chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Friday, 2/25/21, patient came for Covid-19 Vaccination Site for a Pfizer Covid-19 dose. Client stated during check-in process, she received a Covid-19 Janssen dose in February 2021 with no proof of vaccination. Lead RN elevated to Clinical Project Coordinators, employees via text who inquired with MD. MD approved client to restart series and receive Pfizer Covid-19 vaccine dose one today and was documented as first dose appropriately on her vaccination card. Client was vaccinated with Covid-19 Pfizer vaccine (LOT #: FK9895) in her left arm at 11:24 AM. Client has history of hypertension and takes Nifedipine 30 mg everyday and glucasamine. Client denied any allergies and any reactions from first Covid-19 Janssen dose and was to be a 15 minute observation. At 11:38 AM, while waiting in observation area, client stated to EMT she feels "itchiness" in both her hands and fingers and "slight dizziness." Client denied any SOB, nausea and headache. EMT observed no rash, redness or swelling on client's hands and fingers. Client stated she ate a burrito and drank water this morning. At 11:40 PM, BP: 138/80, HR: 59, O2 sat: 98%, RR: 16. Client was given a water bottle by EMT that she drank. At 11:45 AM, BP: 140/84, HR: 60, O2 sat: 96%, RR: 16. RN offered Benadryl to client which she denied. At 11:50 AM, client stated "itchiness is going away." At 11:55 AM, RN advised client to check in with her PCP and was educated on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. At this time, client stated she no longer felt any itchiness in her hands and fingers. No further interventions needed. Client left vaccination site with a steady gait at 12:00 PM.
Extreme headache, dizziness, ringing in ears, extreme tiredness, heaviness to legs & arms
Mild case of chickenpox.  Vaccine given at another facility, no known lot or manufacturer information.
Chills, body aches, muscle and joint pain lasted for 4 days. Lower back and hip pain persists even now does not respond to nsaids. Responds slightly to tizanadine
flu like symptoms; achiness; extreme fatigue, exhausted; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.  Patient experienced flu like symptoms with all of the doses of the Moderna vaccine with achiness, extreme fatigue, and feeling totally exhausted the next day.  She has been taking a long term hormonal treatment under the direction of her oncologist.   This case was linked to MOD-2021-435712, MOD-2021-435755 (Patient Link).
I had severe sharp pain at the time of flu vaccination. My Rt arm has been hurting ever since and have pain with normal daily activities.
Extreme swelling larger than a softball in the arm of the injection with redness, warm to the touch and soreness not radiating in to neck or back.
No additional AE details were provided and no additional AE's were reported; an infant was inadvertently administered ROTATEQ intramuscularly instead of orally; This spontaneous report was received from a physician and refers to an infant patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-JAN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (dose, frequency, vaccination scheme, vaccine injection site, strength, lot number, and expiration date were not provided). The vaccine was inadvertently administered intramuscularly instead of orally (incorrect route of product administration). No additional adverse event was reported.
swollen lymph node glands size of golf ball very tender to touch; Body aches; Vaccine arm swelling sore and swollen; Vaccine arm swelling sore and swollen; Headaches; This is a spontaneous report from a contactable consumer(patient). A 63-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9266 ), second dose via an unspecified route of administration, administered in right arm on 10Feb2021 17:15 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunization. Medical history included high blood pressure and anemic, both from an unknown date and unknown if ongoing. On 25Jan2021 at 5:30 PM patient received first of Bnt162b2 (lot number=EL9262) in right arm. No COVID was found prior vaccination. Other medications were taken in two weeks but not specified. Concomitant medications were not reported. On 11Feb2021 at 7:00 PM the patient experienced swollen lymph node glands size of golf ball very tender to touch, body aches, vaccine arm swelling sore and swollen and headaches. Outcome of the events was recovering.
Awoke from sleep with Heart rate 104 and chills. Heart rate for 2.5 hrs was not below 95 and had extreme fatigue.  Menstrual cycle had skipped as well and came 8 days late with only spotting but severe fatigue and back cramps. Pregnancy test was negative.
Vaccine was stored in the freezer for 19 days, instead of 14 days. the vaccine was supposed to be removed from the freezer on 5/27 and placed in the fridge however it was not and was stored in the freezer and given to the patient.
At the time of this. There was no signs by the time we got home his leg was puffy swollen and red by in the morning he was having a ton of issues as far as starting to regress in language and being more verbal I'm starting to act out in the sons of not being able to get what he needs to get across in November 19 he was diagnosed with autism
Facial swelling, rash, difficulty breathing, tingling in face, tachycardia, dizziness, fever,   Treatment: Epinephrine, clartitin, steroids
Got new vaccine, 6 mo later shingles/Suspected vaccination failure; Full blown shingles on face; 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, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got new vaccine, 6 mo later shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Full blown shingles on face). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient's sister/brother interactive digital media. The patient got new vaccine after physician talked him/her in to it and there was 3 percent chance of getting Shingles they said. The patient stated that 6 months later they had full blown shingles on face.  Now the vaccine said, 11 percent chance of getting after vaccine and guaranteed if he/she did not got shot would never had it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
severely sore arm muscles up and down arm.  lasted three days, disappeared, then returned three days later.  Hard to lift anything and extremely sore muscles all up and down arm.
deathly sick/sick as a dog; major dizzy; almost fainted; complete flu; throwing up; weak; hurt all over bad; headache; allergic to that powerfull shot; felt off for a couple months; Initial information received on 01-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer .  This case involves patient (reported that approximately 70 year) who experienced deathly sick/sick as a dog (illness), major dizzy (dizziness), almost fainted (presyncope), complete flu (influenza), throwing up (vomiting), weak (asthenia), hurt all over bad (pain), headache, allergic to that powerfull shot (allergy to vaccine) and felt off for a couple months (mood altered), while he/she received vaccine INFLUENZA VACCINE.  Medical history included Rhinorrhoea.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious deathly sick/sick as a dog (illness), major dizzy (dizziness), almost fainted (presyncope), complete flu (influenza), throwing up (vomiting), weak (asthenia), hurt all over bad (pain), headache, allergic to that powerfull shot (allergy to vaccine) and felt off for a couple months (mood altered), within two to three hours following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were not reported.  There will be no information available on the batch number for this case.
4 to 5 days after the vaccine it started and would not quite and just let up until a week ago (June 21st). All the weeks I couldn?t eat and was in the bathroom. I went to the ER and the Gastrologist and they were trying to figure it out. All my stool and urinalysis tests came back with no colis (or micro), no chon, no h-polyri no cancer, no parasites or urinary tract infections. When all tests came back negative, that?s when I reported to the CDC. I was weak and lethargic. I had bloating, cramping, tons of of bowel movement (not diarrhea)- 6-8 a day. They were soft, my stomach would cramp and I couldn?t eat and this went on for a few weeks until 6/20 it started to let up gradually.
Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Dept: RN Covid floor Have you missed work? #shifts: no Did you seek emergency care? no Date and Time of Vaccine: 9/16 Age at time of vaccination, ____31____ years ______ months Sex: Male Was the vaccine received at D-H? 5M clinic Site of vaccine (LD or RD): RD Type of Vaccine Pfizer ( ) Moderna ( ) Other _______J&J________ 1st or 2nd dose: n/a When did your symptoms start? 9/17 with fatigue Please note reported symptoms yes or no, these symptoms are considered mild to moderate and are NOT VAERS reportable Injection site pain no Tiredness yes Headache no Muscle Pain no Chills no Joint Pain no Fever (note temp if known) no Injection Site Swelling no Injection Site Redness no Nausea no Feeling Unwell no Swollen Lymph Nodes (lymphadenopathy) no Other: Employee reports THE FOLLOWING SEVERE post vaccine ADVERSE reactions (reportable): Difficulty breathing: no Swelling of your face and throat: no A fast heartbeat: YES also palpitations, night terrors, drenching sweats, and anxiety. Reports that he has no cardiac, sleep or anxiety history A bad rash all over your body: no Dizziness and weakness: no If COVID-19 symptoms persist and/or worsen beyond 48 hours consider COVID-19 testing Treatment/Advise: Plan: Employee to be seen by provider in clinic this afternoon If employee was vaccinated at another facility, they need to contact that facility , it is an expectation that the facility that gave the vaccine complete the VAERS report. Employee verbalizes understanding and agreement with plan. VAERS report is completed electronically at if vaccine given at D-H facility. Signed by on 9/21/2021 at 1:37pm
up to date w/ COVID vax- booster dose listed above, developed sx and tested pos for covid 1/22/22 on binax rapid antigen test
Extreme throat, mouth, soft pallate, jaw, and tooth pain (all teeth), headache, fever
Following day, patient reported vomiting w/o fever, nausea or any other symptom.  Vomiting was accompanied by a constant "gagging" feeling.  Only lasted one day.
1st vaccination-shortness of breath, body aches, flulike symptoms lasting appr. 3 weeks.... shortness of breath increased 2nd vaccination-shortness of breath, flulike symptoms... passing out 8 days later,  was awake when ambulance arrived, was checked out, did not wish to go to the hospital. Several more episode of feelings of passing out but overcame by resting or cold towel on face and head  Sept. 24,2021- doctor visit with primary doctor -increased head spasms, radiating pain flowing from head to chest area, given Gabapentin for pain Oct. 24, 2021 fainting.... taken to Hospital by ambulance Inpatient stay for 5 days found blood clot in heart and needing open heart by pass  surgery.   Nov. 30
Within 24 hrs started to experience slight fever. Within seven (7) days I went to the ER with high fever symptoms. They prescribed Amoxicillan 875mg for 10 days. While on the antibiotic I still experienced fevers  (101.5-103.1) for the first 5-7 days after the ER visit
Pt recvd Influenza vax in the lt deltoid on 26OCT90, & devel pain in rt flank area 19NOV90; This was followed by vesicular eruption on 22NOV90 & devel of shingles covering an area of approx 2" x 4" on rt flank area;
No adverse event; Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial").    No concomitant medications were reported.  The adult patient (above 18) inadvertently received Bivalent booster dose from a Moderna "for booster dose only vial" which was intended for pediatric primary series age group 6-11 years old. No treatment medications were reported.  This case contains information for the 4th of 4 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675671, US-MODERNATX, INC.-MOD-2022-675700 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675671:Patient 1 US-MODERNATX, INC.-MOD-2022-675700:Patient 2
Information has been received from a physician concerning a 12-month-old patient who on 19-NOV-2007 at 11:10 was inadvertently vaccinated subcutaneously in the right thigh with a first 0.5 ml dose of ZOSTAVAX (Merck) (lot # 658209/1085U) instead of varicella virus live (Oka/Merck). On 19-NOV-2007 at 11:10 the patient developed swelling and erythema at the injection site. The patient sought medical attention via an office visit. On 26-NOV-2007 the patient recovered. A product quality complaint was not involved. Additional information is not expected.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown demographics. No pertinent medical history, concurrent conditions or conditions or concomitant medications were reported. On an unknown date in May 2015, about a month ago, the patient was vaccinated with ZOSTAVAX, dose frequency and route unknown. On an unknown date in 2015, the patient was inadvertently administered a second dose of ZOSTAVAX (extra dose administered). No adverse effect reported. The outcome of extra dose administered was unknown. No further information provided. Additional information has been requested.
Same day and 36 hours after: body aches, tired, chills, uncontrollable shaking, painful armpits and neck, headaches  Continues symptoms for months: daily headaches, unbelievable tiredness, body aches  Last 5 days: left leg pain, swollen armpits, aches continuous headaches, arm is still hurting from vaccine. Feels heavy like a brick tied to it. Sore
Patient was without symptoms at 16 min mark- Patient left- Came back about 10 minutes later with symptoms of "arm tingling".  She described a headache at VAS score of 4-5 on left sinus area.  No tongue swelling but after 40 minutes, she described slight tingling on one side of tongue. We recommended them to stay longer but they insisted on leaving at approximately 40 minutes.  She described a history of anxiety related to injections Benadryl 50 mg was given to her and counseling of worsening symptoms to seek emergency care.
pt devel extreme weakness, Guillain Barre type sx, requiring adm to hosp 1NOV97;slow improvement w/gamma globulin administration;tx to rehab 19NOV;
pretty bad tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "pretty bad tinnitus". Therapeutic measures were taken as a result of tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, pain, redness 9.5 cm x 6 cm. Rx: Hydrocortisone cream 1% to area BID Benadryl 25 mg PO qid prn itching or swelling Only slight bruise left on 8/8/06.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
headache, eye pressure, nausea diarrhea, achy, generalized body aches. Treatment include Tylenol with no improvement and Naproxen 220 mg with mild improvement.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 1 time. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) was 16, 33, 0.555555556 and R. This is one of several reports received from the same source. Additional information has been requested.
Pt. was given Pfizer Monovalent instead of Pfizer Bivalent.  As far as I am aware pt. has not suffered any adverse events but just only given the wrong vaccine. Our office has filled out an incident report and have contacted the manufacturer for recommendations on when/if an additional dose is needed.
Body stiffness, loss of movement, head about to explode, nose bleeding and stuffed, vomit, pain fever.
3:30pm - shot given  7:00pm- fatigue and nausea  9:00pm- fatigue, nausea and fever 12:00am-3pm next day- fatigue, nausea, fever, chills, body ache, muscle pain, headache 3:00pm next day - fatigue, fever, body ache, headache 5:00pm- start to get energy back, slowly feeling better
Narrative:  Onset 12 days post 1st vaccination. Rash still present at time of the report. delayed cutaneous hypersensitivity reaction. Rash is itchy.
Day 1: Soreness and pain in arm where injection was given, chills, and body aches Day 2: Soreness and pain in arm where injection was given, chills, body aches, fever of 101.3 Day 3: Soreness and pain in arm where injection was given Day 4: No symptoms noted
20 hours post vaccination, patient experienced rash and severe itching (uncontrollable itching) in lower abdomen, left shoulder, upper chest, scalp, and arms.  The itching was so severe that she felt that she needed to report the reaction.  The rash and itching stopped the next morning.   Patient used witch hazel and nettles tea to help relieve the itch.
left axillary lymphedema identified about 2 weeks after first dose, and still persists as of this report. I received the second dose at 3 months in the right arm.  I am not sure if this is related but I now have acute onset of large area of rash (red, itchy) that started in periaxillary area (both axilla) that is extending outward. This started soon after I got the flu vaccine
0940. Patient complained of numbness, tingling and pain in L arm radiating to her L hand.  Benadryl 25mg po administered at 0942 am. Ice pack applied to vaccination site. Assessment by EMS onsite and NP.  VS 0937-196/95;HR 62- O2 98% on RA- R. 20 0942- BP 172/80; )2 Sat 98% on RA; R. 20. feeling better. Patient observed for additional time. Discharged from clinic at 10:36 am.