chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick; Felt weak/ no energy; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 05Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he took his first dose on 05Mar2021 and was schedule for his second dose on 26Mar2021. He mentioned he got sick last Monday, 22Mar2021, and felt weak and had no energy. He went to his pharmacy to get tested and would be back in two to three days for his results. He inquired about rescheduling his second dose. The clinical outcomes of sick and felt weak/no energy were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
1200 PM Approximately 5 minutes after Pfizer vaccine complained of shakiness and insides vibrating sensation. Hands visibly shaking. BP 125/79 P 80 R 18 Pulse ox 97% Given Benadryl 25 mg for shakiness and sense of dizziness.  1207 PM States shakiness improved. BP 110/71 P80 R 18 States vibrating inside resolved as well.  1210 Continues to improve. Wants to leave. Advised must stay for full half hour but concerned for children in car with mother.  1230 Left facility and states much improved.
Infection Control notifies of hospitalization of a 29 y/o male with chest discomfort and elevated troponin after receipt of 7 Feb 12 vaccines, including SPV, AVA, and Typhoid. Patient develops chest discomfort on 19 Feb, has abnormal Troponin detected on 21 Feb and is admitted to the hospital later that same day.
Body aches, chills, fever 2 x 3 days TYLENOL/MOTRIN.
Headache, Fever, Chills, Muscle Aches, Nausea
6/30/2021 symptoms: cough,  7/6/2021 Positive COVID-19 7/19/2021 died
This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (dose, lot #, expiration date and route were not reported) which was exposed to temperatures outside of recommended condition. No adverse events were reported. The patients did not seek medical condition. This is one of several reports from the same source. Additional information has been requested.
experienced pain and swelling in the arm where I received the shot/pain & swelling in arm where the vaccine was administered; experienced pain and swelling in the arm where I received the shot/pain & swelling in arm where the vaccine was administered; fatigue; headache; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 46 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunization. Relevant medical history included: "hypothyroidism" (unspecified if ongoing), notes: Hashimoto's. Concomitant medication included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; SERTRALINE. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: Unknown), for covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Mar2021, outcome "unknown" and all described as "experienced pain and swelling in the arm where I received the shot/pain & swelling in arm where the vaccine was administered"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache".  Additional information: The patient had the second dose of COVID-19 vaccine on 26Mar21. She experienced pain and swelling in the arm where she received the shot, had fatigue and headache. After receiving the second dose of COVID-19 vaccine, the following day she experienced common side effects including: pain & swelling in arm where the vaccine was administered, headache and fatigue. Her medical history included hypothyroidism (Hashimoto's) and she used 112 mcg levothyroxine/daily and 25 mg sertraline/daily.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347945 same patient, different drug/AE
First two days:  very sore arm; hurts with movement.  Then several days without symptoms.  Then, about a week later, wake up at night with extremely itchy arm.  Vax site has swollen, raised, bright red look for several days after that, about 4 inches long oval shape.  Swelling is nearly size of deltoid.  Tomorrow will be the fifth day of these symptoms, but the swelling has gone down and the redness has lightened, and the itchiness is less extreme.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 27-JAN-2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical group office (by an unspecified health care professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-SEP-2016, the patient was treated by a nurse practitioner family health facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed acyclovir for management of her painful symptoms and pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9693) and on 20May2023 at 14:30 as dose 6 (booster), single (Lot number: GJ3268) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EN6201), on 05Mar2021 as dose 2, single (Lot number: EN6198), on 23Aug2021 as dose 3 (booster), single (Lot number: FC3180) and on 10Feb2022 as dose 4 (booster), single (Lot number: FJ1614) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Autoimmune Hepatitis" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2000; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2005; CALCIUM +D [CALCIUM CARBONATE;COLECALCIFEROL], start date: Jun2005; MYCOPHENOLATE, start date: Feb2020; NIACINAMIDE, start date: Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 07Sep2023 to 12Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300303458 same patient/reporter, different drug/event;
13 weeks. Due date Oct 6. No previous nausea. Woke up very dizzy and nauseated. Could not keep down food or drink. Was given IV fluids and Zofran at Dr office in the afternoon.
Wednesday evening, developed edema to her upper lip and tongue. Shortly after, she experienced some difficulty breathing, and taken to ED. She was given prednisone and Benadryl. She continued to take those every day since seen (last given at 10 am). Thursday afternoon, she developed a rash to her full body. Urticaria and redness still present and itchy. Patient also developed N/V/D yesterday, and continues today. No new detergents, lotions or soaps. She recently used a new lip mask. No new food intakes. Of note, no reaction to the first two doses.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/15/21 and 2/21/21. Covid + 1/5/22. Admitted 1/8/22 for acute hypoxemic respiratory failure 2/2 Covid PNA. Remdesivir given x1, discontinued 2/2 CHB with frequent pauses. Transferred to ICU for DTX infusion and s/p TVPW placement on 1/8/22. Intubated 1/25/22. Admission c/b DVTs, thrombocytopenia, CHB, and worsening hypoxic and hypercapnic respiratory failure. Treated with remdesivir, zosyn, solumedrol and vancomycin. Patient expired 2/02/22.
Pt. reported itching on back and bilateral arms. Pt. did not complain of shortness of breath, GI upset, difficulty breathing; redness to bilateral upper arms and scapular region. Pt. stated she does have an allergy to penicillin but does not carry emergency medication for treatment. Pt. declined EpiPen and shared with pt and husband, the driver, that it was protocol to call EMS at this time due to reaction. Pt and husband upset and concerned about cost of EMS ride. Driver (husband) stated he would take pt to ED if emergency care was needed. Called 911 to have EMS dispatched and while on line with dispatcher, husband stated he was leaving and proceeded to exit the vaccination site.
My period was a whole 9 days late after getting the vaccine. My periods are normally very regular, and I was supposed to get it on May 28th, but didn?t get it until June 9th. The next month (July), my period became regular again and has continued to be regular since.
Begining April 16th, 2021 I developed pain in my uterus and I began having an abnormal period/blood flow. I have already had my monthly period begining April 5th-10th, 2021. The blood flow is very abnormal. What looked like old and black blood initally is now fresh red blood. Along with the blood flow, I developed painful and uncomfortable labial lacertations. I have Nexplanon in my left arm and have not had abnormal reactions to the Nexplanon in over a month. I am concerned that I developed these symptoms after the second dose, but not the first. I am concerned that this vaccine had a reaction with my Nexplanon implant.
so dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (hospitalization), outcome "unknown", described as "so dizzy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201099490 same reporter/drug, different patient/event;
diagnosed with COVID and symptomatic; diagnosed with COVID and symptomatic; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender (retired employee) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date, dose 2 via an unspecified route of administration on an unspecified date, both at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated, diagnosed with COVID and symptomatic. The outcome of the event was unknown.  Information on lot/batch number has been requested.
on 11/08/22 pfizer bivalent was inadvertently given as 1st dose in the primary series instead of monovalent version.    pharmacist did not realized the discrepancy until the morning of  10/10/22 at work. pharmacist tried to contact patient but could not reach him. pharmacist left message for patient to call back. will continue to contact pt
Dizziness, Headache, Fever, Diarrhea &  NauseaVomiting employee rated her symptoms as "severe"  due to headache
Dizziness- following day, until present time (continual) Arm weakness - 4 days after administering   Leg weakness - 4 days after  Muscle twitching / restless legs -4 days after
Received shots on 4/24/12 (3pm appointment time). 5/4/12 went down for nap -> checked in 90 min & not breathing. ER chart received. CPR started at scene 1543. At ER 1553 in triage. Asystole on strip. 1608 temp 96.7. By 1608 pulse without compression, epinephrine drip. Renal failure by next day. No spont respiration. Seizures (+) after event.
29JUL-2AUG fatigue, edema, hives, rash, itching; 3AUG fever; 5AUG red, swollen, painful joint;
Patient came to Pharmacy on 08/30/2021 asking to get the Covid-19 Vaccine. Pt agreed to get the Moderna  Covid -19 vaccine and stated that this would be  his 1st dose. He was asked to fill out the consent form to release his information and the pre-screening questions. He noted the answer "no" to a questions "Have you ever received  a dose of Covid-19 Vaccine?". Pharmacist reviewed the pre-screening form, answered the questions that patient had regarding vaccine side effects and expectations from it and administered the vaccine. Patient waited for 15 minutes and left the pharmacy. Pharmacy tech when submitting the report to the state found out that patient had already received the Janssen vaccine on 03/24/2021. When confronted, Patient stated that he doesn't remember getting the Janssen vaccine in March.  Next day, Ph.  talked to the COVID nurse designated by the department of health and human services to discuss the necessary steps for the safety of the patient:  The following steps were taken: 1. The Ph. discussed with patient what side effects to expect  and also asked patient to inform his PCP of the event so that the PCP can closely monitor the patient. 2. The event was reported  to  the VAERS.
3 May 2018 at 08:16 From note: Her hands and feet are red and swollen, started last night, also reports achy joints. Very brief period of SOB last night. On exam: HEENT unremarkable. Heart: RRR w/o murmur; Lungs: CTA bilat; Skin: warm and dry without lesions or rash. Palms of both hands and soles of both feet are fiery red with some swelling. No pain to touch; Ext: no edema BLE; Psych: A&Ox4; Neuro: CNII-XII grossly intact. Assessment: T50.B95A. Plan: Prednisone 20mg tab; Sig: Take 2 tablets once daily for four days. Disp#8 NR. Recommend she take OTC ZYRTEC BID; RTC if sxs do not resolve. Call 911 if difficulty breathing develops.
Pt recvd vax & exp fever of 102-104 w/in hrs of vax; cried or slept; brought to MD who dx ear infect placed on ATB; cont to be very irritable or lethargic for days; 9APR90 awoke @ 5AM drank bottle & fell back asleeep; 8AM crying;
On Friday morning, December 17, I took a Rapid test as I was visiting my son, daughter-in-law and six week old grandson. That test was negative and I was in complete good health. On Saturday night, I became flushed, feverish and completely congested. On Sunday, I was tested. A Rapid showed a negative result but the PCR came back positive. I stayed isolated for 10 days and was congested for about the first three. I had a fever only on the first outbreak. Otherwise, I had no symptoms and no lasting symptoms. On February 4, I became very sick with an illness that was ultimately diagnosed as sinusitis with fever and very sick. Two rounds of antibiotics and two weeks later, I was healthy again. It is of note that I not gotten sick with flu or infections for the past ten years.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) in a 75-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received on 08-Jun-22, non-significant information reporter details added.
soreness of arm at site of injection; fatigue; Dose: 1st/ Date: 05Oct2022/ Batch/Lot number: GJ3277; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 41-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 1 (bivalent), single (Lot number: GJ3277, Expiration Date: 05Dec2022) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 05Oct2022, outcome "unknown" and all described as "COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient."; WRONG PRODUCT ADMINISTERED (non-serious) with onset 05Oct2022, outcome "unknown", described as "Dose: 1st/ Date: 05Oct2022/ Batch/Lot number: GJ3277"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of arm at site of injection"; FATIGUE (non-serious), outcome "unknown".  Additional information: NDC number of COVID-19 vaccine bivalent: 59267030402. Pharmacist gave the vaccination and used a vial that was punctured the previous day 22 hours prior (not knowing). The error happened during filling the syringe (dispensing). Vial's date label (date and time of puncture), got unstuck fell off the bottle. Patient didn't report any adverse side effects that were out of the ordinary (soreness of arm at site of injection) and fatigue.  Follow-Up (10Oct2022): Follow-up attempts are completed. No further information is expected.  Follow-up (05Jan2023): This is a spontaneous follow-up report received from a contactable Pharmacist in response to HCP letter sent to other pharmacist.  Updated information included: reporter details, historical vaccines removed, suspect dose details (Dose number, dose description, Patient Route of Administration, Anatomical Location, Vaccine Facility Information), new suspect added, new events: Wrong vaccine administered, Product administration error, Vaccination site pain, fatigue and additional information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
First dose was given too early/too young, states " Not Valid". On paperwork person wrote DOB  05-16-2009, but was found DOB 06-16-2009.
Pt c/o numbness @ injection site immediately; somewhat anxious @ time of injection. Within 1 hour c/o discomfort in left jaw and @ injection site at two hours, After two hours, dry throat and discomfort left leg. Pt's grandmother (retired Public Health RN) relates pt dies not require hosp /ER/MD visit as s/s are abating two and a half hours post injection.
several days later, started with high fever (104) with body aches and the development of hives on her arms, legs and upper chest as well as fatigue, cough and nausea.  Went to the ED on 01/01/2022.