chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 4-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies or concomitant medications was provided.    On 17-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not provided) lot # S032355 expiration date 14-OCT-2021, administered subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (Lot number: S032591, Expiration date: 16-AUG-2022).  The improperly stored dose experienced multiple excursions, the first in a temperature of 6 degree Fahrenheit (°F) to 14°F (average temperature was 13.6°F) for 12 hours, and then a temperature of 15°F to 46°F (average temperature was 16.0°F) for 30 min. There was no previous temperature excursions. The call was because a digital data logger.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001233:
"MODERNA COVID-19 VACCINE  PATIENT VOLUNTARILY RECEIVED MODERNA COVID-19 VACCINE TODAY AT 0957, AND IMMEDIATE ANXIETY DRIVEN NEAR SYNCOPAL EPISODE.  OBSERVED SYMPTOMS OF HYPERVENTILATING, FLUSH.  PATIENT REPORTED FEELING IMPENMDING DOOM, DIZZY, INCREASED HEART RATE, FLUSH, AND STATED SHE "IS GOING TO PASS OUT"   EMS FLAGGED TO STATION 6.  FIRST RESPONDER  EMS DID EVALUATE AND ASSESS PATIENT FOR 15 MINUTES.   DOCUMENTED ACTIONS: ORTHOSTATIC VITAL SIGNS BLOOD SUGAR NEURO ASSESSMENT VACCINE SITE ASSESSMENT WNO S/S OF REACTINO QUICK VERBAL H&P
DEHYDRATION; RASH; CHILLS; HIGH FEVER; ANAPHYLACTIC SHOCK; 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 not reported) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, (after she had vaccine) patient had experienced the anaphylactic shock. She had a high fever and chills the same day she received the vaccine. On 15-APR-2021, she had a rash covering the entirety of her body. She called her PCP (Primary care physician) and was told to went to the emergency room but refused because of covid rates in her city. She had gone to urgent care instead and was given a benadryl shot and a prescription for steroid. The same day, the rash cleared up so she had not started the prescription again. On 17-APR-2021 the rashes were back, so she started the prescription again and she went to hospital and she was diagnosed with dehydration. She was given a new dose of benadryl, pepcid, and solumedrol for the treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylactic shock, dehydration, rash, high fever and chills was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210509845- covid-19 vaccine ad26.cov2.s -Anaphylactic shock, Dehydration This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210509845- covid-19 vaccine ad26.cov2.s -Rash. This event(s) is labeled per RSI and is therefore considered potentially related.
Saturday, May 8th woke up with severe tinnitus and then suddenly lost all hearing in left ear. Went to urgent care and go prednisone and ENT on May 10th. Hearing loss in my left ear is totally gone. They have little to no hope of recovery. Will be doing an MRI.
Headache, Myalgia, Fever,  Fatigue Narrative: missed work 1/14/21
My whole body is just went under pain; my whole body is just aching; Terrible headache; I am not feeling well enough; feel nauseate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Sep2023, outcome "unknown", described as "I am not feeling well enough"; PAIN (non-serious) with onset Sep2023, outcome "unknown", described as "My whole body is just went under pain; my whole body is just aching"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "Terrible headache"; NAUSEA (non-serious) with onset Sep2023, outcome "unknown", described as "feel nauseate".  Additional Information: Patient had last covid shot last yesterday and had all of them but never had a reaction and today when woke up, whole body was just went under pain. Patient had a terrible headache and feel nauseate.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
LOSS OF BLOOD; VOMITING; BACK PAIN; ABDOMINAL PAIN; FEELING WEAK; HEADACHE; BLOOD CLOTTING; COULD NOT MOVE; ONLY COULD DO 5 MINUTES OF WORK; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070CCHD,expiry: UNKNOWN) dose was not reported,1 total administered on 20-MAR-2021 for prophylactic vaccination to left arm. No concomitant medications were reported.  On 22-MAR-2021, the patient experienced blood clotting which lasted for three weeks and resolved as per physician on same day the patient experienced headache which got resolved on 22-Apr-2021. On 18-APR-2021, the patient experienced loss of blood, vomiting, back pain, abdominal pain and patient felt weak. On an unspecified date in 2021, the patient went to hospital, it was also reported that patient was not able to move and could do only 5 minutes of work. Patient got confused between clotting with menstruation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clotting on 12-APR-2021, and headache on 22-MAR-2021, was recovering from loss of blood, feeling weak, vomiting, back pain, and abdominal pain, and the outcome of could not move and only could do 5 minutes of work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: In narrative of source document vaccination date is 20-Mar-2021 and in the structured field of source document vaccination date is 20-Apr-2021. So as per conservative approach, date given in narrative 20-Mar-2021 is taken as vaccination date. V0 20210440392-COVID-19 VACCINE AD26.COV2.S-Blood clotting and loss of blood. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
High fever, Chills, weakness, swelling and redness of left arm from site of injection to elbow, face rash,
Lymph nodes swelling by left side collar bone area,Lymph nodes swelling under left armpi,Lymph nodes swelling on left shouldert; Pain under left arm pit; Pain in left shoulder,Pain in left side collar bone area; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swelling by left side collar bone area,Lymph nodes swelling under left armpi,Lymph nodes swelling on left shouldert), AXILLARY PAIN (Pain under left arm pit) and ARTHRALGIA (Pain in left shoulder,Pain in left side collar bone area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swelling by left side collar bone area,Lymph nodes swelling under left armpi,Lymph nodes swelling on left shouldert), AXILLARY PAIN (Pain under left arm pit) and ARTHRALGIA (Pain in left shoulder,Pain in left side collar bone area). The patient was treated with PREDNISONE ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and TRAMADOL ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Lymph nodes swelling by left side collar bone area,Lymph nodes swelling under left armpi,Lymph nodes swelling on left shouldert), AXILLARY PAIN (Pain under left arm pit) and ARTHRALGIA (Pain in left shoulder,Pain in left side collar bone area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound thyroid: (abnormal) a 10 x 9 millimeter swollen lymph node was found under her armpit area..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient reported that she has been experiencing pain for approximately 9 weeks.
Large raised, red, hot to the touch hardened induration at the vaccine site, spreading outward. Fever.
kind of nauseated; bad rash. Opposite side on a different arm and on right breast; chills; little fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (little fever), NAUSEA (kind of nauseated) and RASH (bad rash. Opposite side on a different arm and on right breast) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cellulitis.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (little fever). On 17-Apr-2021, the patient experienced NAUSEA (kind of nauseated) and RASH (bad rash. Opposite side on a different arm and on right breast). On 17-Apr-2021, CHILLS (chills), PYREXIA (little fever), NAUSEA (kind of nauseated) and RASH (bad rash. Opposite side on a different arm and on right breast) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant details were provided Treatment details include Antibiotics- Generic Bactrim.
Pt has been experiencing pain in left shoulder for past year. Has received cortisone shots. Was told by MD that flu shot was given too high on the arm. Pt said shot was given 3-6" from shoulder which seems appropriate.
Patient was given a  flu vaccination intramuscularly.  Approximately 45 seconds after receiving vaccine, patient slumped over in chair and lost consciousness. Her eyes were open but she was completely unaware of surroundings. Her pupils were extremely dilated. Her mother was also present in room, and being shouting her name, tapping and shaking her to try to come out of her state.  Soon, patient had trouble breathing and was not breathing for a few seconds. Patient came to, but then gasping for air, and had a mild seizure . Patient eventually came out of state, drank some orange juice and relaxed for about 10 minutes after episode. Called mom about an hour and a half after vaccine, and mom stated patient had a headache.  Patient has a prior history of anoxic seizures and vasovagal syncope.
pt recvd vax & c/o sore throat; malaise & polyarthralgia;deveel low thyroid function w/ low TSH;
Patient states that the pharmacist that gave him his booster, gave the shot too high on his arm.  He states it was right near his shoulder bone.  As a result he has had pain that has gotten progressively worse and the pain is radiating down his entire arm now.
The pt experienced induration and redness at an area that is 3.5 x 5.5 cm
problems with catching deep breaths; problems moving around easily; The pain radiates to the middle of her back down to her lower back; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (problems with catching deep breaths), GAIT DISTURBANCE (problems moving around easily) and BACK PAIN (The pain radiates to the middle of her back down to her lower back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced DYSPNOEA (problems with catching deep breaths), GAIT DISTURBANCE (problems moving around easily) and BACK PAIN (The pain radiates to the middle of her back down to her lower back). At the time of the report, DYSPNOEA (problems with catching deep breaths), GAIT DISTURBANCE (problems moving around easily) and BACK PAIN (The pain radiates to the middle of her back down to her lower back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatments were reported.   This case was linked to MOD-2021-348389 (E2B Linked Report).; Sender's Comments:  -MOD-2021-348389:dose 1
Severe vertigo (flipping, spinning sensations - inability to walk unassisted. Onset 11/5/13 at 10 PM, continued, with varying degrees through mid-December 2013. Visual problems - reduced field of vision, double/triple vision, blurriness, movement of words on paper onset 11/5/13. Continued through January 2014. Heavy menstrual bleeding/extended periods from November 21 through January 12 bled (heavy and red) for 31 out of 50 days. Lower back pain - onset November 30, 2013, subsided by mid to late December, but still occasionally bothers. Difficulty walking/Irregular gait - onset November 5, 2013, subsided by mid-December. Fainting/Syncope - onset January 6, daily occurrences - often 2-3 times a day - through mid-March. Still has fainting episodes but frequency is reduced with medication. Tremors - uncontrolled tremors in arms and legs. Started after fainting during first week in January; by mid-January the tremors were present throughout the day, not just after fainting.  Tremors continued until early February. Possible Autoimmune Disorder - Antiphospholipid syndrome. Orthostatic Intolerance - ongoing, currently treating with medication.
received more liquid than expected; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced receiving more liquid than expected (accidental overdose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  The patient stated that she thought she received more liquid than expected.  No AEs were reported, and no treatment medications were reported.  Action taken with mRNA-1273 was not reported.  The outcome of the event, accidental overdose was considered recovered.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # unknown) with no associated AEs reported.
fainting; dizziness; almost falling; progressive altered vision/started to loss his vision reduced to 80%; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (fainting) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 079c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), DIZZINESS (dizziness), FALL (almost falling) and VISUAL IMPAIRMENT (progressive altered vision/started to loss his vision reduced to 80%). At the time of the report, SYNCOPE (fainting), DIZZINESS (dizziness), FALL (almost falling) and VISUAL IMPAIRMENT (progressive altered vision/started to loss his vision reduced to 80%) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information were provided by the reporter.  No treatment information was provided.  Company comment: This case concerns a 77-year-old, male subject who experienced the serious events of syncope, and non-serious events of dizziness, fall, and visual impairment . The events occurred approximately 1 day after the first dose of Spikevax.  There was no rechallenge as at the time of the events, as the patient was yet to receive the second dose of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 77-year-old, male subject who experienced the serious events of syncope, and non-serious events of dizziness, fall, and visual impairment . The events occurred approximately 1 day after the first dose of Spikevax.  There was no rechallenge as at the time of the events, as the patient was yet to receive the second dose of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.
Sudden on set of numbness in arms and intense migraine. Had to leave work and go to ER. ER considered admitting, but allowed follow up with neurologist instead. After several test to rule out any other possible reasons for symptoms, it was determined to be a reaction from Pfizer Vaccine. I had many neurological side effects after receiving vaccine. Black eyes,  vertigo, and the common side effects of vaccine. Migraine has gone down to a headache after the help of medication, but has never fully gone away. numbness never resided either. has continued for almost a month now.
Started as red bumps that turned rash-like while patient experienced burning and then what appears to be bruising/broken capillaries.
Pt. states after receiving the Shingrix 02/18/2021, started to experience immediate pain in the shoulder in doctor?s office.  Left arm paralyzed for 2 days from the shoulder to elbow, extreme chills, nauseous subsiding estimated 02/21/2021.
Chills after 12 hours of administration. Went to bed. Woke with Fever of 100.4 20 hours post administration. Headache. Very tired, needed to sleep. Was fine by 8:00 in the evening approximately 24 hours after first symptom started.
Fluzone Quadrivalent was inadvertently administered to 72 year old patient instead of Fluzone HD with no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316288, 2019SA316290, 2019SA316262, 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316261, 2019SA316263, and 2019SA316286 same reporter.  This case involves a 72 years old male patient for whom Fluzone Quadrivalent was inadvertently administered to 72 year old patient instead of Fluzone HD with no AE [Wrong product administered] was reported, while he received vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical treatment(s), vaccination(s) and family history were not provided.  On 07-Nov-2019 the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ305AA, Expiry date 30-Jun-2020] via intramuscular route in the left deltoid for immunization.  It was actual medication error case due to wrong product administration.  No AE had been reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
having headache since vaccine, treated with Excedrin with some improvement, fatigue, exhaustion, breathing difficulty.
He was due for Mcv4 and The M.A ended up only grabbing the juice only, not both vials. So he was vaccinated incorrectly.
high pitched crying for 2 hrs inconsolable-starting a few hrs p/inj; pale & sleepy the next day;
Had redness and itching at injection site.  Currently have twitches and throbbing  several times a day at the injection site, this has been going for a several weeks.
Employee working at Vaccine Clinic in a mixer role reported not being able to swallow well, and throat being tight 4&1/2 hour into her shift. Also, reported feeling her heart beating fast, and chest heaviness.  She also indicated that she wasn't sure if she inhaled the vaccine, or got some on her hands, She was wearing a surgical mask with face shield, but no gloves. This individual was transferred to ER by EMS after receiving 2x diphenhydramine 25 mg caps.
I had redness, warmth, tenderness and swelling of my right leg.  I was hospitalized to received IV antibiotics.
one of two pts vaxed from the same vial who exp pain @ inject site; pain began & has been ongoing for approx 11 days; seen by MD- no redness, swelling or induration; both pts recovered & have a low tolerance to pain;
Fever and shaking episode lasting approximately five minutes.  Temp 105.2 rectally in ER. Patient treated in with Rocephine 450mg IV, Tylenol and Motrin.
Red ring around injection site, became welts on arm, started on a Sunday, still there Tuesday.  Took Claritin Tuesday
Patient reported not feeling well, feeling of flush sensation over body, palpitations, holding hand across chest after receiving vaccine.  He had a 30 minute wait time in observation and had approximately 5 minutes remaining when he complained  of not feeling well.  On assessment, patient found to have BP 200/130 and recheck by EMS was 220/116.  His HR was in the high 80s with pulse ox of 99% on RA.  He was taken to the hospital for further evaluation.