chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Severe fatigue; Severe Urinary incontinence; Headaches; This is a spontaneous report from a contactable consumer (patient) reported herself. A 51-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW0151), via an unknown route of administration in left arm on 17Apr2021 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization at public health department. The patient's medical history included diabetes II, high blood pressure, reflux, anxiety, obesity and menopause. Concomitant medication was not reported. The patient received morphine, Wellbutrin as past medication and experienced known allergies. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: ER8727), via an unknown route of administration in left arm on 19Mar2021 (at the age of 51-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. No other vaccine in four weeks. On 17Apr2021, the patient experienced injection site pain, severe fatigue, severe urinary incontinence and headaches. Continued on day 3. No COVID prior vaccination. No COVID tested post vaccination. No treatment for event. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
1. Pain on inside right leg between knee and groin, enough it was waking me up during night several times. No pain on left leg. 2. Pain left arm elbow to shoulder 3. Low grade fever
On August 22, 2022, in the afternoon (approximately 1:00 p.m.), a vial was opened from which a 0.1ml ID dose was obtained and from which, due to confusion and error, 3 doses were administered the following day. After this I realize that the vial exceeds the stipulated duration time (8 hours) and proceeds to discard it. This situation was discussed with personnel from the health department who told us that this incident report should be completed. Immediately afterwards and after talking with our Medical Director, Dr., we have decided to make an appointment with our patients for the administration of vaccines in order to complete the number of doses and avoid losses. In this email I include the information of the 3 vaccinated patients. Any doubt, question or recommendation, do not hesitate to communicate I remain on the lookout. Patient does not present adverse reaction to incident.
Has continued to want to sleep all the time; Exhausted; 1st dose 12May2021; 2nd dose 25Jul2021; Got sick for 3 days, was in bed for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick for 3 days, was in bed for a week), SOMNOLENCE (Has continued to want to sleep all the time), FATIGUE (Exhausted) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 12May2021; 2nd dose 25Jul2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 12May2021; 2nd dose 25Jul2021). On an unknown date, the patient experienced ILLNESS (Got sick for 3 days, was in bed for a week), SOMNOLENCE (Has continued to want to sleep all the time) and FATIGUE (Exhausted). On 25-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 12May2021; 2nd dose 25Jul2021) had resolved. At the time of the report, ILLNESS (Got sick for 3 days, was in bed for a week), SOMNOLENCE (Has continued to want to sleep all the time) and FATIGUE (Exhausted) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient was reporting their experiences after receiving 2 doses of the Moderna Covid-19 Vaccine. The patient reported that post getting the 2nd dose the patient got sick for 3 days and was in bed for a week. The patient continued to want to sleep all the time and could stay up until a normal bedtime but was exhausted by the time the patient gets to bed. The patient also reported that they don't see a doctor regularly because they never used to get sick.
devel fever of 102-104 in few hrs of vax w/swelling & redness @ site of DTP; APAP given temp above 101; Pediaprofen given;
Day after vaccine given, awoke with slight headache.  Had significant fever and chills all day.  Slept most of the day.  By second day, symptoms were gone, although still a little tired.    Have had a similar reaction (although not quite as severe) to a tetanus shot, but only once, many years ago.    Allergies were fairly bad on the day I received the vaccine.
12 hours after  -- fever around 100 degrees F, chills, headache, body aches, nausea - cleared in a day. Sore at site of shot. 6 days after - still sore at site, but now red, rash, intense itching, swollen, and swollen lymph nodes under arm at the site of shot. This continues 5 days later despite treating with Benadryl and Aleve and topically with hydrocortisone cream.
PT STATED " MY CHEST FEELS LIKE ITS GETTING TIGHT AND MY TONGUE FEELS LIKE ITS GETTING THICK"
Patient was inadvertently given a Pfizer Bio-N-Tech vaccine instead of the Shingrix Shingles Vaccination. According to the patient's husband, the patient had already previously received two pfizer doses. No immediately adverse events observed.
I am pregnant and got the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant and got the vaccine) in a 31-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Ectopic pregnancy, Induced abortion (Induced abortion) and Alcohol use (Sporadically). Concurrent medical conditions included Sugar blood increased (Problems with the sugar(it's been monitored during pregnancy)). Concomitant products included OMEPRAZOLE from 22-Feb-2021 to an unknown date for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-May-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant and got the vaccine). The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) ongoing since an unknown date at an unspecified dose and frequency. On 26-Feb-2021, EXPOSURE DURING PREGNANCY (I am pregnant and got the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, Pregnancy test: positive (Positive) Positive. On 22-Feb-2021, Ultrasound scan: normal (normal) normal Everything fine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were unknown. Patient had cousin with Down syndrome. In Feb 2021, genetic test was performed results were normal, everything was fine. Patient had previous pregnancy which was ectopic pregnancy.
Headache, Myalgia, Arthralgia, Shortness of breath Narrative:  1/19/2021 Evening of second dose of vaccine had joint pain, headache, sore arm & body. 1/20/2021 & 1/21/2021 Pain at sire of injection, pain extending up neck. Shortness of breath (lungs clear, O2 SATS 98%, HR 90, BP 111/79).
This spontaneous report as received from a health care worker (also reported as medical assistant) refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 12-OCT-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L016959, expiration date 12-MAR-2018, dose and not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Received a vaccine after the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine after the 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine after the 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine after the 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The caller wanted to look up for an expiration date of a Moderna Covid-19 vaccine Lot number 042J21A. Agent entered Moderna's look up tool an provide the caller the expiration date 29Apr2022. Then, the caller asked how to proceed with a patient that received a vaccine after the 30-day Use By Date.   No concomitant medication was provided by the reporter.  No treatment was provided by the reporter.
Re-injured my back; Increased inflammation in my body overall due to the recent vaccination; He thinks that adding an injury on top of an already stressed system, is causing; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient reported that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 3249), dose 2 via an unspecified route of administration, administered on 17Feb2021 10:30 as single Dose in left arm for COVID-19 immunization. The patient medical history included attention deficit hyperactivity disorder from an unknown date, asthma from an unknown date, and have a lower back injury from Jul2015 and ongoing. Historical vaccination included the patient received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on 26Jan2021 as single dose  for COVID-19 immunization. The patient concomitant medications included loratadine (CLARITINE), amfetamine aspartate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL, bupropion hydrochloride (WELLBUTRIN). The patient experienced re-injured my back, increased inflammation in my body overall due to the recent vaccination, he thinks that adding an injury on top of an already stressed system, is causing on 20Feb2021. The patient aware that it should be reported late in the day of 25Feb2021 after an appointment with her physician. Since it was an injury and not an illness, or even expected potential side effect, she didn't attribute it as a possible link to the vaccine until she saw her doctor. She reported it as soon as she accessed her laptop following that appointment. The patient treating physician was not sure if her slower than normal healing was related to the vaccine or not, but he hypothesized that since she had recently been vaccinated, her body had an increase in inflammation. The patient treating physician thinks that adding an injury on top of an already stressed system, is causing the slower healing.The patient had taken flexeril and ibuprofen for reported events. The outcome of the events was resolving.   No follow-up attempts are needed. No further information is expected.
Given varicella, Hepatitis A, and MMR vaccines as 1 year immunizations.  Zostavax was given also.
Systemic: Dizziness/Lightheadedness-Medium, Systemic: Fainting/Unresponsive-Medium. Additional Details: Patient fell due to dizziness in the aisle after receiving his Moderna booster dose. Per mother, patient has fainted one other time in the past due to fear when having blood drawn. No injuries were sustained during the fall. Did not lose consciousness. Patient and family did not want to go to ER or have EMS called. Recovered immediately from the fall and asked to sit for observation for an additional 15 minutes. Provided with a glass of water and some pretzels during this time then left.
positive for COVID on 02Apr2022; positive for COVID on 02Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the medical information team. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), and on 18Oct2021 as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Apr2022, outcome "unknown" and all described as "positive for COVID on 02Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2022) Positive, notes: she was positive for COVID on 02Apr2022.  Clinical Course: The reporter is a 56 year old female patient. She refers having her first series of the Pfizer Biontech COVID 19 vaccine last year and then her first booster on 18Oct2021. After that, she was positive for COVID on 02Apr2022. She was asymptomatic, not even had low energy according to her. She asks if she should get her second booster now or wait some months before getting it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
13 days after receiving the injection my left arm at the site of the injection became very hot and red.  The red patch is about the size of a lemon and seems to be spreading.  I experienced no symptoms like this until today.  The only symptoms previously was a sore arm for a couple of days and some mild fatigue immediately following the injection.
start taking Paxlovid two weeks ago; start taking Paxlovid two weeks ago; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "start taking Paxlovid two weeks ago". Therapeutic measures were taken as a result of drug ineffective, covid-19.Patient states he had taken the Covid booster two years ago and had a bad effect on him. Started taking Paxlovid two weeks ago and is feeling very weak and not well. Therapeutic measures were taken as a result of drug ineffective, covid-19. Eight (8) months ago he came down with COVID-19 and was prescribed Paxlovid. Two years ago after getting a Pfizer COVID-19 booster he started having difficulty walking and started falling.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312112 same reporter/patient, different event;
Patient admitted on 8/30 with a PMH of multiple myeloma s/p bone marrow transplant, type 2 DM, and CKD stage IV. He was admitted with concern for acute encephalopathy, febrility in immunosuppressed state with lymphopenia and elevated lactic acid. COVID swab was done on 9/1 and patient was found to be positive.
Patient was given the wrong 2nd dose covid vaccine.  Patient received 1st Covid vaccine on 7/23/2021 of the Moderna.  On 8/20/2021 the patient was administered the 2nd covid vaccine, Pfizer.  Patient was monitored for 20 mins with no adverse reaction.
Administrative deviation only; no adverse event resulted from this deviation. This patient received a  mixed series  of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer-box#4 reflects the date  of the second dose).The decision to administer a mixed series to the patient was due to an "exceptional  circumstance" stemming form the unavailability of of the first vaccine product (Moderna) at the time the second dose was due.We understand that although CDC provides considerations for a mixed series in  exceptional circumstances (such as a vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires reporting.Note second vaccination date is listed.
I was positive for 01/28/2023. My wife had gotten it first, I did not have symptoms at first until she tested positive. I had no symptoms when I tested. The doctor started me on PAXLOVID. After taking the PAXLOVID I was extremely fatigue and a little sore throat. I feel like I recovered in about a week in a half.
Myalgia  delayed worsening of symptoms 72 hours following vaccine administration - left work
I started getting chest pains in the left side it felt like two fingers were poking my chest very hard it was very centralized, pharmacist offered me water I declined an ambulance was then called. I was taken to the Medical Center.
Swollen leg with redness, heat x 2 d diffuse papular urticaria rash legs, trunk, and scattered on arms.
Initial and follow-up information has been received from a physician concerning a year old female with no known allergies and a history of "occasional" migraines who on an unspecified date was vaccinated with the first dose of GARDASIL (yeast) (lot number 654540/0800F). Concomitant therapy included hepatitis A virus vaccine (unspecified). Subsequent to the first dose, the patient experienced fainting and "signs of seizure". Clinical outcome was not reported. On 20-DEC-2006 (also reported as 20-DEC-2007), the patient was vaccinated with a second dose of GARDASIL (yeast) (lot number 654389/0961F). On 20-DEC-2006 (also reported as 20-DEC-2007), the patient experienced fainting. Clinical outcome was not reported. Signs of seizure was considered an other important medical event. Additional information has been requested.
Patient reports "gritty vision", rash along upper chest, fever lasting ~48 hours. Also reports usual side effect of arm soreness. Patient reports she did not have this reaction from the first vaccine. States symptoms only started after vaccine was received. Patient has been taking Tylenol to treat fever. Said she already contacted doctor and was waiting on response. I recommended that if her doctor doesn't respond by the end of the day or if her symptoms worsen, she need to seek care this evening such as urgent care or if more severe, the ER. At this time, patient cannot report exact temperature of fever but states that it broke since she started Tylenol.
swelling and redness on both hands - no issues with breathing or swelling of throat, patient was given 50 mg of liquid diphenhydramine, swelling and redness started to calm down and reduce, patient was stable, she was observed for about 45 minutes since the time of her vaccine until she left the pharmacy
No additional AE information.; Improperly stored vaccines administered to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies,concurrent condition and concomitant medication were not provided.  Between August 2020-September 2020, the following temperature excursions occurred. The vaccines experienced: temperature excursion of 6.5 degree Fahrenheit for 45 minutes. It was confirmed that no precious temperature excursions occurred neither a digital data logger was involved. The temperature excursion was not reported before administering the vaccines to the patient.  On 05-AUG-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin(rHA)) (M-M-R II)(0.5 milliliter, lot # S014430, expiration date 09-MAY-2021, strength and route were not provided) and varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot # S030243, expiration date 26-SEP-2021, strength and route were not provided), both for prophylaxis (Improper storage of product in use). No additional adverse event (AE) information provided.; Sender's Comments:  US-009507513-2102USA008312:
Feb. 19 upon going to bed about 10:00; muscle aches in shoulders, arms, legs, knees. Feb 20 upon waking about 5:00AM; headache, continuation of pain muscles and joints, fever 101.3. Feb22 I don't know if related to vaccine, but fever blisters.
Patient  was vaccinated At 2:20 pm per protocol and monitored for 10 minutes for any adverse reaction. At 2:30 patient had a mild reaction, some erythremia down left the arm and swelling at the injection site. Mom was present verified allergies  again with mother, and then gave patient 4 tablets of children's Benadryl based on patient's weight @ 2:31 pm.   Checked vitals at 2:31 pm vitals were stable and remained stable BP: 116/87   Pulse: 72 Temp: 97.9    2:40 pm BP: 118/85 Pulse: 72 Temp: 98   2:45 pm BP: 117/87 Pulse: 74 Temp: 98   No respiratory distress noted. Patient was assessed at 2:50 pm. Patient did not have any difficulty breathing, as well as no other redness or swelling on the body or extremities. Instructed to patients mom if condition got worse to go to the nearest ER. Patient was checked out and discharged with no other problems.
T/C to Pt. States that she received her first dose of Moderna 03/19/21 and a couple hours later she got really tired and went to sleep. The next day she woke up feeling okay made some coffee then felt fatigued and went back to bed. For 2 days after the immunization she had pain accros her stomach. No diarrhea. States she does not have an appendix, but does still have her gallbladder.   Has had no appetite and states she hardly ate or drank anything for 4 days. She states that she was not nauseous, but all of a sudden had this "strange feeling of indifferent to life". States that her "mind felt fuzzy for about 7 days." Fatigue lasted for about 7 days. All she has been eating is soup, saltine crackers, and drinking Pedialyte. She states that the symptoms have slowly faded away, but even now she is having low energy and trouble with appetite.   Pt declined appt with PCP for evaluation.