chrisvoncsefalvay/vaers-outcomes huggingface dataset:
140 team members was administered Fluzone High-dose quadrivalent instead of FLUBLOK, No AE; the office staff members gave Fluzone High-dose quadrivalent to people under age, No AE; Initial information received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves (140 team members) patients who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE QUADRIVALENT HIGH DOSE] (batch number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QUADRIVALENT] (product administered to patient of inappropriate age and wrong product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (same day latency).  At the time of report no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Pt had fever 102-103, body aches, swelling at injection site , headache starting ~ 6 hours after injection of vaccine. Took NSAIDS + Benadryl. Fever persisted, site swelled, fever worse, gave Prednisone 60 mm taper on day 3. symptoms improved slowly. Site is still inflamed.
I've had these lung and heart rate issues after all three vaccines. Usually start a week to 2 weeks after and are pretty intolerable for a few months. I've missed work due to not being able to perform my duties. Can't catch my breath because it feels like i can't breathe in all the way and evebtyally it just starts to hurt to breathe. My heart rate would be severly elevated if I was just even walking (145+ and my resting is 75ish). Always goes down after I laydown. I had one really bad night where if i was older we would have gone to the ER because my chest pain was severe, I got really dizzy, and then my limbs went numb and tingly like they had all fallen asleep at once. Thankfully that only happened once after my second Moderna. I was hoping it was just bad allergies and some severe anxiety, but with the more 'mild' heart rate and lung problems happening at the same time with all three I think it's unlikely. After my second dose it took about 6 months to go away.
Patient received both PNEUMOVAX and FLUAD injections and said that she could not lift arm for 2 days and developed red swollen hot patches running down arm. Was diagnosed with cellulitis and received doxycycline 100 mg 1 tablet by mouth twice daily for 7 days.
Woke up feeling congested in sinus area, nose runny, ears hurting and thought he had a fever but has not taken temp. Has been taking Tylenol Sinus. Feeling better today. Pt states on 11/2, his throats a little sore but all else is better.
Left temporal headache and eye pain; then few days later: one episode of vertigo and "vibration" in head and 3 swollen pos left ear nodes. Severe hand, feet and ankle pain and swelling on 11/24, worse in AM; progressively subsiding every day since but not resolved yet.
Spontaneous information received on 03MAY2013 and 08MAY2013 from a family member of a consumer. An adult male experienced Valley Fever (coccidioidomycosis), and subsequently died. Medical history - the subject was reportedly in good physical condition. No known medical history. History of events per adult subject's father. Subject was immunized in October of 2007. Within a day of vaccination he experienced pain and illness, though the father could not remember the nature of immediate post-vaccination symptoms. He was eventually diagnosed with Valley Fever (coccidioidomycosis) contracted during his time at work. "He did not respond to treatment. The doctors said his immune system was not working. He had several surgeries. He was given many drugs that did not stop the infection." Reportedly, he was let go due to his illness. In 2011 he had 3 surgeries to remove 2 1/2 ribs and portions of his spinal bones, and further surgery to reinforce his spine. In 2013, he had "pockets" of infection in his bones; belly, and brain as well as his lungs. He refused treatment with a ventilator and subsequently died on 22APR2013. Per the subject's father: "His work gave him the vaccines. The doctors treated his infection. The doctors said the vaccine did not cause his infection. They said the vaccines did not cause his immune system to stop working. The employer said we could not sue. The employer is not telling us everything."
arm pain at the inject site; body aches; This is a spontaneous report from a contactable consumer.   The 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration, on 27Jan2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm pain at the inject site and body aches. The clinical outcome of events was unknown.   Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Had a great deal of swelling; Had a great deal of heat; Had a great deal of uncomfortableness; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Had a great deal of swelling), FEELING HOT (Had a great deal of heat), MALAISE (Had a great deal of uncomfortableness) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Had a great deal of swelling), FEELING HOT (Had a great deal of heat), MALAISE (Had a great deal of uncomfortableness) and EXTRA DOSE ADMINISTERED (Extra dose administered). At the time of the report, SWELLING (Had a great deal of swelling), FEELING HOT (Had a great deal of heat) and MALAISE (Had a great deal of uncomfortableness) outcome was unknown and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.            Concomitant product use was not provider by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-345024 (Patient Link).
hives which started getting worse/ hives on face and some on arm; face is swollen; its scaly; very bad itching; discomfort; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly), PRURITUS (very bad itching) and DISCOMFORT (discomfort) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE JANSSEN (1st dose and lot # 1805031) on 10-Mar-2021.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 03-Nov-2021, the patient experienced URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly), PRURITUS (very bad itching) and DISCOMFORT (discomfort). The patient was treated with PARAFFIN (VASELINE [PARAFFIN]) (topical) in 2021 for Adverse event, at an unspecified dose and frequency. On 28-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly) and PRURITUS (very bad itching) had not resolved and DISCOMFORT (discomfort) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information include applying some water, cream, and possibly milk (agent could not capture for sure, asked consumer again and she said "yes"). Patient states there is no change in her diet and not allergic to anything that she knows of.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow-up received on 11-NOV-2021 include adverse event discomfort added.
Patient called the clinic today (2/10/2023) reporting a rash on her arm near injection site the day after it was given. It is red and warm. Today a friend noticed it had spread up to the left side of her face. Patient indicates it is the same rash, face feels swollen and warm. Advised her to see her provider or a walk in clinic to have the rash evaluated. She asked about next vaccine (2nd in series), advised could be completed with a different COVID primary vaccine if provider indicates.
On 4/08/21 at  3:08 pm,20 years old Asian male received first dose of moderna Vaccine lot #026B21A , 0.5 ml to his let deltoid . At 3:24 pm Patient sitting in the observation area, he was complaining of blurred vision, feeling dizzy, diaphoretic, at 3:25 BP 120/80, pulse 72, 02 sat 98%.  As per patient mother who currently in facility, four years ago after received his MMR and VRA vaccine: he had a seizure. Patient was placed on low dose of keppra for the seizure. However, patient has been off the keppra for five years as instructed by his neurologist. Pas medical history as followed: Seizure, HTN, Acne, Rhinitis, Sinus Brady Cardia. Patient currently on Acne mediation : Tretinion and Clindamycin cream.  Po fluid given as per patient request, he stated ? I am feeling much better? 3:31pm  rechecked Vital sign Bp 128/78, pulse 88, resp 18, o2 sat  97% on room air. Denies any further symptom at present. Patient observed for 30 minutes. Patient AAOx4, Ambulate independently, patient released accompanied his mother and father in stable condition.
Allergic reaction, started with mouth and nose going numb for 1st injection; Allergic reaction, started with mouth and nose going numb for 1st injection; Allergic reaction, started with mouth and nose going numb for 1st injection; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 41-years-old male patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: FR8730), via an unknown route of administration in left arm on 24Mar2021 at 10:00 (at the age of 41-years-old) as dose 1, single for COVID-19 immunization at hospital. The patient's medical history included asthma and had no allergies to medications, food, or other products. Concomitant medication included tizanidine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, the patient experienced allergic reaction, started with mouth and nose going numb for 1st injection. Before the 1st injection he had never had an allergic reaction. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received for the adverse event. The outcome of events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
lost a filling and will need dental work done; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took vaccine on the 30th. On an unspecified date, she just lost a filling and will need dental work done and was wondering if she can take antibiotics. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Dizziness, lightheaded, sweating, pale, rapid heart rate, and nauseous
I am post menopausal and have not gotten my period in 2 1/2 years. I bleed heavily for 5 days after receiving the vaccine.  Severe headaches
URI symptoms (cough, runny nose, congestion), body aches, gi upset (nasueas, abdominal pain), decrease appetites, ear pain
Administer expired vaccine to patient,Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient,Dose administered after 30-day use by date or after manufacturer date of expiry) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient,Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient,Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 07-Apr-2022.No  temperature excursions for the vials was reported. Total of 173 doses were reported with the lot number 070H21A.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document was received and had non-significant information.
Patient was administered Moderna Covid Vaccine and is only 17 years old.  The patient did not have an adverse event to the vaccine. We are only reporting that she was given the vaccine at 17 years and 7 months of age.
This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported that a child of an unspecified age, gender and ethnicity received, on an unknown date, TRUMENBA single dose. Relevant medical history and concomitant medications were not reported. The patient had an immediate seizure when given TRUMENBA. Clinical outcome was unknown at time of this report.
Hospitalized with increased dyspnea, cough, anorexia, O2 saturations in 80s on room air . Refused outpatient treatment when COVID + on 2/26/22.    *** 10/27/2021 booster COVID-19 J&J lot 1822809
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: immediately after vaccination patient became dizzy, started sweating, was flushed and naseaus. rested for about 40 minutes and felt better
Myalgia, Arthralgia, Fatigue, Chills Narrative:  Other Relevant History:
Several minutes after injection, patient reported feeling dizzy and was developing a headache.   She was afraid she was going to faint.  The patient was moved to a private space where I monitored her vitals for one half an hour.  Her BP's were 130's to 140's over 70's.   HR was 100's.  The patient was provided a snack and hydration.   Pharmacist recommended 25 mg of Benadryl as a precautionary measure.  The patients symptoms improved rapidly and it appeared that the patient was recovering from a panic attach.  After chatting for 30 minutes, the patient was smiling, laughing, with stable vital signs.  Patient was discharged with agreement from charge pharmacist.
Hives at the injection site; Dry-cough; Dry heaving; Light-headedness; Itching; swelling redness of face; began feeling exhausted; Hives; redness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 01-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and HISTAMINE for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness), PRURITUS (Itching), ERYTHEMA (swelling redness of face), FATIGUE (began feeling exhausted), URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Hives at the injection site), COUGH (Dry-cough), RETCHING (Dry heaving), DIZZINESS (Light-headedness), PRURITUS (Itching), ERYTHEMA (swelling redness of face), FATIGUE (began feeling exhausted), URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (redness at the injection site) was resolving.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment product information was provided
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that, no adverse reactions were reported by the patient. No treatment medication was reported.
Extended burning at injection site for approximately 3 hours. Numbness and tingling extending to the fingers in the vaccinated arm lasting 3 days. Redness and swelling at the injection site lasting for approximately 8 days.
1/21/2021 started feeling achy joints and restless at HS, reported feeling chilled 1/22/2021 Reports fatigue, states "slept all day" 1/23/2021- 1/26/2021 reports face "puffy", continues with muscle aches Reports used Tylenol to treat symptoms. Not able to recall date/time of initial dose.
Injection site was sore; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was sore) and FATIGUE (A little tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Gabapentin), Drug allergy (Phenergan), Depression, Anxiety and Pain.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection site was sore) and FATIGUE (A little tired). At the time of the report, VACCINATION SITE PAIN (Injection site was sore) and FATIGUE (A little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Anti-depressant medications, Anti-anxiety medications and  Pain medications. Treatment information was not provided.   This case was linked to MOD-2021-110073 (Patient Link).
This spontaneous report was received from a mother refers to a male child of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date in 2007, the patient experienced patient diagnosed with autism after receiving M-M-R II. The outcome of was unknown. Additional information is not expected.