chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from a healthcare professional refers to a 2 years old patient. On 02-JUN-2014 the patient was vaccinated with a dose of improperly stored M-M-R II HSA (lot # J003785, expiration date 28-MAR-2015) (strength, dose, route and site of administration were not reported) and a dose of (Oka/Merck) VARIVAX (lot # J009728, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional information has been requested.
Information has been received from a physician assistant concerning  her son who was vaccinated with VARIVAX (Oka/Merck). The physician assistant reported that her son received a second dose of VARIVAX (Oka/Merck) a couple years ago and a couple months after receiving the dose he developed a severe case of shingles. Her son reported pain prior to any visible symptoms. The analysis of the vesicles were not done at that time. At the time of the report, the physician assistant's son had fully recovered. Additional information has been requested.
n August 26th at 0949 a RN went to obtain a Menveo vaccination. She noted one bottle of diluent without a powder to go with the diluent.  Staff interviewed involving the 5 previous patient administrations.  They all confirm they did not drop or break an orange vial of powder.  Unable to determine which patient received the incorrect diluent for the Menveo powder.  No adverse events.  All 5 patients are being contacted for re-vaccination of Menveo vaccine.
Patient received their first dose of Pfizer vaccine. Began to feel lighted headed and hearing was going in and out.  EMS responded and their blood pressure was low, after 20 mins, vitals were normal.
20 minutes post vax, the pt experienced high-pitched screaming. Her eyes rolled back, became stiff, and started with convulsions. The mother called her daughter's pediatrician who explained that the pt was being extra fussy and there was no need to take the infant to the ER. After 4 hours, the pt recovered without treatment. Convulsion NOS is considered medically important.
suspected Vaccination failure; is it possible to get shingles after getting the vaccine?; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient himself or herself. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient enquired was it possible to get shingles after receiving Shingrix. The call center nurse replied that it was possible as the vaccine was not 100 percent effective and compared with placebo, Shingrix significantly reduced the risk of developing herpes zoster by 97.2 percent in patients 50 years and older. This case was considered as suspected vaccination failure as details regarding time to onset and lab test confirming varicella zoster virus infection was unknown at the time of reporting.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a male consumer regarding his wife who experienced a cough and runny nose.  The pt received a dose on 12/13/03. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The caller's wife experienced a cough and runny nose following administration of Flumist.  The caller himself, also experienced a similar reaction (see related case HQWYE887723DEC03).  The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Patient got PNEUMOVAX, flu vaccine and Tdap. She preferred all vaccines on one arm and 2 days later she had pain on her upper arm soreness and increased temperature.
Left arm swelled shoulder to elbow, got red, hot, no itching. Face and chest got red and hot.
FEELING A SHARP PAIN BEHIND LEFT BREAST. STARTED SHORTLY AFTER VACCINATION. TOOK BABY ASPIRIN WHEN SHE WAS FEELING THE  PAIN. THE PAIN HAS GOTTEN WORSE.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Hypotension-Severe, Additional Details: 5 min after giving the shot patient faints . low blood pressure and pale skin. some tingling on fingertips and pain below chest
The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023; No adverse event; two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Mar-2023, 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 06-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (two patients that received Moderna bivalent booster dose. One was at day 31 of the medication being in the fridge, and another was at day 47/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 3-Feb-2023 and administered on 06-Mar-2023).    No concomitant medication details was reported. The patient did not report any adverse reaction. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Information has been received from a registered nurse referring to a 28 year old male patient. The patient was vaccinated with his first dose of GARDASIL (dose, route and lot number not provided) in 2013 and his second dose of GARDASIL (dose, route and lot number not provided) on 03-DEC-3015 in the office. No adverse effect was reported. There was no product quality issues (PQC). Additional information has been requested.
lightheadedness; very very tired for a day or two; Memory was worsened than that it was before; This is a spontaneous report from a contactable female consumer. This consumer(patient) reported for herself that: An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199), via unspecified route of administration in left arm on 20Feb2021 (at the age of 82-years) as single dose for covid-19 immunization. The patient medical history included osteoarthritis and fibromyalgia. Concomitant medications were not reported. On 21Feb2021, the day after the first dose of covid-19 vaccination, the patient experienced lightheadedness for a day and then it was gone. She stated that she felt "very very tired for a day or two" on an unspecified date in 2021 and then was alright for a while. On an unspecified date in 2021, after the first dose, her memory was worsened than it was before. She stated that she had met two people, who had the same thing. She stated that she had initial symptoms one day and after that she had other things. The patient confirmed the vaccine was Pfizer Covid-19 vaccine. She wanted to know early that how long these symptoms would last and if more symptoms would appear. The outcome of the event lightheadedness was recovered on 22Feb2021. The outcome of the event tired was recovered on an unspecified date in 2021. The outcome of the event memory impairment was unknown.  Reporter seriousness for Memory was worsened than that it was before: Unspecified  Additional information has been requested.
Information has been received from a physician assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates these patients were administered improperly stored RECOMBIVAX HB (lot # M010212, expired date 21-JAN-2019) (dose and frequency were unknown). The RECOMBIVAX HB was stored at 46.8 F for 4 hours 30 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
had fever 100.5 °F for a couple days; had aches and pains, sharp pain; weakness; sharp pains in my stomach, arm; sharp pains in my stomach, arm; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 24Mar2021 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Cancer Remission; COVID-19 virus from an unspecified date Feb2021, had the COVID-19 virus the first part of Feb; noticed hair loss, not from the vaccine, hair loss from COVID, I was not hospitalized or anything like that; and blood thinner, I am on Eliquis blood thinner medication. The patient's concomitant medications included ELIQUIS for Blood thinner. On 24Mar2021, the patient experienced had fever 100.5-degree Fahrenheit for a couple days; had aches and pains, sharp pain; weakness; and sharp pains in my stomach, arm. On an unspecified date, the patient underwent lab tests and procedures which included Pyrexia: 100.5-degree Fahrenheit. Caller wanted to make sure second dose is the same amount, the same quantity of the vaccine on the second scheduled 14Apr2021. Caller wanted to know if she can get a blood clot from taking the vaccine because she is on Eliquis blood thinner. The outcome for all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
two weeks after getting the vaccine is experiencing asthma trouble/A week or two after receiving it, my asthma has flared up and been so bad; is having a horrible cough and has never had covid19; have been getting sick ever since then/illnesses due to my asthma making me more susceptible to them; various colds; I've woken up twice now thinking I'm dying due to an attack; It is hard to breathe; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (two weeks after getting the vaccine is experiencing asthma trouble/A week or two after receiving it, my asthma has flared up and been so bad), COUGH (is having a horrible cough and has never had covid19), ILLNESS (have been getting sick ever since then/illnesses due to my asthma making me more susceptible to them), NASOPHARYNGITIS (various colds) and FEAR OF DEATH (I've woken up twice now thinking I'm dying due to an attack) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to animals (Allergy to pets), Allergy to molds and Asthma (since kid).    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHMA (two weeks after getting the vaccine is experiencing asthma trouble/A week or two after receiving it, my asthma has flared up and been so bad), COUGH (is having a horrible cough and has never had covid19), ILLNESS (have been getting sick ever since then/illnesses due to my asthma making me more susceptible to them), NASOPHARYNGITIS (various colds), FEAR OF DEATH (I've woken up twice now thinking I'm dying due to an attack) and DYSPNOEA (It is hard to breathe). At the time of the report, ASTHMA (two weeks after getting the vaccine is experiencing asthma trouble/A week or two after receiving it, my asthma has flared up and been so bad) had not resolved and COUGH (is having a horrible cough and has never had covid19), ILLNESS (have been getting sick ever since then/illnesses due to my asthma making me more susceptible to them), NASOPHARYNGITIS (various colds), FEAR OF DEATH (I've woken up twice now thinking I'm dying due to an attack) and DYSPNOEA (It is hard to breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  After  two weeks of the vaccine experiencing asthma troubles, and was having to used her asthma treatment almost every hour, was having a horrible cough and had never had covid19. The patient had mild asthma since was a kid and only used the inhaler a handful of times. The patient had eliminated other factors such as allergens, pets, I have tried air purifiers, inspected for mold in my housing.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow up received on 29-NOV-2021: New events added, medical history updated.
Fever to 102.6 with chills and vomiting developed 12 hours after vaccine was given.  She was evaluated 6 hours after the onset of symptoms. She received one dose of tylenol Her exam revealed 3+ red tonsils and generalized abdominal tenderness.  Her  temp was 98.2 and patient stated she was hungry for Burger King.
About 16 hours after receiving 3rd shot I developed frequent urination. I was running to the bathroom every 10 -15 mins to empty a full bladder.; 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Dec2021 12:30 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. IBS; "IBS" (unspecified if ongoing), notes: Other medical history: Asthma. IBS; "known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN, shellfish, bees, pineapple; "known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: PCN, shellfish, bees, pineapple; "known allergies: bees" (unspecified if ongoing), notes: Known allergies: PCN, shellfish, bees, pineapple; "known allergies: pineapple" (unspecified if ongoing), notes: Known allergies: PCN, shellfish, bees, pineapple. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 15Mar2021, when the patient was 44 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 22Feb2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 12:30, outcome "unknown", described as "3rd shot"; POLLAKIURIA (non-serious) with onset 02Jan2022 04:00, outcome "recovering", described as "About 16 hours after receiving 3rd shot I developed frequent urination. I was running to the bathroom every 10 -15 mins to empty a full bladder.".  Additional information: Patient did not received other vaccines in 4 weeks. Patient did not have Covid prior vaccination. Patient did not tested Covid post vaccination. It was reported that the event Lasted 6 hours. Still not 100% after almost 3 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Large, red patchy area around vaccine site.; Very enlarged lymph node in left armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 15May2021 at 11:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included quetiapine (MANUFACTURER UNKNOWN), zolpidem (MANUFACTURER UNKNOWN) and prazosin (MANUFACTURER UNKNOWN) all taken for unknown indication from an unknown date, taken within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 24Apr2021 at 15:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the 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.  On 16May2021, the patient experienced Large, red patchy area around vaccine site, very enlarged lymph node in left arm pit. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The clinical outcome of the events  Large, red patchy area around vaccine site, very enlarged lymph node in left arm pit were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Possible extra dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago) and Shingrix (2nd dose received 5 years ago).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Possible extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 07-NOV-2023 The pharmacist reported on November 7th 2023 that male patient might have received 2 doses of Shingrix in the past (around 5 years ago) but was not sure about it and would like to know what safety information was available after the administration of a 3rd dose. The vaccine administration facility was the same as primary reporter. No patient's identifiers other than male over 65 years of age were provided.
This case was reported by a healthcare professional and described the occurrence of head buzzing in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 14 September 2010 at 12:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 14 September 2010, one hour after vaccination with FLULAVAL, the subject experienced head buzzing. At the time of the report, the subject's vital signs were good. On 14 September 2010, the head buzzing was resolved. The nurse reported two additional patients, see cases A0882394A and A0882705A.
Despite accepting the 2 doses of Moderna Covid-19 vaccine as a Registered Nurse I was diagnosed via Binax and PCR with COVID-19 infection on Thursday September 30, 2021. I have severe symptoms including fever up to 102*, complete loss of smell and taste, severe head ache, tight chest, cough, every joint in by body is effected with pain. I accepted the mAbs ( casirivimab + imdevimab)  injections on 10/1/2021 . I was also prescribed Dexamethasone 8mg p.o. daily x 10 days.  I am at home and working through t he recovery at this time.
Developed Bells Palsey beginning with right eye sagging on Saturday 10/22 by Monday 10/24 all of the right side of my face was numb Went to health care for visit and tests
Information has been received from a consumer who reported that in approximately July 2010, her approximately 20 week old ("five months of age") daughter was vaccinated with the first dose of ROTATEQ (Lot # not reported) at five months of age, instead of 6-12 weeks as stated in the PI. Consumer was unwilling to give physician information. No adverse effect was reported. It was unspecified it the patient sought medical attention. No further information is available.
Headache for 2 1/2 days Exhaustion (slept from 1:00 pm on 4/8/21 to 10:30 am on 4/9/21).  Was awoken only by phone call. All over weakness
Arm sore for two days. Slight body aches, very mild fever, and some fatigue that evening and the following day. A nap and a single 200mg Advil tablet reduced symptoms.