chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT FELT DIZZY AND LIGHTHEADNESS  WHICH LED TO HER FAINTING.  AFTER AWAKING THE PT , PT WAS ASKED TO PUT HER HEAD DOWN,  GAVE HER SIP OF WATER,  AND TOOK HER BLOOD PRESSURE  151/67,. AFTER 15MIN WAS DOWN TO 127/60.  MEANWHILE CALLED HER SISTER TO COME PICK HER UP.   PT FELL LITTLE BETTER BUT STILL FELT  DIZZY AND LIGHTHEADNES EVEN AFTER 30 MIN.  ADVISED PT TO LIE DOWN AND ELEVATE HER LEGS ABOVE HER HEART   WHEN SHE GETS HOME
Pt came to office on 12/11/09 with c/o HA's beginning 2 days after H1N1 administration. HAs last 2-4 days. He has light and sound sensitivity; no nausea. Pain relieved by ibuprofen.
On 02/21/2023 I traveled out of town with some family. By 02/22/2023, my family was commenting on how badly I was walking. I just assumed it was due to age and existing arthritis. I also have a bad knee, but this was a different kind of pain. My ankles were killing me and every joint in my body began to hurt. In January, I went to the doctor for some physicals, and they remarked on how great I was doing. After receiving my third booster, I developed a strange weakness for three months following the vaccine. My doctor advised that I put off taking my next booster. The pain I'm experiencing now is involving most of my joints and my muscles feel so tight in my legs and upper arms that they feel like they could snap. I have no idea what is going on. I have seen a chiropractor who said that they can't help. I  was advised that I see a neurologist, which I will doing in the near future.
Disseminated zoster / primary chickenpox with vaccine strain VZV. Patient was previously non-immune without history of chickenpox as a child. He got a disseminated vesicular rash, predominantly on the trunk but also on head, face, mouth and legs.
Covid infection (fully vaccinated & boostered twice with Pfizer vaccine).; Covid infection (fully vaccinated & boostered twice with Pfizer vaccine).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid infection (fully vaccinated & boostered twice with Pfizer vaccine).". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Acute sensory-motor neuropathy symptoms. Appears consistent with a mild Gullian Barre Syndrome
I have hives all over my body that pops up in different spots and different times. Can't stop the itching  and the hives started about a month after the second dose and has worsen since 01/13/2022 after the booster.  The doctor's stated I was reacting to the PEG additives in the vaccine. I received an injection and topical creams for the hives.
46 year old female states got symptoms of loss of sensation Feb 5 and on way home felt pins and needles and decrease sensation.  Got better until  2/17 when was gone am.  States since them come on as day goes on with face always and  tongue and top of arm at times.  1/5 states no sx.  States slept for 3 days after  shot.  Denies any other symptoms.  No weakiness or numbness.  change loss of sensation.  Felt fine other wise.   Onset sudden  Location face originally and has since included tongue and top of arm at times  Quality change of sensation, pins and needles feeling
Low Titers; Drug dose administration interval too long; Inappropriate schedule of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 2-month-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 3rd October 1995, the patient received the 1st dose of Engerix B. On 23rd February 1996, the patient received the 2nd dose of Engerix B. On 12th August 1996, the patient received the 3rd dose of Engerix B. On 23rd February 1996, not applicable after receiving Engerix B and Engerix B, unknown after receiving Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long. On 12th August 1996, the patient experienced drug dose administration interval too long. On 1st April 2019, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased, drug dose administration interval too long and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the therapeutic response decreased to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The batch number and expiration date was not reported. The health care professional reported that the patient received Hepatitis B series. On 1st April 2019, the titers were tested and they were resulted low. The patient received the 2nd dose late, which led to lengthening of schedule. The patient received the 3rd dose late, which led to lengthening of schedule.      Lab Comments: The titers of the hepatitis B antibody was low.
Client taking antibiotic macrobia 100mg q 12 hrs; now c/o vomiting, decrease appetite, sluggish, aches/pains, decrease taste, soreness at injection site; redness in knee at site of old scar; states she is improving; encourage to see her physician; client's mother also reporting adverse effects.
soreness on her arm; a circular rash; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm), RASH (a circular rash) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on her arm), RASH (a circular rash) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (soreness on her arm), RASH (a circular rash) and PYREXIA (fever) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
Narrative:  Symptoms: & RA INJECTIN SITE SORENESS Treatment: IBUPROFEN
Patient after a few days of getting the vaccine was reporting that they felt weak and were having a hard time breathing. Patient  has oxygen at home to use as needed and patient needed to use this to help with his symptoms. Patient ended up in the hospital and did recover, but is needing to go into a nursing home since he is still weak and short of breath.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she knows a man that told her that he no longer gets the flu vaccine, because when he received the flu vaccine (unknown manufacturer), he got flu-like symptoms. The patient called to report that she was certain SHINGRIX was not causing her symptoms. She was relating it to the flu shot. She did not want any follow up at all. She specifically asked that she not received any mailing of any kind. The reporter did not have any additional information regarding this event.
Hospitalization in fully vaccinated person for Sepsis due to COVID-19 (HCC).
Vaccine administered high up on left deltoid. The nurse administering the vaccine met resistance and forcefully injected vaccine. For last two weeks, I have now had pain upon waking and severe pain with movement in my arm greater than 90 degrees. My provider diagnosed shoulder bursitis from the vaccine being administered incorrectly into the bursa. I have had no relief from pain since the administration and will be starting physical therapy this week.
edema in feet and legs; feet color change from bright red, dark red to purple; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (edema in feet and legs) and SKIN DISCOLOURATION (feet color change from bright red, dark red to purple) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced OEDEMA PERIPHERAL (edema in feet and legs) and SKIN DISCOLOURATION (feet color change from bright red, dark red to purple). The patient was treated with POTASSIUM for Potassium replacement, at an unspecified dose and frequency and LISINOPRIL for Diuretic therapy, at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (edema in feet and legs) and SKIN DISCOLOURATION (feet color change from bright red, dark red to purple) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with response to the events are not applicable.
Soreness, intense muscle pain in shoulders, groin, and hips, fatigue, runny nose for 3 days. Nose bleeds currently taking antibiotics.
About an hour after being vaccinated, I noticed that my skin was very irritated on my chest. It got worse and worse. It was burning and very painful. I was using Cortisone, and then my doctor prescribed a stronger Cortisone cream. I was also using Benadryl. It started to get better in about 2 weeks. It was about ninety percent better in a months' time. It is still very sensitive.
The patient has acute vasculitis with biopsy + purpuric  leg rash, microcytic anemia, acute renal insufficiency with hematuria,  He has been responding to oral prednisone, tapering dose.
Pt. was having difficulty breathing.  Paramedics assessed.  She kept coughing.  Unable to catch breath.  Davie Fire Rescue was called to transport pt.  Received Albuterol treatment.  Pt. transported to hospital.
I woke up this morning with hives/rash/a strange allergic reaction on the left side of my neck. The blotchy welts aren't anywhere else on my body and I've never experienced something like this before.
Intense soreness, stiffness and pain from site of injection and down arm and shoulder for about 32hrs after injection. Bruising and slight swelling at site of injection. 99.5 temperature or slight fever with fatigue around the first 12hours.
Patient called the pharmacy and reported an itchy rash at injection site and blister on back.  The patient said that he contacted the primary MD  but she did not recommend any treatment to patient other than to not receive the second vaccine.
patient received vaccine after it had been exposed to temperatures below the recommended range for 2 hours at a low temperature of 30.9 degrees, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from the other healthcare professional.   This case involves a 85 year old female patient who was vaccinated with a 0.5 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Prefilled syringe, lot UJ453AB and expiration date was 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination on 22-Sep-2020 after it had been exposed to temperature at 30.9 degrees F (Fahrenheit), due to refrigerator malfunction for 2 hours on an unknown date.   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   The patient did not receive concomitant vaccines.  It was an actual medication error case due to product storage error temperature too low.  At the time of reporting, no adverse event was reported to the patient.  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.
Allergic reaction with symptoms similar to that of food allergy reaction. Mild to moderate throat swelling and difficulty swallowing starting approx. 10 mins after the vaccine. Took 1 Zyrtec 15 mins after reaction started, and a second Zyrtec 30 mins after that. Symptoms are still ongoing as of now, 5 hours after start time, but are low-level.
Headache, body aches, fever, pain and soreness at the site of vaccine. symptoms lifted somewhat with the use of a 600 mg Ibuprofen pill at about 05:00 AM, but at about 10:00 AM onset of chills and a 100.6  fever that went up to 103.6 before another 600 mg Ibuprofen was taken at the recommendation of the Doctor, and another 6 hours later, and another 6 hours after that for 3 days. Sequelae: Odd Headaches, traces of blood in snot after blowing nose, pain in the right side of back of neck, large area around the site of vaccine still red and tender with slight itch, 5 days later.
about 10min p/vax pt felt dizzy;pt was cold, pale, sweaty, hypotens;pt responded to maneuver for ? vagal syncope;no need for epi;pt recovered in about 20min;
"Patient" was given a meningococcal vaccine and a Tdap - 2 days later both lymph nodes under chin swelled. No fever, ok energy.
Roughly 20 hours post- second vaccine, the lymph nodes in my left became inflamed; My left underarm, breast, and shoulder became swollen and painful with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; My left underarm, breast, and shoulder became swollen and painful, with my underarm developing a discolored bruise; underarm developing a discolored bruise; underarm developing a discolored bruise; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 28-year-old non pregnant female patient received BNT162B2 (Solution for injection; Batch/Lot Number: EW0198, Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Jul2021 09:15AM as DOSE 2, SINGLE for covid-19 immunization (at the age of 28-year-old). Medical history included asthma and known allergies for penicillin, garlic and sulfur from an unknown date and unknown if ongoing. The patient had not received any other vaccine within 4 weeks and other medication in two weeks. Patient was not pregnant at time of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. There were no concomitant medications. Historical vaccine included patient previously took Pfizer (BNT162B2) dose 1 on 11Jun2021 at 09:00AM in left arm for covid-19 immunization. On 11Jul2021 at 05:00 AM the patient experienced Roughly 20 hours post- second vaccine, the lymph nodes in left became inflamed. The patient left underarm, breast and shoulder became swollen and painful, with underarm developing a discolored bruise. The Patient received no treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Fever, chills, nausea, ringing in my ears, and injection site sore for weeks
Information regarding Prevnar was received from an investigator regarding a 22 month old female participant in a study who experienced neutropenia. The participant received the third dose on 5/29/01. The participant also received the third dose of Hib-Titer vaccine, the first dose of hepatitis B vaccine, and the third dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis vaccine on 5/29/01. The patient's concurrent illnesses include asthma, thalassemia beta and neutropenia since 11/15/01. Indication for Prevnar was immunization. Product was administered on 5/29/01. Dose regimen was 1 dose. Additional suspect medication included Poliomyelitis vaccine inactivated, Hepatitis B vaccine, Hib-Titer vaccine, Diphtheria/Tetanus toxoids/Acellular Pertussis Vaccine, MMR, and Varicella Virus vaccine live. The patient was admitted to the hospital on 9/21/02 with neutropenia. Neutropenia initially diagnosed on 11/15/01. The event resolved. No additional information was available at the time of this report. The investigator considered neutropenia possibly related to the study product. The medical monitor considered neutropenia not related to the study product.
red and burning eyes, oozing eyes, chills, fever, coughing, nasal congestion
Info regarding Prevnar injection was received from a healthcare professional regarding a 24 month old female pt who experienced a large red and warm and swollen area at the injection site. The pt received the third dose on 8/2/05. The patient previously experienced no reaction on previous exposure to Prevnar on 12/8/02 and 2/24/04. Indication for Prevnar was immunization. Product was administered on 8/2/05. Dose regimen was 1 dose, IM. Concomitant medications were not reported. Event Details: The pt experienced a large red (injection site erythema), warm and swollen area at the injection site on 8/4/05. Site of administration was not provided. Outcome was unknown. No additional info was available at the time of this report.
Temporary numbing of his left arm. Bells Palsy. Paralysis of the left side of his face. Very droopy eye. Very droopy left side of his face. He has had multiple surgeries to correct the droopiness of his bottom eyelid and left cheek. His eye doctor was concerned about debris getting in because it was so droopy. His eye also waters constantly. His speech is very slurred. It's difficult to understand certain words. Strangers have an even harder time understanding him. He has difficulty chewing food on the left side of his mouth. He has gone to therapy trying to improve all these things, but after zero improvements, vacated the therapy sessions.
This spontaneous case, initially received on 26-Jan-2017, was reported by a Non-Health Professional and concerns a(n) 77-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 12-JAN-2017 to 12-JAN-2017. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event. On 12-Jan-2017, the patient received vaccine following temperature excursion. The outcome was reported as unknown.
Information has been received from a nurse practitioner concerning her 7 year old white son who on 14-FEB-2000 was vaccinated with a first dose of Varivax. It was noted that the patient was vaccinated at a prior pediatrician's office. On 28-APR-2006, the patient experienced breakthrough varicella with six lesions and no fever thus far. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the reporter who indicated that in April 2006, the patient was diagnosed with varicella. No further information is expected. The nurse also reported that her three other children experienced a similar event after therapy with Varivax (WAES number 0605USA00191, 0605USA00089, and 0605USA00082).
Hypogeusia, appx 24 hours. Chills, fever, usual stuff for Tdap.
Patients administered with vaccines that have undergone temperature excursion; First dose administered on 29-Sep-22 and second dose administered on 31-Jan-22; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 29-Sep-22 and second dose administered on 31-Jan-22) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 29-Sep-22 and second dose administered on 31-Jan-22). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 29-Sep-22 and second dose administered on 31-Jan-22) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. Maximum or minimum temperatures reached inside the refrigerator:- on 28-Jan-2022 temp range: positive 34.7F to positive 41.2F; on 30-Jan-2022 temp range: positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range: positive 35.2F to positive 41.7F for 12 hours. Vials Thawed on 28-JAN-2022 Patient have reported any adverse events to date No Treatment information was reported.
MMR - admin. 9/23/11. Pain at site starting 10/15/11. Subseq. developed redness, warmth and induration. No fever, headache or myalgias. Note - called in on 9/29 stating had "fever". Not confirmed in clinic.