chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per clinical notes: 19 y/o male who developed mildly pruritic skin lesions over bilateral hands, primarily knuckles & right palm, & bilateral elbows approximately 15-16 days following receipt SPV (1/30), AVA#! (1/29) & typhoid (1/29) vaccines. On initial medical exam by PCM 2/15, lesions described as maculopapular on erythematous base w/o discharge or ecchymosis. By 2/19, similar lesions also noted over both knees; there were no systemic symptoms; initial working diagnosis was inflammatory psoriasis & he was prescribed MEDROL dose pack & antihistamines. Per consult 2/20, punch bx taken from right elbow & oral steroids increased to pulse, with addition to topical steroid: working diagnosis changed to hypersensitivity reaction to SPV. By 3/2 all lesions resolved. IZ record indicated past positive titer VZV.
large local reaction 20 x 25 cm plus 15-20 red macules, less than 1 cm each on chest.
I had a sore arm, chills and fatigue about 48 hours after the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: PH9992), in left arm 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: "Rheumatoid arthritis" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "heart attack", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
3:45 pm mother complains of rash. Rash noted on right ear and right cheek. Breath sounds clear bilaterally. BENADRYL 5 mL PO given. Frequent checks on pt with no changes within 20 minute time frame. Mother instructed to seek emergency evaluation if difficulty breathing, wheezing, or rash worsens. Continue OTC BENADRYL for next 24 hours.
severe pain at the site where the tip of the syringe entered his arms at the time of injection; taken away mobility in his arms; makes it difficult for him to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), 8 months after the suspect product(s) administration, outcome "unknown", described as "severe pain at the site where the tip of the syringe entered his arms at the time of injection"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), 8 months after the suspect product(s) administration, outcome "unknown", described as "taken away mobility in his arms"; INSOMNIA (non-serious), 8 months after the suspect product(s) administration, outcome "unknown", described as "makes it difficult for him to sleep".  Additional information: It was reported that the patient received his first dose in the left arm and one month after the second dose in the right arm, approximately 7 months later, experienced events. The pain was very severe and had reduced the mobility in his arms. The pain was very severe when he lifts his arms, his left arm has lost approximately 50% of mobility. He works in a restaurant and this had made it difficult for him to carry heavy objects like pots. The pain he feels was internal. He also wanted to know what he can do to reduce the pain. Reported that he may call in the future to review if his pain treatment could interfere with his vaccination schedule. If the pain continues, he would have to stop working.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At site of injection arm was hot, tender and there was swelling. Pt had been applying ice the inflammation is going down. Advise pt to continue icing and to take BENADRYL and apply Hydrocortisone 1%.
Developed shingles after 3rd shot.  6/3/08 Reviewed PCP medical records & vax records.  Patient received HPV #1 0928U 10/15/2007 LUE; HPV #2 1266U 12/14/2007 LUE; & HPV #3 as reported.  No mention of shingles in notes provided.  Patient's twin sister had shingles after HPV #3 on different dates.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves an adult patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  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 the guidelines. 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Pain in muscle and bone on upper arm and shoulder that has not abated in several days; stiffness and sharp pain near injection site; pain has become unmanageable even with ibuprofen
I started to develop a head fog the day after which also caused pressures to my head then developed to neurologic discretizes between speaking and thinking was becoming impaired. It wasn?t based off my coworkers, but I felt like I wasn?t talking correctly. The head fog and neurologic discretizes. So much so I ended up looking for pronunciations videos because I felt like I wasn?t speaking properly. The pressure was server like a 10 it felt like my head was in a vice and no over the counter medication did not help. My family doctor prescribed prednisone and said that she had heard of other side effects had been reported. I didn?t take the medication out of fear of further side effects. The symptoms took close to three weeks to resolve. At the 6 week point I started to feel like myself again.
A few hrs after shot,  suddenly had both significant difficulty breathing and significant chills, trembling. Super hot steamy bath with menthol, heavy robe, electric blanket on high dissipated in a couple hours. ScareyKindsscarey!
Pt came in and stated that he wanted a booster shot. When asked which one he wanted, he stated that he wanted the Janssen shot. After administering the vaccination, the pt stated that he did not have his previous vaccination card but said that he received his other shots here and asked if I could make a new card for him. I said yes and that was when i realized that he previously received Pfizer and this should have been the second shot in his series and not a booster.
WHEN SHE TOOK THE NEEDLE OUT OF  ARM, SHE ACCIDENTALLY PITCHED FORWARD AND POKED HER LEFT INDEX FINGER WITH THE DIRTY NEEDLE.  WASHED HER HANDS FOR 2 MINUTES WITH SOAP AND HOT WATER AND PUT A BANDAID ON.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. On June 2015 (reported as since 10-JUN-2015), the patient were administered doses of improperly stored VARIVAX (Merck), (lot #, dose and site of administration were not reported) subcutaneously. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt developed 3" erythema around injection site, nausea, headache, and small red rash around injection site.
Information has been received from a physician concerning a female who was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced loss of sensation and use of her arm, numb paralysis which lasted for several days and weeks. The physician did not know if this was caused by the vaccine or the administration of the vaccine. At the time of the report, the patient was recovering. Loss of sensation and use of her arm, numb, paralysis were considered to be disabling. Additional information has been requested.
I got the shot they had to clean up my arm because I was cleaning and put pressure on the arm. I sat for 30 mins. My chest felt a little funny. about 9am my face was really red, I got my BP checked 188/85 Oxygen was good and Dr said  to take benadryl and took two right away and I took 2 more after 6 hours, symptoms subsided that evening. My BP stayed high and I felt not good, I had pressure in my chest and some pressure on the left and right side of my breast,  BP was 177 at 4pm. I went home to bed I woke up with pressure again in my chest. I went to the Dr and he said come back in two weeks and see how you are, I went in this last monday and he put me on medication for high blood pressure
Extreme achiness; extreme fatigue; clogged sinuses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: COVID prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot No: El3247; Anatomical site: arm Left), administration date: 01Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot No: EP6955; Anatomical site: arm Left), administration date: 24Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot No: FL3197;, Anatomical site: arm Left), administration date: 19Jan2022, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 17Dec2022, outcome "recovering", described as "Extreme achiness"; SINUS CONGESTION (non-serious) with onset 17Dec2022, outcome "recovering", described as "clogged sinuses"; FATIGUE (non-serious) with onset 17Dec2022, outcome "recovering", described as "extreme fatigue". Therapeutic measures were not taken as a result of pain, fatigue, sinus congestion.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The patient received medications within two weeks of vaccination included Protoxin. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.
Patient complained of swelling lip, burning in mouth (said it felt like he was drinking hot sauce), irritation at injection site.
This spontaneous report as received from a 70 year old female patient who is also a registered nurse refers to her. The patient's current condition included hypertension, environmental allergies and seasonal allergies. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiry date not reported) in the left posterior upper arm. Concomitant therapies included atenolol, losartan potassium and HYDRODIURIL. On 04-NOV-2014, the patient's injection site was red, itchy, warm, induration and swollen to the size of a grapefruit. She did not consult her healthcare provider, but she did show her injection site reaction to the pharmacist at her local pharmacy. She reported that the pharmacist stated of never seeing an injection site reaction that bad. She also reported that she did not take any pharmaceutical therapy for the injection site adverse symptoms but treated with cold compresses. On 10-NOV-2014, her injection site was just pink and the swelling has improved. The outcomes of the events injection site itchy, warm, indurated was unknown. She did not experience any other adverse effects and she did not develop a rash. Hence VZVIP was not offered to her. The causality of the events were unknown for ZOSTAVAX. A product quality complaint (PQC) was not involved. Additional information has been requested.
Tested positive for COVID; A spontaneous report  was received from consumer, concerning herself, a female patient who received Moderna's covid-19 vaccine (mRNA-1273) and tested positive for COVID.  The patient's medical history and concomitant medication was not provided.  On an unknown date the patient received first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of covid-19 infection.  On an unknown date the patient tested positive for COVID (Coronavirus test positive).  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event coronavirus test positive was unknown.; Reporter's Comments: Although limited information has been provided, based on the known etiology of the disease and known profile of the vaccine, the event is assessed as unlikely related to mRNA-1273 vaccine.
The patient developed a severe local reaction at the left deltoid site of the pneumovax immunization. The vaccine was given on 4/1/05 and the reaction began on 4/3/05. She was seen and admitted to the hospital on 4/6/05 with a fever of 40 degrees centigrade. The admitting diagnosis was "Cellulitis". The patient was given IV antibiotics and improved. Medical redords include hypokenesia, erythema, headache and malaise.
Information has been received from a physician concerning a male who "around October, November or December 2007" was vaccinated in the arm with a 1st dose of pneumococcal 23v polysaccharide vaccine (lot# not reported). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown) administered in the same arm. Subsequently the patient experienced severe body aches and pain after receiving his vaccinations. The patient outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Baby lost ability to control head, lost all mobility and ability to roll. Infant was also having what seemed to be mini seizures.
First symptoms to appear were noticeably sore right arm and fatigue about six hours after injection.  About eleven hours after shot I had headache, feeling of irregular body temperature, nausea, body aches..  I took Pepto-Bismol for the nausea which helped.    About 24 hours after the injection I experienced sore armpit/lymph nodes of shot arm.   All but the symptoms except the sore armpit/lymph nodes  were mostly gone within 30 hours of the shot.  The lymph nodes felt better a day or two later.
This spontaneous pregnancy report as received from a nurse refers to a 24 year old female patient of unknown age. No concomitant medication or medical history were reported. On 01-MAY-2015, the patient was vaccinated with a dose of M-M-R II (route, lot #, and expiration ate were not reported). Concomitant medication was not reported. The reporter stated that on an unspecified date the patient found out she was pregnant. The patient's last menstrual period (LMP) was reported as 30-MAR-2015, estimated delivery date (EDD): 04-JAN-2016. The patient sought medical attention, she went to the office. Additional information has been requested.
Sluggish; pain on the left arm, feels as if some one punched; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) and VACCINATION SITE PAIN (pain on the left arm, feels as if some one punched) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced SLUGGISHNESS (Sluggish) and VACCINATION SITE PAIN (pain on the left arm, feels as if some one punched). At the time of the report, SLUGGISHNESS (Sluggish) and VACCINATION SITE PAIN (pain on the left arm, feels as if some one punched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified medicines for heart conditions. Treatment information was not reported.   Reporter did not allow further contact
Painful cramps; onset of period even though I no longer get periods due to my birth control (Mirena); itchy tongue; numbing of tongue; change in taste for several hours; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201, expiration date not reported), via an unspecified route of administration, administered on the left arm on 27Feb2021 12:30 (at the age of 25-years-old) as first dose, single for COVID-19 immunisation. Medical history included food allergy (shellfish), oropharyngeal squamous cell carcinoma (HPV), obesity, migraines, and ongoing contraception (on birth control). The patient previously received glutaraldehyde (manufacturer unknown) and experienced drug hypersensitivity. Concomitant medications included bupropion (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; magnesium oxide (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported; fish oil (OMEGA 3 [FISH OIL]) taken for an unspecified indication, start and stop date were not reported; and levonorgestrel (MIRENA); taken for contraception (birth control), from an unspecified start date and ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient also reported that she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced painful cramps, onset of period even though she no longer get periods due to her birth control (MIRENA), itchy tongue, numbing of tongue, and change in taste for several hours on an unspecified date. The patient did not received any treatment for the events reported. The outcome of all events reported was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
1. Minor headache 2. Moderate pain in left underarm. Minor swelling of lymph node in the same area. I feel discomfort when trying to place my arm against my body. I have to keep arm extended to avoid discomfort.
Patient received vaccination at 1:45 P.M. At 1;50 p.m. the patient collapsed. Her throat and tongue were swelling and she was having trouble breathing. She was not unconscious.  At 1:52 p.m., epinephrine 0.3mg was administered to patient.  She began to recover and swelling started decreasing, She was able to breath again.  Shortly after this, the patient began to have more swelling of throat and tongue. Another dose of epinephrine 0.3mg was administered at 1:55 p.m.  Again, the epinephrine worked quickly and patient was able to breathe again.  The ambulance arrived and took patient to local medical facility.
low grade fever (100.3), fatigue and headache beginning about 14 hours post dose
Red arm near shot site of MODERNA vaccine Also supraclavicular lympg node swollen Mild side effects Have photograph if needed
fever, chills, generalized body aches, cough, and nausea, vomiting, and diarrhea
Information has been received from a physician concerning an 18 weeks male patient, who approximately on 01-JUL-2011, when he was 10 weeks, was vaccinated with the first dose of ROTATEQ (Lot #, dose and route not reported), then on 02-SEP-2011, when he was 18 weeks, the patient was vaccinated with the second dose of ROTATEQ (Lot #, dose and route not reported). Concomitant therapy included PREVNAR on 02-SEP-2011. The physician reported that on 02-SEP-2011, one hour after receiving the second dose, the patient acted odd, out of character, clenching his jaw and moving his head according to the patient's mother. The physician stated that the patient sought unspecified medical attention by calling the physician. The patient was no given any treatment for the events. On 02-SEP-2011, the symptoms resolved on their own after fifteen minutes. No further information is available.
First time outbreak of Herpetic lesion on buttocks- zoster or simplex- awaiting culture.   Rx:  acyclovir
Approximately, 20 minutes after receiving MMR vaccine, pt c/o itching all over and nausea. Urticaria found at injection site and her abdomen. Pt was taken to her PMD and received "an injection" and diphenhydramine capsules. Client states sx resolved within an hour and was released.
1.5 days after vaccination, I woke up feeling like I had a horrible hangover. I had a migraine, nausea, dizziness and lightheadedness. I felt like I could vomit. My stomach was torn up, cramping and burning. I was clammy and sweating 100% of the time. I had debilitating fatigue. I was sleeping a lot. My chronic pain was much worse. My arthritis was inflamed. I was unable to do anything but lay in bed or help myself to the bathroom. This was all the time!! I am very sick still.