chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/28/21: Pt presents to the ED with SOB x 4 days. Pt states he was recently tested positive for COVID-19 and complains of SOB, body aches, cough, and fever. He also complains of bilateral LE swelling. The onset was 4  days ago. Pt states he was recently admitted to Health Central 4 days ago for evaluation of his symptoms, but was discharged after 2 days. He mentioned he is fully vaccinated with Pfizer  for COVID-19. Last COVID vaccine admin in April 2021.  7/28/2021: SARS CoV 2 PCR COVID-19 Positive  7/30/21: Pt discharged
deferred second dose; covid-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (deferred second dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and XARELTO for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (positive). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. At the time of the report, COVID-19 (positive) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (deferred second dose) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: Positive Patient was tested positive for COVID on 03April2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Several days after receiving the flu vaccine, my upper arm and entire shoulder became painful, and this lasted approximately 10 days.
Patient became febrile after receipt of vaccine: 103.2 degrees F. Attending medical doctor assessed patient and ordered a COVID swab and urinalysis to rule out infection. Fever waned overtime but remained slightly elevated (low-grade fever) and continued to be monitored by staff. Patient was given acetaminophen (dose and frequency unknown).
Swelling, pain, redness, itching, heat and hardness at injection site.  Severe muscle pain across uppper back and neck.
just tired/worn out all week; sluggish; This is a spontaneous report from a contactable consumer.  An 83-year-old female patient (reporter's mother) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 12Jul2021 (Lot Number: EW0181; Expiration Date: 30Aug2021) as dose 1, 0.3 ml single for COVID-19 immunization.  Medical history included pacemaker on an unknown date, fall on 13Feb2021 and a concussion in her head on an unknown date. There were no concomitant medications. The patient was just tired and sluggish and worn out all week which started the day of the first dose of the vaccine, 12Jul2021 and lasted a week or so. The outcome of the events was recovering.
This spontaneous report was received from a pharmacist, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The pharmacist informed that on 26-FEB-2015 the patient was vaccinated with one dose of ZOSTAVAX 0.65 ml, subcutaneous, for prophylaxis (lot# and expiration date were not reported), that was improperly stored. No adverse effects reported. Additional information has been requested.
Started as an itchy rash where the band-aid was day 2 but itching went away next day. On Thursday the 1st (one week after shot) it started itching again and I noticed there were some small red hives on left arm near injection site. The next morning my whole shoulder/bicep (injection site) area looked like a large mosquito bite. Very swollen, red and itchy. Now a whole day later, my arm is still swollen, red and itchy. But I am getting hives on both hands, elbows and feet.
(BTW - don't know time of onset) I started noticing my shoulder was hurting and I could barely lift my arm.  I didn't have bad site pain initially so I didn't connect it at first to the vaccine.  I saw the doctor who was skeptical but I had done research and was pretty sure this was a vaccine injury.  I sent my doctor the information on frozen shoulder and vaccines.  The doctor I saw said if it didn't go away in a couple of weeks it might be an injury but he was very dismissing.  I doubt they are going to report it but it has been a month - I still can barely lift that arm and it is painful when I get to a certain point.  I think vaccines are worthwhile but I am not going to get a flu shot again.  From what I read this is going to take a year to get better and I am frustrated that my doctors are not paying any attention to it.  I think it makes more sense to see if this really is a vaccine injury and help the patient deal with it instead of disregarding the discomfort.
I took the Flu Shot at my Dr's. office, all went well until about 5:30 PM, I began to get very dizzy and a little nausea, this lasted at least a couple of hrs. I was a little concerned, because I have a pacemaker and I had experienced this feeling before I got the pacemaker, but I checked my heart rate and it was good, so I felt it was a reaction from the shot. It soon passed and I began to feel alright. I also read on the instruction sheet given to me at the office that this could happen. Not a very good experience.
Patient was vaccinated on 04/04/2019. The morning of 04/06/2019 redness, warm to touch, and swelling were noted at right upper arm at the injection site. Patient was seen in the ER on 04/06/2019. Patient was give Prednisolone and Benadryl. Patient had immediate improvement after given the treatment. Patient's mother was called on 04/09/2019, and mother reports arm is much better with a barely visible rash.
This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (flu-like symptoms) and diarrhea in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025B21A and 005C21A) for COVID-19 immunization. No medical history reported. On Apr 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 1, 2021, patient experienced influenza-like illness (flu-like symptoms) and diarrhea. On May 3, 2021, influenza-like illness (flu-like symptoms) and diarrhea resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-080333 (patient link).
13JUL92 pt recvd 1st dose of Engerix-B w/no problems; 13AUG92 recvd 2nd dose of Engerix-B & devel severe h/a for 4 hrs which was unresponsive to APAP;
Tenderness at injection site first 2 day, Generalized body aches, fatigue on 4th day most of day took only Tylenol 325 mg X 4 once each day, rested and slept most of 4th day, did not call Dr.
Moderna COVID-19 Vaccine EUA  Around 4am on 5/22 I developed a mild fever. Got up around 7am 5/22 and took my temperature (99.8). I walked down my stairs to make toast and around 7:20 am I fainted in my kitchen. I had eaten and drank plenty of water the night before, so I don't think I was dehydrated or hypoglycemic. No other fainting events the rest of the day but I was extremely dizzy and nauseous.
extreme chest pain for two hours; Struggled to breath with all over lung; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the arm left on 24May2021 at 08:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the arm left on 03May2021 at 08:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021 at 12:00, a little after 24 hours, the patient experienced extreme chest pain for two hours and struggled to breath with all over lung and chest pain. The event resulted in emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event extreme chest pain and Struggled to breath with all over lung was recovering.  No follow-up attempts are needed. No further information is expected.
Shot was administered August 27, 12 and whole arm including area where shot was administered hurts unable to move/sleep on arm at times and painful. Taking nabumetone 750mgs for possible infection.
This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX and SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Last week from the reporting date, the patient came to the reporter's office presenting with a rash. The patient was diagnosed with a mild case of Shingles. This case was considered as suspected vaccination failure as the exact time to onset for the event and lab test confirmation for targeted disease were unknown.
Developed rash on face and cough, hard to swallow. Went to E.R. last night they suggested BENADRYL. Mom will get BENADRYL.
Approximately 5 minutes after vaccination, complained of dizziness, without other symptoms.  He then lost consciousness for approximately 30 seconds.  EMS was called.    At the time, his pulse oximeter reading was 98 %, his pulse was 55 and his blood pressure was 150/80. Once he became responsive, he was oriented to person, place and time.  Once EMS arrived two minutes later,  consented to enter ambulance for evaluation.  With confirmation of stable vital signs, and his evaluation complete, refused further care and left the parking lot on his own accord.
Arm pain the next day followed by fatigue and malaise; Arm pain the next day followed by fatigue and malaise; Arm pain the next day followed by fatigue and malaise; headaches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Jan2021 (Lot number: EL 0142) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Jan2021, outcome "unknown", FATIGUE (non-serious), MALAISE (non-serious) all with onset 13Jan2021, outcome "recovered" (18Jan2021) and all described as "Arm pain the next day followed by fatigue and malaise"; HEADACHE (non-serious) with onset Jan2021, outcome "unknown", described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:Description of Event: Following dose 1 of Pfizer Lot # EL 0142. On 12Jan2021 Patient reported experiencing arm pain the next day followed by fatigue and malaise x 5 days. Patient also reported periodic severe headaches lasting several hours during this time. Patient subsequently received Does to Pfizer lot # EL3247 on 02Feb2021. No reaction. On 08Aug2021 patient received booster dose of Pfizer lot # FC 3180. Next day patient experienced a sore arm followed by five days of general malaise. On day 2 post vaccination patient experienced a fever spike of 100.5F which lasted about six hours per report.  No follow-up attempts are possible. No further information is expected.
ANGIOEDEMA, INIT ALLERGIC REACTION, INIT ALLERGIC REACTION, SUBSEQ
This non serious case was received on 24 February 2009 from VAERS (reference number 334709) via a search of the QSCAN database. A 32 year old male patient received Fluzone SV 2008-2009 (lot number U2741A) intramuscularly on 23 October 2008. On 24 October 2008 the patient developed blood shot eyes, a swollen throat, fever, chills, muscle aches sore throat, fatigue, cough, headache, and muscle aches. The patient was reported as recovered. No further information was provided. List of Documents held by sender: none.
Left arm swelled from shoulder to elbow-very large, hot and tender. B/P increased to 207/104 and normal B/P around 125/76. Took 3 days for arm to return to normal. To ER on 10/11/03. Given Benadryl and prescribed Prednisone 20mg po QD  x6days and Keflex 500mg 1 tab po q 6h x 10days. Dx: Acute Allergic Reaction.
muscle aching and fatigue from about 6 hour post vaccine to 30 hour post vaccine; muscle aching and fatigue from about 6 hour post vaccine to 30 hour post vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 09:30 (Lot number: EW0217) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose dose number was1, Dose vaccine location on Right arm), administration date: 21Jan2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose dose number was 2, dose vaccine location on Right arm), administration date: 11Feb2021, when the patient was 58 years old, for Covid-19 immunization; Flu shot (other vaccine 4weeks product was flu shot, other vaccine 4weeks vaccine date was23Sep2021, other vaccine 4weeks vaccine location on right arm), administration date: 23Sep2021, when the patient was 59 years old. The following information was reported: MYALGIA (non-serious), FATIGUE (non-serious) all with onset 04Oct2021 16:00, outcome "recovering" and all described as "muscle aching and fatigue from about 6 hour post vaccine to 30 hour post vaccine". Therapeutic measures were not taken as a result of myalgia, fatigue.  Additional information: If covid no prior vaccination and no covid tested post vaccination. No allergies and no medical history.  No follow-up attempts are possible. No further information is expected.
Patient states she iw feeling off balance and chest is racing. Patient laid down and stated she is feeling much better. Patient has history of shellfish and tree nut allergies and controlled asthma with daily inhaler and rescue inhaler.
Severe chills with shivering, impaired breathing, impaired movement lasted at least 12 hours, is continuing in a milder form (not yet resloved)  Reddening near (not at) site of injection which appears to be a deep bruise.
On 9/18/14 at 16:00, 59 year old arrived our clinic for immigration immunizations. Patient was inadvertently given Tdap instead of Td. Pt had Tdap vaccine on 4-30-14 so just needed Td at this time.
Severe weakness, body aches, joint pain, fever of 100.7, chills, headache, fatigue, body rash
Patient's arm started hurting on 6/4/19 night. Left arm was swollen, bruised form injection site all the way down to elbow and extremely painful.
45 minutes after receiving vaccine, patient experienced numbness of her upper posterior palate and down her throat.  This lasted about 4 hours and resolved without further treatment. No shortness of breath, rash or swelling noted per patient report.
Patient hospitalized for robotic sleeve gastrectomy within 6 weeks of receiving covid vaccination.
Patient reports facial swelling, headaches, muscle aches, vision disturbances since time of vaccination
Pt with Lt upper arm soreness and redness. There was no numbness, tingling, or weakness. There was no H/A or fever.
Hives and severe itching began about one week after vaccination.  I suspected I had an allergic reaction to something, but could not identify the cause. I had been away at a hotel and had been hiking the weekend the symptoms started. At the time I had no reason to believe it could have been a delayed reaction to the vaccination so I did not report it to my doctor. My Doctor's assessment & treatment is given below: Raised urticarial lesion over left armpit, bilateral wrists and forearms, groin and waist band and popliteal fossa and back of his bilateral legs. (Note: actually was both armpits) Start Prednisone Tablet, 20 MG, 3 x 3 days then 2 x 3 days then 1 x 3 days then off Notes: will treat with pred and antihitamine and rtc if ineffective.  I've had a reaction like this before to poison ivy, but the poison ivy rash was evident prior to the urticaria.  In that case, the poison ivy rash and urticaria both resolved quickly (a few days) once I started taking the Prednisone.  In the recent case, the severe itching and urticaria was significantly reduced within a few days, but minor itching and urticaria continue to this day.  It is slowly getting better, but I am still taking antihistamines (Claritin and/or benadryl) daily.  Some research indicated that this could have been a delayed, non-allergic reaction to the vaccination.  My doctor agreed that this was a possibility and recommended that I continue the antihistamines until the symptoms resolve.  I also want to note that after the second dose and the booster dose of the Moderna Vaccination I also had the more typical reactions of a sore arm, headache, fever (~100F) and fatigue, which started the following morning after the vaccination and lasted about 24 hours.
severe exhaustion to the point of not being able to work a full day - have had to come home half way through work day for over a week.
No menstrual cycle in February 2021 (despite being on HBC and several negative pregnancy tests.) Severe vertigo (could no drive, walk, turn in bed without severe vertigo/nausea.)
Hospitalization for Non-STEMI (then found to have COVID-19) on dates 12/15/22- 12/17/22. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
2 febrile seizures; This is a spontaneous report from a contactable physician. A 2-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced 2 febrile seizures about 2 days after the dose and went to hospital on an unspecified date. At the reporting time, she was ok now. Outcome of event was recovered on an unspecified date.  The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: A possibly contributory role of PREVENAR 13 in triggering the onset of febrile seizures cannot be fully excluded, considering the temporal relationship and known adverse event profile  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
This spontaneous report was received from a licensed practical nurse concerning a 12 year old male patient. The patient's concurrent conditions included henoch-schonlein purpura. The patient's medical history included gastrointestinal disorder. The patient did not have history of drug reactions or allergies. On 03-OCT-2017, the patient was vaccinated with an unspecified dose of GARDASIL 9 lot # N013276, expiration date 21-JAN-2020, for prophylaxis (dose and route of administration were not reported). On the same date, following the administration of GARDASIL 9, the patient experienced  severe nausea and dry heaving (retching); he was at the reporter's office and was administered an unspecified treatment, however no laboratory diagnostic tests were performed.).The reporter also indicated that she checked on patient through call and he was getting better. The causal relationship between the events nausea and retching and therapy with GARDASIL 9 was not reported.
Client here for school vaccines. Administered vaccines per protocols. After vaccines adm, client fainted. Pulse 40 and thready. BP 60/? faint. 911 called. Paramedics transported pt to ER b/c recovery time prolonged.
Fever - 101 degrees - 10/2/10. Itchy, red blotches on 10/5/10 on chest and back. Calamine lotion applied.
Episode of hallucinations last night and went to Hospital ER. Mother worried that was shots. Had a headache as well. Still not feeling well. ATIVAN helped get her settled down. Slept last night and slept late, still felt fuzzy. Mother wanted lot numbers of the shots given and I supplied the manufacturer and lot number to her of the flu, MENACTRA and Tdap. She feels might be related to the flu vaccine. I shared that I had not seen this type of reaction with that vaccine, nor was I aware of any reported in the medical community. Patient is a 12yo with history of PTSD, generalized anxiety disorder, and report of sexual abuse in the past, presenting with abnormal behavior. Her symptoms occur most prominently when they are being discussed during the HPI and otherwise seem to be relatively distractible/suppressible. She follows complex commands and has a normal neurologic exam, and is alert and oriented to numerous questions on my exam. Differential includes toxic ingestion (although no history of ingestion), anxiety, psychosis, conversion disorder. Less likely encephalitis, meningitis, intracranial hemorrhage or increased ICP given lack of fevers and distractibility of her symptoms. Will send labs including urine and serum tox screen, VBG, CBC, chem, LFTs and lipase. Will consult Neurology, and possibly psychiatry pending progression of her symptoms and labs. Will give a dose of ATIVAN for nausea and possible anxiety component of her symptoms. After receiving lorazepam, the patient had returned to her baseline mental status and resolution of her hallucinations. Neurology team evaluated the patient and agree low suspicion for organic etiology of her symptoms. She was observed for multiple hours in the ED without recurrent symptoms. After her mental status improved, I discussed with patient in private and she denied SI, HI, ongoing hallucinations. She endorsed to me that she feels very stressed regarding an upcoming court appearance. I discussed with the patient and her mother that this episode may represent a component of conversion disorder. I discussed the stressors with her mother as well who states that she has significant in home and in school therapeutic resources, and is scheduled to see her therapist tomorrow. I discussed with the psychiatry team who are in agreement with discharge to home with close best team and primary outpatient therapy follow-up. Family is in agreement with this plan, patient can contract for safety, and they understand signs and symptoms to return to care.
lightheaded, dizzy, especially when standing up, started within 30 min. of vaccination, lasted about 5 days