chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 25-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.  Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Rash on lower back and stomach.  Raised bump at injection site (looks like a pimple).
Patient reported  racing heart, tachy 88-100, tingly lips following covid vaccination. Administering RN assessed, provided emotional comfort, provided water/snacks. Continued monitoring. Tachycardia did not resolve after continued observation. Patient escorted to ED by w/c for further observation. Patient discharged from ED in stable condition.
Patient complained of dizziness, lightheadedness. Patient sat and said started to fade to black she said - passed out, shaking, lost consciousness, gave 1 EPIPEN. Patient regained consciousness called 911, pt went by ambulance to hospital.
aching body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aching body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included OXYCODONE, GABAPENTIN and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (aching body). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (aching body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has taken vaccine at the Health Department.   This case was linked to MOD-2021-037486 (Patient Link).
first to be expected--but flu like symptoms, sore arm, fatigue, aches...then a pink rash on my arm but it went away.  However, the main issue is my legs. My legs ache so much since the 2nd vaccine that it is almost unbearable.  I could not walk for a few days.  I do not know what to do. I have tried to tell a couple practitioners but they really don't seem to care.  My legs (and feet) have been aching severely.
received dose from expired vial; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE (FLU VACCINE VII) (Intramuscular) at an unspecified dose. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs  were provided. No treatment drugs are provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received and updated patient demographics and flu vaccine were added.
Intense arm pain at time of vaccination Intense ongoing arm pain for 3-4 weeks Difficulty sleeping at night Took Motrin and Tylenol for 3 weeks
Pain at injection site persisted through night of injection, redness. Given Prednisone 40mg for three days then Prednisone 20mg for three days. Also given: Benadryl 25mg IM in office,  Prescription for Bactrim one tablet twice daily for 10 days and hydrocodone 5/325 one tablet every 6 hours as needed for pain.
No additional AE information was available.; Caller reporting AE for expired product (VAQTA) administered 3 times with previous temperature excursion.; Caller reporting AE for expired product (VAQTA) administered 3 times with previous temperature excursion.; This spontaneous report was received from a medical assistant referring to a 44 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 21-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 1.0 milliliter (mL) as prophylaxis (strength, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number S034296, has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date reported and established as 09-JAN-2021) (expired product administered). Additionally, it was reported that the vaccine was administered with previous temperature excursions (product storage error). No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034296; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001891:
Fiancee developed smallpox contact innoculation following "grappling" w/ recipient of SMPX approx WEd-Sat 2/12 2006. By Sat he had a pimple on his neck he scratched with resulting spread to arm, etc.  Seen at clinic Monday-MD's have filed his VAERS.  HIS GIRLFRIEND  began to develop red pimples to her wrist within then next 2-4 days. She sought treatment in an ER and was advised Not SMPX.  There has been no comunication betw this individual and this center. No contact numbers given. I have him here at my office now.  He will call you with the info for the VAERS report [as he's not sure of her contact info or exact date of birth].  He also notes that his fiancee is otherwise completely healthy without any heart or skin conditions.  She is presently in a different part of the sate, so I will not be able to assess her here.
About a week after receiving the vaccine, my face swelled, I had blisters in mouth and on my tongue. My throat was also swollen. I went to my doctor and he told me it was a virus type infection. He prescribed Acyclovir. I was off work for about 7 days. I have recovered but I am still fatigued which was also a symptom I experienced.
Woke up the morning after receiving my second shot of Pfizer vaccine with throbbing ache in the right side of the back of head near neck.  Pain increased over three days to the point of nausea.  I was also very short of breath unable to do normal tasks with running out of breath.  On July 3 2021,  after attempting to mow the lawn, I felt as though I was going to have a heart attack and could not breathe.  I went to the emergency room at Medical Center.  Tests revealed I had elevated  Brain natriuretic peptide  at 190 and elevated D-Dimer at 975.  I was diagnosed with fluid on my heart and lungs and my heart was enlarged.  The doctor on duty diagnosed it as congestive heart failure and I was admitted into the hospital.  I was in the hospital for three days while fluid was taken off via medication.
Mixed series: patient received Pfizer on 3/25 when he should have received Moderna
ActHIB vaccine was expired; Patient was informed. Patient not experiencing side effects of any kind.
No additional AEs; pediatrics dose of VAQTA was administered to a 20 years old patient; This spontaneous report was received from a medical assistance and refers to a 20 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 06-OCT-2021, the 20-year-old patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter, intramuscularly (IM), lot number reported as T03304 with expiration date 02-APR-2022 for prophylaxis (anatomical location was not reported) (product use issue). No additional adverse events (AE) or product quality complain reported.    Lot number T03304 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA). Lot number T03304 does not match any Company product as confirmed by Lot Verification team.
Vaccine administered 12/13 and patient reports was hurting & hot by the time he got home. Saw Dr 12/14 & put on prednisone. Patient still having pain & cannot raise arm independently on 12/18/12 arm had swollen & turned blackish & is still discolored today 12/18/12.
Patient got Engerix-B instead of Pediarix; Patient got Engerix-B instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 20th October 2021, the patient received Engerix B. On 8th September 2021, the patient received Engerix B. On 8th September 2021, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On 20th October 2021, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and wrong vaccine administered were unknown.  Additional details were provided as follows: The reporter intended to give the patient 2 doses of Pediarix, but inadvertently gave Engerix B instead, which led to wrong vaccine administered. The reporter consented to follow up.
I am going to see Dr today at Internal Medicine.  Everyday since my shot I have been nauseous and weak.  Each day progressively more weak.  Yesterday whole body tremors started and went on for hours. Today they are constant, although sometimes stronger than others. It feels like the inside of my whole body is cramping up, twitching and having spasms.  This is by far the worst thing I have ever dealt with medically.
The patient had their first Moderna Covid shot 1/6/2021 and was given the second  shot on the 20th day by accident on 1/26/2021.
Bursitis; Vaccine administered too high in arm;  This spontaneous case was reported by a health care professional and describes the occurrence of BURSITIS (Bursitis) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine administered too high in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURSITIS (Bursitis) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine administered too high in arm). At the time of the report, BURSITIS (Bursitis) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine administered too high in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information in response to events was not provided.
Information has been received from a pharmacist concerning a 79 year old female patient who on 05-MAY-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 664535/0060Z, exp 03-FEB-2011) in left arm. On 06-MAY-2010 the patient had redness, pain and swelling at the injection site. Patient was treated with warm compress, TYLENOL. Patient sought unknown medical attention. At the time of report the patient's status was recovering. The patient was hospitalized at the hospital for unrelated issue and PNEUMOVAX 23 was given as routine vaccination and did not prolong the hospitalization. This is one of several reports from the same source. No further information is available.
increased congestion; fatigue; sore throat; congestion; extreme Lethargy; Arm pain; This is a spontaneous report from a non-contactable healthcare professional, the patient.  A 38-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 left arm on 13Jan2021 at 10:15 as a single dose for COVID-19 immunization.   Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included ethinylestradiol,/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE).  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the influenza vaccine (FLU VACCINE) on an unknown date for immunization and experienced drug allergy. The patient experienced arm pain on 14Jan2021, extreme lethargy on 15Jan2021, congestion on 16Jan2021, sore throat on 16Jan2021, increased congestion on 17Jan2021, and fatigue on 17Jan2021.  On 14Jan2021, the patient had a COVID-19 nasal swab which was negative. The patient did not receive any treatment for the events. The clinical outcomes of the arm pain, extreme lethargy, congestion, sore throat, increased congestion, and fatigue were recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
Eve of shot (3-25-21): Pressure on chest, headache,  queasy, chills, armpit pain on shot side. Next day, really sore arm, chills, diarrhea. Through 4-3-21: sore throat, dry cough, itchy shot site, low grade fever (99.3) and burning eyes, most troublesome? swollen achy/bruised feeling armpits and behind knees, both sides.
pt recvd vax 20OCT93 & the following day devel a blotchy, itchy rash which progressed to an overall rash w/in 24 hrs;
Reports tinnitus in bilateral ears starting 2 weeks after first Covid vaccine dose.  Did not seek care, declined care when offered at 4/15 second dose.
Patient developed generalized weakness with peripheral neuropathy four days after getting second injection.  Patient had a right MCA distribution infarct on 3/24/21.  Last injection was on 2/25/21.  Patient died on 4/7/21 from consequences of infarct.
had 2 high-pitched crying spells 1 lasted about 1 hr & the other lasted about 20 minutes; slept during the noc & woke up next morning acting nl;
After both shots I had the SEVERE headaches, lethargy, body aches but after the second shot my arm was swollen for 4 days and the symptoms were much worse in severity with additional dizziness, nausea.  I was sick in bed for 2 days.
Pt had too many covid shots 12/19/2021pfizer, 1/8/2021 pfizer, 5/11/2021 janssen, 9/27/2021 pfizer, 1/24/2022 janssen
injection site pain that day, following morning woke up with tiredness, muscle pain, joint pain, nausea,chills, and overall feeling unwell. Continued to have these symptoms on Tuesday (1st full day after vaccine on Monday) and Wednesday (2nd day) until about 3pm Wed. On Wed, additional symptom - I had headache all day.  Treatment - rest, fluids, tylenol for headache Feeling better by Wed after 3pm
Covid-19 mRNA primary vaccine tris (Pfizer) injection was ordered for this patient at 11/2/22 at 1445. When I was reporting the vaccines punctured for the day to my pharmacy director I saw that there was no primary vaccine for Pfizer that was opened for today. Turns out Covid-19 mRNA updated bivalent booster vaccine Pfizer was dispensed to the patient instead. This dose reached the patient in which on the database primary Pfizer order was charted on but the Lot# recorded on the immunization matches the that of the bivalent booster vaccine Pfizer.
inlarged lymphnodes discovered under left arm . One is pea sized the other is smaller.
Rheumatoid arthritis flares; Flu like symptoms; Headache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-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 started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-Mar-2021, the patient experienced the first episode of HEADACHE (Headache). On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and the second episode of HEADACHE (Headache). On 21-Oct-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares), INFLUENZA LIKE ILLNESS (Flu like symptoms) and the last episode of HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported.  Patient reported non-serious events Headache, flu like symptoms and rheumatoid arthritis flares with RINVOQ (UPADACITINIB).    MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered as suspect.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns a 51  year  old, female patient, in treatment with Upadacitinib for Rheumatoid arthritis, who experienced the unexpected, serious medically significant AESI of rheumatoid arthritis (described as "Rheumatoid arthritis flares") approximately 6 months after the second dose of mRNA  1273 vaccine. No further details were provided for medical reviewing. Co  suspect product included Upadacitinib. Flaring of symptoms is part of the natural course of Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-631709 (Patient Link).; Sender's Comments: This spontaneous case concerns a 51  year  old, female patient, in treatment with Upadacitinib for Rheumatoid arthritis, who experienced the unexpected, serious medically significant AESI of rheumatoid arthritis (described as "Rheumatoid arthritis flares") approximately 6 months after the second dose of mRNA  1273 vaccine. No further details were provided for medical reviewing. Co  suspect product included Upadacitinib. Flaring of symptoms is part of the natural course of Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient stated that he had a significant nose bleed greater than one hour after receiving the vaccine. The patient was hospitalized and was treated for hypertension.
Local reaction - zoster vaccine (R) deltoid. Recommended Topical hydrocortisone.
Patient reported severe hives - all over 4 days after getting flu shot, swelling around eyes and face, minor wheezing. Hives appeared suddenly Monday evening. Resolved without treatment in 1-2 days.
Dose 1:11/29/2019: Dose 2:06/9/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (On 29th November 2019, 1st dose received with batch number M57C5 and expiry date 9th April 2022).   On 9th June 2021, the patient received the 2nd dose of Shingrix. On 9th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was a registered pharmacist manager. The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. The reporter would like to know if a 3rd dose was needed. The reporter consented to follow up. This case had been linked to the case US2021125158, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021125158:same reporter
Member states that he had numbing and paralysis starting in his fingers and toes. He began to start having trouble turning door knobs and writing. Urgent Care clinic tested him for Swine Flu but it came back negative. Member was referred to a neurologist who documented that he had acquired Guillain-Barre Syndrome from the flu vaccination.
I had almost finished my 15 mins of wait time. At 12 mins in I started feeling light headed. A National Guard took me to a medical cubical where the Dr. had me lie down with my feet elevated.  Other than being light headed, fatigue started setting in as well. I was also given cranberry juice and notes were taken by the Dr. and someone else. At one time I must have had four people in the cubical with me.   After about 40 mins they had me sit up with my legs dangling off the gurney. I sat for another 20 mins when I felt well enough but a bit shaky to walk to the car where my husband was waiting. Two men escorted me, one being an EMT and the other who was taking notes.  I started feeling extremely sleepy on the way home. I ended up sleeping on and off for almost three days, but had spent the rest of the day into the next morning sleeping.   From then on I?ve never really shaken the extreme fatigue. I also had minor headaches each day. They have since tapered off. Also my arm hurt quite a lot for a few days the day after my second dose. I couldn?t raise my arm past 45 degrees.  I can?t remember what else I reported during my weekly checkups but the fatigue is one that is definitely still with me. I was hesitant to get my booster but I did as soon as the high risk  category was eligible to receive one. I tolerated it well and  felt the fatigue creep in as I headed home (this site was 10 mins from my house). I had more fatigue and didn?t have to sleep as much as I did with my second dose. Weirdly enough, I also tolerated my first dose well with little fatigue.