chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About the reaction I'm currently feeling after the 2nd dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (About the reaction I'm currently feeling after the 2nd dose.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (About the reaction I'm currently feeling after the 2nd dose.). At the time of the report, VACCINATION COMPLICATION (About the reaction I'm currently feeling after the 2nd dose.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
High fever, severe chills, headache, nausea, injection site pain and swelling, dry heaves,  joint pain.
Employee received the Flu vaccine and then later that night states that she started to have itching on her face, she took a Benadryl that night, woke up the next morning with a slight rash to face., then the next day she had a bright red rash and hives around face, mouth and eyes. Employee was seen at ED and was treated for allergic reaction
Received vaccine on Sat 9/26 at 12:00 noon; onset of symptoms a 3hr later; Pt experience 1st stomach cramps / pain later vomiting, diarrhea; loss of appetite, fever (sweating-chills); stomach cramping and diarrhea for 48 hrs; Symptoms subsided by 3rd day.
Fatigue noted two days p/pt & husband were administered the vax; Reporter was not informed of this "rxn" until this form was recvd;
Itchy rash at injection site since receiving the jab.  Sometimes topical anti-itch medications work, sometimes they don't.
5 minutes after vaccination, flushing/sweating, pallor, diaphoretic, dizziness. Patient stable, released from vaccination site.
Patient c/o diff breathing with hives on her chest, arms, and face accompanied by pruritic 15 min after vaccine injection.  Epi-Pen x1 injected in Right vastus lateralis muscle.  O2 face mask on at 10L.  BP 135/86, HR 88, RR20, O2 Sat 100%.  BP remained unremarkable.  Patient cont to c/o symptoms with itchy throat.  EMS called and patient transported to local hospital.
Body aches (back, neck and head), nausea for 24 hours.  Soreness at injection site which continues as of 4/17/21.  In bed taking Ibuprofen to help with pain during 24 hours of symptoms
ACTHIB was administered to a patient using sterile water instead of the diluent provided with no reported adverse event; Initial information was received on 14-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.   This case involves a 5 months old male patient who experienced acthib was administered to a patient using sterile water instead of the diluent provided with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Immunisation.  On 13-Jun-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine (lot, expiry, formulation, and strength: unknown) via intramuscular route in left thigh for immunisation.  On 13-JUN-2022 the patient developed a non-serious acthib was administered to a patient using sterile water instead of the diluent provided with no reported adverse event (product preparation error) (latency same day) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event acthib was administered to a patient using sterile water instead of the diluent provided with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Temp 105 F, slow to come down with Tylenol & baths.  Immunization given in a.m. Rxn in p.m. of same day.  Had gotten DPT/OPV/MMR/HIB vaccine that day
Numbness of scalp, face, ear and neck on right side.  Started around 1:30 PM the day after injection of the vaccine.  Symptoms persist 24 hours later.
When entering into Immunization Registry learned the child was only 4. On paper consent parent put DOB as 5/3/2016 so looked as if child was 5 to be eligible to receive Pfizer vaccine. When parent called on 11/20/2021 verified correct DOB is the 5/3/2017 and was informed dose #2 will not be given until child turns 5. Mother states child is not having any problems or reactions and will call if something does develop.
Vaccine administered 2-19-07 in thigh.  Dark red, circular patch 3x5 cm approx.  Lighter red excoriated surrounding patch w/indistinct borders.  Mildly indurated.  Severe puritic, warm to touch. Presented to office 2-20 and 2-21 w/above symptoms. Oral antibiotic-Amoxicillin given and Benadryl to be used PRN. Left thigh
pt started fever/pain, swelling of arm 22JUN95 104 x 2 days still fever;low grade 100 x 3wk-given ATB-Amoxil-x 1wk PMD;t104 p/2 wk 16JUL95 Ceclor
At 8:00 am the morning after I felt nauseous. About noon I started feeling extreme fatigue and a headache. By 2:00 pm I felt body aches, fever and chills.
the muscle pain and weakness has worsened to the point of near immobility; muscle pain; weakness; in constant pain; cannot raise my arms above shoulder height/knees and other joints do not want to bend; in the worst condition of my life; first dose in Feb2021/second dose on 05Feb2021; first dose in Feb2021/second dose on 05Feb2021; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported as Misplaced/discarded), via an unspecified route of administration on 05Feb2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Feb2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. For the past 10 weeks, since the second dose of vaccination, the muscle pain and weakness had worsened to the point of near immobility. It took both hands to lift a half full coffee cup, and patient could barely manage that. Patient could not raise his arms above shoulder height, his knees and other joints did not want to bend, and he was in constant pain. Patient had had to receive five (5) steroid shots in an attempt to counteract this, and the doctor had stated he could receive no more. Patient contacted his doctor's office and local health department, but neither could help me. Patient was healthy and had no such issues before the shot, and now he was in the worst condition of my life. All these events with start date 09Mar2021, resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and received treatment Steroid Shots. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included UTI.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No new information received.
Discharge Physician: MD Primary Care Physician: DO  Date of Admission: 9/21/2022 Discharge Date: 9/27/2022  PRESENTING PROBLEM: Generalized weakness  Multiple falls  COVID-19      HOSPITAL COURSE: Patient is a 87-year-old gentleman with known dementia presented to the Hospital after experiencing falls at home.  Patient was recently in our facility secondary to falls and noted dementia.  During this admission patient did test positive for COVID.  Multiple discussions with the family and Case Management, the wife is having difficulty caring for the patient is requesting long-term care.  Case management has been working with family to acquire a bed in the long-term care facility.  Patient has been medically stable for discharge for the duration of the stay.  Patient was relatively asymptomatic from a COVID perspective, he was on room air throughout admission.     Electrolytes were monitored and repleted throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge.
Pt presents reporting that he had generalized tingling all over starting 90 minutes after receiving the Pneumococcal vaccine and the Tdap vaccine on June 8, 2010. The tingling was constant and lasted for 4 days before decreasing in intensity. He had no rashes or itching. On June 10, he difficulty swallowing all day. He felt as though the throat was tight. No respiratory symptoms such as SOB. This also resolved. He did not contact us regarding these symptoms. He also notes muscle cramps in calves and tightness in the hamstrings. He also noted some queasiness and nausea after eating from June 12, through June 18. He describes "hot flashes" lasting 4 or 5 minutes on 3 occasions from June 15 through June 26. He as improving up until June 27 but the tingling recurred 2 evenings ago. He does not have the tingling today.
Flu like symptoms began to occur at about six hours after I received the shot. I had a loss of appetite, chills, headache and muscle aches. My left arm at the site of the shot was very sore. I retired and had the symptoms throughout the night. In the morning, I felt better but did not fully recover until about noon. This also occurred when I received the first dose on 08/03/2018.
Below injection site (by armpit)is pink slightly swollen tender to touch; Below injection site (by armpit)is pink slightly swollen tender to touch; Below injection site (by armpit)is pink slightly swollen tender to touch; This is a spontaneous report from a contactable nurse (patient) reported that a 38-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number : EL9263) via an unspecified route of administration on left arm on 27Jan2021 13:30 at single dose for covid-19 immunisation at workplace clinic. Medical history included allergies to sulfa, nickel and latex. The patient's concomitant medications included prenatal vitamins within 2 weeks of vaccination. The patient previously received first single dose of bnt162b2 on 06Jan2021 01:45 PM via unknown route on left arm for Covid-19 immunization (Lot number: EK09231). On 29Jan2021, patient had below injection site (by armpit) is pink slightly swollen tender to touch. The events did not result in emergency room or physician visit. There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient had been tested for COVID-19, patient underwent covid test type post vaccination nasal swab, rapids and PCR in 2021, all results were unknow. The outcome of the events was recovering.
Prior to vaccination pt was on inhaler for asthma developed  hoarseness  and treating physician  (FMD) discontinued the inhaler.  Hoarseness improved and pt's doctor ok'd flu shot.                                            -Approximately one week post flu vaccination pt developed wheezing. FMD prescribed Amoxil with noimprovement.                                   - Two weeks post  flu vaccination pt developed cough, body aches, extreme fatigue and FMD prescribed  Levaquin    which helped her symptoms but seemed to have a relapse according to pt and  needed to take an additional week of    Levaquin.   Cough resolved  but up to present pt notes upper extremity aches, neck soreness and malaise.     She did note that overall she feels much better but there is residual.                                         -  Due to persistence of symptoms pt's FMD drew bloodwork today.
The parent put down on the patient's form that the child's birthdate was date, making the child 12 years old.  The immunization records show the child's birthdate is date, making the child 11 years old and not meeting the age limit per the FDA.
Headache and Fever (Friday) On Saturday, vaginal pain worsening into multiple vaginal ulcers, very painful and some itching Given antiviral and lidocaine for pain Improved in around three days
transient ischemic attack episode; A spontaneous report was received from a Physician concerning a 71 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transient ischemic attack episode.  The patient's medical history and products known to have been used by the patient were not reported.  The patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) on 25 Jan 2021, approximately four days prior to the onset of the symptoms intramuscularly  for prophylaxis of COVID-19 infection.  On 28 Jan 2021 the patient experienced transient ischemic attack episode and was hospitalized for 24 hours and then was discharged.  No treatment information was provided.  No relevant laboratory details were included.  Action taken with the drug in response to the events were not reported.  The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Per mother pt c/o "I am not able to see and pressure on nose." Pt pale, without SOB, calm. Pt denied any other discomfort. No rash on body or extremities.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's medical history, drug reactions or allergies and concomitant medications was not reported. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K008409, with expiration date 04-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced different temperature excursions of 88, 64, 184, 152, 264 and 328 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree), 33 F (0.555555556 Celsius degree), 29 F (-1.666666667 Celsius degree), 30 F (-1.111111111 Celsius degree), 32 F (0 Celsius degrees), 31 F (-0.555555556 Celsius degree) respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Got vaccine then got Shingles. Had Shingles for a year  /Suspected vaccination failure; now I have throbbing pain; now I have inching; Got vaccine then got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got vaccine then got Shingles. Had Shingles for a year  /Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got vaccine then got Shingles), throbbing pain (Verbatim: now I have throbbing pain) and pruritus (Verbatim: now I have inching). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 1 year) and the outcome of the throbbing pain and pruritus were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, throbbing pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, throbbing pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-Jun-2023 This case was reported the patient via interactive digital media. That happened to the patient. The patient got vaccine then got shingles. The patient had shingles for a year and now (at the time of reporting) the patient had throbbing pain and itching. The patient was really tired of this. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  Follow-up not possible as no contact details provided.
I95.9 HYPOTENSION 6/17/2021 ADJUSTMENT DISORDER W MIXED ANXIETY AND DEPRESSED MOOD I95.9 HYPOTENSION 6/17/2021 COLITIS
This spontaneous report was received from a male patient of unknown age, who was a physician and was reporting on himself. The patient's concurrent conditions included asthma and an allergy to animal dander. His concomitant medications included QVAR. On 12-SEP-2017, around 10:30 AM, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) for pneumonia prophylaxis. On 12-SEP-2017, around 03:00 PM, the patient experienced shortness of breath. The symptoms resolved after use of a levalbuterol inhaler. On 13-SEP-2017, the patient experienced another bout of shortness of breath after a light workout. This time the event was not resolved by the use of the levalbuterol inhaler and the outcome was reported as not recovered/not resolved. The patient sought medical attention by calling his asthma specialist. No laboratory diagnostics were performed. The patient reported that he would use an albuterol nebulizer, which he expected would resolve his symptoms. The patient's asthma symptoms were well controlled prior to the PNEUMOVAX 23 vaccination. The relatedness between the events and the PNEUMOVAX 23 was not assessed by the reporter.
doses were given after expiration date; Vaccine stored in refrigerator on 18-Oct-2021, expired product on 13-Oct-2021 and administered on 21-Oct-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product on 13-Oct-2021 and administered on 21-Oct-2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product on 13-Oct-2021 and administered on 21-Oct-2021). On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product on 13-Oct-2021 and administered on 21-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Date the vial placed in refrigerator was on 18-Oct-2021. There was no temperature excursion. The patient had no adverse event.   This case was linked to MOD-2022-491837 (Patient Link).
Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA576A, expiry date July 2022) for prophylaxis.   In January 2022, the patient received Menveo. In January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The case was reported by the Medical assistant. The age at vaccination was not reported. The reporter stated that, last month the patient was administered Menveo which was reconstituted with sterile water instead of the liquid component provided with the vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter didn't have the demographics from patient since the vaccination was long ago. The reporter consented to follow up.
Lips burning, lips swollen 45 mins post flu shot. Sent to ER and started on Prednisone.
PT REPORTS REDNESS AND SWELLING ON UPPER RIGHT ARM AROUND SITE OF INJECTION. PT REPORTS "ACHY AND STIFF' FEELING IN ARM. PT ALSO REPORTS HEADACHE FROM PRIOR NIGHT. PT TOOK UNKNOWN DOSE OF IBUPROFEN WHICH CLEARED HEADACHE BUT DID NOT REDUCE REDNESS OR SWELLIN AT INJECTION SITE. PT WAS GIVEN VACCINE INFORMATION SHEET AND REASSURED THAT THE REACTION IS WITHING NORMAL REALMS OF FLU SHOT REACTION AND THAT SYMPTOMS USUALLY RESOLVE IN 1 TO 2 DYAS.. PT INSTRUCTED TO USE IBUPROFEN EVERY 6 HOURS FOR PAIN AND STIFFNESS AND TO USE ICE PACKS ON SITE FOR COMFORT.
Patient presented with headache rated at 8/10 on pain scale. Pain improved with acetaminophen. Labs, CT unremarkable (chronic changes noted on CT. Patient discharged with instructions to notify his PMD of  the reaction, but to plan to continue to receive the second dose of the vaccine as scheduled.
Mild to moderate body aches begin approximately 6 hours after injection. At around 12 hours chills, headache, and body aches severe in nature with fever of 100.8. Bed ridden from the 12 hour mark until 27 hour mark. Symptoms gradually subside until gone the morning of 03/07/21.
Increase heart palpitations that forced me to the ER on two occasions.  Dizziness, short of breath, lack of movement in left arm.