chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A doctor in (name unknown) recommended the male patient have the HPV vaccine for his throat cancer.; No Additional AE reported; This spontaneous report was received from a physician via company representative referred to a male patient in his 60s. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant therapies were unknown.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, anatomical location and route of administration were unknown) for throat cancer which was advised by a specialist (off label use).  It was reported that the patient had a dental practice office next door to the physician's practice. The patient had retired from his dental practice and moved out of the area. No Additional adverse event was reported (no adverse event).
pt recv vax 1APR97 & 8APR97 mom reported temp 101, nasal congestion devel 6APR97 fever up to 103.8 max from 7APR97-12APR97;rash devel 10APR97-14APR97;also devel watery stool exam 11APR97;diffuse, sparce # lesions, erythematous maculopapular
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-NOV-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (strength was unknown) (lot# M034856 and expiration date 27-JUL-2018) subcutaneously for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017; 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 07-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium
Patient, received his first dose of moderna covid vaccine 5/8/21 administered by myself staff. Today 6/5/21 he came in for his second dose. He said he still feels discomfort in his arm but not enough to not want to receive the second dose. He said its not painful, he just feels a little discomfort sometimes when he touches the area or lays on it. I told him that if he still feels like this in a week after the second dose he should make an appointment with is doctor.
12:30pm, red Swollen bump on upper lip. Felt like a bruise, it was gone the next Day. Around 5pm, my skin (all over) started to Tingle and itch.  Call Doctor and I?m taking Zyrtec and Tagamet for the itching. Still itching today, but not as bad.
I started experiencing severe Migraines a few years ago however the frequency and intensity has increased since receiving all of my vaccinations. In 09/2022 I was taken by ambulance to the ER with a severe migraine. The Physician on staff prescribed candesartan, and sumatriptan medication since then it has been replaced with NURTEC and was also put on UBRELVY. I had an MRI done in 10/2022 which showed no abnormalities.
On 3/12/99, the pt received the first injection of Lymerix with no adverse effects. On 4/12/99, he received the second dose and approximately 5 months later, he experienced a sore stiff knee. He reports he may have hyperextended the knee while exercising.  No treatment was given and the pt plans to get the third injection of Lymerix. The information received on 3/8/00 reports the symptoms are improving but are ongoing.
couldn't stand for a day or 2; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 14Jan2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included inguinal hernia and concurrent condition included prostate too large. Concomitant medications included tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin (OXYBUTYNIN), and ocrelizumab (OCREVUS). The patient reported he "couldn't stand for a day or 2", on an unspecified date in 2021. The patient reported that he did not have the second dose. No further information was reported. The outcome of the event was reported as resolved on an unspecified date in 2021.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
UrticariaPruritus 2" inferior to vaccine erythematous area Narrative:
Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported for reporter's mother. The age at vaccination was not reported. The patient received the vaccine and few days later came down with shingles, now few years later she has shingles again. The reporter did not trust this vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Heartbeat really fast; Rash in the face; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heartbeat really fast) and RASH (Rash in the face) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HEART RATE INCREASED (Heartbeat really fast) and RASH (Rash in the face). At the time of the report, HEART RATE INCREASED (Heartbeat really fast) and RASH (Rash in the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Patient developed nausea/vomiting approx 1 hour after vaccine administration. Patient requested paramedics. EMT noted slightly elevated pulse rate and administered ondansetron IV on site. Patient was taken to ER for observation. I spoke with pt on 10-12-10. She is recovered but said ER MD feels the N/V was related to FLUZONE admin.
non-pruritic rash to B/L lower extremities developed the day of after receiving vaccines. Vaccines admin on 6/7/2021, sx reported to have started on 6/8/2021. On 6/11/2021, mom made initial contact w/ our office regarding the rash, at which point, it was mostly resolved per her account. Baby did not develop fever or rash to other parts of her body. Rash per photos emailed on 6/11/2021 was flesh color papules localized to the lower extremities only.
Initial misuse report received from a non-healthcare professional on 29 April 2013. A dose of DAPTACEL was administered to an adult. No adverse event as reported. List of documents held by sender: none.
12/25/2022 started getting symptoms of respiratory illness; dry cough; headache; sever sore throat; difficulty swallowing; laryngitis; nasal congestion; fatigue, malaise and low grade fever for 18 days. Sore throat and dry cough remain.
Adverse event = 12 yr and 4 mo old male adolescent receiving Moderna Covid vaccine in error, in lieu of Pfzer Covid vaccine.  Patient waited, was observed for 15+ minutes after vaccination, uneventful with no adverse events.  Not aware of any other subsequent adverse events or sequelae subsequent to vaccination
Continuous sinus problems, pressure, having to blow nose once every hour or two from late October to early January. Sinus polyp found on x-ray. Unknown if related.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Abdominal Pain-Medium, Systemic: Fever-Mild, Additional Details: pt states that arm was sore or tender for few days. then became very painful and feels like there is hard knot in there with redness swelling. not hotness to touch. pt states that it is so painful it has limited to her mobility. she did get slight fever (that night after administration) and stomach pain (few days after administration) above the belly button.
Patient was a healthy 12-year old boy with no prior instances of illness (and he did not ever test positive for Covid) when he suffered from a headache, low fever, and fatigue. On the third day of symptoms, he said he had chest pains only after trying to eat. We were currently living in an another country and he was taken to the hospital ICU. One day later, he suffered cardiac arrest and was put on ECMO because his heart was not functioning well. He was later diagnosed with acute myocarditis and needed a heart transplant. Unfortunately, after the transplant operation, he suffered a severe subarachnoid intracranial hemorrhage and lost all brain stem functions. He never recovered.
NARRATIVE: no information other than patient requesting exemption from Covid vaccine due to having a reaction to  the influenza vaccine
Lower lips full of fever blisters / days later / new blisters appeared; This case was reported by a consumer and described the occurrence of fever blister in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included fever blister (had 2 or 3 episodes in past).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patients wife reported that they both received first dose of shingles vaccine recently. Post vaccination exactly 2 weeks later they both experienced lower lips full of fever blisters,6 to 10 in numbers. 4 days later a few new blisters appeared. The patient thought the blisters must be a side effect of the shot because of the timing. The patient also stated that rarely she get fever blisters and had 2 or 3 episodes in her whole life, not sick or stressed. Also stated that none of them  exposed to someone with fever blisters either. Case created for husband refer linked case US2021AMR168314.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR168314:Same reporter. Husband's case.
Shingrix + Administration of liquid portion only.; Shingrix + Administration of liquid portion only.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number YC547, expiry date 25-OCT-2024) for prophylaxis.   On 15-MAY-2023, the patient received Shingrix. On 15-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix + Administration of liquid portion only.) and inappropriate dose of vaccine administered (Verbatim: Shingrix + Administration of liquid portion only.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-May-2023  Medical assistant reported that another medical assistant administered the liquid portion only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter.
Pt vaccinated with DTP/OPV developed 4 hrs of inconsolable crying & swelling & redness of thigh. No significant fever.
HEADACHE, EAR PAIN AND PRESSURE, TINGLING, NUMBNESS SIDE OF FACE, SWOLLEN GLANDS.
This spontaneous report was received from a physician, concerning a 22 year old female patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 26-JUL-2018, the patient inadvertently vaccinated by the physician's medical assistant, with a dose of PROQUAD subcutaneously, for prophylaxis, lot #R003295, albumin status rHA, and expiration date 31-JUL-2019 (strength, dose and frequency were not reported). No adverse effects were reported.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ from lot # M032636 with expiry: 06-APR-2018 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature excursion of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005936:
This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in an adult male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B, GlaxoSmithKline) for prophylaxis. On 28 September 2008, the subject received 1st dose of Engerix B (unknown). On 2 October 2008, 4 days after vaccination with Engerix B, the subject experienced hepatitis b surface antigen positive, antigenemia and hepatitis b core antigen positive. An adult subject raised in the Philippines was seen in the United stated by a healthcare professional in a missionary organization. The subject may have a possible history of Hepatitis b infection due to positive hepatitis b virus core antibodies. The subject received an Engerix B vaccination on 28 September 2008 and a hepatitis panel on 02 October 2008. The subject tested positive for hepatitis b surface antigen also possible due to vaccination. Subjects' liver function testes were normal. The healthcare professional plans to repeat the hepatitis panel in two months to determine if the antigenemia is related to the vaccine or to an infection. No other adverse events reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Engerix B.
This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6205) via an unspecified route of administration in the arm right on 09Apr2021 at 10:00 hours (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and depression. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) 10mg, famotidine (MANUFACTURER UNKNOWN) 5mg, D3 (MANUFACTURER UNKNOWN) 50 ug and ubidecarenone (COQ10) all for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm right on 19Mar2021 at 11:00 hours (at the age of 29-year-old) as a single dose for COVID-19 immunisation.  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 09Apr2021, first day afternoon, the patient was mostly fine but tired. In the evening patient started getting chills/shaking and achy/sensitive all over. Very bad headache in the middle of the night, took acetaminophen to relieve the pain. On 10Apr2021, second day the patient was fine in morning then got chills again with aches and a fever in the afternoon. Took Acetaminophen again. On 11Apr2021, the third day patient experienced stiff neck, sore (and slightly swollen) right arm and slightly stiff back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of pain, headache and fever which included treatment with acetaminophen (MANUFACTURER UNKNOWN). The clinical outcome of the events tired, very bad headache in the middle of the night, getting chills/shaking and achy/sensitive all over, fever, stiff neck, sore right arm and slightly swollen right arm and slightly stiff back were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shortly after receiving the vaccine I was lightheaded.  That evening I was achy and nauseous. The next day I had a fever of 101 along with exhaustion, headache and body aches.  I also had a  heartbeat of 120.  The fever broke that night but I still felt unwell the following day.  The injection site welted.  The 2nd night the fever returned but not as high.  Today is the 3rd day.  The fever is gone for now.  The injection site is still red and hot and now itchy.  Welt size is 5 inches by 3 inches.  Still a little nauseous and headachy.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies. On 29-MAR-2017, the patient was inadvertently vaccinated with an expired GARDASIL lot number K009482, expiration date 06-MAR-2017, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The reporter reported also the GARDASIL 9, then, unidentified expired Merck HPV vaccine was administered. Additionally, the lot number K009482 was valid only for GARDASIL. No adverse effects were reported. Product quality complain was not involved. Additional information has been requested.
Information has been received from a physical therapist concerning her daughter a 16 year old female with no pertinent medical history reported and no known drug allergies who on 06-NOV-2007 was vaccinated with the first dose of GARDASIL (lot n. 658490/08020), 0.5 mL, intramuscularly. On 08-JAN-2008, the patient was vaccinated with a second dose of GARDASIL (lot n. 658094/0524U). On 22-JUL-2008, the patient was vaccinated with a third dose of GARDASIL (lot n. 660391/0063X). The physical therapist reported that her daughter has had irregular menstrual cycles since administration of her third dose of GARDASIL. Her one and only menstrual period occurred 6 to 7 weeks after receiving her third dose. The patient also experienced injection site soreness on an unspecified date. The patient called to the office. At the same time of reporting the patient had not recovered.  This is one of two reports from the same source. Additional information has been requested
Worsening in migraines causing nausea and vomiting. Missing school and dance.
Within hours of the shot my arm experience swelling and pain.  By that night my arm was experiencing pain which involved the entire arm down to the fingers.  Later during the night by arm scoket and the base of my neck was in pain, I experience headache, sinus pressure and underarm swelling.  I had to take tylenol 500mg twice one at about 8 pm and the other 7 hrs later.  The next day I experience fatigue and did a few activitites such as household chores but experienced sleepiness and was generally unwell.  Slept extra hours during the day timeup to 5 hours during the day.  By the 2nd day I was feeling better but had a massive swelling under my arm pit on the arm where the injection was given.  The swelling has improved by day 5 today but still have soreness under the arm pit.
This is the first of eight spontaneous reports as received from a physician concerning a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. Outcome was reported as recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
After first dose Leg pain after about 1 hour on the side shot was given. Same thing happened on the second dose  pain on the leg where the shot was given.  Been having headaches once or twice a weeks since the second shot.
2-3 days post vax the pt experienced swelling of the left thigh accompanied by a fever of 103+.
erythema, swelling, increased pain over injection site 8 days after injection with also myalgia and fatigue
Pt under the age requirement to receive Moderna. No adverse event was noted.  Admin worker did not notice the patient was under age when signing member into database and when asking questions.  When member arrive for his second dose it was identified he was underage and he was given Pfizer for his second MRNA to complete series.  He was told to come back in 5 months for Booster.
Fine for 15 minutes during wait time.  During drive home, about 30 minutes after, I felt a sort of ripple of energy across the right side of my face.  My throat did not close, but it clenched or got tight and my tongue seemed to tense.  Before I had time to think about that, I had a surge of adrenaline which left me a bit startled.  The tongue and throat tightening happened without an adrenaline surge approximately 4 more times.  I lost feeling in my left arm and felt lightheaded.  This lasted about 30 minutes, after which I felt fine.  I experienced sharp stabbing pains in hands, feet, pelvis and fingers, which are still present 48 hours later.  At 24 hours post-vaccine, I felt chills and developed muscle aches and a low fever, which are still present at 48 hours post-vaccine.