chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient received Moderna vaccine after the vaccine had been refrozen and rethawed; the patient received Moderna vaccine after the vaccine had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment- This is a case of Expired product administered and Product storage error for this 77-year-old patient of of an unknown gender with no medical history provided. Reportedly, the patient received the dose of the Moderna COVID-19 Vaccine (batch no. 047C21A) which had been refrozen and again rethawed. No adverse events were reported at the time of this report. The company causality for the events of Expired product administered and Product storage error is not applicable.   This case was linked to MOD-2021-381132 (Patient Link).; Sender's Comments: This is a case of Expired product administered and Product storage error for this 77-year-old patient of of an unknown gender with no medical history provided. Reportedly, the patient received the dose of the Moderna COVID-19 Vaccine (batch no. 047C21A) which had been refrozen and again rethawed. No adverse events were reported at the time of this report. The company causality for the events of Expired product administered and Product storage error is not applicable.
51 year old male PUI reported that he 'felt lethargic, felt nauseated, felt tired' on 7/25/21. On 7/26, he 'started to have a cough,' and he was 'overall not feeling well.' PUI went to the doctor to get tested for COVID-19. Positive result. PUI stated that his 'eyes watered,' and 'more and more' his throat and head hurt. He was nauseated. On 7/29, PUI reported that he could 'barely get out of bed.' He was tired, feverish, and 'so nauseated.' PUI stated that he must have 'tore up my esophagus' because he was 'throwing up blood.' PUI's wife urged him to go to the Hospital. Clinicians kept him to stabilize his blood count. They were not sure where the 'dark blood' was coming from that he vomited. PUI stated that nausea and vomiting were the 'worst part of it.' PUI reported that he was also kept in the hospital because he was 'so dehydrated.' PUI stated that Hospital was 'very accommodating' and 'very thorough.'
No additional AEs were reported.; Physician reported that a patient received an expired MMR II vaccine; This spontaneous report has been received from a physician and refers to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. There was no information regarding the patient's medical history and concurrent conditions provided.  On 08-DEC-2022, the patient was vaccinated with one expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, lot # T033815 confirmed to be valid with an expiration date 05-OCT-2022 (exact dose, dose number, route of administration, and anatomical location were not reported), for prophylaxis (expired product administered). No additional adverse events were reported.
fine maculopapular rash on right side of face, onset ~4-6 hours after vaccination, not painful or pruritic
Patient had been at primary care office earlier today noted to have increased confusion over the past 3 days.  Had fallen and become more weak.  Had MRI prior to arrival in the emergency room today. History of present illness, ROS, and physical exam are all limited by patient's condition.
Still with pain at injection sight and tight muscle on top left shoulder behind ear to head and cause pain when move head
contract shingles after the first dose; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but was selected an adult as per vaccine indication. The patient had received first dose of Shingrix and experienced Shingles. The reporter was wondering what the recommendation was on receiving dose 2 if contracted shingles after the first dose. No other information was reported.
Migraine, dizziness, and nausea for 6 full days. Very off balance, sensitive to lights and noises. Finally felt relief after 2 full days of magnesium, aspirin, Prednisone, and summatriptan.
Sluggish; rash around the left arm; Headaches; muscle pains; chills; nausea; low-grade fever (reached 102 F); Fatigue/tired; "very sick" for two days; Dry cough; very sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), PAIN IN EXTREMITY (very sore left arm), SLUGGISHNESS (Sluggish) and RASH (rash around the left arm) in a 67-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.     Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia, Depression and COPD. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular). On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), PAIN IN EXTREMITY (very sore left arm), RASH (rash around the left arm), HEADACHE (Headaches), MYALGIA (muscle pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (low-grade fever (reached 102 F)) and FATIGUE (Fatigue/tired). On 12-Feb-2021, the patient experienced SLUGGISHNESS (Sluggish). On 12-Feb-2021, VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), MYALGIA (muscle pains), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low-grade fever (reached 102 F)) had resolved. On 13-Feb-2021, PAIN IN EXTREMITY (very sore left arm) and RASH (rash around the left arm) had resolved. At the time of the report, SLUGGISHNESS (Sluggish) outcome was unknown and HEADACHE (Headaches) and FATIGUE (Fatigue/tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes medications to treat current medical conditions but did not provide the names of them all. Patient uses an inhaler (unspecified) to treat COPD.  The patient did not use any medications for treatment of the events.
high fevers; uncontrollable body shakes; teeth chattering; Intense headaches; chest pain; light headedness; rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0161, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0171, Location of injection: Arm Right), administration date: 06May2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fevers"; TREMOR (non-serious), outcome "unknown", described as "uncontrollable body shakes"; CHILLS (non-serious), outcome "unknown", described as "teeth chattering"; HEADACHE (non-serious), outcome "unknown", described as "Intense headaches"; CHEST PAIN (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "light headedness"; RASH (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, tremor, chills, headache, chest pain, dizziness, rash.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026408 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300026409 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300026410 same reporter/patient/product, different dose/AE;
Intermittent fever/chills, lasting about 1 day, starting 2 days after vaccination. Ongoing bilateral knee/hands, neck and shoulder pain. 15 pound weight loss between Dec 2002-May 2003. Short Prednisone course Feb and June 2003 with dramatic improvement.
OBSTRUCTIVE SLEEP APNEA 4/12/2023 CERVICAL RADICULOPATHY
pt recv vax 30APR96 930AM had low grade fever;2MAY96 t was 101 had 10 min tonic clonic sz 430PM;recovered very well;
Patient was behind on injections and mother not wanting to do many sticks.  Incorrect combination vaccination pulled by LPN.
I experienced weakness in my legs on 08/28/2021 as I was getting ready for work and at 11:00PM my legs gave out and I fell. An ambulance was called and the EMT checked my blood pressure along with my heart rate. He stated that I was fine. The ER performed an X-ray on my knee and said that I was fine. I was released from the ER that day. I was given a prescription for my arthritis (don't remember the name of the medication). An EKG was also performed before I left.
Pt received Hep-B immunization #1 in the early afternoon and by that evening, he had a rash all over both arms, both legs and torso. It was red and itchy. No SOB, lip swelling or difficulty breathing.
Dizziness, lightheadedness, some nausea- constant and daily; tried Meclizine but only resolves briefly
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 02Apr2021 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Other medications in two weeks was reported as yes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 at 13:15, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event sore arm was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients was vaccinated with improperly stored GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017, dose and route not reported). It was reported that the vaccine was improperly stored at 50 F for 2 hours and 40 minutes and 33.8 F for 1 hour and 20 minutes (totally 4 hours). Digital data logger (DDL) was used to capture this temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the physician.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
itching @ inj site;became very red & swollen;swelling extended to elbow;duration of local rxn-5 days;
Pt c/o symptoms including urticaria and flushing. Presented to the clinic post shot exercise. Provider administered diphenhydramine 50mg, 2 tabs, po. Prescribed at diphenhydramine 1-2 tabs TID PRN. Monitored for 45 minutes. RTC instructions provided if symptoms return.
but now I have the flu; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient and reported but now i have the flu after receiving  INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient said but now i have the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (but now I have the flu).  At time of reporting, the outcome was Unknown for the event but now I have the flu.
PRESSING  PAIN IN MY LEFT SIDE OF MY CHEST GOING DOWN TO MY LEFT ARM AND SQUEZZING INTO MY BREAST AND BACK.   NONE OF THESE SYMPTOM BEFORE THE VACCINE....JOHNSON & JOHNSON VACCINE
Deep radiating pain in upper left arm. When I lie down on left side painful. Through the day off and on pain. Lift arm painful. Wake up from pain in arm at night. Very uncomfortable.
In bed all day the day; "thought she was gonna die"; Felt so sick; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed all day the day), FEELING ABNORMAL ("thought she was gonna die") and ILLNESS (Felt so sick) in a 74-year-old female patient 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced BEDRIDDEN (In bed all day the day), FEELING ABNORMAL ("thought she was gonna die") and ILLNESS (Felt so sick). At the time of the report, BEDRIDDEN (In bed all day the day), FEELING ABNORMAL ("thought she was gonna die") and ILLNESS (Felt so sick) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.
Patient received 2 Pfizer doses and 1 Pfizer booster in 12/01/2021. A few months after booster, patient complained of hip pain. Began PT & hip pain worsened. MRI was taken and revealed avascular necrosis of right femoral head pre-collapse stage. Not bilateral. Core decompression w/ bone grafting surgery was done July 25, 2022. After surgery, patient complained about knee pain. MRI ordered and showed bone infarct (avascular necrosis) at distal femur and proximal tibia. Treated with core decompression. Date of surgery was December 8, 2022.  Patient is now complaining about right lower rib-fib and ankle pain. MRI ordered, scheduled for 01/07/2023.    Patient was evaluated by hematologist to check for clotting disorders and variety of other causes. Labs were unremarkable and no clotting disorders identified. Negative for Lupus and Sjogren's syndrome.   Patient was competitive athlete in teen years and early 20s. No serious injuries aside from left ankle medial malleolus fracture in 2017, which was surgically corrected in 2017 with ankle ORIF surgery.  PATIENT HAS NO HISTORY OF ANY CLOTS OR MICRO CLOTS PRIOR TO RECEIVING COVID VACCINES.
Information has been received from a medical assistant reported that a 33 year old female patient who on 14-JUL-2010 was vaccinated inadvertently with a dose of PNEUMOVAX 23 instead of a TB test due to nursing error. The PNEUMOVAX 23 was given subdermally in her right forearm. The patient had a tennis ball size area of warmth, swelling and soreness. The patient sought medical attention by seeing in office. The physician had prescribed BENADRYL and ALLEGRA. At the time of report the patient's status was not recovered. Additional information has been requested.
Vaccinator administered one dose of Moderna vaccine to patient, reported that "it didn't feel like anything went in" and administered a second dose of Moderna vaccine to patient in same arm.
Arm very sore and hot got red by midnight. On Sunday felt malaise, tired, fever climbed to 102.5 degrees. Monday morning had to drink lots of fluids, almost passed out on couch. Went to doctor and got chest x-rays and ekg which came back with white cell blood count elevated. On Monday blacked out while driving 3 times on way home. Tuesday had another doctor visit and doctor considered sending him to cardiologist and prescribing antibiotics for possible infection.  On Sunday also had stiff neck mostly on right side and joint aches mainly on Sunday. Today doing well, slightly red at injection site. Asthma condition worsen during this period so had to use the inhaler more often.
Itching all over, headaches, severe gastrointestinal issues. Ulcerative Colitis now active.
Info from office visit is this: Flulaval Quad 2019-2020 (PF) 60 mcg (15 mcg x 4)/0.5 mL IM syringe  Sore muscle, itching, range of motion limitation, Note - The shot was given high on my upper arm (left). The assistant put the band aid on lower than the injection site and I pointed it out and we moved the band-aid.
No adverse event. Patient is 65 so would be eligible for second booster. Patient received second booster 1 month too early. Vaccine was given by - CMA. Reviewed with MA time and spacing for second boosters. Patient was informed of the spacing error and that she will not need another shot per CDC guidelines.
Pt recvd APAP @ approx 930AM 28APR92 about 1/2 hr p/vax given; Arched body backwards, stiffened body, eyes rolled back in orbits & body began shaking & tremoring; pupils of both eyes constricted very small;
This is a 37 y.o. woman who developed an episode of acute self-limited hemolysis just over a week following her second injection of the Pfizer COVID-19 vaccine.  She has been treated with ciprofloxacin and phenazopyridine immediately prior to the episode for a urinary tract infection.  She had no history of hemolysis prior to this episode.  She was in her usual state of health and received COVID-19 vaccines on 12/24 and 1/14 with the Pfizer vaccine and had no serious side effects at that time.  She then developed dysuria and was seen by telehleath by her primary care physician who prescribed ciprofloxacin and phenazopyridine for her for 3 days ending 1/22.  She took these and her dysuria resolved, however the day after developed what appeared to be blood in her urine.  Then in the following 2 days which were a weekend this worsened and she started feeling poorly.  She also noted that she appeared yellow.  On Monday 1/25 her boyfriend took her to urgent care and she was subsequently sent to an ER at the hospital that referred her to our hospital.  There she was evaluated for gross hematuria with no evidence of urinary bleeding and found to be anemic due to hemolysis.  Her hemoglobin was in the 5's and she received 2 units of PRBCs.  She was transferred here to Medical Center for further management.  After the initial transfusion she did not require blood transfusion and her hemoglobin continued to increase until it was 10.4 on 2/1 which was the day of discharge.  At a follow up appointment on 2/8/2021 she was recovering and feeling well.   Her jaundice had resolved.   No treatment was given from the hemolysis aside from the blood transfusion and it was self-limited.  It is most likely that her acute hemolysis was due to the phenazopyridine as this agent is known to cause hemolysis and she took it for 3 days prior to the onset of hemolysis.  She has no prior history of drug induced hemolysis and had not taken this medication previously.  As this occurred just over a week following her second vaccination I cannot exclude that is could be related to the vaccine.
49 year old male scratched by a raccoon on right ankle he was treated at ER with rabies immunoglobin and rabies vaccine. Beginning with Immun and following Rabies vaccine immunization, pt describes dizziness, headache, nausea (no vomiting) that lasts 6-7 hours. Symptoms have worsened with each administration of Rabies vaccine in this series completed series on 6/27/06.
Pt vaccinated with DTP/OPV fell asleep 1/2 hr after vaccine given. slept 2 1/2 hr ate lunch became lethargic 2 hrs later, skin pale yellow.
Extreme nausea, drop in blood pressure which caused me to pass out and severely sprain my foot.
Pt has had urticarial outbreak after each of the first 3 Anthrax vaccines given by the Navy. Treated with Zortec and Dexepan.
Above shot area down to app. 3" above elbow - Hot - very red, swelling, painful to touch. Last a week even treatment of BENADRYL prior to shot on 2nd dose - requested per Dr. BENADRYL throughout that week. 1st dose of SHINGRIX - no BENADRYL prior to #1 - shot - reaction lasted 5 days. Site of shot (L) arm. 2nd dose - of SHINGRIX - Reaction lasted 7 days.