chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/PQC was reported; improperly stored VARlVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 24-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T006347, expiration date 20-FEB-2022) for prophylaxis (product storage error).Temperature excursion was 18.1 Fahrenheit degree for 408 hours 0 minutes and 0 seconds. Previous temperature excursions were - 7.0 Fahrenheit degree for 0 hours 20 minutes and 0 seconds; 7.7 Fahrenheit degree for 0 hours 15 minutes and 0 seconds; 5.4 Fahrenheit degree for 0 hours 5 minutes and 0 seconds. No additional AE/PQC was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003761: US-009507513-2109USA003760: US-009507513-2109USA003762:
Information has been received from a physician via a field representative referring to two or three patients of unknown ages and gender. On unknown dates the patients were vaccinated with GARDASIL (strength, lot#, dose in the series and dosage unspecified). On an unknown dates after receiving the vaccines, all the patients experienced dizziness. The patient sought medical attention via office visit, but no treatment was given for the event. The outcome of dizziness was unknown. Causality was not provided. Additional information is not expected because the reporting physician did not want to be contacted.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 19-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Rash and redness on the arm and it's tender to the touch; Rash and redness on the arm and it's tender to the touch; Rash and redness on the arm and it's tender to the touch; Golf ball size swelling at the injection site; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04047) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2020, reported as within the last week from initial reporting, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for prevention of seasonal influenza. The batch number reported was 283852 and expiration date 30-Jun-2021.  On an unspecified date in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient developed a golf ball size swelling at the injection site on arm. The patient also developed a rash and redness on the arm, and it was tender to the touch. The reporter stated it was not life threatening.  The outcome of the events was unknown.  The reporter assessed the events to be related to Flucelvax QIV. Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.  This case is linked with cases 202005387, 202005388 and 202005390 (due to same reporter).  Additional information received on 05-Nov-2020 from pharmacist via Med Communications (SEQW20-04786): Reported provided causality. Causality changed from not reported to related. New reference number added. New reporter added. Narrative amended.  Company comment:The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.; Sender's Comments: The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Red, induration; 5cm X 5cm skin irritation, itch at site of VARIVAX inj. (R) triceps area Symptoms started 3/8/17.
hospitalized 9/8/21 with Salmonella enteritis- SARS-CoV-2 positive. Patient denies shortness of breath, cough; oxygen saturation documented 95-97% on room air
SWOLLEN LIPS; ROSACEA; RASH COVERING ENTIRE BODY INCLUDING PALMS OF HANDS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer survivor, and other pre-existing medical conditions included on 19-APR-2021, patient received steroid injection. The patient experienced drug allergy when treated with vancomycin. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced swollen lips, rosacea, and rash covering entire body including palms of hands. The action taken with covid-19 vaccine was not applicable. The patient was recovering from rosacea, had not recovered from swollen lips, and the outcome of rash covering entire body including palms of hands was not reported. This report was non-serious.
Severe itching, redness, swelling covering portions if body at various times, head to feet. Treatments: Benadryl allergy, Methylprednisolone
patient came in on 06/12/2021 and got a moderna covid vaccine. This pharmacy system does not allow us to add moderna to our vaccine schedule so patient was added as a pfizer in the system. patient came in 07/06/2021 for a second and forgot his covid 19 vaccination record and our vaccine schedule showed he was a pfizer patient so we gave him pfizer as a second dose. when patient came back and brought his card we noticed he had moderna and should have gotten moderna second dose on 07/10/2021 instead of the pfizer he got today.
Patient about 3 minutes after receiving vaccine felt light headed, vision blurred, and felt like he was going to black out. Pharmacist had patient get down on floor to bend knees and get them above heart level and he started feeling relief. Patient quickly recovered.
Pt received vaccine on 10-30-08 @ 830 am called on 10/31/08 9 am states had lower abdominal pain with lower back pain with chest tightness with 99.2 fever @ 230 pm the same day. Feels better today. Does not need to go to ER or do not feel need to follow up. Stated will call if any problems.
PATIENT REPORTS HEAD -TO -TOE RASH AND THAT TONGUE "ROLLED UP" AFTER FIRST MODERNA COVID-19 VACCINE. HAD MD VISIT 03/05/2021 WITH DR AND THAT HE GAVE HER DECADRON. CALLED MD OFFICE AND THEY CONFIRMED THAT DECADRON AND DEPOMEDROL 1CC EACH WERE GIVEN BUT VAERS REPORT WAS NOT COMPLETED. PATIENT CAME IN FOR SECOND DOSE OF MODERNA COVID-19 MRNA VACCINE BUT SAID SHE DIDN'T WANT VACCINE BUT JUST WANTED TO SHOW US THE RASH. VACCINE NOT GIVEN. CONTINUES TO SHOW RASH ON ARMS AND LEGS.
Beginning 16 hours after injection, fever/chills followed by headache and flu-like symptoms for approximately 18 hours   Today, 6 days after injection, itchy rash on both thighs, upper arms and torso front/back
Experienced a high fever, muscular pain throughout the body, headache, and was sweating profusely. Went to bed due to the fatigue and woke up with sheets soaked in sweat. Severe symptoms continued for approximately 18 hours with the headache continuing after 18 hours.
The symptoms are reported as being mild. The symptoms occur daily. The location is right arm. He states the symptoms are acute and have worsened. Patient is in today due to an allergic reaction after receiving a shot here at the clinic on right arm. He endorses pruritis around the shot area.
Information has been received from a nurse practitioner concerning a female patient "in her thirties" with a known allergy to ibuprofen, who in an unspecified year as a child was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On an unspecified date, the patient underwent a mumps titer test that was resulted as negative. It was indicated that no adverse events were related to this event. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant regarding a 3 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 14-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
My daughter was extremely tired, and fussy.  She is not a fussy baby and screamed inconsolably for 2 and half hours straight that night.  She also was constipated for almost 24 hours.  She went from having at least 6 poops a day to nothing for almost 24 hours and when she did start pooping again it was very runny and green.  She had a fever and was not wanting to eat.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were administered improperly stored VAQTA (dose and route unknown, lot # M018644, expiration date: 20-SEP-2017). The vaccines were exposed to temperature excursions in 3 different refrigerators, but not exposed to multiple excursions. The three refrigerators are described as "A: temperature: max 48 Fahrenheit degree for 15 hours, B: temperature: max 49.3 Fahrenheit degree for 15 hours, a C: temperature max 51.4 Fahrenheit degree for 15 hours". There were no previous excursions. There was no data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced swelling of the whole arm after administration of PNEUMOVAX 23. The patient sought unspecified medical attention. At the time of this report, the outcome of the patient was unknown. The physician also reported that on an unknown date the patient developed a local reaction after administration of a flu vaccine (manufacturer unknown). Additional information has been requested.
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (received 1st dose on 27th June 2022, refer link case US2022AMR171047) and Hiberix with an associated reaction of skin discolouration (received 1st dose on 27th June 2022, refer link case US2022AMR171047).   On 29th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. Rechallenge with Hiberix was positive. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171047   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (right thigh) after receiving 2nd dose of Pediarix, 2nd dose of Hiberix. The reporter was consented to follow up. Additional supportive information: This case linked with US2022AMR171047 as same patient. This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR149561: US-GSK-US2022AMR148961: US-GSK-US2022AMR149560:
After both shots, had reaction with bumps and hives. Took benadryl. Started having pain in area of arm where shots were given. Still today pain is consistent and when patient feels the area where shot was given, it has a  spongy feeling, per patient
Pt vaccinated with MERUVAX II developed a rash, headache & general malaise. Two days later developed stiffness of the rt & lt knees. Moderately large effusions were noted on both knees.
Bad headache, fever (100.1F), body aches, weakness Rested and took Ibuprofen/Tylenol for symptoms
Patient began having brief spells of eyes rolling up and loss of tone in April, or possibly March. They happened every few days and perhaps 5-6 times a day. DTaP and IPV were given 5/5/04. Episodes increased so that family returned to office on 5/12/04. EEG showed hypsarrythmia. Baby has infantile spasms.  Nurse follow up on 05/27/04 states: completed.
Near-constant tinnitus.  Ringing in both ears.  Told my PCP during my last checkup.
12/21: woke up with full body aches, pressure in ears bilaterally. Took 200mg motrin, body aches resolved by early evening.  12/22: Right tonsil inflamed/irritated, painful to swallow. Ear pain bilaterally. Went to clinic, temp 99.1, some fluid in ears; strep and influenza tests came back negative. Given zyrtec, flonase, and tylenol for symptom management and advised to get a covid test when possible.
SORE ARM; 104 FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and 104 fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 104. The action taken with covid-19 vaccine was not applicable. The patient was recovering from 104 fever, and the outcome of sore arm was not reported. This report was non-serious.
Dry cough; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6208), via an unspecified route of administration in left arm on 17Mar2021 at 15:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation at Health Department. The patient had no medical history and no known allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ALLERTEC) (received within 2 weeks of vaccination). The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration on 24Feb2021 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021, the patient experienced dry cough. Patient did not receive any treatment for the event. The patient underwent Covid-19 test (nasal swab test) on an unknown date in 2021 and the test result was negative. The outcome of dry cough was recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Added reporter details, historical vaccine age and clinical course. Medical history, patient initials, concomitant medication, lab test date, second dose details and event treatment details were updated.
No fever patient complained of swelling, redness and pain. Vacc. adm. 12/27/11 around 4:30. No sign of adv. symptoms then. Patient called 12/28/11 about 11:30 AM. I advised her to apply cold compresses and take ADVIL. Ask her to wait 24 hours if sympt. continue go to her DRs office. 12-29-11 I called patient to see how was she doing, she told us her arm was getting better, but still swollen. I advised her to go to see her DR., she responded by telling us that she wanted to wait another day. Then I offer to call her DR. but she absolutely did not want for me to call. I insisted if her arm turned for the worst she had to go see a DR. With that she thank us for my concern and use said good bye.
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: She received the pfizer vaccine on the left arm. Patient complained of itchy throat and swelling so nurse who gave shot provided water. Started sweating and called 911. Patient was alert and responsive and was monitored until the paramedics arrived. She was visibly sweating and shaking but otherwise responsive. Did not mention throat closing worsening. Was monitored by the nurse who gave and pharmacist.
5/21 - began with diarrhea, mucousy, watery stools. Multiple episodes q day. 6/4 seen in office for continued green/mucousy stools. Hemoccult positive stools. Diagnosed with milk protein allergy/sensitivity.
rash on both insides of arms/ rash on top of legs/ rash on belly/rash on back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both insides of arms/ rash on top of legs/ rash on belly/rash on back) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 010A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included EMPAGLIFLOZIN (JARDIANCE), ROSUVASTATIN, METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), TOCOPHERYL ACETATE (LANTUROL), ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D 3) and RAMIPRIL for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on both insides of arms/ rash on top of legs/ rash on belly/rash on back). At the time of the report, RASH (rash on both insides of arms/ rash on top of legs/ rash on belly/rash on back) outcome was unknown.            Treatment included benadryl cream  Approximately 27-Feb-2021, patient developed a rash on both insides of arms, top of legs, belly and back 2 weeks.The rash comes and goes getting lighter and then darker and is sometimes scaly.
Patient started feeling dizziness, later had weakness in lower extremities that progressed to upper ext.