chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 01-MAR-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route in 2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. During 2015, the patient was treated at a medical center for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Presented to ED w/SOB & cough; COVD+ w/PNA; admitted for acute hypoxic resp failure d/t COVID-19 PNA; 10/27 - tx w/ Cefipime, remdesivir, zinc, azithromycin & ceftriaxone; pt developed Afib w/ RVR during stay; prolonged hospital stay d/t SOB & O2 requirements; pt discharged on 4L NC.
Patient experienced severe pain and decreased range of motion starting the morning after administration. Patient has tried rest and NSAIDs with minimal relief now almost 4 weeks after administration. Patient with likely incorrect administration-into joint space-and with resultant bursitis and supraspinatus tendonitis.
Swelling and soreness in armpit of right arm . First observed last evening and still evident this A.M.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 26-MAR-2015 the patient was vaccinated with a dose of improperly stored GARDASIL lot # K006191, exp. Date: 02-FEB-2017, dose/frequency: 0.5 ml/1 dose, intramuscularly. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Broke out in a rash on left arm, then also on right arm and on both thighs
indigestion; coughing; sneezing; body aches; congestion; insomnia; Fever; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and anxiety. The patient received unspecified concomitant medications. The patient previously received lamotrigine (LAMICTAL) and oxcarbazepine (TRILEPTAL) and experienced drug allergy. Prior to 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 four weeks prior to the COVID vaccine. On 27Mar2021, the patient experienced fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia. The clinical outcomes of the events fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Vertigo, tinnitus, pressure headaches, chills, fever, weakness, fatigue
SORENESS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced fever, nausea, and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of nausea and soreness was not reported. This report was non-serious.
After the second vaccine, I started to have allergies that I've never had before. I became severely allergic to my dog and airborne allergies. I ended up with multiple bronchitis diagnoses and given antibiotics as a precaution since they had no idea what was going on. Additionally I had severe ringing in the ears--so much so that I went to the ER --while visiting my son. Doc diagnosed me with tinnitus. I suffer every day from tinnitus--although it is a bit milder. I've NEVER had hearing issues before. I also had to re-home my puppy because of the severe coughing and allergic reaction to the dander/fur. I've had 3 other dogs over the past 12 years and have NEVER had a problem.
pt recv vax & devel a red,itchy area on lip,which progressed to welts on arms that looked like a spider bite;sx had progressed to the entire body & were becoming larger;pt was treated w/antihistamine
Patient had difficulty going to sleep due to "jerking" movements that persisted for several hours, even during brief periods of sleep. Evaluated in two separate ERs - first on night of symptom onset, then on second night - diagnosed with myoclonic jerks. Symptoms continue to occur nightly and during naps. Evaluated by pediatrician 14 Nov and diagnosed with sleep myoclonus.
See attached progress note. Client has discussed at length that she is "very sensitive to many foods and many medicines. Did not received vaccines as a child". Had Td injection approximately equal to 2001 for severe cut to hand. "I was advised by "Quakers" and they don't believe in vaccine."
To ER same day of flu vaccine with weakness, SOB, no pain, weak, falling - Dx. with Pneumonia.
We received a call from pharmacy at 3:03pm alerting us that patient fainted at their store and required transportation to the hospital.
Generalized papular rash, intermittent fever, sore neck and headache.  Seen at ED on 9-28-2015, diagnosed with headache and sore neck of unknown origin.
pt has dropfoot in right foot, cannot move big toe in right foot, pt has no sense of balance
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 26-SEP-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Mother here with child wishing the nurse to view the left leg where the child received DTAP 08/14/01. The left leg noticeably swollen compared to the right leg. The mother states the child is complaining of knee pain. The child has red raised irregular area on the left leg. Has history of staph infection involving surgery to the right thigh. The child very active and activity level uncompromised during the visit. The nurse referred the patient to the doctor ASAP.
Patient reported with complaint of body swelling and rash all over the body. Per patient, experienced a slight shortness of breath as well. Still swollen for 4 days from injection with trembling and body chills.
Red bump at site of injection, onset 3-4 hours after shot. Local swelling and redness and itchiness for last 48 hours
Blood pressure spike (220/105) after vaccination #1. Lots of stated side effects for 1 week after each shot. I have had continuing blood pressure problems after vaccination #2. In addition, I now have a Fib and my mitral valve progressed too quickly to severe. I am facing surgery in the near future.
Received Vac 1/28/21 @10:40 am.  No adverse reaction first day.  Only slight swelling and slight pain x24 hrs.  on 1/29/21 started itching over abdomen area, gradually proceeded to cover entire trunk.  If scratched skin turned into welts of various sizes.  On 1/30/21 around 4:00 pm felt tingling around lips; by 7:00 pm lips were abnormally swollen to the point of interfering with my word pronunciation.  Took Benadryl 25 mg around 7:30 pm and swelling of upper lip began to decrease.  Night itching quite aggressive; rash progressed to scalp.  On 1/31/21 rash progressed to arms,  legs and feet.  On 2/1/21 rash progressed to forehead  and perimeter of face.
Low grade fever of 99 degrees; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever of 99 degrees) and HEADACHE (Headache) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Low grade fever of 99 degrees) and HEADACHE (Headache). At the time of the report, PYREXIA (Low grade fever of 99 degrees) and HEADACHE (Headache) 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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
pt recv vax 10OCT95 & the following day pt devel a rash on the thigh of the injected leg 1mm from the puncture site & on the rt side of the abd;pt also had a vesicle on the thigh;DPH was resolving the rxn as of the date of this report
Horrible headache, body ache, very tired, low grade fever, chills, Nauseated.  Could not get out of bed.  Lasted 24 hrs.   I took Tylenol and went to bed
Arm ached, back rash that itched, hip joints in pain, thigh muscle ache. Today's date is 07/13/2015 and hip joints, thigh muscle pain has not diminished. Joint pain is worse, so took an Advil.
Redness, swelling, warmth below the injection site, started 2 days after administration of the vaccine at the pharmacy.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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 ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Pain and soreness in left hand and fingers; Stiffness developed in my left hand and fingers; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Jul2021 at 17:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to red dye. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jul2021 at 00:30 the patient experienced pain, soreness and stiffness in her left hand and fingers approximately six to eight hours after injection. The pain was still present and however comes and goes. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain, soreness and stiffness in her left hand and fingers approximately six to eight hours after injection was recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Injected 5 cm below the axilla,  anterior approach.  Next day patient had erythema of a 6x8cm area, edema, and local pain at injection site. Erythema persists  and has grown to a 10x10cm area to 4/11/2022, 5 days after onset despite intervention with Tylenol and cold packs.
1-2 days, post vax, pt had redness and rash over and around the injection site which progressed to rash all over body. Pt was on Amoxicillin concurrently from 1/8/01 thru 1/18/01 and rash persisted even after antibiotic was completed. Dx'd with allergic rash. Benadryl for treatment started on 1/23/01.
Arm is red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm is red). At the time of the report, ERYTHEMA (Arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Fup-Report not scheduled for Follow up as initial report is pending for submission
Syncope and collapse. I was cutting my sons hair while he was standing up (as I always do) and halfway through he passed out and fell backwards. He was out for a good 6-8 seconds, maybe longer before coming too. His skin was really tacky and sweating profusely. We called 911 right after he collapsed. By the time they arrived, he was alert and vitals were good. Blood sugar was good. Still tacky and sweaty. We took him into the ER to follow up and run additional tests.
soreness and pain in the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient partner). A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced soreness and pain in the arm. Patient put ice and took Advil and that helped, and her symptoms were more pronounced. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Chills, low fever for 8 hours after onset of symptoms. Nausea, lack of appetite, tiredness, muscle aches  for 48 hours after onset. Joint pain, especially in hips, lower back, knees, and feet for 36 hours after onset. Hot, painful, swollen arm at injection site  from  immediately after injection lasting for 72 hours
Got covid; This spontaneous case was reported by another health care professional and describes the occurrence of COVID-19 (Got covid) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid). In November 2021, COVID-19 (Got covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient got Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Company comment: This case concerns a 46-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine).  Onset latency was unknown as the specific dates of the vaccine and the event was not given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 46-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19 on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine).  Onset latency was unknown as the specific dates of the vaccine and the event was not given. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
She was not feeling well when she got up on Saturday morning. We went to the neighbors house and were outside for maybe 15 minutes (it was a warm day) when she passed out momentarily. We immediately got her some water and got her in the AC and she did fine since then. She did have mild finger swelling on the distal joint of both index fingers after the first injection on 5/14/2021(same lot #). We are not sure if the finger swelling was related to the vaccine. It started about 5 days after first vaccine.
The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022; Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) 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.  It was reported that the vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-500959 (Patient Link).
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756536A, A0756538A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
RASH ON INSIDE CORNER OF RIGHT EYE SPREADING OVER BRIDGE OF NOSE TO LEFT EYE. EMPLOYEE DENIES ITCHING, BURNING, OR PAIN.
death J12.82 - Pneumonia due to coronavirus disease 2019 U07.1 - COVID-19 N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified