking the 2nd dose on April 30th.
Information has been received from a consumer concerning her 75 year old mother with leukemia, memory loss and a history of two strokes, and "allergic to sulfate drugs" who on 20-NOV-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 662971/1213X). Concomitant therapy included COUMADIN, PAXIL and VALIUM. It was reported that the patient experienced high blood pressure (160-98), a stomachache and she has been bleeding out of her ears. The reporter also mentioned that her mother was immunosuppressed due to leukemia. The patient had not recovered at the time of the report. The patient sought medical attention with the physician. Additional information has been requested.
I received the Pfizer Bivalent booster for COVID-19 on 9/27/2022. In early October, I developed hormonal symptoms that included acne, weight gain, and extreme pain in lower right quadrant. These continued through November and December 2022. On 12/9/2022, I was unable to walk, because the pain was so excruciating, and I had abdominal bleeding. I saw my gynecologist on 12/12/2022 and I underwent an abdominal ultrasound. On 12/14/2022, the results of the ultrasound came back, and I was informed that I had had a ruptured cyst in the right ovary. She did not prescribe any medication, but she recommended that I treat my symptoms with OTC ADVIL. I am due to see her again in the near future for a follow-up. After the cyst rupture, I had abdominal pain for about a week, but the ADVIL has helped it.
Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of age") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction reaction involving redness, At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patient also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00509, 0708USA00510, 0708USA00511, and  0708USA00512). Additional information has been requested.
Low grade fever approx. 100.0 F and chills, muscle aches, malaise starting approx. 24 hours after vaccine and continued for 36 hours at which point hives developed at vaccine site. Initially developed intense pain in region of injection within 8 hours of immunization and persisted until after hives developed.
Information has been received from a physician concerning 3 patients who were age 10 and up both female and male, who on unspecified dates were vaccinated RECOMBIVAX HB (manufacturer unknown) (Lot # unknown) and tested negative titer for Hep B. Additional information has been received from a female office manager reported that there were 45 patients that didn't seroconvert. In follow-up, one of the 45 patients was identified (WAES # 1008USA01261). Follow up information has been received from the physician indicated that there were a group of patients that had Hepatitis B vaccine (unspecified) (manufacturer unknown) and no longer immune. Attempts are being made to contain additional identifying information to distinguish the remaining multiple patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested. This is an amended report, AE term was updated from "test negative for Hep B" to "negative titer results/no longer immune per blood test titers" and mapped to "Anti-HBs Antibody Negative".
Feb. 12 slight headache, temp 100, slight nausea Feb. 13 itchy rash around the neck and chest area
Information has been received from a physician concerning a 32 month old male with no past medical history and no known drug allergies who on 08/13/1999 was vaccinated with the first dose of varicella vaccine in the left thigh. There were no concomitant medications or illness at the time of vaccination. On 05/09/2001, the pt developed vesicular, chicken pox-like lesions on the left side of his chest. On 05/11/2001, the pt presented to his physician with 10-12 lesions. On a follow-up phone call to the pt's mother, she reported the pt had lesions on entire body a week later. The pt was treated with Cefzil for two lesions that appeared slightly infected. The rash lasted for one week, a new rash similar to the previous rash appeared on 0/30/2001. The pt saw a dermatologist who diagnosed him with chicken pox. The pt was seen again on 06/11/2001. The rash was not cleared and getting similar rash "off and on." The pt was continuing to be followed by a dermatologist. It was also noted that the pt did not have any adverse events following prior vaccinations. Additional info has been requested.
Site was reddened warm to touch, & with pain; swelling Pt stated "I am feeling better".  "I did have a fever".  T 97.0.
A report was received from a healthcare professional on 20/Oct/2006 concerning a 34 year old pregnant vaccinee. No details of the vaccinees past medical history or details of any concomitant medications were provided. On 13/Oct/2006 the vaccinee was administered Fluvirin 0.5mls by intramuscular injection. By the following day (19/Oct/2006) she had developed a hugh wheal, about 3 inches in diameter, at the injection site, which was also hot, red and itchy. Further information is requested. A follow-up report was received from a healthcare professional concerning a pregnant 34-year-old female vaccinee. The vaccinee has a history of Hypothyroid since 2003 which is on going. The vaccinee's concomitant medications include Levoxyl, 0.05 mg once a day, orally for Hypothyroid, since 2003 and is on going, Pre-natal vitamins with Doxalymine, 1 tablet once a day, orally for pregnancy since Jun/2006 and is on going, Unisom, 1 tablet once a day, orally for nausea from Sep/2006 to Oct/2006 and Nitrofurantoin, as required, orally for bladder infections in 2004. The vaccinee also received an influenza vaccinee (brand unspecified) in Oct/2005. On 18/Oct/2006, the vaccinee received 0.5ml of Fluvirin, once, intramuscularly into her upper left arm. On 19/Oct/2006, the vaccinee experienced a red wheal at the injection site, which resolved on 23/Oct/2006. On 27/Oct/2006, the vaccine had an elective termination of pregnancy, due to Spina Bifida. The infant was a 12 oz male. The reporter dose not considered the red wheal at the injection site to be serious and is unknown if it is related to Fluvirin. No further information is expected.
Diagnosed Autism-developmental delay. No speech.  Not potty trained. 2/7/06  Review of medical records done. By 3/3/97 (prior to vax) there were developmental delays (language & social) and these continued to increase until autism was suspected by age 4.5.  2/7/06  Review of medical records done. Immunization record shows Tetramune, Lederle, 4400-744, site not specified, and 3 previous doses. Oral polio 4/27/06-reviewed medical records confirmed pre-existing developmental delay and autism by 1/7/99.
Throwing up; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain) and VOMITING (Throwing up) 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 08-Mar-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) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On an unknown date, the patient experienced VOMITING (Throwing up). At the time of the report, INJECTION SITE PAIN (Injection site pain) and VOMITING (Throwing up) outcome was unknown. Not Provided          No concomitant and treatment medications were reported.
This spontaneous report was received from a back office lead and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed itchy skin all over body (no hives). Developed migraine headache and aches from my elbow to my chest radiating from the site of the injection on my arm. Symptoms lasted 48-72 hours.
ONE WEEK LATER RASH APPEARED AT SITE OF INJECTION.  SWELLING AT INJECTION SITE.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053c21a and 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications details were not reported by the reporter.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.  Treatment details were not reported by the reporter.
Pt had vaccine @ 240, on 2/17/21 (2nd dose) of Moderna, administered by Public Health. Had sore arm that night. Next day joint aches and temp of 99.7 at 5pm. Took 1 extra strength Tylenol @ 7p then went back tobed. 2/19 woke up feeling fine, energy level back to normal. At 130p pt noticed neck itching : noticed rash on neck : tarso,  upon exam  rash an back as well! Pt given 50 mg Benadryl with instructions to seek emergent care  with any ^ in symptoms
pt recvd vax;emesis eve of 17jan95;to er for emesis;was told it was stomach virus;on 18jan95 started fever 100-101; apap;started episode episode high pitched cries; fussy since vax on 17jan95;
injection site pain, abdominal cramps, chills, vaginal spotting (20 days prior to menstruation due date)
Fatigue, increased tinnitus (angry cicada sounding), itchy rash at the injection spot (very itchy and bubbly rash).
Tenderness and swelling below under arm (not on arm), severe chills, nausea, headache, severe achiness in lower back., insomnia. Had all these symptoms starting the day after the shot except swelling and tenderness under arm pit started this morning (2 days after shot)
Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative.  The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021.  Information on the lot/batch number has been requested.
20 mins post vax devel warmness & pruritus over entire body; DPH given; no hives noted;
Pain on the upper arm. It lasted around 24 hours The lymph nodes at the neck also had pain and swollen the next day after shot. It disappeared  after 24 hours
COVID-19; Small flare on knee; COVID-19; Nausea; Fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4098161-00.   A 50 year-old male patient received BNT162B2 (BNT162B2), intramuscular, administration date 31Jul2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and intramuscular, administration date 31Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unknown (cf) for psoriasis. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: SUSPECTED COVID-19 (medically significant) with onset Nov2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; ARTHROPATHY (non-serious), outcome "recovering", described as "Small flare on knee"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "Nausea"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "Fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. The action taken for adalimumab was unknown.   The reporter considered "small flare on knee", "nausea" and "fever" not related to bnt162b2.   The lot number for bnt162b2 was not provided and will be requested during follow up.   Follow-up (07Dec2021): New information received in a follow-up solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4098161-00). A contactable consumer (patient) reported, which included: Updated information on reporter's Email, onset date, events.; Sender's Comments: Based on the information available in narrative the reported  events of pyrexia and nausea were assessed as related to suspected vaccine BNT162B2, However the event of arthropathy aggravated  was consider not related to suspected vaccine and more likely due to pervious illness.