chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 67 year old female patient who on 06-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662841/0626Y) SC, right arm. Concomitant therapy included FLUZONE. The nurse stated that on 08-OCT-2009 the patient's right arm was red, warm at touch and swollen at injection site. Patient was instructed to apply a cold pack, and took BENADRYL (dose and duration not reported). Unspecified medical attention was sought. At the time of this report the patient had recovered. Additional information is not expected.
Body aches; chills; fatigue; sore arm lasting 48 hours post vaccination.  Resolved with Acetaminophen
Received H1N1 nasal mist on Tuesday 11-17 after school. C/o stomach upset at approx midnight that night. Began vomiting at approx 3:30 am. Continued c/o stomach cramps and vomiting until approx 6:00 pm on Nov. 18 ran fever of approx 100.6 throughout the same time frame.
patient request bivalent covid vaccine, but in error, received monovalent pfizer covid expired 9.22.2022
developed swelling, redness and pain at injection site - inner biceps of the left arm; developed swelling, redness and pain at injection site - inner biceps of the left arm; developed swelling, redness and pain at injection site - inner biceps of the left arm; This spontaneous report was received from a licensed practical nurse and refers to a 69 years old male patient of unknown race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.   On 04-JUN-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 0.5 mL, intramuscular in left deltoid, lot number R025296 with expiration date on 08-JUN-2020 (frequency was not reported) for prophylaxis.   On 05-JUN-2019, the patient developed swelling, redness and pain at the injection site-inner biceps of the left arm. That was stated by the patient on 06-JUN-2019, in a visit to the office to sought medical attention for the adverse event. The patient also received treatment for the adverse event, but it was unknown if laboratory diagnostics or other studies were performed for the even. At the moment of this report the patient was recovering from swelling, redness and pain at the injection site (reported as swelling on the site was reduce).     The relatedness between the events occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) administration was not reported.
Area of injection red and quite swollen - thigh noticeably larger than other leg. Next day vomited twice.  Rash around mouth.
pt was seen for the 1st 6month visit in ofc on exam MD noted some eczema on scalp; pt given vax & w/in 24 hr period 18APR 1230PM pt was fussy-crying spells w/t101; 18-19APR rash on face, arms & trunk w/itching;
This spontaneous report was received from a registered nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 25-JAN-2017, the patient was vaccinated with an improperly stored doses of ZOSTAVAX injection (lot# M015926 expiration date 28-JUN-2017) for prophylaxis (strength, dose and route were not provided). The vaccines were exposed to a temperature excursion between 14 Fahrenheit degrees and 46 Fahrenheit degrees for 3 hours. Prior temperature excursion was registered on an unspecified date, between 5 Fahrenheit degrees and 14 Fahrenheit degrees for 25 minutes. The call was placed because of a Digital data logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000264:
Patient became nauseated with HA after vaccine and continue to have nausea also site is sore with a 10 mm induration noted.
He is currently having a medical issue.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He is currently having a medical issue.) in a male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (He is currently having a medical issue.). At the time of the report, VACCINATION COMPLICATION (He is currently having a medical issue.) outcome was unknown. Not Provided          No Concomitant medication information was reported. No Treatment medications were provided.
hospitalization  due to symptomatic COVID-19 after 2 doses of Moderna vaccine 1/24/22: symptoms started 1/28/22: pt presents to ED with SOB, cough and tests Positive for COVID-19 Imaging: CTPA: no pulmonary embolism, atelectasis involving right middle lobe, diffuse emphysematous changes of lungs Oxygen requirements on admission: 4LNC Current oxygen requirements: 2-3LNC. Baseline 3LNC CRP 28, PCT normal Medical therapy: steroids Consultants following: none Anticipated special isolation end date: 2/3/22 2/1/22: discharged to home
patient presented with abdominal pain which started on 4/13, resent the ER 4/15.CT of the abdomen and pelvis was performed and showed a right hepatic lobe infarction. additional findings included beaded appearance of the SMA, proximal celiac artery and hepatic artery concerning for vasculitis. patient also had a pseudoaneurysm present which was embolized by IR via coiling. patient became hypotensive on day 6 of admission was found to have a large expanding hepatic hematoma which required multiple embolizations. Majority of the liver tissue required embolization to improve the hemorrhage. patient is now listed for a potential emergent liver transplant.
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe
Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and hand.  No treatment prescribed.
Muscle aches on legs and lower bag that will not resolve even after 2 weeks.  Also hot flash and sweating and pain in Liver.
severe headaches, migraines, tinniuts, ear pressure/pain, eye twitching, insommia, numbness tingling arms at night
Narrative: COVID infection following COVID vaccine series 03/16, Pfizer, dose #1 04/08, Pfizer, dose #2 09/05 pt cc: exposure: unknown 09/1 pt admit to ED cc: cold symptoms dx: COVID 19 LOS: 1 day 09/13 COVID swab, result: detected 09/13 SARS-COV-2 Variant Sequencing result: pending 09/13 COVID-19 ANTIGEN BINAX: NOT detected 09/13 CXR impression: FINDINGS AND IMPRESSION: Support devices: None identified Mediastinum: Normal cardiac size. No central pulmonary vascular enlargement. Lungs and pleura: No dense consolidation or pleural effusion is identified. Bones; Within normal limits 09/16 clinically resolved
Redness swelling at site & over upper arm warm. No treatment needed. Some fever 1st day none 2nd day.
Vomiting Asthma and trouble breathing Chest pains Severe back pain Severe head ache  Er visit 5/9/2021
24OCT92 pt recvd 1st dose of Engerix B & 27OCT92 found w/ antigenemia & hyperbilirubinemia; day 4 in hosp mom serum was neg for HBSAG;
soreness itchiness redness x 9 days swollen headaches axillary pain/ swelling
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 8 months old patient and reported if a second dose of FLUZONE QD pediatric dose was given early, is it safe to use a third dose from the 20 day lot, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of 0.25 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date and route was not reported) in the left thigh. It was a case of actual medication error due to inappropriate schedule of product administration. It was unknown if the patient had any adverse 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 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. List of documents held by sender: none.
inflammatory autoimmune disease known as demyelinating neuropathy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001252 (Novavax).  A 78-year-old female patient received bnt162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 2022, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "inflammatory autoimmune disease known as demyelinating neuropathy". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and absence of factors which may provide an alternative cause, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported event neuropathy peripheral. 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.
Information regarding PREVNAR 13 was received from a consumer regarding an 18 month old male patient who experienced warm with a fever to the touch, a little swelling at the injection site, did not want to walk, crying, second dose of PREVNAR 13 given 4 weeks too early and pain/tenderness/soreness at the injection site. At 18 months of age, the patient received the second dose on 21 Sep 2010. On 21 Sep 2010 the patient experienced warm with a fever to the touch, a little swelling at the injection site, second dose of PREVNAR 13 given 4 weeks too early, crying and pain/tenderness/soreness at the injection site. The patient did not want to walk and laid on a pillow on the floor for a couple of hours and later he was walking some. Although the patient's temperature was not taken, the fever was treated with TYLENOL. On 22 Sep 2010 the outcome of the events was unknown since the child had not yet awoken at the time the reporter called. See related case(s): US WYE H17733710 (adverse event, non expedited). No additional information was available at the time of this report.
This spontaneous report was received from a pharmacist refers to a 64 years old female patient. The patient's medical history included hypertension. The patient was vaccinated intramuscularly in left arm, with an expired 0.5 ml dose of PNEUMOVAX 23, (lot # 667912/0933Z, expired date 25-FEB-2012) on 14-JUL-2012. Concomitant medications included: digoxin. Any adverse effects reported. Additional information has been requested,
This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 74-year-old male patient who received INFANRIX (batch number 2J534, expiry date 13th September 2015). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered, wrong vaccine administered and underdose. On an unknown date, the outcome of the wrong vaccine administered, wrong vaccine administered and underdose were unknown. Additional information received: 74 years old male patient received a dose of INFANRIX instead of the intended BOOSTRIX.
Extreme pain in left arm and left side, sharp pains in left arm and left side. Difficulty breathing, dizzyness,  fluttering pulse. Extreme muscle pain was originally localized to injection site but within 5 days affects my entire left side especially my arm and leg. Nausea has been ongoing since I received the vaccine
vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) outcome was unknown.            Concomitant medication under use was said to be Antihypertensive. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-046323 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046323:1st Dose
Our vaccinating pharmacy technician accidentally administered a fluzone high dose flu shot to a 59 year old patient at an off-site vaccine clinic.  I am submitting this report to document the incident. The patient has not reported any adverse events. I contacted the assisted living facility where we were when the vaccine was administered to inform them of the error since the patient has memory problems.
miscarriage 21NOV92 pt was 2-3 wks along @ tim eof immun; 2nd Recombivax 10NOV92 1st immun was 30SEp92 & thought the 2 inject may have caused th miscarriage;
Missed menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Sep2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 14Sep2021 the patient experienced missed menstrual cycle. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event missed menstrual cycle was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Approximately one month after first shot experienced itchy hands and feet in the morning.  Also at times hands would go red and itch - no blisters or other artifacts.  Eating cold foods make mouth swell and itch.  Other parts of body itch with no outward appearance  of redness etc.   Issue happens at random times no know other cause.  No other health conditions.    Obtained second dose 4/20/21 Lot Number 039B21A.  Itching redness issue no change to date after second dose.  Unknown if issue related to vaccine.  Only significant event was the vaccine shot.  Have not seeked medical treatment.  If issue persists or gets worse will seek medical advise.
I was sitting at work, got really bad chest pain, became dizzy, and then blacked out. According to coworkers I was unresponsive and was having tremors. This lasted a few minutes. I was taken to the ER where they drew labs, did an EKG and CXR. They also gave me 2 liters of normal saline through an IV. I eventually started feeling better but have continued to have intermittent dizzy spells since then.
This spontaneous case reported by a consumer, describes the occurrence of exposure to SARS-CoV-2 (exposed to COVID-19 on the second vaccination day/no symptoms yet) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 003B21A and 031B21A) for COVID-19 immunization. Concurrent medical conditions included COPD and heart disease (unspecified). On Apr 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 7, 2021, patient experienced exposure to SARS-CoV-2 (exposed to COVID-19 on the second vaccination day/no symptoms yet). At the time of the report, exposure to SARS-CoV-2 (exposed to COVID-19 on the second vaccination day/no symptoms yet) resolved. Patient in a state of panic following exposure to COVID-19 positive driver on the day she received the second dose of vaccine. This case linked to MOD-2021-116721 (patient link). Most recent follow-up information incorporated: On Jun 17, 2021: Follow-up received Jun 17, 2021; no new information recorded.
dizziness, woozy,  feeling faint, loss of balance/equalibrium, tired, unsteady
Pins and needles in all finger tips,  both hands. Recovered in about 1 hour following a nap
Patient called Friday am saying he developed a raised rash at injection site. 1-2 days after receiving inj. Patient will call his physician and seek medical attention; per phone call with patient. Have not heard frm patient since.
This is an instance of breakthrough COVID-19 after which death occurred. The Individual was vaccinated with the Moderna Product on 01/28/2021, 02/25/2021, and 11/03/2022. The individual was admitted to a hospice facility on 08/24/2022 because of a diagnosis of mesothelioma. They tested positive for COVID-19 on 09/09/2022. It is not known if the individual was having symptoms of COVID-19--they were a poor historian due to their overall poor health. The individual remained in the hospice facility until their death on 10/06/2022.
I experienced tremendous pain and swelling and had terrible itching on my arm with redness, hardness of my arm. That was pretty much killed for me on getting any future COVID-19 vaccinations. I was taking antihistamines to help with the itching in my arm. It lasted about a week and the fatigue is still a factor. I did not see a doctor for this.
Hypoxia readmission 1 hour after discharge from initial admission for seizure, hyperglycemia, and trach procedure
L thigh injection given. Site remains localized erythematous on 1/3/2000 with vesicle formation c/w varicella.
Tues 13 DEC PM - Fatigue, muscle and headaches, late PM fever 102 deg. Wed 14 DEC AM - 102 deg. fever, nausea, sore throat, fatigue, dizzy, muscle and headaches, and PM vomiting, sweats and chills. Thu 15 DEC AM - nausea, sweats and chills, sore throat, fatigue, dizzy, muscle and headaches. Early PM temp 98.6 Fri 16 DEC - fatigue, dizzy, muscle and headaches. Treated with OTC medications 3 days of work lost.
This study case was received from the investigator in a trial on 15 October 2013. A 19-year-old male subject with no reported past medical history had received on 19 July 2010 the following vaccines: ACAM2000 (lot number, route and site not reported) and anthrax (manufacturer, lot number, route and site of administration not reported) and seven days later on 26 July 2010 was found to have an elevated Troponin I level of 0.11 ng/ml. On 02 August 2010 was subject was found to have a Troponin I level of 0.13 ng/ml and a normal ECG. The subject had no cardiac symptoms. The subject had no concomitant medications. According to the investigator, the subject was unable to be reached for further follow-up but was referred appropriately. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of elevated Troponin was considered an other important event and definitely related to vaccination. Per the investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Arthralgia, NauseaVomiting, fatigue, chills, red swollen warm injection site Narrative:
The pt developed neck pain, over all joint pain, wrist pain, weakness in limbs, numbness, problems chewing, hip pain, vision problems, hearing problems and memory problems. Annual follow up information states patient still continues to have pains and aches in wrists, neck, hips, shoulders, arms and jaw.
Temp 101, headache, fatigue. Notified primary MD. Advised Tylenol, rest, fluids, symptomatic treatment. Symptoms resolved in 24 hours.
Headache; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 11:45 as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies to medications, food, or other products. Concomitant medication was reported as yes (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 09:00, the patient experienced headache and nausea. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache and nausea were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient presented to the ED and was subsequently hospitalized for weakness within 6 weeks of receiving covid vaccination.