chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-extremely sore arm, could barely move and very tender to any light touch starting the evening of the injection (12/31/20) -nausea (throughout day) and diarrhea (1 episode) same day of injection -fatigue x1 day on 1/1/21
9/19/21: Patient arrived to ER due to increased O2 requirement being on 4 L. Assessment on admission is viral pneumonia POA, acute on chronic respiratory failure, plan for patient is to monitor O2 saturation keep greater than 92% and monitor and trend inflammatory markers and CMP. Please note: Patient received first dose Pfizer vaccine on 12/21/2020 Lot # EL0140 and the second dose on 1/12/2021 Lot # EL3302
Rash developed on left are 9 days after shot. Rash is hot to touch and raised. No pain but rash is getting larger.
Pt died in hospital on 12/29/21. Pt admitted due to respiratory failure/acute stroke with pontine hemorrhage. Pt remained unresponsive throughout stay. Family transitioned patient to comfort care and she expired.
syncopal, vomiting, , nausea. Evaluated by EMS-Refusal to transport.
Flu; Initial information received on 08-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) patient who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's vaccination included flu shot after patient experienced influenza.  The patient's medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via a subcutaneous route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "At age 25 through 28, I got the flu shot. EVERY TIME I also got the flu. All the years prior and not since 29 have I got the shot. Neither have I had the flu! So it's a hard pass from me".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
About 9-10 days after receiving my Moderna booster, I started experiencing intense scalp itchiness, my ears itched and my nose did too. By Thursday, Nov 25 I developed hives all around my neck and on the lower part of my body (mainly upper thighs and around underwear lines). I went to urgent care and was told I must have had some allergic reaction to something. I was told to take Zyrtec and prednisone. After two days of this hives only intensified and were worse, all over my body. I was then told to start a new course of prednisone and take Benadryl and pepcid. After two days, the hives improved, the intense itchiness went down, but the hives have continued. Sometimes they are all over, sometimes they are just on my hands or my neck, they are sometimes intensely itching and other times not. I am no longer on prednisone but continue taking pepcid and Allegra now twice a day to try and keep the hives down.
Breakthrough case admission after 2 vaccines  Moderna 3/15/21 Lot# 010A21A;  Moderna 04/12/2021 Lot# 002B21A
arm really hurts; he's freezing; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and feeling cold. On an unknown date, the outcome of the pain in arm and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and feeling cold to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's wife. The patient got the first dose of Shingrix on day before reporting.  The patient's arm really hurts and he was freezing. The reporter enquired how long would this event last. The follow up was not required.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 22-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    Concomitant medication was not reported. Patient received 25 micrograms of monovalent vaccine dose 1 on 22-Mar-2023. Batch number was AS1903B. The route of administration of suspect Moderna bivalent dose 2 was reported as BI. No adverse effect was noted. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case, Patient 67
Temp 106-had seizure @ clinic in waiting room; mom had taken pt in as was sick w/URI & had t101; pt hospitalized overnight & sent home on ATB;
Symptoms: ? I can barely walk ? I cannot stand for very long ? I struggle with balance ? Extreme fatigue (has gotten better this week) ? Cannot drive or I get lightheaded and vertigo ? Increased motion sickness while riding in car ? My legs feel like they are swelling at night and will hurt all night long ? My toes have fallen asleep and are constantly numb  ? I have brain fog and often struggle to find the right words ? Weakness all over. Started in legs but is also in upper body ? Back hurts ? Frequent Blurred vision ? Have had 3 instances of involuntary upper body "nodding" ? Nearly fainted a couple of times ?  Time & Events  ? first Pfizer vaccine on April 7. About 28 minutes in, my arm started to ache. It quickly went across my shoulders and into my neck. At 30 minutes, I got up to leave and pain shot down my back and brought me to tears. I sat down and the EMTs came to my assistance. They stayed with me until my heart rate was back down and the color came back into my face, my muscles hurt and I was extremely exhausted!  ? I stayed exhausted.  ? My back began to hurt and I was beginning to have a hard time walking.  ? 2nd vaccine on May 3, person wheeled me in. It was difficult to walk but still didn't think it was from the vaccine. When I got the 2nd vaccine it hit me in the middle of the night like a ton of bricks. I felt like I had the flu with fever, body aches and extreme tiredness.  ? My back and hips were hurting for several weeks and it was much harder for me to walk. It progressively got worse as the weeks went by.  ? My legs started cramping often.  ? On June 4 the day started with a leg cramp that wouldn't go away.  ? June 5th my legs were not working properly.  ? On June 7 I went to see my doctor and could barely walk. It wasn't really pain but EXTREME weakness.  ?  It has just gotten worse and worse until now I have weakness ALL over. I can barely function. I cannot stand for very long without getting out of breath. ? June 8 diagnosed with Aggressive UTI- given Cipro- I seemed to get better.  ? June 25 doctor called in 2nd round of Cipro- Again seemed to get better. ? July 13 Extreme weakness- Had to call husband to pick me up at store. Doctor called in 3rd antibiotic- different but was awful! ? July 22 Abdominal and pelvic ultrasound- nothing abnormal found ? August 12 CT scans on abdominal & pelvic- nothing abnormal found ? Sep. 1 MRI of brain and spine- Nothing abnormal found ? Sept. 30 Saw Neurologist- He prescribed PT 3x a week October 12- began physical therapy
Initial unsolicited report received from a non health care professional (office staff) on 20 Oct 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE INTRADERMAL QUADRIVALENT (batch number, expiration date, dose, site and route were not reported) on an unspecified date. Patient medical history and concomitant medication was not reported. On an unspecified date, post vaccination; the patient experienced hard red welt under the skin. Lab data and corrective treatment was not reported. The patient was not yet recovered from the events (reported as still having events six weeks after administration). List of documents held by sender: none.
Tingling and numbness within one hour.  That subsided after another 30 minutes but then I lost  control of thumb and pointer finger.  That loss of control/strength has continued until today(2/11/2021).  I tend to drop things from my left hand.
Patient received dose #2 of Pfizer vaccine on 6/8/2021. And was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/14/2021 as recommended. No adverse reactions identified on site.
boil, hurts and big; Rapid heart beat that night; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 29Sep2021 12:00 (Batch/Lot Number: FF2588) at the age of 52 years old, as dose 2, single for covid-19 immunisation. Medical history included known allergies: latex. Concomitant medication(s) included iron taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: FF2587) administered in arm left on 08Sep2021 12:00. No other vaccine in four weeks. No COVID prior vaccination; not COVID tested post vaccination. Events started on 07Oct2021 12:00. The patient experienced rapid heartbeat that night (as reported). Unknown treatment for adverse event. Later (as reported), the patient started feeling a burning sensation on her middle back to later be a boil. She doesn't get boils and it hurts and was big. She was prescribed amoxicillin Events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events were recovering.
Within an hour, strong abdominal cramping, diarrhea, nausea. Mouth very dry, choking sensation which resolved quickly. The abdominal pain was very uncomfortable, and that along with diarrhea and nausea lasted nearly a week.
I only had a sore arm after receiving the vaccine. I tested positive for COVID-19 on June 21, 2022. I took a home test and called my doctors office (telehealth visit) and I was prescribed PAXLOVID. I also took TYLENOL to help with my symptoms. I had a fever and bad nasal congestion.
During an audit, vaccine consent form was marked as IM instead of Sub-Q. Patient was contacted a numerous of time but no response.
I developed severe shoulder pain within 3 hours of my vaccination.  The injection was given high on my shoulder, and after consultation with a physician it became apparent that the injection was into a bursa of my shoulder instead of intramuscularly. I am currently in a sling and unable to use my affected arm.
Tinnitus. Blocked right ear, pressure. Eye Pressure right side. Similar to 1st dose back in March 17, Moderna. ( I filed that review with you back then ) Insomnia , I feel my thyroid level are off.  Hypothyroid symptoms returning and upping my meds hoping to resolve? Phantom smells have returned more frequent now too.  I skipped 2nd dose back in April due to these side effects. The ear issues resolved but still had Tinnitus, decided to get the Booster 1/2 dose thinking the side effects would be less severe? ( Had my antibodies checked at 6 months and they were still detectable, 37,
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date in 2012, the patient was vaccinated with first dose of GARDASIL (strength, dose, route of administration, anatomical location, lot # and expiration date not reported). No concomitant medication was reported. On an unknown date in 2013, the patient received the second dose of GARDASIL one year after the first dose. The physician was unsure of the dates that the first dose and second dose of GARDASIL were administered on but stated that the patient received her second dose of GARDASIL at least a year ago. No adverse effect was reported. The outcome of the events were unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
4 days following vax pt started to run a temp an hr or 2 later started to have a sz & was taken to ER, had another sz in the ER which lasted longer & hospitalization;
Itching at the injection site after receiving the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site after receiving the first dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site after receiving the first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form every four hours. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site after receiving the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: positive (Positive) IgG qualitative test after the first dose and was positive.     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 medication were provided.   This case was linked to MOD-2021-015600 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Email On 01-Jun-2021: Initial Additional-2 : Translated Document
Constant headaches associated with nausea, neck stiffness upon awakening, patient seen at the office for f/u.
Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was not reported.
Moderna 2/10/21, 3/11/21. Positive on 1/31/22
pt describes flu like sxs on side vax adm; MD prescribed Toradol stating reaction directly attributable to MMR;
102 FEVER; 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 09-APR-2021, the subject experienced 102 fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 102 fever on 10-APR-2021. This report was non-serious.
Patient received Zostavax vaccine SQ in left upper arm 3-21-07. On 3-23-07 patient stopped in and showed us arm where injection was given. Large red area 2 1/4" x 1 1/2". No itching, burning or irritation. No trouble breathing. Next day it had increased in size to 4" x 4" and another red spot developed on that same arm. Patient visited Dr and concluded it was ADR from vaccine but no further evaluation needed (no treatment)
8/17/20 L axillary swelling 7cm and draining w bx 9/4/20 acute necrotizing lymphadenitis w giant cells and granuloma  9/24/20 L subclavicular mass 6 cm  resolved by early November  10/7/2020 LUE lymphadema  requiring repeated lymphedema PT  for 2 mo - cntinued pressure in LUE - feels heavy and fat.
Pt vax 3rd dose;  was non responder; 1st 2 doses Recombivax;
broke out in rash, started itching, on cest, lower back, blisters on leg, scalp itches
Pt stated 2 days after receiving FLUZONE she had rash extending down her arm and on chest (of arm that vaccine was administered). She already takes BENADRYL and allergy medication so she did not take anything extra for her rash.
flu; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non- health care professional.  This case involves an unknown age and unknown gender patient who experienced flu (influenza) while receiving INFLUENZA VACCINE.  The patient past vaccination(s) included INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient, medical treatment(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I took my vitamins and brushed my teeth today. I haven't had a flu shot in about 40 years. Last time I had the flu was 17 years ago, and no idea how long ago before that one. I know people that get the flu shot every year, then get the flu that same year. Every year same conversation. I don't understand it. I got the flu shot, but I still got the flu.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment for the event (flu).  At time of reporting, the outcome was unknown for the event flu.  There will be no information available on the batch number for this case.
Fever x 3 days, fatigue, body aches, joint pain, pain at injection site, headache
COVID-19 THREE TIMES; B CELL LYMPHOCYTE ANTIBODY SOMEWHAT DEFICIENT; 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 three times, and b cell lymphocyte antibody somewhat deficient. Laboratory data (dates unspecified) included: Antibody test somewhat deficient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the b cell lymphocyte antibody somewhat deficient and covid-19 three times was not reported. This report was non-serious.
couldn't get up or move; extreme lethargy that was so extreme; panicked because she thought that she had COVID; feeling like she was frozen and she was so cold; fever; didn't get out of bed for two days; This case was reported by a consumer via call center representative and described the occurrence of immobile in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2021 11:00, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2021, less than a day after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant), lethargy, panic reaction, feeling cold, fever and bedridden. On an unknown date, the outcome of the immobile, lethargy, panic reaction, feeling cold and fever were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the immobile, lethargy, panic reaction, feeling cold, fever and bedridden to be related to Shingrix.  Additional details were provided as follows:  After receiving 1st dose of Shingrix, the patient experienced bad reaction that including feeling like she was frozen and she was so cold that she couldn't get up or move and then she got a fever and she didn't get out of bed for two days. The patient also reported that during this experience she was panicked because she thought that she had COVID. The patient described her experience as having extreme lethargy that was so extreme. The patient couldn't move on Saturday and Sunday and then on Monday she felt like she never had anything. The reporter consent to follow up.
Pain in entire chest cavity- visited Urgent Care emergency facility on 5/24/2021.  Irregular heartbeat and shortness of breathe- received EKG and chest X-ray.  Blood draw taken to perform lab work.  Was told to take Ibuprofen for inflammation of chest.  Ibuprofen is not working.  Chest x-ray showed inflammation.  Lab work came back normal- no issues.   Also developed a lump on right breast near armpit on 5/31/2021.  Lots of pain and soreness.  Visited doctor on 6/2/2021.  Diagnostic mammogram performed on 6/3/2021.  Biopsy being taken on 6/18/2021