chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu shot 10/19/18 eye started irritating her and itching and watery eyes. Apply cool compress and took BENADRYL.
Acute on chronic respiratory failure. CAP (community acquired pneumonia): Admitted with evidence of pneumonia.  She was treated with Zosyn and doxycycline.  Her cough and SOB improved as did her hypoxia although she was still requiring low flow oxygen at 2 liters per minute to maintain sats over 90%.  She will discharge on 2 more days of Augmentin and doxycycline. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
On 6 October 2017, employee had Influenza vaccine placed to left deltoid(relatively high ) 1 in from acromion process, pain started at 0600 next morning with pain 7/10 with numbness and tingling from left axilla to fingertips down Left arm. Still has discomfort and tingling/numbness today. Her provider ordered an Ultrasound completed on 10 October 2017, resulting in two cm borderline enlarged lymph nodules. Today, she has pain 4/10 to left axilla with numbness and tingling to fingertips.
Extreme Dizziness, Vertigo, Syncope, Unsteadiness, Bouncy vision Nystagmus, Nausea, Shakiness Balance issues weakness
We were in the kitchen chatting and all of the sudden she stopped communicating and she was unstable. I called 911.  She was taken to the ER of a local Medical Center.
Myalgia, Arthralgia, NauseaVomiting, FATIGUE Narrative:
Loss of hair at the front in two separate  sections.  Additional to balding significant hair breakage throughout the front and middle of my hair; Loss of hair at the front in two separate  sections.  Additional to balding significant hair breakage throughout the front and middle of my hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 (Lot number: EW0169) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EW0175, administration date: 27Apr2021, vaccine location: Left arm), administration date: 27Apr2021, when the patient was 34 years old, for Covid-19 immunisation.  The following information was reported: ALOPECIA (non-serious), TRICHORRHEXIS (non-serious) all with onset 09Jun2021, outcome "not recovered" and all described as "Loss of hair at the front in two separate sections.  Additional to balding significant hair breakage throughout the front and middle of my hair". Therapeutic measures were not taken as a result of alopecia, trichorrhexis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Loss of hair at the front in two separate sections. Additional to balding significant hair breakage throughout the front and middle of my hair.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 2/18/99; on same day pt exp seizure activity (tonic) x 30 sec -multiple times
Mild Soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild Soreness) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-24) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (Mild Soreness) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Headache, at an unspecified dose and frequency. At the time of the report, PAIN (Mild Soreness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.
Redness and swollen at site of injection but once patient took some ibuprofen and benadryl swelling decreased. no other reaction except red and swollen also hard to touch.
5OCT95 pt exp chills described by pt as shaking & didn't feel good; pt did not take temp & did not take APAP or ASA;went to be 830PM; slept well & recovered by morning 6OCT95;
Information has been received from a 28 year old female consumer reporting on her son, concerning male baby patient whose mother (previously reported in WAES# 1107USA00135) with no pertinent medical history and no drug reactions or allergies who in "first week" of April 2011, was vaccinated with GARDASIL, a Pregnancy Registry product (lot number, dose and route not
Event: Swelling in my hands, hives rashes from head to toe, pain and itching  Treatment: prednisone  Outcome: gone after about 6 days from symptom onset
headache; teeth hurt; leg pain; chills; low grade fever; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 04Feb2021 at 09:00, patient experienced headache, teeth hurt, leg pain, chills and low-grade fever. Since the event onset date was presented as 04Feb2021, however, PRD was noted as 08Feb2021, query was raised to provide the awareness date of AEs. The patient responded that the symptoms started on 04Feb2021, the day after receiving the second vaccine shot. Patient reported this to the health clinic on 04Feb2021 and filled out the report when he returned to work on 08Feb2021. The date of start of event in the report is correct and the date of receipt of the most recent information is on 08Feb2021. The outcome of the event was recovered.  Information on the lot/batch number has been requested.
4 month old was given ActHIB and Pentacel on same day; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who received 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ033AA, expiry date 07-Oct-2020) via intramuscular route in thigh and 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]  (lot number and Expiry date unknown) via intramuscular route in thigh.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due extra dose administered.   It was reported that that 4 month old was given ActHIB and Pentacel on same day.  At the time of vaccination no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number of Pentacel was requested.  List of documents held by sender: none.
2/28/2021-received second dose of Moderna COVID Vaccine.  3/1/2021-Emergency Room visit for cough-after labs and xray, and she being at baseline, was discharged back to facility.  Return to ED on 3/5/2021 with altered mental status, shortness of breath, wet cough, and fever.  Patient admitted to hospital.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Fever to 103, delirium, HA, lightheaded, dizziness.
Left arm with deeply erythematous 8cm circular, edematous rash surrounded by less erythematous, 4cm none edematous rash, (+) tender, (+) warm to touch per MH note.
Information has been received from a registered nurse concerning an approximately 7-year-old female with no pertinent medical history pr allergies who on 10-JUL-2001 was vaccinated subcutaneous with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) was seen in the office on 17-OCT-2007 and was diagnosed with chickenpox of the face, ears, head, trunk, buttocks and both legs. No therapy was prescribed. No concomitant medications and no diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Pt developed rash from chest and extended to thighs. Within 24 hours, post vax, rash extended over entire body, over the next 2 days.
itchy palm, itchy legs and itchy chest; itchy stomach; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy palm, itchy legs and itchy chest) and ABDOMINAL DISCOMFORT (itchy stomach) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy palm, itchy legs and itchy chest) and ABDOMINAL DISCOMFORT (itchy stomach). At the time of the report, PRURITUS (itchy palm, itchy legs and itchy chest) and ABDOMINAL DISCOMFORT (itchy stomach) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Given adult diphtheria/tetanus vaccine on 06/16/2009.  The following day experienced headache, muscle and joint aching, flushing of skin, and malaise.
Sudden chills with fever 99.4 - body aches and malaise. Fever lasted 16hrs - body aches and malaise still present 3/19/21.
This spontaneous report has been received from a physician assistant via a company representative, concerning to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis and additionally on an unknown date received a dose of M-M-R II (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unspecified date, the patient was then inadvertently administered other dose (reported as a second dose) of VARIVAX (frequency, route of administration, lot # and expiration date were not reported) and other dose (reported as a second dose) of M-M-R II (frequency, route of administration, lot # and expiration date were not reported) on another unspecified date. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Rash on chest and some on legs, 4 hours after the vaccine was given to me. My PCP Recommended taking Benadryl, one every four hours, which I have done, and it is helping.
dizziness, not feeling well, felt better laying down, had headache which worsened upon sitting. Generalized rigors, has had in the past after and epidural.  96/64, HR 72, SPo2 99%. Taken to ED at 9:15 am. Given Ativan and observed for 4 hours.
Patient has COVID-19 + diagnosis 2/16, recovered, received first dose Pfizer on 3/5/21. Admitted to outside hospital on 3/17 with acute on chronic respiratory failure due to HCAP and acute Congestive Heart Failure exacerbation. Discharged 3/22.
I had changes in menstrual cycle. It was extremely heavy and my menstrual period lasted for 3 months.
Behind Lt ear red, swollen. Bil eyes swelled, red. Felt weird given BENADRYL. Woke up not as swollen.
Nausea; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that an unspecified age received first dose of bnt162b2 (formulation: Solution for injection), via an unspecified route of administration on Jun2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history was and concomitant medications were not reported. He took the Pfizer BioNTech Covid-19 Vaccine in Jun2021, with first dose he experienced nausea for 12 to 14 hours. The outcome of event was recovered in Jun2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a pharmacist concerning a 17 year old female who in 1998 was vaccinated with the first dose of VARIVAX (Merck). In 2007 the patient received the second dose of VARIVAX (Merck). On an unspecified date the patient had titers drawn showing that she failed to seroconvert. No adverse effects noted. At the report time the outcome was unknown. Additional information has been requested.
Tingling on the face, leg and foot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on the face, leg and foot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling on the face, leg and foot). At the time of the report, PARAESTHESIA (Tingling on the face, leg and foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   This case was linked to MOD-2021-020765 (Patient Link).
Chills and fatigue 7 hours after the shot, body aches 15 hours after shot, fever 100-101 degrees Fahrenheit starting 24 hours after shot, all symptoms resolved about 48-56 hours after 2nd does. Soreness in arm at site of vaccination within in three hours of shot - also phantom pain in opposite arm (where I had my first dose) immediately after the second dose for several hours until chills/aches overtook my body. Slight fatigue and insomnia 4 days after shot
Patient called several days after the shot and complained of arm pain, The Rph advised pt and then recommended callinf the MD if no relief. Pt called several days ago stating that she saw her MD and then went to a specialist and was diagnosed with SIRVA.
23 y/o is referred to clinic for evaluation of skin rash after multiple vaccines. Rash actually commences two days after receipt of SPV and YF vaccines and 8-9 days after immunization with AVA #1 and Hep B #1.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild
Urticaria, hives x18 days. First onset 4 days after receiving 3rd dose of the vax. Treated with over-the-counter Benadryl and topical Calamine for relief of urticaria. Localized edema at injection site.
12/09/2022 I started experiencing a cough, nasal congestion, pain in my left ear. I went to see a physician and was prescribed prednisone and erythromycin. On 12/15 I started experiencing shortness of breath I went to urgent care and was diagnosed with Acute Bronchitis, I was prescribed erythromycin, prednisone and cough medication with codeine. My symptoms lasted for 19 days. 02/2023 I felt like I had a sinus infection, I had nasal congestion and drainage and swelling in my eyes I tested positive for COVID-19 on 02/17 I had ear discomfort, eye swelling  and shortness of breath in addition to bronchial spasms. I was put on SPIRIVA and am currently on it for the next 6 weeks.
Headache, chills, body aches, joint pain, slight fever, fatigue and soreness in the arm.
Information has been received from a consumer regarding a female patient who on 17-OCT-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX. On approximately 17-OCT-2007 the patient developed chicken pox. The consumer could not tell how may lesions there were. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. No further information is available.
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
GAVE SHOT AT 12:25 CALLED 911 12:37 THICK TONGUE HARD TO BREATH AND SWALLOW
Pain at injection site. returned 5 months later with pain persisting. poss SIRVA  Narrative:  pain to injection site persisting over 5 months. referred to treating provider.
Expired Kinrix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-DEC-2022 Reporters comment: The physician reported that a dose of Kinrix with expiration date of 30th September 2022 was given to a patient. The reporter consent to follow-up via email. Additional Supportive information: The patient received expired dose of Kinrix, which led to expired vaccine used.
No known adverse events at this time.  Patient's prior vaccine record was misread and it was thought he was due for dose 4 in DTaP series, however, he had actually already received the 4th dose on 2/6/2023. This represents an additional dose. Discussed with parent immediately in clinic and provided guidance/return precautions.
Information has been received from a physician concerning an approximately 6 month old male who in approximately January 2007 (about four months ago), was vaccinated with oral Rotateq (Lot # 655864/1082F). In approximately January 2007 (about four months ago), the patient was "gassy and irritable". The patient sought unspecified medical attention. Subsequently, the patient recovered from gassy and irritable. The patient's parents are refusing additional doses of Rotateq. Additional information has been requested.
COVID vaccine breakthrough case. Moderna 043B21A on 04/15/2021, Moderna 043B21A on 05/13/2021 and boosted Moderna 017F21A on 10/21/2021.
Multiple erythematosis.  Macular papular rash on face, back, head and extremities.
First two shots no reaction except sore arm was on non-prescription vitamins.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: ER2613) as dose 1, single and administered in arm left, administration date 12Apr2021 (Lot number: EW0162) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; ZINC. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "First two shots no reaction except sore arm was on non-prescription vitamins.". Therapeutic measures were taken as a result of pain in extremity.  Additional Information :Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Female feeling light headed after receiving shot. Denies any C/P, SOB, DIB. Requested to stay with her daughter seated in a chair. refused to lay down. Vitals obtained. Refused further care or evaluation.
8 members in their family have covid now; 8 members in their family have covid now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "8 members in their family have covid now".  Additional Information: Additionally, she's reported on behalf of others in her community: 8 members in their family have covid now. . The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient experienced large (2-3 inch diameter) localized red, irritated local reaction. I advised ice for 15 minutes a few times a day, ibuprofen and visit the walk-in facility if fever occurs or affected areas worsens or becomes warm.