chrisvoncsefalvay/vaers-outcomes huggingface dataset:
42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. Patient notified one of the observation nurses that he was not feeling well. The NP was assisting another patient but saw that the patient with his head back and pale. As soon as the NP was at the patient side, it was noted that the patient?s eyes were rolling back, his face was pale, and his lips were blue. The NP attempted a sternal rub with no response from patient. NP instructed police to please call Fire Rescue to transport patient to the ER. Patients left upper extremity was flexed at the elbow and stiff. At that time the patient was placed on the floor by several nurses and the paramedic and patient legs were elevated. Within 10-15 mins patient immediately sat up but was instructed to lay down. Patient was placed on 3L of O2 by nasal cannula and vitals were taken. Patient initial vitals 166/94 L Arm, 98% 3L O2, 84 Pulse and EKG was NSR. Patient no longer with pallor and lips were pink. Patient states that he isn?t feeling well and feels a nervousness throughout his body. Patient placed on stretcher in Trendelenburg. Vitals retaken, 137/97 BP, 98% 3L O2, 80 P. Patient pulses were thready and patient became diaphoretic. Fire Rescue arrive to site and transported patient to the ER. CNO and PM present during event and aware that patient transported to the ER for further evaluation
Vaccine administered 09/01/2005, for the next 3 days child ran fever up to 101.5 degrees without other symptoms.  On 09/05 developed rash - starting on chest, neck progressed over body ; itchy.
died from pneumonia even though she got her shot [Prevnar 13]; pneumonia; This is a spontaneous report from a Pfizer-sponsored program - Sept 2020 from a contactable consumer reported for a female patient (Mother). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient died from pneumonia even though she got her shot pneumococcal 13-val conj vac (dipht crm197 protein). It's been a year. The patient died on an unspecified date. It was unknown if an autopsy was performed.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Reported Cause(s) of Death: pneumonia; pneumonia even though she got her shot [Prevnar 13]
Hospitalized 11/28/2021-still admitted currently; COVID-19 positive 11/26/2021; fully vaccinated  CHIEF COMPLAINT COVID ASSESSMENT AND PLAN COVID pneumonia Acute respiratory failure with hypoxia - patient with symptoms starting around 11/20.  Progressively worsening cough and shortness of breath. Hypoxic at home to low 80s on RA. Patient is vaccinated with Moderna but has not gotten 3rd booster - requiring 2-4 L via NC - COVID positive 11/26 - CT thorax negative for PE.  Scattered bilateral ground-glass opacities consistent with COVID - started on Decadron, continue - will start remdesivir - prn supportive care - monitor on pulse ox 12/1/2021 note:  PLAN COVID pneumonia Acute respiratory failure with hypoxia - Symptom Onset: 11/20 - Vaccinated -COVID positive 11/26  - Switched to HFNC overnight. 75% FiO2 - CT thorax 11/28: negative for PE.  Scattered bilateral ground-glass opacities consistent with COVID - Decadron 6mg (11/29-11/30) Transitioned to solumedrol 40mg IV bid (12/1-present) - Remdesivir (11/29-present) plan for 5 days  - prn supportive care -Continue to trend inflammatory markers  -Check infectious workup: procal, blood cx, strep pneumonia and legionella 12/3/2021 note: PLAN COVID pneumonia Acute respiratory failure with hypoxia - Switched to HFNC overnight. 55% FiO2
This spontaneous report as received from a physician refers to a 9 month old female patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 01-JUN-2017, the patient was vaccinated with fourth dose of ROTATEQ, at 9 months of age (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis (extra dose administered). No adverse effects were reported. No PQC was involved. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6665) for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: EW0175) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: 067F21A) and on 05Jun2022 as dose 4 (booster), single (Lot number: 037A22B) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: treated with linosipril / HCTZ; "Known allergies: Sulfonamides" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "dose #1: UNKNOWN/ dose #2: Pfizer / dose #3: Moderna / dose #4: Moderna / dose #5:Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Positive, notes: lateral flow. Antigen test on 26Dec; (19Dec2022) Negative, notes: First day with negative lateral flow after the Paxlovid course was 19Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Client had been waiting in observation area about 10 mins when she alerted EMT and RN she was "feeling nausea and pressure on her head". EMT assisted client to sit on anti-gravity chair. RN alerted PHN. Upon arrival at 1400 client was being assisted by EMT  to transfer to anti-gravity chair. Client was able to transfer unassisted. Vitals at 1400: blood pressure 114/84 pulse 115, oxygen sat 97%. RN began initial assessment. Client denied chest pain, shortness of breath, dizziness, itchiness. RN provider client with emesis bad and Capri-Sun juice upon client's request. At 1403 pulse 74. Client stated no chronic conditions, had recently been diagnosed with high cholesterol, no current medications and no known allergies. Vitals at 1405: blood pressure 113/81, pulse 72, oxygen sat 97%. Client reported headache pain 3/10 and nausea was improving. PHN  asked if client she had driven, client responded she would call husband to pick her up since she was her kids with her. Vitals at 1410: blood pressure: 115/73, pulse 73, oxygen sat 98%. Per client headache the same, pain 3/10, nausea improving, "almost gone" and that she was "feeling hot". PHN  assessed for rash, noted face was flushed. Client denied feeling itchiness, shortness or breath or warmth feeling throughout body. PHN offered client Bendaryl with precautions about possible side effect of drowsiness. Client declined at this time, would like to continue observation to see for improvement. At 1419 RN provided client ice pack. Vitals at 1420: blood pressure: 117/86, pulse 75, oxygen sat 98%. Client reported headache 2/10, nausea had resoved, warmth feeling to face improving. Client asked if she could self medicate once she got home. PHN advised client to not self medicate, to seek medical care if symptoms return or worsen and gave ER precautions. At 1431 client stated "feeling fine to drive and go home". Per client, "feeling better and no new symptoms". At 1432 client stood up unassisted and walked with no concerns. Client left facility with steady gait at 1439.
THE DAY AFTER THE SHOT WAS ADMINISTERED THE PATIENT DEVELOPED A SMALL RED SORE JUST ABOVE THE CREASE OF HER ELBOW
TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 11-Apr-2023 at 10:11 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Apr-2023 at 10:11 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (TE-00023958 in response to clarification regarding temperature excursion where liquid vaccine was exposed to temperatures greater than 46F for greater than 24 hours) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications was provided. No treatment medications was provided. Product temperature excursion issue was happened on 9-APR-2023.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2023: Live non significant follow up
chills, fever, sweating, loss of appetite, soreness, swelling at injection site, itching
Patient on intake lied about not receiving a prior dose.  He received a JJ vaccination, and when we went to hand him his card, he refused the card saying he already had one.  Client was AOx4 during time of intake.  Refused to provide address or contact number.
Patient stated after receiving vaccine he left store, walked across the street and felt back pain, neurological symptoms resulting in feeling unable to remain standing.  Patient felt light-headed.  Ambulance was called to the scene.  Patient stated he felt ill for about 10 to 15 minutes.  When ambulance arrived they check all vitals and all were within normal range.  BP was 150/75 per patient at initial check.
Day of vaccine generalized bodybaches. Did not take any Tylenol or Ibuprofen. Next day felt with increased body aches. Reported to work at 0805am. At 10am face turned completely red z& felt flushed. Left work due to not feeling well and on way to pharmacy to get Benadryl. Pharmacy directly next door to place of work. Arrived & unable to get out of car due to feeling extremely nauseous, dizziness and felt was going to passout. Needed to call 911. Taken to ER FOR CODE HEART AND STROKE due to hypotension and decreased LOC. complete work up done. DC home to follow up with Neurology
1 of 2 pts who was vaxed from the same vial & had adverse event; pt devel inject site reaction consisting of erythema, induration, tenderness & fever 102; treatment included APAP & warm compresses; not seen by MD;
Pfizer Covid-19 booster, administered shortly after 10:00am on 11/8/2021. At 1:43am on 11/9 awoke to extreme chills, could not control with additional blankets. Shortly thereafter, shivers began, that turned into shakes, that turned into quakes. Could not stand, could not walk, could not open door. Had to cling to the wall with wife's help to make it to the bathroom to urinate. Could not draw cup of water to drink. Could not hold cup to mouth without wife's help. Quaking came in waves for approximately 5 hours, then slowly subsided to shakes, then back to shivering. On 11/10, had extreme difficulty with body temperature - fever up to 102 degrees, mixed with chills. Severe headaches, severe joint pain, sever muscle aches (Could be due to efforts to minimize quaking symptoms). Imagine having chills, them magnify them by perhaps 500%. Wife considered calling 911 but I didn't find anything life-threatening. Spent 11/9 dozing. Ate minimal food, sits like a lump in my stomach. Fever has abated as of today, but lethargy persists. Headache persists. Joint pain persists.
Pfizer monovalent vaccine was given to patient instead of ordered Pfizer bivalent vaccine.  Patient contacted and notified of error, advised they should receive bivalent booster 2 months after the incorrect monovalent dose.  PCP notified of error.  No signs or symptoms of adverse reaction reported by patient.
red blotchy rash below injection site.  Showed up the day after the injection, No heat or itching. Rash is still present but does not seem to be spreading, will keep an eye on it.
Pain in left shoulder much pain at top-down arm into hand. Couldn't raise arm, can't sleep on left side, it's been over 2 years. Can't lift much still much pain. Now into 3 yrs. 11/6/17 my intent was the pain and disability of this shoulder and arm would go away. I've been to 3 doctors. Can't help. Said perhaps it would go away in 2 yrs or so. Am now in 3rd year. Am awakened at night from pain in left shoulder, arm, and hand. I should have reported it much sooner. The shot was given very high up in left arm. Perhaps in bursa sac or deltoid tissue. Whatever it certainly disabled my arm for good. Hope you can compensate me for not only disability but pain and suffering I'm still having.
Extreme nausea and vomiting. Barely able to keep water down yesterday. Doing a little better today.
Had a fever of 103 starting 12/15/21 lasting 12/18/21, experiencing muscle aches, loss of appetite, sever congestion and cough that is still present 12/20/21
Information has been received from a healthcare worker concerning a 19 year old female with no pertinent medical history, who in April 2008, was vaccinated with her first dose of GARDASIL vaccine (yeast) (dose and site not reported). In 2008 the patient developed a small raised fibrotic scar tissue near the injection site after receiving her first and only dose of GARDASIL vaccine (yeast). The patient sought medical attention by seeing the physician in the office. As of 07-AUG-2008, the fibrotic scar tissue persisted. Additional information has been requested.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 65 year female patient who received 0.5 mL an expired dose of FLUZONE HIGH DOSE (batch number UI840AC, expiry date 06-APR-2018) in left deltoid on 27 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error as expired vaccine used. No known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.
Due to fluttering heart, I had difficulty sleeping between the hours of 1:00 a.m. and 5:00 a.m. on Aug 26 and Augt 27.   On morning of Aug.  29 around 11am, I notice numbness in the 4th finger on my right hand. Today, I still have numbness and notice a bit of swelling but no discoloration.  In general, my heart pace seemed high and overall fatigue for the initial 2 weeks following the vaccination. So much fatigue, I couldn't properly mow my lawn on Sept. 5.   Feeling great fatigue and concerned about my heart on Sept. 5, I schedule an appointment with a community doctor on Sept. 9.
LOST COMPLETE SENSE OF SMELL AFTER VACCINE AND STILL HAS NOT RETURNED
For more than a week the case has had trouble breathing more than normal, congestion, and coughing.
headache; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 84 year-old patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 20Oct2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Left Deltoid, EN9581), administration date: 09Feb2021, for Covid-19 immunization; Bnt162b2 (Dose 2, Left Deltoid, EN6200), administration date: 02Mar2021, for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness.  No follow-up attempts are possible. No further information is expected.
On 2/27 patient presented with numbness to face and was seen at the hospital. Thought to have been a stroke but Dr at the hospital thought Bell's Palsy from the COVID-19 Vaccine. Patient states it is getting better
First vaccination 3/16/21 (EN6203): Very slight headache the evening after the injection, faded away without any pain meds.Second vaccination 4/6/21 (ER8733): Headache and general flu symptoms with low grade fever began the evening after the first vaccination. Fever and general malaise faded away over two to three days, the headache persisted for one week. Began to feel shortness of breath within two to three days after second injection. Shortness of breath has continued. When resting it is only slightly noticeable. When attempting to do any physical activities to include walking up or down stairs, carrying packages, or any physical exertion it has gotten continuously more noticeable. It got to the point where I felt like I was gasping for breath on Monday 10/11/21, when I assisted a friend lifting a dishwasher. I have always been physically fit, a runner, and continuous exercise all my life, and now am becoming concerned about my health conditions. I did not feel shortness of breath prior to receiving the vaccination. I reported this to my doctor,on 13 September. No action was taken.
pt recv 20FEB98 & 23FEB98 pt exp a local rxn described as a 12x6 in raised area that was hot & tender to touch swollen & there was a blister over the site of inj;
(L) upper thigh swollen - hard area at inj. site. Infant cries when (L) leg extended and limits her own movement of the limb.
Large local reaction and hives occurring few hours after vaccine. Hives noted on neck, forearm and legs. States had 2 or 3 in each area. Felt lightheaded and feverish for 3 hours post vaccine.
Beginning 6 hours after injection and continuing for 4 days (so far): Headache Body aches Exhaustion Easily out of breath Swollen lymph nodes (tender and very swollen over left collar bone)
PATIENT CALLED AND STATED THAT AFTER HER TDAP THAT HER ARM WAS SWOLLEN, RED, RASHY AND WARM TO INJECTION SITE.  PT ALSO STATED THAT SHE HAD A LOW GRADE TEMP AND WAS VERY TIRED.
Patient received Td injection on 06/14/06 and came back to doctor's office on 06/16/06 with red and raised "egg sized" local reaction, warm to touch but not tender.
For about 15 minutes, I had the following symptoms: a. Difficulty breaking b. dizziness c. weakness  After 15 minutes and for the next 24 hours, I felt tired and sick.
pneumonia; pneumonia; COPD; emphysema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 60-year-old male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization, medically significant) with onset 2022, outcome "unknown", described as "COPD"; EMPHYSEMA (hospitalization, medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "pneumonia". The patient was hospitalized for chronic obstructive pulmonary disease, emphysema, drug ineffective, pneumonia (start date: 2022). Therapeutic measures were taken as a result of chronic obstructive pulmonary disease, emphysema, drug ineffective, pneumonia. A year ago he was in the hospital on a ventilator with COPD, pneumonia and emphysema." The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
running a temperature; 1.5 mL booster administered; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running a temperature) and ACCIDENTAL OVERDOSE (1.5 mL booster administered) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06AH21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1.5 milliliter. On 10-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (1.5 mL booster administered). On an unknown date, the patient experienced PYREXIA (running a temperature). On 10-Jan-2022, ACCIDENTAL OVERDOSE (1.5 mL booster administered) had resolved. At the time of the report, PYREXIA (running a temperature) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: high (High) Running a temperature.         No concomitant medications were reported No treatment medications were reported
Acute Idiopathic Thrombocytopenic Purpura -food sensitivities. Petechiae on legs and face, supportive measures and observe for Sx of high fevers and pt being ill. Sx comes and goes. Ongoing.
Patient had vasovagal response post injections while walking out of clinic. Patient was found on the floor conscious, alert and oriented x3. Stable VS: BP 110/72, P 88, R 12. Patient waited to feel completely better before leaving office. Had no questions, was instructed to call with any concerns.
Storage unit did not record temperature of vaccine. Could not verify for a period of time, vaccine may have been ineffective; No treatment or adverse reaction.