chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dead feeling has escalated to tinnitus; dead feeling has escalated to tinnitus; This is a spontaneous report from a contactable consumer(patient).  A 35-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 10:30 (Batch/Lot Number: ER2614) as SINGLE DOSE for covid-19 immunisation. Medical history included bradycardia from an unknown date and unknown if ongoing. The patient has no Covid prior vaccination and not Covid tested post vaccination. The patient also has no known allergies. No other vaccine in four weeks. The patient was vaccinated at Public Health Department. The patient previously took bnt162b2 first dose on 27Feb2021 02:00 PM (Lot number: EN6198) at the left arm for covid-19 immunization. Concomitant medications (reported as Other medications in two weeks) included: ibuprofen, vitamin C and unspecified multivitamin; all taken for an unspecified indication, start and stop date were not reported. The patient reported that "Two hours after receiving my second dose on 20Mar2021, I went on a car ride that had several thousand feet of elevation change. Throughout the drive, my ears equalized pressure comfortably. When I reached my destination about three hours later (3:30 PM), my left ear began experiencing a "dead" feeling, but I could still hear and distinguish sounds and tones. I went to sleep, and the sensation remained. The dead feeling has escalated to tinnitus, which is a condition that I have rarely experienced in my life." The outcome of the events was not recovered. No treatment was given.
This literature marketed report as received from a other health professional refers to a 3.9 year old patient. Effectiveness of varicella vaccine (manufacturer unknown) is assessed by reviewing the medical records of closely monitored HIV-infected children, including those receiving highly active antiretroviral therapy (HAART) between 1998 and 2007. The medical records of 164 perinatally HIV-infected children from between 1989 and 2007 were reviewed to determine whether and when they had received varicella vaccine (manufacturer unknown), developed varicella, and/or developed herpes zoster. All perinatally HIV-infected children were included except for those who developed varicella before 1 year of age, because varicella vaccine (manufacturer unknown) is not given before then. Immunized children received at least 1 dose of live attenuated varicella vaccine. The effectiveness of the vaccine was calculated as 1 minus the rate ratio. Incidence rates of varicella were calculated for 2 periods: the prevaccine era for HIV-infected children (1989-1998, when none of the children received varicella vaccine) and the vaccine era (1999-2007). Rate ratios for development of herpes zoster among children who had been immunized versus those who had varicella were calculated. It was reported that patient developed breakthrough varicella at 3.9 years after the last immunization. The outcome of the event reported was unknown. The author considered the event was related to varicella vaccine (manufacturer unknown). This case is linked to the case 1405USA005189 via Same Literature Link. Additional information has been requested.
Ten minutes after given flu vaccine child became pale, cold and clammy skin, slightly lethargic and bradycardic. O2 inhalation given. EMS activated. Brought to ER.
Information has been received from a RN concerning a 66 year old female who on 05/08/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  On 05/08/2003 the patient developed a red, swollen left arm.  Unspecified medical attention was sought.  No product quality complaint was noted.  Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. He previously received a COVID-19 Vaccine. Proprietary medicinal product name was Paxlovid. Date of start of drug was on 17Aug2022 and date of last administration was on 22Aug2022. Reported Events were Congestion, cough on 26Aug2022 at 12:00 AM. No treatment received for AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever of 101.7, chills and itching that started on awakening the next morning, as listed in the side effects on the info sheet.  However, large (2 inches across) bruise that resolved into a blister at the injection site.  Blister has reduced in size but is still visible 2 weeks after the shot (today, 5/14).  Itching and blisters at my original shingles site (I had shingles in July 2014).
Patient got flu shot at pharmacy 9/20/14. Came in on 10/6/14 with an infected flu shot site of entry. It was black necrotic tissue about the size of a dime. Pt did not feel any pain or any other symptoms. Will go to doctor to get it checked out.
Chills, slight headache, overall fatigue,  injection site pain for approx 24 hours
Initial report received from a healthcare professional on 16 July 2012. A 57-year-old female patient with no reported medical history and concomitant medications had received first doses of both YF vax vaccine (Batch number UH296AB) subcutaneously in left upper arm and TYPHIM Vi (batch number G0508) intramuscularly in left deltoid region on 09 July 2012. On 15 July 2012, 6 days post vaccination, the patient experienced redness, swelling and warmth at the YF injection site. The patient was involved in physical activity on the day she noticed the events. The patient did not seek any medical intervention nor did she self treat. Laboratory investigations were none. As of 16 July 2012, the patient had recovered from the events; however the date of recovery was unspecified. Documents held by sender: None.
Srvere shaking and chills, lymph node enlargement both left axilla and breast. Loss of appetite. Severe migraine requiring infusion.
Patient received 2nd dose of vaccine . Waited approximately 15 minutes in observation. Started driving home and felt dizzy. Developed rash on chest. Patient drove back to health department to be seen.  Patient stayed in EMS room for approximately 15 minutes. Drank water and had an ice pack on neck. Patient stated she felt better and no longer dizzy.
Staring episode with inability to be roused, inability to change posture, but no tonic/ clonic beahvior. He had incontinence of urine and became somnolent.
The booster was administered incorrectly (subcutaneously). The person pinched my shoulder over the deltoid, inserted a small portion of the needle under the skin sideways at an angle, with a significant portion of the needle still protruding. The side effects were minimal and localized, some superficial tenderness/firmness around the injection site. I am concerned that this will lead to vaccine failure, and with waning immunity, I will not have the protection typically provided by the booster shot.  I would like a booster administered properly to ensure that I have good protection from COVID-19 to protect myself and my household. I would also like to ensure that the people administering the doses at my site are doing them correctly.
little swelling in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CONCERTA; FINASTERIDE. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "little swelling in the arm". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: Patient stated, "he got his booster this morning at 10 am. He dont know what time you are under in, right now its 2:20 am, so he got his second Pfizer dose back in April and when he had his first dose he was totally fine you know, just little swelling in the arm just like any vaccine will give you (Further clarification unknown) and he got second dose however like almost right away it kind of gave a headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown ages and genders. The patient's medical history and concurrent condition were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored doses of ROTATEQ, lot number N034401 and expiration date of 09-MAY-2019 and RECOMBIVAX HB, lot number R015160 and expiration date of 09-NOV-2020 both for prophylaxis (dose, route of administration and anatomical location were not reported). These vaccines were exposed to temperature excursions of (34.8F) (32 degrees F up to 35 degrees F), with a time frame of 1 hour 9 minutes. There was no previous temperature excursion. A "data logger" was involved. There was no treatment given for the event, no lab diagnostics/studies performed and not seek medical attention. The causality between the event and ROTATEQ and RECOMBIVAX HB was not provided. This is a non-valid case due to the lack of patients' identifiers.
whole body is achy and sore; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (whole body is achy and sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced MYALGIA (whole body is achy and sore). At the time of the report, MYALGIA (whole body is achy and sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided. Patient did not have any reaction to the first two shorts.
Full body aches, extreme fatigue, chills, head ache, had to leave work early, felt "horrible" for 2 days, around 48 hours
Itchy red and warm 10*9 area at site of injection on left upper arm.  Started Keflex orally since seems to be worsening from yesterday.
Narrative:  Pt was a 58 YO male with PMH of HLD, HTN, DM2, CAD, rheumatoid arthritis, depression, and anxiety who was admitted to Hospital for stroke and CAD. Pt subsequently passed away.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. Since 22-SEP-2014 the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose and route were unknown). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Lump on the injection site; Red rash injection site 1/2 inch; Swollen injection site; A spontaneous report was received from a consumer concerning a 65-year old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, red rash about 1/2" on the injection site/injection site rash, it is swollen/injection site swelling and feels like there is a lump on the injection site/injection site mass.  The patient's medical history as provided by the reporter included cancer. No relevant concomitant medications were reported.  On 04 Jan 2021, approximately eight days prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received the vaccine and on 12 Jan 2021, the patient experienced red rash about 1/2" on the injection site, it is swollen and feels like there is a lump on the injection site. No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.  At the time of the report, the outcome of the events, red rash about 1/2" on the injection site, it is swollen and feels like there is a lump on the injection site were not resolved.; Sender'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
One week prior to my first vaccine I had COVID-19. I got the vaccine, and I went back to work that day, became very tired as the day went on. I had to take the next day off. I was having headaches between the first and second dose, those have since fizzled out. After the second vaccine, I did not have any side effects, with the exception of soreness in my arm. But I just later I just did not feel right, I was very forgetful and had brain fog, I don't know exactly when it all started maybe 5 days out. Since receiving the vaccines, I have had heightened anxiety and my meds are no longer working. I have been getting a lot of colds and bronchitis which I was out of work for 10 days due to that. I have been having a sore throat, which the doctor said that could be allergies. My immune system seems to have weakened.
Lightheaded, dizzy, palpitations, patient went to ER and was given fluids.
Heavy sweating, nausea, fainted completely unconscious. First time ever went unconscious. Woke up shortly after, sore ankle from falling on it. Stayed on floor for a while, feeling better now.
Severe vomiting and dry heaving/wretching.   She couldn't even keep down water or Pedialyte, and the wretching was prolonged (more that just a typical dry heave).
Patient states she received the Pfizer two dose series plus one booster: 4/9/21, 4/27/21, 11/12/21.   Any information requests left blank were done so intentionally due to inability of information procurement.   Patient presents to ED with extremely low hemoglobin, cough, subjective fevers, SOA.
Information has been received from a licensed professional nurse (LPN) concerning a 76 yr old female who on 18Oct05 was vaccinated IM in the deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot reported as 7091P). The LPN reported that the pt was on multiple drugs concomitantly. On approx 18Oct05 the pt experienced injection site swelling, redness and pain. Unspecified medical attention was sought, no diagnostic or laboratory studies were performed. Subsequently, the pt recovered. Additional information has been requested.
Started with vomiting , which was severe and very sudden Fever started and was really tired and couldn't sleep had chills and muscle spasm everywhere very severe leg muscle spasm are worse in right leg. Next morning the muscle spasms stopped in right leg  and then left leg started hurting really bad became more severe thorough out the day Couldn't walk  Pain in the left leg by hip started moving down her leg I noticed that behind my left knee was hurting Pain throughout entire body After a week hip and knee started feeling better Left calf feeling funny Went to doctor the second week Every since shot I have had muscle fatigue  Pain  in hand Taking Motrin around the clck.
expired Menactra was administered to a 12 year old female, no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12-year-old female patient who was vaccinated with an expired 0.5 mL once dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6346AA and expiry date: 30-Aug-2020) via an intramuscular route in the left deltoid for prophylactic vaccination on 02-Sep-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency same day).   At the time of this report, no adverse event symptoms reported.  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 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.
Approximately 6-7 minutes of observation she developed flushing and warm sensation about the face and neck. Also developed red rash, non pruritic about the neck and chest.  Also behind both ears right greater than left.  No shortness of breath and no wheezing.  Rash only on upper chest and neck.  Vitals signs taken BP 174/91, pulse 73, 173/86, pulse 68, 163/92, pulse 64.  Benadryl  50mgs by mouth.  Observed additional 15 minutes.  Patient had complete resolution of symptoms.  O2 saturations were 97-98% the entire time.  Patient discharged ambulatory.
no additional AE; Improperly stored vaccine was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 26-SEP-2022, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose, route of administration, and vaccine scheme were not reported; lot number W017567 has been verified to be valid, expiration date reported as 29-DEC-2023 but upon internal verification was established as 29-NOV-2023) for prophylaxis.  The vaccine was exposed to a temperature excursion of minus 11.8 degrees Celsius during a time frame of 1 hour and 45 minutes (product storage error). No additional adverse event was reported (no adverse event).
Pt experienced a near syncopal episode at 9:30am. client A&O x 3. Client upon standing turned pale and stated he felt funny. Client placed supine and lifted feet. V/S bp 86/50 at 9:30am, bp 100/64 at 9:35am pulse 66 reg.
cellulitis of left thigh that started the night of getting the flu shot; worsening in redness, warmth and induration by the next day; no fever. patient was treated with cool compresses and Benadryl with improvement by 48 hours after shot.
High fever (101.8 degrees F) in evening on the day of vaccination. Severe chills leading to difficult to control teeth chattering. Muscle weakness. Nausea & vomiting. Symptoms felt very similar to flu.  Slept for ~11 hours, and was largely recovered in the morning (mild headache & tiredness remains the next day)
First night and for about 24 hours very achy, chills, tired and headache. Arm sore where shot given.  Then that went away and on day 3, my arm swelled, was red and hot and had a hard lump.  That has continued and is still there, 10 days later. The swelling and redness is a bit better, but the soreness and heat are still present.
Patient described having fever and chills along with nausea and vomiting for 2 days after receiving the vaccine. When I followed up with him today on the 4th day after taking the vaccine he said he felt much better. I counseled the patient that if he starts feeling this way again to call his doctor.
Expired Pfizer COVID-19 vaccine was administered. Expired on 6/10/22 and administered on 6/16/22
Pt developed rash over whole body, including toes, scrotum, ears, outside of lips. Doesn't feel involves inside lips/tongue/throat. No difficulty breathing/talking. Rash developed a few hours after receiving vaccine; disappeared after taking Benedryl.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of PNEUMOVAX 23 (Lot # 1174Z; exp. date 10-MAR-2012) (dose and route not reported) on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Information has been received from a licensed visiting nurse concerning an unidentified pt who was vaccinated with a 1st dose of inadvertently vaccinated with a 2nd dose of MMRII on 9/19/99 and 07/31/00, respectively. Subsequently, after the 2nd dose, on 7/31/00, the pt experienced "swelling, 1/2" wheal and an area that is red and hot." The pt sought unspecified medical attention. Additional information has bee requested.
A report has been received from a Health Professional concerning a patient born on 13-Jan-2015, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated FLUMIST administration to child less than 2 years old. The outcome of off-label administration to child less then 2 years old and off label use is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationships between off-label administration to child less then 2 years old and FLUMIST QUADRIVALENT.
heavy bleeding from rectum; being totally exhausted; very high (for me) heart rates; lab results showed that I had irregularities in my blood; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiry date was not reported), (age 80 year at the time of vaccination) via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:00 as dose 2, single for COVID-19 immunisation. Medical history included several chronic autoimmune conditions, known allergies: Penicillin, Known allergies: Sulfa, from an unknown date and unknown if ongoing. Concomitant medication includes medications prescribed in two weeks was yes. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on Feb2021as dose 1, single for COVID-19 immunization. On Mar2021, patient experienced heavy bleeding from rectum, being totally exhausted, very high (for me) heart rates, lab results showed that i had irregularities in my blood. No other vaccine in four weeks. No covid prior vaccination was reported. No covid tested post vaccination. Adverse event was resulted in Emergency room/department or urgent care. No treatment received for adverse event. The patient underwent lab tests and procedures which included heart rate was higher than normal (sleeping heart rate of 84 average) and lab investigation was irregularities in my blood on an unspecified date. The outcome of the event for heavy bleeding from rectum was recovered on an unspecified date 2021 where as rest all events was unknown.  Information on lot/ batch number has been requested.