chrisvoncsefalvay/vaers-outcomes huggingface dataset:
collapses during game from heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp via social media.  This case involves a 28 years old male patient who had collapses during game from heart attack while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, frequency, formulation, lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient had collapses during game from heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses during game from heart attack).  At time of reporting, the outcome was Unknown for the event collapses during game from heart attack.; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves 28 years old male had myocardial infarction with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies, lifestyle/dietary history/habits, pre-existing risk factors and clinical course details would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Breakthrough case admission after 4 vaccines Moderna 3/16/21 lot# 045A21A;  Moderna 4/13/21 lot# 016B21A;  Moderna 11/19/21 lot# 039F21A;  Pfizer 6/3/22 Lot# FM755
lymph nodes in arm & neck very swollen & extremely tender;muscles in arm are very sore;pain wakes pt @ noc;no fever;
Given DTaP and Hib on 6-26-14 -> hives? Red spots on legs and some around mouth. Ate yogurt without berries? Hx milk allergy. Advised BENADRYL 2.5 ml q 6 hrs prn.
shingles; Information has been received regarding a case in litigation. It referred to a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On an unknown date in 2009, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).         Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles (herpes zoster) and was hospitalized due to it (dates not reported). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
It started with a sore throat that didn't go away, then went to my head then my right ear. I was achy and kept a headache the whole time. I had chills, cough and little congestion. I felt rundown like I wanted to lay around and do nothing. The symptoms fluctuated in severity some days they were 7 and others a nagging 5. I was told to take OTC on the 7th and I was told it was RSV. When it didn't go away I tested for COVID-19 and it was positive. I was given a Z-PAK. I'm not testing positive now but still feel rundown and sometimes still feel it in my chest and throat.
Pt noticed discoloration/mottled appearance of skin near joints on lower extremities. Adverse event lasted less than 36 hours and resolved without treatment.
PATIENT COMPLAINED OF FEELING FAINT. DRANK WATER. PATIENT LAYED DOWN ON COT WITH FEET ELEVATED AND OBSERVED.
felt a surge of anger; overwhelming feeling; became very emotional.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in left arm on 30Apr2021 at 14:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), pregabalin (LYRICA), naproxen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and multi city (MANUFACTURER UNKNOWN)) all for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021 at 15:30, an hour and a half after receiving the vaccine the patient felt a surge of anger, overwhelming feeling and became very emotional. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt a surge of anger, overwhelming feeling and became very emotional was recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
pt  went home 15 min after immunization and then went to drive home and developed throat tightening, she and soa, this happened twice , pt went to the hospital ER for treatment
Back pain and Spasm; Back pain and spasm; This is a spontaneous report. A contactable male consumer (patient). A male patient of unspecified age received second dose of  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 26Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history included that the patient had received the fist dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection as a single dose for COVID-19 immunisation. The patient's concomitant medications was not reported. The patient experienced back pain and spasm. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Two sets of reactions: 1st - couple days after 3/15-3/17 arm pain at injection site and mild headache  2nd on 3/20- noticeable swelling, hard bump, large red circle around injection site, itching, slight pain
weakness  Narrative:  96 y/o male received 2nd COVID 19 (Moderna) shot on 03/11/21 @1700. Tolerated first COVID 19 vaccine shot with no issues. History of afib, CKD, basal cell carcinoma of neck and ear, squamous cell carcinoma, valvular heart disease, coronary arteriosclerosis, pacemaker, hypertension, aortic valve stenosis s/p aortic valve replacement. No prior ADR to vaccine or severe allergy to medications. Brought in by ambulance to outside hospital after being found on the floor by neighbor on 03/13/21; may have been down for up to 24 hours. Patient reported feeling woozy the day prior and very weak. Currently being treated for pneumonia. Had elevated troponin likely secondary to prolonged downtime and thabdomyolysis, but cannot r/0 NSTEMI. Currently still hospitalized today 03/15/21.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 30-APR-2014, the patient received an expired dose of PNEUMOVAX 23 injection, 0.5 ml, intramuscular (batch number J006082, lot # 0744AE, expiration date 12-APR-2014). No adverse effect reported. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-JAN-2009, the patient received improperly stored VARIVAX dose 2, from lot # 661445/0525X, expiry date 27-MAR-2010 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Mother noted initial blood in stool with diaper change on 10/22 at 11 am.  Spoke with triage nurse and appointment the same day.  Did not come to appointment.  Called again 10/27/09 with continued complaint of blood in stools. Was seen by physician 10/27/09 and had positive hemocult stool with suspected anal fissure and instructed to use vaseline with diaper changes.  Physician spoke with mother on 11/2/09 to notify her that stool culture was negative.  Mother reported no further blood in stool at that time.
Approximately 1 hour after the patient received injection began having mild hiving down left arm (arm in which he received the H1N1 vaccine).  Hiving and itching became generalized over the next hour and 1/2.  (Pt is a police officer wearing kevlar vest.)  He reported off duty and took 50mg diphenhydramine with rapid relief.
First day: Swollen painful injection site. Fever, back and sternum pain. Just feeling awful. 2nd day early morning: swollen upper lip back and sternum pain.
Patient reports she received the Covid-19 vaccine at 0835. She reports at 0905  symptoms of tingling at the tip of the tongue. No other symptoms, no respiratory distress. SP02 = 99%, P = 75, B/P = 141//85.   0910, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 =100%, P = 72, B/P = 132/88. Rapid response team called.   At 0915, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 = 100%, P = 74, B/P = 130/83.   At 0920 Rapid Response Team arrived. Care of pt. transferred to RRT. RRT talking with pt. regarding transfer to ED vs. discharge home Patient reports she received the Covid-19 vaccine at 0835. She reports at 0905  symptoms of tingling at the tip of the tongue. No other symptoms, no respiratory distress. SP02 = 99%, P = 75, B/P = 141//85.   0910, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 =100%, P = 72, B/P = 132/88. Rapid response team called.   At 0915, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 = 100%, P = 74, B/P = 130/83.   At 0920 Rapid Response Team arrived. Care of pt. transferred to RRT. RRT talking with pt. regarding transfer to ED vs. discharge home
pt recv vax 16MAY96 & pt exp a red morbilliform rash that appeared purplish on top all over body & erythema multiforme;20MAY96 pt exp fever of 101 which later inc to 103;22MAY96 pt presented to MD;
Pt presented to the ED with Fever, sore throat, dizziness and Syncope/Fall.  Covid19 detected.
Headache, Myalgia, Arthralgia, Fever, CHILLS Narrative: SIDE EFFECT LASTED 5 DAYS.
Child vaccinated with MMR, Varivax on 3/20/04. Presented on 4/2/04 with fever to 100.7, irritability, poor po intake and rashx 3 days. Rash firm maculo-papular, erythematous, started on face, spread down and bilat. o. Medial tonsilitis. Rx: benadryl, Omnicef, Motrin.
17 year old male inadvertently given moderna Covid 19 vaccine 2nd dose after receiving Pfizer for 1st dose.
severe headache, fatigue, uncontrolled shaking (separate from the chills),nausea, severe vomiting, severe diarrhea, severe abdominal and muscle/joint pain, fever, chills and loss of taste (but not smell). This last symptom is what prompted her to retest for covid (came back  negative). Symptoms lasted 4  days total.
Fever; body ache; Miserable; Tired; This is a spontaneous report from a contactable consumer. This consumer reported same events for 2 patients. This is 2nd of 2 report. A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had fever, body ache, couldn't even lay in bed, the patient was miserable. The patient was tired. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044957 same reporter/drug/event, different patient.
Child complained of dizziness. Looked pale. No respiratory distresses observed or reported by patient. No hives were noted. Heart rate 150/mt of 70/62. Event lasted 1-2 minutes. Child was positioned with head down between legs. Family reported child had not eaten since the night before. Crackers and juice given. Observation before discharge.
Received my first pneumonia 13 vaccine last year without any major reaction then just got the 2nd vaccine this year....PNEUMOVAX 23 became very tender after several hours swelling far beyond injection sight..bicep area began pain and swelling that night now 2 days later... area from above elbow around bicep and deltoid of arm looks to have "sunburn" very warm and arm muscles still swollen/painful to touch. Intermittent low grade fever 99-100.8. Normal this morning been treating with 3 ibuprofen 200 mg and icing bicep/deltoid. Looking at reviews appears will just have to wait it out.
administration of daptacel past the expiration date with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA213495, 2023SA213561, 2023SA214713, 2023SA213484, 2023SA214480 and 2023SA214127.  This case involves 4 years old and unknown gender patient who had administration of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] past the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (VERO) (IPOL [polio vaccine inact 3v (vero)]) for immunisation; measles vaccine, mumps vaccine, rubella vaccine (MMR) for immunisation; and varicella zoster vaccine live (OKA/MERCK) (Varivax [varicella zoster vaccine live (OKA/MERCK)]) for Immunisation.  On 07-Jun-2023, the patient received a standard dose 5 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 mL (lot C5829AA; Expiry date: 03-Jan-2023) via intramuscular route in unknown administration site for Immunization, past the expiration date with no reported adverse event (expired product administered) (same day latency). Caller is looking for re-vaccination information  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
18 y/o F with no known prior medical conditions or NKDA presented for her first dose of Pfizer vaccine. 7-min post vaccination the patient began to feel dizzy and light-headed. The patient experienced a syncopal event resulting in an assisted fall from chair.  The fall was atraumatic and the patient instantly regained consciousness. Patient was alert and oriented x3, and rapidly improved back to her baseline. Patient denied any SOB, difficulty breathing, throat swelling, itching, or HA. Parental guardian was advised to keep patient hydrated and educated on any signs or symptoms that would warrant urgent care.
sudden onset loss of vision in left eye, optic neuritis diagnosis 12/31/07-records received for DOS 7/16-7/17/07-DC DX: Papillitis.Decreased visual acuity. Presented to ED with 3 day C/O blurry vision, seeing gray in left eye in upper lateral eye fields along with pain with movment of left eye. On vacation at time of onset, camping. also has sick contacts, sister who has blurry vision and is taking antibiotics and steroids. Per 60 day follow up: Continued loss of vision in partial area of left eye. 1/21/2010 Still has some loss of vision in affected eye.
Received 4doses of Pfizer BioNtech Covid-19 vaccine before, now Has Covid; Received 4doses of Pfizer BioNtech Covid-19 vaccine before, now Has Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received 4doses of Pfizer BioNtech Covid-19 vaccine before, now Has Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Received 4 doses of Pfizer BioNtech Covid-19 vaccine before, now Has Covid. Caller also misses doses from Paxlovid packs. States he took the Paxlovid treatment since saturday 03Dec2022 and took the last remaining dose this AM 07Dec2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Extreme flushing and fatigue, nausea, cough, headache, brain fog, burning sensation in both lungs. The fatigue and nausea still present one week after vaccination.
pain which did hurt for few days; round red marks on their arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN and ERYTHEMA 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN and ERYTHEMA. At the time of the report, PAIN and ERYTHEMA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided. No concomitant medication was provided.
Significant rash on left arm. It's warm to the touch and a little tender. Noticed it today but could have been there yesterday and I didn't see it.
pt began to feel weak & dizzy & chills-flu like sx-achiness throughout body;nl body temp;vomit,diarrhea,t103 & soreness of the arm & inj site
Aching; Muscle Cramps in Left Arm; Soreness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via unspecified route of administration in left arm on 19Feb2021 at 23:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation and also received second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via unspecified route of administration in left arm on 14Mar2021 at 12:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient medical history included ascending aortic aneurism, high blood pressure and high cholesterol. The concomitant medications included metoprolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) for an unknown indication. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Feb2021, the patient experienced soreness, aching, muscle cramps in left arm. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events soreness, aching, muscle Cramps in left arm were not recovered at the time of the report.    No follow-up attempts are needed. No further information is expected.
Within 20 minutes Pt reported difficulty breathing, mild facial swelling, drooling, wheezing.  09/19/2007  MR received for hospital DOS 8/20-21/2007 for DX of Anaphylactic reaction.  Approximately 10 minutes s/p vax pt developed sneezing, red eyes, swollen lips drooling, sore throat and difficulty breathing. TX on site with albuterol, Bendaryl IM, and O2 and transfered to ER. PE significant for scattered expiratory rhonchi, facial edema, mildly injected sclera. Epi SQ and Decadron po given. Observed O/N. D/C improved.
12/17/2022 late in the evening I started with a sore throat. 12/18 congestion got worse, sore throat persisted. 12/19 congestion got worse and all others consistent. 12/20 continued symptoms with nasal drainage. Tested positive with at home COVID-19 test. Telehealth with doctor who prescribed PAXLOVID and to treat symptomatically. By 12/21 evening of feeling better with symptoms slightly diminished. By the evening of 12/22 symptoms substantially diminished but fatigue remained. All symptoms but fatigue resolved by 12/24. Feeling recovered by 12/28/2022.
Pt was seen on 1-17-12 two vaccines were administered. Pt came back next day 1-18-12 with cellulitis (R) deltoid. He was treated Amoxicillin 400mg was prescribed a pt  f/u appt was made for 1-25-12 and cellulitis was resolved.
muscle aches, fatigue, headache, low grade fever, joint pain, shakiness. Symptoms started with a headache at 2am on 5/2, grew steadily worse throughout the night/day, but only lasted until about 4pm on 5/2. Tylenol helped alleviate symptoms.