chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported.; Series schedule interrupted: first dose on 16Dec2019, second dose on 9Mar2020 and third dose on 20Apr2021.; This spontaneous report as received from a pharmacist, referring to 21 years old patient of unknown gender. The patient's historical condition, concurrent condition and concomitant medication were not reported.   On 16-DEC-2019, 09-MAR-2020 and 20-APR-2021, the patient was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis, respectively (inappropriate schedule of product administration). The reporter did not have lot# and expiration dates for any of the doses administered. The dose and strength for suspect vaccine were not reported. No additional adverse events reported. It was reported that the patient was 20 years old at time of initiation. A pharmacist inquiring if a currently 22 years old patient received 3-doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but the series schedule was not adhered to should the patient be re-vaccinated.
Got the vaccine on Apr 6 Fever and leg pain started on Apr 7 Sever headache, nausea occurred on Apr 11, called 911 immediately and sent to emergency room of hospital  The diagnosis is large volume of subarachnoid hemorrhage in the brain. Surgery conducted on April 11 and the patient is still in ICU now
Nonspecific headache, malaise and swollen eyes after the vaccination. The patient the developed sudden-onset of difficulty breathing 2 days after the vaccine administration.
My arm was extremely sore to the point that I could not move it without crying. I could not undress or bathe myself the night after the vaccine and had a severe lack of mobility in the arm that was injected. The pain started about 3 hours after the injection and severe pain lasted from about 7 hours after the vaccine until about 24 hours after the injection. Moderate pain continued through at least Sunday (2 days after vaccine). The night after getting vaccinated, I could not sleep the entire night, and I do not usually have trouble sleeping. I did not do anything differently that day other than getting the vaccine. The morning after the vaccine,  I was crying uncontrollably after waking up at 6am. The crying lasted until about 7am.
When I got my vaccine, I waited the 15 minutes before leaving, and as soon as I walked out the building I could taste this metal taste in my mouth. That symptom lasted for almost a month. I went about my day and I kind of noticed that as the day went on my throat was scratchy so I started taking Emergen-C because I thought I was getting a cold. I took a Covid home test because I thought I could be getting Covid, but it was negative. My glands were swollen and my throat was sore but I had no fever and it was lingering for a day or two and then it was fine and then it would just come back. I was exposed to Covid on New Years Eve and I took another covid test and it was negative. The sore throat subsided last week. This is the most reaction I've had with all three of my vaccines. I'm getting a physical in 2 weeks and she will see if my glands are still swollen.
approximately 6 days following my second COVID 19 dose, i woke up in the morning with dizziness which progressed throughout the day. The dizziness resulted in vomiting, diarrhea, headache, weakness and exhaustion by the end of the day. I do feel better today (that was yesterday) although slightly dizzy.
First dose administered in February, the patient said no one told her to get another one in 7 days; second dose received in August; Case reference number US-BN-2021-002224 is a spontaneous case report initially received from a nurse via Agency (reference number: USBAV21-0440) on 27-Aug-2021 and concerns an adult female patient (probably in her 30s).  The patient's medical history and concomitant medication details were not provided.  On 18-Feb-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine, batch number was not provided) at an unknown dose, intramuscularly, for pre-exposure immunisation.  On 27-Aug-2021, six months and nine days after receiving the first dose, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine, batch number: ARBA851B) at a dose reported as one shot/vaccine, administered intramuscularly, for pre-exposure immunisation.  The reporter stated that the patient claimed that she didn't know that the second dose of RabAvert had to be given seven days after the first dose (explicitly coded as Inappropriate schedule of product administration').  The reporter asked if the patient should start over the series.  It was not reported if the patient experienced any adverse events.  The reporter assessed the event as non-serious and not-related to the vaccine.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed for RabAvert per convention. Reportedly, the patient received second dose of the suspect product six months and nine days after the first dose because patient did not know that second dose should be administered seven days after first dose, which is considered as inappropriate schedule of product administration. No associated adverse events were reported. No information regrading medical history and concomitant medication were provided. Inappropriate schedule of product administration is not related to suspect product but to human action. The case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed for RabAvert per convention. Reportedly, the patient received second dose of the suspect product six months and nine days after the first dose because patient did not know that second dose should be administered seven days after first dose, which is considered as inappropriate schedule of product administration. No associated adverse events were reported. No information regrading medical history and concomitant medication were provided. Inappropriate schedule of product administration is not related to suspect product but to human action. The case is considered as non-serious.
Person had tingling and numbness of upper and lower lips, fullness feeling 10 minutes after vaccination given.  vaccine given at 1402, started feeling the tingling at 1412.  Lips were not swollen.  No swelling of tongue.  Oxygen sat 99% throughout the event.  Blood pressure 150/88.  Alert and oriented, injection site not swollen or red. Given Benadryl 25 mg orally at 1415.   At 1430 patient feels like the numbness and tingling are getting better.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 02-APR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.
Dizziness that began 35 hours after vaccine was administered. Dizziness lasted 43 hours.
I received 3 doses of the COVID vaccine from March 2021 (2 doses) with booster on 11/5/2021.  Started feeling symptomatic on 12/23/2021 with low fever, slight aches, headache, and moderate to severe sinus congestion with two bouts of diarrhea.  I tested myself at home with home test kit that come up positive for COVID.  Thought the cdc should fully vaccinated and boosted and still had a breakthrough case.  No under lying conditions and have been illness free for over two years.  You may contact for more info if needed.
Hives on left hand itchy skin, within an hour. Cough, fatigue, headache, upset stomach sore arm (hard to move) fever 99.9. Hives went away after a few hours.
Vaccine was provided during school located vaccine event. School nurse notified clinic that the student had vomited one time by 1 P.M. Advised nurse to notify student's parent of incident and parent to follow up with PCP if needed. Vaccine information statement was provided to student at time of vaccination. 4-10-23- I called mom, to follow up with child. Mom reported he complained about arm being sore and he did vomit again on 4/7/23. Mom denies any other complaints or concerns.
Information regarding smallpox vaccine, dried calf lymph type injection was received from a published literature article. Autoinoculation vaccinia. In light of the anthrax attacks in 2001 and the threat of further bioterrorism, this article discusses the issues of smallpox vaccination within the current dermatologic environment, presenting the case of a 19 year old male pt who developed autoinoculation vaccinia. Four to five days post-immunization, the pt developed a "major reaction" at the site of vaccination. A few days later, he noticed the onset of a painful, erythematous, edematous eruption on his upper thighs and scrotum. Small papules develped into umbilicated pustules. The pt admitted to scratching the vaccination site. After he was seen during the second week of his illness, he was admitted to the hospital. Viral culture results were positive for vaccinia. Tzanck smear was negative for multinucleated giant cells, and no Guarnieri bodies were seen. He was treated with compresses, and the eruption resolved in two days without scarring. The authors concluded that "smallpox vaccination complications were relatively common when it was a routine inoculation in the 1950s and 1960s. The most common complication, occurring at a rate of 1 in 1000 vaccinations, was accidental inoculation. Accidental inoculation can be due to either autoinoculation, as in the case presented, or to contact with a vaccinated person, often a sibling or a close contact." The common and occasionally severe complications must be taken into account when shaping our national strategy.
This non-naive vaccinee reported onset of "itchy" eyes and an oral ulcer on 03-15-03, day 2 post vaccination.  Vaccinee reported being afrebile.  Reported symptoms resolved approximately 3 days after onset.  Reports prior history of similar type of oral lesions.
This infant had an onset of fever within one hour of the vaccination. The temperature was 103 to 104 for 48 hours. The patient had severe loss of appetite, he would drink but did not eat any solids. She also complained of leg pains at the injection site and was limping.
Mom noted pt felt warm at 345 am (7/19/11). Gave her TYLENOL & seemed ok. Took her to daycare. Between 5-5pm, pt had high fever (104.8 Rectal) & seizure. Transported by EMS to ER. Given 150 mg TYLENOL, fever decreased. Otitis media diagnosed, antibiotics prescribed (AMOXIL). Some macules over arms/legs, & fine rash on facial cheeks bilat.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Testing positive for COVID 19 (10 days after finishing treatment).         No concomitant medication were reported.  It was reported that Batch/LOT number of suspect drug was misplaced or mismatched.  Company comment: This spontaneous case concerns a 43-year-old female patient who experienced the unexpected non-serious AESI, Covid-19, on an unspecified date after receiving the 3rd dose of mRNA-1273 vaccine. The patient was started on Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19 and 10 days after finishing the course he was tested positive for SARS-CoV-2. Details of previous doses was not provided. Details of medical history, symptoms, clinical course, diagnostic reports, and further treatment was not provided. The outcome of the event was unknown. Recent Covid-19 infection could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old female patient who experienced the unexpected non-serious AESI, Covid-19, on an unspecified date after receiving the 3rd dose of mRNA-1273 vaccine. The patient was started on Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19 and 10 days after finishing the course he was tested positive for SARS-CoV-2. Details of previous doses was not provided. Details of medical history, symptoms, clinical course, diagnostic reports, and further treatment was not provided. The outcome of the event was unknown. Recent Covid-19 infection could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Administration of booster shot which was more than 18 hr in fridge/ gave a patient a booster does from a vile that had been started The previous day, it had been refrigerated the whole time; Administration of booster shot which was more than 18 hr in fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge/ gave a patient a booster does from a vile that had been started The previous day, it had been refrigerated the whole time) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge/ gave a patient a booster does from a vile that had been started The previous day, it had been refrigerated the whole time) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of booster shot which was more than 18 hr in fridge/ gave a patient a booster does from a vile that had been started The previous day, it had been refrigerated the whole time) and PRODUCT STORAGE ERROR (Administration of booster shot which was more than 18 hr in fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-388723, MOD-2021-388696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up appended on 12-nov-2021 contains Event related information. On 16-Nov-2021: Follow up received contains Patient demographics and Vaccine information.
Patient received a two FLUAD doses. She got an initial dose on 10/13/2021 and a second dose on 10/25/2021. Patient has dementia and memory loss. Patient did not recall receiving the doses from the pharmacy; she believed they were administered at her doctor's office. Administration was confirmed by checking consent forms and electronic records. The patient did not experience any unusual symptoms or side effects and was instructed to notify pharmacy if anything develops.
Patient stated she felt hot and heart rate was rising.  Staff vital patient and was 175/110 with pulse of 85. Doctor spoke with her and checked her out and we vital again around 2:30pm and was 134/82 with pulse of 85.  Patient was observed another 15 minutes and she stated she felt a lot better and was cleared to go.  Patient was called at 5:30pm and stated she felt good.
There has not been any adverse event at this time. Patient was administered 0.3 ml of undiluted pfizer dose
Got one in Jan2021 for the first dose and had a reaction/Clarified he did have the typical sore arm for a few days that then went away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "Got one in Jan2021 for the first dose and had a reaction/Clarified he did have the typical sore arm for a few days that then went away.".  Additional Information : The patient got one in Jan2021 for the first dose and had a reaction. Patient wanted to know if the reaction came from the Pfizer COVID-19 vaccine or not. Clarified his first COVID-19 shot was in Jan2021 and since that time he had a booster shot, and after the booster shot had another booster shot. In 2022 had another booster shot and then in Nov2022 had an additional booster shot that would take care of all the viruses up to that point. Out of all the shots he had he never had a bad reaction to any of them. Clarified he did have the typical sore arm for a few days that then went away. After the most recent COVID-19 Vaccine shot he noticed two weeks later he had tinnitus in one ear or ringing in one ear. Wonders if other people have had the same thing?. Clarified he hasn't had a hearing loss but he never had tinnitus and started having it shortly after the COVID-19 Vaccine shot. Have other people reported the same thing?. Declined to complete a report and requested to be transferred to Pfizer Medical Information. Wanted to know if it has to do with the shot and if it will go away?.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024573 Same patient/vaccine, different dose/event.;
The patient developed a 4cm x 4cm area of swelling below the right mandible within 5 minutes of vaccine administration. The patient was referred to ENT.
Transient bradycardia with exhaustion. I am a physician and this resolved.  I wear a fitness watch, which indicted the bradycardia. It resolved completely at some point without treatment. Additionally,  after the  first shot (12/20/20), I had a headache lasting days. After the second shot, (01/13/2021) I had another headache lasting days.
pt recv vax 7AUG96 & 4SEP96 pt SGOT & SGPT were elevated & hepatitis B surface antigen tested positive;9SEP96 SGPT returned to nl;pt was placed in isolation;
Very swollen in left armpit for several weeks; Sore and tender for weeks; Sore and tender for weeks.; This is a spontaneous report from a non-contactable other healthcare professional. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm  on an unknown date (at the age of 34-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not receive any medication within two weeks of vaccination. 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 an unknown date, the patient experienced very swollen in left armpit for several weeks, sore and tender for weeks. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for reported events. The clinical outcome of the events very swollen in left armpit for several weeks, sore and tender for weeks were recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated that at the time of the vaccination she had some stinging in her arm, and then a fever of 100.00 to 101.00 that evening with redness, swelling and warmth.  Swelling continued through 03/09/2011 but fever subsided
Back pain because of fusion; Back pain because of fusion; Low B12; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4421179-00.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1161756) at cf, subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPINAL FUSION SURGERY (medically significant), PROCEDURAL PAIN (non-serious), outcome "unknown" and all described as "Back pain because of fusion"; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "Low B12". The patient underwent the following laboratory tests and procedures: Blood test: Low, notes: Low B12. The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event (s) of back pain because of fusion unknown onset, back pain because of fusion unknown onset and low B12 was not provided. Agency' s opinion is that there is no reasonable possibility that the events of back pain because of fusion unknown onset, back pain because of fusion unknown onset and low B12 are related to Humira (Adalimumab).   The reporter considered "back pain because of fusion" and "low b12" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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.