chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives throughout body within 1-2 hours after shot, continued for about 3 days consistently. Arm also swelled about 2 inches around injection site within 2 hours, it continued to swell to about 3.5 inches around injection site over the next 36hours. Hives continued on & off about 3 more days. Injection site stayed swollen. On day 7-8 hives & swelling seemed to lessen, but on day 9, swelling/pain/discomfort got much worse & hives returned on & off throughout body. I then went to our local urgent care.
Body ache; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recvd vax & exp weakness; headaches; nausea; fever 103; pain;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree (also reported as Celsius degree). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree (also reported as Celsius degree). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
After second injection of GARDASIL, experienced fatigue, malaise, joint swelling and pain (joint symptoms continued to worsen for next 6 weeks) the next day. She had severe upper respiratory infection 2 weeks following vaccine.
Patient woke up complaining her hand wouldn't stop shaking, eyes rolled to back of her head, followed by a major Grand Mal seizure, lasting roughly 45 mins, 911 called, patient then had another focal seizure- this one lasting 30 seconds. Paramedics took her to hospital for evaluation. ER observed her, blood drawn, released. Follow up with PCP next day for neurology consult and order tests.
Covid arm on 8th day after injection.  Itchy, swollen, hot and red
Red swollen arm at injection site about 12 hours after injection. Treatment given - Ice, BENADRYL.
Growing bigger and bigger; Feel soar; 3 inch diameter knot towards the inside of the arm not on the injection site; Warm to touch; Reddish not bright red nor pink; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (3 inch diameter knot towards the inside of the arm not on the injection site), VACCINATION SITE WARMTH (Warm to touch), ERYTHEMA (Reddish not bright red nor pink), VACCINATION SITE SWELLING (Growing bigger and bigger) and MYALGIA (Feel soar) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Hypertension and Congestive heart failure.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (3 inch diameter knot towards the inside of the arm not on the injection site), VACCINATION SITE WARMTH (Warm to touch), ERYTHEMA (Reddish not bright red nor pink) and MYALGIA (Feel soar). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Growing bigger and bigger). At the time of the report, PERIPHERAL SWELLING (3 inch diameter knot towards the inside of the arm not on the injection site), VACCINATION SITE WARMTH (Warm to touch), ERYTHEMA (Reddish not bright red nor pink), VACCINATION SITE SWELLING (Growing bigger and bigger) and MYALGIA (Feel soar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-MAY-2021, updated contact information. Patient request that the forms be physically mailed to her.  She is unable to read them from her email due to her going legally blind.
My side efffect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My side efffect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My side efffect). At the time of the report, VACCINATION COMPLICATION (My side efffect) outcome was unknown.            No concomitant medication and treatment information was reported.
My healthy 45 year old sister-in-law just died a few days before the Holiday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "My healthy 45 year old sister-in-law just died a few days before the Holiday". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Reporters healthy 45 year old sister-in-law just died a few days before the Holiday. She just got your new multi variant booster shot. Cause of death: Unknown! Reporters uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: My healthy 45 year old sister-in-law just died a few days before the Holiday
Was awakened by Fitbit at 4 am heart rate was 137, normal heart rate 70. Lessened over time but continuous fatigue for 2 days, no appetite, nausea
10 hours post vaccine sore arm, low grade fever, generalized aches and pains. Fever and aches still persist on day two
Next day developed right leg pain.  Following day diagnosed with a new deep venous thrombosis of the popliteal vein, right leg
Mom called, complaining of 1 1/2" redness at injection site and swelling from shoulder to elbow on 6/22/01 to right arm after TriHibit shot. Giving Tylenol and compresses.
The patient received  his second Pfizer COVID vaccine at 15 days and not the minimum of 17 days apart
Patient received 5 doses of the Janssen vaccine instead of one dose. This was an administration error. Follow-up conducted with the patient. She did not have any side effects.
This spontaneous report was received from a medical assistant referring to unknown number of patients of unknown gender and age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. In September 2016, the patients were vaccinated with improperly stored ROTATEQ (lot # L008997, expiration date: 04-DEC-2016) orally for prophylaxis. No adverse effects noted. No product quality complaint was involved. The medical assistant reported that the vaccine reached 9 C degrees for 8 hours. There were no prior excursions. This is one of the two reports received from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1701USA003143:
Skilled SNF:    PCC placed a call to Post Acute ; I spoke to staff she states she is unable to hod the bed throughout the whole day but, will hold it for a few hours.    PCC spoke with staff and updated on BM. Okay to send the pt at 12 noon. Nurse updated. SNF Packet provided.   for PT; provided patient preferences: Yes   Transportation: Ambulance transport: Enhanced Contact/Airborne  precautions *COVID Scheduled pick up: TBD DME: Not Applicable Transition Support Level: LOW   Patient notified that Program will make initial contact within 48 hours after discharge: Not Applicable appts arranged: Not Applicable Follow up appt with PCP/MD: YES PCP: MD   Patient referred to the following case management program: Not Applicable Patient currently in following case management program: Not Applicable Patient/family aware and agree w/ DC plan: YES. Discussed discharge plan and preferences with: patient/self and sister:  RN notified: Yes Patient's primary contact information @ discharge:  Primary Emergency Contact: sister   ADDITIONAL COMMENTS  Chart reviewed and case discussed with: (M.D.). Follow up outpatient as per discharge instructions.   We want you to be involved with the preferences and decisions regarding your discharge process so let me us know of anything that needs to be addressed.YES    PCC placed a call to sister,she was updated and included in the DCP. She is in agreement of transfer to facility today, if bed is available.   Health Care Agents     Alternate Agent - Friend Not Active Primary Phone: (Home) Mobile Phone:            Primary Agent - Sister Not Active Primary Phone: (Mobile)          Alternate Agent - Friend Not Active Primary Phone: (Mobile)             As per Previous PCC" Dr. requested to send dc meds orders to Pharmacy  Spoke to from Pharmacy, able to confirm receipt of the orders.    Telephone call received from bedside RN, re: patient's belongings.  Spoke to patient's friend.  Stated that she had mad an arrangements for patient's best friend, to pick up patient's belongings at facility possibly tomorrow.  He will also bring patient's belongings to patient's new SNF  Bedside RN updated.    Electronically signed by  RN, MSN/ED PCC 8/8/2023             Note Details  Author  (R.N.) File Time 8/8/2023 10:46 AM Author Type REGISTERED NURSE Status Addendum Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct # Admit Date 8/3/2023  ED to Hosp-Admission (Discharged) on 8/3/2023  ED to Hosp-Admission (Discharged) on 8/3/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  08/04   Admitted from ED (Observation) 0555 08/06   Admitted 0907 08/08   Discharged 1410
no additional AE/PQC reported; expired dose of rotateq was given to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 26-JAN-2021, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S006050, expiration date was reported as 12-DEC-202, but upon internal validation was established as 12-DEC-2020) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. Caller verified that there were no known temperature excursions. No additional adverse events were reported.
itching on back; hives in a small area; This is a spontaneous report from two contactable consumers (patient and patient's mother). A 22-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EH9899, expiry date: 31Mar2021), intramuscular in left arm on 21Dec2020 (about 9:45 -09:50 a.m. this morning) at a single dose for COVID-19 immunization. The patient has no other patient history, no concomitant medications, and no investigation assessment provided. The patient has no previous immunizations. The patient received the COVID vaccine about 9:45 -09:50 a.m. this morning (21Dec2020). She noticed just recently that she was starting to itch on her back and has hives and did not know if it was a side effect. Time of onset of itching on back was around 15:00-15:30 (estimated at within past 30 minutes), while the hives started around 5 minutes later than the itching. No ER or physician's office required. She is a nursing student, so it was recommended she receive the vaccine by the college of nursing. She received it at the hospital. They put Neosporin on her back, and it helped. She does not feel the itching. When asked to provide outcome of the hives, she stated it looks like the hives are getting smaller, but they are still there. The outcome of the events was recovering.
He tolerated the injection and went to the waiting room for sit.  About 13 minutes after the injection, the patient walked back to the nurse's station, stating that he did not feel good.  He was pale and clammy and started to fall.  He was sat in the chair, and he started to lose consciousness.  Pulse was faint and the blood pressure was initially 61, pulse about 60.  He has no skin rash, stridor, respiratory distress.  Respiration was regular and unlabored.  Within 10 minutes, he opens his eyes and started responding, his blood pressure improved to 110-120's, pulses 60's, O2 sat 98%, unlabored breathing.  He was transferred to a wheelchair and laid down on the exam table.  He was observed for another 30 minutes.  His vital signs remained stable.  He is able to drink water and able to walk around in his own power without difficulty.   The patient stated that he does not like needles, and he has not had any vaccination for a long time.   Impression: Vasovagal syncope Adverse reaction to the SARS-CoV-2 vaccine, not anaphylactic reaction.
arm was sore the next day; felt tired; headache; flu like but without fever; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in May 2019 and experienced ache, headache and injction site pain, refer case US2020AMR024894.).   In July 2019, the patient received the 2nd dose of Shingrix and the 1st dose of Hepatitis A vaccine. In 2019, 1 day after receiving Shingrix and Hepatitis A vaccine, the patient experienced fatigue, headache and influenza-like symptoms. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fatigue, headache and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue, headache and influenza-like symptoms to be related to Shingrix and Hepatitis A vaccine.  Additional information was provided as follows: This case was reported by patient herself and she was an orthodontic employee. The patient received 1st dose of hepatitis A vaccine in right arm and 2nd dose of Shingrix in left arm. The patient's arm was sore the next day and she felt tired, headache, and flu like but without fever. The symptoms resolved in about 24 hours from the start of symptoms. In January of 2020, the patient received her second dose of hepatitis A and experienced no adverse effects.
In am had 2 red spots on forehead. Then in evening had stomach pains, felt like he ran a temp. and nausea.
Information has been received from a registered pharmacist concerning a 14 year old female with no medical history and no allergies who on 06-MAY-2009 was vaccinated with the 1st dose of GARDASIL, 0.5ml, IM (lot#661846/1312X). There was no concomitant medication. Subsequently the patient experienced unspecified diabetes symptoms. Her only abnormal lab was an increased in bilirubin. She had sought medical attention, and was seen. The patient's diabetes persisted at the time of report. Additional information has been requested.
Raised hives scattered throughout body began few hours afterwards that came and went. Today, they came back again but brought swelling to the upper lip as well with facial pain.
Huge 4x7cm inflammation and induration from DTaP. 2nd pt in our office in 1 week, both from the same lot #!! We have not seen this before with DTaP!! Recovered in 2 days.
4 month old developed intussusception and was hospitalized 05/05/2018, after two trips to the emergency room. The initial visit at the ER was on 05/04/2018.
BlurredVision, Diarrhea,  JOINT PAIN, APPETITE LOSS, BACK PAIN, BODY  PAIN, FAITUGE, SWOLLEN LEFT EYE LID  Narrative:   Other Relevant History:
pt received the regular booster and not the bivalent booster. the vials are extremely close (blue cap) and printing is similar.
Expired Moderna vaccine administered to patients; Vials were initially stored in the refrigerator on 05 Apr 2022 and Expiration date was on 01 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05 Apr 2022 and Expiration date was on 01 Apr 2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05 Apr 2022 and Expiration date was on 01 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05 Apr 2022 and Expiration date was on 01 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Reporter reported that the administration of vaccine occurred from 6 Apr 2022 to 9 Apr 2022. Patient had no adverse reaction after the vaccination. The manufacturing date of the vial was 01 Dec 2021. Vial was initially placed in refrigerator on 05 Apr 2022. The product did not undergo any temperature excursion issue.  No treatment medication was reported.   This case was linked to MOD-2022-537580, MOD-2022-538614, MOD-2022-538672, MOD-2022-538673, MOD-2022-538675, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538689, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672 (Patient Link).
Shortly After the second dose patient started to have weakness in her left hand, which after a few weeks went to her right hand and arm then her legs. She was diagnosed with ALS on September 8 2021 and died on November 6, 2021. We want report this event so others could be informed of any possible adverse reactions due to the fact that this occurred shortly after patient had the second vaccine. If there are any studies or similar events that occurred to others I would like to be informed.
Moderna COVID-19 Vaccine EUA  IMMEDIATELY UPON RECEIVING THE SHOT I STARTED TO FEEL DIZZY, LIGHTHEADED, AND TIRED. IT HAS BEEN 3 HOURS AND I STILL FEEL THE SAME.
Suffered from COVID-19 symptoms with negative test.  Headache, sinus pressure, body aches, loss of taste and smell.  Husband and children tested positive. Certain it was COVID
ITCHING; REGULAR HIVES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hives.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, treatment medications included: cetirizine hydrochloride, diphenhydramine hydrochloride, omalizumab, and prednisone. On 12-APR-2021, the subject experienced itching. On 12-APR-2021, the subject experienced regular hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, and regular hives. This report was non-serious.
slight arm discomfort that latest about a day and a half after the first dose.; arm pain less than the first two doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (slight arm discomfort that latest about a day and a half after the first dose.) and VACCINATION SITE PAIN (arm pain less than the first two doses) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (slight arm discomfort that latest about a day and a half after the first dose.). In 2021, the patient experienced VACCINATION SITE PAIN (arm pain less than the first two doses). At the time of the report, VACCINATION SITE DISCOMFORT (slight arm discomfort that latest about a day and a half after the first dose.) had resolved and VACCINATION SITE PAIN (arm pain less than the first two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-428659, MOD-2021-428660 (Patient Link).
Very sore injection site, red rash moving down shoulder to arm pit with swelling in shoulder, head aches, alternating chills and fevers, loss of apatite, pain in joints and back, severe back itching, limited arm use/movement, frequent urination, general fatigue.
Patient reports feeling warm and coughing (coughing spell) she reports feeling lips a little numb. Pt reports she had covid-19 in Nov. 2020. Patient reports symptoms improved, cleared by EMS. BP171/93, 170/90, pulse 91, Spo2 99-100%
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received KINRIX (batch number A75D7, expiry date 30th September 2016). On 5th December 2014, the patient received KINRIX .5 ml. On 5th December 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: KINRIX given as primary series instead of individual components.