chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in today to receive his #3 booster Pfizer vaccine.  After his 15 minutes window , he did not complain of any adverse affects but later came back to us 5 minutes later complaining that he he had a headache and felt dizzy. Upon sitting for an additional 15 minutes, staff laid him down on a gurney  for patient was complaining of nausea and vomiting in addition. Vital signs  stable at 137/85, O2 sat 99%, afebrile, heart rate 77, no labored breathing seen.  Patient vomited x 1.  He also said had symptoms on his 2nd vaccine as well.  Patient was given sips of water. He called a family member to drive him home.  Upon leaving , he only complained of a headache.  His supervisor was notified. He will f/u with his doctors for any other s/s.
covid again; Started with palpitations; then I became extremely sick for 3 days; Fever; chills; too weak to even get to the bathroom; body aches; began to have joint pain in all of my joints; my eyesight has declined; I have developed a cataract in one eye; my tongue swelled with ulcers with the pinkeye type symptoms; my tongue swelled with ulcers with the pineye type symptoms; my tongue swelled with ulcers with the pineye type symptoms; The worst part is how much my legs have not stopped hurting; This is a spontaneous report from a contactable Nurse (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EK5730) via intramuscular, administered in Arm Left on 23Dec2020 (at the age of 48-years-old) as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia, egg sensitivity, allergy to molds and COVID-19 from an unknown date and unknown if ongoing. There were no concomitant medications. No other medications in two weeks. No vaccine in four weeks. On 23Dec2020, the patient experienced COVID again, started with palpitations, then I became extremely sick for 3 days, fever, chills, too weak to even get to the bathroom, body aches, began to have joint pain in all of my joints, my eyesight has declined, I have developed a cataract in one eye that I didn't have previously. This has not stopped and its been almost a year; my tongue swelled with ulcers with the pinkeye type symptoms along with all other symptoms and the worst part is how much my legs have not stopped hurting since I got this vaccine, but I haven't been able to see a doctor because of no insurance. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown results on Nasal Swab. The case was considered as Serious. The adverse events resulted in disability or permanent damage. No treatment was given for the adverse events. The outcome of the events was not recovered.  No follow-up attempts were possible. No further information was expected.; Sender's Comments: Based on the temporal relation, the association between the events of COVID-19, palpitations, illness, pyrexia, chills, asthenia, pain, arthralgia, visual impairment, cataract, swollen tongue, tongue ulceration, conjunctivitis and pain in extremity and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "Obesity" (unspecified if ongoing), notes: other medical history: Obesity; "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication was reported in 2weeks. No Known allergies was reported. Starting on 20Jul, patient began to feel symptoms of COVID again. These included nasal congestion and scratchy throat. Yesterday, a persistent, wet cough started. It seems to be getting worse as of today. No fevers yet.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
C/o swollen reddened area on right arm. 7cm by 5cm, erythematous patch, warm to touch on right arm, mildly TTP.
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 or about 28-MAR-2012, the patient was prescribed by his physician and inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at physician office as recommended for long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. On or about 27-JUN-2016, the patient was treated by a physician for the sudden onset of a red rash in his upper rib cage area, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir and lidocaine for management of his symptoms. As a direct and proximate result of the ZOSTAVAX, the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events is unknown. The outcome of the events is unknown. Additional information has been requested.
Approximately 5 minutes after administration my child complained of nausea and dizziness, she appeared pale.  About 10 min later she vomitted.  About 15 min after administration she felt ok.
Itching, redness swelling, fever, chill, body aches in joints, with a headache. Small bumps developed around injection site which turned into sores that lasted up to two weeks.  I used antibiotic ointment on the site.
The day of the vaccine at 10PM. I developed severe chills temperature of 101 headache and body aches lasted 2 days
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (lot# L018351, expiry date: 11-AUG-2017; lot # L037554, expiry date: 25-DEC-2017) (incorrect product storage). The vaccine was stored at a temperature of 53.3 F for a time of 3 hours and 23 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was diagnosed and tested Positive for Covid 19 despite receiving vaccine on 3/19/2021  SARS-COV-2, QUALITATIVE, NAA (COVID-19), KP LAB    Component 2 d ago Comments SP SOURCE NP/OP   CORONAVIR PAN 2019-NCOV, NAA, QL COVID DETECTED Abnormal   See comments Specimen Collected: 05/04/21 10:07 AM
RASH MORBILLIFORM; PYREXIA; RASH ERYTHEMATOUS; FLATULENCE  Information has been received from a licensed practical nurse concerning a 12 month old male with no medical history or allergies who on 22-SEP-2006 was vaccinated with a 0.5 mL SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 654474/0815F). Suspect therapy on the same date included a dose of Hib conj vaccine (OMPC) (MSD) (lot # 652863/0401F. On 12-OCT-2006, the patient developed a fever of 99F, and a red measles like rash on his upper body on the trunk, face, arms, chest, and back and was gassy with no diarrhea.  He was seen in the clinic on 13-OCT-2006 with diffuse slightly erythematous papules, pea sized to dime size. He was treated with acetaminophen (TYLENOL).  He underwent a urine test and blood test and an abdominal X-ray, results not reported. On 16-OCT-2006, most of the patient's rash was gone and he had a good intake of food and liquids.  The patient's outcome was recovering.  There was no product quality complaint involved.  Additional information has been requested.
dizziness; chills; temperature of up to 101.9*F.; sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced initially nothing but a sore arm which went away within 24 hours. On 22Mar2021, mid evening, she experienced dizziness, chills and had a temperature of up to 101.9 degree F. On 23Mar2021 at 07:45, the temperature became normal. The outcome of the event temperature of up to 101.9*F was recovered on 23Mar2021 and rest of the events recovered in Mar2021. The reporter considered the event to be non-serious.  Response: Referenced PI Section 6 LAB-1457-6.0 Revised: 25 February 2021.  Information on the lot/batch number has been requested.
Neighbors that tested positive on 29Dec2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (neighbors that tested positive on 29Dec2022) 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) 1 dosage form. On 29-Dec-2022, the patient experienced COVID-19 (neighbors that tested positive on 29Dec2022). At the time of the report, COVID-19 (neighbors that tested positive on 29Dec2022) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2022, SARS-CoV-2 test: Positive. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient had had less symptoms. Treatment medication was not reported. This case contains information for the 1st of 3 adult patients described by the reporter. This case was linked to MODERNATX, INC.-MOD-2023-696687 (E2B Linked Report). Sender's Comments: MODERNATX, INC.-MOD-2023-696687:Reporter's case.
In May, 1999 and June, 1999, the pt received the 1st and 2nd doses of Lymerix. Rheumatologist reports that subsequently, the pt experienced pain in all of his joints except the distal interphalangeal joints. The metacarpophalangeal joints were a little tender on exam. The exam was mostly unremarkable. There was no swelling. The pt claimed he had intermittent swelling and pain but none were found. There were no warm joints on exam. There was a small effusion in the right knee, too small to tap. The rheumatologist stated that this effusion could be due to degenerative joint disease and he noted some loss of range of motion to the right knee. The pt also complained of abnormal sensations in his legs which started as pain but was now a numbness. He could not identify when this started. He was referred to a neurologist. No treatment was given. The rhematologist saw no joint changes indicating arthritis. There were no erosions and no inflammatory changes. The most recent information, received on 6/14/00, reports the outcome of the event as unresolved.
Wednesday 9/23: received 2 shots in 1 arm, felt sore in the muscles and tired ; not feeling well  Thursday 9/24: woke up feeling wiped out and nauseated  Friday 9/25: arm swelled up and inflamed, hot when touching arm.  Sad the inflammation was a baseball size in diameter and growing.  Went to Clinic Friday night and doctor stated potential bacterial infection and gave minocycline 100mg BID for 7 days, information was shared with floating pharmacist  Saturday 9/26: FU with PM; states that after antiobitc, less inflamed but same size in redness; felt better after starting antibiotic
This spontaneous report was received from a female consumer concerning her 17 years old daughter with no pertinent medical history or drug reactions. The patient was vaccinated with dose 1 GARDASIL on 14-JUN-2012. On 27-AUG-2012, the patient was vaccinated with the second dose of GARDASIL. No other co-suspects were reported. There was no concomitant medication. On 27-AUG-2012, approximately 1 minute after received the second dose, the patient had seizure (medically significant) in the physician's office. The consumer mentioned her daughter did not have a history of seizures. The reporter mentioned that her daughter was retained in the physician's office for 2 hours following the vaccine administration. When the patient was sent home from the physician's office, she felt lightheaded, dizzy, and fatigued and had difficulty walking to the parking lot where her mother's car was parked. The consumer stated her daughter vomited in the physician's parking lot and "looked extremely pale". The patient continued to feel extremely fatigued and that she had soreness in the arm where she received GARDASIL. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
ACHES; FLU-LIKE SYMPTOMS; HARD TO WALK; This spontaneous report received from a consumer concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced aches. On 03-MAY-2021, the subject experienced flu-like symptoms. On 03-MAY-2021, the subject experienced hard to walk. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, flu-like symptoms, and hard to walk. This report was non-serious.
12SEP97 redness started & tender on 14SEP was put on DPH & Cephalexin @ hosp ER;
c/o blurry vision & feeling strange;BP 94/50, P96 apically, pale, diaphoretic;placed child in lying position, applied cool cloth to forehead, gave Pepsi  to drunk;20min later;color improved, skin warm & dry, BP 124/72, P88 radial;
Patient stated she had lymph node swelling in armpit, neck, groin, also significant red, hot spot below shot site, said she can no longer feel bumps (lymph nodes today).
Customer reported had 8 doses of GARDASIL 9. She said the patient completed the series in 2014 and now got additional doses to make 8 doses total. Her 8th dose was on 12/13/2022; Customer reported had 8 doses of GARDASIL 9.; No additional AE reported; This spontaneous report was received from a consumer (reported as "educator") and refers to a female of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, reported as "completed the series in 2014", the patient received 7 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 13-DEC-2022, the patient was vaccinated with 8th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration, Extra dose administered).  No additional adverse event reported.
Face has been numb; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10May2021 at 08:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 respiratory infection. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient had no known allergies. On 10May2021 at 10:00, the patient experienced that her face had been numb ever since and the doctors could not find any other reason why her face went numb right after getting the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event face had been numb was not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
The patient had possible syncopal episode and  an increased white blood count with lactic acidosis on admission. He is currently still in hospital and had delirium and acute hypercapnic respiratory failure requiring BiPAP ventilatory support.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after dose and was slow to respond to questions. BP: 70/40, 65/40. Patient states he did not eat very much during day prior to vaccine. Patient was kept for observation for 45 minutes until recovered, still shaky/dizzy afterward.
Zoster-involving the posterior left arm with some notable vesicles and crusting. Patient is symptomatic. -begin Valtrex 1 g p.o. Q.12 hours with a plan to treat for 7 days -cover arm -serial exams
Information has been received from a nurse referring to a 38 years old female patient. The patient had no pertinent medical history or drug reactions. Concomitant therapies included sterile diluent, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and FLUZONE. On 27-DEC-2018 (reported as 3 weeks ago), the patient was vaccinated with M-M-R II (lot# N032751, expiration date 20-NOV-2019, subcutaneously for prophylaxis; dose and frequency were not provided) and VARIVAX (lot# R018138, expiration date 25-JUN-2020, subcutaneously for prophylaxis; dose and frequency were not provided). On 17-JAN-2019 (reported as 3 weeks after vaccination), the patient returned to office to take a pregnancy test and the patient was 4 weeks pregnant. The last menstrual period (LMP) was calculated as 20-DEC-2018 (17-JAN-2019 subtracting 4 weeks) and estimated date of delivery (EDD) was calculated as 26-SEP-2019. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse effects were reported. There was no treatment given for the event.
A day or two after I started getting neurological symptoms in my leg. It's hard to describe, but it was all over my legs. I called my neurologist cause i was concern it was traveling into my body from my legs, which it did. I had twinkling feeling, and the hot feeling of heat which is neurological damage. All this year from that time, it has progress very slowly, I'd say in the last two months. The arm in which I took the vaccine hurts around the site. I took the vaccine in my right hand, and it tingles from time to time. In my head, I feel off balanced. It's been everywhere throughout and a burning feeling that goes with it. And it's effected my head, which is what I'm dealing with now, my eye sight. It's a very serious reaction to the vaccine.   4 ER visits
12/30 Vaccination The next day, started out with rash on neck and L arm. Took Benadryl. Lasted for 3 days.  Spoke to pharmacist and PCM.
This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend, who was also a physician. The age at vaccination was not reported. The batch number of the vaccine was unknown. The physician reported limited information and declined contact. The patient had denied permission to contact their physician. The physician did not want to be contacted for follow up information. All questions were asked, only information known is that provided.
Wed palpitations, pain radiating to neck. Still having palpitations on Friday. Sent to ED.
Continuing pain in left arm and left shoulder towards back and behind the arm pit region. This began on 9/6/2020, the day after the first dose of the vaccination (first dose) and remaining up to now 9/19/2020. Next dose is 11/4/2020.
pt recvd vax & exp hives around ankles, eventually extending to back;by 4th days p/vax had hives on arms;seen by MD who prescribed DPH for itching;
PATIENT RECEIVED FLU VACCINE(FLUBLOK QUAD) ON 1/22/2020 AT 2PM.  SHE COMPLAINED ABOUT NUMBNESS IN THE LEFT ARM AT 2:06PM. SHE IS EMPLOYEE AT THIS LOCATION. AFTER COMPLETING HER SHIFT AT 3:00PM SHE STOPPED BY AT PHARMACY AND SAID SHE STILL HAVE NUMBNESS IN LEFT ARM. SHE CAN MOVE HER ARM AND FINGERS BUT SHE FEELS HEAVYNESS/TIGHTNESS/NUMBNESS IN LEFT ARM. SHE WENT HOME AND SHE SAID SHE WILL UPDATE  PHARMACY ABOUT CONDITION . CALLED AT 5:00PM SHE SAID FEELS LOT BETTER BUT STILL GOT TIGHTNESS.
Uncontrollable chills lasting about 5 hours, hallucinations during that time, headache, joint pain, skin sensitivity/pain, fatigue, nasal congestion. All but the chills and hallucinations are ongoing as of almost 30 hours after being vaccinated.
Initial report was received on 03 August 2011 from a consumer who is also the patient. A 31 year-old first trimester pregnant female patient with a history of nocturnal seizures and an allergy to sulfa medications, had received 22 December 2010 a left arm injection of FLUZONE (lot number and route not reported). On 03 January 2011, the patient experienced a miscarriage. She stated that five days prior to miscarriage she had a "test" that showed no fetal growth. The patient's reported that her expected due date had been August of 2011. The patient had no illness at the time of vaccination. Concomitant medications included multi-vitamins, folic acid and KEPPRA. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.