chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick; Reactivated Herpes virus; Reactivated Herpes virus; Bleeding nose; Bleeding gums; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, 0.3 ml single (Lot number: ER8734, Expiration Date: 31Jul2021) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes virus" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Location of injection: right arm, Vaccine administration time: 11:00 AM, Batch/Lot number: EN6199), administration date: 15Mar2021, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick"; EPISTAXIS (non-serious), outcome "recovered", described as "Bleeding nose"; GINGIVAL BLEEDING (non-serious), outcome "recovered", described as "Bleeding gums"; HERPES VIRUS INFECTION (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "Reactivated Herpes virus".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  This follow-up report is being submitted to amend previously reported information: condition type in medical history updated from "past drug event" to "Historical Vaccine" and narrative updated.  Follow-up (07Mar2023): This is a spontaneous follow up report received from same contactable Consumer and additional consumer. Updated information included: Middle name added for reporter slider 1, patient information, Additional Reporter (Consumer), Relevant medical history (Herpes virus), Events (Sick, Epistaxis, Gingival bleeding, Herpes virus infection and Disease recurrence) were added. Notes of Historical vaccine, Dosage regimen of Suspect Comirnaty updated. At risk classification and event Inappropriate schedule of vaccine administered were removed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318595 same patient, different drug/events.;US-PFIZER INC-202201318604 same patient/drug, different dose/events.;
Client held his breath while immunizations were being administered. I kept telling him to breathe - he became diaphoretic & developed clubbed hands - he insisted that he couldn't open his hands. I called 911 - when EMTs put O2 on him, his color returned & he had full use of both hands & arms . The pt. was a near syncopal episode not a syncopal episode - Mom refused transport since the pt. had no ins. & he was fine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9809) at the age of 50 years, in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198) at the age of 51 years, in right arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 51 years, in left arm and on 20May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Sulfa" (unspecified if ongoing); "known allergies Mold" (unspecified if ongoing). The patient took concomitant medications: UP&UP (Women's Multivitamins, Probiotic Gummies) from Sep2019 to 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid (Lot number: GA6206) from 31May2022 to 01Jun2022 for covid-19.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FUNGAL INFECTION (recurring yeast infections), URINARY TRACT DISORDER (urinary problems), BLOOD URINE PRESENT (blood in urine) and RASH (rash expanding to stomach, legs, back and arms; rash was so bad the only place she did not get it were on her head and feet) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FUNGAL INFECTION (recurring yeast infections) and BLOOD URINE PRESENT (blood in urine). On 01-Jan-2021, the patient experienced RASH (rash expanding to stomach, legs, back and arms; rash was so bad the only place she did not get it were on her head and feet). On an unknown date, the patient experienced URINARY TRACT DISORDER (urinary problems). The patient was treated with PREDNISONE for Rash, at a dose of 1 dosage form. At the time of the report, FUNGAL INFECTION (recurring yeast infections), URINARY TRACT DISORDER (urinary problems) and BLOOD URINE PRESENT (blood in urine) outcome was unknown and RASH (rash expanding to stomach, legs, back and arms; rash was so bad the only place she did not get it were on her head and feet) had resolved.            Concomitant medications were not provided by the reporter.   The patient reported taking numerous oral and topical medications for the event including prednisone shots.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: TCR provided additional event and treatment details On 03-Jun-2021: New events added after 1st dose, 2nd dose details provided
Tinnitus made dramatically worse.  Now covers a broader frequency range and distorts music to the point that it is unpleasant to listen to.   Has also deceased speech recognition dramatically.
Reaction to pneumonia vaccine given in the left arm (deltoid). Mild pain, redness and streaking from injection site.
Pfizer COVID Vaccine ages 6mo-4y diluted on 10/31/23 at 506pm was given on 11/1/23 at 806am. This is beyond the MIFU time of 12h post-dilution. Made call to Pfizer and spoke to a pharmacist who said extended stability data post-dilution at 35-86F showed no impact for up to 24h storage in vials and in syringes. Dilution information not written on internal documentation sheet. Administrating MA did not see time written on labeled syringe.
Patient received expired vaccine (refrigerated expired by 1 day). Patient repeat vaccination on 5/24/2021
FIRST TWO DAYS-NORMAL ACHES, FEVER, NERVE PAIN WHICH SUBSIDED. THIRD EVENING STARTED WITH SEVER DIARRHEA THAT LASTED TWO MORE DAYS ACCOMPANIED BY NAUSEA AND DIZZINESS. THE NAUSEA AND DIZZINESS PERSISTED FOR SIX DAYS AT WHICH TIME I WAS SENT TO THE EMERGENCY ROOM BY URGENT CARE.  THEY THOUGHT THAT I MAY HAVE HAD BRAIN SWELLING.
started getting dizzy about 10 minutes after shot .. she got some water and went on after about 20 minutes ..  I called to check on her 2 hours later and still a little dizzy.  I checked on her the next morning and she said dizziness gone but lasted about 4.5 hours.
now I am having seizures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: SEIZURE (medically significant), outcome "unknown", described as "now I am having seizures". Clinical course: Patient was a member of the covid vaccination study and now she was having seizures. She would like some additional work ups to ensure there was no connection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had to postpone the second dose because of a medical issue, anemia; Red blood cell aplasia; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), first dose intramuscularly, administered in arm left at 23Mar2021 07:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at age of 64-year-old. Medical history included Addison's disease from 1980 and ongoing, slightly hypothyroid from 1980 and ongoing, ongoing Good syndrome, cholesterol increased from 2018 and ongoing, adrenal insufficiency and IGG deficiency (diagnosed with it five to six years prior to this report). No family medical history relevant to event. Concomitant medications included hydrocortisone taken for Addison's disease from 1980 and ongoing; fludrocortisone taken for Addison's disease from 1980 and ongoing; atorvastatin (LIPITOR) taken for lowering cholesterol from 2018 and ongoing; levothyroxine taken for slightly hypothyroid from 1980 and ongoing; immunoglobulin human normal (HIZENTRA) taken for Good syndrome. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient got his first dose on 23Mar2021. He knew it is supposed to be within 42 days for the second dose, but his was scheduled about 60 days. He would like to get his second dose. His second dose was scheduled pretty far apart, about 60-70 days since his first dose. The patient had anemia and still had it. The patient had to postpone the second dose because of a medical issue, anemia. They decided to postpone. He was diagnosed with a red blood cell aplasia. He got blood transfusions. He was hospitalized three weeks after getting the first dose. The same day he was supposed to have the second vaccine they discovered the problem and he had to be hospitalized. He had blood transfusions. They are still trying to figure out why he had it. The treatment included blood transfusions, he got concentrated red blood cells. Four times, once in the hospital. Confirmed as he received four units. The third one he just had outpatient. He had one two weeks after, since the beginning of April. He just had one yesterday. He had them about every two weeks. He was about to start treatment for this anemia. The both events require a visit to emergency room and physician office. The patient had relevant tests and was diagnosed with red blood cell aplasia and then hospitalized, but unable to provide exact details. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
felt like the top of my head was vibrating; nausea; headache; numbness / stroke-like symptom (numbness); term transient dizziness / dizziness; migraine; This spontaneous case was reported by a pharmacist and describes the occurrence of HEAD DISCOMFORT (felt like the top of my head was vibrating), DIZZINESS (term transient dizziness / dizziness), NAUSEA (nausea), HYPOAESTHESIA (numbness / stroke-like symptom (numbness)) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029C20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History reported by reporter.  Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and VITAMINS NOS for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2021, the patient experienced DIZZINESS (term transient dizziness / dizziness) and MIGRAINE (migraine). On 19-Apr-2021, the patient experienced HYPOAESTHESIA (numbness / stroke-like symptom (numbness)). On an unknown date, the patient experienced HEAD DISCOMFORT (felt like the top of my head was vibrating), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 05-Jan-2021, DIZZINESS (term transient dizziness / dizziness) and MIGRAINE (migraine) had resolved. On 19-Apr-2021, HYPOAESTHESIA (numbness / stroke-like symptom (numbness)) had resolved. At the time of the report, HEAD DISCOMFORT (felt like the top of my head was vibrating), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: No Indication of Stroke.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable   This case was linked to MOD-2021-116510 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No specific follow-up information recorded.
Large, hard, red bump at injection site that is growing over time. I'm currently 72 hours post injection. I have a mild, red, itchy rash around the large red bump as well. Bump is currently about 2 inches in diameter and growing.
Patient experienced subjective fever, headache, dizziness/lightheaded, and body aches starting the day after administration of this vaccine. 3 days after vaccine administration, patient developed pharyngitis and petechiae of the soft palate.
Approx 12 hours after second dose of Pfizer COVID vaccine, my son experienced severe chills (teeth chattering so bad he couldn?t talk) , heart palpitations, said his heart hurt so bad he was crying, rapid uncontrollable breathing, fever, headache (said his head felt like it was going to pop), aches and pains to the point he couldn?t walk.
In the week following the vaccination, patient states he felt very tired.  In the second week, he had a sore throat.  In the third week he had a cough, nasal congestion, and other flu-like aches.  In the fourth week following vaccination, he developed "mild bronchitis symptoms."  After about six weeks, he recovered.
Redness, swelling, pain (localized) left deltoid 3 day course of prednisolone 15mg/5mL = 10mL one daily.
This spontaneous report was received from a female patient of unknown age, who was also a pharmacist and was reporting on herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patient was vaccinated with two (also reported as previous) doses of (Oka/Merck) VARIVAX injection (strength, route and site of administration, dose, lot number and expiration date were not reported) as routine vaccination. On an unknown date (reported as recent), the patient had titer testing performed, which was required for employment purposes and showed "borderline immunity" to varicella (exact results of titer testing were not reported). Product quality complaint was not involved. The outcome of "borderline immunity" to varicella and the relatedness between this event and (Oka/Merck) VARIVAX were not reported. Additional information has been requested.
small blister type rash; 23MAY94 most body area inc temp; 25MAY94 24 hrs t103 responded to APAP; wheezing;  dx asthma;
Vaccine received on 9/22/15. Localized redness and swelling to injection site beginning on 9/23/15.
35 weeks 4 days pregnant at time of vaccination. 60 hours after injection (on 1-23-21 at 10:30 pm) developed fever of 103, severe chills and tremors, low blood pressure (80/60), high resting heart rate (115 beats per minute). Treated with acetaminophen. Symptoms continued for a week, with ongoing fever spikes of 103 and dips down to about 100. Requested antibiotics from OB on 1-28-21 and began taking amoxicillin that evening. Symptoms began to lessen by 1-29-21 and disappeared after 1-30-21. OB tested for UTI on 1-28-21; returned positive result on 2-4-21.
Patient developed severe abdominal pain, lightheadedness, and tingling in arms when stood up approximately 2:00am, on 8/4/17.
About 5 minutes after vaccine, pt stated she was not feeling well, felt lightheaded and sweaty.  Pt appeared pale.  Applied cool wet paper towels to pt's neck and forehead, had her take deep breaths.  Started to also feel nauseated.  Then had her lay on exam table for a few minutes.  Pt started feeling better and sat up for a few minutes.  Further monitored pt for a total of 30 minutes from the time she said she did not feel well.  Pt recovered, color back in face, was able to walk out of clinic area without assistance.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 2nd October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. In October 2018, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the pain in arm, injection site swelling and injection site warmth were unknown and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. Less than a week after receiving SHINGRIX vaccine, the patient developed a large, red, raised, hot ring (about 2 inches in diameter) around the injection site. The patient also reported arm soreness in the vaccinated arm right after receiving the injection.
Pt had Anthrax vaccine #4 administered in left deltoid on Thursday 30 May 2008.  Noted mild tenderness and redness around area the next day. Came into clinic on Monday 2 June with significant erythema and warmth and mild tenderness approx 2 inch diameter all around the site of injection.  Area outlined with pen. Patient returned 24 hours later and area of redness had extended slightly outside of outline, but degree of erythema and warmth was significantly less than day before. Minimal tenderness to region. patient had no systemic s/s in this timeframe.
Fever for 3 days reaching 103.4; chills; sweats; shaking; headache; Hard lump on left arm size of baseball that has not gone away.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 52-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration in left arm on 28Feb2021 at 16:30 (age at the time of vaccination 52-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had no known allergies. No other medications in two weeks. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration in left arm on 07Feb2021 as historical vaccination as single dose for COVID-19 immunisation. On 01Mar2021 at 08:00, the patient experienced fever for 3 days reaching 103.4, chills, sweats, shaking, headache and hard lump on left arm size of baseball that has not gone away. The patient had neither COVID prior vaccination nor COVID tested post vaccination. No treatment received for adverse events. The outcome of the adverse events was not recovered.  No follow-up attempts are needed. information about lot/batch number could not be obtained. No further information is expected.
<1 hr of vax, c/o chilling;devel fever that eve of 104;APAP x2-t103;next day had intermittent LE numbness w/weakness vs feeling like on fire in thighs & calves;no resp involvement lasted 2 days;last few months has had diff w/allergy
This spontaneous report was received from a medical assistant who reported that ZOSTAVAX reached temperatures that were outside the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
At approxiamtely 1655 observation nurse reported 42 year old female with allergy to aspirin complaining of throat swelling and tounge swelling after receiving Janssen vaccine ( Lot # 204A21A) at 1653. Patient assessed, no visual swelling noted on evaluation. Patient denies difficulty breathing or difficulty swallowing. Vitals stable BP 130/80, HR 78, RR 18, O2 Sats 98% on room air. Patient was alert and oriented and in no visible distress. 1702- EMS called for further evaluation. Patient monitored while awaiting EMS arrival. 1720 EMS arrived. Patient assessed by EMS. Pt stable and refuses transport. Patient states she "feels better" and ?I don't feel it getting worse, I am OK". Patient discharged in stable condition in care of spouse. Patient educated to seek medical attention for any difficulty breathing, difficulty swallowing or any concerning symptoms.
HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fatigue. This report was non-serious.
Pt was given injection  of hep B vaccine (20mcg/cc) in left deltoid muscle in the AM of 06/11/02. Pt states he began feeling tingling and numbness in 4th and 5th digits of left hand 5 to 10 minutes after the injection. Pt states no improvement as of today 06/21/02 and states possible workman's comp. claim.
Patient had extremely heavy period after receiving the vaccine in August.  Bleeding was so bad that she was going through one pad an hour.  This lasted two days. The next month (September) patient started her period one week early and had the same extremely heavy bleeding as she did in August.   Patient bled through one pad an hour for 48 hours. Prior to receiving vaccine, patient had very light periods, lasting only 2-4 days.  Now, periods are VERY heavy for the first two days and are lasting 5-7 days.  Extremely abnormal and this only changed after receiving the vaccine.
After the first shot she only had a sore left arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the first shot she only had a sore left arm for a couple of days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy (Surgery Hysterectomy 2017 or 2018). Concurrent medical conditions included Breathing difficult (not gotten worst after vaccination) and Low blood pressure.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (After the first shot she only had a sore left arm for a couple of days). On 08-May-2021, PAIN IN EXTREMITY (After the first shot she only had a sore left arm for a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-382581 (Patient Link).