chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness in pinky finger and finger next to pinky finger; Lymph node swollen; Very fatigued; slept all day; Felt hot on injection site; Knot located at injection site; Pain in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger), VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site) and VACCINATION SITE PAIN (Pain in injection arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site) and VACCINATION SITE PAIN (Pain in injection arm). On 21-Feb-2021, the patient experienced SOMNOLENCE (slept all day), LYMPHADENOPATHY (Lymph node swollen) and FATIGUE (Very fatigued). On 24-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger). On 22-Feb-2021, VACCINATION SITE WARMTH (Felt hot on injection site), VACCINATION SITE MASS (Knot located at injection site), LYMPHADENOPATHY (Lymph node swollen) and FATIGUE (Very fatigued) had resolved. At the time of the report, SOMNOLENCE (slept all day) and HYPOAESTHESIA (numbness in pinky finger and finger next to pinky finger) outcome was unknown and VACCINATION SITE PAIN (Pain in injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18-Mar-2021, event details Hypoaesthesia was updated.
Injection given 07:58 am, at 08:12 Patient described feeling dizzy, was diaphoretic V/S at 0812 178/99 Temp 97.0,  0813- 182/101 P-112, O2 Sat 98% on room air Respirations within normal limits, alert oriented,  patient described feeling a little shortness of breath able to speak in full sentences, transferred to gurney and taken to Emergency Room, skin pale. While waiting for intake patient stated shortness of breath was feeling a little better, repeated BP 0827- 146/94 care transferred to Emergency Room
1/14/21  1400 dizzy, fatigue, HA, chills, hot flashes, nausea, pain at inj. site  4cmx10cm. Unable to lift arm above head   1/17/21 Pain resolved - arm swelling, red "baseball size"
Fever (101.1), chills, headache, body aches, soreness at injection sight
Ten days after vaccination emp c/o tinnitus. Two weeks later he realized deafness in R ear. Sent for audiometry and work up for autoimmune and allergy disorder. Treatment with prednisone. Deafness resolved.
SORE THROAT; CONGESTION; RUNNY NOSE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, congestion, runny nose, muscle aches, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, congestion, runny nose, muscle aches, and fatigue. This report was non-serious.
4 year child received Kinrix as 1st dose of IPV and DTaP; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Kinrix. In JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: 4 year child received Kinrix as 1st dose of IPV and DTaP). The outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter reported that the 4 years old patient received Kinrix vaccine in clinic this past week.  The reporter stated that afterward it was realized that the patient did not had any prior vaccinations.   The Kinrix vaccine was their first DTaP and IPV vaccine.   The reporter did not have exact date of administration, lot number or expiration date. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received Kinrix as a first dose of IPV and DTaP series, which led to Inappropriate schedule of vaccine administered. This case had been linked with US2023088089 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023088089:1 of 2
She could not get out of her bed that day; fever; aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She could not get out of her bed that day), PYREXIA (fever) and MYALGIA (aches) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ILLNESS (She could not get out of her bed that day), PYREXIA (fever) and MYALGIA (aches). On 11-Apr-2021, ILLNESS (She could not get out of her bed that day), PYREXIA (fever) and MYALGIA (aches) had resolved.            No Concomitant Medications were provided by the reporter.  No Treatment medications was provided by the reported.   This case was linked to MOD-2021-406154, MOD-2021-406162 (Patient Link).
After vaccination patient described stomach hurting, nausea, sweating, and loss of hearing. Patient felt immediately better after moving up from chair and being transferred to Med OBVs at 17:18. First set of VS were taken at 17:21, HR:83, RR:20, BP: 121/68, SPO2: 98. Patient then stated that she had not eaten a meal before the vaccine, only a chewy bar. Second set of VS were taken at 17:28, HR: 89, RR: 20, BP: 116/67, SPO2: 98. Patient stated she felt fine and was comfortable heading home, last set of VS were taken at 17:45, HR: 82, RR: 20, BP: 112/63, SPO2: 98. Patient was released at 17:45 with her father.
Suspected vaccination failure; I got the. Shingles shot but still got the shingles, a couple of yrs. Later; This case was reported by a consumer  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and had shingles couple of years later. It was stated that problem was not as bad, if the patient had not received the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a company representative refers to his wife, a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On 30-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX in the fatty part of her arm (arm unspecified), which reporter "thought" was subcutaneous (strength, exact dose, frequency, lot# and expiration date were not provided). No concomitant therapy was reported. On unknown dates in 2016, the patient experienced warmth and "a little" pain and  "a little" swelling at the ZOSTAVAX injection site. Then the patient developed redness at the ZOSTAVAX injection site (also on an unspecified date). The outcome of reported events was recovering/resolving at the time of the report, as the reporter stated that his wife's injection site where ZOSTAVAX was administered "looked better". Product quality complaint was not involved. The reporter did not provide a casual relationship between the reported events and vaccination with ZOSTAVAX. Additional information has been requested.
Severe headache. Burning in chest, coughing up thick yellow sputum, very painful cough, fever/chills, achiness in lower back.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 7-year-old daughter who experienced a severe red, sore throat and a fever of 100 degrees. At 7 years of age, the patient received a dose on 15-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regiment was 0.5 mL (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, 3 days post-immunization, the child experienced a severe red, sore throat and a fever of 100 degrees. As of 19-Dec-2003, her symptoms persisted. Of note, the patient's brother had "strep throat", and had tested positive for strep on the day of his sister's vaccination. No additional information was available at the time of this report.
On 12/20, I woke up to swollen eyes, ears, and face.  I had itchy, red patches and welts on my legs and forearms, and a burning red rash across my forehead that circled my face and went around my chin.  I went to the ER, where I was given benedryl, a steroid, and pepcid.  I was sent home with a prescription for the same. On 12/21, I woke up with the same rash as described from the day before.  I continued my prescriptions. On 12/22, I woke with with the rash only on my legs.  I continued with my prescriptions. On 12/23, I went to an immediate care facility where I asked for a COVID test.  My rapid test was resulted as positive.  I never had any of the listed COVID 19 symptoms.  I continued my prescriptions.   On 12/24, I woke up with no rash, no COVID 19 symptoms, and I continued with my prescriptions.
I don't know that this has any relation to the vaccine, but felt I should report anyway.  This was just over 24 hours after the second dose. I took my blood pressure at home for my regular tracking purposes.  My BP was 151/113 when I normally run in the neighborhood of 117/68.   My monitor also indicated my heart rate was 96 BPM which is unusually high for me as I normally run in the 50/60's.  I didn't feel bad at all and my only indication came when I did the actual reading.   I did some deep breathing and took my BP again later in the evening and it was down to 143/91.  Checking back on my heart rate trends for March 24, I can see my heart rate had risen to a high of 117 BPM between the hours of 7-8pm and finally returned to my normal range between 11pm and midnight.  From then on during my sleep cycle between Midnight and 7am March 25, my heart rate remained in the 50's as expected.     There are no other issues to report.  Again, I can't say conclusively this was due to the vaccine, but I can't rule it out either.  I thought I should report the information regardless.
Tuesday July 20 I had a severe headache and loss of vision in my right eye. I thought it was a migraine. The two days that followed my headached got better but I still didn't feel right. On Friday the right side of my body started going numb. I went to the ER where they did a CT scan and an EKG. CT scan showed I had a stroke. They transferred me to another hospital where they did a MRI to confirm the stroke and did an echocardiogram to check my heart. Everything with my heart checked out  perfectly fine, my blood pressure was good. They could find no reason for me to have a stroke at 34.
Diarrhea, low grade fever, chills, nausea, really tired , no appetite
No additional adverse events reported; a dose of VARlVAX has been administered to administered to a patient while being improperly stored on 03MAR2022; This spontaneous report was received from a certified medical assistant and refers to a 15-month-old patient of unknown gender. The patient's concurrent conditions, concomitant medications, medical history and drug allergies were not provided.  On 03-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) in dose 0,5 ml, (lot # U022320, expiration date 15-JUL-2023) (formulation, route of administration and injection site were not provided) for prophylaxis. The temperature to which the vaccine was exposed was 13.4 degrees of Celsius (C) and the time frame was reported as 7 hours 55 minutes 0 seconds. No previous temperature excursion was reported. It was unknown if digital data logger was involved. No adverse events were reported.
Patient received Moderna COVID 19 vaccine on 1/30/21 and 2/27/21. He underwent preop PCR screening and had a positive result as of 5/13/21.
"Caller got his 1st dose a week ago (05Feb2021) and was tested positive of Covid-19 today/He had symptoms like headache, fever"; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC number, UPC number, Batch/Lot number, Expiry date: unknown), via an unspecified route of administration on 05Feb2021 at single dose for covid-19 immunisation. Covid19 vaccine was a Pfizer product. Covid19 vaccine manufacturer was unspecified. Relevant medical history and concomitant medications were reported None. The patient got his 1st dose a week ago (05Feb2021) (reported as 8 days after the first dose) and was tested positive for Covid today (12Feb2021). His 2nd dose was on 28Feb2021. The patient stated, "I do not have that card." Investigation assessment was no. Patient was already negative in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test and results were positive (drug ineffective) on 12Feb2021. The outcome of event positive COVID-19 was recovered in 2021.  Information on the lot/batch number has been requested.
Starting about 11pm the day of receiving the 2nd Shringrix vaccine, began to experience excessive urination that continued for 8 hours overnight. Could not sleep, partly due to the expected muscle aches & chills, but also the need to get up & urinate. On Oct 3, excessively dehydrated with dizziness & low Blood pressure. Realizing the problem - drank large amounts of fluid to rehydrate -- and found I did not have a return to normal urinary patterns until about 6pm Oct 3 -- meaning I did not urinate much during that day, but have been normal for about 12 hrs at this time. Muscle aches & fever has subsided. My main reason for reporting this side effect is that I found no mention of excessive urination on any of the websites I consult for side effects from medications.
Pt is G1P0. EDD was 8/15 by LMP. The patient had an ultrasound on 1/6 showing a live intrauterine pregnancy with crown rump length measuring 8 weeks 0 days. She had covid vaccine 1/7. Came in with vaginal bleeding 1/29 and found to have missed abortion on ultrasound (no heart tones, crown rump length measuring 8 weeks 3 days). Underwent D&C 2/1.
Patient received the vaccine 1/5, and on the next day 1/6, her arm begin to swell.  The swelling continued to worsen and was very painful.  She was seen at an urgent care and diagnosed it as a "post vaccination reaction" per the patient on 1/10.  She was given an injection (unknown) and  prednisone course.  She was to follow up with her primary care on 1/13 that was rescheduled until 1/19 which was also resheduled until 1/24
Patient complained of trouble swallowing, swelling of the tongue, tingling, and flushed neck. Symptoms developed within 5 minutes after administering the vaccine. Offered Benadryl and patient denied, we recommended evaluation at an urgent care nearby and patient accepted.
Tdap and Covid 19 booster in left arm 5/12/22. Patient reported left arm pain to his family and was found down by them 5/13/22. He was noted to have left arm swelling, erythema, hypotension, hypoglycemia with elevated CPK.  Diagnosis:  Secondary cellulitis of left UE extending to left chest wall 2/2 vaccinations.
Pt received Hep A injection and felt dizzy right after injection. Then had an episode of syncope. Only lasted 5-7 seconds. Pt was tx with fluids and calories (pt was fasting). Vitals were stable.
Pt developed rash that changed to cellulitis per ER MD. Was prescribed AB, steroid, and BENADRYL.
Case number PHEH2012US009542 is an initial spontaneous report received from a medical assistant on 02 May 2012: This report refers to an adult male patient. He was given only the Men A powder component of MENVEO (batch number: X10129) reconstituted with sterile water instead of Men CYW liquid component on 02 May 2012. No adverse event was reported following this administration error.
Patient received 1st dose Pfizer at 1245 on 12/17/2022. Five minutes into observation, patient began complaining of shortness of breath, difficulty breathing, and bluish discoloration was present around her lips.   Interventions Performed: 1250 Vitals were taken ? 94% oxygen saturation and 108 heart rate, and Safety Specialist called emergency medical services (EMS). Patient was given Benadryl 50mg at 1259. Symptoms did not improve. Epinephrine was administered at 1304 ? NDC 4950210201, Lot number 0FM499, Exp 5/22. Immediately patient experienced relief of symptoms.  Vitals taken again  - 129/79 blood pressure, 99% oxygen saturation, 91 heart rate.   Patient Outcome: Patient was transferred to care of EMS at 1315 ? patient headed to hospital ED.  Concern/Issue Resolved?: Immediate danger resolved ? patient in care of EMS 911 Contacted?: Yes Patient Transported Via EMS?: Yes Did Patient Refuse EMS Transport Upon Arrival?: No
There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient information (patient initials, age, gender), vaccine information (dose number, date of vaccination)
Pain at injection site in left arm at initial time of injection. Patient within one day had pain that radiates down the arm into the thumb. Patient is left hand subjective decreased grip strength with normal grip strength on exam. Patient also reports uncontrolled twitching in left thumb.
BODY ACHES; ABDOMINAL PAIN; NUMBNESS IN LEG; RIGHT LEG PAIN; HEADACHE; PAIN AT INJECTION SITE; FEELING TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced feeling tired. On 07-APR-2021, the subject experienced pain at injection site. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced abdominal pain. On 08-APR-2021, the subject experienced numbness in leg. On 08-APR-2021, the subject experienced right leg pain. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and abdominal pain on 11-APR-2021, and right leg pain on 09-APR-2021, was recovering from pain at injection site, had not recovered from headache, and feeling tired, and the outcome of numbness in leg was not reported. This report was non-serious.
Blotchy redness (not single red spot) tender, on arm that got TRUMENBA. Have photo if needed.
Patient became pale and lightheaded during the 15 minute observation period. EMT's observed this and immediately assisted the patient to the syncope chair and also gave her water. The patient did report eating lunch a few hours earlier. Vital signs were all within normal limits. Denied any shortness of breath, chest pain, dizziness, rash, itching, hives, or difficulty swallowing. The patient's vital signs were taken again in 5 minutes and was observed for 30 additional minutes. The patient denied any nausea, vomiting, dizziness, lightheadedness, and was no longer experiencing pallor. The patient was educated about if she experienced any chest pain, shortness of breath, difficulty swallowing, or other worsening symptoms, to go to the emergency room immediately. The patient had a history of fainting with pain and denied any chronic medical conditions. The patient ambulated to her car with EMT's accompanying her, and the patient's mother drove her away from the vaccination site.
Mom was concerned about giving multiple immunizations at same visit.  Therefore, child was only given Hib at 2 mo. well-baby visit.  Child returned 1 month later (3mo old) for further immunizations.  Child was given DTaP and Hib/HepB(Combvax) at that visit.  Child  developed an almost immediate urticarial reaction mostly on lower extremities.  Was given dose of diphenhydramine with gradual resolution of urticaria.