chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 38 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included in 2 weeks: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Aug2022, stop date: 31Aug2022. The patient had no known allergies. The patient was not pregnant at time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2022, outcome "unknown", COVID-19 (medically significant) with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Rebound infection beginning on 26Aug. Therapeutic measures were taken as a result of covid-19. Clinical course: Therapeutic measures included, Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment started on 17Aug2022 and stopped on 22Aug2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 18-year-old male. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
3cm x 2cm erythematous tender site around injection site of right lateral thigh.
Patient is a 4 month old female that was supposed to get the IPV 2nd dose. I gave the patient the wrong vaccine. Instead of the IPV I gave the patient the HPV on the left thigh. I called mother and asked how the baby was doing she stated that she is good and sleeping. Mother stated that she is going to take her to get re-evaluated. I'm not sure if mother is taking her to the ER to be seen.
Took the shingles vaccine on 10-15-14 at drug store. That night I began to get a headache and the injection site was inflamed with bumps. The next day I felt weak, my eyes were sensitive to light, I had stomach upset. I have chills and sweats during the night. The varicose vein on my leg began to throb. I was barely able to get out of bed because of feeling so weak and ill. This is the third day of feeling ill.
Narrative:  HISTORY OF PRESENT ILLNESS:  63-year-old male with a past medical history of severe COPD and morbid obesity who presented to the hospital with a chief complaint of cough and shortness of breath. Patient states his symptoms started about a week ago and have gotten progressively worse since that time. Patient also endorses a mild fever and chills. Patient was tested for Covid yesterday and was positive. Patient was supposed to get monoclonal antibodies but was never called to get these. Patient states he has gotten worse and feels like he needs oxygen now. Patient states he has done some belly breathing at home. ER work-up which is included routine labs was fairly unremarkable. Chest x-ray shows bilateral infiltrates. Given the patient's severe COPD and the belly breathing, we were consulted for admission. HOSPITAL COURSE: 1. COVID PNA 2. Mild transaminitis 3. Hyponatremia 4. Morbid obesity with a BMI of 30 5. Severe COPD The patient stated he started feeling bad about a week ago and then was diagnosed with Covid on the day prior to admission. Patient was supposed to get the monoclonal antibodies on the day prior to admission but was never called to get these. The patient states at home he has gotten worse but his oxygen sat had never dropped below 92% but the patient stated he felt like he needed oxygen. The patient was really more anxious than anything. On the day of discharge the patient was noted to be satting 95% on room air and this was checked by myself at the bedside. Patient stated he took a shower that morning without oxygen and his oxygen saturation never dropped below 93%. Patient is stable for discharge and will continue steroids on the outpatient setting. The patient was having continued chills and is told to take Tylenol or ibuprofen as needed for this. Patient was also prescribed a PPI to take while on the steroid
Patient administered Janssen vaccine on 5/5/21 at 1011AM by pharmacist on duty. Patient did not admit any anxiety surrounding vaccine during counseling prior to receiving the vaccine. After administration patient mentioned she has can get anxious sometimes and has tendency to create symptoms in her head. She asked what to be on the look out for for signs of syncope and described starting to feel nauseous, clamy, and tunnel vision. Within seconds she briefly lost consciousness and started to slump in chair within immunization room. Pharmacist prevented her from falling out of chair while opening door to waiting room and asked for assistance from patients boyfriend. Together we held patient in place on chair and propped feet up on another chair. Immediately patient regained consciousness enough to explain what she was feeling but then quickly lost consciousness again and started snoring as if she immediately fell asleep. Boyfriend said no history of sleep issues/narcolepsy, together we laid patient on floor of immunization room with feet slightly elevated and boyfriend at her head and again she immediately regained consciousness. Patient explained that she was immediately starting to feel better and felt dizzy and described having very odd dream like scenarios. She laid on floor for 10 min, Alert and orientedx4, moved to seated position for another 10 min, accepted offer for apple juice, moved to waiting area to sit for another 10min before OK leaving. MOD/PDM aware....Called patient at 6pm that same evening and patient reported feeling great.
Was given the FLUARIX Quadrivalent single serving shot after my annual physical exam (nominal/no issues) and blood work (nominal/no issues). Within 2-3 hours began feeling chills and fatigued, after which I developed a strong headache. Body temperature alternated between hot and cold, skin was very sensitive. Had an extremely difficult time sleeping due to body temperature issues, and headache. Eventually took three tylenol to relieve pain and allow myself to sleep (around T+20hrs). Slowly improved over the course of the next few hours, but still having issues with body temperature, soreness, and headache at the time of this reporting (T+47hrs).   I am specifically reporting this because this flu shot reaction is by far the strongest I've ever had, and I religiously get my flu shot each year. Vaccinated against COVID-19 in April/May of 2021 with Moderna, had COVID in mid-December 2020.
PATIENTS ARM SWELLED,  INCLUDING ARM PIT, 102 DEGREE FEVER, SEVERE FLU-LIKE SYMPTOMS, DIAHRRHEA, HEADACHE, NAUSEA, SYMPTOMS LASTED 5 DAYS, PATIENT BED RIDDEN, LOSS OF APPETITE
pt recv vax 16SEP97 & w/in 30min pt exp a pruritic papular urticaria that started around the inj site followed by rapid spread to both arms, chest & neck;pt was tx w/pred;
Patient was to receive Booster dose 0.25ml, instead received 0.50ml dose. Denies any symptoms.
Patient reported immediate onset of pain in extremities, arm numbness. Resolved in about 2 days.
pooling in upper arm, swelling, bruising. 8/2/19 can still see signs of pooling and bruising .  patient states bleed really bad after vaccination.
swollen lymph node Narrative: He developed right axillary lymphadenopathy with 1x painful/palpable enlarged LN about 5x days after the initial vaccination (right deltoid)  This persisted for ~2x days prior to resolving. During that time, he was able to complete all ADLs/IADLs and regular exercise and took ibuprofen. No other common adverse effects other than mild fatigue reported.
An 11 year old female was given the  age 12+ formula of the Pfizer COVID-19 vaccine in error. No adverse reaction or side effects reported. Patient received a 12+ dose (30mg purple cap Comirnaty formulation) Mother, when notified by phone on discovery of  vaccine administration error and mother reported higher dose was well tolerated with no adverse effects observed.
Severe arthritic flare. Pain in entire body (all joints) for 2 weeks after each injection to the point of being unable to work.
12/28/05 C/O stiff neck, mid back pain, hip and ankle joint paint. C/O shortness of breath and disorientation. Took Ibuprofen. Returned to PMD.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 53-year-old female patient who received SHINGRIX 9batch number B327C, expiry date 4th July 2020 and (batch number X3M27, expiry date 29th August 2020). Concurrent medical conditions included latex allergy. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 31st March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site induration and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that her sister, who was nurse had received SHINGRIX vaccine. The vaccine was administered by the reporting pharmacist. The pharmacist noted that her sister was allergic to latex and made aware the product vial stoppers did not contain natural rubber latex. The pharmacist stated that she was also changed the needle to a new one before giving the injection after mixing it. The patient had quarter size area of hard, red and hot appears at the injection site the next day after her vaccination. She stated that it was the appearance of a normal reaction that was common with vaccinations. The pharmacist noted the injection site was given late in the day and the next morning the issues appeared. The events were resolved after a couple of days.
10 AM 6/27/2020 SHOT ADMINISTERED IM TO LEFT ARM.   PER PT ACCOUNT: 11PM 6/26/20 REPORT OF FEELING HOT/COLD/FEVERISH, SHAKING, TROUBLE BREATHING, HYPERVENTILATING, SORE MUSCLE (NO VISIBLE INFLAMMATION AT INJECTION SITE), TROUBLE ELEVATING ARM. PT SYMPTOMS DID NOT ABATE UNTIL 10AM 06/27/2020.
I21.4 ACUTE NON ST ELEVATION MI 3/15/2022 AIDS (ACQUIRED IMMUNE DEFICIENCY SYNDROME) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/15/2022 AIDS (ACQUIRED IMMUNE DEFICIENCY SYNDROME) J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/19/2022 AIDS (ACQUIRED IMMUNE DEFICIENCY SYNDROME)
Patient complained of experiencing overall weakness, headaches, and muscle pain. Patient advised to follow up with PCP
SORE ARM AFTER VACCINE; This spontaneous report received from a consumer via a company representative concerned a 50 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, the subject experienced sore arm after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm after vaccine was not reported. This report was non-serious.
One day after vaccine left lymph nodes in neck, arm pit, and left breast swelled.   Swelling in left breat and arm pit subsided approx 1 week. Swelling decreased but remains on left neck.
Moderna Covid-19 Vaccine EUA I had vaccine on 1/11/21 and had itching, redness, swollen on site of injection. Mainly what bottered me was the itching. Got better to normal color of skin. But returned on January 18 again out of the blue. And it is getting better again.
This is a spontaneous report received from a noncontactable (nurse). A 32-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 31, on Nov 19, 2021, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 23, 2021, and the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 2, 2021; both single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced influenza-like illness, onset May 7, 2022, with outcome of unknown, vaccination failure (medically significant) and COVID-19/flu-like symptoms May 7; positive Ag test May 9 (medically significant), onset May 9, 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May 9, 2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of COVID-19/influenza-like illness. Clinical course: Unknown if patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, unknown if patient diagnosed with COVID-19. Since the vaccination, patient tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Based on the information available a possible contributory role of the suspect cannot be excluded for the reported events of COVID-19 and ineffective drug.
fevers, chills, and painful lymphadenopthy admitted to facility  treated with IV antibiotics
24 hours after vaccination experienced fatigue, fever (99.9) which lasted about 36 hours.  4 days after vaccination (9/20/21), experienced numbness that started at the left side of my head and spread down through the left side of my neck, shoulder, arm.  Became hypersensitive to lights and sounds, felt nerve "shocks" in extremities, occasional tinnitus.  These symptoms would wax and wane over the course of the next couple of days progressing into head to toe full body numbness 2 days after the initial event (9/22/21).  Visited ER on 9/23/21 when experiencing numbness/paresthesias from arms to hands and from legs to feet.  numbness and paresthesias would wax and wane with gradually lessening intensity/episodes over the next several weeks.  Also would experience orthostatic episodes of dizziness/faintness periodically that would impact driving, standing for long periods of time.  Have occasional headaches in varying areas of my head.  Noticed bowel changes (constipation) that would last longer than occasional episodes prior to vaccination (up to 4 to 5 days with regular meals).  Paresthesias have now become more temperature sensitive neuropathies in hands and feet.  Still experience occasional headaches, orthostatic dizziness/faintness. Currently approaching  week 11 post vaccination and am recovered to about 85% of my baseline having been evaluated and receiving treatment for the past 6 weeks.  Treatment is currently ongoing and symptoms much less intense but ongoing (received POTS diagnosis)
Pt had sore arm and fever of 101 degrees took TYLENOL (helped some).
Pulsating tinnitus. Starting May 5 duration 2-3 hours, recurred several times a week. Subsided May 29. Returned June 10 for a few hours. Recurred June 17 and woke me from sleep. Causing insomnia. So far pulsing has lasted 6 hours.
Severe increase in pain sensitivity. Hurt to take Band-Aid off,  any thing that caused pain was worse.
1. Infection at injection site- treated with 7 days antibiotics. 2. Rapid heartbeat evening of injection date - taken to ER by ambulance and admitted to hospital.
not feeling well/feel so sick after taking the Moderna booster; not able to do anything/still laying around unable to do anything; swelling underneath armpit/swollen lymph nodes; swelling underneath armpit/swollen lymph nodes; headache; muscle aches; fatigue/fatigued; have chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue/fatigued) and CHILLS (have chills). At the time of the report, MALAISE (not feeling well/feel so sick after taking the Moderna booster), DECREASED ACTIVITY (not able to do anything/still laying around unable to do anything), HYPERHIDROSIS (swelling underneath armpit/swollen lymph nodes), LYMPHADENOPATHY (swelling underneath armpit/swollen lymph nodes), HEADACHE (headache), MYALGIA (muscle aches), FATIGUE (fatigue/fatigued) and CHILLS (have chills) had not resolved.            No concomitant medication was provided by reporter. No treatment information was provided was provided by reporter.  The patient was completely fine after receiving the second dose of vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow up received included updated outcome of all events
Pt recieved dose one of Moderna COVID19 Vaccine about 1255pm LOT 046A21A, Exp.9/3/21. Within about 3 min of entering waiting room, pt felt faint/ passed out, hit his head on end table, tried to get up into a seat and lost consciousness again for 1-2 SEC.  Assissted byt wife and NP to the floor. 911 called by PCT, BP 90/52, HR 65, o2 99%. After evaluation per EMS team, pt chooses not to go with EMS to ED for further care, recommended by NP and EMS. Pt chose to go with wife and will go to ED if worsening symptoms. AMA signed for EMS and clinic
Tinnitus; Committed suicide; Fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: ER8730), on 05Mar2021 11:15 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: ER8730), on 26Mar2021 10:30; both via an intramuscular route of administration, administered in Arm left (left shoulder), as single dose, for covid-19 immunization. Medical history included multiple sclerosis (MS) from 07Jul2002 and ongoing. Patient's prior vaccination was none. The patient's concomitant medications were not reported. Caller reported the side effects after the administration of the Covid-19 vaccine. On unknown date in Mar2021, after the first shot his tinnitus started and he was also fatigued; and he committed suicide eventually. The caller went to a specialist and was told that he had heard about that symptom before from 6 patients who reported the same thing. Later the reporter mentioned he didn't know the guy other than he was a founder of one organization (name no provided) and he committed suicide. Had spoken with one of his friends who knew of a friend who also had tinnitus shortly after getting Covid and it was serious because the guy committed suicide. The guy was about his age and he ended up committing suicide and he had similar symptoms. This all happened around the same time in March when he had his vaccine and it's kind of eerie. It stated on the guy's obituary he had covid and tinnitus, but caller unable to clarify if guy had covid virus or vaccine. He didn't know the guy, but his other friend who have friends that were doctors said that you could go crazy. No further details provided for this person or other persons. This was the report two of three. Upon receipt of the follow up, it was stated that approximately 1-2 days after just vaccine, the patient started with hissing second on both ears which stated was diagnosed as tinnitus. As of today, 12Jun2021, the "hissins" was consistent or worse than the start and it fall day and night. On an unspecified date in Mar2021, the patient died, and the autopsy was not performed. The outcome of the events committed suicide and tinnitus was fatal while the outcome of the event fatigue was unknown.  Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Tinnitus; committed suicide
03/11/2021 3:05 pm Patient observed in chair pale with stiffened body and eyes rolling on back of head. Patient initially unresponsive V/S 97.2 20,71, 96/50, O2 sat@ 98% on room air. Blood glucose monitored @ 105 mg 1d1.  911 called patient responsive to verbal and tactile stimulation. Legs elevate, patient stated that he only ate breakfast for the day water and snacks offered and consumed. BP rechecked 80/50 Legs remains elevated. Awaiting for 911 to arrive close monitored is in progress.   3:20 pm The Fire Department arrives and assesses the patient.  3:30 pm  BP 110/70 Patient awake and verbally responsive. Patient lift facility with rescue via stretcher en route to the hospital.
Tinnitus Began one day after receiving the first shot and condition remains 3 weeks later
This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # M035486, expiry date: 05-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 degrees C to 1 degree C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.