chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 40-year-old female patient had received an intramuscular, left deltoid injection of Fluzone SV 2006-2007, lot number U2195AA, on 04 October 2006. Immediately following administration, she noticed a black dot at the injection site. After several hours, it still had not resolved. The patient provided pictures of the site which demonstrate a small, dark, discoloration on the skin surface. The needle used was a BD Safety Glide, 23 gauge, one inch needle, lot number 611520 CAV03. The reporter indicated that there were 12 other patients (out of 46 administrations) that also experienced a black dot following vaccination. The black dot was present on some of the patients up to a week later. Per the reporter, "all kinds of needles" were used including BD Safety Glide and BO Integra as well as two other types for which she was not sure of the names. The reporter stated that they, "tested drawing up the vaccine and then wiping the needle on an alcohol pad, and the black residue was visible." "We ran three of the same needles through the alcohol pad right out of their packages and there was no residue." At the time of this report, recovery status was unknown. Follow-up information received on 03 November 2006 from the patient. Per the reporter, the dot does not resolve until either the skin is removed or over time as the skin is shed. The patient removed the dot by removing the affected skin. The patient recovered from the event.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2014, the patient as inoculated by a physician 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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Didn't feel good; Stayed in bed all day; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good), BEDRIDDEN (Stayed in bed all day) and FATIGUE (Very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 048A21A and 030MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced MALAISE (Didn't feel good), BEDRIDDEN (Stayed in bed all day) and FATIGUE (Very tired). At the time of the report, MALAISE (Didn't feel good), BEDRIDDEN (Stayed in bed all day) and FATIGUE (Very tired) outcome was unknown.            Concomitant medication not reported.  Treatment medication not reported.   This case was linked to MOD-2021-381452 (Patient Link).
BRIEF OVERVIEW: Admission Date: 6/9/2023 Discharge Date: Jun 12, 2023 Discharge Disposition:  skilled nursing facility   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Sepsis [A41.9] Severe sepsis [A41.9, R65.20]   HOSPITAL COURSE: Patient is a 84 y.o. male with a past medical history of Alzheimer's dementia A&Ox1 at baseline, CKD three, BPH, hypertension, anxiety, AAA who presents with confusion and fever found to have COVID-19 infection and potential urinary tract infection.  Patient lives in a facility, he is typically oriented to self and recognizes family and his caregivers, but is not oriented to situation or place.  Today, he became confused and speaking gibberish, which is not usual for him, and has had a cough for the past couple days.  He also had episode of rigors.  Multiple residents at his facility are COVID positive, including one he has close contact with.  EMS was called when patient became progressively less responsive.   In the emergency department, he was noted to be febrile to 39.3, tachycardic to 138, hypotensive to 91/48, and satting in the low to mid 90s on room air.  Chest x-ray reveals no acute process.  Labs reveal positive for COVID-19, creatinine 1.48 which is near his baseline, phosphorus 2.3, lactic acid 0.9, WBC 6.7, hemoglobin 13.6, UA reveals 27 wbc's and 54 RBCs.  In the emergency department, he received IV Tylenol, Zosyn, and 3 L of IV fluid.  When patient first arrived in the emergency department, he was obtunded, and throughout his stay he progressive became more alert.  He intermittently will spontaneously open his eyes and look around and attempts to answer questions, though his speech is unintelligible.  He was admitted to Internal Medicine for further evaluation and management.                Even though, patient was covid positive he was asymptomatic and remdesivir was discontinued.  Patient return to baseline. His urine culture grew Enterococcus Faecalis and he received 4 doses of ceftriaxone and one dose of Fosfomycin was given prior to discharge. The patient went back to SNF in a stable condition.
Could not control movements from waist up.  Having spasms of muscles from waist to head.  Could move legs and feet purposely.  No seizure activity.  BP 116/70, HR 72 Reg, R 18  Skin cold and clammy.  Laid him down, elevated feet, covered with blankets.  Unable to obtain O2 sat with pulse oximeter. He could not communicate orally.  Only by blinking.   Event started at 2:30 am about 13 hours after vaccine.  Symptoms slowly resolved over 2 hours until he was able to rest. Administered ( 2)  325 mg Tylenol at 4:30 am.  Able to communicate orally, squeeze both hands, awake, alert and oriented.  All symptoms subsided. O2 sat 99.  Next day only extremely sore muscles from waist up
Lip started to swell; A fever of 102 degrees Fahrenheit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lip started to swell), PYREXIA (A fever of 102 degrees Fahrenheit) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2021. Previously administered products included for Product used for unknown indication: Aspirin (Patient's lip had swelled up). Past adverse reactions to the above products included Anaphylactic reaction with Aspirin.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (A fever of 102 degrees Fahrenheit) and CHILLS (Chills). On 04-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Lip started to swell). The patient was treated with PARACETAMOL (TYLENOL) on 03-Aug-2021 for Fever and Chills, at an unspecified dose and frequency. On 03-Aug-2021, PYREXIA (A fever of 102 degrees Fahrenheit) and CHILLS (Chills) had resolved. At the time of the report, LIP SWELLING (Lip started to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  The reporter stated that they have confirmed antibodies to COVID due to natural immunity.
Information has been received from a registered nurse concerning a 25 year old female patient with no pertinent medical history and no drug reactions who on 17-JUL-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 659184/0843X). On 13-OCT-2009 the patient was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (Lot # 662404/0312Y). There was no concomitant medication. Within a few hours after her second vaccination, the patient developed a red raised rash at the injection site and hives on her forehead. The patient was seen back in the office that day (13-OCT-2009) and was give BENADRYL and her symptoms were resolved. No laboratory diagnostics studies were performed. The patient mentioned when she came back into the office to be evaluated that the same thing happened after she received the first dose of GARDASIL. At the time of the report, the patient had recovered. Follow up information was received from the registered nurse concerning the 25 year old black female patient who on 15:04 of 13-OCT-2009 was vaccinated intramuscularly into the right upper arm with her second 0.5 ml dose of GARDAIL (Lot # 662404/0312Y). One the same day at 15:50, the patient developed a rash at the injection site, hives on her forehead, wheals and red raised rash on upper arm. The patient was treated with BENADRYL 10 ml by mouth and the treatment was effective. No further information was available.
Within 2 hrs of the vaccine, pt noted throat tightness, shaky feeling; eyes red. Seen in ER, given racemic epinephrine; Claritin Dx2d, Benadryl 25mg IVP.
When administering the vaccine, the patient pulled her arm away as the medication was being injected. Less than 0.1 mL of the vaccine was lost and not injected into her arm. The patient was informed and did not have an immediate adverse reactions.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 15-APR-2015, the patient was vaccinated with improperly store PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 0.55 C for 704 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient's chronic eczema flared up about five hours later. Her upper lip started tingling at which time patient took 25mg of Benadryl and 40mg of Famotidine. In about one hour symptoms reduced. Patient called her Dermatologist that monitors her eczema on the following day. Dr. told patient to take 25mg of Benadryl one hour before next vaccination and to be monitored for 30 minutes after the injection.
Both vaccines given on left arm (pt had mastectomy). C/o minor swelling and tenderness on arm. Pt was advised to use NSAID & cold compresses. F/u with patient 9-27-10 - Sx has been resolved!
Left deltoid with swelling involving the epidermis with edema building up in a layer the lower portion of the deltoid within and outside the redness. Redness with min vesicle production and significant warmth over the red areas. Non-tender on palpation. Moving left shoulder and elbow easily without tenderness or stiffness. Keflex x7 days for developing cellulitis but believed to be a localized reaction. Patient had the Pneumovax vaccine on December 29 2009.
Left deltoid with edema, painful, and tender to touch. Duration approximately 3 days, fever and chills. Client start analgesics and Panadol. Used cold compress and alcohol solution.
patient with IM vaccination on 11/13. on 11/15, developed dermatitis on right facial cheek. Resolved overnight, but developed same rash on right arm, from shoulder to wrist, on 11/16. Cortisone and Zyrtec with minimal relief. Small patch developed on left elbow on 11/17. Still present with itching on 11/19. Family unable to identify any other possible triggers. Rash and history not consistent with an infectious process or infestation.
This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 31-year-old female patient who received BOOSTRIX (batch number 3457Y, expiry date 20th May 2019). On 30th May 2017, the patient received BOOSTRIX .5 ml. On 30th May 2017, less than a day after receiving BOOSTRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. The reporter considered the shoulder pain to be almost certainly related to BOOSTRIX. Additional details were reported as follows: The pain had lasted for 7 days and had not subsided.
Patient with mom present to office with c/o increase swelling & pain to (R) arm from shoulder to elbow. Mod edema noted (+) tenderness no redness. No meds given by parent. MOTRIN 40 mg/1cc, 2 ml po Q 6 hrs prn. Treatment: Hydroxyzine 25/5cc 1/2 tsp po Q 6 hrs x 3 days.
This spontaneous report was received from a medical assistant via company representative concerning a 6 month old patient of unknown gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reported. On an unknown date, the patient was vaccinated with the second dose of ROTATEQ vial, orally for routine vaccination (strength, dose, dosage schedule, lot # and expiry date were not provided).  On an unknown date (reported as after receiving second dose of ROTATEQ, the patient threw it all up (vomiting; underdose). The outcome of vomiting was reported as recovered. The reporter's causality assessment between ROTATEQ and vomiting was not reported.
Received Yellow Fever, IPOL, Typhoid Vi on 1/11/08 at 2 pm.  Had fever, sweating, muscle, back and shoulder aching/pain for about 6 hours on night of 1/11/08. 1/14/08 developed subconjunctival hemorrhage and on 11/15 had itching of feet and swelling of lip that resolved with Benadryl.  Pt was advised to me PMD.
Pt arrived to ED with c/o bilat lower extremity edema and occassional wet cough.  Pt states fully vaccinated with booster.  Tested +Covid19.  Given IV abx.
Information has been received from a nurse practitioner concerning an approximately 20 female patients who on unspecified date were vaccinated intramuscularly with 0.5 ml of GARDASIL vaccine (yeast) (dose and lot # unspecified). Immediately post vaccination the patients developed stinging at the injection site. Unspecified medical attention was sought. It was reported that the stinging resolved prior to the patients leaving the office or within 1-5 minutes. No other information is available. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided when available. Additional information has been requested.
Pain, erythema and vesicular rash in l. deltoid area around vaccination injection of Zostavax. Onset 7-9 days post vaccination.
Painful in area immediately upon injection. Swelling. Redness. Low grade fever. Body aches. Approximately 100.4 F.
erythema, warmth, pain in deltoid in region of the vaccine starting 2 days after.  14x20 cm in diameter. Still with some redness as of 2/19 but improving.
Huge red knot, very hot temperature. Sore arm. Getting worse (bigger red spot, darker red,  warmer still at day 4. Very sore to the touch and anytime there is movement.
Severe acute abdominal upper left quad pain cramping, 5/18 until 5/20, difficulty swallowing, nausea. Dizziness, intermittent headache and poor equilibrium 5/18 until 5/21. Out break of white spots on upper lips 5/20 turning to swollen yellow white painful lesions 5/21. More lesions inside lower lips 5/21, upper lip with more large lesions. Most healing no more observed as of 5/22 report.
Case number PHEH2013US008346, is an initial spontaneous report received from a nurse on 10 APR 2013. This report refers to a 14-years-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M102006 and expiry date: OCT 2014), at dose of 0.5 ml intramuscularly on 14 MAR 2013. MENVEO vaccine was stored at 33-36 F for 19 days and vaccine was not frozen. No adverse event was reported following this administration error.
Got Vax and got shingles, does not work/ suspected vaccination failure; Got shingles, really bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got Vax and got shingles, does not work/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles, really bad). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's relative via interactive digital media. The reporter reported that the patient received shingles vaccine and still experienced shingles really bad. The reporter stated that the vaccine does not work. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR067014 and US2023AMR067010 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR067014:Same reporter US-GSK-US2023AMR067010:Same reporter
Diabetic foot infection -  taken to the OR for irrigation and debridement and also amputation of the left 5th metatarsal. # days later he was taken back to the OR for a second irrigation and debridement of the left foot and cultures were taken. 4 days after that given his improvement as far as labs were concerned, he was taken back to the OR for another irrigation and debridement of the left foot and also delayed primary closure of the left foot. Patient was discharged home the next day as his labs continued to show improvement. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 15-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Pain, tenderness, and swelling at injection site (approx 6 x 10 x 1 cm); body aches, headache, dizziness, and mild nausea.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-APR-2017, the patient was treated by a healthcare at an Emergency room provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Recieved vaccine on 1/15/2021. On 1/16 and 1/17 had arm pain, headache, fatigue. Then felt "fine" until 1/25/2021 when she noted itching at the inf. site. At 5pm on 1/25, she discovered large red mark and raised area @ injection site; very itchy. By 1/26, swelling was size of "X-large egg" with localized redness thesem size of swelling.  She described "bumpiness of skin" in center of reddened area.  She traced borfer of redness with marker. Site was very painful.  On 1/27/21, the redness was spreading outside of marked area. Went to PCP. Prescribed ice to site, Benedryl at night and was given Rx for Prednisone 4mg tabs, tapering dose of 6tabsx 1day, 5 tabsx 1 day, 4 tabsx1day, 3 tabsx1day, 2tabsx1day, 1 tabx1 day.