chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose May2021, Shingles Oct2021/Suspected vaccination failure; Mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2016 prior to being vaccinated with Shingrix).   On 16th May 2019, the patient received the 2nd dose of Shingrix. In November 2018, the patient received the 1st dose of Shingrix. On 1st October 2021, 869 days after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix in November 2018 and on 16th May 2019 and later more than 2 years after receiving 1st dose and 869 days after receiving 2nd dose the patient had another case of shingles. The patient explained this case mild and was now resolved. The patient did not remember the exact dates. The patient provided information on clinical trials as per package insert. The patient refused to provide date of birth, mailing address and health care professional information. This case was considered as suspected vaccination failure as details regarding the laboratory test confirmation for shingles were unknown at the time of reporting. The patient did not consent to follow-up.
really sick; freezing; couldn't move; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (couldn't move), ILLNESS (really sick) and FEELING COLD (freezing) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00UM20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HYPOKINESIA (couldn't move) and FEELING COLD (freezing). On 18-Feb-2021 at 3:00 AM, the patient experienced ILLNESS (really sick). At the time of the report, HYPOKINESIA (couldn't move), ILLNESS (really sick) and FEELING COLD (freezing) was resolving.            No Concomitant medications were provided No Treatment information provided
10 minutes after receiving first Pfizer dose at outside pharmacy (unknown location), patient had facial swelling and hives on the face, no tongue swelling or lip swelling, no difficulty with breathing, given Benadryl 25mg once at the time of the episode, was monitored for 1 hour at the pharmacy before leaving, did not seek any further care that day, seen in our office 3/24/22 and still has significant facial swelling including swelling of the right upper lid which makes it difficult to fully open the right eye, given Orapred for 4 days, started on Zyrtec daily in the morning, and Benadryl at nighttime
Hair loss after vaccine in April and booster in October .  Severe shedding .  Noticeable thinning .
She received Prevnar injection at same time as Hep- A.  Parent of patient believes the brands noted were the ones used, around 2:30 pm same day as vaccine , my daughter started to show signs of excessive fussiness, flushed skin, and a fever of 103.3 that held for a full 24+ hours. Vomiting occurred several times over the course of the afternoon/night while asleep at 1:45am the following day (7/30/2020) and into the 31st. Fever broke and lowered after 30+ hours, around 8:30pm 7/31/2020  She was seen at a different location than the initial injection that triggered reaction. Dr. Was not thorough for follow up.  We were instructed to take my daughter back within 2 days of holding fever over 101.
They started on 8/15 I had a sore throat. On the 16th I had a runny nose. By the 17th I had extreme fatigue, headache, runny nose, cough, and body ache. I tested myself on the 15th it was negative on the 17th it was positive. I called the doctor on the 18 or 19th for a virtual visit. All I did was take cough drops; I tried some nasal decongestant. I hardly 15th to the 19th I probably got 2 hours of sleep each day. My doctor prescribed me, Paxlovid and Tessalon Perles. I continued to take an over-the-counter antihistamine, Benadryl. I was also using a cold vaporizer. I went back to the doctor because the cough was still pretty horrible on 9/2. She prescribed more Tessalon Perles. I still couldn't get rid of the cough, so I went back again, she gave me steroids and a round of antibiotics. Until this day I have been coughing up phlegm that is very thick like a paste. The headaches have gone away now. It all turned into bronchitis, I got an x-ray, but it didn't show any signs of pneumonia.
Woke up, approximately 36hrs after first vaccine dose, circa 0200hrs on 24MAR2021, with a bit of a racing heart. Felt almost as if the heart wasn't "doing" much -- in terms of pumping blood. Not aware of anything ingested to have caused this and I do not recall this having happened before (hence the association, possibly having to do with the vaccine -- speculative, obviously). Uncertain how long it lasted. Guessing 20-30mins(?).
Fever 101.8, aches all over body, fatigue, sweats lasted for about 24 hours then headache lingered for 3 more days.
I started getting symptoms of scratchy throat, nasal congestion on the first day. The next day I had no energy, body aches, fever, congestion, and cough. I did an at home COVID-19 test which was positive. I did a telehealth visit and was prescribed Paxlovid. I started feeling some better on the third day. That gradually improved but I still have some nasal congestion, fatigue, and lightheadedness.
This is a CCU nurse who received vaccine on 12/18/20 and later that day while at work developed nausea, vomited x1, became tachy and pale. Coworkers provided basic care. Patient went to ED at approx. 4p that day and was later discharged.
Patient is age 16 as opposed to the approved age of 18 or over for the vaccine. Patient was observed for approximately 20 minutes, no adverse events reported. Counseled to contact 911 in case of any emergency symptoms. Contacted Moderna and Corporate office for further guidance - stated age 16 and 17 year olds may receive 2nd dose after 28 days per manufacturer and state guidelines.
This second dose of the vaccine has left me with fatigue, on and off low grade fever,  joint and muscle soreness and very very dizzy.   From My first dose of the vaccine, on April 15, 2021, I was slightly dizzy, had joint soreness, slight bleed dots under the abdomen skin and muscle pain.  That was within 2 days. That was why I waited so long before getting the second dose.
Patient wanted a flu shot, but received a Moderna booster instead. Patient was eligible for one, but did not want to risk feeling unwell for holiday.
2nd dose 3 weeks after 1st dose; This case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: This case was reported by the physician. The physician reported that patient was given second dose only 3 weeks after the first dose. No adverse event reported by the patient.
Received DTaP, MMR, IPV, Varivax on 6-17-2009.  Had had brief joint pain and mild rash approx 5 days prior and only faint pinpoint macular rash on ventral forearms at well visit on 6-17-2009.  Developed Fever (102) and joint pain at the lower extremities on 6-18-2009 that worsened.  She was seen for ankle swelling and rash on 6-20-2009 in ED, labwork unremarkable except ESR 36. Subsequently admitted on 6-21-09 for Henoch Schoenlein Purpura.  She has recovered fully after 2 days in the hospital.  7/6/09 Hospital records received DOS 6/21/09 0/23/09. Assessment: Henoch-Schonlein purpura. Patient presented with joint pain, petechial purpuric rash buttocks, lower extremities and feet, swelling, and discomfort. Difficulty walking. Later worsening of symptoms, swelling on the lower back area with tenderness. Lesions raised and tender, angioedema back. Swelling of feet, ankles, knees.
(L) shoulder with about 6cm x 6 cm area of redness, swelling & pain. School nurse gave MOTRIN & BENADRYL.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a physician for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had 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 cost included 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 suffered such losses, and damages in the future. The outcome of the event shingles was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a Licensed Practical Nurse referring to unspecified multiple patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On 29-MAR-2016, 05-MAY-2016 and 06-MAY-2016, the patients were vaccinated with an improperly stored dose of ROTATEQ (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. The Licensed Practical Nurse stated, that the first vaccine administered had a lot # of L013192 with an expiration date of 19-JAN-2017 and it was exposed to a temperature excursion of 23.4 degrees C for 2 hours and 4 minutes. Moreover, the other two vaccines administered, since the beginning of the cumulative excursion, had a lot number of L033545 with an expiration date of 30-MAR-2017 and were exposed to a temperature excursion of 23.4 degrees C for 3842 minutes (64.03 hours). Data logger and no previous exposures were reported. Furthermore, no adverse effect was stated and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Five days after receiving the vaccine, I noticed significant upper back pain. Muscle cramping followed a day or two later with nerve pain. This nerve and muscle pain is identical to the shingles pain (without a rash) I had September of 2020. For the first week it was nonstop. Since then the muscle cramping isn't as severe but the nerve pain is still there. Having had shingles a little over a year ago, I can say with complete certainty this is the exact same pain. I went to my GP for an examination. There is no rash but my overall symptoms are the same as the shingles virus. I am four weeks into this and the nerve pain is intermittent particularly worse at night.
J96.00 ACUTE RESPIRATORY FAILURE 4/15/2023 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 4/15/2023 ATHEROSCLEROSIS OF AORTA
She had a urinary tract infection on 17Aug2021 for 7 days; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer (patient) reported.  A 71-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history includes Cancer and concomitant medications were not reported. On 17Aug2021, after the vaccination, the patient experienced a urinary tract infection for 7 days and was prescribed with cephalexin. Her primary care and oncologist recommended to get the 3rd dose of Pfizer's COVID vaccine on Monday, 13Sep2021. Caller is wondering if that may affect her 3rd dose. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
This serious spontaneous case, initially received on 14-Feb-2018, from the other health professional (pharmacist), concerns a patient of unspecified age and unspecified gender. On an unspecified date, the patient was administered with INN (dose, route of administration, anatomical location, manufacturer, trade, batch number and expiry date: not reported). On an unspecified date, after vaccination, the patient had an anaphylactic reaction. The reporter stated that, it was unclear whether the reaction was due to egg or egg-based unspecified influenza vaccine which was administered to the patient. The outcome of the event-anaphylactic reaction was not reported.
SOB, chest pain, numbness, tingling in mouth, nausea, weak. Cleared by EMS
Directly after receiving flu vaccine employee came to me with c/o itching, red patchy macular rash to forearms, face and flushed and feels like a "heating pad on my neck. Sent to ER and on arrival rash spread to trunk and began vomiting. Treated with IM BENADRYL and IM SOLUMEDROL and symptoms subsided.
Although precautions in place to help prevent error, consumer was given mixed dose series.  Pfizer was first dose.
Pt vaccinated with DTP/OPV started acting cranky; waking up crying a few times during the night. While at babysitter, started crying a lot, very cranky, slight fever, throwing up, & refusing to take a bottle or sleep.
Product was accidentally administered to ta patient,with no reported adverse event; Initial information received f on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves  patient (unknown age and gender) who experienced product was accidentally administered to ta patient,with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6952AA; expiry date:09-Jun-2022) (strength, dose, formulation, route: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported  product was accidentally administered to ta patient,with no reported adverse event (accidental exposure to product) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product was accidentally administered to ta patient,with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 14Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis, fibromyalgia and known allergies to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 22Mar2021 at 10:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 00:00, the patient experienced loss of taste. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the event. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the events loss of taste was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case admission after 5 vaccines 3/17/21 ModernaLot# 038A21A;  Moderna 4/14/21 Lot# 037B21A;  Pfizer 10/1/21 Lot# EW0186'  Modern 12/22/21 Lot# 066H21A;  Moderna 10/28/22 Lot# 051D22A
(PLEASE NOTE LOT NUMBER ABOVE MIGHT NOT BE CORRECT HARD TO READ)  JUST THE TIGHNESS OF MY THROAT AFTER THE SHOT AND ONCE THE BENADRYL KICKED IN I WAS FINE. JUST THE TIME BETWEEN THE THROAT AND COULD NOT SWALLOW AND WHEN THE DRUG KICKED IN
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 07- JUN-2013, the patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Received Moderna COVID-19 bivalent booster FIRST before any COVID-19 primary dose vaccines.
Dose administered to patient after 30 day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30 day Use By Date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30 day Use By Date). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30 day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that the officer received Moderna vaccine on 2-Sep-2021 but was unaware that the vial should have been discarded on 02-Oct-2021.They are not sure that the vail was thawed on 2-Sep-2021.The vial didn't undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2021-366199 (Patient Link).
pt reports a sore arm; This is a spontaneous report from a contactable other health care professional. A 72-year-old female patient received first dose BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history included positive covid infection (she has had to hold Xeljanz in the past due to a positive covid infection). Concomitant medications were not reported. On an unspecified date, patient reports a sore arm currently that patient attributes to recent covid vaccination. Advised to notify MD. Outcome of event was unknown.  Information about lot/batch number has been requested.
Information has been received from a nurse practitioner concerning a 20 year old female who on 03-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 0151X).  Concomitant therapy included PROZAC, SEROQUEL and YAZ.  On 03-APR-2008 the patient experienced a generalized pruritic erythematous rash.  She called the physician's office and was instructed to take BENADRYL 50 mg and ice the site of injection.  Subsequently, the patient recovered from generalized pruritic  erythematous rash after a few hours.  Additional information has been requested.
Feeling really bottom down; chills; Nauseous; Every bone is aching so bad; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Every bone is aching so bad), HYPERHIDROSIS (Sweating), MALAISE (Feeling really bottom down), CHILLS (chills) and NAUSEA (Nauseous) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced BONE PAIN (Every bone is aching so bad), HYPERHIDROSIS (Sweating), CHILLS (chills) and NAUSEA (Nauseous). On an unknown date, the patient experienced MALAISE (Feeling really bottom down). The patient was treated with CAMPHOR, MENTHOL, METHYL SALICYLATE (BENGAY [CAMPHOR;MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency. At the time of the report, BONE PAIN (Every bone is aching so bad), HYPERHIDROSIS (Sweating), MALAISE (Feeling really bottom down), CHILLS (chills) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not taking any other concomitant medications.  Reportedly, the symptoms started on the night of 15-Mar-2021. The patient rubbed Bengay to treat symptoms.