chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient described a "vicious headache" upon awakening the following morning that lasted until about suppertime. She said sh felt like she was kicked in the back the head and a vein was pulsing out. She reported nausea for the following 2 days.
Approximately 5-6 hours after administration of vaccine, developed pronounced injected sclera (bilateral) with no itching. Also pronounced facial flush - by 10-12 hours later, noted moderate muscle aches, neck ache (occipital area) and photophobia - bed rest and PO Ibuprofen and no S/S next morning.
Swelling, redness, warmth below injection site.  Patient also reported having fever on 11/8/16 but subsided as of 11/9/16. Patient took Aspirin after injection.  Advised patient to take Ibuprofen and use cool compress over the area.
The patient was administered a Moderna Bivalent dose and when we entered our data to the Vaccine system we realized that she had been administered a previous bivalent dose in September. The patient did not present any evidence of the previous vaccination.
Spoke with mother. Vaccine given 6-27-19. Arm was sore initially but child had increased complaints at bedtime on 6-29-19. Left Upper arm was red and swollen, but child able to sleep after ibuprofen. It was still increasing on Sunday, so she was seen at urgent care and begun on Clindamycin(seen at Urgent Care). Child is much better today and swelling and redness have decreased. I gave mother the info about lot number and manufacturer as above.Sister got same vaccine from same lot on Thursday 6-27-19 as well and is fine. It seemed to respond dramatically to the clindamycin, so that is consistent with secondary infection rather than vaccine reaction. Mother will call back if any questions or if she has any difficulty tolerating antibiotic.
Systemic: Exhaustion / Lethargy-Severe, Systemic: Seizure-Severe
I keep having intermittent hives at various locations on my body everyday.  Not a lot of hives but they occur everyday and quite often at different times throughout the day and night.  They are not severe but they are very itchy and last for an hour or more every time they occur. I received my second COVID vaccine on April 5th so tomorrow will make it two weeks that this condition has persisted.
A female subject, received FLUBLOK Intramuscular on an unknown date at a pharmacy. The subject developed bumps and redness around the injection site for a time after the shot. The pharmacist did speak with the subject the next day and said upon looking at her arm, it looked good and the subject said she was fine. At the time of the report, the outcome for the events was complete recovery. Concomitant medications were not reported. The company's assessment of the causal relationship between bumps around the injection site FLUBLOK is a possible relationship and between redness around the injection site and FLUBLOK is a possible relationship. In summary, this case report does not change the known safety profile of FLUBLOK.
First dose / around May 2019 / second dose / about a year later; First dose around May 2019 / second about a year later / Shingles occurred 2 days ago/ Suspected Vaccination failure; Got shingles despite getting 2 doses / Shingles occurred 2 days ago; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, the patient received the 1st dose of Shingrix. On 7th June 2021, more than 2 years after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination for 2nd dose was not reported, however it could be 50 or 51 years. The first dose was given to the patient around May 2019 and second dose was given about a year later, which led to lengthening of vaccination schedule. The patient did not remember the exact date of administration. The patient mentioned that she got shingles despite getting 2 doses of Shingrix vaccine, shingles occurred 2 days ago from the time of reporting (7th June 2021). The patient inquired if Shingrix vaccine was not effective for her and if second dose of Shingrix vaccine was less effective because it was not given during 2-6-month window.  Shingles were not resolved.   The patient did not have lot number, expiration date, and dose of both doses of Shingrix. The reporter did not give a consent to follow up with healthcare professional. The reporter did not consent to follow up. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Developed swollen lymph nodes in both of my upper legs and groin. Muscle pain also in both upper legs and groin. Saw my primary care physician to discuss receiving a second dose as this was my first dose. No treatment at this time. Plan is to wait and watch to see if the lymph nodes decrease in size. At the time I saw my doctor, the nodes had increased in size over a 2 week span. They are easily palpable and painful. I was instructed not to get my second dose unless these nodes return to normal. He felt in time I should be ok to get my second dose but urged me to report this to VAERS.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patient received the first and second doses of GARDASIL injection, (lot numbers, doses, routes and anatomical sites of injection were not reported). After that, on 25-MAY-2016, the patient was vaccinated with GARDASIL 9 injection, (lot number, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. No adverse effect was reported. No product quality complain (PQC) was involved. Additional information has been requested.
pt recv vax 28JUN95 & 2JUN97 pt devel 50 scattered pox but no other s/s;
patient received ActHIB that was prepared with sterile water instead of the proper diluent/no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA276702 same reporter.  This case involves a 12 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] that was prepared with sterile water instead of the proper diluent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Aug-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UI905AAA via unknown route in the right thigh (The lot of the diluent found by itself is: lot U6057AA expiry 24 Oct 2019.).  It was a case of actual medication error due to Wrong solution used in drug reconstitution.  At the time of report 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 holder's compliance with the requirements set out in Directive and Module VI of the 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.  Documents held by sender: none.
I experienced fever of 104.F, severe muscle and bone aches, horrible aches and bit of nausea lasted three days then it went away. Then the first week of April 2021, I noticed I was feeling feverish and started taking my temperature, I have had a fever between 98F-102F, every single day. On 04-22-2021, started to have the swollen lymph nodes in my arm pit, left side. My lymph nodes would swell up for a week. At the end of May 2021, started to get real bad aches and pain, felt like my bones were going to ache and my migraine headaches and lymph nodes. Then the nausea and vomiting started in July 2021.  I went in to see a doctor, all my tests results are good and my doctor said that it could be an auto immune response or if there is something else. I still have lymph nodes on the side of my body at the base of my skull and one under my collar bone. Abnormal slightly AST or ALT, unknown if it is related to the vaccine.
This spontaneous report as received from a 85 year old female patient regarding herself. The patient's pertinent medical history was none and the current conditions included allergic to iodine (which caused rash) and allergic to PERCOCET (which caused nausea). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) vial. Concomitant medications were none. Approximately on 06-SEP-2013 (reported as 2 weeks ago), the patient experienced shingles after receiving ZOSTAVAX. The patient was treated with Valacyclovir. Approximately on 16-SEP-2013 (reported as 4 days ago) the event shingles was recovered. The patient also stated that after taking Valacyclovir she developed renal failure and hallucinations, approximately on an unknown date in September 2013. Patient sought medical attention and had visited a Physician. Laboratory tests was none. The outcome of renal failure and hallucinations was unknown. Upon internal review, the event renal failure was considered as medically significant. Additional information has been requested.
Covid-19 Virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
We gave 2 doses of Moderna bivalent BUD; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of Moderna bivalent BUD) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of Moderna bivalent BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of Moderna bivalent BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of Moderna bivalent BUD).    No concomitant medications were provided. No treatment medication was provided.
Fever of 99.2 as of 10:30 a.m. on 10/13/2020.
May 14th, 2022, I woke up to get ready for work and I was drowsy, had a stuffy nose and my head was pounding. When I got to work I couldn't concentrate and wasn't feeling good. I spoke with my leader and she told me to go to the wellness center and take a COVID-19 test. They sent me home after the test, about an hour later I got the positive results. While at home I lost my sense of taste and smell. A week later I went back to work and was having some chest heaviness, and would practice holding my breath to make sure I was still breathing properly. June 10th I was laying in bed one night and my lower abdomen was hurting. The next day I woke up and I couldn't walk correctly. I called my friend to take me to the emergency room and they said I had a pulmonary embolism, two blood clots. I was taken to ICU as a COVID-19 precaution, and stayed a few nights there. They gave me ELIQUIS for the blood clots, twice a day. I stopped taking that on 12/1, and was feeling better. No lingering pains or effects.
I never have had COVID until I received the vaccine I was diagnosed on 13 I now have had a severe infection  after that has been treated with two different  antibiotics and still has not been resolved. I also started having tinnitus..
Around 12 am, I was washing my hands getting ready for bed.  I lost half of my left side vision and serve headache. I call the doctor office and was told to the ER.  They did a CT scan of my head, told me that I have a brain bleed in my left side of my brain.  They did a MRI of my head.  They did a scan of my head and neck.  About an hour later the did another CT to make sure the bleeding had stop.  I was dx with a stroke.  I was in the ICU for 3 days.  I still having a lot of headache since then.  In early July, my shoulder started hurting.  So, I contact my doctor about it.  She wanted me to do physical therapy to help with the pain.
Patient received DPaT on 9/24/03.  Mother noted swelling on the next day.  Swelling increased over the next day and was seen on 9/26/03.  Pt was afebrile, alert and in no distress.  There was 4" to 5" swelling at site of injection (warm, red and tender).
Golf ball sized knit in shoulder sore collarbone neck pain throat pain all on left side (side where shot was given)
Adult Pfizer diluted with 1.3mL (pediatric dose) of diluent instead of 1.8 mL.
I had the following side effects. I had mild fever 99.9, headache, extreme tiredness for apx 2 days, couldn't lift my arm more than 1/2 way for 2 days, stomach pain on lower left side w/ diarrhea. I took Tylenol every 4 hours throughout the following two or three days.  The side effect or adverse reaction that started within 2 hours of my dosage and lasted apx 12 hours was a pulse rate in the range of 125 along with being lightheaded and feeling short of breath.
Patient experienced cramping in lower back that radiated upwards shortly after receiving Shingrix vaccine. Was driving and had to pull over to call 911.
pt resturned several hours after injection and stated that he was feeling chest tightness, and slightly SOB Pt was taken to ER for evaluation
AUTOIMMUNE DISEASES UNDER CONTROL; INITIAL REACTION WAS HORRIFIC; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced autoimmune diseases under control, and initial reaction was horrific. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) improving. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the autoimmune diseases under control and initial reaction was horrific was not reported. This report was non-serious.
COVID-19; COVID-19; 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-163-4444009-00 (Abbvie).  A 71-year-old patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1163244) at 15 mg 1x/day, oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID positive. The action taken for upadacitinib was unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
bad rash; It itched like crazy; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that an 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 24Feb2021 (at the age of 88 years-old), as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 03Feb2021 (at the age of 88 years-old), as dose 1, single for COVID-19 immunization and experienced lightheadedness/dizzy, super nauseous, vomit, sore arm, tired, and muscle soreness. After receiving the second dose, the patient experienced bad rash, and it itched like crazy on 28Feb2021. It was reported that on 28Feb2021, patient broke out with a bad rash. Patient's daughter reported this to the Pfizer system and patient wanted to reaffirm this information. He read the information a few days after this about a bad rash that could occur all over your body. It itched like crazy. Patient saw his primary doctor who prescribed a cream that helped a little bit. A week ago, patient saw his dermatologist who prescribed the same cream. Though the rash was starting to clear up on his legs and arms where he had it, now it's getting worse on his back and chest. As he was looking at it now, it's a little better today than yesterday. The outcome of rash was recovering while pruritus was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives all over my body hands,leg and tummy. Itchy and 5he effect lost for 10 to 15 mins then go away I have taken video and pics.
Only had sore arm for 1 1/2 days. Filling out VAERS as patient was only 17 years 6 months old at the time of the vaccination.
became terribly sick after the flu shot; Crippling pain; A year later he kept going from bad to worse.; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient's friend) via social media on 03-Dec-2020.  This case involves a  65 years old male patient who became terribly sick after the flu shot (Illness), had crippling pain (pain) and that for whom it was reported that a year later he kept going from bad to worse (general physical health deterioration), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date (unknown latency), the patient became terribly sick after the flu shot (Illness). The patient's doctor said he needed it and that the patient regretted taking it. On an unknown date (latency unknown) the patient was in crippling pain (pain) for four months. The reporter reported that the patient's health did not rebound and that on an unknown date (reported a year later), (latency unknown) the patient kept going from bad to worse (general physical health deterioration). The reporter also advised to build up the immune system and that the vaccines were not good for everyone. People can be allergic to components in the serum.   It was not reported if the patient received a corrective treatment for the events  Outcome of the events were unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Pt reports difficulty eating and falling at home for approx 1 week. Pt denies cough but did cough occ during encounter. No SOB. No fever. Pt's sister states that she was with him on 12/24 and he seemed his normal self and was not sick. When she talked to him on phone 2 days ago he seemed more confused than baseline. .
SPITTING UP BLOOD; TIGHTNESS IN CHEST; NOT FEELING WELL; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced spitting up blood, tightness in chest, and not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spitting up blood, tightness in chest and not feeling well was not reported. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
pt recvd vax;mom states pt had crying episode around 12:30am,16jun94, cont for 3 hrs;unconsolable;ran t of around 100;was relieved by apap;to er around 3am on 16jun94;shortly p/ arrival in er,crying stopped;EMD said pt was fine;
Initial report was received from a consumer, who was also the patient's mother, on 13 December 2011. A 30-year-old male patient (date of birth not reported) had received an intramuscular injection in the left arm of INFLUENZA vaccine (manufacturer, lot number and exact date of administration not reported) in 2010. The patient's left arm had been hurting since the vaccine last year and the doctor said it may be tendonitis. It was not reported if the patient had any illness at the time of vaccination, pre-existing medical conditions or took any concomitant medications. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Vomiting, high fever 102.5, screaming, extremely sleepy, diarrhea, refusing to eat or drink. Extreme fussiness and irritability.