chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject of unspecified age who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of H1N1 (unknown route, site of injection and batch number). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at an unspecified trimester. At an unspecified time after vaccination with H1N1 and prior to 20 week's gestation, the subject experienced spontaneous abortion. This case was assessed as medically serious by GSK. This case is linked to 27 other cases (related by publication). The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remains less than optimal. . Surveys have demonstrated that mothers' concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 pandemic season, when lack of safety data about the pandemic H1N1 (pH1N1) monovalent vaccine was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on pH1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. To assess risks and relative safety of the pH1N1-containing vaccines, the author conducted a prospective cohort study of pH1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 20009 and August 2012. There were 1032 subjects available for analysis; 841 were exposed to a pH1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
VACCINATION ERROR; This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced vaccination error. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccination error was not reported. This report was non-serious.
Received An Expired Dose; Initial Report Received on 13-Mar-2023  A registered nurse reported that a 46-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was expired.   Medical history, allergies, and concomitant medications at the time of vaccination were not reported.  On 13-Mar-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05) intramuscularly in the right deltoid. The HEPLISAV-B vaccine had expired 2 days before the injection. Additional vaccines received on the same day included typhoid, tetanus, diphtheria, and pertussis (TDAP), and hepatitis A vaccines (no details provided) in preparation for traveling and prophylaxis.  No additional information was provided at the time of the report.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Fever 101.5 8 hours after second dose subsided at 24 hours post dose. Headache 8-48 hours post dose. Nausea and vomiting 12-24 hours post dose. Severely Swollen lymph nodes on left neck and armpit.
EAR PRESSURE; HEAVY PERIOD FIRST DAY; HOT FLASH ON FACE; SINUS PRESSURE; CHILLS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, and graves disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroid.  On APR-2021, Laboratory data included: CBC (NR: not provided) Good, Liver function test (NR: not provided) Good, and Pregnancy test (NR: not provided) Good. On 09-APR-2021, the subject experienced ear pressure. On 09-APR-2021, the subject experienced heavy period first day. On 09-APR-2021, the subject experienced hot flash on face. On 09-APR-2021, the subject experienced sinus pressure. On 09-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: cetirizine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy period first day on 09-APR-2021, and sinus pressure on 14-APR-2021, was recovering from ear pressure, and hot flash on face, and had not recovered from chills. This report was non-serious.
This spontaneous report as received from a consumer via Clinic refers to a currently 6 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
A large rash formed on my arm that was rounded and raised. It was warm to the touch, itched, and caused muscle soreness. This occurred a week after the shot and is ongoing, though lessening every day.
1hr p/vax pt returned to the office obtunded, devel gen sz;on further eval it was determined that pt had new onset of partial complex sz unrelated to the vax;
vaccine adm 1/8/21 to left deltoid.  on 1/22/21 the left upper arm has a  rash approximately 3ish cm below inj site.  longest measurement from shoulder towards elbow measures 13.5 cm and the width in the widest area is 11.5 cm.  skin is warm to touch, and has a "plaque" like appearance.
shingles; Information has been received from a lawyer referring to a patient (pt) of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 02-MAY-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported and causality assessment was assessed as related.
10/20/2006 1pm pt c/o chest pain from one shoulder to the other denies SOB, But sounds SOB and anxious over the phone. Has had previous heart attacks x 2. She is alone at home advised to call 911 states she will. Rn 10/23/06 call to pt pt was admitted for heart problems which she said was unrelated to flu vaccine.  Patient developed chest pain and a rapid heartbeat approximately 1.5 hours after Fluvirin.  911 was called and she presented in the ER with atrial fibrillation with rapid ventricular response. MI was ruled out via EKG and cardiac enzymes.  Patient coverted to sinus rhythm without intervention and was admitted for observation. Medications were adjusted and the patient was dicharged home.  No discharge summary written. Assessment on date of discharge: 1. Chest pain.  Myocardial Infarction ruled out. 2. Cardiac dysrhythmia 3. Hypertension. 4. DM, anxiety, GERD, chronic back pain. Of note:  Medical record also included 3 additional hospital admissions over the next week for cardiac issues.  Patient later recalled falling on her chest and hitting her pacemaker several weeks ago.  A later final DX (10/29/06) included questionable pacemaker abnormality.
Bloody nose about 2 hours after injection; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW953) via an unspecified route of administration in the left arm on 08Apr2021 at 12:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Patient did not receive any other medications within two weeks of vaccination. 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 08Apr2021 at 14:30, the patient experienced bloody nose about 2 hours after injection. The patient did not receive any treatment for the event. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event bloody nose about 2 hours after injection was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
recipient stated they were getting a tightness in their throat which was what they had felt in previous allergic reaction issues
Prescribed amoxicillin for ear infection. Felt bad the next day symptoms aggravated as day progressed, complaining of aching today, fever 101, headache, chills. Taken to ER at night, given Benadryl and stopped amoxicillin. Problems continued and lasted for entire weekend. Today pt feels fine.
The reporter, is spouse of the patient and I know her as a friend. Patient was diagnosed with Glioblastoma (GBM) stage IV on May 31st 2021, few weeks after administering second do; This is a spontaneous report received from a non-contactable consumer (patients' wife) .  A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) age at vaccination of 47-years-old, as single dose, for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date (Batch/Lot number was not reported) age at vaccination of 47-years-old, for covid-19 immunisation. The patient  was diagnosed with Glioblastoma (GBM) stage IV on 31May2021, few weeks after administering second dose of Pfizer-BioNTech COVID-19 Vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit, Hospitalization, Life threatening illness (immediate risk of death from the event). Reporter also believed that "the tumor got rogue/aggravated after the vaccine; her reasoning was: 1) all the GBM symptoms appeared after vaccination and 2) their healthcare provider also suggested COVID vaccination could have made it worst". No treatment was administered. Outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Bradycardia and apnea, desats requiring oxygen. Patient was scheduled for sedated hearing exam. No sedation was given. Symptoms started before procedure.
12/11/11 Fever between 102 degrees to 104 degrees (down to 100 degrees with ibuprofen) pain in all joints. Red non-raised, non-itchy rash over chest, bilateral upper arms. 12/19/11 "Im just fine now. Everything's gone."
PATIENT VISITED HOSPITAL ER FOR NAUSEA, FEVER, AND PAIN.
drug ineffective; suspected covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: E146207), on 27Apr2021 as dose 2, single (Lot number: Ew0169) and on 07Dec2021 as dose 3 (booster), single (Lot number: Fj8757) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "former smoker" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; MELATONIN; IBUPROFEN; VITAFUSION CALCIUM; NATROL ACAI BERRY ANTIOXIDANT PROTECTION; FIBER SUPPLEMENT.   The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, 12 hrs after the suspect product(s) administration, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset Apr2022, 12 hrs after the suspect product(s) administration, outcome "unknown", described as "suspected covid 19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: The patient took Meijer (lot number: Ohe2514a), start date: 03Apr2022 and stop date: 06Apr2022 in 2 weeks.
p/vax devel blotchy rash lt arm; face & body chills, vertigo, cough;
Itching.  Palms of hands, feet, torso and hair line along back of head and neck,  a few hives have emerged along ribs, but the itching is  almost unbearable and itching it does not help! Seems to be worse at night, and traveling to other areas . Hoping it will subside in few days.
The patient starting feeling nausea and vomiting about 21 hours after receiving the vaccine and has reported feeling nausea and vomiting over the past week. She also reports feeling tired and having hot flashes.
Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Moderna vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat tightness and scratchy throat.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Hx of allergy to flu shot 2013.  Had extremity weakness within 12 hours of shot.  Resolved within a few days. No medications given.  Seen by ER. Hx of 2010 allergy shots to food allergy, corn, wheat and citrus.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the digital data loggers and freezers expired before they were re-calibrated. The reporter was aware in some of the freezers there was a temperature excursion that the data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised. The reporter wanted to know whether need to take any action since the vaccines stored in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The beyond used date was reported as 02-Feb-2022. Moderna date ordered was reported as 03-Jan-2022. No treatment medications were reported.
Information has been received from a physician concerning a female patient who was over 65 year old, who beginning November 2008, was vaccinated with a dose of ZOSTAVAX. In approximately December 2008, the patient developed mild case of shingles in her right chest wall. No treatment required. The patient's mild case of shingles in her right chest wall persisted. Additional information has been requested.
Morning after administration I had the typical extremely sore arm from injection.  Around noon that Wednesday (13th), I started to experience lower back muscle aches. As the day progressed my whole back was achy and began to have the chills. I felt as if I had "been hit by a car," extreme aches. Through the night I had chills and drenched in sweat all night. I only took ibuprofen and rested. I never had a fever when I took my temperature. Thursday (14th) I woke up with minor back aches and the chills had resided. Just very tired from my body working in over drive. Again, I only took ibuprofen and began to feel better. I thought I was done with reactions.  Friday (15th) I woke up feeling better, no more aches or chills. However, I had extreme pain in my left arm pit, same arm of injection. My armpit was swollen and uncomfortable and seemed to be a swollen lymph node. I had no other symptoms this day, felt totally fine, just had this swollen lymph node. Again, took ibuprofen.  Saturday (16th) I was back to feeling like myself.   All the while I had a headache, however I experience headaches/migraines very often, so I did not include this as a direct reaction.
CHRONIC SYSTOLIC CONGESTIVE HEART FAILURE CORONARY ARTERY DISEASE S/P MI HYPERTENSION AND HYPERLIPIDEMIA __ PRIOR COVID 19 (9-13- 2021), LIKELY MALIGNANT SOFT TISSUE MASS, CKD, COPD, RECENT GI BLEED & MDR UTI
Rash/red base/blister in center, multiple lesions. Looks like varicella.
Approximately 22 minutes after she received the second dose she began to have itchy, watery eyes, nasal congestion, and felt itchy.  Had side effects for 3 days after she received the first dose of Moderna.  Gave 50mg of Benadryl and observed for an additional 25 minutes (for a total observation time of 47 minutes).  Was feeling better 20 minutes after taking Benadryl, no longer had itchy, watery eyes, and nasal congestion subsided.  Advised to contact primary care provider as a precaution.
4 hrs after injection, pt developed irritability, redness at site, tenderness & slight puffiness at site of injection. No temp. symptoms resolved within 24 hrs. Treatment; Tylenol, warm/cool compresses.
Fever- 101.9 Chills Injection site pain and soreness Headache
I noticed I had menstrual spotting around 4pm after having had my second dose of the Pfizer vaccine on April 28th.  Spotting is not a normal occurrence in my menstrual cycle.  April 28 was day 23 of my cycle.  My cycles are usually around 35-45 days long.  The spotting started out as brown/pink.  It was light for the first few days.   I have been spotting every day since getting the vaccine.  It has progressively gotten heavier and requires pads.   It is red and there is also  dark brown blood.  I have been bleeding for 8 days.  It is ongoing and has not stopped.
All body parts and tendons were painful in the middle of the night after the shingles shot. The pain lasted for about 2 hours, could not fall back to sleep. RED in area where shot was given and very sore.
4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit.  6 days post vaccine she devleoped flu like sxs with positive covid 19 test results on day 8 post vaccine as per pateint. 10 days post vaccine patient with dyspnea and hypoxemia-admitted to hospital.