chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath that is painful. Breathlessness when I attempt to speak full sentences, total body joint pain and feeling like there is lead weights on my limbs, severe nausea and bouts of diarrhea as well as headaches and feeling my throat tight like its swollen but I can still swallow softer foods and breath. Radiating arm pain from injection site All the way down to my hand. It also hurts to take a full breath  and feeling the internal shivers.
MODERNA COVID VACCINE GIVEN 12/29/21, LOT #066H21A; patient in and out of hospital and rehab since September 2021; January 2022 another hospitalization with DX of sepsis and UTI; no hospitalization records received in records from nursing home; 2/10/22 patient had a positive COVID test in rehab facility. Patient's condition continued to worsen with loss of appetite, vomiting and weight loss; patient passed away in the Nursing Home.
Information has been received from a registered nurse who reported that RECOMBIVAX (dose, route and lot number were not provided) was exposed to 57F for 418 hours. The excursion was not supported. He stated that he was not sure if any of the doses were administered to patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Initial misuse report received from healthcare professional on 18 Aug 2014. A patient (age and sex not reported) had received a dose of FLUZONE HD (dose, lot number, dose number and site of vaccination not reported) on an unspecified date. It was reported that while administration of dose, the needle was not tight and a lot of vaccine leaked out. At the time of this report, the patient did not experience any adverse events. Documents held by sender: None.
very tired and experienced fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired and experienced fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Bronchitis, Anxiety, Panic attack and Ulcer. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety and Panic attacks, SERTRALINE, LOSARTAN, ROSUVASTATIN, ACETYLSALICYLIC ACID (ASPRIN) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 12-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 FATIGUE (very tired and experienced fatigue). At the time of the report, FATIGUE (very tired and experienced fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient slept for 6-7 hours. Treatment information was not reported.
Patient came in and showed her arm. Received ZOSTAVAX on Friday and on Monday complained of rash going down arm, itching, redness, bruising and warm.
Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 19-JAN-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-APR-2014, patient was treated by physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, patient had been prescribed valacyclovir (VALTREX) to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Additional information has been requested.
pt recv vax 15SEP98 pt died of presumptive sudden infant death synd following morning 16SEP98;
COVID-19 Treatment; COVID-19 Treatment; Dose 1 and Dose 2 BNT162B2, Dose 3 and Dose 4 Moderna, Dose 5 BNT162B2, BNT162B2 OMI BA.4-5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 11:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 at 12:45 as dose 1, single (Lot number: EL3246), in left arm and on 12Feb2021 at 12:45 as dose 2, single (Lot number: EM9709), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Oct2021 at 18:00 as dose 3 (booster), single (Lot number: 027C21A), in left arm and on 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "known allergies: Minor non-specific food allergy (runny nose)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2022 at 11:45, outcome "unknown", described as "Dose 1 and Dose 2 BNT162B2, Dose 3 and Dose 4 Moderna, Dose 5 BNT162B2, BNT162B2 OMI BA.4-5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: initial positive test; (16Dec2022) Negative, notes: negative test on day 8; (17Dec2022) Positive, notes: Positive test on Day 9. Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a nurse concerning two twins patients (gender and age unknown). On unknown date, the patients was vaccinated with two doses of VARIVAX (Merck) (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that their county was experienced an out break of chickenpox. The nurse stated that this county had a very high right of parents who opt-out of vaccines. At the time of the report, the outcome of chickenpox was unknown. The relatedness for chickenpox was unknown for VARIVAX (Merck). This is one of the several reports of the same source. Follow up information has been received from the nurse concerning one of the two twins who is a 13 years old male patient. On an unknown dates, the patient was vaccinated with 2 doses of VARIVAX (Merck). On 31-OCT-2012, the patient experienced chickenpox. The patient had recovered from chickenpox. Additional information is not expected.
606 doses were given after expiration date; Vial refrigerated on 3-11-2021 after expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 3-11-2021 after expiry date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 3-11-2021 after expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 3-11-2021 after expiry date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medication was not reported. No adverse events reported. No temperature excursion of the product was reported. Date place in refrigerator: 03-Nov-2021.
This case was reported by a other health professional via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain, fever, chills and headache. On an unknown date, the outcome of the pain, fever, chills and headache were recovered/resolved. It was unknown if the reporter considered the pain, fever, chills and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who herself was a healthcare professional (HCP). The age at vaccination was not reported. The patient experienced soreness, fevers, chills and headaches that lasted about 24 hours. This case has been linked with case US2019GSK030864 reported by the same reporter.
Immediately after vaccination patient developed a headache. Within 30-45 min after vaccinations, patient had a syncope episode where patient was unconscious for less than 1 minute. Patient had pallor which did not return to normal for about 30 minutes.
6x4cm pink macular rash below injection site on L arm in deltoid area.  No fever or itching.
Injection site was itchy approximately 3.5 hours after administration (Wednesday 2/24/21).  Felt like a hard lump under the skin that was hot to the touch.  Skin was visibly red for about 1-2 inches all around the injection site.  The lump under the skin grew and red area was even larger and redder the next day (Thursday 2/25/21).  It grew even larger and redder the day after that (Friday 2/26/21).   The lump under the skin was much smaller and less red the day after that, but still itchy (Saturday).  Skin is still itchy and developed some small bumps on top of the skin (as of today, Monday).  Lump under the skin is currently small, but still there.
Information has been received from an anonymous consumer concerning her daughter who in October 2008, was vaccinated with the first dose of GARDASIL (LOT#, route not reported). Then after 2 weeks, the patient experienced a "movement disorder". The reporter refused to give any additional information. No further information is available.
Big red circle on her arm, 3 inches wide and hot; Itching; Knees and back were affected, couldn't hardly walk; Big red circle on her arm hot to touch; Rash on arms; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Big red circle on her arm, 3 inches wide and hot), PRURITUS (Itching), GAIT DISTURBANCE (Knees and back were affected, couldn't hardly walk), FEELING HOT (Big red circle on her arm hot to touch) and RASH (Rash on arms) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder NOS and Allergy (Allergic to oranges). Concomitant products included LEVOTHYROXINE, TRAMADOL, GABAPENTIN and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ERYTHEMA (Big red circle on her arm, 3 inches wide and hot), PRURITUS (Itching), GAIT DISTURBANCE (Knees and back were affected, couldn't hardly walk), FEELING HOT (Big red circle on her arm hot to touch) and RASH (Rash on arms). At the time of the report, ERYTHEMA (Big red circle on her arm, 3 inches wide and hot), PRURITUS (Itching), GAIT DISTURBANCE (Knees and back were affected, couldn't hardly walk), FEELING HOT (Big red circle on her arm hot to touch) and RASH (Rash on arms) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included unspecified allergy pills. Additional concomitant medication included unspecified blood pressure pills.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 3:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 3:58 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's age was reported as 61.96 years.  No concomitant medications were reported.  Number of vials sent to clinic were 19. Vial moved to fridge on 09-Mar-2021. Vial was moved to clinic on 20-Mar-2021. Batch number 031A21A administered on 20-Mar-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09: 00 am and 37 degrees Fahrenheit at 10:00 am.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43. Beyond use date for these vials was reported as 08-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Nausea, Vomiting, Severe Stomach, Diarrhea, currently under medical supervision of Hospital and Dr. Patient is still sick, awaiting referral to specialist to see Gastroenterology. Patient is still not well and is bleeding rectally, he has lost 17 pounds is unable to attend school regularly or play sports. Due diligence has not been performed by responsible medical parties, this could be Life Threatening. We do not know. There has been no progress for his diagnosis in 9+ weeks.
The first day of the vaccine later that night I had body ache and chills (moderna ). The next day I leg  pain. after 4 weeks I still had leg pain with numbness and tingling started. I was told to take otc medication  for the leg pain and they gave me gabapentin the numbness and tingling. Ive been feeling like this since 04/25/2021 and today is June 07/2021. This vaccine is has done something to my body that the doctors cant find .
Patient's arm swelled up and was very red. Patient reports that the site was itchy and not painful. Patient reports that the swelling went away in one week.
Client became pale and complained of being nauseated and light-headed.  RN assisted client in putting her in a supine position with legs elevated.  This releaved the light-headedness but client continued to be pale and nauseated.  These symptoms began immediately after injection and continued for 20 minutes at which time the client stated she felt okay, skin color had returned to normal and she was sent home with her mother.
Patient discharged after (4) inpatient admission from 11/20-11/24/2021. Patient is a 47 y.o. female with past medical history significant for HTN, HLD, migraines, GERD, depression and anxiety who presents today with chills, fever and cough in setting of known Covid 19 infection. The patient reports first developing fatigue and cough 8 days ago. She has been experiencing intermittent chills and fever over the last five days. She took an at home Covid 19 test which was positive, later confirmed by a PCR. She complains of diffuse myalgias and joint pain. She has also been having loose stool. This morning, the patient woke up with chills and a temperature of 103.8F with nausea, vomiting and shortness of breath, at which time she presented to the ED. The patient is vaccinated.    In the ED, the patient was febrile (T102.7F), tachycardic (HR 107), tachypneic (RR 28) and hypoxic requiring 2LNC. Baseline lab work showed sodium 131, chloride 97, BUN 11, Cr 0.74, WBC 7.19, Hgb 13.5. CXR showed probable left lower lobe infiltrate. The patient received tylenol. IV Rocephin, IV doxycyline, IV decadron, IV toradol, IV morphine and IV zofran while in the ED. She will be admitted for further management.
Increased Rxn 1 cm x 1 cm immediately after immunization MMR. No anaphylaxis no cough.
facial paralysis, lower leg swelling, coughing, rappid heartrate, muscle aches, body trembes, high bp, nausea, diahrrea
First I had swollen lymph nodes, then severe pain behind right eye, at two weeks I developed severe right side of head pain, base of skull, ear, eye.  Diagnosed with shingles, but no rash.  Internal shingles possibly.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 at 11:00 as dose 1, single (Lot number: ER8727), in left arm, on 10Apr2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 06Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reflux" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Additional information: The patient took Paxlovid from 19Oct2022 to 24Oct2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
weakness; some nausea; I have a little bit of borderline fever; My blood pressure is going up a bit; Vertigo/spinning in his head; feeling rough; dizziness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number ER8729), via an unspecified route of administration on 13Apr2021 (At the age of 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration (at the age of 71-year-old) as dose 1, single  for covid-19 immunisation and experienced soreness in his arm. The patient experienced dizziness on 13Apr2021. On an unspecified date patient experienced weakness, some nausea, I have a little bit of borderline fever, my blood pressure is going up a bit, Vertigo/spinning in his head and feeling rough. The clinical course reported as follows the consumer stated, "I had my 2nd Pfizer COVID shot on Tuesday, 13Apr2021. Caller is calling because he was having issues.  He was three days out from his second vaccine and is wondering if people have anything similar to what he was having.  Caller adds that his symptoms were worsening and according to the paper he received, what he was experiencing would have happened 15 minutes to an hour later after getting the vaccine.  Caller adds that he needs to find information out. The second dose was given three days ago on 13Apr2021.  Caller was having dizziness, vertigo, weakness, and nausea from time to time.  Caller adds that after the first shot of course he had no issues except for soreness in his arm. At the end of the first day on 13Apr2021, he had dizziness.  Then, on the second day, dizziness and spinning in his head.  Today, he was doing okay but then all of a sudden he got an acute dizzy spell that made him dizzy, weak, and nauseated.  Caller asks if Pfizer is having this dizziness and weakness three days out being reported like he is having.  He is kind of right now feeling rough, he adds he would like to expedite the call a little bit, because he has been getting worse as he is going along.  Caller adds this may not be related to Covid at all. Caller wants to find out because his wife is getting ready to sign up for the vaccine that if here are any issues that she should be aware of as well.  Caller adds that he has never had heart surgery, he is almost 71 years old and he has never had a reaction to any drugs or vaccination of drugs.  He does not know if it is tied to the vaccine or not. The patient underwent lab test blood pressure going up a bit and have a little bit of borderline fever on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information expected.
Noticed rash on legs on 11/3/00. Presented here with primarily scabbed lesions, some vesicles and papules over all of body including diaper area. Temperature 99.3F, runny nose and rash is pruritic.
22 year old female patient presents with dizziness and blurry vision 5 minutes after vaccination. Pale and sweaty from head to toe.
Off label- past 35 days since first dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Off label- past 35 days since first dose.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Off label- past 35 days since first dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Off label- past 35 days since first dose.) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.
pt reeived the bivalent covid vaccine in error.  patient came to pharmacy for primary series dose#1