chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2466) was received from a consumer on 30-Sep-2019. It described a female consumer who "took unrefrigerated dose of Vivotif" (PT: Product storage error), while therapy on Vivotif (lot no: 3003281) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 28-Sep-2019, which was left out of the refrigerator for almost 24 hour. On 30-Sep-2019, she took the second dose.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated dose of Vivotif" was considered as not applicable.
booster; temperature range of 41-43 degrees Fahrenheit.; stored in refrigerator state and intact with a  temperature range of 41-43 degrees Fahrenheit.; expired on the 14Nov2021 but 4 doses were administered on 19Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, solution for injection), administration date 19Nov2021 (Batch/Lot number: unknown, Expiration Date: 14Nov2021) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1.), for Covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2.), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 19Nov2021, outcome "unknown", described as "temperature range of 41-43 degrees Fahrenheit."; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "stored in refrigerator state and intact with a  temperature range of 41-43 degrees Fahrenheit."; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 19Nov2021, outcome "unknown", described as "expired on the 14Nov2021 but 4 doses were administered on 19Nov2021".  Additional information: Reporter said that the vaccines should be discarded on 14Nov (30th day) but 4 doses were given to patients on 19Nov. I am a nurse for a medical office, and we received Pfizer vaccines for our patients and of course when they come out of deep freeze, they are good for 30 days after and we had patients that received the dose of the booster doses five days past the date that they should have been discarded.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101656254 same reporter/drug/event, different pt;US-PFIZER INC-202101656255 same reporter/drug/event, different pt;US-PFIZER INC-202101656256 same reporter/drug/event, different pt
Rash in the site of injection; Lump in the injection site; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site  rash and vaccination site mass.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) vaccination site rash, and vaccination site mass.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash in the site of injection, lump in the site of injection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I got the flu; Initial information received on 21-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who reported i got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received of suspect INFLUENZA  VACCINE (dose, frequency, form, strength, lot number not reported)  via unknown route in unknown administration site for immunization. Information on batch number will not be available.  On an unknown date the patient developed a non-serious event of "i got the flu" (flu) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the flu).  At time of reporting, the outcome was Unknown for the event i got the flu.
Patient fainted approximately 5 minutes after vaccination. Patient regained consciousness immediately. Patient also reported cold sweats.
Patient's first dose of COVID vaccine administered on 3-31-2021 in the left arm was at the age of 16 was Moderna, Lot # 017B21A.  Per DH/CDC guidelines a second Moderna, Lot # 038B21A was administered on 4-28-2021 into the left arm to complete the series.  Patient stated she tolerated the first Moderna vaccine without any isuue.
Itching on the site of injection then spread to anterior chest wall and one welt of the body.
Hives and itching about 30 minutes post vaccine, brain fog started about 1 week post , major change in PMS, Major change in menstrual cycle (ie went from very regular to very irregular has gotten more severe as more time as past) Headache about 5 days a week started immediately after .
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Jul2022 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Jul2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 28Aug2021 as dose 5 (booster), single (Batch/Lot number: unknown), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "hypothyroid" (ongoing), notes: on treatment for hypothyroid; "GERD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 04Jun2023 to 08Jun2023. No Other medication in 2 weeks. No Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225109 Same patient, different drug/ events;US-PFIZER INC-202300226199 Same Reporter/Patient/Drug, Different Vaccine Dose;US-PFIZER INC-202300226198 Same Reporter/Patient/Drug, Different Vaccine Dose;
march 4th,bliters on back and waistline, hip, knees, march 11-left hip pain, , march 12th low grade temp, march 13th, chills, body aches back  and joint pain, left lower back, heart palpitations, difficulty lifting head
Information has been received from a nurse practitioner concerning a patient who on 30-JUN-2008 was vaccinated with the first dose of ROTATEQ vaccine live (human-bovine) and on 22-JUL-2008 was vaccinated with the second dose of ROTATEQ vaccine live (human-bovine).The nurse reported that the patient received ROTATEQ vaccine live (human-bovine) in shorter than recommended interval. The patient also was vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on an unknown date which was reported as too early also. No adverse effect reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Fatigue, aches over body, severe chills. Symptoms started about 5-6 hours after vaccination and were severe after 8-9 hours. Less intense symptoms the following day. Treated with Tylenol and Motrin for aches and chills which help with pain, but symptoms  would return after medicine wore off
Headache, Myalgia, Arthralgia, Fever, Right arm pain, fatigue
Member presented to pharmacy complaining of pain/soreness at exact location of injection site; member states it comes and goes and it may be related to change in weather; member is referred to primary healthcare provider
No known adverse events. Patient received dose of Pfizer Covid vaccine when had previously received Janssen Covid vaccine 3/30/21.
The patient's left arm at the injection and all of the deltoid area of the arm blistered and the skin sloughed off. It looks like a sever burn.
headache; chills; fatigue; This is a spontaneous report from a non-contactable consumer. A 73-year-old non-pregnant female patient received BNT162B2 (COVID 19, brand: Pfizer; Solution for injection, Lot number: EL3249), via an unspecified route of administration on 21Jan2021 as single for COVID-19 immunization. The patient medical history includes iron deficiency. The patient did not have any allergies to medications, food, or other products. Concomitant medication included iron supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 22Jan2021, the patient experienced headache, chills, and fatigue. The patient did not received treatment due to the events. No seriousness criteria reported. The outcome of events was recovered on an unspecified date in 2021.
80 yo M with multiple comorbidities and recent prolonged hospitalization which included multiple endoscopies, multiple imaging modalities, blood transfusions, new C-19 dx on 5/10, and a TAVR on 5/11 with DC on 05/13/2022 here with a new c/o acute onset of severe abdominal pain.  Reports chronic black stools, but denies other symptoms such as NVD.  Pain began a few hours ago.  VS are reassuring.  Exam shows umbilical TTP, but he is not peritoneal.
Telephone call received on 3/21/01 from client to clinic PHN stating she has continued to experience muscle soreness and some weakness of left arm off and on since receiving flu shot on 1/2/01. Saw her doctor who stated there was no infection and did not order any meds. Returned call from supervisor on 4/1/01. Client's arm is "gradually getting better" but still bothersome. Suggested comfort measures and to return to doctor if condition worsens.
Hives to site of MMR/Varicella - local reaction gave 1/2 tsp of diphenhydramine HCl - observed for 15 mins. - hives cleared up.
after recv vax pt devel chickenpox that consisted of 20-30 lesions, red pimples w/little puss liquid inside on back, neck, groin, buttocks.
At 2:30 am the morning after my shot, I woke up from a sound sleep with a racing heart beat, 140 bpm. In the next 30 minutes, I vomited several times. Between 3:00 am Wednesday morning and 6:00 am my sleep was frequently interrupted by racing heart beat events that ranged from 110-140 bpm. I rested all day Wednesday, mostly laying on my couch; my smart watch continued to report high resting heart rate events throughout the day. Most events were between 110-115 bpm. It?s Thursday morning, almost 48 hours after my shot and my heart rate is still elevated, averaging around 115 bpm this morning. I also feel dizzy, light headed and nauseous.
Dizziness, brain fog, confusion, headaches, unstable gait and blurred vision.
My wife was sent to the ER with a headache this morning and has confirmed cerebral embolism
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Per patient's mother, symptoms began on 07/21/2022 night.  Patient's mother reported patient told her she was "itchy" under her arm on the side that the vaccine was given.  Per the mother the next afternoon the patient had developed hives to her face, forehead, neck, chest, abdomen, right hip.  Per the mother the child had no new foods, lotions, fragrances, been around any new animals that day.  Per the mother she spoke with a Pharmacist and the patient's Pediatrician.
booster; experienced loss of hearing in one ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "experienced loss of hearing in one ear".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is to report my side effects since the vaccine shot, because I haven?t heard any of these regarding this vaccine. Lower leg below the knee on the left and right leg varicose veins have constantly burned and ached. Only my right leg had previous varicose veins that would burn ache in the evenings following a day of manual labor. From Friday morning to Monday late night my left temple would randomly throb. Same days either my lower left or right lung would ache or be sore. For about 2 hours everyday same days above I would have a metallic taste in my mouth no matter what I ate or drank. No pain ever severe enough for immediate medical attention
Diarrhea; Dizziness; High blood pressure; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HYPERTENSION (High blood pressure) and HEADACHE (Headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder. Concomitant products included CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HYPERTENSION (High blood pressure) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), HYPERTENSION (High blood pressure) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Blood pressure measurement: 119/117 (Inconclusive) Hypertension (high blood pressure).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included: Blood pressure medication.  Treatment information also included: Blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information received: Patient had declined further follow-up.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department reporting three weeks of progressively worse dyspnea on exertion with chest tightness and tachycardia. Initial vital signs within normal ranges. Patient admitted to hospital for observation and testing but left against medical advice before completion.
Patient stated she felt woozy and slightly nauseated after her vaccine but that she had walked 5 miles and taken an extra losartan this morning on accident and hadn't eaten. BP taken, was 115/63. She waited about 45 minutes, drank apple juice and ate cheese wedges and felt "much better." RN walked with patient down the stairs and patient stated she felt safe to drive home. Declining check up at ER and alternate driver.
Patient developed rash at 16 days after smallpox vaccination.  Rash was erythematous macules coalesced in groin, axilla, palms, less on chest and shoulders.  Lesion blanch, nontender, nonscaling, appeared to be dermal.  Smallpox site with scab, no surrounding erythema.  On day 4 of rash, was placed on Prednisone.  Within next couple days, rash resolved except small areas of hyperpigmentation current today.  No causes of rash found.
He got his vaccine, had no problems.  In the early morning hours of Saturday he got a fever and a headache.  His fever went away by morning but the headache did not.  Later on in the day he got tightness across the chest and muscle pain.  He was to the point that he was going to call the paramedics.  By the evening the pain had subsided.  He called his brother who is an ER nurse and he they gave him some advice.  By the time he finished talking to them it subsided and went away.    His arm is still red though.    He was in the military and has never had a reaction like this to any vaccine.
Information has been received from a physician concerning an approximately 10-11 year-old female who was vaccinated with a dose of Varivax (Oka/Merck). The physician reported that on approximately 03-MAR-2006, the patient developed a case of chickenpox. It was considered a more severe case of chickenpox and not a mild case as there were several lesions. The patient was not hospitalized. The patient's case of chickenpox was confirmed by a pediatrician. The patient's chickenpox subsequently resolved. Additional information has been requested.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID-19. The patient was scheduled for her second vaccination and asked if she still needed to receive the second dose. The clinical outcome of tested positive for COVID-19 was unknown.  Information on the lot/batch number has been requested.
Pt recvd Japanese B Encephalitis vax followed in 48 hrs by Plague vax; @ approx 1230AM next day pt was found unresponsive & apparently dead; Pt previously recvd 2 doses of Plague w/no problems reported;
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient experienced only a sore arm after vaccination with the 1st dose of SHINGRIX. This case was linked with case US2018GSK171142 (2nd dose), reported by the same reporter for the same patient.
I got covid 28Dec2021; I got covid 28Dec2021; that time the itching moved to my front and back neck areas; Dose 2:23Jun2021/Dose 1: 04May2021; 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 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jun2021 (Lot number: EW0196) at the age of 41 years as dose 2, single and administered in arm left, administration date 04May2021 (Lot number: EW0167) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MIRENA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "I got covid 28Dec2021"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Jun2021, outcome "unknown", described as "Dose 2:23Jun2021/Dose 1: 04May2021"; PRURITUS (non-serious) with onset 28Dec2021, outcome "unknown", described as "that time the itching moved to my front and back neck areas". The events "i got covid 28dec2021", "i got covid 28dec2021", "that time the itching moved to my front and back neck areas" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: antibody test: (01Jun2021) 5812.3, notes: My covid antibody level is 5812.3 AU/ml; sars-cov-2 antibody test: (25Jan2022) positive, notes: covid test type post vaccination: Blood test. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, pruritus.  Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination:Morena IUD.  Follow-Up (02Feb2022): Follow-up attempts are completed. No further information is expected.
Nosebleed 1:15 minutes long 06/08/2021 Nosebleed 20 minutes 06/09/2021 Nosebleed 20 minutes on Stop 5-7 minutes  this pattern for about 3 hours 06/10/2021 Nosebleed 10 minutes 06/11/2021 Noseblee 7 minutes. 06/12/2021 Nosebleed  5 minutes. 06/13/2021