chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2022 as dose 4 (booster), single (Lot number: FJ5682) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid (Oral) from 27Jul2022 to 31Jul2022.  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 with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
?Covid arm? Red rash that was painful and grew bigger and bigger each day, started the size of a quarter and is now the size of my palm. Pain went away with Tylenol but is still hot to touch and starting to itch after 3 days.
Patient was administered incorrect vaccine product - Age 6mo-4yrs - patient was 5yrs 2mo old.
18JUL95 onset welts rt hip feet, belt waistline; itching; 19JUL95 3AM woke w/eyes swollen, covered w/welts; chills; no breathing problems; seen by MD given DPH, Pred
Sore arm, headache, light headed, stiff neck.  Took over the counter aspirin.
no arm pain at injection site until following morning; my face became warm and beet red; my face became warm and beet red; experienced incredible thirst; intermittent nausea and lethargy; intermittent nausea and lethargy; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient (non pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, in Arm Left on 02Feb2021 12:00 (12:00 PM) (age at vaccination 75 Years) as single dose for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin, NSAIDS, doxycycline, lidocaine and prednisone. Concomitant medication(s) included atorvastatin at 10 mg; calcium citrate (CITRACAL [CALCIUM CITRATE]); bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]); ubidecarenone (COQ-10) and Magn (as reported). Pateint reported that "on 02Feb2021 at 12:00 PM, Shortly after receiving first dose my face became warm and beet red, didn't realize until I'd gotten to my car and taken off my mask, at which time I also experienced incredible thirst. Other symptoms that day (02Feb2021), Wednesday and today have been intermittent nausea and lethargy, no arm pain at injection site until following morning (03Feb2021), okay now." No treatment was received for the events. This case is reported as non-serious. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome "no arm pain at injection site until following morning" was recovered while other events was recovering.  No follow-up attempts are possible. No further information is expected.
got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got very sick). At the time of the report, ILLNESS (got very sick) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up received , contains No New Information.
Tingling and itchiness  of mouth starting shortly after administration which then spread to entire body.  Shortness of breath, felt body inflamed. Took Benedryl and symptoms subsided.
pt said 1st flu shot Friday afternoon. Woke up Saturday morning with rash and welts on buttock area.
Area where shot was given became inflamed, tender and hot. Doctor said BACTERIAL CELLULITIS - took antibiotics for 10 days
Patient was given a dose of Pfizer 5-11 yr orange cap that had been diluted with 1.0 ml diluent instead of 1.3 ml diluent.  There were no immediate reactions noted; parents were instructed to watch and notify us of any adverse reaction.
At 1123, pt began to complain of itching all over body, SOB, and coughing. Pt transported to ER for further evaluation.
symptoms at the site, where the patient got the shot, felt very painful, red, it was hot to touch; symptoms at the site, where the patient got the shot, felt very painful, red, it was hot to touch; symptoms at the site, where the patient got the shot, felt very painful, red, it was hot to touch; it felt that might be there was infection, swollen; it felt that might be there was infection, swollen; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced symptoms at the site, where the patient got the shot, felt very painful, red, it was hot to touch, it felt that might be there was infection, swollen. The patient was getting concerned about the symptoms at the site where the patient got the shot, it felt very painful, red, it was mot hot to touch. The patient did not know if this was a symptom that was expected or the patient should probably seek some medical attention for it, when it was hot to touch, the patient felt that might be there was infection. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mental confusion and disorientation. Inability to discern if I was saying things or only thinking them. Symptoms started at 6 PM on 10/16. I went to the ER, where I was given a CT scan, EKG, blood work, etc. Was admitted to Hospital at 4 AM on 10/17 and discharged at 4 PM on 10/17 with a diagnosis of "transient global amnesia."
Severe pain in arm muscle where shot was given,  Radiates down to the elbow. Been in constant pain since the 2nd vaccine on February 26, 2021.
This spontaneous report as received from a nurse refers to a 12 month old patient. On an unknown date, 12 month old patient received the third dose of ROTATEQ. No adverse effects were reported. No further details were provided.
My entire left side of my face was numb for 4 to 5 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FE3590) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Polycystic ovarian syndrome" (unspecified if ongoing). Concomitant medication(s) included: VIT D; ZINC; MAGNESIUM. The following information was reported: HYPOAESTHESIA (non-serious) with onset 12Oct2021, outcome "recovered" (Oct2021), described as "My entire left side of my face was numb for 4 to 5 hours". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated, she got her first shot last Tuesday and about an hour or one and half after she got her shot, her entire left side of face was numb for 4 to 5 hours. It went away. She called her primary healthcare provider and she said that it was entirely up to the patient to get the second shot. So she have 'waiver' for her job that says she could not get the second shot. Her primary care providers (PCP) refused to sign a 'waiver' that says that it is not ideal for her to get the second shot. He said contact the company where you got the shot. So she called the companies that actually was administering the Pfizer shots. The pharmacist said for legal purposes, a doctor, primary care should be signing up 'waiver'. So, neither one of them will find. Patient contacted a telehealth doctor and they said that because telehealth doctor did not see what had happened, then they could not give her a 'waiver' either. So they suggested her that I contact insurance company and here I am. They also said it was not a right idea for patient to take the second shot either. On confirming that She had taken the first shot of Pfizer COVID-19 Vaccine, she stated "The very first one, yes." On paraphrasing if the patient wants to know whether she should take the second shot or not, she stated "Yes." Patient was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. Patient stated It didn't give me an expiration date on her card. It says Pfizer and then the LOT number. When again probed for anatomical site, Patient stated Left shoulder. Scheduled date for second shot was 02Nov2021. No Investigation Assessment.  Follow-up attempts are completed. No further information is expected.
I started feeling really dizzy and sick and then I just passed out and my mom said I had a small seizure.  I still have a fever of 100.7 but other than that I feel fine now.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with high blood pressure, cholesterol and allergy to sulfa. On 18-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous, lot # was reported as H018798, expiration date on 15-JAN-2014) in upper deltoid and developed redness and warmth in elbow of the same arm where vaccine administered within 36 hours. The outcome of event was reported as not recovered/not resolved. No treatment was given for adverse event. No lab diagnosis studies performed, The patient had sought medical attention via consulting pharmacy. Additional information has been requested.
Feling something strange; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feling something strange) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feling something strange). At the time of the report, FEELING ABNORMAL (Feling something strange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
11/29/10 Pt called and c/o back pain stabbing through to front and right arm numbness starting with fingers and moving up arm, and muscle spasms started to next day after receiving second Inj Polio vaccine; woke up that AM with symptoms really bad at first. Heat pad to back all weekend helped some. C/O exact same symptoms after first Inj. Polio vaccine but thought it was stress from school. 11/29/10 11:30AM refer to emerg room. Pt also received 11/22/10 HBV Adult dose Health Dept and #2 dose MMR II subQ Rt Arm Lot 0254Z Health Dept.
Full body rash, itching, redness, tachycardia, shortness of breath. Cleared up within one hour after treatment with otc Benadryl.
Immediate pain at the site of injection; Diminished ability to more his right arm; Soreness in his arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, immediately after receiving Shingrix, the patient experienced injection site pain, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site pain, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: Consumer reports receiving 1st Shingrix dose in middle or late October 2019 in his right arm. Consumer reports immediate pain at the site of injection followed by the onset of soreness in his arm 2 hours later that lasted for approximately 1 month. In addition to the soreness, consumer also reports a diminished ability to more his right arm starting 2 hours after vaccination lasting approximately 1.5 months. The patient reports being due to for 2nd dose within days but hesitant to receive it due to first dose reactions on top of being 75 years old while coronavirus was a threat. He mentioned he might not receive it at appropriate time as the recommended schedule.
Patient states that she has had muscle spasms ever since the day after the vaccine was given. She reported this to us here at the pharmacy today.
This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. In 2015 (about a year ago), the patient was vaccinated with first dose of GARDASIL 9, (lot/expiry date, dose, frequency and route of administration were unspecified). Patient was in the office to receive a second dose of GARDASIL 9 (unspecified lot/unspecified expiration). No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information available. Additional information has been requested.
This spontaneous report as received from a company representative refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 15-OCT-2015, the patient was vaccinated earlier than recommended (unspecified amount of time) with a dose of GARDASIL 9 (lot number, expiration date, dose and route were not provided). Concomitant medication was not reported. No adverse reactions have been reported. Additional information has been requested.
dizzy/ lightheaded, nausea, sweating, trembling, head pounding, chest tightness, ear ringing
there have been doses administered/temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On an unspecified date in August 2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 ml, lot number S031882 was verified to be valid, expiration date reported and validated as 07-APR-2021 (route of administration was not provided) for prophylaxis.  On 17-AUG-2020, the administered dose of vaccine experienced a temperature excursion of -14 to -10 Celsius degrees (maximum -9.5 Celsius degrees) intermittently for 38 hours and 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.  It was not reported, if the patient experienced any additional adverse reactions.
Patient's mother reports that she noticed "Non-Raised" Red Rash Started on patient's Torso, with patient feeling general malaise, flu-like symptoms - took child to their Pediatrician no other treatment given
6/7/12 Day of injection - none. 6/8/12 Arm/shoulder sore & tender. No fever, no redness, no swelling, x 4 days. 6/11/12 Evening - two fingers of hand of arm of injection, stiffness, curled up, very hard to open them back - worse 1st couple days - 6/12/12 Experienced stiffness in jaw x 2 days. Other hand experiencing stiffness in ring and pinkie fingers- not as severe. 6/28/12 As of today still experiencing (R) hand stiffness in a.m. after night.
Beginning November 14th, I experienced waves of mild nausea that persisted for the full week and resolved by November 20th. There were no illnesses or other contributing factors for nausea. Additionally, I acquired full-body itching, with no rash or hives that started November 10th and has not fully resolved as of November 22nd. In consultation with our family nurse, am treating the symptoms with Pepcid (H2 blocker) and Allegra (H1 blocker), along with Ibuprofen.
Injection site became hot, swollen, and itchy one hour after injection.  Pt given ibuprofen 800 and Benadryl 25mg, this took care of the problem.
This case was reported by a consumer via call center representative and described the occurrence of metastasis in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cancer. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced metastasis (serious criteria GSK medically significant). On an unknown date, the outcome of the metastasis was unknown. It was unknown if the reporter considered the metastasis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was informed that her cancer had metastasized. The patient did not provide any contact information, but she would have her physician contact medical information.
This spontaneous report as received from a medical assistant refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced nausea, vomiting, and sweating after injection. She was pale. There were no bleeding, bruising or swelling at injection site. EMT took vital signs about 25 minutes after injection and vital signs were normal.
Patient received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication reported.  Total 190 patient received a vaccine past the beyond used by date with 9 different lots numbers.  No treatment medication reported.  This case pertains to the 67th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
On December 20th my friend told me that they tested positive for Covid. The next day I started having a fever, aches, chills, and a tingling scratchy throat. I tested positive at home. The fever lasted for four days. I have a throat cold still, but all other symptoms has subsided. I took another Covid test today and it is still showing positive.
pt recvd vax & became pale & SOB by 2-3PM w/some blueness around lips & transient blotching rash on trunk; lethargic & tachycardia;
w/in 2hr p/vax began to have dry cough & scratchy throat;w/in 24 hr had devel into pharyngitis & cold like sx;no fever;lasted approx 10 days from onset;
Pt presents to ER with Shingle like rash located Left C4 and C5.
24SEP91 about 130PM mom TC clinic & said PT's rt leg was swollen to "twice" normal size & PT high-pitched "scream" for 4-5 hrs p/vaxs; t99.2; to MD @2PM; rt leg edematous around inject site; PT was smiling & contented; rx: Tempra 80mg q4;
Developed Bell?s Palsy on right side of my face. Gained most movement back in 1 1/2 weeks.
Pt reported node under armpit and rash on arms and underneath pectoral muscles. Pt to consult with physician. Started 2 days after administration.
became hyporesponsive, cyanotic, jerking of hands 2 episodes 730AM & approx 845PM spontaneous recovery;adm for observation, EEG, pneumogram, blood work all WNL;no further problems;
Bulbous Pemphigoid on arms and legs. Treated with steroids and anti-histamines.
FEVER; SORE ARM; This spontaneous report received from a parent concerned a male of unspecified age. 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: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 04-APR-2021, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210410075.
Patient complaining of a pricking needles to head.  At 10:30, patient was constantly jerking and not responding to questioning.  Episode lasted 2 minutes.  911 called.  Placed patient in supine position and at 10:30 patient showed visible signs of not breathing, holding throat, gasping for air.  EpiPen given. Patient transported to ED at 11:17. Upon arrival to ED at 11:19 am, left sided facial droop and weakness with slurred speech and complaints of a severe headache noted. Patient received keppra 3000 mg intravenous x 1 dose at 1211. Patient was discharged from emergency department 5/28/21 at 1330 with prescription for keppra 500 mg by mouth twice daily and ambulatory referral to neurology.