chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling unwell; Eye pain; Pain; Shortness of breath; Shallow breathing; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), EYE PAIN (Eye pain), PAIN (Pain), DYSPNOEA (Shortness of breath) and HYPOPNOEA (Shallow breathing) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell), EYE PAIN (Eye pain), PAIN (Pain), DYSPNOEA (Shortness of breath), HYPOPNOEA (Shallow breathing), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling unwell), EYE PAIN (Eye pain), PAIN (Pain), DYSPNOEA (Shortness of breath), HYPOPNOEA (Shallow breathing), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information included Tylenol.
Patient with red circular area around injection site that is increasing in size each day, warm to touch, beginning to itch.
Headache; dizziness; sore arm; body aches; chills; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received the second of bnt162b2 (formulation: solution for injection, lot number: EL9264), via an unspecified route of administration in left arm on 02Feb2021 at 14:00 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL3302), in left arm on 12Jan2021 at 14:00 as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 14:00, the patient experienced headache, dizziness, sore arm, body aches and chills. The patient did not received treatment for the events. The outcome of the events was recovered.
Pt sweated, turned pale, felt lightheaded shortly after the flu shot. She recovered after 10 minutes of sitting, raising her legs on chair, and drinking some water.
started with a headache, then the muscle fatigue set in and i was so tired i could barely get up. fever got to 101.7  fever reducer meds were taken once before trying to go to sleep.  woke up in morning feeling much better, a little bit of muscle ache still but fever is down to 99.3
I started experiencing mild to moderate heart palpations around 10 days after the first dose of the vaccine. A need to cough followed by a feeling of fogginess would normally occur during these episodes.  Palpations would happen consistently every 1-2 hours for more than 6 weeks from onset and primarily at rest.
No adverse event; The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015m20a and 012l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021).    No concomitant medication information was provided.  Patient was not immunocompromised. The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2022-628869 (Patient Link).
This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of headache in a 31-year-old subject of unspecified gender who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On an unspecified date in 2013, the subject received dose of FLUARIX Quadrivalent (.5 ml, details unknown). On an unspecified date in 2013, within months of vaccination with FLUARIX Quadrivalent, the subject experienced headache, fever, vomiting and body pain. At the time of reporting the outcome of the events were unspecified. The healthcare professional also reported that two other patients experienced headache, fever, vomiting, and body pain following vaccination with FLUARIX Quadrivalent (see case IDs A1046612 and A1046613A for more details). Follow up was received from nurse on 1 November 2013. The nurse reported concurrent medications included ADDERALL and BALZIVA. The nurse reported that the events began on 2 October 2013 and ended on 5 October 2013. The outcome for the events was reported as resolved. The nurse did not consider the events to be serious. The subject does not use tobacco or alcohol. The subject had received flu vaccine in the past. The subject had not experienced any adverse events following previous vaccinations. The immunization series was not discontinued or delayed. Symptoms did recur following subsequent administration "within 24 hours" however, the nurse did not provide documentation of subsequent administration. It as unclear if the nurse misinterpreted the requested information.
This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specific information. At the first facility they might have administered VAQTA, RECOMBIVAX HB, GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been administered to patients. The first set of vaccines were RECOMBIVAX HB, Meningococcal Protein Conjugate and COMVAX, GARDASIL, ROTATEQ which were exposed to 30F to 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported. The second set of vaccines for this facility were Meningococcal Protein Conjugate and COMVAX and GARDASIL which were exposed to 32F for 221 hours and 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source (same reporter link: 1406USA000768, 1406USA007003, 1406USA007005, 1406USA007006). Additional information has been requested.
Awoke about 12 hours after vaccine was administered with a burning sore throat with painful swallowing. Pain increased over the next 24 hours and then diminished quickly to mild soreness with post-nasal drip.  Slight fever increase of 1.5-2.0 degrees which also diminished over 48 hour period.
Seven days after getting vaccine, got servere sinus pain and pressure. As I write this 4 days later, it is getting worse.
Pt presented to the pharmacy on 11/15 @ 10 am. Pt states that her arm was swollen and inflamed and that it started swelling 2-3 days after administration of vaccine. It is swollen to about the size of half a golf ball, and Pt states that she saw a nurse  practitioner 11/14, about a different reason, and they told her to put some neosporin on it. I counseled the pt on Ibuprofen and Benadryl and to ice the area.
Pt cried non-stop for 5 hrs during this time refused bottle t101; very fussy x 48 hrs, leg tender to touch, redness & swelling size approx 25mm (size of quarter);
Nasal H1N1 administered. Remained in administration area for 15 min. No problems - returned to class. Return ~ 30 min later c/o headache, nausea- skin cool & clammy. Face flushed. Cold pack applied back of neck. Vitals stable, B/P 110/82 P84 R16 & clear. After 30 min skin warm, dry - no further flushing. Major complaint nausea - Returned to class.
Per blood test: Atypical measles positive  (Rubeola IgM 1.98), Atypical Rubella positive (Rubella IgM 149.0), Atypical Mumps (Mumps Equivocal 1.00). Asymptomatic
increased heart rate; This case was reported by a physician via call center representative and described the occurrence of heart rate increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 2nd dose of Shingrix. On 4th November 2019, 1 days after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: The day before the reporting date, the patient received Shingrix. On the reporting date, the patient's heart rate was high at 92 beats per minute. The healthcare professional did not had the lot number and expiry date. The reporter consented to follow up. There was discrepancy in the reported event outcome in file and in database, however it is captured as per database.
UNKNOWN.  PT'S WIFE CALLED US TODAY 3/30/2021 TO INFORM US THAT PATIENT PASSED AWAY ON 3/29/2021 DUE TO MASSIVE HEART ATTACKED
Ongoing bladder irritation/overactive bladder symptoms since 2nd dose in November 2021.
Myalgia, Fever, Swelling, Redness, Warmth at injection site Narrative:
09/21/22 presents to ED for "headache". PMHx of "R breast ca s/p bilateral mastectomy (2018) and cervical dysplasia"
Atrial fibrillation Narrative: Patient with a history of atrial fibrillation (in 2018, with successful cardioversion) on diltiazem 30mg tid. He received his 1st COVID vaccine on 2/13/21. He reported fever, nausea and arm soreness on 2/14/21. On 2/15/21 he reported increased shortness of breath with BP ranging 101-126/74-86 and pulse from 69-108. Reported feeling a rapid heart rate. Had a visit with his PCP on 2/16/21 and noted to be in a-fib. Diltiazem dose increased to 60mg tid, and patient initiated on rivaroxaban. Referral placed to cardiology. Remains in a-fib as of 3/10/21, did receive his 2nd dose on 3/13/21.
Suspected Vaccination failure; ended up getting the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient ended up getting the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Symptoms began as very tired, a bit of soreness with mild flu-like symptoms with a bit of soreness at site for 3-5 days.  Some diarrhea which is still prevalent to this date (03-07-2021) . Am counter acting diarrhea with an OTC anti-diarrheal medicine. The adverse symptoms I experienced  did not seem necessary to follow-up as listed in item No. 21
This spontaneous report as received from a healthcare worker/medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with PNEUMOVA23 (dose, frequency, lot#, expiry date and indication were not reported), which was stored improperly for a period of 25 days. No adverse effect was reported. This is one of three linked reports from the same reporter. Additional information has been requested.
SLIGHT DISORIENTATION FOR 1 DAY FOLLOWING INJECTION, OVERALL MUSCLE STIFFNESS AND HARDNESS OF TISSUE AT SITE OF INJECTION CONTINUING THROUGH 3RD DAY.
TOOK ONLY ONE DOSE; This spontaneous case report (PVX2019-2856) was received from a pharmacist on 19-Nov-2019. It described an adult (18 to 22-year-old) male consumer who "took only one dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took only first dose of Vivotif on 14-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company comment: It was reported that a patient only took one dose of Vivotif (missed dose). Further detail of the event is limited.  Considering the nature of the event, the causality of the event missed dose is assessed as not related.; Sender's Comments: It was reported that a patient only took one dose of Vivotif (missed dose). Further detail of the event is limited.  Considering the nature of the event, the causality of the event missed dose is assessed as not related.
This spontaneous report as received from a Registered Nurse via a company representative refers to a female patient of unknown age. In October 2014 the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported). Concomitant medications included a Flu (manufacturer unknown). The nurse stated that she administered both a Flu (manufacturer unknown) and the GARDASIL vaccines to the patient during this office visit. Shortly after both vaccinations were administered the patient then passed out (occurred during the last week of October 2014). Treatment given to the patient was not specified and the patient did not regain consciousness for two hours. Upon internal review, "the patient then passed out/the patient did not regain consciousness for two hours" was determined to be medically significant. Additional information has been requested.
I was on a trip abroad, and we had been doing a lot of walking tours.  I started having symptoms of COVID-19 for about three days and tested and negative on the first day but was positive on the third day. While I was out on the tours, I was having a runny nose and a cough, but I was also very out of breath at the end of walk and fatigued which is not normal for me.  By the third day I had a fever I was very hot and very fatigued. Throughout I had fever, chills, bad runny nose, cough and a lot of upper chest and cold like symptoms. I ended up coming home from the trip early. The group that we were traveling with was all taking COVID-19 tests and were all negative but after a stop that we had made one person was positive and then three days later the whole group was positive. After coming home, I did go to my doctor and was still positive about a week later on October the 19th.
2nd dose MMR on 8/2/21. Began with symptoms of pain with ROM. unable to sit straight and pain using comp mouse and driving as well.  Pain in R shoulder joint, arm /elbow / wrist joint.  intermittent numbness and weakness to R arm since day of vaccination.  OTC pain medicine has not helped, did PT  which helped temporarily only. At this time symptoms remain.
Acute onset crying x 4 hrs. During cry - went limp, turned pale, eyes rolled. Mom called 911 > local ER. Normal CBC, BMP, UA and head CT without contrast, chest x-ray mild patchy infiltrate.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-APR-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) Lot# K008579, expiration date 13-DEC-2015 (route and dose were not reported). There was no concomitant therapy reported. The temperature excursion for PROQUAD (Merck) was unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
patient thought her tongue was swelling , she was given  10 ml's of benadryl and said she felt fine
Had numbing, tingling sensation back throat. Throat felt full. Difficulty swallowing.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: rash around injection-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: patient called to confirm about possible side effects or adverse events of rash, possible lip swallon, and redness, bruise around the injection site. patient also confirmed using benadryl and the problems seems to go away. patient was properly monitored before and after giving a shot, no adverse events at the time of injection. consult provided to seek medical help and patient will be monitored closely in a weekly/periodic basis to make sure about her health safety
given the Fluzone Quad 0.5 ml instead of the Fluzone high dose/no ae; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was Linked with 2019SA310468 (same reporter).  This case involves a 66 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via intramuscular route in unknown administration site), on unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to wrong vaccine administered.  At the time of reporting the adverse event was not 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.  Information on the batch number was requested.
Pt received his second dose of Pfizer COVID vaccine on 5/19. That same day he developed diarrhea and shortness of breath. He presented to hospital emergency department on 5/23. They recommended COVID test, but patient refused and he was discharged home. He re-presented to ED on 5/26 and was admitted and treated for bacterial pneumonia with CTX/Azithromycin. During that admit he was newly diagnosed with Atrial fibrillation. Discharged on Eliquis. He then re-presented on 6/2 and tested positive for COVID. Pt got upset with the diagnosis, refused care, and left hospital. His daughter lives in the northwest suburbs, so she brought him to Hospital, where patient also tested positive for COVID on 6/4 and was admitted for COVID treatment (noted to be hypoxic (89% O2 sat) on room air).
GI upset; Cramping; Diarrhea; This is a spontaneous report from a contactable healthcare professional. A 39-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration right arm on 05Jan2021 06:30 at a single dose for covid-19 immunization. Medical history included lymphoma and was identified with Covid prior vaccination. The patient has not received other vaccines in four weeks. There were no concomitant medications. The patient previously took acetazolamide (DIAMOX) but had allergies. The patient received her vaccine in a hospital. The patient experienced GI (gastrointestinal) upset, cramping and diarrhea on 05Jan2021 13:00. No treatment was received for the adverse events. The patient has not been tested post vaccination. The outcome of the events was recovered on Jan2021.   The following information on the batch/lot number has been requested.
Tested positive for COIVD-19 after fully vaccinated and immunized. Received 1st dose 13th Jan 2021 and 2nd dose on 3rd Feb 2021.
Noticed red, warm, a little itchy spot at injection site. No systemic symptoms. Improved w/heating pad. Mother took child to ER. Has increased in size by 1cm over time. Advised con't heat. Seek medical care if indicated.
I cannot say for sure that this is related to the vaccine, however I have new skin problems that I have never experienced prior to the vaccine I have developed a rash on the back of my left leg which appeared shortly after my 1st booster and then got even more pronounced after the 2nd booster. While it might not be related, the timing seemed suspicious, so I decided to report it.