chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of taste; Drying mouth; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EN6198 and expiration date was not reported), via an unspecified route of administration, administered in upper Left Arm on an unspecified date at dose 1, single for covid-19 immunization. Patient had no medical history. There were no concomitant medications. The patient experienced loss of taste, drying mouth, fever, chills, body aches on an unspecified date. Patient took Tylenol as a treatment for the events fever, chills, body aches. Patient wanted to know if these are common when got the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
the diameter of the needle used was larger than typical; the diameter of the needle used was larger than typical; swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 19Mar2021 (Lot number: EP7534) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EN6202), in left arm), administration date: 24Feb2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "unknown", described as "swollen lymph nodes"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) all with onset 19Mar2021, outcome "unknown" and all described as "the diameter of the needle used was larger than typical". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: Both dose of vaccine were reported to be given around 4:00 PM or 4:30 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no relevant family history.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331461 Same reporter, suspect drug, and event, different patient.;US-PFIZER INC-2021320011 Same reporter, suspect drug, and event, different patient.
On 09/20/2001, 9 days after MMR, patient had a temperature of 103 for 2 days. He then broke out in a rash on his neck and back. Mother did not take him to doctor.
Low grade fever,  fatigue, chills, mild headache,          No treatment seeked.     Only lasted 24 hours
Information has been received from a medical assistant concerning her 28 year old female cousin who "years ago" on an unspecified date, was vaccinated with the three doses of GARDASIL (lot number, dose and route not reported). The medical assistant reported that her cousin developed cervical cancer at an unknown time period. The patient was vaccinated at work. It was unknown if the patient sought medical attention. At the time of the report the patient's outcome was unknown. Upon internal review, patient developed cervical cancer was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
pt is unsure when symptoms started exactly as her memory was affected. she had a sore arm the first day and then the day after (tues morning) spoke with a family member over the phone who became concerned b/c her speech was not normal/was difficult to understand. her brother came to the house and felt that she might be having a stroke. the pt told her family she felt fine (but did not remember this).  pt went to hospital and did not have stroke; they felt if may be related to vaccine
did not yet get her second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not yet get her second dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not yet get her second dose). On 29-Jun-2021, PRODUCT DOSE OMISSION ISSUE (did not yet get her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Fever all day on 4/4/21 up to 100.7 Fahrenheit Mild headache all day on 4/4/21 Fatigue/weakness all day on 4/4/21
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On unknown dates, improperly stored ZOSTAVAX (2 dose, frequency, route and lot number not provided) were administered to unspecified patients (incorrect product storage). No adverse effects were reported. Names of vaccines involved (including lot/exp): ZOSTAVAX (lot number# reported as L046900, expiration date 23-FEB-2017). Temperature: 12F. Time frame: 72 hours. Was it administered (AE)? Yes. Previous temperature excursion: No. Was call because of a "data logger"? (Y/N): No. Additional information has been requested.
Systemic: Confusion-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Severe, Additional Details: Pt had a seizure and fainted, EMS was called and brought pt to hospital
Pt presented with flu like symptoms and severe illness in June 2021. Influenza and COVID tests negative. Developed SVT (PAT vs Aflutter) in August 2021 with associated dyspnea, air hunger and palpitations
This is a cluster of 2 patients who experienced adverse events following administration of FLUZONE INTRADERMAL; lot number UT4163BA. The event for the other patient was captured in case number 2011-10002. Initial report was received on 13 October 2011 from a healthcare provider. A female patient (age and date of birth not reported) had received FLUZONE INTRADERMAL (ID) injection; lot number UT4163BA on 07 October 2011. On an unspecified date, the patient developed a welt "3 inches in diameter" which turned into a bruise and painful to the touch. The bruise is still visible to the eye five days post vaccination. No further information was available at the time of the report. The patient outcome was not reported. Follow-up information was received on 09 January 2012 from a health care professional. The patient was reported as recovered (date not reported). Documents held by sender: none.
COVID+ 12/31/2022.  Vaccination Status - moderna x4 BRIEF OVERVIEW: Discharge Provider: DO  Primary Care Provider at Discharge: DO  Admission Date: 12/31/2022 Discharge Date: 01/10/2023 Discharge disposition: Home Condition on discharge: Stable DETAILS OF HOSPITAL STAY:   Intractable back pain [M54.9] ADMISSION AND DISCHARGE DIAGNOSES:  HOSPITAL COURSE: Intractable low back pain CT L-spine negative for any acute findings MRI lumbar and thoracic spine as below  PT and OT evaluated  Supportive care and outpatient followup    Acute hypoxic respiratory failure improving  COVID 19 PNA Aspiration PNA - Treated with Decadron/ S/P course of Remdesivir  - s/p IV Unasyn x5 days  - CTA as below  - D-dimer 3700. CTA negative for PE.  Lower extremity ultrasound negative for DVT. Echo without intracardiac thrombus. ? Due to thrombosis related to aortic aneurysm    Dysphagia Episodes of aspiration with water Dysphagia diet. SLP evaluated    Infrarenal abdominal aortic aneurysm with mural thrombus Chronic severe bilateral lower extremity peripheral artery disease Evaluated by vascular surgery, no indication for any urgent intervention. Outpatient followup  Continue aspirin, Plavix and statin   History of Multiple sclerosis Chronic right upper extremity and bilateral lower extremity weakness Severe deconditioning PT/OT/nutrition evaluated    Hypertension Dyslipidemia Coronary artery disease Hypothyroidism Continue home meds   Urinary retention, foley placed x 2 weeks with outpatient followup with urology , started Flomax
Her arm had been sore and painful; This spontaneous case was received on 07-Dec-2020 from other non-health professional (consumer) via Communications (reference number: SEQW20-05636) and concerned a female patient of unknown age. At the time of reporting, the patient was 84-year-old.   The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.   On an unknown date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient's arm was sore and painful but not for long period of time as in case 202007547.   On an unknown date, the patient recovered from the event of 'painful arm'.  The reporter did not provide a causality assessment to influenza virus vaccine polyvalent.  This case is linked to case 202007547 (due to the same patient and reporter).  Company comment: A patient of an unknown age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving influenza virus vaccine polyvalent, the patient's arm was sore and painful. Causality is assessed as possibly related for pain in extremity.; Sender's Comments: A patient of an unknown age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving influenza virus vaccine polyvalent, the patient's arm was sore and painful. Causality is assessed as possibly related for pain in extremity.
Bruising deltoid at injection site and upper arm and on outer forearm. Hard area around injection site.
Pt experienced erythema, edema at injection site; myalgia; warmth over region; fever of 102F and diarrhea.
Pt recv vax & devel a fever & flu-like sx; In f/u the nurse stated that pt was not reporting a pt, but inquiring about a question asked to a MD: No further details were provided;
Within 30 minutes patient experienced moderate swelling and mild erythema of left thigh extending to superior portion of knee joint. The joint was not involved. No warmth noted. From of knee and hip. Reflexes and motor strength were normal and limping was observed. Treated with Motrin and Benadryl as needed.
February 2008 first shot experienced headaches, dizziness, back pain, soreness at injection site (still feels pain in arm today). April 2008 after second infection in addition to above symptoms, confustion, lethargic, gagging, nausea, vomiting, massive warts on the bottom of feet, mood swings, altered personality, shaking. In May 2008 was brought to the hospital had a MRI and cat-scan both normal. The doctor said she was experiencing headaches. In June 2008 she woke up with a headache and vomiting, collasped into a grand-mal seizure. Tranferred to a hosptal. Went through every test possible and came home for a few days. Went into another grand-mal seizure that lasted about three hours, had to be intabated again and transported to the hospital again where they did another MRI, EEG, Spinal Tap and more and more blood tests. Her protein level in her Spinal Tap was very high (159). We are still dealing with a very ill child. On Christmas day she had a seizure and back to hospital which is two and a half hours away from where we live. She takes 14 pills a day with really no answers to why she is ill. Her immune system is confused, confusing her brain. Her life has changed dramatically as she is unable to do the things a healthy 17 year old should be able to do.  2/17/09 Neuro consult dated 1/2/09 received with dx: probable Hashimoto's Encephalopathy.  Report reveals pt had 2 prolonged seizures in summer 2008 with behavioral and mood changes.  Dx with Hashimoto's Encephalopathy and tx with steroids x 3 mon which were tapered off. On 12/25/09 pt woke feeling nauseous and gagging, tremoulous, and feeling sick.  Felt like face "was pulling off".  Unable to yell or move. Found by parents seizing ~ 10 minutes.  Diastat administered. Transferred to hospital. Post-ictal then later combative and agitative. Pt reports being tired and achey since 11/08.  Neuro exam WNL.   3/19/09 Additional records received from 7/23/08, 8/26/08 and 2/20/09 Neuro consults as well as rheum consult 2/20/20009 as well. Pt hospitalized in June 2008 and July 2, 2008 for prolonged seizure in status epilepticus which required intubation and ICU time. Pt had prodrome beginning 2/2008 which consisted of H/A, personality changes and deterioration in school performance. Seen in 8/2008 for increased shakiness, twitching of extremities and unusual posturing with walking. Tx with Ativan for anxiety. W/U (-). Seen in f/u 7/23/08 and 8/26/08. Still with decreased energy, weakness and H/A. Recent weight loss of 15-20lbs 2' to decreased appetite. PE (+) for brisk reflexes.  Improving on steroids. DX:  Presumed Hashimoto's encephalopathy.  Rheum consult 2/20/09. DX not suggestive of Lupus. No further dx noted.
Developed fever, chills that evening, achiness, headache, arm pain through 1/7/21 evening. Was to the point of being unable to function and leave couch which is unusual for her.
Moderna COVID-19 Vaccine EUA 12/23/2020: Received vaccine at 1:00 pm. Experienced left arm soreness, injection site tenderness, body aches, and chills from 10:00 pm throughout the night.  12/24/2020: Awoke with left arm soreness, injection site tenderness, body aches, chills, and a fever of 100.6 F at 8:00 am. Fever rose to a maximum of 102.0 F at 9:30 am. Took acetaminophen and ibuprofen around the clock starting at 9:30 am until I went to bed that night. Symptoms were completely controlled with the acetaminophen and ibuprofen by about 3:00 pm.  12/25/2020: Arm soreness and injection site tenderness throughout the day. Chills with temp of 99.8 F at 2:00 pm. Took single dose of acetaminophen (1 g). Chills and low-grade fever resolved and did not recur.  12/26/2020: Mild injection site tenderness only (did not require treatment) 12/27/2020: all symptoms resolved
Pregnancy 16 weeks gestation.  Vaccine administered prior to recommended time frame of 27-36 weeks gestation.  No symptoms noted post vaccine.
Dose was given at 0.25mL IM instead of 0.5mL IM. Pt is pregnant in late 2nd trimester, due sometime in July 2023.
Spiked fever of 102.4, grunting respirations, retraction in breathing, red swollen face, red puffy eyes, heart rate 188, inconsolable, decrease in appetite.
he got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he got sick".  Additional information: Caller said that he took the dose of the Pfizer COVID-19 vaccine last 07Dec2021 and could not find anywhere the vaccine to get his second dose. He asked if it was safe for him to take the Pfizer COVID-19 vaccine Bivalent. Caller said he took his Pfizer COVID-19 vaccine way back in 07Dec2021 and he got sick although he did not mention if it was before or after taking the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vial underwent a temperature excursion; No adverse event; patient received vaccine from vial that underwent a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) 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. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, 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 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion).    No concomitant medication was reported.   The pharmacist reported that, temperature excursion occurred several days ago in the freezer.The patient received vaccine that underwent a temperature excursion in the freezer, and they just found out about the excursion in an audit. No adverse event reported for the patient.   No treatment medication was reported.
Left arm local reaction -> swollen and red - woke up in night and had wet the bed - mother described muscles as solid and he was walking funny and crying the night after vaccinations - mother reported this child "had a seizure after a shot when really little" - mother and sister have seizure diagnosis.
Patient come in day after receiving flu and pneumonia shot. Left arm covered with rash at injection sites. Pt. complained of dizziness, tinnitus, body aches. Pt. went to ER, had fever was given TYLENOL and felt better. Follow up next day pt. was doing ok.
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the nurse inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The nurse then alerted the APRN, who escalated the situation to the manager. The manager then contacted Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
When giving the vaccine I had twins and grabbed the other's vaccine and gave the patient 2 polio's the other twin received the correct vaccines.
I received the COVID 19, vaccine January 7, 2021. Around 12:30 AM on January 8 I felt nauseous, was very clammy and ending up fainting.  I will be calling out my primary due to this issue. I still need a second dose and unsure if I should get one now.
TOOK LAST DOSE ON DAY 9; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a nurse (PVX2019-383) on 11-Feb-2019. The report describes a male consumer who "took an unrefrigerated dose" and "took last dose on day 9". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer put Vivotif in his luggage while traveling  and his luggage got lost for two days. He took his last dose on day 9 (08-Feb-2019). His first three doses had been taken appropriately. He was unsure of the temperature that Vivotif was exposed to while the luggage was lost.  The action taken with Vivotif with respect to the events "took an unrefrigerated dose" and "took last dose on day 9" was not applicable.  The clinical outcome of the events "took an unrefrigerated dose" and "took last dose on day 9" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" and "took last dose on day 9" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" and "took last dose on day 9" was considered as not applicable.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-JAN-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003097: US-009507513-1805USA003098: US-009507513-1805USA003099: US-009507513-1805USA003100: US-009507513-1805USA003101: US-009507513-1805USA003102: US-009507513-1805USA003103: US-009507513-1805USA003104: US-009507513-1805USA003105: US-009507513-1805USA003106: US-009507513-1805USA003107: US-009507513-1805USA003108: US-009507513-1805USA003109: US-009507513-1805USA003110: US-009507513-1805USA003111: US-009507513-1805USA003112: US-009507513-1805USA003096: US-009507513-1805USA003095: US-009507513-1805USA003094:
Hives that started on trunk and moved to legs and arms. He also experienced edema in feet and ankles. Hives increased in size and lasted from 12/4 to 12/8/2021, for a total of 5 days. On 12/8/21 he began taking  Benedryl, and now symptoms are decreasing.
Slight bleeding at injection site followed by swelling size of nickel to quarter around injection hole. Per pt. via phone hours later swelling had gone down. Cold compress applied to site no feeling of irritation per pt. Recommended Antihistamine if persists. Site normal skin color and hard to touch.