chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 2 pfizer vaccines, exactly 21 days apart. As of yesterday I was diagnosed positive for covid with symptoms; Received 2 pfizer vaccines, exactly 21 days apart. As of yesterday I was diagnosed positive for covid with symptoms; This is a spontaneous report from a contactable other health professional. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular, administered in Arm Left on 12Jan2021 at 18:00 (Batch/Lot Number: EL1284) as single dose, then dose 2 on 02Feb2021 (Batch/Lot Number: Unknown), as single dose for COVID-19 immunization. The patient had known allergies. The patient's concomitant medications were not reported. The patient experienced received 2 Pfizer vaccines, exactly 21 days apart. As of 11Apr2021 (reported as yesterday), the patient was diagnosed positive for covid with symptoms.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021 (Rapid covid test). The outcome of the events was recovering. The patient did not had COVID prior to vaccination and the patient was tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 virus test positive  cannot be totally excluded.  The case will be reassessed if additional information becomes available.
getting terrible heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Lot number: EL9267) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EL9264, 1st dose), administration date: Jan2021, when the patient was 91 years old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "getting terrible heart palpitations". Therapeutic measures were taken as a result of palpitations.  Additional information: Therapeutic measures were taken as a result of events with Magnesium.  No follow-up attempts are possible. No further information is expected.
This report is being submitted by the guidance of the DOH. 3 patients were affected by storage and handling excursions.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.55 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Brain clot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown, Expiration date: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBRAL THROMBOSIS (death, medically significant), outcome "fatal", described as "Brain clot". The patient date of death was unknown. The reported cause of death was cerebral thrombosis. It was not reported if an autopsy was performed. It was reported that 2 men was died from a brain clot after receiving Pfizer Covid Vaccine. One of the patients died on the way to the emergency department before they got to the hospital, but reporter was unable to clarify which of those 2 patients that was. Reporter did not know if patient died last night, several days ago or when.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200108937 same reporter, different patient; Reported Cause(s) of Death: Brain clot
Unusual tiredness at times, numbness and tingling for 11 days, 3 days post vax. Symptoms still exist today. Surface of skin, at times, feels sunburned. Palms of hand appear sticky at times. Numbness, particularly noted in hands, feet and penis.
a eight years old female patient received a 0.5 ml dose of Flublok Quadrivalent, No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a eight years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QSAA1908, expiry date: 24-May-2020 via intramuscular route in the left deltoid on 30-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; POOR QUALITY DRUG ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced poor quality drug administered. On 29-JUL-2021, the subject experienced incorrect storage of drug. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality drug administered, sore throat, headache, fever, pain at the injection site and incorrect storage of drug was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802801 and 20210803269.
Had a little shoulder soreness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: EW0178) as SINGLE for covid-19 immunization. The patient denied for any medical history and concomitant medications. It was reported that the patient took her 1st dose in Jul2021, maybe the second week of Jul2021 and had a little shoulder soreness that day and it had only lasted a couple of days. She didn't even see a mark barely where shoulder the COVID vaccine. The patient confirms that she recovered completely from this. The outcome of event was recovered in Jul2021.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
HEADACHES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headaches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210354213.
On that morning I notice a oval red area around injection site.  Warm to the touch, no pain.  Went by Pharmacist and she said I needed to report and she also reported it to.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that FLUMIST that had been between 10.2 degrees Celcius and 0.2 degrees Celcius was administered to 21 patients which started on 20-Oct-2015. The outcome of the event of FLUMIST that had been between 10.2 degrees Celcius and 0.2 degrees celcius was administered to 21 patients is unknown. The report was considered to be non-serious.
Approximately 15 hrs after receiving immunizations & being fussy mom found him not breathing, mom stimulated him, he started breathing called 911 went to ER. Was lethargic. Arrived ER at 1 AM 4 month old male with cyanotic episode. Was admitted for observation. Discharged 9/26/12 at 10:13 am.
Extreme fatigue, fever, body aches, shivering. Lasted from 8 pm on Wednesday until sometime after 4 am on Thursday morning, at which time I took Tylenol and was finally comfortable enough to sleep.  The body aches and fatigue returned Thursday afternoon and lasted until Friday morning.  Sore arm for another day or two.  I missed two days of work.  I slept all day Thursday and most of Friday.
Red splotch 2 inches long and 1.5 in width at the injection site.
Patient was administered  the bivalent vaccine on the day the 2nd dose was to be given of Covid the patient did not experience any adverse reactions to vaccine.
Menstruation one day early and especially intense. Lightheadedness.  No treatment.
my husbands arm was sore/sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my husband's arm was sore/sore arm".  Additional information: The caller stated that she had to listen to more than 20 minutes of explanations before she was transferred over. The caller wants to know how many months it will be before she can receive the comirnaty vaccine after receiving the bivalent booster. She did not have any reactions when she got the vaccine. However, her husband's arm was sore. Could it be because she was taking Humira (adalimumab) and she was immunocompromised? The caller stated that she had read the information available online and found out about a new COMINNATY vaccine. She has had all Pfizer COVID-19 vaccines from the primary series leading to the bivalent booster. 4 doses. Does it protect against more strains than the bivalent booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique
Developed rash over back, chest, abdomen, upper arms, thighs, fever 104.  Started within 24 after injection.  Physician ordered steroids, cream and benadryl.
This spontaneous report was received from a pharmacist refers to a 69 year old male patient. Patient's pertinent medical history and drug allergies were not reported. On 15-NOV-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml (lot # K009874, expiry date: 19-MAR-2016), intramuscular in the right arm (reported as age appropriate vaccination after 65 years of age). Concomitant medications were not reported. In November 2014 (on an unspecified date), patient stated that his right arm was very painful and had redness and swelling from the deltoid injection site down to the elbow of his right arm after the administration of PNEUMOVAX 23. On an unspecified date, the patient was treated with non-steroidal anti-inflammatories. Outcome of the events was reported as not recovered. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
The day after I received the shot, I noticed the area between my clavicle and neck was swollen. My neck was already stiff but the swollen area was sensitive to touch and I noticed two hard lumps in the same area.
Left arm numbness, then L leg numbness, foot felt heavy and could not lift foot. L shoulder and neck muscles tight and sore to area under L ear. Blood pressure elevated to 170/90.
This spontaneous report was received from a pharmacy intern concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 31-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot number L035687 and expiration date 16-FEB-2017 (dose and route were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Headache, chills, fever, muscle soreness, stomachache, general lethargy, brain fog.
Was given shot at about 2PM by 6PM, pain in my upper arm especially when moving, tingling both hands for about 30 seconds, nausea and vomiting during night, dizzy, faint when out of bed. Arm red, swollen from elbow to over shoulder, slight headache. Next day, pain in arm continued, fever 100, n/v subsided, three itchy pimple type areas on chest under affected arm, third day applied heat to arm with relief, pain subsided but still red underneath arm, about 1 wk later, large itchy welts appeared on inner aspect of each thigh lasting for about a day. Then about two wks later, several large about 4 inch diameter itchy welts appeared on back of leg, swollen red with several dark red centers, warm to touch lasting about three days. After itching, the area became sore. Redness and swelling gone, but a week later the area down my leg is still slightly itchy, some mild stiffness on arising in morning. Also, off and on until last week I had several small hive areas on my arm.
Same adverse reactions as the first dose. I felt immediately unsteady and dizzy. I was walking into things. I had a terrible fever, 106 degrees, that lasted for days. It felt as though I had covid all over again. I was laid out in the couch for six days before I could return to work. It was terrible.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated at a health care facility with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-JUL-2016, the patient was treated by a certified physician assistant (PA-C) at a health care facility for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events was unknown. Upon internal review, Severe varicella pneumonia was determined to be a medically significant event. Additional information has been requested.
Injection site became red and swollen. Continuing to swell with redness area size increasing. Arm aching and general body aches throughout body, headache also. Will call MD today for advice.  Shingles vaccine to Right arm.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to an 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 14-MAR-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Hard lump at site of injection. Rough raised area on surface of skin. Almost feels like shingles in area of vaccination.
Headache, Myalgia, Fever, Localized pain; chills, fatigue Narrative:
both injection sites arms itchy, swollen red; Spots on her arm where both injections were, she said they were itchy and warm to touch, red and swollen; Spots on her arm where both injections were, she said they were itchy and warm to touch, red and swollen; When she got injection it was sore/spots on her arm where both injections; sick; I don't have a fever; I am not dizzy anymore; I am not hot or weak anymore; I am not hot or weak anymore; I am not having muscle aches any more; I still don't have an appetite; I have asthma/I noticed with a first shot I sopped wheezing/can take a deep breath without coughing, without wheezing/improved my lungs as well; I am thirsty right now I am drinking so much water; I have not been out of the house out of the bed/trouble getting out of bed; I lost a low weight/maybe 4-5 lb; chills and shakes; chills and shakes; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: Unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 22Feb2021 as SINGLE DOSE for covid-19 immunization.  Medical history included obesity, asthma (with a first shot of vaccine the patient stopped wheezing/can take a deep breath without coughing, without wheezing, improved the lungs as well (therapeutic response unexpected), blood pressure measurement, illness from an unknown date. The patient's concomitant medications were not reported.  The patient received 1st dose on 22Feb2021 and 2nd dose on 15Mar2021. The patient experienced both injection sites arms itchy, swollen red, spots on her arm were itchy and warm to touch, red and swollen in 2021 with outcome of not recovered. The patient also conveyed that she doesn't have a fever, not dizzy anymore, not hot or weak anymore, not having muscle aches anymore in 2021 with outcome of recovered. The patient also complained that she still doesn't have an appetite don't have an appetite on 2021 with outcome of not recovered. The patient also complained of thirst, lost 4-5lb weight, chills and shakes in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 96.4 on 22Mar2021.  Information on Lot/Batch number was available. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of blood sugar increased in a 76-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included insulin nos (Insulin). On 4th November 2018, the patient received SHINGRIX. On 5th November 2018, 1 days after receiving SHINGRIX, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was unknown. It was unknown if the reporter considered the blood sugar increased to be related to SHINGRIX. Additional details were reported as follows: The patient noted that his blood sugar readings increased the next day after vaccination and had remained high. The patient reported that prior to the injection, his morning glucose would be 107-117. The day after, the readings were 152. The patient's afternoon readings had been as high at 200.
Initial report received from a healthcare professional via other company (Merck national service center) on 02 August 2013. Other company reference number: 1-7937382277. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of Tetanus vaccine (manufacturer: Sanofi-Pasteur, lot number, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient had experienced an unspecified allergic reaction. Laboratory data and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by sender: none.
Patient denied she received the COVID-19 vaccine. Disclosed information she got a full dose of Sinovac in another country after receiving the Moderna 1st dose vaccine. Patient stayed 45 mins in the observation for extra monitoring. Patient denied SOB, chest pain, nausea or vomiting. Sister is with the patient, and verbalized if they can go now. Patient educated if experienced significant changes like breathing problem and chest pressure, she may seek medical attention right away.