chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A physician described the occurrence of autism in a 5 year old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received from manufacturer. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 7/7/98, the subject received an injection of Infanrix. In 12/98, the subject received an injection of Infanrix. In 12/02, the subject developed somnolence, fever, a feeding problem, and autism. Treatment and outcomes of the events were not reported. The autism in this report is considered medically serious. The follow up received on 4/1/03 states medical history included allergies to aspirin and pcn. The subject experienced no adverse events following previous immunizations. Concurrent medications were not reported. On 7/7/98, the subject received an injection of Infanrix. On the same date, the subject received injections of MMRII and haemohilus influenzae type B. In December 2002, the subject developed somnolence, fever, a "feeding problem," and autism. Treatment of the events was not reported. The reporting physician considered the autism to be not related to Infanrix administration. The reporting physiican considered the somnolence, feeding problem, and fever to be possibly related to Infanrix administration. As of 4/1/03, the outcomes of the events were unknown. The reporting physician considered the events to be nonserious; however, the autism in this report is considered medically serious (OMIC).
The soreness is the same as a bruise; The soreness is the same as a bruise; Again, the white circle appeared at the injection site; fatigue; abscessed tooth; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in Left Arm on 17Apr2021 11:30 (at the age of 63-years-old) as dose 2, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. Concomitant medications included TYLENOL taken for an unspecified indication, start and stop date were not reported; Z-PAK taken for an unspecified indication, start and stop date were not reported in two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported) ), via an unspecified route of administration, administered in Left Arm on an unspecified date as dose1, single for covid-19 immunisation and experienced a white circle appeared around the injection site, The soreness is the same as a bruise, dizziness, and fatigue. The patient had allergy to penicillin. The patient previously received albuterol, duricef, steroids, and experienced allergy. On an unspecified date in 2021, experienced the soreness is the same as a bruise, again, the white circle appeared at the injection, fatigue, and abscessed tooth. After all, three vaccinations, a white circle appeared around the injection site. There is no pigment in her arm in that 1/2" diameter circle. The soreness is the same as a bruise.The patient was on azithromycin due to an abscessed tooth. The patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in Left Arm on02Nov2021 11:00 as dose 3, single for covid-19 immunisation The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-FEB-2015, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5ml (lot # J006995, expiration date 14-JUN-2015). No adverse effects were reported. The specified lot number vaccine was exposed to temperature excursion eight times. The total cumulative excursion time of the first time was 8 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 28 Fahrenheit degree. The total cumulative excursion time of the third time was 344 hours with the highest recorded temperature of 6 Fahrenheit degree. The total cumulative excursion time of the fourth time was 64 hours with the highest recorded temperature of 17 Fahrenheit degree. The total cumulative excursion time of the fifth time was 160 hours with the highest recorded temperature of 10 Fahrenheit degree. The total cumulative excursion time of the sixth time was 40 hours with the highest recorded temperature of 8 Fahrenheit degree. The total cumulative excursion time of the seventh time was 40 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the eighth time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria were refrigerator/freezer (R/F) and the type of excursion for this vaccine (from the third time to sixth time) was freezer (F); the type of excursion for this vaccine of the other times was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Diarrhea (with stomach cramps preceding it) at 9:00 PM on 7/30/2021 and again at approximately 4:05 AM on 7/31/2021
opthalmic zoster; This case was reported by a physician via sales rep and described the occurrence of ophthalmic zoster in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced ophthalmic zoster (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic zoster was recovered/resolved.   It was unknown if the reporter considered the ophthalmic zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was nor provided, The patient did not have any significant medical history for this patient. The patient was treated with Valtrex and the issue resolved without complications.   The patient was reluctant to get the second dose. There was discrepancy in the source document for the outcome of event ophthalmic zoster, as per xml sheet the outcome reported was recovered with sequel where as, as per argus the outcome reported was recovered.
did contract covid on 09Jun2021; did contract covid on 09Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 13:30 (Lot number: EP7534) at the age of 24 years as dose 2, single and administered in arm left, administration date 17Mar2021 13:30 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: JUNEL taken for contraception, start date: Jan2021, stop date: Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jun2021, outcome "unknown" and all described as "did contract covid on 09Jun2021". The patient did contract covid on 09Jun2021 (at least that was the day the patient started showing symptoms).   No follow-up attempts are possible. No further information is expected.
Aching muscles and joints; Aching muscles and joints; sed rate of eighty and anemia; Joint pain inflammation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Aching muscles and joints"; ANAEMIA (non-serious), outcome "unknown", described as "sed rate of eighty and anemia"; ARTHRITIS (non-serious), outcome "unknown", described as "Joint pain inflammation". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: aching muscles and joints after the first shot for a week, continued aching muscle and joint pain inflammation at sed rate of eighty and anemia after the 2nd vaccine it has been 10 weeks and she was barely able to walk. She was barely able to walk due to inflammation in my legs, she was barely move her arms due to inflammation in my shoulders, She was barely able to get into and out of the bed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
w/in 6 hrs of vax pt had fever to 104.5 & had a brief febrile sz;
Severe vomiting after the vaccine, headache, and fatigue; Severe vomiting after the vaccine, headache, and fatigue; Severe vomiting after the vaccine, headache, and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 9 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: 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: VOMITING (non-serious), HEADACHE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Severe vomiting after the vaccine, headache, and fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a doctor of pharmacy concerning to an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced facial swelling and lymph nodes enlarged after received GARDASIL. On an unknown date, the patient recovered from facial swelling and lymph nodes enlarged. The relationship between the events and GARDASIL was not reported. Additional information has been requested.
Fever, red spots on head (Hives) tired, crying. Bad reaction to either combination of shots or prevnar.
Syncope approximately 5-7 minutes after receiving vaccination. Patient spontaneously recovered approximately 20-30 seconds later.  She had recurrent vomiting over the next hour. She was observed. At no time did she have recurrent syncope of develop rash or respiratory or upper airway symptoms.  No medications were administered. Due to her persistent vomiting  she was transported to the ER for further evaluation.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning a 66 year old female patient. On 26-AUG-2013, the patient was vaccinated SC with a dose of ZOSTAVAX (lot # J003359, expire on 21-JUN-2014). On an unspecified date, it's reported that the patient experienced redness and swelling at the injection site. The patient was given treatment instructions to use ice on affected redness and swelling, around injection site. Additionally, if pain increased, it was reported, that the patient was to use over the counter ibuprofen. During the week of 02-SEP-2013, date unspecified. The pharmacist had spoken to the patient. The patient reported that redness and swelling had resolved. This is one of several reports received from the same source. It was linked to MARRS# 1309USA000812. Additional information has been requested.
Minutes after shot: swelling appeared about more than 3 inches below shot site on the left arm Morning after shot: swelling about the area of a softball, warm to touch, tender/painful when pressed down; redness appears mainly at the site of swelling; redness, but no swelling also noticed on the area below main swelling site and continues to a little pass elbow (the area tapers down as it reaches elbow area) Pt went to ER around 1140am, they think this is an adverse reaction (possible allergic?) to Flublok. Pt is refered to see primary care MD on Thurs (10/8/2020)
Left arm with significant swelling, warm to the touch, redness and pain. Swelling resolved by the third day. Redness resolved within a week. Ache and Itch continue.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (30Jul2022) Positive. Therapeutic measures were taken as a result of covid-19 from 20Jul2022 to 24Jul2022.  Clinical course: It was reported that Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. patient previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breakthrough case after two doses Janssen 3/17/21 Lot# 1802071 Moderna 12/10/21 Lot# 031H21A
Besides brain fog, frontal headache and right arm pain, I felt lightheaded about 5 hours after the vaccine on  Thursday 1/21. Went to work at hospice on the Covid unit for 12 hours on Friday 1/22.  Felt really foggy and unable to concentrate at work. After work I was relaxing at home trying watching television but not able to focus when about 09:30 I started to not feel my big toes and started to have muscle twitching (no fever, no chills). By 11pm my all body was shaking like if I had Parkinson?s disease.  My neighbors drove me to the ER. My blood pressure was 160/100 (my norm is 100/60), and Parkinsonian syndrome.  I got scared as the heart is a muscle and I did not want my heart to go into  irregular rhythm . Better to be safe than sorry.
After 48 hrs post vaccination, the pt broke out into hives for several days. Now with petechia rash.
Information has been received from a registered nurse concerning a 7 month old patient who on 14-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 instead of PREVNAR due to an office error. No adverse reactions reported. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Dizziness. Given water and laid down. Reported having this reaction after prior vaccines. After 30 minutes, patient improved, stable, released from vaccination site.
Pt woke up that night w/ nausea, body aches, chills, fever, fatigue, and swelling/redness/soreness at injection site that spread up left neck; s/s continued for 2 days. Pt unable to complete work day and left early on 2nd day of symptoms.
herpes zoster; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 30-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by a healthcare provider for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster. The patient claimed the damages as a result of injury to themselves, loss of consortium, loss of service and economic losses. The outcome of the event herpes zoster was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M003658, expiration date 02-JUN-2018; lot # L048848, expiration date 09-AUG-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered doses of RECOMBIVAX HB were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 1 hour and 45 minutes. There were no previous temperature excursions reported. Data logger was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002309: US-009507513-1707USA006294: US-009507513-1707USA006296: US-009507513-1707USA006293.
Acute pain in left testicle. Doctor advised that it was a bacterial infection Epididymitis despite no other symptom and zero chance of STI and no known trauma. and prescribed an antibiotic and the pain subsided over the next five days.
After the 2nd injection I waited 15min to make sure I am feeling ok. At that time I had no symptoms. As I was walking home walking home within 5min I had heavy bleeding, I wasn't suppose to get my period for another 2 weeks. The heavy bleeding lasted full 2 days, that day within 5hrs I had body aching and later had a fever. I had the fever and body aching for about 24hrs and my period for 2days. Since then I have been having random spotting of light or heavy bleeding. I had my period on 3-6-21 to 3-16-21 full days bleeding. Now I still have random spotting of blood cloth and heavy bleeding for few hours and it stops.
Chest and throat pain, and breathing tightness went to ER room to get checked out and treat asthma or any other chest related symptoms.
DTaP and IPV both given "IM" in right leg and MMR "subq" in left leg at approx. 11:00 am on 03-12-04 reviewed expectation of possible reactions with mom before she left the clinic on Sunday at approx. 4:30 pm mom stopped by my home (without child) to visit/ask; Child's right leg had gotten very reddened, feverish, was not wanting to bear wt; temp was 100 degrees, mom described as leg "looking like it had been slapped"- advised to check with personal physician and she said she might bring child by the health dept. On Monday had reviewed the written info taken home from the clinic. 3-15-04 child and mother here in office 12 noon after visit with doctor temp 97.8 orally. Child walking without difficulty jumped up on exam table without complaints. Notice to right ant. thigh pinkish/white non raised blotchy area approx. 2 1/2 diameter. Slight edema notice to right ant.  lateral thigh. Cool to touch. 3-17-04 Telephone call mom at work; had attempted to call at home past 3 days but no answering machine; related above events to doctor and visit hospital day; today is 1st day can see knee cap and is walking without any complaint or reluctance according mom; no problem seen with any of the other injection sites; discussed "what" reacted-cannot know for sure- will be mindful when get Td booster in future; asked mom
Headache, Myalgia, Fever, NauseaVomiting, fatigue, injection site swelling itching and redness Narrative: Moderate fever 5/6/2021, moderate headache 5/6/2021. moderate muscle pain 5/6/2021, severe fatigue 5/7/2021 and mild nausea following dose 5/5/2021. In addition, injection site moderate swelling, itching and redness.  Resulted in unable to work 5/6/2021 and 5/7/2021. Self treated with acetaminophen, gatorade and rest.
Pt received FLUZONE HD vaccine on 10/08/2012. Pt had tingling in the arm occur and as a result went to ER that night. It's been about more than a month and pt still tingling & numb.
Mom called states red, warm to touch describes as mosquito bite maybe a little larger per PA. Pt to apply cool compress Q20min specifically daily & TYLENOL/Ibu PRN.
More than 35 days passed since the first dose and the patient did not receive the second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and the patient did not receive the second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and the patient did not receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and the patient did not receive the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Vaccine given outside 30 day expiration window. no actual adverse reaction. Patient is fine.
The reaction is due to the SECOND dose in the series. I had a fever of 102.5 along with body aches, chills, etc, the day following the vaccine (2/9), but that resolved within 24 hours. The second day after was fine (2/10). The third day after I developed a deep red rash like pattern extending down my arm more than halfway down my arm from the injection site. The injection site was extremely high, just below the top of my shoulder and immediately below the body part of my shoulder, so the extent of the redness is ~6inches long.  It is extremely painful, warm to the touch, and slightly swollen. I went to the urgent care where I was diagnosed with cellulitis. I was prescribed doxycycline 100mg PO BID x5days. I am reporting this on the day of the reaction, and it is unknown how it will respond to the antibiotics or if it will get any worse.
The patient did not require a 4th dose of the Pfizer vaccine because she did not meet the criteria. She was under the age of 50 years old and she did not designate herself as immunocompromised. The patient did not report any adverse effects.
Follow up information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) (lot# was reported as K016161, expiration date 13-SEP-2016, dose and route were unknown) which had been exposed to temperatures outside of the recommended range. No adverse effects were reported. Additional information has been requested.