chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 8 hours after immunization with swelling redness at medial (R) arm, to area just above elbow joint; length 20 cm x width 12 cm at 6 cm from elbow approx. arm are 27/at left 25. Min edema 1" at injection site. T 99.1.
This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, therapy type: recombinant human album, lot # M036158, expiration date 12-FEB-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit (also reported as 6.4 degrees Fahrenheit) for 2 hours. Data logger was involved. The vaccine experienced previous temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit (also reported as 6.4 degrees Fahrenheit) for 30 minutes.
Having muscle aches, agitation, leg cramps, blood pressure varies, depression, energy loss, headaches, impotence, insomnia, memory loss, leg pain, lower back pain, lower back skin rashes, infection with rash, herpes simplex, pain in shoulder and hips and leg.
This spontaneous report as received from a physician via a field representative refers to a female patient of an unknown age. The patient's concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9, both, intramuscularly (unknown strength and lot#). Concomitant medications were not reported. The physician stated that after receiving the injection, the patient fainted on an unknown date. It could not be determined if the injection was GARDASIL or GARDASIL 9. The outcome of the event was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
increased frequency of urination; insomnia; chills; headache; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (increased frequency of urination), INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], TRAZODONE, AMLODIPINE, VITAMINS NOS (MVI [VITAMINS NOS]) and SIMVASTATIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced POLLAKIURIA (increased frequency of urination), INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, SALICYLAMIDE (STANBACK HEADACHE) at an unspecified dose and frequency. On 26-Feb-2021, POLLAKIURIA (increased frequency of urination) had resolved. At the time of the report, INSOMNIA (insomnia), CHILLS (chills), HEADACHE (headache) and INJECTION SITE PAIN (soreness at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY-2021 contains non-significant information.
rash was present when they vaccinated the patient; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 2A3Z9, expiry date 14th October 2022) and (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   Concurrent medical conditions included shingles (had shingles 2 weeks ago) and rash.   On 8th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 8th April 2021, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The reporter stated that, had a patient that received the shingrix vaccine on the day of reporting and was diagnosed with shingles 2 weeks ago. The reporter asked should they expect any adverse events and should they get the 2 vaccine. It was confirmed with health care professional, that the patient still had an active rash. The reporter stated that, it was known by the health care professional, that rash was present when they vaccinated the patient, which led to off label use. The reporter consented to follow up. The batch number of Shingrix was updated from 2A329 to 2A3Z9, as per sales data sheet.
myocarditis with fever, tachycardia, pleuritic chest pain, elevated troponin, accelerated junctional rhythm, normal echo, tachycardia. MRI and two day hospitalization and follow-up with pediatric cardiologist.
Severe Body Aches and Chills for 48 hours post injection. Severe abdominal pain and Ulcerative Colitis Flare within 5 days of vaccine. I contacted my Gastroenterologist and he placed me on high dose Entocort EC at 12 mg daily for 2 months then lowered the dosage to 9 mg daily. He suggested that I not get another Covid 19 vaccine. I remain on Entocort EC 9 mg daily presently as flare continues through 11 months post vaccine. I also experience servere chills every 3 weeks lasting 3 days since receiving this vaccine. Tylenol can lessen intensity but does not eliminate symptoms.
Migraine headache lasting 2-4 minutes, room-spinning sensation, decreased motor functionality
No additional AE reported; Patient was administered Improperly Stored, Separate PNEUMOVAX 23; This spontaneous report was received from Healthcare Business Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-JAN-2023, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #W007035, expiration date: 20-OCT-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) (Product storage error).  On 23-DEC-2022, administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit (F) for 153 hours. There was no previous temperature excursion. There was no adverse event reported.  This is one of the several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA007699:Same Reporter US-009507513-2301USA007405:Same Reporter US-009507513-2301USA007605:Same Reporter US-009507513-2301USA007693:Same Reporter US-009507513-2301USA007635:Same Reporter
This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency unspecified). On an unknown date the patient reported that her rash had not gone away yet. The outcome of the event was unknown. Additional information is not expected.
One week after Zostavax vaccine in Left arm pain up and down the arm, tightness. Also unable to raise arm above head.
Haziness in R eye corneal transplant. Seen by Dr at eye clinic on 10/10/13 and diagnosed with corneal rejection. Started on Medrol dose pack and hourly pred forte eye drops. F/U appt on 10/21/13.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male 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 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) 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 (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.  Patient had been administered with the 2 Moderna vaccine which were beyond the 30 day beyond use date.  For lot 053C21A (dose 1 and 2) BUD was 01-Jul-2021.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
This spontaneous report has been received from a pharmacist and refers an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The pharmacist reported that since May 2016 (reported as "11 months period"), an unspecified number of patients were possibly vaccinated with seven (out of a pack of ten) improperly stored doses of ZOSTAVAX 19400 "PFU" (lot # reported as M014340 with an expiration date in 26-MAY-2017), 0.65 ml, once, subcutaneously, for prophylaxis. The vaccine data logger measure a temperature below 6 Fahrenheit (F) degrees to minus 2 F degrees for a time frame of 11 months. There was no previous temperature excursion. No adverse effects were reported, and product quality complaint (PQC) was not involved. Lot number M014340 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-APR-2013,  the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-MAR-2016, the patient was treated (by an unspecified health care professional) at the neurology medical group office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 20-JUN-2016, the patient sought subsequent treatment at the neurology medical group office for continued and worsening symptoms of shingles pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. On or about the dates of 26-AUG-2016, 15-MAR-2017, and 17-APR-2017, the patient sought additional treatment at the neurology medical group office for post-herpetic neuralgia across the right flank and back that was uncontrolled by pain medication. The patient has been prescribed gabapentin in increasing dosages in attempts to curb his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
trouble talking; Headache; Vomiting; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (trouble talking), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SPEECH DISORDER (trouble talking), VOMITING (Vomiting) and NAUSEA (Nausea). 01-Feb-2021, the patient experienced HEADACHE (Headache). In February 2021, the patient experienced CHILLS (Chills). At the time of the report, SPEECH DISORDER (trouble talking), HEADACHE (Headache), VOMITING (Vomiting), CHILLS (Chills) and NAUSEA (Nausea) had resolved.            No relevant concomitant medications were reported. The patient experienced headaches that were so bad that felt like she was going to die. The patient had gone to urgent care and the patient was given a shot used for migraine headaches and given anti-nausea medication. The patient could not remember the name of the shot given for migraine headaches and anti nausea medication.   This case was linked to MOD-2022-512561 (Patient Link).
I tested positive for COVID a year after my vaccine. After I tested positive I started getting hives. After testing positive I've been getting hives on and off for 5 months.
admitted with covid pneumonia and resp failure, eventually placed on vent, passed on 1/24/2022
Sore arm / Arm soreness was at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included postnasal drip.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th August 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a sore arm within that day. She states this arm soreness was at the injection site and resolved within 24-hours. The reporter consented to follow up. For tolerances of 2nd dose, refer case US2019190823, reported by same reporter for the same patient.
Shot 9:42a, waited the 15 minute, was given my card, walked out of store 9:57, and drove home 5 minutes.  Maybe 5-10 minutes later, I started to feel weird, and like my throat was swelling and my fingers were tingly.  I took a benadryl, then 5 minutes later another one and another one.  Left at 10:25 for the ER, felt worse the whole drive there.  Was thinking my husband driving me was shorter than 911.
received the pediatric  dose for first dose of series even though she was already 12 years old
Four days after receiving her Covid vaccination patient started bleeding vaginally. Had blood clots and large amount of blood and it lasted 2 weeks. Patient has been post-menopausal for 10+ years.
Irregular menstrual cycles; Irregular menstrual cycles, as long as 50 days apart; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 19Feb2021 at 08:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 25Jan2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 21Feb2021 at 00:00, the patient experienced irregular menstrual cycles, as long as 50 days apart. This began the first cycle after the vaccine and maintained since. 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 irregular menstrual cycles, as long as 50 days apart were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Had a reaction as if I had a bad case of COVID after my first dose, body aches, chills, cough, nasal issues, headache.  lasted for 4-5 days. After 2d dose, I had no reactions at all.  In July I was diagnosed with stage 1 prostate cancer due to a wellness program physical from work where Dr noticed my PSA levels at a high rate and sent me to get checked out by a urologist and after MRI and Biopsy it was confirmed I had prostate cancer.  This is not anything that has ever been in my family and wanted to bring this to your attention in case the vaccine may be reason for myself and others who may have gotten cancer after the shot.
My right knee has a lot of pain and is swollen. It occurred the morning after I received the vaccine. I?ve never had knee issues or pain but the day after the vaccine my right knee has been very painful. Feels like it?s joint pain or arthritis. It is very painful. There has been no injury twisting falling etc this happened the next morning after the vaccine
A 1 year old presenting with high fever and swelling of the right side of the neck, Cefazolin given IV.  10/24/06 Received medical records from hospital which reveal patient admitted to hospital from 9/9/06 to 9/16/06 with Admit dx: fever, right neck swelling of unknown etiology.  D/C dx: Lymphadenitis resolving, parotitis. Hosp Course:  Started IV antibiotics but developed abscess within the swelling.  ENT consulted & I&D done 9/15.  Surgical drain removed on 9/16. D/C to continue on oral antibiotics for 7 additional days & f/u with ENT & PCP.
Patient was given an expired Moderna booster vaccine on 02/23/22. Moderna booster vaccine expired on 02/22/22 @ 06:30pm. Patient did not have any adverse reaction after medication administration.
@ approximately 0850 itching which lead to anaphylactic reaction was sent to the ED O2 Saturation 71%, SOB, nausea, emesis x1, fatigue, coughing.  CG given Epi, Benadryl, Steroids, Neb tx. D/c'd to home w/ Epi pen, steroids, and Benadryl. Advised possible reoccurrence anaphylactic symptoms. Advised to f/u w/PCP.
Had 2 doses of VARIVAX, developed 20-30 classic varicella lesions over axillary/trunk area, no cough, coryza, URI symptoms, otherwise well, lesions and associated pruritis - no impetigo.
very mild typical arm soreness at injection site for few days after injection, then noticeable and increasing deep muscle (brachialis) pain  during movement. has not decreased after 2 months,
Pifizer BioNTech COVID-19 vaccine administered at 9:19am. At 0930 patient reports feeling lightheaded. Vital signs taken x3 -WNL. Patient given water. After 20 minutes client reports feeling dizzy, but wants to leave. AMA paper signed, left at 0956. Vital signs: 0938 BP 168/68, HR 62 RES 20 02 SAT 97% 0943 BP 158/73, HR 68, RES 20, 02 SAT 96% 0948 BP 152/73, HR 69, RES 20 02 SAT 97%
hives, itching, vomiting, syncope - started 2 days after Pfizer 2nd booster administration
No adverse event; 1 patient was administered a dose of Improperly stroed recombivax; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were unknown.      On 19-NOV-2019, the patient administered a dose of improperly stored (product storage error) hepatitis b vaccine thimerosal free (recombinant) (RECOMBIVAX HB) injection, lot # R031052 and expiry date 03-JUN-2021 reported for prophylaxis (strength, dose, frequency, route, anatomical location not reported). No adverse symptoms were reported. Doses of suspect vaccines experienced the temperature excursion below 36 degree Fahrenheit (F) (31.8 F) for 15 minutes. It was reported that there was no previous temperature excursion done. Data logger was involved. No product quality complaint was involved in this report.  This is one of the 3 reports received from the same reporter.
4 cm x 4.25 cm red raised area, painful provider told mom to do BENADRYL and keep us informed of progress.
24 yr old patient vaccination developed body aches, fatigue, headache, joint pain, stiffness, neck pain, low back pain, felt "out of sorts" light headedness, intermittent nausea, feels the same, sometimes worse 2 1/2 weeks post vaccination.
I cannot breathe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (reported as on 16th), as dose number unknown, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date (reported as 28th), like almost two weeks later, the patient was laying watching TV and suddenly, could not breathe. So, the patient had to go to the emergency hospital. It was reported that, nobody tells the patient if that was a reaction of vaccine after 2 weeks. The reporter questioned if the event has something to do with the vaccine. The patient underwent lab tests and procedures which included COVID-19 test negative (further clarification unknown) on an unspecified date. The outcome for the event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.