chrisvoncsefalvay/vaers-outcomes huggingface dataset:
over the last ten years the hair loss has slowly increased to 60-70%. After I took the Pfizer vaccine, hair loss increased to over 75%; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Alopecia" (ongoing); "stress management" (unspecified if ongoing). Concomitant medication(s) included: CLOBETASOL; ROGAINE. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "over the last ten years the hair loss has slowly increased to 60-70%. After I took the Pfizer vaccine, hair loss increased to over 75%".  Additional information: The patient reported she was single 71 yo. female with two adult children who has struggled with Alopecia for nearly 40 years. She had been treated with cortisone shots, Clobetasol, Rogain and stress management. Given that treatment, over the last ten years the hair loss had slowly increased to 60-70%. After she took the Pfizer vaccine, hair loss increased to over 75%. She was so concerned she looked for clinical studies and found a research study which she volunteered for. This study is looking at DNA predisposition to alopecia. It included three biopsies. Following, She met with the alopecia specialist, Dr. PRIVACY who recommended Xeljanz has the best potential treatment. She have insurance which will not cover Xeljanz for alopecia as it is not yet approved for this diagnosis. The out of pocket cost for me would be over $3000 per month. The patient was a (Privacy) with a private practice. She made a solid income but given home and business expenses,  she was not able to spend $36,000 per year for Xeljanz. She was hoping we will consider this appeal as it is an important and effective drug. Folks like her have struggled with this condition and have no access to this Important treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt became pregnant (LMP 12JUN96, estimated date of delivery 19MAR97);@ 16wk gestation an unspecified diagnostic test revealed bilat choroid plexus cysts;diagnostic test was nl @ 27wk gestation;29wk pt devel bacterial enteritis & hosp;
Bruise like soreness and slight red rash at the chin.  It lasted 18 hours
little sore arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional information: The patient reported that she and her husband both received the second dose (Batch/lot number: EN6202) on 20Mar2021. The first dose was little lower to the down on the arm. The first one they got was on 27Feb2021 which they had very little to know reaction. Her husband had nothing; she had a little sore arm, put ice on it that was the end of it, and it was not yet (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a field representative who was advised by a 15 year old female who was vaccinated with the first dose of GARDASIL on 20-SEP-2012. While on GARDASIL, the patient had fainted. On 21-SEP-2012, the patient had a severe headache. The patient sought medical attention and recovered from both events (dates not provided). No additional information is expected.
pt had yellow fever vaccine right arm SQ on 8/9/07. Redness and swelling and itching of arm started 8/10/07 in the afternoon.Came to office 8/11/07 c/o redness , warmth,swelling and pruritus on Rt forearm and upper arm for 1day. Denies SOB or dyspnea.   Size:260mm x150mm flat erythematous patches, well delineated redness and swelling.  No pain - just itching.  Red swollen area extends from injection site posterior upper arm, around arm almost to axilla and down 100mm below the elbow.Instructed to take Benadryl or loratadine PO and Benadryl cream to arm to help with itching. Instructed pt and wife - pt is to go to ER if swelling and redness become worse or s/s anaphylaxsis. We will call pt tomorrow Sunday 8/12 to check on condition.
Patient was in the 15 minute post vaccination waiting area of drive-thru Covid 19 vaccination clinic and began to have symptoms of intense, uncontrollable, systemic itching, hives and wheezing.   Patient given epinephrine injection 0.3mg IM @ 1:14 PM per protocol. Emergency Management System (EMS) notified and responded @ 1:14 PM.  Vital Signs per EMS staff were blood pressure 130/86, pulse 110, Respirations 16,  Oxygen saturation 100%.  Patient transported to Hospital Emergency Department at 1:18 PM via EMS ambulance.
got shingles / suspect vaccination failure; Shingles; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles/ suspect vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: painful). The outcome of the vaccination failure, shingles and pain were not reported.   It was not reported if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient complaint of numbness to upper lip, no swelling to lip, no itching, no trouble talking, no problems swallowing. Patient monitored from 5:26pm to 6:00pm Pt was given benadryl 25mg PO at 5:29pm 5:45pm Patient stated that lip numbness was gone, "feels like normal" 6:00pm Patient went home with husband.
Refridgeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient had any known allergies.     On 26-Sep-2022 at 12:01 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 12:01 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) 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)) (Intramuscular), 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 was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.  No adverse reactions were reported for any of the patients at the time of the report.   No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158, US-MODERNATX, INC.-MOD-2022-654537 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:Same reporter US-MODERNATX, INC.-MOD-2022-654537:Same reporter
None stated  9/5/08 Reviewed neuropsychiatric evaluation of 7/18/2008. FINAL DX: psychotic disorder NOS; seizure disorder w/history of tuberculosis meningitis; compromised carotid bifurcation on right side. Records reveal patient experienced increase in acting out.  Hx of recurrent behavior problems at home w/anger, combativeness, running away which had been increasing since 12/2007.  Was on epilepsy meds, dose remained unchanged.  Started on anti-psychotic med & psychotherapy.
Maculopapular rash on anterior and posterior trunk, neck and face. Fever to 102.0 F.
she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (she does not feel that she got a full dose. After administering the vaccine, she had a small drop of vaccine that came out of her arm).    No concomitant medication were reported.  No treatment information was provided by the reporter.
Pt's left arm - swollen & itching 10 days after the vaccination & got better after couple of days.
This spontaneous report was received from a physician assistant referring to a 11 years old female patient with rhinitis allergic and sinusitis. The patient's medical history included adenoidectomy and tonsillectomy. Concomitant therapies included AUGMENTIN. The patient had no drug reactions/allergies. On an unknown date in September 2018 (reported as 7 months ago), the patient was vaccinated with the first dose of GARDASIL 9 (dose, lot# and expiration date were not reported) route was unknown (given in another clinic), for normal childhood immunization schedule. On 10-APR-2019, the patient was seen for a sinus infection with a temperature of 101-102 Fahrenheit and she was vaccinated with the second dose of GARDASIL 9 (dose was not reported) (lot# was R029117, expiration date was 10-JUL-2021), route was unknown in the left arm for prophylaxis. Approximately 3 hours after receiving the GARDASIL 9, she started AUGMENTIN for her sinus infection. On that day, she experienced diarrhea, headache, neck pain and dizziness. The patient did not have any reaction with the first GARDASIL 9. No treatment was given for the events. The patient sought medical attention and at the reporting time she was recovering from the events. Action taken with the suspect vaccine was not applicable. The reporter did not provide the causality between the events and the suspect vaccine.
Chills and aches started about 8-9 hours after vaccine (10-11pm). Chills and likely fever all night. On 1/28 at 6:15 am, fever 101, vasovagal syncopal episode and nausea. Took Tylenol at 6:30am and drank fluids. Temperature down to 99.7 by 8:30am, 99.6 at 1pm, 99.0 at 10pm on 1/28 (day after vaccine).  Headache and fatigue on 1/28 also.
covid-19; covid-19; This is a Spontaneous report received from a contactable other-health care professional, based on the information received by a Regulatory Authority. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 25Apr2021, at dose1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Aug2021,the patient experienced COVID-19. The outcome of the event was recovered on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Swelling of throat; Difficulty swallowing; Muscle/joint pain; Muscle/joint pain; Chill; Tired/run down; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Aug2021 at 14:45 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Aug2021 (also reported at 01:45), the patient experienced swelling of throat, difficulty swallowing, muscle/joint pain, chill, tired and run down. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling of throat, difficulty swallowing, muscle/joint pain, chill, tired was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Intense burning, itching, redness all over body starting approx 10 days after injection. Could not be controlled with oral antihistamines, was interfering with daily life and sleep. Received steroid injection and oral steroid course, which then allowed itching to be controlled by oral antihistamines. It has now been over 1 month and still have dermatographia symptoms (rash appears after any friction on skin). Taking Zyrtec daily to control itching, nothing is controlling friction rash.
redness, swelling in arm that extends the entire arm with associated numbness/tingling of hand and fingers
Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023).    No concomitant medication details was reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions.  It was reported that the expired Moderna COVID-19 monovalent vaccine was administered to patient on 15-MAR-2023. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patient.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was rHA. Follow up information was received on 12-FEB-2016, regarding a 4 year old male patient. On 11-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Rash over both sides of my abdomen and arms. As a teacher, I talked with my schools nurse first. She mentioned it may just be a "viral rash" and just to keep watch over it to see if anything worse develops. Only took OTC for other symptoms (fever, aches, chills tiredness and fatigue) from the days before the rash. After the rash appeared I was mostly recovered from the other symptoms. It faded throughout the course of 5 days and was clear by the end of 5th day.
Patient was administered Flu shot around 9:05am and shortly reported feeling faint afterwards. Shortly, she started sliding off the chair to the floor. Pharmacist rushed to aid her safely to the floor in the consultation room. Patient went unconscious for a few minutes (~3 minutes) but was still moving arms and legs with eyes closed. Opened her eyes and asked, "where am I"? Blood pressure and heart rates were taken and also was observed by a medical provider onsite. Patient regained full consciousness and was monitored for about 30 minutes before leaving Pharmacy. Patient stated she reacts to the sight of blood and has  history of such with a skin tag removal but denies any fainting history with vaccinations or blood draw.
ADMINISTRATION OF EXPIRED VACCINE FROM THE AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 20 year old male. 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the patient experienced administration of expired vaccine from the affected vials due to temperature excursion. On 07-JUN-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine from the affected vials due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916808, 20210916401, 20210916553, 20210915719, 20210915731, 20210915852, 20210916228, 20210915623, 20210915646, 20210915661, 20210915748, 20210916300, 20210916312, 20210916415, 20210916455, 20210916520, 20210916584, 20210916658, 20210916715, 20210916768, 20210916811, 20210916849, 20210916910, 20210916959, 20210916129, 20210916907, 20210917163, 20210917515, 20210917226, 20210913164, 20210916465, 20210916498, 20210916697, 20210917074, 20210917160, 20210917603 and 20210917500.