chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 63-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 8th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site discomfort and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site discomfort and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site discomfort and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Beginning within 5 days, the patient experienced a reaction described as discomfort, itching and swelling just passed the deltoid towards the elbow. The reporter consented to follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 multivalent nos (COVID-19 VACCINE MULTIVALENT NOS MANUFACTURER UNKNOWN), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. No information about medical history, drug reactions and allergies was specified. On unspecified dates the patients were vaccinated with doses of PROQUAD (Merck) (lot#, dose, route not reported) that were exposed to a temperature excursion (temperatures of 6 Fahrenheit (F) for 20 minutes) on 15-JUL-2014, that was supported, have been administered to unspecified patients. No concomitant medications were reported. No adverse effects have been observed or reported. This is one of the two reports received from the same reporter (same reporter case 1408USA002172). Additional information has been requested.
Information has been received from a physician concerning an 8 year old male patient who, on an unspecified date, was vaccinated with the second dose of VARIVAX (lot number not provided).  On 11-MAR-2008, the patient immediately developed an itchy feeling in his throat and began choking.  He also broke out in hives and his face and ears became "fiery" red.  This was determined to be an anaphylactic experience.  The patient was treated with an injection of Epi Pen.  Subsequently, on 11-MAR-2008, the patient recovered from his anaphylactic experience.  It was unknown as to whether or not this patient had the same experience with the first dose of the vaccine.  Upon internal review, it was determined that the events were considered serious as other important medical event.  There was no product quality complaint.  Additional information has been requested.
Per pt report: Pt started having body aches within a couple hours of vaccine, developed severe 9/10 pain over the next several days. L shoulder pain radiating to ribs and neck w/ muscle spasms, causing HA, R hip and sacral pain, flank pain radiating down R leg. Pt reports that vision in L eye is blurry, R eye vision intact, numbness to L arm and hand, able to move. Pt reports 1in x 0.5 in blood clot when blowing nose Thursday morning, small clot subsequently about 1/2 the size, smaller clots later.
Shot was given approx. at 5:00 pm on 4/7/08. Around 9 am on 4/8/08 I started feeling an oppression in my head and a sick feeling to my stomach. My head felt like it was being compressed, with a slight headache. I felt also very sleepy. I am on High Blood pressure medication (Cozaar 50 mg), and I took it earlier than I usually do, because I thought it could be high. I went on feeling sick and sleepy for the rest of the day. Besides, my stomach was distended, as if my body was swollen. I was at work, so I could not have my blood pressure checked. When I did check it around 6 p.m. it was 164 over 89, when the day before (at my doctor's office) it had been 121 over ?. I took 25 extra mg of Cozaar. Besides, I was so sleepy that I fell momentarily asleep TWICE while driving home from work! On 4/9/08, I woke up with the shot area swollen, red, and tender. But my blood pressure was back to normal, and I felt OK otherwise.
Mom came into health dept on 8/2/01 to describe a possible reaction. Child was not with her. She says he has Weisenberger's Syndrome ( a muscle tone disorder) but Thursday, post vax, 2 days later, had lower leg stiffness. Friday, legs twitched a few seconds and quit at different times during the night. On Monday, this happened 1 time that night. Mom was on her way to discuss with family doctor and recommendations for other Hep-B doses. Spoke with mother on the phone about incident on 8/7/01 and she said she would research and call back.
small fever on 99-100 the day of and arm and muscle were sore, she started feeling sore, she began experiencing abdominal cramping on 6/29,
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for End stage renal disease, peritoneal dialysis, renal allograft failure, nephrotic syndrome, t2dm, hyperlipidemia, overweight. No notation regarding cause of death or recent illness. Decreased 5/2/21.
TRUMENBA was given as an alternative to MENACTRA or MENVEO. No adverse reactions reported to this facility.
Patient received moderna vaccine on 1/29/21 and 3/1/21. Presented to ER on 5/20/22 and found to be COVID positive. Noted to have a fever at home.   Apparently she was hypotensive in the emergency waiting room, came back to the  ER room where she was found to be normotensive.  She is found to have AKI,  COVID positive.  She is significantly weak and debilitated at this time.  CT  of her abdomen and pelvis was obtained due to elevated liver enzymes, which  shows possible pneumonia.  She has been ordered IV fluids.  She was admitted to the medical floor. REceived ceftriaxone and azithromycin. Discharged on 5/31/22
Redness, tenderness, and inflammation on the right arm (8" x 4") following Shingrix vaccine.
Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Patient received flu vaccine at clinic. Within 10 minutes came back to injection room and her left arm was swollen, red and hot to touch. While examing patient she was clearing her throat several times. When questioned further she also stated that her throat felt "like it was closing up." Patient was immediately taken to our observation room and given epinephrine in LLT. She was also given 50 mg Benadryl. She was monitored in clinic for an hour with some improvement of symptoms however at around 12:45 pm she said she was having a burning sensation in her chest and she was having abdominal cramping. Patient also was continuously clearing her throat and said "it felt like something is caught in my throat." PA came back down to observation area to see patient. Patient was given another 0.3 mg dose of epi. She was transported to ED by medics.
On my arm where I got the vaccine it was very tender and I got a rash. My shirt being against this arm even caused discomforted. I also had body aches , pain , and chills. This was for a couple of days. I was on antibiotics for a week to get rid of the rash on my arm.
got sick with both of her vaccines; This spontaneous report from a contactable consumer reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST dose single dose and 2ND dose single dose for covid-19 immunization. The patient past medical history and concomitant medication was not reported. The patient got sick with both of her vaccines and she received her last dose on Monday and she was still out of work. The outcome for the event was unknown.  Information on the lot/batch number has been requested
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain for 2 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (little pain for 2 days). On 28-Jan-2021, PAIN (little pain for 2 days) had resolved. Not Provided          No concomitant medications were provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-047936 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: The follow up received was NNI.
Chief Complaint Patient presents with o Shortness of Breath HPI   79 year old female patient with a history of hypertension and diabetes presents to the emergency department with complaint of dyspnea since March 3. Patient states that she received her first COVID vaccine last week and felt like she initially had mild chills. No fever, denies chest pain or leg swelling. Patient notes her symptoms have become progressively worse over the past couple days, she has been uncomfortable at night sleeping. She states she feels short of breath all the time, even at rest.   Assessment:  79 year old female patient presents to the emergency department with complaint of worsening shortness of breath for over one week.  Differential diagnosis:  Pneumonia, hypoxia, acute respiratory failure, CHF, flash pulmonary edema  ED Course and Disposition:  Patient received about 1 min of therapy from a duo neb treatment and became increasingly anxious and hypoxic. Patient became progressively more anxious and was unable to keep non re breather mask on. SpO2 in the low 80s patient anxious stating "help me, give me a tranquilizer", unable to speak in full sentences and acutely confused. Patient was intubated by Dr. for acute respiratory failure, tolerated well. BP and HR improved after labetalol. Chest xray showed patchy opacities suspicious for viral or atypical bacterial pneumonia. Clinical presentation and acuity of condition concerning for flash pulmonary edema. COVID negative. Treated with Rocephin and doxycyline to cover pneumonia. IV lasix given for diuresis. Patient will be admitted to the ICU.    I had a detailed discussion with the patient's daughter regarding the historical points, exam findings, and any diagnostic results supporting ICU admission. Based on the patient's history, exam, and diagnositic evaluation, there is indication for further emergent intervention and inpatient treatment.   Discussed case & plan with Dr. who also independently evaluated the patient and agrees with the course of care and plan.  Critical Care   There is a high probability of imminent or life threatening deterioration due to respiratory failure.   Acute interventions include develop tx plan w/pt or surrogate, eval pt's response to tx, documenting the case, initial hx & physical exam, order & review of radiology studies, order & perform tx & interventions, re-eval of pt's condition and vent management.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2015, the patient was inoculated 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 ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in July 2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Extremely heavy menstrual bleeding started thirteen days post vaccine and has not stopped (going on two weeks). This bleeding includes huge clots, some so large that they have to be ?pushed? out...some clots are the size of a small fist.  The bleeding is consistent and has several episodes of gushing causing blood to overtake feminine hygiene products and spill all over clothing/furniture. During this bleeding clots can be felt passing as well even when seated.  The clots have subsided somewhat compared to when this first started and bleeding appears to be slowing somewhat in the past day.
Muscle tug; Large medium dark pink area; Itching at the injection site; Pain at the injection site; Pain in the area, in the upper part of her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the area, in the upper part of her left arm), SKIN DISCOLOURATION (Large medium dark pink area), MUSCLE STRAIN (Muscle tug), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 19-Feb-2021 to an unknown date for Osteoporosis, RISEDRONATE SODIUM (RISEDRONATE), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the area, in the upper part of her left arm). On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE PAIN (Pain at the injection site). On 20-Mar-2021, the patient experienced SKIN DISCOLOURATION (Large medium dark pink area). On 22-Mar-2021, the patient experienced MUSCLE STRAIN (Muscle tug). The patient was treated with HYDROCORTISONE (HYDROCORTISON AL) for Itching, at a dose of 1 % hydrocortisone used only once. On 22-Mar-2021, SKIN DISCOLOURATION (Large medium dark pink area) and VACCINATION SITE PRURITUS (Itching at the injection site) had resolved, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Pain in the area, in the upper part of her left arm) had resolved and MUSCLE STRAIN (Muscle tug) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Patient had a large medium dark pink area and it was so big 4 inches wide x 2 inches side to side.  On 21FEB2020, size was 3 1/2 by 1 1/2.
11-08:Hep A adm at apprx 2pm noticed lesion to chest at approx 11pm that same day. 11-16:16 lesions on trunk of body, 11/19 appt with Dr, 11/20 38 lesions, lesions appear similar to chickpox but without liquid in them. Taking Bactrim and topical altabax as per Dr. 11/29 To Infectious Disease for evaluation. 12/03 57 lesions, 12/047 79 lesions no fever or malaise. 12/06 Referred to PA Dermatologist for evaluation to cont with current antibiotic and topicla cream. 12/07 129 lesions and 12/09 now 200 lesions, old lesions still present.
pt recv vax & devel fever 10 days;v x2, fussy,sl cough, neck & ax nodes;dx viral synd;fever x 2 1/2 days;pt reported not to use or be moving lt leg;dec activity lt leg;referred to orthopedist;lt leg paresis;dx viral infect;
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Macular rash devoped on post-vaccination day 4, worsed on post vaccination day 6. Hospitalized on 8/31 for concern for eczema herpeticum. Rash mildly pruritic. Well appearing however febrile to > 102F over disease course. Received dose of acyclovir in ED, not continued inpatient. Evidence of rash crusting over on post-vaccination day 10. Rash worse at vaccination site (thighs, right > left), sparsely scattered lesions on trunk and face.
48 hours post vax, the pt developed a large, local induration around elbow. No prior history of vaccine side effects. No systemic symptoms present.
Edema peripheral; injection site erythema; injections site discoloration; injection site warmth; local reaction; malaise; erythema Information has been received from a a medical assistant and a 58 year old female consumer with a history of "some times medications have the reverse of their intended effect" and allergies to penicillin and indomethacin sodium (Indocin) who on 18-NOV-2005 at approximately 12:00 PM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #650648/0967P). There was no illness at the time of vaccination. Concomitant therapy included estrogens, conjugated (Premarin), vitamins (unspecified), metronidazole (Metrogel), alendronate sodium (Fosamax) and doxycycline. On 18-NOV-2005 by 5:00 PM on the same day the patient had a "huge red circle with white in the middle at injection site," The patient also noted that "her arm was very swollen". The patient took 800mg Ibuprofen and did not return to the physician until the next morning. On the morning of 19-NOV-2005 the patient was given cetirizine hydrochloride (Zyrtec) an unspecified injection and an unspecified antihistamine. The patient reported that after the treatment the swelling went down but the arm was "very red and still tender.: The patient noted that as of 21-NOV-2005 that her elbow was still a "little bit swollen: and her arm "still had tender areas." It was also reported that the patient had local reaction, redness, swelling, tenderness to touch and warmth at site with general malaise. Subsequently the patient recovered. Additional information is not expected.
Extreme fatigue, chills and fever of 101.8. Big red knot on arm given injection. Could not work and had to stay home in bed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 07Apr2022 as dose 4 (booster), single (Lot number: 083J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulpa" (unspecified if ongoing); "Nonalcoholic Fatty Liver Mild" (unspecified if ongoing); "controlled high blood pressure" (unspecified if ongoing), notes: controlled high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: I tested positive; (18Dec2022) Positive; (24Dec2022) Negative; (26Dec2022) Negative; (07Jan2023) Negative; (09Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment with Paxlovid, from 18Dec2022 to 22Dec2022.
Sever rashes covering legs and arms developed over the two weeks following influenza immunization.  Treatment included Prednisone (80gs/day).
08/03/07: Client presented at clinic with increased redness, swelling, soreness, warm to touch on Right upper arm, below deltoid.  Advised to seek medical attention today.  Upon follow up contact on 08/05/07, client had been to an urgent care office and given prescriptions for Keflex and steroidal dose pack.  Steroids started, but Keflex delayed until consultation with his primary physician who had treated him for Stevens Johnson syndrome in January 2007. Symptoms were resolving by the time of this follow up contact.
Arm was sore for a few days after injection, been less stable walking but with vaccine has gotten worse, extremely tired and less patient, a really big change on how well he could walk, Things that I was doing before I wasn't able to do, Vomiting his regular medication.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA296383, 2018SA297469, 2018SA297470, 2018SA297472, and 2018SA297473 (same reporter). This case involves a four year old patient (gender not reported) who received 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259JA and expiration date 30-Jun-2019) (frequency once, Suspension for injection) instead of the 0.5 ml via unknown route in the right thigh on 25-Oct-2012. It is an actual medication error case due to vaccine underdose. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.