chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fell and ended up in the hospital; it is more than 42 days after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell and ended up in the hospital) in a 78-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.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FALL (Fell and ended up in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (it is more than 42 days after receiving 1st dose). At the time of the report, FALL (Fell and ended up in the hospital) and PRODUCT DOSE OMISSION ISSUE (it is more than 42 days after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient fell down and ended up in the hospital on the way to get their 2nd dose. Now it has been more than 42 days since receiving their first dose.  Company Comment: This case concerns a 78-year-old female patient who did not receive second dose due to a fall on the way to receiving second dose  and yet to receive the 2nd dose after more than 42 days from receiving 1st dose (missed dose).   There is not enough information to assess the relatedness of fall to product use  The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a 78-year-old female patient who did not receive second dose due to a fall on the way to receiving second dose  and yet to receive the 2nd dose after more than 42 days from receiving 1st dose (missed dose).   There is not enough information to assess the relatedness of fall to product use  The event of missed dose is assessed as not applicable.
Information has been received from a physician's assistant concerning a female (age not reported) who on 14-JUN-2006 received a 0.1 mL dose of Pneumovax 23 intradermally instead of tuberculin purified protein derivative skin testing in error. Subsequently, the patient developed redness in her arm with a 7.5 cm erythematous area at the injection site. The patient sought unspecified medical attention. No other symptoms were reported. At the time of this report, the outcome was unknown. Additional information has been requested.
8-19-17-Pt noticed red bumps, soreness-good bit of pain for several days after receiving. Also experienced itching on 8/22/17. Also, patient noticed red whelp on 8/22/17. On 8/23/17 then area gone down a good bit.
First day not hardly anything on Friday, then Saturday came and I was pretty good in the morning the come the evening I started having some chest pain so I took some slow deep breaths and laid down holding my chest and did some tossing and turning all night. THen Sunday I started having more pain and heaviness on the left of my chest like tightness. When I moved around id was ok but when I laid sown it felt worse. That's why I am calling today but feels like it is subsiding today I managed to get out and move around, eat, drink and take my pills.
Patient noted a raised lump hours after initially receiving the vaccine. Patient states lump remained through work travel. Patient returned from the work travel in April 2019. Patient noted an enlargement of the lump and a redness starting in September. Mild itch and discomfort noted at location.
MODERNA, COVID VAC #3 GIVEN 1/7/22, LOT #069H21A; pt on comfort care; in Hospice; positive COVID test 2/19/23; pt passed away in Hospice Care
reports that they administered 2 expired daptacel to patients with no reported adverse event; Initial information received on 10-Jul-2023 from an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age female patient for whom it was reported that they administered 2 expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Jun-2023, the patient received an expired dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C5893AA; expiry date: 21-Jun-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event reports that they administered 2 expired daptacel to patients with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Voice goes in and out; Little nagging cough; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: EW0165; Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Apr2021 at 13:20 (age at vaccination: 62-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing sciatica (started 5-6 years ago when she was in a really bad car accident). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: ER2613) via an unspecified route of administration, administered in left arm on 25Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, patient had shingles vaccine and experienced sore arm. Concomitant medications included ongoing ibuprofen for pain, ongoing hydrocodone and methocarbamol both taken for back, start dates were not reported. It was reported that patient was taking concomitant medication for couple of years. On an unspecified date in Apr2021, the patient experienced little nagging cough and on an unspecified date in May2021 patient voice goes in and out. It was reported that patient had vaccine to protect herself from getting the corona and to protect herself from others. She got the second dose of the Covid-19 vaccine on 16Apr2021 and right after that started to cough, she had this little nagging cough and that since Apr2021 the cough had been ongoing. She thought that the cough would have gone away but it's like constant. Patient added, at first, she thought the cough was something unrelated to the Covid-19 vaccine, but she knew that the cough didn't start until she took that. She added that the cough began a day or two after she received the second dose of the Covid-19 vaccine on 16Apr2021. Patient reported that her son also received the Covid-19 vaccine and was experiencing the same symptoms. Patient had her second vaccination at Health Department. Patient had not been administered with any additional vaccines, neither she had any prior vaccinations within 4 weeks. AEs did not require to visit emergency room/ physician office. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
ABDOMINAL PAIN; A spontaneous case report was received from a physician on 28-Jun-2019 for two consumers.  Based on the information obtained from the physician, two individual case safety reports PVX201907-000549 (husband) and PVX201907-000550 (wife) were created and cross-linked in the database.  This case describes a male consumer who had abdominal pain, after administration of first dose Vivotif for an unknown indication.  Action taken with Vivotif with respect to the event was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that a male consumer had abdominal pain after administration of first dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer had abdominal pain after administration of first dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201907-000550:
Patient received second Moderna vaccine on 1/31/22. Noticed tenderness at injection site on 2/1/22. Contacted pharmacy on 2/2/22 as she noted the injection site was red/swollen and warm to touch
COVID-19; COVID-19; Moderna, Dose: 1-4 / Pfizer, Dose: 5; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH970205309) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Jan2021 at 12:00 as dose 1, single (Lot number: 037K20a), on 03Feb2021 at 15:00 as dose 2, single (Lot number: 013M20A), on 30Oct2021 at 16:00 as dose 3 (booster), single (Lot number: 039F21A) and on 20May2022 at 17:00 as dose 4 (booster), single (Lot number: 0J8A22A) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "axial spondyloarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrochlorothiazide, reaction(s): "known allergies". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Moderna, Dose: 1-4 / Pfizer, Dose: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 20Mar2023 to 25Mar2023 for treatment of COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 05-FEB-2014, the patient was vaccinated with expired dose of GARDASIL (lot # 669285/0691AA, 0.5 ml, intramuscular). No adverse effect was reported. Additional information has been requested.
No adverse event, patient received moderna for 1st dose and pfizer for 2nd. Told have to submit report.
Feels like arm is numb (left arm) Seen by EMS on site  Discharged home at 14:15. Recorded by RN.
Severe left arm pain from fingers to shoulder  Fever, chills, nausea, vomiting  and rigors Syncope
Information has been received from a nurse concerning a 29 year old female pt who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 12Jun2003 had a measles titer performed and the result was borderline for measles. The nurse did not have the pt's early childhood immunization records to see if she received measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) in the past. Additional information was not available at this time. In follow up information the nurse reported that the pt had no adverse reaction from the vaccine. The pt was immunized with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) as a baby. It was noted that the pt just didn't have immunity. No further information was available according to the reporter. Unspecified medical attention was sought.
devel rash papular on back, chest & few on face 26MAY97 per mom;by 28MAY97 lesions were beginning to go away;
nausea, fatigue, arm extremely sore, dizziness, fever, chills, achy
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications or concurrent conditions was provided. On 10-OCT-2017, the patient was vaccinated with an expired dose of VARIVAX (lot # L029466 with no expiration date in 06-AUG-2017), for prophylaxis (dose, frequency and route were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT). No adverse effects were reported. No product quality complaint (PQC) was involved. Lot Number N000808 has been verified to be NOT valid for STERILE DILUENT.
Resident previously positive for Covid-19 on 6/29/20.  She received both doses of the Pfizer vaccine - 12/17/20 and 1/5/21.  She tested positive again for Covid-19 on 3/1/21.
Vaccine was given too high, into my shoulder. Injection was only one finger width from top of shoulder. Pain at time of injection (3:20 p.m.).  Reminded me of the pain one would experience getting a cortisone shot. Three to four hours later pain in shoulder was substantial. Unable to lift arm, at all.  Pain continued throughout the night. Twenty-four hours later some improvement in arm mobility and marked pain.  Forty-five hours later not yet at full mobility and with slight to moderate pain.  Feel more attention to vaccine injection site is needed.
2 days of redness, swelling, warmth of lt deltoid; PE 5cm area @ induration w/10cm area of induration & warmth; imp cellulitis poss abscess; tx Keflex
Vial was intially stored on 08-Sep-2022 and given on 37 days; No adverse event; Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days)), PRODUCT STORAGE ERROR (Vial was intially stored on 08-Sep-2022 and given on 37 days) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was intially stored on 08-Sep-2022 and given on 37 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days)), PRODUCT STORAGE ERROR (Vial was intially stored on 08-Sep-2022 and given on 37 days) 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 (Patients received dosage after BUD,Dose administered after 30-day Use By Date (37 days)) and PRODUCT STORAGE ERROR (Vial was intially stored on 08-Sep-2022 and given on 37 days).    No concomitant medication was reported.   The vial was initially stored in the refrigerator on 08-Sep-2022. The vial size was 5.5 ml. The vial did not undergo any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-670209 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670209:Bivalent Invalid female case (4 female) same reporter
Patient was anxious after the vaccine and within 15 minutes of receiving the vaccine, she fainted. We elevated Patient's feet and laid her on her side. We used Ammonia nasal inhalant on patient and she reacted and started screaming.  We called 9-1-1 and meantime we checked her blood pressure and heart rate which were elevated.
Large induration with erythema at left leg at injection site 7cm x 7cm. Redness.
Breakthrough admission after three vaccines Moderna 3/8/21 Lot# 023M20A;  Moderan 4/15/21 Lot# 025B21A;   Moderna 12/17/21 Lot# 031H21A;
Patient lost consciousness for several seconds in seated position immediately after receiving flu shot.  He woke up and sat for several minutes before leaving the store.
A lump developed after about a week at injection site.  On about October 17, 2021 a rash developed around the injection site and has stayed consistent for the last several days.
high fever w/in hr of inj, leg pain, brief generalized sz on 10DEC96;
Developed a headache evening 2/8/2022 and not subsided since as of today 5/4/2022, neurologist diagnosed patient with NDPH 3/24/2022
A physician reported that a 14 month old female received her 2nd injection of Prevnar on 11/10/00. One day, post vax, the child was seen in the clinic after developing angioedema and urticaria. The child recovered. Angioedema was considered to be "Medically Important". Both the investigator and the medical monitor considered the events to be "possibly" related to Prevnar administration. Follow up information received 03/09/2001 clarified that the patient did not experience angioedema as originally reported. The patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious.
Pt received Hep A and B, and TD given on left detoid on 03/22/2002. Arm pain, hot with fever and hives. Seen in ER IM Benadryl given.
Injection site rash; rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number KC9C4, expiry date 30th March 2020) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site rash and generalized rash. On an unknown date, the outcome of the injection site rash and generalized rash were unknown.   It was unknown if the reporter considered the injection site rash and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced an injection site rash, which then spread to other parts of her body including legs and feet.  No time frame was known about initial onset of events. The reporter consented to follow up.
Fever, head ache and body ache for several days post vaccine. Documented Temp of 101.0 F, pulse 68 and otherwise normal exam.
I am a 25 year old female with no underlying/otherwise known health conditions. I received the vaccine Saturday, March 27th at ~1:30pm. No initial side effects, barely any arm pain, and I felt completely normal and fine for about 8 hours post vaccination. After ~8 hours, I began to develop body aches and tiredness, and within an hour of this onset I got severe chills. A few hours later (this is the middle of the night going into Sunday March 28th) I developed a fever that lasted into the next day. I was not able to take my temperature in the middle of the night but the next morning it had come down to 99.6F (still a slight fever). I had fatigue and tiredness the entire next day. I did not take any medication/fever reducer.  To sum up, I had no side effects upon initially receiving the vaccine, side effects set in ~8 hours post-vaccination and overall lasted about 24 hours. I have had no additional side effects other than those reported and have felt well since those subsided.
I woke up with injection site pain. The original 2nd dose Injection site pain had subsided after three days-so this is very strange.
Around 11:00 p.m. on the same day as the shot, I had a very bad reaction. I was extremely dizzy and weak.  I would take a couple of steps forward, then a couple backward or sideways. I was sweating profusely and my whole mattress where I lay was wet. I never shook so severely in all my life and could not control it. That went on for about a half-hour. When back in bed I put two heavy blankets over me and that seemed to help. And I was hallucinating, something I'd never done before----When I looked at my bed, it was covered by hundreds of small, yellow, balls. The whole top of the bed was covered.  I was and am physically exhausted from this event.
Narrative:  Patient was hospitalized due new onset renal failure with acidosis, confusion, and tremors, and then subsequently found to be COVID positive.
pt recvd vax 19JAN95; On 21JAN pt reports rt arm (deltoid was very warm to touch edematous & hard w/tenderness, also c/o sleeping for 24 hrs & vomiting; pt stated had a react to Td shot;
5x7cm erythema at injection site. Prescribed Augmentin/Cool compresses.
At approximately 1:00 PM, the injection site in the right arm became very painful.  By 8:00 PM, I had a fever of 101 F  and chills.  After taking 400 mg of Ibuprofen,  the fever had reduced to 100 F.  Sleeping was not possible on the right arm due to the pain.  The pain has continued into today (5/22/2021), one day after the injection.
Nausea, joint pain, back pain, vomiting, inability to keep down fluids
girl dies hours after getting HPV vaccine; This spontaneous report as received from a journalist refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot number, expiration date, dose, frequency and route of administration were not reported) for prophylaxis.  On an unknown date, hours after getting HPV vaccine, the patient died. It was unknown if an autopsy was performed.  The relatedness between the patient's death and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.
Sporadic Rash type Left index fingure inner aspect has a Small ~2mm bumb that itches Laft On the arch between the thumb and index fingure dorsal side the is a 1.5  flat red itching spot  Left medial aspect of forarm 2mm  itching flat red spot. Right ring fingure itching bump Break through menses day 2 and 3 past vaccination with bilateral groin pain.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received and refers to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.