chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up with positional vertigo; This spontaneous case was reported by a consumer and describes the occurrence of   in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo positional. Concurrent medical conditions included Hashimoto's thyroiditis, Penicillin allergy, High cholesterol and Breast cancer aggravated. Concomitant products included LEVOTHYROXINE and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.
24 hours after, swelling of underarm lymph nodes, tiredness, headache, nausea.  Beginning 1/4/2022 reactivation of chickenpox. (Originally had 40 years ago).
Child has no history of chicken pox disease or chicken pox exposure.  He was diagnosed with Shingles on 8/14/2007
Headache 20 mins after injection on Thursday. Friday had cellulitis around area was given KEFLEX on Sat couldn't move arm or neck very well. Very swollen up into facial area and back.
Patient has recent lip filler and called complained about increase in lip swelling and facial and arm pain. Patient was advised to take Benadryl and seek medical attention. Patient stated no anaphylaxis reaction.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
Patient recieved second dose of Covid-19 pfizer vaccine on 2/21/22 (monday) in his right deltoid muscle,  on Wednesday he woke with swollen lymph nodes on left side of neck the size of ping pong ball. he did not have this reaction on the first dose.
Delayed allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Delayed allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Delayed allergic reaction). At the time of the report, HYPERSENSITIVITY (Delayed allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
This spontaneous report was received from a consumer referring to his son, a patient of unknown age. Information about concurrent condition, medical history and historical medication was unknown. On an unknown date in June 2017 (reported as a year ago), the patient was administered the first dose of GARDASIL (lot #, expiration date, dose and frequency unknown) intramuscularly for prophylaxis. On an unknown date, the patient did complete the dosing series (inappropriate schedule of vaccine administered). The reporter would contact the physician to follow up.
Patient was vaccinated on 3-12-21 and tested positive for COVID on 11-20-21.  He expired 12-17-21.
This is a spontaneous report from a contactable pharmacist via a Pfizer representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced redness that was quite excessive after the use of the vaccine, like her whole arm was red and red for a while, like a week or so. The final outcome of the event was unknown. Information on the batch number has been requested.
Nurse reported that a patient received his first dose of GARDASIL9 at age 15 years and is currently 24 years receiving the second dose in 3 dose series; No additional AE/PQC reported at time of call.; This spontaneous report was received from a registered nurse and refers to a 24-year-old male patient. His medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in approximately 2014 (when he was 15-year-old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (exact dose, lot #, expiry date, and route of administration were not provided). The nurse reported the patient was receiving the second dose in 3 dose series, however, the date of administration was not known (inappropriate schedule of product administration). No additional adverse event (AE) was reported.
In January 2022, I began having mild to moderate sharp chest pain, and those would be a little offset from the middle of my chest to the left and those types of pains lasted about 6 weeks. So then on March 24, I was sitting at the computer and speaking with my wife, I had a really intense pain that made me double over in my chest at a pain level at 8 and got worse after a half and hour so then I went to the ED and they admitted me over night for observation. Everything indicated that there was no suggestion of heart attack at all. So then I had a Calcium CT scan and then I followed up with the cardiologist.
Patient reports heart palpitations starting immediately after the vaccine was administered and lasted 2 to 2 1/2 hours. She also reports breathing problems but is unsure if it is related to her asthma. Patient reports no chest pains.
MASSIVE UNRELENTING FEVER- initially began with exhaustion Sunday/Monday- then Tuesday night- the chills and fever hit for 32 hours.
Weakness/fatigue - onset 1/31/2021. Persisting thru 2/4/ Nausea - 2/4.  Mild cough & nasal congestion since 1/31.
Heart attack; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized on 30-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Heart rate: 209 (High) beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Fever, chills/shivering, shortness of breath, swollen throat, watery eyes, sniffles, and sore muscles.
Shingles 4-5 months after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles 4-5 months after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HERPES ZOSTER (Shingles 4-5 months after vaccination). At the time of the report, HERPES ZOSTER (Shingles 4-5 months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-295070 (Patient Link).
"Brief Summary of Hospital Stay: Per HPI, a 79 YO male with a PMHx of HFpEF, CAD, HTN, CKD, HLD, PVD, tobacco abuse and T2DM who presents with ongoing dyspnea at rest and with exertion.  He states the shortness of breath has been ongoing for about 3 weeks but has been progressing to where he was seen here on 8/11 for evaluation of chest pressure and shortness of breath which he was diagnosed with a CAP and started on doxycycline.  He started the doxycycline yesterday morning and has taken 3 doses.  He reports when he woke up this morning felt "just really bad." He also endorses a dry "shallow cough," weakness in his legs and body aches.  He reports history of tobacco use, unable to quantify amount and reports smoked cigarettes for about 60 years recently stopping a year and a half ago; no alcohol use, no illicit drugs. In the ED, he is afebrile and hemodynamically stable; no leukocytosis on CBC, baseline anemia noted; elevated ddimer at 1950, CMP with elevated Cr of 2.4 (baseline 1.7) and elevated transaminases.  Initial trop 407 and repeat 336.  He was briefly hypotensive into the 80s which resolved after receiving 1L IVF; he was started on heparin drip and was given 1 duoneb.  CT pulmonary Cta with left upper lobe mass, no PE, and bilateral infiltrates in lower lobes.   Hospital Course:  1. Acute respiratory insuffiencey: suspect due to COVID +/- component of bacterial PNA, possibly post obstructive PNA given newly found lung mass-like object - Switch ceftriaxone to Augmentin, continue doxycycline to complete total of 5 day course of abx therapy    2. AKI on CKD: suspect hypotension/dehydration, improved with IVF, near baseline now - Encourage oral intake  - Restarted home ARB   3. NSTEMI: suspect demand ischemia, troponin downtrending. Hx of CAD s/p stents  - Continue DAPT, BB, statin, Imdur    4. Elevated LFTs: likely related to hypotension, asymptomatic. Improving - Will defer further workup for now, though continue to monitor outpt to ensure resolution    5. HTN: pt initially hypotensive in the ED, responded to fluids  - Restarted on home antihypertensives    6. PVD - DAPT, statin   7. Hx CHB s/p PPM   8. QTC prolongation - Avoid QT prolonging meds    9. HLD - Statin   10. Lung mass: newly found, malignancy vs infectious. Will need a follow up imaging study once stable.    11. Diastolic CHF - Stable    12. Generalized weakness: suspect related to above - PT/OT   13. Hyperkalemia: mild, improved      Issues Requiring Follow Up:  - Monitor renal/hepatic function  - High risk mass referral placed for newly found mass like object in lung "
Bilateral swollen forearms, numbness on left fingers, chest tightness; seen & cleared by EMS. Due to past medical history of asbestos lungs, client instructed to go to emergency room
Second shot on 10/08/2021 caused my period to start on 10/09/2021 with heavy bleeding which lasted for one day. Had chills and shortness of breath as well. On 11/05/2021, I began to experience severe head pressure, right ear pain and the beginning of a temporal headache. I took Excedrin which always helps, but this time it did nothing for me. I went to urgent care of 11/09/2021, same day my period started. Again, my cycle does not begin the middle of the month. This is unusual for me - my cycle always starts on the 24th of each month. I was prescribed Sudafed & Afirin, which only amplified my pain. No help whatsoever. I went to the ER on 11/21/2021 (once before this date as well) but on this ER visit. they prescribed me a Toradol shot and a migraine cocktail via IV. This only subsided the pain for one day before coming back. I am stuck with a constant, 24/7 headaches in my temples + facial pain in my sinuses. This is not sinusitis. I am not congested. I believe this vaccine has given me NDPH and I will have to suffer with a headache from this vaccine I never wanted but was forced to take in order to remain employed. I cannot be the only individual complaining of constant headaches. Please do something about this.
I started to have blood coming out of my butt in the morning a week after the shot.  The blood was enough to fill up my toilet but it only happens in the morning when I first wake up.
24 hours after receiving first dose, developed pleurisy.   48 hours after receiving first dose, Er visit sharp pains right side chest upon every breath. Slept sitting up for 2 weeks.
PATIENT WAS GIVEN FLUZONE FIRST THEN THEN ENGERIX-B , WITHIN 1 MINUTE OF ENEGERIX B INJECTION PT STATED HE WAS FEELING LIGHT HEADED . HE THEN START SHOWING SIGNS OF BECOMING UNRESPONSIVE  AT WHICH TIME EMS WAS CALLED , AFTER ABOUT 2 MINUTES  HE  WAS VERBALLY UNRESPONSIVE BUT  WAS ABLE TO MOVE EYES  WHEN TALKED TO  FOR ABOUT 30 SECONDS THEN HE VOMITED . AFTER THAT HE REAGAINED  RESPONSIVNESS , PARAMEDICS ARRIVED 4 TO 5 MINUTES AFTER  BEING CALLED . AT THAT TIME  VITALS WERE GOOD AND HE VOLUNTARILY WENT WITH PARAMEDICS TO ER.  TOTAL TIME OF THIS EVENT FROM INJECTIONS TO  LEASVING WITH PARAMEDICS  WAS ABOUT 12 MINUTES
having reactivation of EBV virus after getting the vaccine; lymphadenopathy; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that:  A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included Lymphoma, stem cell transplant, Epstein Barr virus infection. The concomitant medications were not reported. The patient experienced having reactivation of ebv virus after getting the vaccine, lymphadenopathy on an unspecified date. The patient underwent lab tests and procedures in 2021 which included biopsy: questionable for lymphoma questionable for lymphoma, that is her history, and another biopsy that was not lymphoma, that is her history, and biopsy: not lymphoma, positron emission tomogram: having lymphadenopathy months after receiving the Pfizer BioNTech COVID19 vaccine and it was all over her body internally, it showed in the PET scan/and caused lymphadenopathy on a PET scan. Stated she had 3 scans in the last 6 months. They don't know what it is, she had a history of lymphoma, and they jump to that conclusion, but they were looking at the scans and suggesting they did not think biopsy as it did not look suspicious enough for lymphoma, she had no symptoms. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Shortness of breath is primary complaint,  BP = 219/91 on arrival.  Cardiology consult.  Patient admitted to critical care unit, pacemaker placed.  Patient to go home with furosemide, spironolactone, adjustments in antihypertensive meds with follow up with cardiology.
This spontaneous report as received from a consumer refers to a 65 years old female patient. The patient was vaccinated with ZOSTAVAX on 04-DEC-2012. No other co-suspects were reported. Concomitant medications included ADVAIR, SINGULAIR, paroxetine and pravastatin sodium. On 04-DEC-2012 the patient experienced itchy, warm red patch on her skin that is painful to the touch after receiving ZOSTAVAX, 1 day after onset of therapy, painful to the touch, red patch and warm. No treatment information was reported. The outcome of itchy, warm red patch on her skin that is painful to the touch after receiving ZOSTAVAX, painful to the touch, red patch and warm is unknown. The relatedness for itchy, warm red patch on her skin that is painful to the touch after receiving ZOSTAVAX, painful to the touch, red patch and warm is unknown for ZOSTAVAX. No further AE information was provided. Additional information is not expected.
54 year old patient was given Fluzone high dose / no AE; 54 year old patient was given Fluzone high dose / no AE; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 54 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number UJ288AB  and Expiry date unknown) via intramuscular route in the left deltoid On 04-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included TDAP.  It was an actual medication error case due Inappropriate age at vaccine administration and overdose.  It was reported that 54 year old patient was given Fluzone high dose.  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.
First shot didn't feel it. Second shot I have a huge welt, red arm and swollen.  Had migraine next day, low fever, nauseous.  Today, March 24, 2021, I have a bump under my left arm - swollen lymph node.  Arm is still very red. , I was very fatigue d next day.
Pt. fainted in parking lot after receiving vaccines. Drowsy, but responsive within 1-2 minutes. Returned to clinic to be seen by Dr. Pt. stated she had not eaten that day and was dizzy before coming in. She had also been having heavy menstrual bleeding due to inconsistency with taking medication.
I contracted a break through case of COVID-19. Minor symptoms began on January 3, 2022, which included a runny nose and muffled hearing (like with an ear infection). Symptoms remained very minor but then my husband tested positive on a rapid antigen test at home on January 4, 2022. I also took a rapid test that same day, which was negative. Symptoms got worse to include fatigue and increased congestion so I took a PCR test on January 5,  2022, which was negative. I then developed a cough and generalized body aches by January 7, 2022 and went for a second PCR, which then resulted positive. I spoke with my PCP via online messaging and she recommended that I get the monoclonal antibody infusion as I was still feeling poorly at day 7 of symptoms. I went for the infusion on 1/10/2022.
hips are swollen; significant aches and pain in her hips after the first dose/worsened after the 2nd dose; have to rest and painful to walk; My shoulder was hurting started in my joints; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 17Mar2021 as second dose, single for COVID-19 immunisation. The patient's medical history included underlying condition of lower back pain since unspecified years ago. She also suffered from COVID-19 from 21Dec2020 to 11Jan2021 (for 3 weeks).  The patient's concomitant medications were not reported. She had antibodies but did not know how long they would last. The patient experienced aggravated swelling and pain in her hips after the second dose on an unspecified date post vaccination. It was painful to walk, and she had to sit down a lot and rest in between. She had joints pain as additional new event after second vaccination. She had joint pain in her shoulders which she noticed when she was lifting weights. She went to a Pain specialist doctor and was prescribed Tramadol (unspecified dosage and formulation). She took the pain away only for a day but that was it. The outcome of the events was reported as unknown at the time of report.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021642671 Same reporter / drug, different patient
Anaphylaxis with swollen lips; Anaphylaxis with swollen lips; felt like throat was closing; difficulty breathing, could not take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 at 12:00 (Lot Number: ER8B2) as SINGLE DOSE for COVID-19 immunization. Medical history included possible rheumatoid arthritis from an unknown date and allergy to poultry from an unknown date. There were no concomitant medications. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 23:00, the patient experienced anaphylaxis with swollen lips and reported that he felt like his throat was closing and had difficulty breathing, could not take a deep breath. The patient went to emergency room as well as the physician office for the reported events. As therapeutic measures multiple Intravenous (IVs), oral benadryl and steroids were taken by the patient for the reported events. The outcome was reported as recovered with sequel for the reported events.
Nervous teeth  grinding condition that feels like constantly having food between the bottom two front teeth.  I am having to get a special plate for my teeth to prevent any damage to them.  Possible permanent damage as it has been 3 months since it began.
Postherpetic neuralgia of right 2nd trigeminal nerves. Symptoms unilateral sharp headache, eye pain, jaw pain, feeling of earache and mouth sores without concomitant clinical signs, neuropathy upper lip. Also had fatigue and chills. Symptoms persist over 2 months later but are less severe. Previously had herpes zoster, shingles, at age 52, 8 years prior. It also was on the right 2nd trigeminal nerve. Treated with Valacyclovir tid x 10 days. Medication lessened symptoms but did not clear them permanently.
Patient received Pfizer BioNtech  higher than authorized dose. No side effects. Patient was contacted after 3:00Hours and patient was completely fine. We called the patient again on 07/17/2021 at 12:00PM and patient was completely fine with absolutely no side effects.
Approx 24 hours after she received the IMZ she developed severe soreness and weakness and could not raise her arm above shoulder height.
This spontaneous report as received from the nurse refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinat4edd with improperly stored doses of ROTATEQ vial (oral, lot number and dose not reported). No adverse effects were reported. The outcome of improperly stored product was unknown. There was no product quality complaint involved. Upon telephonic follow up, the nurse stated that no additional information was available. This is one of the two reprots received from the same reporter. Additional information has been requested.
Received vaccine, had some discomfort at the injection site. Ringing in my ears started a few hours afterward.
I had a fever and chills after the vaccine, and it was gone the next day. On 10/08/2022 I started not feeling well with a sore throat. On 10/11/2022, I tested positive with a home test for COVID-19.  I had sore throat, fever, headache and chills. I contacted my doctor by phone, and they prescribed Paxlovid. I started taking Paxlovid, rested and try to stay hydrated.