chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 61 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Drug name not reported), and other pre-existing medical conditions included: The patient stated he was not taking any other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 1808980, expiry: unknown) dose was not reported, 1 in total was administered on 30-MAR-2021 13:00 to left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 total administered on 26-NOV-2021 10:00 to left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 61 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 3) (form of administration, route of administration not reported, batch number: FK9893 expiry: UNKNOWN), dose was not reported, administered on 18-APR-2022 13:00 to left arm for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 3). On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 3). For which the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported administered on 19-AUG-2022 to 23-AUG-2022. On 25-AUG-2022 20:00, the patient experienced rebounded with flu like symptoms, congestion and sniffles, low grade fever and chills (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and with Paxlovid was drug discontinued.  The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Did hurt 1 day; This is a spontaneous report from a contactable consumer (patient relative). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that my niece (withheld) took shot of Pfizer and did hurt one day and that was it. The outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested
Information has been received from a nurse practitioner concerning a 24 year old white female who on 26-JAN-2007 at 1:45 PM was vaccinated IM in the deltoid with the first dose of Gardasil (lot # 653736/0014U).  On 26-JAN-2007, at 1:45 PM, during the first injection, the patient complained of tingling and dead arm.  It lasted only a short time and was better the same day.  On 04-APR-2007 at 10:00 AM, the patient was vaccinated IM in the deltoid with the second dose of Gardasil (lot # 657617/0384U).  On 04-APR-2007, at approximately 10:00 AM, with the second injection, the patient experienced the same exact complaints.  The patient recovered on the same day.  No further information is available. The patient recovered on the same day. It was reported that the "patent was fine when she got home". This is a consolidation of two reports concerning the same patient. No further information is available. Follow-up information indicated that WAES#0705USA00161 is a duplicate of WAES # 0705USA01053. Therefore, WAES # 0705USA0016 is being deleted from our files and the reports consolidated into WAES 0705uSA01053.
Severe flu like symptoms. Nausea, diarrhea, fever, chills, body aches and extremely enlarged lymph nodes under left arm (injection arm).
Patient had a positive COVID test on 1/18/22 at local Health Care and spent a week in the hospital; patient brought to ED at alternate Medical Center and was in respiratory distress; intubated; suffered cardiac arrest after intubation; CPR performed x 12 mins with success; 1/31/22 transferred patient to County General Hospital; no muscle or motor activity; pupils nonreactive; had a positive COVID test; pneumonia; DNR with limited therapy; found to have non-Hodgkin's lymphoma and heavy cell leukemia; suffered a prolonged hospital course; ventilator dependent; 2/18/22 tracheostomy; 2/24/22 PEG placement; developed AKI; staph bacteremia; Klebsiella pneumonia; NSTEMI; 3/6/22 seizures; 3/12/22 palliatively extubated and made comfort measures only; patient died in the hospital.
Patient received her 15 month shots and seemed fine. When her mother strapped her in car seat she vomited, seemed unresponsive. She rushed her back into the clinic. She was 88% hypoxic -> responded to O2 and minimally responsive. She didn't improve over a period of about 10 minutes; we transported via EMS en route she returned to baseline, about 30 min after the start of the episode.
36 hours after injection, experienced severe swelling at injection site, fever of 101 which lasted from 9pm 4/24 to 7am 4/25 and pain
Immediate numbness in my left pinky and then my arm; Racing heart; Weakness; Throat constriction; Difficulty taking a deep breath; Feeling faint; Allergic reaction; This spontaneous case was received on 28-Oct-2020 from other non-health professional via Agency (reference number: SEQW20-04424) and concerned a 40-year-old, female patient.  The patient was healthy and had no medical history. The patient was not taking any concomitant medications. The patient had Flu shots for decades and never had any allergic reaction.   On 09-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prophylaxis. The batch number reported was 276578.  On the same day, immediately after receiving Flucelvax QIV, the patient had an allergic reaction which included immediate numbness in his left pinky and then in arm, heart racing, weakness, throat constriction, difficulty taking a deep breath, and the patient felt faint. The patient was treated in the emergency room (ER), and he received prednisone and Benadryl (diphenhydramine hydrochloride).  On an unspecified date in Oct-2020, the patient recovered from the events. It was reported that his symptoms lasted for about nine days.  The reporter considered the events as related to Flucelvax QIV. Reporter stated that after receiving flu shot he had an allergic reaction immediately, and that he get the flu shot every season, for over a decade, and never had any allergic reactions.   The reporter assessed the events as serious due to the criterion of medically significance.  Company comment: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The patient was healthy and had no medical history. The patient was not taking any concomitant medications. 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: I received a flu shot manufactured by your company at my local pharmacy on 10/9/2020 and had an allergic reaction immediately. I'm writing because I am a dental hygienist and got the flu shot every season, for over a decade, and never had any allergic reactions.; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. The patient was healthy and had no medical history. The patient was not taking any concomitant medications. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Swelling, redness to (L) arm, itching all over, rash on back, dizziness/lightheaded, difficulty concentrating, chills, shortness of breath. Treatment: MEDROL dose pack, Triamcinolone cream.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Additional Details: patient had a seizure when she was 12 after taking hep b vaccine (22 years ago).  Patient had no reaction from COVAX dose 1.
Severe muscle aches and Pains from neck to hips to point in tears; Severe muscle aches and Pains from neck to hips to point in tears; Severe muscle aches and Pains from neck to hips to point in tears; Second shot-first afternoon fatigue; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Apr2021 09:30 as DOSE 2, SINGLE (at the age of 58-year-old) for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Prior and post vaccination, the patient was not tested for covid. The patient had no other vaccine in four weeks.The patient had no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN), dexlansoprazole (DEXILANT) all taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced only pain in arm where injection given. On 07Apr2021 15:00, the patient experienced second shot-first afternoon fatigue. On 08Apr2021, the patient experienced severe muscle aches and pains from neck to hips to point in tears (myalgia, neck pain, arthralgia). The patient had not received treatment.On an unspecified date in 2021, outcome of the events was recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
TOOK VIVOTIF THAT WAS NOT REFRIGERATED; This spontaneous case report (PVX2019-2667) was received from a pharmacist on 25-Oct-2019. It described an adult female consumer who "took Vivotif that was not refrigerated" (PT: Product storage error), while being on Vivotif for an unknown indication.  Case report: The consumer did not refrigerate the Vivotif doses and completed full course from 18-Oct-2019 to 24-Oct-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif that was not refrigerated" was considered as not applicable. .; Sender's Comments: Company's Comment: The causality of the event "took Vivotif that was not refrigerated" was considered as not applicable.
This case was reported by a nurse via out of hour services and described the occurrence of fatigue in a 53-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, fever, injection site pain, myalgia and neck pain. On an unknown date, the outcome of the fatigue, fever and myalgia were recovered/resolved and the outcome of the injection site pain and neck pain were not recovered/not resolved. It was unknown if the reporter considered the fatigue, fever, injection site pain, myalgia and neck pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the manufacturer. The patient received a dose of SHINGRIX in left deltoid. Caller is a nurse practitioner. The patient stated that after receiving a dose of SHINGRIX, she experienced fatigue, myalgia, low grade fever and soreness at the injection site. The patient stated that the symptoms lasted approximately a couple of days. However, the soreness at the injection site lasted approximately 1 week and turned into neck pain. This case was link to case US2018146850, reported by the same reporter for the same patient.
headache; muscle pain; chills; Joint pain; injection site redness swelling & pain; injection site redness swelling & pain; injection site redness swelling & pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient). This 82-yerar-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6198; expiration date: unknown), via an unspecified route of administration in right arm on 24Feb2021 09:00am, as a unknown single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included hypertension, arthritis and patient had known allergy's adverse reaction to compazine. The patient's concomitant medications were metoprolol, spironolactone, HCTZ, Azelastine nasal. On 24Feb2021, the patient experienced headache, muscle pain, chills, joint pain, injection site redness, swelling & Pain. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of events was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax; urticarial type rash,started p/ 12 hrs;
Beginning two days after getting the vaccine, I completely lost my appetite and developed severe abdominal pain, my blood pressure and heart rate were elevated and my stomach continued to hurt.  I also had chest and back pain, muscle aches, insomnia and cramping. Finally went to the Emergency Room on the third night.
This case was reported by a pharmacist via sales rep and described the occurrence of needle stick/puncture in a adult patient who intended to administer SHINGRIX to the patient for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced needle stick/puncture. On an unknown date, the outcome of the needle stick/puncture was unknown. It was unknown if the reporter considered the needle stick/puncture to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. One of the pharmacists suffered a needle stick while preparing or administering a dose of SHINGRIX.
1 hour after injection: metallic taste in mouth for 30 minutes 4 hours after injection: soreness at injection site 8 hours after injection: myalgia 24 hours after injection: fever all day, headache all day, myalgia all day 48 hours after injection: 2 inch by 3 inch rash on same arm as injection
Upper left thigh bruised and swollen (April 20) Ultrasound (4/21) results showed DVT.  Prescribed treatment Xarelto starter pack 15/20 mg.  Maintenance dose 20 mg once per day
before was a regular layer of Tinnitus,  it got acute ; the acute stage is more worse; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration, administered on 16Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history included ongoing tinnitus and reported that patient already had a mild case of Tinnitus. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration, administered on unspecified date as a single dose for covid-19 immunisation. It was reported that patient had second shot on 16Mar2021 of this year and patient previously had a mild case of Tinnitus. After getting the second shot, patient would say within 2-3 days something or maybe its 3-4 days, patient noticed a profound increase in the Tinnitus and patient waited for a long. patient had before was a regular layer of Tinnitus, but this time it got acute now the regular. The patient further reported that if normal layer of Tinnitus, the acute stage it was more worse. Patient went to see an ENT and he doesn't see anything that would had been causing it structurally and now also went see an Audiologist it was nothing that they could do about it. Anyhow patient had been reading that there are people reporting this not in huge amount, what the experiences they occur, or any information can give to patient about expecting it to decrease or patient was concerned about getting a booster shot if that were to be necessary. The patient was not recovered from the event. Outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Mild to moderate pain in upper left abdomen.  Pain more generalized through abdomen by evening.  Generalized abdominal pain the next day (10/23), plus fatigue and mild headache.
Started getting chills about 8 hours later.  3/17/2021 10pm Fever reached 103 3/18/2021 12:00 am Excessive sweating with high fever 12:30 am Fever dropped to 97.6 3/18/2021 8am Fever increased to 101 3/18/2021 1pm Fever broke 3/18/2021 9 pm Fever came back 101  3/19/2021 6 am, excessive sweating Fever dropped to 99 3/19/2021 Fever came back averaging 99-101 3/20/2021 Fever broke evening of 3/2021 Temperature in normal range 3/21/2021,  Very tired seem to be improving.
Swelling, redness, hot feeling to arm that was injected - elbow to shoulder. Resolved after 7 days. No medical treatment or advice sought. Event reported to pharmacy on 10-21-15.
report vague symptoms of feeling unwell- little "dizzy, slight nausea" - "probably just anxiety" - onset at vaccination.  Reports c/o anxiety - takes anxiolytics PRn.  TX - mask removal - fresh air; emotional support symptoms abated with time.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administered unspecified number of improperly stored doses of M-M-R II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, rout and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 06-MAR-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot# reported as J006137, expiration date: 24-MAY-2015, strength, rout and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information products and narrative were updated.
PT PARENTS CAME TO CLINIC 8/19/23 AND INFORMED CLINIC STAFF THAT PT HAD SMALL, RAISED BUMPS (RASH) ON ARM, HANDS, AND ABDOMINAL AREA. PT PARENT SAID RASH IS NOW SPREADING TO LEGS. PT PARENT BROUGHT PT TO ER DAY AFTER VACCINATIONS 8/13/2023 AND ER ASSESSED AND ADVISED PT PARENT TO BRING TO DOCTORS. I ADVISED THE SAME. PT PARENT CLAIMS NO FEVER AND MINIMAL ITCHINESS.
VIGOROUSLY SHOOK THE VACCINE VIAL BEFORE ADMINISTERING; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 132 pounds, and height was 68 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A expiry: 11-DEC-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced vigorously shook the vaccine vial before administering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vigorously shook the vaccine vial before administering was not reported. This report was associated with product quality complaint 90000195049 This report was non-serious.
Muscle pain and headache a day after the vaccination Swollen collarbone lymph the day after
Pt state left arm was redness and swelling and some itching after receiving the pneumovax and flu shot. Pt had flu shots before without reaction. Could be pneumovax.
Red and swollen around injection site. Nurse gave 10ml (25mg total) of diphenhist 12.5/5.
Swelling of entire thigh at injection site of DTaP.  Hot, firm, red, swelling distorted normal shape of leg. Site still evident 11/19/2013, but improving.
Local reaction - redness, swelling and soreness at injection site in right deltoid.  Seen in Emergency Center and sent home on OTC Benadryl and Motrin.
Information has been received from a physician concerning an unspecified amount of female patients who on unspecified dates were vaccinated IM with three doses of GARDASIL. Subsequently the patients had PAP smears which were positive for Human papillomavirus (HPV). No lot number, expiration date, patient demographics, or number of patients provided. At the time of reporting, the patient's outcome were unknown. It was unspecified if the patients sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the physician. The approximately  21 year old patient informed the physician that she received the full series of vaccines from her pediatrician and had Pap smear by HPV positive with Atypical Squamous Cells of Undetermined Significance (ASCUS). This is one of several reports received from the same source. Additional information has been requested.
Patient became dizzy, nauseous, and had difficulty seeing approximately 15 minutes after his vaccine. Checked patients blood pressure which was low 70s/50s mmhg initially, patient remained conscious  the entire time. He had no trouble breathing or swallowing. Patient was given a cold water and stated this helped. after initial BP reading EMS was called. Patients BP gradually rose and was 110/74 mmhg when EMS arrived. Glucose was also tested and was 101. Patient was feeling much better and declined transport to the hospital.