chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 16OCT95 & 17JUN97 pt presented w/chickenpox;pt recovered;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-APR-2008, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On an unknown date (reported as on or about 04-JAN-2008), the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
This patient was seen for a well child check on 05/15/01. First office visit since birth. No previous immunizations. Received DTaP, IPV, HIB, Prevnar, and Hep B. The patient was found dead in the crib 05/16/01 in the AM. Autopsy shows congestion in lungs. A cause of death could not be determined. Petechial hemorrhages were found on several serosal surfaces raising the possibility of SIDS but suffocation by overlying cannot be excluded.
This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix. Additional details were provided as follows: This case was reported by nurse via email received during non- GSK business hours for herself. The age at vaccination was not reported. After receiving Shingrix, the patient had some of the side effects and asked if they are contagious. Especially around infants and children.
Per patient, reported on 06/01/2021, she has been having increased episodes of menopausal sx (i.e. hot flashes "every 5-10 minutes" and night sweats) since receiving 2nd Covid vaccination on 04/01/2021. Prior to vaccination, patient states symptoms "were under control."
Have had mild tinnitus now it?s moderate. Been over a week and it?s still awful
Hives starting with redness on back and stomach by morning of Dec 16, 2001, raised spots. disappeared within 3 days.
COVID BREAKTHROUGH:  65-year-old fully vaccinated and booster. Initially tested positive on June 8th, had a repeat test 2 weeks later,and  approximately June 22nd which was negative.  He states that since then he has had progressive cough with associated shortness of breath.  He states last night he was unable to really sleep well because of the cough and shortness of breath. Once in the ED, patient was found to be hypertensive with a blood pressure of 175/137, WBC was normal, patient was afebrile. Patient was given nebulizers, ceftriaxone, azithromycin, Decadron for presumed post viral pneumonia. Patient denies current fever, nausea, vomiting, diarrhea. Shortness of breath,-established problem, stable.  LVEF by echo 35-40%, Atrial fibrillation-established problem, stable,HTN-established problem, stable, Hypercholesterolemia-established problem, stable , Acute systolic CHF exacerbation, POA, Cardiomyopathy newly diagnosed, and Pulmonary edema.
At the time of the vaccine I was 5 weeks 4 days pregnant. It was discovered at my first ultrasound at 8 weeks 3 days on July 6th that the baby had stopped growing at 5 weeks 6 days two days after the second vaccine. I officially miscarried naturally 5 days later. This was my first first pregnancy.
Pain,  swelling at injection site.   Nausea,  body aches,  headache,
itching throat, mouth, lips, tongue swelling. Given the following in ED: Benadryl, solumedrol, famotidine, Zofran. Resolved.
Tired; Chills; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01May2021 at 16:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced asthma and foot surgery. Patient did not receive any medication within two weeks of vaccination. Past drug history included penicillin. 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 other vaccines within four weeks prior to the COVID vaccine. On 02May2021 at 04:00, the patient experienced chills, soreness and tired. The clinical outcome of the event chills, soreness and tired were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a nurse to a sales rep and described the occurrence of headache in a 43 year old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. On 21Jun05 the subject received a dose of Havrix in the left arm (dose number not provided). On 21Jun05 the subject also received injections of rubella virus vaccine (Meruvax II) in the right deltoid, typhoid vaccine (unk manf) in the right deltoid, and inactivated poliomyelitis virus vaccine (Ipol) in the left deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the subject experienced headache, back and neck pain, and injection site redness, pain and swelling. The site of the injection reaction was not specified to Havrix or Ipol. On 22Jun05, the subject experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion of the left arm and injection site warmth. The events were ongoing at the time of initial reporting, 23Jun05.
Chills Fever of 101.9 Patient reported feeling cold Headache Body Aches
pt recv vax 3MAR97 430PM & 5PM temp 99.5, given Ibuprofen, t102, eyes different, lifeless, breathing labored called MD & took pt to ER;930PM t104.4, sz in car;thought was ear infect;had sz in ER;viral infect devel;
Initial misuse report received from a healthcare professional on 25 September 2013. This case is invalid as no patient identifiers reported. Gave last year's FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Information has been received from a registered nurse concerning a 35 year old female pt with no past medical history who on 04/20/2001 and 05/24/2001 at 5pm was vaccinated with the first and second dose of hep b vaccine recombinant, respectively, both IM in the right deltoid. There were no concomitant medications and no known illness at the time of vaccination. Within a few hours of vaccination, the pt developed a slight pain followed by intense itching at the injection site. The area was two by three inches and continued to itch for 72 hours. The area was reddened and warm to tough. The pt was treated with topical applications and the symptoms subsided. On 05/24/2001 the second injection resulted in less itching and lasted only for several hours. The pt did have pain in her arm from the injection site to elbow for nearly 24 hrs. It was reported that the pt recovered. No further info is expected.
Joint pain - most noticeable at elbows and knees.  Back pain - across lower back and radiated up along spine.  Ibuprofen relieved joint pain, but not back pain.  Symptoms first noticed morning after 2nd injection, symptoms persisted throughout the day and back pain subsided around 9pm on 4/17/21.  No symptoms experienced following days.
pt recvd vax 28NOV95 & 24DEC95 pt exp ataxia & stiff neck;25DEC95 pt devel vesicular rash & arthralgia;pt's father stated pt's neuro sx were almost gone;rash described by MD small vesicles-macular papular rash;fever;rt ataxia;arthritis
local reaction of flood up area surrounding the shoulder; local reaction of flood up area surrounding the shoulder; A spontaneous report was received from a Consumer concerning a 92year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of a local reaction - flood up area surrounding the shoulder (3x3 inches) which was warm, sore, and tender.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: Not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date (reported as two weeks later), the patient experienced a local reaction of flood up area surrounding the shoulder (3x3 inches), which was warm, sore, and tender.  Treatment details included antiallergy medication orally.  Action taken with mRNA-1273 in response to the events, of a local reaction of flood up area surrounding the shoulder (3x3 inches), which was warm, sore, and tender was not reported.   The outcome of the reported events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
7/6/04: started with low grade fever, now rash (sun burn like). Complete front of thigh, tender to touch, swollen. Seen by  CPNP 7/7/04. Per CPNP. Ice pack. RTC no imp. 2-3 days, Augmentin ES 2 tsp BID x 10 days.
Information has been received from an RN concerning a pt who was vaccinated with 3 doses of varicella virus vaccine live. The 3rd dose had expired in June of 1999. It was noted that after the 1st 2 doses, the pt's lab results indicated a lack of seroconversion. The pt sought unspecified medical attention. Additional information has been requested.
LIGHT HEADED; FEELING LIKE WAS RUN OVER BY A  TRAIN (LOWER BACK PAIN); PRE-EXISTING LEFT SIDED FACE PAIN  MADE WORSE BY VACCINE (IN LEFT  EYE, CHEEK AND EAR); FEELING STRANGE NOT COMFORTABLE; CHILLS; FEELING LIKE WAS RUN OVER BY A  TRAIN (HIP PAIN); FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included thalassemia trait, and previous neck injury that causes pain on left side. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for to right deltoid prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced light headed. On 20-MAR-2021, the subject experienced feeling like was run over by a train (lower back pain). On 20-MAR-2021, the subject experienced pre-existing left sided face pain made worse by vaccine (in left eye, cheek and ear). On 20-MAR-2021, the subject experienced feeling strange not comfortable. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced feeling like was run over by a train (hip pain). On 20-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and feeling like was run over by a train (lower back pain), and had not recovered from fever, light headed, feeling like was run over by a train (hip pain), pre-existing left sided face pain made worse by vaccine (in left eye, cheek and ear), and feeling strange not comfortable. This report was non-serious.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). suspect vaccination administered at the same visit included a dose of Hib conj vaccine (CMPC) (manufacturer unknown). Subsequently the patient developed blood in the stool. The patient's outcome was not known. There was no product quality complaint involved. The patient's sibling (WAES# 0610USA11149) experienced a similar reaction after vaccination with hepatitis B virus vaccine rHBsAg (yeast) and Hib conj vaccine (CMPC) (MSD).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bipolar 2" (unspecified if ongoing); "allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; OXCARBAZEPINE; MONTELUKAST; LORATADINE; BUPROPION; BUDESONIDE; FLUTICASONE. Past drug history included: Aspirin, reaction(s): "Known allergies: aspirin", notes: Known allergies: aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19 which included Paxlovid started on 23Jun2022 and stopped on 27Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pregnant parent exposed to child who recv varicella vax 19SEP98;20OCT98 the parent had a spontaneous abortion;parent reported this was the second time she suffered a miscarriage p/being exposed to some who recv varicella vax;
PT HAS A SIEZURE DISORDER AND HAD A STRESS SEIZURE FROM THE INJECTION. STATED THAT THIS WAS HER 4TH SEIZURE TODAY AND IT STOPPED AFTER ABOUT 10 SECONDS. NO OTHER REACTION TO THE VACCINE
This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 59-year-old female patient who received SHINGRIX (batch number 273BZ, expiry date 15th May 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 25th September 2018). On 21st December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced contusion. On an unknown date, the outcome of the contusion was not recovered/not resolved. It was unknown if the reporter considered the contusion to be related to SHINGRIX. Additional details were reported as follows: The reporter on the line who gave a patient dose of SHINGRIX and for some strange reason it left a bruise. The reporter would like to know if that was common. The patient was not complaining, but the caller had never seen or heard of it. The caller stated he was not sure when it started/showed up, but he knows it was ongoing. No other details regarding bruise was provided.
Urticaria, flushing, wheezing, increased need for albuterol inhaler, feeling like something is stuck in throat, headache, tinnitus, dizziness, left arm/elbow  pain (not improving after >1mo), fainting at dinner table (fell onto floor from a seated position upon completion of meal), brain fog (difficulty finding correct words about subjects that I'm well versed in), extreme fatigue (requiring 14+ hours of sleep, still tired upon waking)
Information has been received from a registered nurse concerning an 84 year old female pt with no allergies and no medical history, who on 10/21/02 was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (640981/1050L). Concomitant vaccination included a first dose of influenza virus vaccine (Fluvirin) (E34722HA) IM in the left deltoid. The pt stated to the nurse that she had received both vaccines in the left arm. However, the nurse confirmed that pneumococcal vaccine 23 polyvalent was administered in the right deltoid. There was no illness at the time of vaccination. On 10/22/02, the pt developed a "10 1/2 by 7 1/2 centimeter area, left arm erythematous, which developed  into mild case of cellulitis, warm to touch." The area was also described as "red, raised with induration" and swelling was also reported. The pt sought unspecified medical attention and was treated with cephalexin 250mg orally three times a day for 10 days. Subsequently, the pt recovered. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that a second pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (640981/1050L) WAES0210USA02516 and a third pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (637345/1449K) WAES0210USA02517. Additional info is not expected.
Information has been received from a physician (also reported as medical assistant) concerning a 16 year old female with no known allergies or medical history, who on 28-JUL-2008 was vaccinated with a first, 0.5 mL dose of GARDASIL (LOT# 659964/1978U), intramuscular. There was no concomitant medication. Five or four days later the patient experienced joint pain. The patient is a golfer and indicated that her joints are so painful at the end of a golf game that she has to rest for the reminder of the time. At the time of the report, the patient had not recovered. She mentioned that she tried ice and BIO-FREE, but only ADVIL made it tolerable. The patient sought medical attention, she was seen. The patient's joint pain was considered to be disabling. Additional information has been requested.
the injection I received consisted of less than (.2 cc) of the recommended dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (the injection I received consisted of less than (.2 cc) of the recommended dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced INCORRECT DOSE ADMINISTERED (the injection I received consisted of less than (.2 cc) of the recommended dose). On 14-Jan-2021, INCORRECT DOSE ADMINISTERED (the injection I received consisted of less than (.2 cc) of the recommended dose) had resolved.            Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a male patient, pharmacist's nephew, of unknown age. None pertinent medical history, drug reactions or allergies were reported. On an unknown date (reported as as a baby) the patiens was vaccinated with M-M-R II (dose, dose schedule, route, anatomical location, lot number and expiration date were not reported). None concomitant therapies were reported. On an unknown date (reported as college age) the patient went on a trip, and, when he went back to his country, experienced cold with fever and a "lingering cough". The patient sought medical attention by office visit. The pharmacist stated that the patient was treated by his physician with amoxicillin (unspecified). The reporter also stated that the patient had MMR titers drawn for entrance into a college program, and that the result was 150 (units not provided); reporter was concerned because that was a high value, but stated the laboratory did not provide an acceptable range for their testing. The outcome of "lingering cough", fever and cold was reported as recovering. The outcome of the increased titers was not reported. The relatedness between M-M-R II and the events were not reported. Additional information is not expected because the reporter refused additional contact.
Allergic reaction about 5 hours later. Body started shaking and was cold. Next morning patients temp was 102.2, felt extreme weakness. Lost 5 lbs. By 3rd day temp was normal & symptoms had resolved by themselves.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 54 years, 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: "history of ovarian cancer 2016", start date: 2016 (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; ZINC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (19Jul2022) Negative, notes: previously tested negative; (26Jul2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Rebound (tested positive again on 26Jul2022) previously tested negative on 19Jul2022. Mild congestion and sore throat.