chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; Vaccine brand=Pfizer / BioNTech; vaccine dose number=1/ vaccine brand other=Janssen/ vaccine dose number=2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 13May2021 as dose 2, single (Lot number: 1805020) and on 23Oct2021 as dose 3 (booster), single (Lot number: 1822809) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 016J21-2A) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 22Sep2022 as dose 5 (booster), single (Lot number: AS7162B) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13May2021, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech; vaccine dose number=1/ vaccine brand other=Janssen/ vaccine dose number=2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Pfizer / BioNTech Vaccine lot number was 1805020 (as reported). Known allergies: none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vertigo, dizziness, brain fog, tachycardia, pounding heartbeat, nausea, feelings of anxiety
sharp pains in arm, & throughout the body shot area hot to the touch, knot @ the site;
Patient got a flu shot on 9/2/20. On 9/6/20, patient noticed redness, tenderness, and tightness lasting until the date of report 9/12/20. The vaccine site looked inflammed and was radiating heat. Potential infection identified.
Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 51-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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 21Jan2023, outcome "not recovered" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The event "since the vaccination, has the patient been tested for covid-19?:yes" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, an association between the reported events  DRUG INEFFECTIVE & COVID-19 and The suspected drug cannot be ruled out.
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022; No adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022).    Concomitant drugs were not reported. Treatment details were not given.  The patient was administered with Moderna COVID-19 Vaccine after 30-day use by date.  The vials were initially stored in the fridge on 08-Jul-2022. HCP was not aware of any symptoms for any patient after the vaccine was given.  The vial did not undergo any temperature excursions.
Vaccine adm. into L deltoid on 10-27-09 on 10-29-09 developed enlarged lymph glands in L axilla. One gland 1 1/2 x 1in and several smaller nodules.
This spontaneous report as received from a 67 year old female patient refers to herself with blood pressure and anxiety. The patient's medical history included heart attack 5 years ago. A week ago, on 08-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (dose, route and lot # not reported) in the left arm. It was reported that the next day on 09-AUG-2014, the patient developed sore muscles and aches in her joints, shoulders, knees and arms. The patient was treated with ADVIL. There was no lab diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. The patient did not seek any  medical attention. Additional information is not expected. There is no HCP's contact information.
Shingles; This is a spontaneous report from a contactable other health professional reporting similar events under the same suspect product for 4 patients. This is second of 4 reports.   An elderly patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was one of the 4 seniors that the doctor knewof that has had developed shingles on an unspecified date with Pfizer vaccine for COVID 19. The outcome was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481986 same reporter/drug, similar events, different patient
24/7 RINGING IN BOTH OF MY EARS. I NEVER HAD ANY ISSUES AT ALL WITH MY EARS BEFORE THE VACINNE AND NOW I HAVE A CONTSTANT RINGING IN BOTH OF MY EARS. IT IS SO OVERWHELMING AND I AM BESIDES MYSELF
31OCT97 430PM while driving car became very dizzy, & disoriented pulled over building & the road were moving for 10-15min;c/o tingling in lt leg from the foot to the knee lasted 10-15min;felt disoriented & apprehensive until 11PM 1NOV97;
Redness; Swelling; This case was reported by a nurse via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. On 22nd June 2019, 3 days after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovering/resolving.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced redness and swelling after 1st dose of Shingrix vaccine. Redness and swelling characterized by MD as grade 3 (about 100 mm). Antibiotics and prednisone taper were prescribed at emergency room.
Sore right arm after injection. Jaw pain right side, unable to open mouth or eat for over 24 hours. Right arm 2 weeks later still has a red rash like area and warm to the touch and painful.
A lot of Muscle Pain; Tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0180), via intramuscular route of administration, administered in arm left on 05Jun2021 (at the age of 56-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. The patient previously took first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via intramuscular route of administration, administered in arm right on 30Apr2021 (at the age of 56-year-old) at a 1st dose, single dose for COVID-19 immunization. The patient experienced a lot of muscle pain, tiredness, feeling unwell on 06Jun2021. Patient stated, I am just calling because the pains that they gave me when I got my shot that they report side effects. I got my second shot and I am having side effects. Patient stated, a lot of muscle pain, tiredness and just basically feeling unwell. Patient confirmed that he experienced the side effects after the second shot. The patient received Aspirin as a treatment medication for the events a lot of muscle pain, tiredness, feeling unwell. Outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Pt was administered the flu vaccine at 1:40 pm on 10/11/07. Pt reported following flu vaccine swollen lips and chest tightness. In addition, a diffuse rash appeared over his body that was itchy, pink and papular.
Sore arm immediately after. Fatigue on day of vaccine (Friday) and Saturday. Sunday evening diarrhea, chills, and nausea that lasted until 7am Monday morning.
No additional adverse effects reported; The nurse reported improperly stored doses of ROTATEQ, VAQTA, MMRII, PROQUAD and VARIVAX since 23-JUL-2020; This non-valid spontaneous report was received from a nurse and was referring to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  Since 23-JUL-2020, unspecified number of patients were vaccinated for prophylaxis with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number: S024844 and expiration date: 01-APR-2021); with Hepatitis A Vaccine, Inactivated (VAQTA) (lot number: S037574 and expiration date: 10-APR-2021); with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number: S035110 and expiration date: 03-MAY-2021, and lot number: S035105 and expiration date: 03-MAY-2021); with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number: S035354 and expiration date: 05-NOV-2021); and with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number: T000341 and expiration date: 05-JAN-2022, and lot number: T002843 and expiration date: 23-JAN-2022). Dosage regimen, route of administration and anatomical location were not reported).   The improperly stored of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), Hepatitis A Vaccine, Inactivated (VAQTA), Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of 0.2 C in the freezer and 11.9 C in the refrigerator for 4 hours and 20 minutes, without a previous temperature excursion and was call because a digital data logger. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient presented to clinic for 1st dose Moderna on 6/17/2021. Upon chart review, patient received Pfizer COVID-19 vaccine on 2/6/2021. The provider told the nurse, patient needs to restart the series and it was okay to administer Moderna. Nurse administered Moderna vaccine. Patient reported he had no symptoms after the Moderna.
CLOTS; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. 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, expiry: unknown) dose was not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter stated that, "Yep I got clots. Vaers did not even acknowledge they heard from me". On an unspecified date, the patient had clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221211513- clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
I have always gotten flu shot and it's always a little sore for a day or two. This time it was beyond sore that night and for about 3 days where injection went in. Then pain down the arm started. It goes into my hand. My range of motion has changed. It hurts to push, pull, lift. It for some reason really hurts at night while sleeping. I've never had such pain in my arm till this vaccine. I believe it was given to high causing some sort of nerve damage or inflammation in my rotator cuff. It hurts to wash hair, drive ect. This has become a constant problem now.
12/17/2020 at 1250 Pt complained of itching, noted slight red spots about circumference of  small tangerine on right hand, left lateral hand, and lower left leg, S/P  COVID 19 #1 Injection; about 5 minutes after injection.
Upon vaccine administration, and removal of syringe from the left deltoid, the patient bleed significantly more than 99% of other patient encounters, and bleeding persisted for about 10 to 15 seconds before clotting and application of a cottonball. Immediately, the injection site became visibly swollen, and hardened. The patient reported fast heart rate,  anxiety, and "seeing spots".  The patient remained very close to the immunization location and immunizer for more than 15 minutes of time. The injection site was inspected twice, and a noticable decrease in swelling and hardening had occurred during this time, however, still present. The patient remained near the pharmacy area for at least 10 more minutes, returned, and sat down near the initial immunization area. She reported that the palms of her hands had become very warm and very red, while tingling and numbness occurred in her left arm and left hand. The numbness and tingling seemed to subside over several minutes. The patient showed signs of lessened anxiety, and was able to return home, after being instructed to contact the pharmacy or a physician/medical professional if any serious symptoms remained after several days.
2 days p/vax pt had flu-like sx, chills, myalgia, local swelling, erythema, warm;pt states knows sx are from pneumovax site;
Pt is a 57-year-old female who is seen for evaluation of left arm lesion. Patient states she received an influenza injection on 10/3/18 in the left arm. Patient states the area overlying her left deltoid on her left upper extremity swells intermittently and becomes red and inflamed. Denies noticing any drainage. Denies fever, sweats, chills. States the area is worse with tender to palpation and rates pain 4/10.  I&D performed.
On 11/7/2006, Patient was administered Hepatitis B vaccine (dose #2) and Gardasil (dose #1), and developed severe nausea and vomiting approximately 12 hours later, lasting for approximately 1 hour.  Patient felt ill the following day, then recovered.  No rash, no fevers.  No other reactions.  No prior reactions to HepB vaccine.
Fever, body aches, chills, nausea, sore arm, and swollen lump nodes.
parent and patient wanted the jj vaccine since she was about to be 18 and she was over 250 pounds and the state of emergency to get vaccinations done it was decided to do the vaccine eventhough she was 17
Nausea & Vomiting x2 10min after recieving the shot W/ paleness and Mild Fever.
Diarrhea continue for a couple days, resolved for a couple days, and then returned for a couple more days before resolving; Dehydrated from the diarrhea; Stomach cramps; Headache; Migraine; This is a spontaneous report from a contactable other HCP (patient) via Pfizer sales representative. This other HCP reported information for two patients. This is the first of the two reports. A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose via unknown route of administration for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported diarrhea that began about 1 hour after receiving the vaccine. Diarrhea continued for a couple days, resolved for a couple days, and then returned for a couple more days before resolving. The patient was dehydrated from the diarrhea and also had stomach cramps the days that she had the diarrhea. Patient also reported headache/migraine since she received the vaccine. The outcome of the event Diarrhea was recovering. The outcome of other events was unknown.  Information on the lot/batch number has been requested.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received expired 1st dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 024C21A) for COVID-19 immunization. No medical history reported. On Jun 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 29, 2021, patient administered expired product (received expired 1st dose). On Jun 29, 2021, administered expired product (received expired 1st dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19  vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
PATIENT COMPLAINED OF DOUBLE VISION FOR 1 HOUR ON MONDAY.  EPISODE RESOLVED AND NO FURTHER ISSUES REPORTED
Patient came in with appointment for second dose of moderna vaccine which they received on 4/16/2021. Patient mistakenly signed up for pfizer vaccine using an online scheduling tool. Mistake was not found until weeks after incident when patient came in looking for a booster dose for their vaccination series.
Patient is a 75 y male who presents with Other (AMS). Per EMS, the patient was sent to the ECC for evaluation after the staff reports that the patient is "not acting right" and is "not as bubbly as usual". According to EMS, the assisted living facility has no heat and is sending certain patients to the ECC, whom they deem are unfit to go to a hotel. There are no complaints voiced by the patient at this time. Pt found to be COVID positive, placed in isolation
received the second dose one week short of the 6 month minimum interval for the 2-dose schedule/received a third dose of GARDASIL 9 on 19 Dec 2021; No additional AE reported; This spontaneous report has been received from a medical assistant referring to an adolescent patient of unspecified gender, who was 15 years old at the time of the report. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications and were not reported.  On an unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.   On an unspecified date, one week short for the 6-month minimal interval for the 2-dose vaccine scheme, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.  On 19-DEC-2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliters, once (route of administration and anatomical site of vaccination were not reported; lot number 1780867 has been verified to be valid, expiration date reported and established as 08-AUG-2023) as prophylaxis (inappropriate schedule of product administration).   The reporter enquired about available information if a patient received an extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event was reported (no adverse event).
Patient was standing at the checkout window when he fainted. Patient was in supine position and feet elevated for 10 mins and a cold compress. Was monitored in office for 45 mins.
Pt developed dizziness only upon standing approx 30 min after receiving vaccination. Denies SOB, difficulty breathing, chest pain, headache, lightheadedness. BP 170/90, repeat 146/82. HR 98. O2sat 96 RA. No symptoms while sitting.  Discharged home with daughter and spouse in stable condition.
Patient received Moderna vaccine dose 1 at approximately 2:30 pm on 4/14/21. After about 10 minutes, the patient had a syncopal event. 2 pharmacists quickly rushed over and aided in laying him on the floor. His feet were lifted off the floor and leaned against a chair. He was sweating profusely and his face was red. He has no prior history of fainting. He stated he only had a power bar to eat all day and has severe anxiety from receiving vaccines. After the patient started to feel better, he sat up on his own on the ground. He given a granola bar, chips, a soda, and some candy. After finishing the snacks, the patient sat in the chair and was advised to stay for at least an additional 15 minutes.
Fridge temp went out of range by 4 degrees overnight sunday due to storm, Facility closed on 1/17. Vaccines were administered to patients in the morning