chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from Merck Pregnancy Registry for GARDASIL from a health care worker concerning a her 15 year old daughter with hip dysplasia and two hip surgeries who on 25-OCT-2007 was vaccinated with a first dose of GARDASIL (Lot # 648563/1063U) 0/5ml, intramuscularly.  On 07-FEB-2008 she received second dose of GARDASIL (Lot # 655327/1287U) 0.5ml, intramuscularly.  There was no Concomitant therapy.  Patient had a baby on 17-MAR-2008.  Mother and baby were doing well and due to be discharged home on 19-MAR-2009.  There were no Laboratory Diagnostics Studies performed.  The patient was seen by the physician.  Follow up information has been received from a physician concerning a 15 year old pregnant female who on 25-OCT-2007 was vaccinated with GARDASIL.  Concomitant therapy included vitamins (unspecified) and NAPROSYN for pain in the III trimester.  There were no complications or infections during the pregnancy.  Subsequently, on 17-MAR-2009 the patient delivered a normal, healthy male baby weighting 3448 grams.  APGAR score was 8/9.  Additional information is not expected.
Eight days after the vaccination, the injection site became sensitive and felt like there was a hard ball under the skin. By that night, the site had become red, raised, and warm (like a rash) and felt itchy. Since then, it has become patchy/blotchy and has remained red, slightly raised, and itchy.  However, it does not hurt anymore.
Report 20010143451 described anaphylactic reaction in an employee of unspecified age and gender who received hep B vaccine for the prevention of hep B. Allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received a dose of hep B vaccine; it was known whether the vaccine had received previous doses of hep B vaccine. Subsequently, the vaccinee experienced an anaphylactic reaction. As of 06/11/2001, the outcome of the event was unknown.
3/27/03 Child had Varicella/DTaP.  Mother reports He was initally red & a little swollen.  On 4/8/03, injection site suddenly became red, swollen(1 1/2- 2 cm) with induration & vesicle.  No drainage noted.  childs twin also received the same injection without any reportable reaction.
EXPIRED VACCINE ADMINISTERED This spontaneous report received from a health care professional concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946811.
Following Day: Fever of 99.6 Fatigue Nausea Diarrhea  Lasted one day.
Approximately 12hrs after 2nd dose patient woke at 01:30 noted swelling of lower lip. He took 5Omg Benadryl PO at home and came to clinic Urgent Care. He was seen and noted to have large swelling of lower lip without tongue or throat involvement. Vitals stable. Given Solu-Medellin 40mg IM x1 monitored and discharged with Zyrtec10mg BID AND 1 week follow up.
Patient noticed a rash on her left arm, rash was red/brightly colored cluster near the top of the lower arm, lighter rash went down the bottom of the arm.  The rash was itchy immediately after vaccine administration - rash started showing about five minutes after.  small rash marks were noted o nthe right arem - upper, lower arm.  EMS provider administered 20ml of benadryl, put marks around the rash, and schecked stomach and back for rash.  Itiching stopped, rash stayed localized to original, monitored for 5 more minutes.  EMS staff administered additional 20 ml of liquid benadryl and added 15 more minutes to her wait time.  Monitored patient - rash color went down and stayed localized.  EMS staff let patient know if things get worse, what she should do.  Patient felt better, released at 5:45pm.
My husband and I were both fully vaccinated (Pfizer) last Apr2021 and boosted in Dec2021, yet we both contracted COVID-19; My husband and I were both fully vaccinated (Pfizer) last Apr2021 and boosted in Dec2021, yet we both contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Apr2022 as dose 4 (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: COVID-19 (medically significant) with onset 27Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "My husband and I were both fully vaccinated (Pfizer) last Apr2021 and boosted in Dec2021, yet we both contracted COVID-19".  Additional information: Description of Potential AE/PC: The patient and his wife were both fully vaccinated (Pfizer) last Apr2021 and boosted in Dec2021, yet both contracted COVID-19? (Him first, 27Apr2022, even after receiving his second booster on 15Apr2022). The patient's wife was symptomatic 30Apr2022, yet tested negative that day and 01May2022, but then positive 02May2022.She had been separated as best as possible from her (21-year-old) daughter, but curious to know if she'd qualify to participate?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bloody stools started day after vaccination and continued intermittently for 6 days - culture is pending but neg so far.
Within a few minutes after receiving vaccines, patient turned pale and collapsed with eyes rolled back, no seizure activity. Lasted less than 1 minute. Also lost bladder control. BP 106/75 P 71 O2 Sat 100% Re-check 83/55 90/62
Diffuse redness all over with whelps.  Ears red & swollen.  Rash appeared 30 minutes after shots.
A nurse reported that an 18 month old male received an injection of Prevnar on 6/29/00. The next day, he developed swelling, redness and pain in his extremities. The child would not walk. He recovered.
This is a spontaneous report from a contactable HCP (Nurse Practitioner or a Physician's Assistant) received via a sales representative. An adult female patient (in late 50's, early 60's) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on unknown date in Aug2015 at 0.5 ml, single. The patient medical history and the patient's concomitant medications were not reported. The patient experienced redness, itching and swelling. For the events the patient received steroids. The outcome of the events was reported as unknown. The events were assessed as important medical events.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with the improperly stored dose of M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer lot #FJ6369 with temp excursion. Reported to Pfizer company and ok'd for use. Instructed by their staff to report each dose given in this system.
PATIENT REPORTS THAT SHE RECEIVED A MODERNA COVID-19 BOOSTER VACCINE IN THE AM OF 11/19/2021. PATIENT HAD PREVIOUSLY RECEIVED 2 DOSES OF THE PFIZER COVID-19 VACCINE. PER PATIENT, BY THE EVENING OF 11/19/2021 SHE WAS EXPERIENCING LOCALIZED PAIN AT THE INJECTION SITE, FEVERS UP TO 102, CHILLS, FATIGUE AND MYALGIAS. PATIENT SEEN IN MINUTE CLINIC 11/22/2021 FOR EVAL. PATIENT REPORTING FEVERS HAVE RESOLVED AS OF THIS MORNING. PATIENT REQUESTED INFLUENZA TESTING. RIGHT UPPER ARM, SITE OF INJECTION, WARM TO TOUCH, TENDER TO TOUCH, MILDLY ERYTHEMATOUS AND MILDLY EDEMATOUS. NO INDURATION PALPATED.
received her booster dose earlier than the recommended time frame. Her second dose was 7/6/21. She is not immunocompromised.
Approximately 3:00 pm on 1/8/21 of my first vaccination, I started feeling very achy and the injection site started to hurt.  At 8:30 pm of the same date, I had a fever of 102 degrees, chills, severe body aches, headache and lethargy.  During that night, I experienced nausea and my whole left arm (injection arm) started to hurt a lot.  This lasted the entire next day 1/9/21 .  My fever finally broke that night.  I was still slightly achy and fatigued on 1/10/21.  On Monday 1/11/21 I was fine.
Severe vomiting, diarrhea, headache. I vomited hard at least 20 times in a span of 3 hours, diarrhea for 2 days, headache for 3 days, nausea continues since vomiting stopped. This started Sunday during the night and I still feel weak, nauseated and have a headache and this is Tuesday.
2/15/2021 -8pm - fever, body aches, weakness and fatigue, seemed o resolve after 24 hours, but during that following week, had forgetfulness, second week, forgetting was more frequent, by third week, daily and repetitive , can remember meds, Dr. names,  whereimportant papers are , why we were going to the Dr. or where his office is.......etc She says she knows something is wrong, id fearful to walk the dog "I might get lost", she cant remember how to lay cards or marjong, which she did weekly for years.  Saw PCP 3/10, went to hospital had CBC, CMP,, lipids, CXR, CAT head, UA,  EKG, discharged on aricept and told to make an Neuro appt for eval,, First available was mid April, went back to ER next day 3/11, condition worse,  "keep an eye on
injection site is severely itchy; injection site is bright red; right arm was red; right arm was hard; right arm was itchy; right arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (right arm was red), INDURATION (right arm was hard), PRURITUS (right arm was itchy), PAIN IN EXTREMITY (right arm was painful) and VACCINATION SITE PRURITUS (injection site is severely itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (right arm was red), INDURATION (right arm was hard), PRURITUS (right arm was itchy) and PAIN IN EXTREMITY (right arm was painful). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site is severely itchy) and VACCINATION SITE ERYTHEMA (injection site is bright red). On 02-Feb-2021, ERYTHEMA (right arm was red), INDURATION (right arm was hard), PRURITUS (right arm was itchy) and PAIN IN EXTREMITY (right arm was painful) had resolved. At the time of the report, VACCINATION SITE PRURITUS (injection site is severely itchy) and VACCINATION SITE ERYTHEMA (injection site is bright red) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: No new information was reported
pt very sleepy x 48 hr; no fever; awoke @ 48 & fine;
1" to 1 1/2" diameter slightly erythematous macule around injection site. Area is slightly pruritic and warm to touch. Pt noted reaction about 16 hours, post vax.
Strong taste of metal in her mouth; Tiredness; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6205), via an unspecified route of administration, administered in the left arm on 07Mar2021 14:45 (at the age of 70-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included mitral valve prolapse with regurgitation and contrast dye allergy. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to the vaccination. Concomitant medications included fish oil, alendronate sodium (FOSAMAX), colecalciferol (VIT D3), and an unspecified multivitamin. The patient previously took naproxen and experienced allergy. The patient did not receive any other vaccines within four weeks of the COVID-19 vaccination. On 07Mar2021 15:45, the patient had a strong taste of metal in her mouth. The patient called the pharmacy where she got the shot and the patient was told to take a Benadryl, which she did. The taste went away in about 45 minutes. The patient also experienced tiredness on the same day. The patient was not tested for COVID post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Received Flu shot from provider;  Administration of vaccine was extremely high on shoulder; Adverse reaction has included loss of function in the shoulder, excrutiating shoulder pain, weakness, stiffness and nerve inflammation.
3 episodes vomiting within minutes of injection accompanied by pallor and inattention. Resolved fully within 20 minutes.
Information was received from a 74 year-old male patient who was vaccinated with a dose of PNEUMOVAX 23. The patient reported that in September "my heart was bothering me, and I had nausea after receiving PNEUMOVAX 23. The patient was hospitalized. Additional information is expected.
After leaving office, pt. started crying with feet burning and itching. Proceeded to break out in rash all over with severe itching, vomited x 2.
Immediate taste and tickly/tingly feeling in back of throat that left tongue and back of throat feeling a little numb. This all lasted a couple of days. Face and neck were itchy for a couple days. Face became red and splotchy 7 hours later but only lasted 30 min.  Felt generally off for a couple days (tired, achy, nauseous, pain at injection site). Itchy rash and pain at injection site started 1 week later and lasted 3-4 days.
Patient called 24 hours after immunization, stating injection site the size of a dime & was red & raised. I told patient to take 2 BENADRYL & I would call Monday. Patient called Monday AM to say red spot is now size of her hand. Told patient to see MD that day. Pt saw MD.
then his heart hurt/ very slowly as when breathing normally his heart hurt; couldnt breathe at 100%/had to breathe at 50% like the hens; He stated that if he breathed strong, when his lungs are inflated, his heart hurt; headache; felt very painful/ his arm hurt , his body, his soul, his spirit hurt; Heart was inflamed; bone pain; felt dizzy; was in bed for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart was inflamed), BONE PAIN (bone pain), DIZZINESS (felt dizzy), BEDRIDDEN (was in bed for 3 days) and CHEST PAIN (then his heart hurt/ very slowly as when breathing normally his heart hurt) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced CARDIAC DISORDER (Heart was inflamed), BONE PAIN (bone pain), DIZZINESS (felt dizzy), BEDRIDDEN (was in bed for 3 days), HEADACHE (headache) and MYALGIA (felt very painful/ his arm hurt , his body, his soul, his spirit hurt). On an unknown date, the patient experienced CHEST PAIN (then his heart hurt/ very slowly as when breathing normally his heart hurt), DYSPNOEA (couldnt breathe at 100%/had to breathe at 50% like the hens) and PNEUMONITIS (He stated that if he breathed strong, when his lungs are inflated, his heart hurt). On 29-May-2021, CARDIAC DISORDER (Heart was inflamed), BONE PAIN (bone pain), DIZZINESS (felt dizzy) and BEDRIDDEN (was in bed for 3 days) had resolved, HEADACHE (headache) and MYALGIA (felt very painful/ his arm hurt , his body, his soul, his spirit hurt) outcome was unknown. At the time of the report, CHEST PAIN (then his heart hurt/ very slowly as when breathing normally his heart hurt), DYSPNOEA (couldnt breathe at 100%/had to breathe at 50% like the hens) and PNEUMONITIS (He stated that if he breathed strong, when his lungs are inflated, his heart hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication includes for back pain, blood pressure and blood pressure no treatment details reported.
Initial report received from a health care professional on 29 July 2008.  A 17-year-old female patient had received a dose of MENACTRA (lot number and route/site of administration not reported) on 27 June 2008.  Approximately one month post-vaccination, the patient experienced weakness-paralysis-like symptoms from the knee down and was also having difficulty in trying to inhale deeply.  The patient also reported that her toes were "jumping".  The reporter indicated a concern about Guillain-Barre Syndrome.  The patient underwent evaluation (not specified).  Evaluation findings and patient outcome was not reported.  No additional details were provided.
Tired; Fever; Chills; This is a spontaneous report from a contactable consumer (patients mother) via a Pfizer sponsored program Support.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 14May2021 the patient experienced tired, fever, chills. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The symptoms happened after a few days my throat started to hurt a lot & I still have the throat pain as I keep continuing typing this & my throat pains gets worse at night, it?s hard to pass down saliva, eat, drinking or even talking. I feel like there?s a rock inside my throat.
No additional adverse effect reported.; My daughter received the GARDASIL 9 shots at her wellness visits and not at the regular dosing schedule.; My daughter received the GARDASIL 9 shots at her wellness visits and not at the regular dosing schedule.; This spontaneous report was received from the patient's mother, referring to her daughter, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On an unspecified date in June 2018, 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) injection, one dose as prophylaxis (strength, route of administration, anatomical site of injection, lot number and expiration date were not reported). On an unspecified date in 2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, one dose as prophylaxis (strength, route of administration, anatomical site of injection, lot number and expiration date were not reported) (inappropriate schedule of product administration). On an unspecified date in 2020, the patient was administered the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, one dose as prophylaxis (strength, route of administration, anatomical site of injection, lot number and expiration date were not reported) (inappropriate schedule of product administration). No additional adverse effects were reported.
Chest pains, trouble breathing symptoms such as mycocardia , 80BPM  no irregular heartbeats just chest feels heavy and headaches near the back bottom of head. These symptoms I?ve never experienced before in my life and have been persistent 12 days after the vaccine to present date.
Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via intramuscular route of administration in the right arm on 01Oct2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Oct2021, the patient experienced below the injection site was red, warm, hard and tender. 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 not been tested for COVID-19. The clinical outcome of the events below the injection site was red, warm, hard and tender was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.