chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was accidentally given the incorrect vaccine product on 10.4.22, by CMA, when they presented to our Pediatric Department. She accidentally drew up and administered the Pfizer 12+ bi-valent 0.3 ml dose, rather than the Pfizer 12+ 0.3 ml dose for their second vaccine. Patient only received one dose prior to this vaccine, which was the Pfizer 12+ monovalent dose on 9.13.2022. They should have completed their primary series on 10.4.2022 with the Pfizer 12+ second dose monovalent. Due to error of being given bi-valent rather than monovalent, parent was notified that per CDC, as well as our vaccine safety team rep, patient should be vaccinated with the correct Pfizer 12+ 0.3 ml monovalent dose to complete their primary series. They do NOT have to wait any standard set amount of time between vaccines, per CDC and they should get vaccinated right away. Parent was advised of error. they will be coming back to the office within the next week or two to receive the correct dose. provider was advised. error was discovered next day after incident and investigated further, so on 10.6.22 and parent was advised right away via telephone call 10.6.22 of incident. no adverse effects were experienced in office after vaccine originally, and mom reported out via telephone call 10.6.22 no adverse effects at home either. CMA was counseled and coached by CNS 10.6.22 regarding vaccine safety and administration to prevent future errors from occurring.
On Monday I started to get nerve shocks on the left side of my foot to the top of my tooth. All on the left side. I noticed this was the same problem I had when I had the second Pfizer shot but had no idea that it was due to the shot.
R arm 5 1/2 x 7/14" redness and swelling, warm to the touch, (+) itchy, some tenderness. Tx: Motrin q 6 prn, Benadryl prn and ice to area.
After my 2nd dose of PFIZER COVID Vaccine on 1/27/2021, I started developing heart palpitations approximately 3-4 weeks after the vaccine. On 5/14/2021 I suffered a cardiac event at my place of work that entailed elevated blood pressure and heart arrhythmias.  Since this time, I have developed chronic heart palpitations, elevated blood pressure and diagnosed with heart valve disease with aortic dilation, I have no history of cardiac issues and have been a healthy woman prior to this vaccine. After doing some research, I felt it was best to report my case.
PATIENT EXPERIENCED A SEIZURE OF APPROXIMATELY 5 TO 7 SECONDS AFTER APPROXIMATELY 5 MINUTES OF VACCINE ADMINISTRATION.
Near syncopal event immediately following Flumist.  Patient had increased heart rate, decreased blood pressure, pallor, diaphoresis and disorientation, all self resolved.
Raspy voice, tightening of throat, sweating, flushed, tingling feeling in face, one elevated BP reading, shaking.  Received Diphenhydramine 50 mg IM at 1:20 PM
About 12 hours after imm's (DTAP, IPV). Fever 103, eyes burning, swollen, headache, stomach ache. Later through evening 5/13 -> 5/14 eyes rolled back into head, giggling, incoherent laughing. Improving by morning but inappropriate, agitated behavior persisted to a milder extent.
daughter tested positive for covid; daughter tested positive for covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 39 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 08Jan2022, outcome "recovering" and all described as "daughter tested positive for covid". The event "daughter tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: tested positive for covid.  Clinical course: It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient didn't tested for COVID-19.  No follow-up attempts are possible. No further information was expected.; Sender's Comments: Based on the information in the case report, a causal association between reported events vaccination failure, covid-19 and the suspect BNT162B2 is possible.
losing train of thought; constant headache in the right side of his head, even to the touch; constant fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of THINKING ABNORMAL (losing train of thought), HEADACHE (constant headache in the right side of his head, even to the touch) and FATIGUE (constant fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date. Concomitant products included METFORMIN for Diabetes.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced THINKING ABNORMAL (losing train of thought), HEADACHE (constant headache in the right side of his head, even to the touch) and FATIGUE (constant fatigue). At the time of the report, THINKING ABNORMAL (losing train of thought), HEADACHE (constant headache in the right side of his head, even to the touch) and FATIGUE (constant fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Patient reports that the bandage for her vaccine was a bit high on her arm. She felt right hand numbness and pins/needles sensation.
I20.9 ANGINA, UNSPECIFIED 4/6/2023 INTERSTITIAL LUNG DISEASE I20.9 ANGINA, UNSPECIFIED 4/6/2023 ANGINA, UNSPECIFIED
10/13/2017 - Developed maculopapular and vesicular lesions face/chest/back/arms. Low grade temp. Sore throat. 10/16/2017
Had covid 2 times; Had covid 2 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid 2 times".  Clinical course: The patient got vaccinated with all 3 vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacist concerning a 63 year old female with asthma, elevated cholesterol and an aspirin allergy who on approximately 03-DEC-2007 ("6 weeks ago") was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant drug therapy included ezetimibe (+) simvastatin (MSD), PREMARIN, TOPAMAX and an unspecified tranquilizer.  On 10-JAN-2008 the patient was diagnosed with shingles, located on the left side of her face in the temple area.  The patient sought medical attention through a physician's office visit.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested.
first Moderna dose on 2/18 but have not received my second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first Moderna dose on 2/18 but have not received my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first Moderna dose on 2/18 but have not received my second dose). On 18-Feb-2021, PRODUCT DOSE OMISSION ISSUE (first Moderna dose on 2/18 but have not received my second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive second dose since 12 weeks after the first dose. No treatment information, concomitant medication provided.   Reporter did not allow further contact
On an unspecified date,the pt received a dose of Lymerix.  Subsequently, he experienced induration the size of a golf ball, swelling, redness and tenderness at the injection site.  The most recent information received on 1/7/00 reports the condition of the pt is unknown.
Initial report was received from a health care professional on 08 December 2011. An 82-year-old male patient received an INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported). The reporter stated the patient had an allergy to the flu vaccine. The reporter further clarified the patient had a severe anaphylactic reaction to a flu vaccine. The patient is allergic to ampicillin, codeine, DEMEROL, morphine, sulfa and ANECTINE. The patient had a splenectomy. Concomitant medications were not reported. No further information was available at the time of the report. The outcome was not reported. Documents held by sender: none.
Headache, Myalgia, Arthralgia, Fever,  NauseaVomiting,  FATIGUE, INJECTION SITE PAIN  Narrative:  Other Relevant History:
Erythema, edema, tightness on outer aspect of right arm on 10/20/00. On 10/21/00, it worsened with erythema extending to inner aspect of lower right arm to fingers. Still some erythema but better mobility of hand on 10/23/00.
Wife called stating pt was experiencing chills, fever & achiness. Pt took phone, stated he was fine & informed me he would be hanging up & did. F/u call on 11/4, pt returned call & left message that he was fine.
1/11:motrin 800mg  1 hr prior to injection.  minor pain at injection site. no redness or swelling noted. 1/12: still minor soreness at injection site but around bed time , I noticed pain in my armpit and swelling( fluid filled area) around possible lymph node. Palpable lymph node along left clavicle with similar fluid filled swelling. Took motrin throughout the day and 50 mg of benadryl at bedtime. 1/13: Left arm pit still swollen. more tender with movement. While at work i put hot compress in my arm pit to help with the pain and shortly after i noticed my left arm had bright red streaks from my arm pit to my wrist. It also was very mottled looking. My arm felt tight/heavy  or kind of like a pinched nerve feeling.. I took motrin throughout the day for soreness and took benadryl at bedtime. I place ice pack under my arm during the evening as well.  1/14: Swelling remains in the armpit. Tenderness is getting better. Similar swelling around clavicle . Still taking motrin for inflammation and using ice pack under my arm.
Patient stated they were 18 years old on their form, and it was later found that they were 17 years old. They should not have received the vaccine, but were given it by mistake. No serious side effects
diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left arm between the elbow and the shoulder; positive for COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration, in Left Arm on Jan2021 around 10:30 or 11:00, (at the age of 76-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (Solution for injection) via an unspecified route of administration in left arm on Jan2021 around 10:30 or 11:00 (at the age of 76-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller is on doxycycline and a couple of other things. The patient has had the flu shot over the years. On an unspecified date, the patient experienced diagnosed with pneumonia; on 18Jun2021 positive for covid-19, drug ineffective; and on an unspecified date pain in the left arm between the elbow and the shoulder. The caller stated there were no Emergency room visits. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The pain in the caller's left arm between the elbow and the shoulder began about two hours after the caller received both the first and second dose Pfizer Covid 19 shot.  The patient stated that the pain in the left arm between the elbow and shoulder has gone away. On 18Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The caller clarifies he was tested for Covid on 13Jun2021 and received the positive test result today, 18Jun2021. The outcome of event pneumonia was recovering, and outcome for pain in the left arm between the elbow and the shoulder was recovered  and outcome for other events was unknown.  Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733999 similar report from same reporter
raised area on her arm at the injection site of the second dose of GARDASIL 9; This spontaneous report was received from a healthcare student concerning a 12 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not provided) for prevention of human papillomavirus.      On an unknown date, the patient experienced a raised area on her arm at the injection site of the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (injection site mass). At the time of the report, the outcome of the event was unknown. The causal relationship between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Right eye swollen; eye pain (slightly); eye feels itchy; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the arm left on 30Sep2021 at 09:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and high cholesterol. It was reported that the patient was not aware of her allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 01Oct2021 at 16:30, the patient experienced right eye swollen, eye pain (slightly) and eye feels itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 03Sep2021, the patient underwent nasal swab test and the result was found to be negative. The clinical outcome of the events right eye swollen, eye pain (slightly) and eye feels itchy was unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Patient with Moderna vaccinations, last dose 03/26/21, who admitted with COVID detected test for self harm behavioral concerns.  Asymptomatic for COVID during stay.
This spontaneous report was received from a licensed practical nurse (LPN) and refers a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M022947 with an expiration date 12-NOV-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Administered doses of PNEUMOVAX 23 experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 4 full days. There was no previous temperature excursion. A digital data logger was not in involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004379: US-009507513-1706USA004378: US-009507513-1706USA002585: US-009507513-1706USA004377:
The pointer finger knuckle on my right hand is very swollen and tender to the touch.  It hurts to do daily activities, including but not limited to holding a cup of water.  Additionally, my entire face broke out worse than I've ever had before.  I am still dealing with these adverse events.  My knuckle swelled up after the first dose then got even bigger and more tender after the second shot.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
hot to the touch; itching; very painful; big, red rash around injection site; big, red rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful), VACCINATION SITE ERYTHEMA (big, red rash around injection site) and VACCINATION SITE RASH (big, red rash around injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), CETIRIZINE for Allergy, LEVOTHYROXINE, METFORMIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 27-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced VACCINATION SITE RASH (big, red rash around injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful) and VACCINATION SITE ERYTHEMA (big, red rash around injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency; IBUPROFEN for Adverse reaction, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful), VACCINATION SITE ERYTHEMA (big, red rash around injection site) and VACCINATION SITE RASH (big, red rash around injection site) outcome was unknown.
Received first COVID vaccine. A few minutes after vaccine, arm felt abnormal, tingly, then 5 minutes after that felt lightheaded and tachycardic. Rapid response called while patient laid flat, transported to the ED. In the ED, vital signs were stable and was able to ambulate without problems.
Breakthrough case admission after 2 vaccines Moderna 4/6/21 Lot# 018B21A;  Moderna 5/5/21 Lot# 006C21
Pt presented to observation room post second Moderna vaccine @7 minutes post vaccination pt c/o intermittent left arm tingling from injection site through fingers with numbness of 3-4 phalanges. Site assessed-negative for bleeding, warmth, redness.  Pt with positive ROM capability  Pt advised to wait additional 15 minutes  Pt did report has similar intermittent symptoms since first vaccination though symptoms had subsided this past week.  Pt also reports has had intermittent vertigo, but negative for vertigo symptoms while in observation. Pt left for home independent, advised to all if s/s worsen and or any other s/s occur to call KP advice for further evaluation. Advised if arm is numb and or has vertigo while driving to park car and call advice/911 Pt verbalized understanding and agreed w/plan. RN
Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 17-JAN-2013 (lot number H011350, expiration date 21-FEB-2015) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Rash to whole body except for face and top of arms, red, itching and burning. Swelling and pain in her feet and hands.  Onset of symptoms 7 days after MMR #2 administered.  Sent to an Occupational Med physician for evaluation.  CBC, sed rate, and CMP obtained.
positive covid test  a month after getting the vacinne; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive covid test  a month after getting the vacinne) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive covid test  a month after getting the vacinne). At the time of the report, COVID-19 (positive covid test  a month after getting the vacinne) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: positive (Positive) positive.         No concomitant medication reported  Treatment information not provided
I developed a red, itchy rash at the injection site a FULL WEEK after the vaccination. I did not seek treatment.
Numbness in left arm and left leg.  left side of body.  Severe pain in left arm, triceps area.