chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE and no PQC; Physician calling for herself to report she received 2 doses of GARDASIL QUADRIVALENT and completed the series with a third dose of GARDASIL 9 in 2016.; Physician calling for herself to report she received 2 doses of GARDASIL QUADRIVALENT and completed the series with a third dose of GARDASIL 9 in 2016.; This spontaneous report has been received from a physician referring to herself as a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On unknown dates, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, anatomical location, route of administration, lot#, and expiration date were not reported). On an unspecified date in 2016, the patient completed the series with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, anatomical location, route of administration, lot#, and expiration date were not reported). Both vaccines were given for prophylaxis (interchange of vaccine products) (wrong product administered). No adverse event was reported.
Caller also states she developed gross hematuria twice after receiving unknown hepatitis B vaccine; Caller also states she developed gross hematuria twice after receiving unknown hepatitis B vaccine; pneumonia; This spontaneous report was received from a consumer, reporting on herself, who was a 74-year-old female patient.  Patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with unknown hepatitis B vaccine (potentially Hepatitis B Vaccine (Recombinant)) (manufacturer unknown) (dose, units, frequency, route of administration, lot#, and expiration date were not reported) for prophylaxis.  The patient stated she developed gross hematuria twice after receiving unknown hepatitis B vaccine (potentially Hepatitis B Vaccine (Recombinant) (manufacturer unknown). The patient also reported she believed she contracted pneumonia from her spouse who received an unknown pneumonia vaccine on an unknown day in October 2023 (reported as 3 weeks ago) (captured in #2311USA001866). At the reporting time, the patient has not recovered from the events.  The causality between the events and suspect vaccine was not provided.  Upon internal review, the event of pneumonia was considered to be medically significant.
This spontaneous report as received from a nurse refers to unspecified number of patients' of unknown demographics. On unknown date(s), the patients' were vaccinated with improperly stored doses of M-M-R II (lot # M045391, expiry date: 14-NOV-2018) (subcutaneous route) reconstituted with STERILE WATER DILUENT (details not reported) for prophylaxis. The doses were stored at a temperature of 0 to 1 degree Centigrade (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same reporter. Sender's Comments:  US-009507513-1708USA007422: US-009507513-1708USA007425: US-009507513-1708USA007438: US-009507513-1708USA007441.
I had a sore arm and a red lump which lasted two days after receiving the vaccine. On 12/18/2022 I began not feeling well with a runny nose, sneezing and I had slight temperature. On 12/23/2022, I tested positive for COVID-19. I contacted my doctor, and I was too late to start taking PAXLOVID. As of today, I still have a cough and a runny nose. Cough and runny nose.
started with metallic taste in mouth, progressed rapidly to clammy, light headed, elevated BP and HR. All of these progressed within minutes starting at 8:20 AM. Treated by drinking water, relaxation breathing, sitting for a half hour. Left the facility at approx 9:15 AM, but stayed close as requested and was told not to drive as still not feeling right, but better. As the day progressed, developed chills, fatigue, nausea, some shortness of breath, mild exacerbation of asthma- cough, then mild fever, runny nose, severe pain left arm. Symptoms finally moderated to just fatigue and body aches by the evening.  Took 2 puff sof albuterol inhaler and 2 advil in the afternoon. Woke the next day with left arm pain, fatigue and continued to treat with advil through the day.  Woke today, Jan 9 feeling normal. I did decline suggestion of going to the ER or my PCP when BP remained elevated at 11:30 AM on date of vaccination, chose to go home to self monitor.
pt recvd vax & 10 mins later became limp & sleepy & difficult to arouse; no cyanosis noted; VS remained stable & p/10 mins pt awoke & became active;
Two staff members read the micr wrong, we thought today's date was 09/28/2020 and it was actually 08/28/2020. it was misread, we did inform mother of information and the provider is aware as well.
Swelling to entire thigh, red, hard area 3" x 2" to injection site.
pt recvd vax & 14NOV92 exp flu-like sx, stomach pain which persisted for 2 days; On 16NOV92 devel facial edema;
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration: 07-May-2021 No concomitants and treatment drugs are provided.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of   in a 25-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No past medical history not provided) and Pregnancy (Pregnancy end date, Live full term birth  1 previous pregnancy) on 24-Apr-2018. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Morning sickness, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 30-Sep-2020 and the estimated date of delivery was 07-Jul-2021. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood test: was carrier for genetic disease with lip accumulat (Inconclusive) was carrier for genetic disease with lip accumulation.         On an unspecified date the patient had a normal ultrasound and anatomy scan,
Pt was administered expired flu vaccine consulted with district, state, and manufacturer, revaccinated 10/05/06 no problems from expired vaccine.
Patient complaining of redness, swelling, tenderness, and itching around injection site of Prevnar 13 (right arm). Advised patient to take Benadryl as directed and to contact us if the condition worsened or persisted longer than 7 days.
no immediate reaction after each shot other than mild pain at the injection site.. However, noticed an increase in systolic blood pressure after the vaccine series (last shot was the booster) was completed.  It may have impacted my blood pressure earlier but didn't notice until after the booster.  I started noticing an increase while using the gym's automatic bp machine.  I'm in pretty good health, on antihypertensive medication and under physician care  since age 39, weight is good, exercise regularly  so it was shocking to see my systolic bp measures going up.  So, I contacted by MD to get a professional bp reading to monitor the situation.  Sure enough, it was elevated. My wife and I had also started researching  this possibility that the covid vaccine was causing elevated blood pressure in some patients.  Turns out that there have indeed been numerous reports of this. And, it seems only associated with the Pfizer product.
Information has been received from a certified medical assistant concerning a 21 year old female with penicillin allergy who on 25-JAN-2007 was vaccinated with first dose of Gardasil (lot #654702/0011U), 0.5 ml IM in the deltoid. Concomitant therapy included Yasmin and Wellbutrin. On 28-JAN-2007, three days later, the patient woke up with a rash on her entire body. The patient sought medical attention. The patient took Benadryl, but it had not improved. The medical assistant reported that the patient stated the rash is the same over her entire body, the injection site is not any worse than the rest of her body. At the time of reporting, the patient's rash persisted. No further information was available at the time of reporting. Additional information has been requested.
Pt complained of feeling badly, Fever 101F swelling from swelling site to below elbow felt like had chicken pox w/out pox. Went to MD they gave him steroid shot.
Patient received her first dose of Pfizer Covid19 vaccine on 8/27/21 and her second dose early on 9/10/21
Information has been rec'd concerning a pt with peanut allergy who on 6/20/95 was vaccinated with varicella virus vaccine live. The reporter stated that the pt broke out with very mild bumps, almost acne looking bumps on 12/7/00. They were mainly on his forehead. The reporter contacted the pt's physician. The reporter also noted that her other son experienced headache. fever, and mild rash on 12/7/00. (WAES#010309241). additional information has been requested.
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, since 08-OCT-2015, the patients were vaccinated with doses of PNEUMOVAX 23, lot # L001311 with expiration date 06-JUL-2016, (dose and route of administration were not provided); which were exposed to temperatures outside of the recommended range. The reporter was not aware of any adverse experiences. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare professional (the administrator) via company representative referring to a female patient of unknown age. Information regarding the medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23, injection, 0.5 ml (lot#, expiration date and route were not reported). On an unknown date the patient experienced an unspecified adverse reaction after receiving the PNEUMOVAX 23, which resulted in the patient being admitted to the Emergency room and ended up in the Intensive Care Unit at an unspecified hospital on an unspecified date (hospitalization). The outcome of adverse event was unknown. The reporter considered the event as life threatening. Additional information has been requested.
Diarrhea; Nausea; Vomiting; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Mar2021 15:45 (Lot number: EN6202) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOESTRIN taken for contraception; ALLEGRA; ADVIL [IBUPROFEN]; TYLENOL.  The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional Information: The patient had no known allergies.The patient was not pregnant at the time of vaccination. It was reported that the patient did not take any other vaccine in the last four weeks. The patient never had Covid prior vaccination and was not tested for Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.
1st injection: 2/11/21 sore left arm for 24 hrs. 2nd injection: 3/11/21 7:30pm sore arm developed, became exhausted, slight headache & wheezing.  3/12/21 arm hurt, exhausted, headache, wheezing. In bed all day sleeping.  3/13/21 Walked 10,000 steps, tired, headache, wheezing during the day.  3/14/21 walked 10,000 steps. Feeling better. Then 5 pm began feeling achy, tired., bed 9pm. Awoke 10:30pm with nausea stomach pains. 12:30 am vomited. No more sleeping and increased wheezing.  3/15/21 no walk, exhausted and slept in bed all day.  Upset stomach.  3/16/21 no walk. felt ok until 10:30am. Became exhausted, increased wheezing and upset stomach.  3/17/21 No walk. Felt slightly better, did nothing but sat in chair. Increased wheezing, started Albuterol inhaler, upset stomach, slight headache.  3/18/21 no walk. Felt terrible , in bed all day sleeping. Headache, wheezing, called doc to renew Albuterol inhaler.  3/19/21 Felt good but still wheezing.  3/20/21 Wheezing but feel pretty good, so far.
body aches; lymph node soreness; Shot 1 - very sick for 3 days; fever; headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. This is the second of three reports. A 65-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Apr2021 16:00 (Lot number: EW0161) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no health issues other than extreme sensitivity to medications, migraines" (unspecified if ongoing). There were no concomitant medications. Past drug history included: None. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shot 1 - very sick for 3 days"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "body aches"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "unknown", described as "lymph node soreness".  Additional information: No other medications in two weeks and no other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient had no covid prior vaccination and not covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101647144 Same reporter, patient, product; Different dose, events;US-PFIZER INC-202101647145 Same reporter, patient, product; Different dose, events
Left armpit/lymph nodes swollen & sore for a week.  Did not report to Doctor as it was listed as a common side effect.
Patient described a severe rash at the injection site that increased over time.  Also had some fever, chills, and flu like symptoms.  Patient has had COVID previously.
12hours after shot -mild to moderate pain at injection site (no redness or swelling).    12/27/20 (day 5) Skin reaction to few mosquito bite (1 inch red spot around bites). Its the first time I react to mosquito bites.  Resolved overnight.  12/28/20 (day 6) Dark reddening around  both eyes (specially in eyelids) when removing my makeup.  Same routine/products as always.  Also resolved overnight.
Arm swollen, red and itchy at injection site and remains slightly so through today 2/8/21.
Moderna COVID-19 Vaccine EUA  I am currently experience tenderness in my lymph nodes under my left arm (injection arm). I did experience other side effects as well but this one more intrusive. I experienced soreness at the injection site for a few days and a headache.
INMEDIATELY AFTER VACCINATION, THE PATIENT DEVELOPED  DIZZINESS, SWEATING, AND TREMORS.  THE SYMPTOMS RESOLVED AFTER 30 MINUTES APPROXIMATELY.
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 16-JAN-2015, at age 60, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Postherpetic neuralgia. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the postherpetic neuralgia is unknown. Additional information has been requested.
Numbness noted in tongue and back of mouth/throat starting morning after injection. No other associated symptoms noted
Chronic kidney disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown". Clinical course: Caller has a schedule to get his booster tomorrow (03Oct2023), received a questionnaire from the pharmacy. One question is asking if he is allergic to Gentromicine. Caller mentioned that he has a Chronic Kidney disease and asking about the Gentromicine. Caller was already vaccinated with 1st and 2nd dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
IMZ given with no indication, gave PPSV23 should have given Prevnar 13, will give Prevnar 13 in 1 year.
Presents to clinic with 4" x 3" hard, warm and red, tender, edematous, (+) blanching area to posterior of right thigh. Seen 24 hrs after immunization. Redness: edema noted later in evening by mother.
Pharmacy called 9 days after injection to advise that they did not give the patient the 2nd dose of vaccine as requested. They gave her a booster in error. She has been sick with Fever, Chills, Body ache, stuffy nose since the day after.
Presented second day post shot, Left deltoid @ DTaP site, reddened  7 cm X 4 cm edematous, warm to touch, Denies pain, full ROM to right arm, Pt advised to return to office if worsens otherwise come in to office 07/29/02 for recheck, Resolved by 07/29/2002, no erythema, no redness , no heat
pt recvd vax 3MAR93 & hx of fever that noc-ER visit 4MAR93 w/t105.4; CBC, blood culture, chem 20 urinc cx & UA, CSF done;
consumer devel an itchy rash following vax; rash devel on hips, rt side of stomach, across the lower back & lasted for 3 wks;
Information has been received from a Ph.D. concerning a 20 year old female who on 08/05/2002 was vaccinated with hepatitis A virus vaccine inactivated.  It was reported that the patient's titer was drawn on 08/19/2002 (no results provided).  It was reported that the client was asymptomatic but in August 2002, she developed a slight elevation in liver enzymes with a serum aspartate aminotransferase of 61.  The reporter questioned if the patient's IgM could be positive two weeks post vaccination with hepatitis A virus vaccine inactivated.  Additional information has been requested.
This patient received the monovalent Pfizer COVID-19 (6 months-4 years) vaccine for doses 1 and 2 on 8/7/22 and 11/30/22 when he was 4 years old. He was scheduled for dose 3 at the injection center on 1/25/23 and was 5 year old at the time.  CDC recommends that patients who turn 4 years to 5 years and start the primary series with Pfizer?s 6 months-4 years formulation should complete it with the 6 month-4 years formulation even though they turn 5 years old.  Based on this, the patient should receive the bivalent Pfizer COVID-19 (6 months-4 years) vaccine as the 3rd dose to complete the primary series, however the patient was incidentally given the 5-11 year formulation.   Patient's parent and provider was informed of the error.  No adverse event reported yet by patient's parent following vaccination.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 15-JUL-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Awoke between 2am and 3am with chills and fever of 99.9f. The chills lasted about 15 minutes. I awoke two more times during the night with chills also. The fever persisted until about 5pm that evening. However, there were no more chills. I also had injection site soreness for about 36 hours.
Information has been received from a physician concerning a female patient of unknown age. On unspecified dates, the patient was vaccinated with the first and second doses of GARDASIL (Dose, route and frequency were not reported) (lot # not reported), and on an unspecified date, "one month early", the patient received intramuscularly the third 0.5 ml dose of GARDASIL (lot # not reported). No adverse effect was reported. Additional information has been requested.
The pt experienced fevers, chills, myalgias, extreme fatigue for 3 days starting 24 hours post vax. On second day, the pt experienced a pre-syncopal episode. Treated with Motrin. Symptoms resolved by day 5.