chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received regarding a case in litigation from a lawyer, a 69 year old male patient, and his wife. 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 15-JAN-2010, the male patient was administered the ZOSTAVAX by a healthcare provider at a health department (lot number, dosage and route of administration not provided). On or about 20-JUL-2010, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claims damages as a result of the ZOSTAVAX including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Arm turned a "dark plum" color, swollen, unable to lift the arm.  Advised to take patient to the doctor.
Pt received DTaP #4 5/10/08-> 5/11/08 with swelling and redness at vaccine site -> 5/12/08 with rash all over. Subjective fever per mom. Pt brought into clinic 5/16/08: Temp=99.6, on exam with diffuse urticaria. Rx'd Benadryl 12.5/5mg one tspn Q6 hr prn and Hydrocortisone cream. Will follow up in clinic 5/20/08.
It started with a sore throat and mild malaise. I also had some nasal stuffiness and sneezing. The following morning, I developed a cough. I took a COVID-19 test. The result was positive. I called my doctor. She prescribed Paxlovid. I started it that afternoon. After 48 hours, I was on the mend and the symptoms were almost gone. By the last dose of Paxlovid, the symptoms resolved. After 48 hours, the cough came back, but it was mild. It was completely gone in about a week.
This spontaneous report was received from a healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patients received improperly stored GARDASIL 9 (lot # M007764, expiry date: 30-JAN-2018; lot # M021407, expiry date: 30-APR-2018 and lot # M018810, expiry date: 28-MAY-2018). She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the several reports received from the same reporter. Additional information has been requested.
having a fever; This is a Spontaneous report from a Pfizer sponsored program Support. A contactable consumer or other non-HCP (wife) reported for patient (Husband). A male patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on 09Apr2021 as DOSE 2, SINGLE for covid-19 immunization. The relevant medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient having a fever. The caller reported that, her husband got the second dose yesterday which is 09Apr2021 and received the first dose 3 weeks ago. Caller did not mention the date of the first dose. Her husband was having a fever and she was getting information if her husband can take Tylenol. Outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Erythema and swelling 6 1/2 inches x 6 inches. Right deltoid.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 28-AUG-2014, the patient received VARIVAX (Merck) lot number J014400, expiration date: 13-NOV-2015 (dose and route were not provided), which was improperly stored on 05-AUG-2014 at 11:18 am for 3 hours 10 minutes. Other suspect and concomitant therapies were not reported. No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
My arm was very swollen, red, hot to the touch, painful, could not lift.Then I went into 36 hour of chills, heart racing, fever of 101.5 to 102, paleness, weakness. I still do not have my full stamina back. It was bad. I have never had a reaction like this to a flu shot, and may consider, not getting the swine flu shot this year, or the regular flu shot next year, contrary to recommendations. My arm is still swollen,and feels like I have a bad sunburn,and now it is spreading down my arm. My doctor said to ride it all out, as they were hearing of many reaction. If I had to do it over, I would have gone in for the office visit or ER. I probably should have been admitted. Tylenol was of only short mild comfort, and the fever spiked again.Being on coumidin, made this all very difficult, as I can not take asprin, and very limited Tylenol. The shot this year, was too scary for comfort. I wonder when I will feel completely better.
All day on 13JAN91 pt cried occassionally consolable. At 5PM 14JAN90 pt had hypotonic-hyporesponsive episode lasting second.
I have another episode of Iritis, more painful this time.; I have another episode of Iritis, more painful this time.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 09Apr2021 11:00 (Batch/Lot Number: ER8731) as a single dose for covid-19 immunization. Medical history included HLA-b27 positive, iritis and allergies to some processed flours allergy. The patient has not been diagnosed with Covid-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 59-year-old in the left arm on 19Mar2021 11:15 AM (lot number: EN6204) for COVID-19 Immunization but had iritis flared up. Concomitant medications included brimonidine tartrate (BRIMONIDINE TARTRATE) taken for an unspecified indication, start and stop date were not reported. The patient received the most recent vaccine from the public clinic/administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As reported after first COVID shot, the patient had iritis flared up and had another episode of Iritis on 10Apr2021 06:30 AM which was more painful this time. The patient has not been tested for COVID-19 since vaccination. The adverse event did not received treatment and was considered as non-serious. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbearable pain in that arm. Ended up with a trip to the ER with diagnoses of cellulitis to the right arm, (same as vaccinated arm). Currently taking antibiotics.
This spontaneous report as received from a physician refers to a 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 07-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on 12Apr2021 at 15:00 (batch/lot number: EW0153) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient was not pregnant. The patient has no known allergies. There were no concomitant medications. Historical vaccine included BNT162B2 first dose on 22Mar2021 at 01:30 PM (batch/lot number: EP7534) administered in the right arm for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced urinary tract infection: group B strep on 16Apr2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of urinary tract infection: group B strep which included antibiotic, Macrobid. The outcome of the event was recovering.
This nurse administered a 0.3 ml of pediatric Pfizer COVID vaccine rather than 0.2 ml, as required, to the  client's left deltoid. Client tolerated injection without incidence and denied any pain or discomfort at anatomical site while in clinic.   No treatment given. Client's parent informed, through interpreter, follow up with physician or take client to emergency department should client experience fever, generalize fatigue, or symptoms of respiratory infection that does not subside within 48 hours. Client's parent verbalized understanding and released to check out.
Redness, swelling and a nodule. Gave .4 Tylenol and warm compresses for 2 days.
I was rooming the patient and i offered them the covid vaccine, i offered pfizer and J&J and they wanted a one time dose vaccine so i gave them the paperwork to fill out and it totally slkipped my m,ind that the patient was turning 18 in 4 months, My coworkerl ended up giving the vaccine and then we realized the pt was 17 and we made a mistake so i myself went and spoke with the mother of the pt and explained on how i made a mistake. The mother was very understanding and was okay with the mistake, there was no adverse reactions
COVID infection; COVID infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (pregnant) received BNT162b2 (BNT162B2), 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 is expected to deliver a baby(s) on 29Nov2021. 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 01Jun2022, outcome "recovering" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive, notes: covid test type post vaccination= Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive other vaccine in four weeks and not had covid prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse practitioner concerning a female who on 05-SEP-2008 was vaccinated with the second dose of GARDASIL and on 25-NOV-2008 she received her third dose. She was recently tested positive for HPV. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
196 Patients received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received narrative updated.
Soreness in small area in right armpit crease; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm right on 27Apr2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 07Apr2021 at 15:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021, the patient experienced soreness in small area in right armpit crease (armpit pain). Therapeutic measures were not reported. The clinical outcome of the event soreness in small area in right armpit crease was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
severe headache, longer than 24 hours unalleviated with tylenol, nausea and vomiting, chills, hot flashes
Devel local rxn to rt upper arm about the size of a baseball; no abscess felt warm but temp not taken; rxn 1st noticed on 25APR PM; no rxn present when called for 7 day f/u;
FEELING LIKE COVID SYMPTOMS; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced feeling like covid-19 symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling like covid-19 symptoms. This report was non-serious. This case, from the same reporter is linked to 20210438886.
Pt received Pediarix, PCV, Hib, Rotateq at 1835. At 1840 parents reported pts legs were red. Assessment BLE bright red. Pts face and head also bright red. Dr notified and Benadryl given at 1844. no s/s respiratory distress. Pt left at 1910 and skin color normal.
On about Day 3 after my first dose, my arm felt back to normal, and I had no other side effects other than a tender arm for the first 3 days.  But one week after receiving the first dose, my arm started to itch around the injection site.  It was inflamed, swollen, itchy, and hot to the touch.  It didn't really hurt, though it was a bit tender, but more itchy than anything.  It is no longer itchy or hot to touch, but there is still a bit of redness and some swelling one week after I first noticed the reaction, so it's been now 2 weeks post first dose.  But I've had no other symptoms.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with public health and environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Agency is working with public health on a compliance improvement plan and has been reinstated vaccination privileges.
Localized muscle pain and tenderness at the injection site; Fatigue; Loss of appetite; Nausea; Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Mar2021 11:30 (Lot number: EN6205) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Neurological functioning disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pineapple allergy" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; VYVANSE; PREGABALIN; MONTELUKAST. Vaccination history included: Bnt162b2 (1st dose, Lot number: EM9809, Administration time: 09:00 AM, Vaccine location: Left arm), administration date: 12Feb2021, when the patient was 25 years old, for COVID-19 immunisation, reaction(s): "Tired/Fatigue", "Slurred Speech", "Red skin on hands, face, neck", "Balance problems", "Dizziness", "Swollen hands", "Severe flu like symptoms", "Vertigo", "Full body muscle aches", "No appetite", "Temperature was slightly elevated (98.7) from my "baseline,"  which is around 96.7". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Mar2021, outcome "recovering", described as "Localized muscle pain and tenderness at the injection site"; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Fatigue"; DECREASED APPETITE (non-serious) with onset 06Mar2021, outcome "recovering", described as "Loss of appetite"; NAUSEA (non-serious) with onset 06Mar2021, outcome "recovering", described as "Nausea"; VERTIGO (non-serious) with onset 06Mar2021, outcome "recovering", described as "Vertigo". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue, decreased appetite, nausea, vertigo.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
No symptoms until approximately 14 hours after receiving vaccine. At that time, developed diffuse hives for 12 days straight (intermittently responsive to antihistamines) and then developed angioedema of her upper lip (moderate to severe) requiring emergency department visit. She had never had urticaria/angioedema in the past.
Information has been received from a physician concerning a 13 year old female, with no relevant medical history and no known drug allergies, who on 16-MAY-2008 ("two weeks ago") was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). There was no concomitant medication. On 28-MAY-2008 the patient experienced multiple herpetic lesions, inguinal adenopathy and fever. The patient sought unspecified medical attention by seeing the physician. As of the time of third report, patient's multiple herpetic lesions and inguinal adenopathy and fever persisted. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previoulsy submitted on 6/13/2008. Information has been received from a physician concerning a 13 year old female, with a history of inguinal hernia repair, no history of type I herpes and no known drug allergies, who on 16-MAY-2008 "two weeks ago" was vaccinated with her first dose of GARDASIL vaccine (Lot #, site and route not reported). There was no concomitant medication. The patient had not been exposed to anybody witha herpes outbreak. On 28-MAY-2008 the patient felt like she had the flu, fever, chills and muscle pain. On 29-MAY-2008, the patient visitied the physician. The patient described the burning pain as sharp, "not too bad" it was worse with urination and more painful that day than the previous day. Physicial findings included: Bilateral inguinal adenopathies with erythema over the left inguinal area. The lymphnodes were not tender. The labia majora and minora, right more than left, were swollen with multiple sharply delineated "kissing" ulcerations of different sizes. The center of the unlcerations was covered with some fibrin and there were some dialted, purple colored blood vessels radiating off the edge of the ulcerations. The hyman appeared intact and there was no vaginal discharge. The patient denied intercourse and oral sex. The patient was diagnosed with vulvar ulcorations. VALTREX and XYLOCAINE were prescribed for the patient. Herpes simplex virus (HSV) culture was negative. As of 30-MAY-2008, the patient was not recovered. Additional information is not expected.
Patient got both shots at 2:10 on 10/16/18. Said she had fever and chills night of 10/16/18. She went to town morning of 10/17/18. She passed out at 9:30 AM morning of 10/17/18. Paramedics evaluated patient. Blood pressure, blood sugar, heart moniter and temperature was all perfect patient said.
Sweating.  Complained of being dizzy.  He feels this way when he gives blood.  EMT observed and monitored.  Patient responded to water and no other intervention needed.
Post vax, the pt developed a red rash. The reporter stated that he assumed this occurred at the injection site, but could not be sure.