chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine induced rash; One infant younger than 12 months;  Information has been received from author concerning to one infant younger than 12 months that had been exposed to measles in authors pediatric emergency department (ED), resulting in his receipt of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (strength, lot number and expiration date not reported) in accordance with protocol 3 days after exposure. He returned to the pediatric ED on 2 occasions thereafter for fever and febrile seizure, and during his second visit developed a rash. This was 12 days after his original exposure, a timeline that would be consistent with contracting measles. This initiated a full postexposure investigation of 80 children who were considered at risk of measles exposure during either of his 2 visits. Ultimately, through polymerase chain reaction sequencing, he was determined to have vaccine-induced rash, a reaction that occurs in approximately 5% of individuals immunized. The sequencing results were not available until after the exposure investigation was completed. The time for sequencing in the vaccine-associated rash was 8 days, and in this time frame, critical decisions on prophylaxis needed to be made regarding suspected measles exposure. The patient's outcome was not reported.  This report is linked to case US-009507513-2009USA001403 from the same literature article.
It was reported that a 25 year old female pt received a Rabies Imovax ID vaccination on 4/24/01. Reportedly, on 4/26/01, at the site and the entire pt's arm became numb. She was able to hold a cup in her left hand for 2 minutes until she relaxed.
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not provided. On unknown dates the patients were vaccinated with doses of improperly stored (at 24 Fahrenheit for 24 hours) VARIVAX (lot # L046888, expiration date 23-NOV-2017, dose and route unknown). There was no temperature excursions previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 2 year old female patient. The patient's pertinent medical history, drug reactions or allergies were not reported. On 02-FEB-2015, the patient was vaccinated with PROQUAD (Merck) lot # K020753, expiration date: 30-APR-2016, 0.5 ml, subcutaneous in the left thigh. Other suspect was Merck sterile diluent lot # K011430, expiration date: 30-MAY-2017 which was used to dissolve the vaccine. No information regarding concomitant medication was reported. On an unspecified date in February 2015, the patient experienced measles. The medical assistant reported that, on 16-FEB-2015, the patient was at the hospital laboratory and had blood work performed which confirmed that the patient had measles. The patient was not hospitalized. The patient's parent sought medical attention by contacting physician's office. The outcome of the child has measles was reported as not recovered/not resolved. The relatedness between the event and the vaccination with PROQUAD (Merck) which was dissolve in Merck sterile diluent was not provided. Additional information has been requested.
Local reaction on area that vaccine was given.Erythema,swelling and tenderness on left deltoid area.
PT RECEIVED VACCINE ON 6/19/19. ON FOLLOWING DAY 6/20/2019 PT SAID SHE WOKE  UP WITH SWOLLEN LIPS AND ULCERS/BLISTERS INSIDE HER LOWER LIP AND A BLISTER/ULCER ON HER UPPER LIP.
The Patient had Swelling, redness, itchiness, bruising and his left arm was warm to the touch.  He also had a headache and low grade fever. The above were all noted the very next day by his mother and reported to the clinic.  She was advised to give him some fever reducer and benadryl and to continue to monitor him.  The next day mom reported that the swelling had gone down but his arm was still warm to the touch and has discoloration.  He was brought back to the clinic on  09/28/2020 and his left upper arm was noted to have erythema and echymosis spanning about 7 cm and it was warm to the touch.  There was a noted crusted area as well.  He was given Keflex Suspension, 250 MG/5ML, 5.5 ml, Orally,TID,7 days.
Extra dose administered; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) had not resolved and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medication information was provided. It was reported that patient received additional booster 2 months after the first bivalent booster. All vials was thawed on 16-Dec-2022.  This case contains the information of 02 out of 13 elderly patient who received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:master case 1 of 13
Patient is a 48 y.o. male with a history of primary progressive MS (on ocrevus), HTN who presented to RMH 12/7/2022 with complaints of fatigue, fever and profound weakness. He was found to have COVID infection and AKI.    1. COVID-19 Infection: Partially vaccinated, symptom onset 12/5/22, positive test 12/7/22. With sepsis on admit. Completed 5 days of paxlovid on 12/12/22.  2. Primary Progressive MS: Follows with Dr. Receives Ocrevus infusions, last 8/2022. Baseline weakness in both legs, able to ambulate. With psuedoexacerbation on admit due to COVID infection. Neurology followed with no further recommendations. PTOT recommended IPR. 3. AKI with Obstructive Nephropathy: baseline Cr 0.7, Cr up to 1.6 by 12/8/22, PVR > 800ml, Cr improved 0.8 by 12/11/22 after foley placement. Voiding trial at IPR.   4. Acute Urinary Retention: with associated AKI, required foley placement. Urology recommended to stop Oxybutynin, added Flomax and continue foley at discharge. Follow up with urology as outpatient.  5. Chronic Constipation: due to immobility, CT abdomen pelvis on admission with large stool burden. Continued bowel regimen.  6. Chronic LE Edema: due to chronic debility.  7. HTN: Continued home meds.  8. Code status: full code
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
This spontaneous report was received from a nurse practitioner regarding multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # L044475, expiry date 12-MAY-2017 (dose number, dose units, route and anatomical location were not specified), (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
Diluent was not used in vial before giving to patient. Mother notified to watch for any adverse reactions including rash, swelling, nausea, headache.
Redness and heat covering entire anterior, outer arm surface. No red streaks noted. Rec OTC BENADRYL 25mg TID and cool compresses per MD. She is to return if sx are prolonged or worsens.
PATIENT WAS GIVEN THE J&J COVID VACCINE DOSE OUTSIDE THE 6 HOUR WINDOW. After contacting patient no unusual side effects reported.
Itchy red rash, warm and swollen arm, raised white bumps in rash at injection site
Patient complaint that arm has been sore since receiving shot & is to the point where it can't move
Received pneumovax at about 10am. started feeling chills and possibly low grade temp and sweats 10pm. subsequently developed swelling and increased warmth and a red rash.  left arm got achy 2 days later.  seen in office and diagnosed with cellulitis. treated with keflex.
Slept too much; This spontaneous case was reported by a health care professional and describes the occurrence of SOMNOLENCE (Slept too much) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept too much). At the time of the report, SOMNOLENCE (Slept too much) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication taken. No treatment provided.
aches; getting a little itching feeling around the injection site; red - around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site). At the time of the report, PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 23-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route, dose, lot # and expiration date were not provided) which were exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
SLUGGISHNESS; FEVERISH; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced sluggishness. On APR-2021, the patient experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggishness, and feverish. This report was non-serious.
Case number PHEH2014US003882 is an initial spontnaeous report from the pharmacist received on 21 Feb 2014. This rpeot refers to a 13-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: 009021A, expiry date: Jun 2014) at a dose of 0.5 ml intrmauscularly on an unknown date. No adverse event occurred to the patient following this medication error (inappropaite age of vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 21 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as Drug use in unapproved population.
Pt to ED 10/3 for c/o persistent abd pain with n/v. RRT called for hypotension. Pt COVID+ 10/3. 10/4 Pt is A&Ox4 ,airway is patent, speech is clear, respirations are even and unlabored. 10/4 to OR for ERCP. 10/5 pt is aox4,on RA not in distress,ambulatory, denies pain or sob. 10/6 pt discharged.
A week after receiving the first dose of the vaccine I began to see hives after two years of no hives.
The child was diagnosed with pertussis infection on 4/28/00. Cough started on 4/14/00, Mother feels source of infection was the immunization.
I had the vaccine and not even 10 minutes later I had a seizure. Paramedics arrived I declined going to the ER because the high cases of Covid so my wife took me to my family Dr office.  As of today I'm light headed when I'm up too long, my speech is a little delayed I've had hives since last night and diarrhea.
Left thigh swelling (induration measuring 4x4 inches) with warmth and tenderness.
Increasing, severe, generalized dermatitis of 2 wks duration. 1-2 days before onset received flu shot (Connaught) and Pnu-Imune.
Pfizer-BioNTech COVID-19 Vaccine EUA Metallic taste in my mouth, started right after the vaccination and lasted about a week.
Profusely sweating, rapid heartbeat, dizziness, fatigue, seeing spots, passing dark red/black stool for three days
On 12/15/04 at 6PM Pt began having mild tremor of head lasting approx 45 seconds. At 6:02PM again noted head tremor lasting approx 60 seconds.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Patient seemed disoriented and semiconscious.  Husband reported she had a history of seizures.  Patient was breathing and had a pulse.  911 was called, and paramedics arrived at the scene where they evaluated the patient.  Patient refused to be taken to the hospital, and husband proceeded to take her home.  Followed up with patient the following day, and they were contacting patient's neurologist to report what happened.
This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age and ethnicity received the 2nd dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for meningitis immunization. The patient medical history and concomitant medications were not reported. The patient previously took TRUMENBA dose 1 on an unknown date. The patient experienced stiffness of both hands and migraine after getting the shot and lasted for about 30 minutes. The outcome was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017056092 same reporter/drug, different patient.
loss of consciousness 45-120 sec p/vax; mom described shaking but no sz activity observed; pt awake & alert w/in 1 1/2 mins-febrile react following day-limp, vasovagal episdoe vs shock-collapse phenomenon;
Got a rash with second dose at site of injection and then covering left  side of body. Only lasted 15hours. This was booster shot - rash  covered face about   three hours post injection, and now is covering other areas of body
Severe body pain in head, neck, back, hips, knees, feet, teeth and eye sockets. Could not hold up head. Feet numb bilaterally. Nausea. Exhaustion. All lasting 24 hours. Profuse sweating as well for last 8 hours. kidney pain.  I have never experienced such pain in my entire life.
Headache; was in bed; Experienced chills; Body aches; Flu-like symptoms; Feeling lousy; Sensation of a needle stick; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 7s7mf, expiry date 27-SEP-2025) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On 09-OCT-2023, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: Headache) and bedridden (Verbatim: was in bed). In OCT-2023, the patient experienced shivers (Verbatim: Experienced chills), general body pain (Verbatim: Body aches), influenza-like symptoms (Verbatim: Flu-like symptoms), feeling bad (Verbatim: Feeling lousy) and paresthesia (Verbatim: Sensation of a needle stick). On 11-OCT-2023, the outcome of the bedridden was resolved (duration 2 days). The outcome of the headache, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia were resolved.   It was unknown if the reporter considered the headache, bedridden, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia to be related to Shingrix.     It was unknown if the company considered the headache, bedridden, shivers, general body pain, influenza-like symptoms, feeling bad and paresthesia to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2023 The patient was self-reported this case. The reporter reported that the she received Shingrix vaccine on a Monday at 5:30 pm and By 9 pm that same evening she experienced headache and went to bed and was in bed until Wednesday.  The reporter stated that exactly one week later the she was playing tennis and experienced the sensation of a needle stick in her left arm where she was vaccinated with Shingrix.  The patient reports she feeling lousy throughout the day.   She experienced chills, flu-like symptoms, headache and body aches.   Tuesday morning she took a COVID test which results negative.   The reporter reported that by the end of day Tuesday all symptoms was resolved. The reporter consented to follow up.
20 minute episode of crying, associated with "choking", pale, clamminess, "white lips". Starting associated with lethargy, drowsiness.  Resolved after 20 minutes with stimulation and feeding.  Slept 2 hours in AM.  Mom reports similar episode day after 4 month vaccination, lasting 5-10 minutes.
vaccine given on 3/30/2021-no pain till 4/6/2021-  on 4/6/2021 patient started having pain in left arm after lifting something one week after injection.  4/7/2021 states that pain radiates from the injection site to the back of the arm when he rises his arm to shoulder level-- arm feels weak after carrying something  pain level 8/10  when he lifts his arm.  No pain otherwise.
No additional AE; RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020; This spontaneous report was received from a registered nurse and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 12-AUG-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin(rHA)) (PROQUAD) dose 0.5 milliliter (strength, route of administration and anatomical location were not reported; lot number T009929 was confirmed to be valid, expiration date 16-SEP-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature from -14 degrees Celsius (C) to -10 C (maximum -9.5 C) for 38 hours and 30 minutes. The temperature excursion started on 28-JUL-2020. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported.
After administration of prevnar 13/syringe broke off body; luer-lock portion of the prefilled prevnar syringe broke off of the body of the syringe; Edges of both pieces of syringe were jagged and cracked under little pressure, indicating possible defect in administration device.; Edges of both pieces of syringe were jagged and cracked under little pressure, indicating possible defect in administration device.; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 2-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 13Sep2023 at 10:00 as dose 1, single (Lot number: GH4086), in right thigh for immunisation; for immunisation, Device Lot Number: GH4086. The patient's relevant medical history was not reported. Concomitant medication(s) included: VAXELIS taken for immunisation, on 13Sep2023; ROTARIX PREFILLED taken for immunisation; GRIPE WATER FOR COLIC. The following information was reported: POOR QUALITY DEVICE USED (non-serious) with onset 13Sep2023, described as "After administration of prevnar 13/syringe broke off body"; DEVICE DEFECTIVE (non-serious), DEVICE BREAKAGE (non-serious) all with onset 13Sep2023 and all described as "Edges of both pieces of syringe were jagged and cracked under little pressure, indicating possible defect in administration device."; NEEDLE ISSUE (non-serious) with onset 13Sep2023, described as "luer-lock portion of the prefilled prevnar syringe broke off of the body of the syringe". Therapeutic measures were not taken as a result of poor quality device used, needle issue, device defective, device breakage. Additional information: The patient was not affected by this adverse event. After administration of PREVNAR 13, once the needle was removed from the patient, the healthcare provider-initiated safety mechanism on attached needle. When this was done, the luer-lock portion of the prefilled prevnar syringe broke off of the body of the syringe. Edges of both pieces of syringe were jagged and cracked under little pressure, indicating possible defect in administration device.     The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.