chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe lower body joint swelling; stiffness; This case was reported by a consumer via interactive digital media and described the occurrence of swollen joints in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced swollen joints and stiffness. The patient was treated with ibuprofen. On an unknown date, the outcome of the swollen joints and stiffness were unknown.   It was unknown if the reporter considered the swollen joints and stiffness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient received first Shingrix injection about 5 weeks ago and have had severe lower body joint swelling and stiffness starting about 5 days after the vaccine and it has not gotten better.  The patient take ibuprofen.  The patient asked how much longer would it last.
C/O BILATERAL FACIAL NUMBNESS.  NO SOB, TONGUE, LIP OR FACE SWELLING.   0940 BENEDRYL 25MG GIVEN ORALLY.  PATIENT OBSERVED FOR APPROXIMATELY 45 MIN.  NO PROGRESSION OF SYMPTOMS.  PATIENT HOME WITH GRANDSON.  INSTRUCTED TO CALL 911 FOR SOB OR FACIAL SWELLING.  TO CALL MD IF FACIAL NUMBESS CONTINUES.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In approximately July 2015, the patient received one dose of ZOSTAVAX (subcutaneously, dose, lot # and expiration date were not provided) and approximately 3 weeks later, on approximately 10-AUG-2015 (reported as 'approximately 3 weeks go') the patient received another dose of ZOSTAVAX (lot# and expiration date were not provided, 0.65 ml, subcutaneously). The patient did not seek medical attention. No treatment was given for the event. No adverse effect reported. Additional information has been requested.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 01-MAY-2016, the patient was inoculated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-MAY-2016, the patient was treated at a hospital for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct an proximate result of the ZOSTAVAX, 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Pt received MENACTRA vaccine and left the office. About 15 min. later mom called because pt started getting hives on her wrist & face. Mom brought her back. She was breathing fine. We gave her BENADRYL and instructions for anaphylaxis.
Following vaccination client was in observation and c/o burning in her nose. Next, the client started to c/o it feeling like something was in her throat. She was then take to a private area and assessed. Client then started to cough and clear her throat. I immediately tried to administer epinephrine but client refused. I then took her pulse o2 (100%) and auscultate her lung (no wheezing or condensation presented. vitals were 122/84 b/p, 97.1 temp, 60 pulse, 18 resp. after explaining what was going on several times to the client she agreed to taking the epi. I injected it in her left thigh IM. After a couple of minutes she started to cough up mucous and the cough had stopped. Her breathing was  regular and unlabored. She continued to bring up mucus but signs and symptoms of any distress was gone. I re-took her vital which remained normal and she continued to breath with no distress and o2 remained at 100%. Clients  privacy and safety was maintained throughout  the adverse event. After a reassessment and the client stating she felt  okay an did not need any emergency services client was released (self ambulated to car) accompanied by her Spouse with no s/s of distress noted. I did advise the client to follow-up with her primary care Physician as soon as possible (she did acknowledge an understanding).
Developed pain in shoulder, under arm. Lymph nodes swollen, painful, fever with chills.
Client received vaccines on 10/23/12 am.  About 2:30 am on 10/24/12 patient awoke and complained of being hot, his head felt "funny" and had a headache, said his legs felt "funny" like he couldn't feel them.  He was able to walk to his aunt's bedroom.  She gave him extra strength Tylenol at about 3:30 am.  Patient then took a warm bath because his legs were still feeling "funny".  He went back to bed after his bath and fell asleep.  He woke at 6:30 am for school but was still not feeling well so he stayed home.  He now feels nauseated.  His aunt said that his legs are feeling better as is his head.  He is still hot and generally not feeling well.  Explained to his aunt that he needs to be seen by a physician.
Recieved vaccination for third Hib shot at  11:30 AM on 11-06-03. while playing she started lifting her left leg where the shot had been given,not wanting to put her full weight on it.took a longer than usual nap (2 hours) and at 5 PM woke from nap crying, whimpering then in a few minutes changed to hysterical screaming and crying and snuffing,didnt know what to do! none of the usual tricks worked to calm her down.there was a small blotch of redness around area where shot was administered. had a low fever.called doc and they said watch and if keeps crying every 2 hours bring in next day or if redness increases to a larger scale on leg. when i asked if they would report this to VAERS refused to report unless they saw her. i asked if they would report if i had to bring her in the next day and they answerd no without really saying no,very evassive. her crying lasted 49 minutes. acted a little off the next few hours.while crying hysterically i tried to rub the site of the shot and she just cried worse.
Became very ill with chills and body ache then the next day I had extreme pain in my shoulder down my back and in to my right arm.  It got better after some stretching Ice and anti inflammatory I also noticed I could not press any weight over my head and my right scapula was winging then the pain came back about four days later. The pain was so bad I went to urgent care and was given muscle relaxers.  The pain went away after a couple days but after giving it several weeks to see if the winging and weakness in my arm went away.  When it didn't I contacted Orthopedics to have my arm looked at.  The PA and was seen by noticed the scapular winging and believes its due to damage of my long thoracic nerve.
From telephone contact with pt it was stated that a 50 yo female pt rec'd a TD adult vaccine on 3/23/01. Reportedly 23 hrs post vaccine the pt experienced a grand mal seizure. 6 days later the pt experienced another and was hospitalized for four days. Further information is requested.
After receiving both vaccines the patient immediately said that she did not feel good. She reported feeling dizzy and not being able to see good. Blood pressure dropped and patient became very pale  and sweaty.
Approximately one day after vaccination pt started to develop redness, warm, itching, swelling of injection site. Pt also developed maculopapular and vesicular rash. Pt advised to continue using BENADRYL.
NONE-  AGE-APPROPRIATE BIVALENT MODERNA VACCINE WAS ADMINISTERED ONE AFTER FDA WITHDREW AUTHORIZATION FOR USE
patient experienced chills, redness, swelling, bruising, pain, and a superclavicular swollen lymph node resulting in visit to physician where they told her shot was given too high in arm closer to the shoulder. she is taking advil and using a warm compress to decrease swelling.  symptoms started with a painful swollen lymph node about 6 hours after vaccine
Same as I said before.  Lungs filled up as part of 48-hour reaction, but then didn't empty for a long time.  My cough continues.
had difficulty breathing afterwards; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "had difficulty breathing afterwards".  Additional information: To Whom It May Concern: As you may be aware, the FDA Guidelines (Docket No. withheld), require that: Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant. Additionally, per CFR withheld, Post-marketing Reporting of Adverse Drug Experiences, updated 01Apr2016, the requirements of paragraphs of this section, concerning the submission of post-marketing 15-day Alert reports, also apply to any person other than the applicant whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor (non-applicant). To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs of this section, obligations of a non-applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a non-applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the non-applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the non-applicant, and the applicant must then comply with the requirements of this section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started like a little red bump; Red Bump itched; Left arm has a rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 98162) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Allergy.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included medications for blood pressure and allergy.
1 day after shot diarrhea (moderate), headache. Mild symptoms. By Day 4 after shot (march 9), sinus pressure, headaches, nausea, fatigue, continuing through today, day 10, where sinus pressure worsening, headache persistent, dizziness. Likely now have a sinus infection.
Chills; fever; This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received her second dose of bnt162b2 (BNT162B2 reported as Covid 19 vaccine/ Covid Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient had the first dose on an unspecified date for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fever after second dose of Covid 19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ACHING IN RIGHT LEG FOR ABOUT 1 HOUR/ACHING IN LEFT ARM; This spontaneous report received from a patient concerned a 63 year male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808482 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-APR-2021 at left arm for prophylactic vaccination. Age at time of vaccination 63 years old. No concomitant medications were reported.  On 10-APR-2021, after vaccination the patient had some aching in his left arm and about 11 hours later the patient experienced some aching in his right leg for about 1 hour (aching in right leg for about 1 hour/aching in left arm) (Dose number in series 1).  The patient also received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 2112A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-OCT-2021 for prophylactic vaccination. The patient had not experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching in right leg for about 1 hour/aching in left arm on 10-APR-2021. This report was non-serious.
patient reports she received J&J vaccine at local grocery store on 7/7 @ 3 pm. within 2 hours developed shortness of breath, headache, body aches, fever (102.1F), loss of smell, taste "like metal"
Initial and follow-up information has been received from a nurse practitioner concerning a healthy 42 year old HIV negative male pt with who was vaccinated with measles virus vaccine live on approximately 10/07/2001. The nurse practitioner stated that the pt had no past medical history of any problems with vaccinations. The pt had a negative titer for measles, was a hospital employee and therrefore, was immunized with measles virus vaccine live. On 10/17/2001, approximately 5-10 days post vaccination, the pt presented to the ER with a severe local reaction including redness, swelling and development of an abscess. The pt was treated with three different intravenous antibiotics. The nurse practitioner stated that one antibiotic was vancomycin and she was unsure of the other two. Subsequently, the pt had recovered from the severe local reaction including redness, swelling and abscess. Since thetime of recovery the pt developed a postivie measles titer of 6 and had been advised to not get anymore measles vaccines. The infectious idsease physician stated that he thinks that this pt developed an atypical measles response to the measles vaccine. The nurse practitioner also discussed the events of a second pt who was vaccinated with measles virus vaccine live from the same lot, and she was concerned about the particular lot of vaccine. Upon internal medical review the pt's atypical measles response to vaccine, severe local reaction, redness, swelling and abscess were considered an other medical event. Additional information has been requested.
Information has been received from a healthcare worker referring to a 23 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 12-MAR-2010 the patient was vaccinated with the first dose of VAQTA (25/0.5 (united unspecified); lot#, dosage, frequency and route unspecified). On 03-AUG-2010, a second dose of VAQTA (25/0.5 (unit unspecified); lot#, dosage, frequency and route unspecified) was administered (inappropriate schedule of vaccine administration). No adverse events were reported. Additional information has been requested.
The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006M20A) for COVID-19 vaccination.     No medical history and allergies were reported by the reporter.  Concomitant products included PROPRANOLOL, TICAGRELOR (BRILINTA), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], BUSPIRONE, VITAMIN D [VITAMIN D NOS], MONTELUKAST, CITALOPRAM, FISH OIL, LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], ESTROGENS CONJUGATED (PREMARIN) and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021) outcome was unknown.            Patient didn't have COVID-19 test or diagnosis previously.  Patient went to the cardiologist on 06-Jun-2022 for treatment.     This case was linked to MOD-2022-600726 (Patient Link).
>client noted dropping phone & papers and slumped a little >client was not responding to verbal commands but his eyes were open >client was transferred from chair to cot and the client was able to answer questions. vitals taken. on call MD contacted >assessed by MD, legs elevated until BP Increased. >Alert & oriented X 5; able to walk around the room unassisted >client refused water or crackers; advised client to eat >Advised client to have somebody pick him up
The adverse event was not vaccine-related.  First dose 1/23/2021 Second dose 02/12/2021  Wednesday evening, July 21, 2021, I was very very tired. This continued through Thursday. Thursday evening, I was started to feel sick; run down, some congestion, a bit of what felt like a pressure headache, fatigued, just exhausted. Friday morning, I woke up feeling terrible.  I had a slight fever, a pretty bad headache, and some congestion. I scheduled a PCR test for COVID that afternoon, which came back positive.  I spent the rest of the day napping as I could and just generally feeling bad. Saturday, however, I was doing pretty badly.  I woke about 9AM. My fever spiked to 102, I had chills, my skin got so hot it actually ached.  My o2 dropped to the mid-80s very briefly and, thankfully, popped back up to the low 90s.  I had *severe* congestion, a very bad headache (but not a migraine), significant body aches, and incredible fatigue.  Some dry coughs, but not many.  I took vitamins C, D, zinc, and fish oil, as well as acetaminophen as advised by the urgent care and drank a LOT of water, as I was able. Within about 24 hours, I was feeling a little better.  My o2 had gone back to about 96 and stayed there and my fever lessened to about 100 degrees. Sunday was better, but the fever, congestion, body aches, headache, and fatigue remained. By Monday, July 26, my temperature was holding steady at 99, the headache had mostly subsided, the chills, skin aches, and body aches were gone. I was still incredibly congested and fatigued.  I began using DayQuil and NyQuil to combat the remaining flu-like symptoms, and this helped significantly, in conjunction with the D, C, zinc, and fish oil. I got better daily.. but had a slight regression Wednesday, July 27, but felt better again by Thursday. The congestion cleared up by July 30th. As of this writing, I am still fatigued, but that is the only lingering symptom, aside from the rare dry cough, usually brought on by laughing. :)
Redness, swelling and itching of skin (very similar to hives). The reaction occurs spontaneously as well as after scratching the skin. Mainly occurs on arms, chest, stomach and back. Goes away within 15-30 minutes after appearing. Cause unknown. No known allergens or prior allergies.
Received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month.  They both then received a second full dose of Moderna 4 weeks late; Interchange of vaccine products; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month.  They both then received a second full dose of Moderna 4 weeks late) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 (1st dose) in March 2021.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month.  They both then received a second full dose of Moderna 4 weeks late) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month.  They both then received a second full dose of Moderna 4 weeks late) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
it was rpt fr RN who was exposed to person who was vax on approx 12feb99. on 8mar99 pt began onset of shingles by 12mar full outbreak of shingles, also 7-8 varicella like rash. considerable pain, exp nausea, vomiting. maybe secondary trans
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date of 2014, reported as since 14-OCT-2014, the unknown number of patients were vaccinated with VAQTA (dose, route, lot # and expiration dates were not provided) that had been improperly stored. No concomitant medications were reported. No adverse effects reported. This is one of the several report received from the same reporter. Additional information has been requested.
The two components of Menveo were not mixed together prior to administration.  The dry component of Menveo was mixed with Sterile Water diluent intended for Varicella.  We caught this error during our shot clinic and narrowed this mixing error down to this client and one other client.  We will reach out to both client families to revaccinate with properly mixed Menveo.
The patient's arm was paralyzed for a week starting a few hours after immunization.  It got better each day.  Now, 10 days later, she still has a knot in her left clavicular region.  The painful knot feels like burning and tightness on the left side.