chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This report is for 32nd patient of 37 patients.  A 72-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9266, expiry date was unknown), via an unspecified route of administration on 22Feb2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318, expiry date was unknown), via an unspecified route of administration, at an unknown administration site on 27Jan2021 as dose 1, single for COVID-19 immunization, at physician's office. The patient's medical history and concomitant medications were not reported. On 09Aug2021, the patient was tested positive for Covid virus, after being fully vaccinated (covid-19 confirmed by positive covid-19 test). Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included Antigen COVID-19 test on 09Aug2021, with positive results. Also, the patient had body mass index: 27.5 (calculated on an unknown date). On an unknown date, it was reported that the reporter had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided EN5318 and there was an investigation assessment, and a product complaint was initiated. The outcome of the event was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
p/vax pt exp swelling, redness, soreness, pain at inj site arm past elbow; f/u information indicated react due to poor inj technique; pt condition resolved
Booster dose of 0.25 mL given too soon (4 months after 2nd dose, instead of 6 months). Pt received primary series Moderna doses in June 2021 and August 2021.
Pt recvd 2nd dose of vax 14FEB91 @ 1/2 dose to minimize the risk of adverse exp; pt did exp dizziness which was not as severe as 1st dose; on 18MAR91 recvd 3rd dose & did not have any adverse exp;
Severe Stomach Pain, Severe Lower Back Pain, loss of Appetite, no sleep ... Over 60 hours of adverse sudden onset effects.
21 yo developed LE weakness on 12/26 that spread distal to proximal over the next day resulting in flaccid paralysis of his body up to the neck. He was intubated, placed on mechanical ventilation and cared for at Hospital. He remains hospitalized. Previous history of URI x 3 weeks. One other admitted with GBS last week.
Per telephone from client- reporting developing a rash. Described as red raised area approximately size of a "pencil eraser". Rash located on back, stomach, arms and legs.
Diarrhea; This is a spontaneous report received from a contactable consumer (patient) reported for herself that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8729) via an unspecified route of administration, administered in upper left arm on 03Apr2021 as single dose for covid-19 immunisation. Medical history included blood pressure (disorder). Concomitant medications included couple of unspecified medications. Patient previously received first dose of BNT162B2 (lot number looked like 6205 as reported) on 13Mar2021 at the age of 72 years for covid-19 immunisation. The patient had the Covid second dose on Saturday and last night (04Mar2021) she had a reaction. She had diarrhea for all night long. Patient wondered if it's not one of the listed side effects as well as how she should handle this, if she should be taking something for it or she should see her doctor. She confirmed no treatment was taken for the side effects. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
1 Pfizer dose administered after pt received 3 Moderma doses (1 initial dose, 1 secondary dose and 1 booster dose).  There no adverse events after vaccine administered.  Pt waited 15 mins after adminstration,  Healthcare assessment: pt denies c/o discomfort, and /or pain, ambulates w/o difficulty.  Pt advised to report to Emergency room for symptoms of  itching, hives, swelling, shortness of breath, dizziness, abdominal pain, confusion, aggressive behavior
patient stated she got hives starting 1 day after administration.  she took benadryl to help with the hives
Pt presented ~17 hrs after administration of MMRV, DTaP, IPV (4 yr vaccines) w/ 3-4 min episode of suspected seizure (GTC). Slight temp to 38.1 afterwards. Fully recovered.
Got first dose Pfizer  12/28/2020 Tested positive for pregnancy with @ home test on Dec 30, 2020 Got second dose Pfizer 1/20/2021 Had first ultrasound showing 5 weeks 6 days on Feb 2, 2021; no heart beat detected Had second ultrasound showing 5 weeks 6 days on Feb 23, 2021; no heart beat detected
itch at the injection site; raised bumps at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (itch at the injection site) and INJECTION SITE MASS (raised bumps at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (itch at the injection site) and INJECTION SITE MASS (raised bumps at the injection site). At the time of the report, INJECTION SITE PRURITUS (itch at the injection site) and INJECTION SITE MASS (raised bumps at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient called today and informed us that the day after she got her first dose of the Pfizer vaccine, she woke up and had facial swelling. She went to the hospital and was treated for the reaction and the doctor recommended for her not to get her second dose of the vaccine. Patient felt fine afterwards.
Adverse reaction on left thigh, 10x9 cm, reddened and warm. Treatment plan includes ice and BENADRYL.
Patient had booster dose of Moderna COVID vaccine at the hospital Tuesday. After he went home became weak. He tried to get out of bed and had difficulty moving and lowered himself to the floor.  Since that time he was on the floor for about 2 days as was too weak to get up. Family was trying to reach him and patient was not answering his phone and today went to his home and found him on the floor and called EMS.
SHAKING/DIZZY/IMBALANCE/DISORIENTED/CONVULSION; CHILLS; This spontaneous report received from a patient 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced shaking/dizzy/imbalance/disoriented/convulsion and chills. After about 48 hours later the patient reported that the adverse event did not get resolved and in addition the patient felt dizzy, experienced imbalance and disoriented. Through call it was not possible to provide medical advice for which he was upset and he was asked to get in touch with local HCP.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and shaking/dizzy/imbalance/disoriented/convulsion. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422232-covid-19 vaccine ad26.cov2.s -CONVULSION. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
GAVE ADULT DOSE OF 0.3 MLS TO A 10 YEAR OLD (SHOULD OF BEEN 0.2 MLS)
CLIENT BECAME DIZZY 10 MIN AFTER DOSE ADMINISTERED WITH FRONTAL HEADACHE.
Left neck gland connecting to left ear is swollen and earache.  Has lessened everyday.  Almost gone at this submittal.  Self care,  325 mg aspirin first day.  Nothing taken since.
I received my second Covid Vaccine on 2-22-2021 I had no symptoms just the usual anxiety so just tingly, I did not report this to my nurse there with me at the time because I believed it to be my usual anxiety attacks I get. The next day 2-23-2021 I noticed the left side of my face feeling rather numb and two of my fingers on the left side kinda numb as well. I am still experiencing these symptoms as of today not as severe as before.
Pt received J and J vaccine previously for her first dose, then received Moderna today for booster.  After 5 min, pt states feels "headache", tightness in upper chest area.  No resp. distress.  No itching or hives. Pulse 84 and regular, O2 Sat. 98%.  Pt talkative and oriented x 3.  BP 82/47.  Given cool water to drink.  Vital signs after 1 min:  BP 100/56, O2 sat 98 %, Pulse 88.  Vitals:  BP 116/59.  O2 Sat. 97 %, pulse 82. Pt states "feeling better" after 5 min.  HA gone,  denies chest tightness or discomfort.  No resp. distress.  Pt alert, talking, moving extremities without difficulty.  Pt remained with staff for additional 15min.  No sx. at that time.  Pt discharged to home.
Blood Pressure dropped very low; Tingling; Flushed; This is a spontaneous report from a contactable consumer reporting for his cousin. A male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 20Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included the patient previously received the meningitis vaccine on an unknown date. Concomitant medication were not provided. The patient did not have any known allergies. On Jan2021, the patient experienced blood pressure dropped very low, tingling and flushed. He has reported similar reaction to the meningitis vaccine when he received it. The outcome of the events blood pressure dropped very low, tingling and flushed was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
ADMINISTERED DOSES TO PATIENT BEYOND THE 2 HOUR RECOMMENDED STORAGE WINDOW; This spontaneous report received from a pharmacist concerned a 23 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient have no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced administered doses to patient beyond the 2 hour recommended storage window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered doses to patient beyond the 2 hour recommended storage window was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. Patient's concurrent conditions or historical information were not reported. On an unspecified dates in February 2015, unspecified number of patients were administered with six doses of GARDASIL (lot# K009202, expiration date: 17-DEC-2016), 0.5 ml, intramuscular, (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range. No adverse effects reported. Follow up has been received. The nurse stated that 5 patients received doses of improperly stored GARDASIL (lot#K009202, expiration date: 17-DEC-2016). Additional information was received from the registered nurse, concerning one out of five patients, namely a 13 year old female patient. She was vaccinated with improperly stored (temperature excursion) GARDASIL (lot#K009202, expiration date: 17-DEC-20160, intramuscularly on 17-FEB-2015. This one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
This spontaneous report was received from a medical assistant referring to a 12 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml (dosage schedule, route and anatomical location were not reported), lot # R024008, expiration date 15-NOV-2018, indicated for prophylaxis. No adverse effect was reported.
Patient reported having advanced heartburn, starting 28 hours after second dose of monitoring the vaccine, and although she has history of chronic reflux and heartburn, this was a dramatic change that was severe enough to require emergency room visit
Patient received Covid Vaccine booster 60 days after monoclonal antibodies, instead of recommended 90 days. Patient did not have any adverse events.
7/19/21: Head itching following 9am vaccine, eyes started burning at noon, canker sores and red spots in mouth 10pm. Vision issues when tried to read print on electronics.  7/20/21: Tongue swelling around noon. Was so weak could barely walk across the room. Was put on dexamethasone for 3 days and started benadryl.  7/21 - 7/23: Completed dexamethesone. Continued to be very weak, dizzy, skin on entire body turned red.  7/25 - 7/26: Extreme fatigue, attack acardia, so weak couldn't walk across house and bed ridden.  7/27 - 7/30: More canker sores and red spots in mouth on inside of cheeks and swelling and on lip. Inner cheeks and lip top layers peeled off. Eyes turned red and crusty  with stringy puss, legs and skin on back and chest felt like they were burning. Developed rash on hands.  7/31 - 8/18: While standing or walking felt like collapsing. Fell 4 times when standing still or walking. Very limited stamina to be able to walk more than a couple of houses (day before vax ran 4 miles and regularly run 5 miles a day). Had d-dimer test and leg ultrasound to rule out bloodclots. Had repeated ultrashound of both legs because blood is pooling in feet and they are turning bright red and purple and dark gray. Still cannot walk my dog or run. Doctor said may have induced condition called POTS.
Patient already had a bivalent moderna in October of 2022 that was not discovered until after shot was given.
Little pain in her arm.; This is a spontaneous report received from a Pfizer sponsored program. A contactable female consumer (patient) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. Patient previously took Celebrex (discontinued taking her daily Celebrex for two days before her vaccine). The concomitant medications were not reported. Patient stated that she received her 1st COVID vaccine last 09Feb2021 and she said she was advised not to take celebrex. She asked if this would affect the efficacy of our vaccine. She also felt a little pain in her arm. Patient asked can she take her celebrex around her vaccination or is this recommendation the same for the second dose.The outcome of the event pain in her arm was unknown.  Information about batch/lot number has been requested.
Swelling, erythematous, hot, 3/12 cm. TX: KEFLEX, BENADRYL. Cool compresses.
Pt. states that after receiving the 2nd dose of Phizer 04/09/2021, started experiencing symptoms 04/23/2021 of swelling in the hands and joints, and difficulty closing hands. Primary visit *Unknown recommendation just observation.
This spontaneous report was received from a physician and refers to a 12-month-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-AUG-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N001527 with expiration date on 13-JAN-2019 (dose and route of administration was not reported). A properly stored dose of MERCK STERILE DILUENT (dose, route of administration, lot number and expiration date were not reported) was used to reconstitute the dose of the vaccine. There was no adverse effect reported. The administered dose of the vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 47 minutes. There were no previous excursions reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of 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 physician concerning a female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced fever and depression after vaccination. No further information is available.
Patient received Moderna COVID vaccine on 3/16/21 (lot # 040A21A), 4/3/21 (lot # 027B21A), and 9/14/21 (lot # 004F21A). On 5/10/22, patient admitted to our inpatient facility due to COVID-19 positive with generalized weakness, ESRD on PD, mild hyponatremia, and anion gap metabolic acidosis. Patient was discharged home on 5/12/22.
Hot, Red, sore and a 4 cm in diameter redness; Hot, Red, sore and a 4 cm in diameter redness; Hot, Red, sore and a 4 cm in diameter redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID prior vaccination Yes. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SINGULAIR; ROSUVASTATIN. Vaccination history included: BNT162b2 (Dose 3 (Booster), Single, Lot No: FJ8757, via an intramuscular at arm Left), administration date: 10Dec2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot No: EP6955, via an intramuscular at arm Left), administration date: 24Mar2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Lot No: EL3248, via an intramuscular at arm Left, Time: 14:00), administration date: 03Mar2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "Arm soreness at injection site", "Slight headache", "Fatigue". The following information was reported: FEELING HOT (non-serious) with onset 20Oct2022 at 09:00, outcome "not recovered", ERYTHEMA (non-serious), PAIN (non-serious) all with onset 20Oct2022 at 09:00, outcome "not recovered" and all described as "Hot, Red, sore and a 4 cm in diameter redness". The events "hot, red, sore and a 4 cm in diameter redness" required emergency room visit. Therapeutic measures were not taken as a result of feeling hot, erythema, pain.  Additional information: Patient had no known allergies. Patient received no other vaccine in four weeks. COVID prior vaccination. Patient did not get COVID tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Patient is 16 years old and received Moderna vaccine. Mom says the patient did not have any complications.
Burning at injection site both during time of injection and on occasion daily, 4 days after. Inflammation at the injection site > 4 days after. Headache 1-2 days after. Vaginal yeast infection that initiated in the evening 2 days after vaccination. No other possible causes at least 6 weeks prior, same day, or any days after vaccination.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
reC'D BOOSTER APPROX 1600. aT 2200 STARTED HAVING SEVERE HEADACHE; SEVERE EYE PAIN AND NECK PAIN AND SPINAL CRD PAIN. pAIN WAS LIKE SWELLING/INFLAMMATION. cOULD HARDLY MOVE MY HEAD. cOULD NOT GET OUT OF BED. fEELINGS OF IMPENDING DOOM. fELT LIKE i WAS GOING TO DIE. sYMPTOMS LASTED APPROX 12 HRS. ALSO WITH THIS i HAD MUSCLE ACHES; FEELINGS OF CHILLS AND FEVER. AFTER 12 HRS. SYMPTOMS WERE MORE LIKE THE 1ST 2 DOSES. jUST MILD MUSCLE ACHES AND SORENESS TO INJECTION SITE.