chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient has panic attacks from all medical procedures even blood pressure readings at the MD office. He felt faint and asked to lay down. Patient did not want intervention due to his deep fear and dread of medical facilities in general. Wife said this happens and if I would step away she would monitor and get us if needed. To respect patients wishes we put a fan on him while he laid on the floor with a pillow and wife gave him some electrolyte fluids by mouth.Better within 30min left on own will
Skin rash; Pins and Needles feelings on skin; Burning feeling; Worse with warm temperatures and exercise; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old female patient received her unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8735) via an unspecified route of administration on the left arm on 22Apr2021 at 9:30 hours (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Afib (atrial fibrillation) and a bad lower back. The patient received unknown medication as concomitant within 2 weeks of vaccination. The past drug history of the patient included penicillin, sulfur drugs and contrast dyes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient was not tested positive for COVID-19. On 23Apr2021 the patient experienced Skin rash, Pins and Needles feelings on skin, burning feeling and worse with warm temperatures and exercise. The clinical outcome of the events skin rash, pins and needles, burning skin and pyrexia were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Injection site was red, swollen, hot to touch, diameter of reaction was over 3 inches
Immediate arm swelling and pain.  Lymph-node swelling (under left vaccinated arm) swelled to size of small orange within 12 hours; swelling and intense stabbing pain in lymph node continued for over 10 days.  mild fever and severe body aches for over seven days.  muscle in arm and chest muscle from armpit to collar bone swelled to almost double normal size, swelling lasted for over a week.  stabbing chest pain in middle of chest, no difficulty breathing. heart rate and blood pressure elevated  in week two, developed extreme rash over large portions of body, skin hives and swelling continued for up to four weeks.  after four weeks,  most swelling subsided, chest pains going away, heart rate, blood pressure are normal  skin sensitivity remains, skin welts easily with slight touch or scratch  after four weeks
Parent called to our facility less than 1 hour after leaving the office. Patient complained of scratchy throat. 20 min afterwards the patient was found to have a generalized rash - (hives) erythematous wheals. Tx BENADRYL.
This is a spontaneous report from a non-contactable consumer (patient's parent). A female patient of an unspecified age and ethnicity received the 2nd dose of TRUMENBA via an unspecified route of administration at single dose on 23Jun2017 at around 2 O'clock for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the 1st dose of TRUMENBA on an unknown date for immunisation. Starting on 24Jun2017 morning she did not had much energy, she was a kind of swollen around the vaccination site and she was just really tired. The reporter was concerned because the patient was actually leaving for 3 weeks of school tomorrow. The reporter was going to call the Pediatrician. No follow-up attempts are possible. No further information is expected.
9 months after his two first Pfizer vaccines, he developed type 1 diabetes. There was no other major viral illness. Per endocrinologist, his pancreas had been failing for 6-12 months. This lines up with his COVID vaccines.
Intrauterine fetal demise at 16 weeks by dates, measuring 15 weeks by crown rump length
Immunocompromised patient received 2 full does and a booster (improper series); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received 2 full does and a booster (improper series)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant since an unknown date. Concurrent medical conditions included Immunocompromised.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received 2 full does and a booster (improper series)). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received 2 full does and a booster (improper series)) outcome was unknown.        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
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: Pt felt lightheaded after receiving vaccine. Instructed to sit for a few minutes before heading to the post vaccination area. Pt fainted within 10 secs onto the immunizer (me). Asked for help to move pt to a lying down position. Upon lifting pt up, her body/arms seized up. Asked someone to call 911 and I went to grab an epipen just incase. Within 5 secs, patient woke up, so did not admin epi. Pt was alert but did not know what happened. Pt refused ambulance, left after 30 min, was feeling ok.
The day after the 1st dose I developed bumps on my left heel and ankle which were itchy and burning. I tried Benadryl but it didn't help. They following morning the pain was worse and I couldn't put weight on my leg. I went to the doctor. 1 week later and got some ointment and pain medication. They went away a few days later.
Malaise; Headache; draggy/ feel as draggy; Possibly a slightly elevated temp; This case was reported by a consumer and described the occurrence of malaise in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced malaise, headache, feeling abnormal and body temperature increased. On an unknown date, the outcome of the malaise, headache, feeling abnormal and body temperature increased were unknown.   It was unknown if the reporter considered the malaise, headache, feeling abnormal and body temperature increased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had shingle ricks vaccination last evening, from day of vaccination. The patient felt malaise, headache on day of reporting and enquired how long does that typically last. The patient reported possibly a slightly elevated temperature. The patient was surprised to feel as draggy and headachy on day of reporting. The follow up was not required.
Symptoms started last night, around bedtime, been dizzy; Sick to my stomach; Arm is very sore; Back where my ribs are is killing and body is itching me; Nauseas this morning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Symptoms started last night, around bedtime, been dizzy), ILLNESS (Sick to my stomach), PAIN IN EXTREMITY (Arm is very sore), PRURITUS (Back where my ribs are is killing and body is itching me) and NAUSEA (Nauseas this morning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Symptoms started last night, around bedtime, been dizzy), ILLNESS (Sick to my stomach), PAIN IN EXTREMITY (Arm is very sore), PRURITUS (Back where my ribs are is killing and body is itching me) and NAUSEA (Nauseas this morning). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Symptoms started last night, around bedtime, been dizzy), ILLNESS (Sick to my stomach), PAIN IN EXTREMITY (Arm is very sore), PRURITUS (Back where my ribs are is killing and body is itching me) and NAUSEA (Nauseas this morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
pt recv 2 doses of vax 9 wk apart;subsequently, it was reported that the pt failed to seroconvert;these findings were based on lab values, which were negative;
bad reaction from Gardasil 9; swelling; Neurology was called; This spontaneous report was received from a medical assistant via company representative refers to an adult female patient who was 23 or 24 year old. Information on patient's pertinent medical history, concurrent conditions, drug allergies/reactions and concomitant therapies were unknown by the reporter.  On an unknown date (also reported as "a few days ago") the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (anatomical location, lot/batch# and expiration date were unknown) at a dose of 0.5 milliliter via injection to prevent HPV(human papillomavirus) as recommended by health care provider.  On an unknown date after leaving the physician's office the patient experienced a bad reaction (adverse reaction following immunization) from HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and went to the emergency room of an unspecified hospital where the patient was "admitted over night for one night". The patient experienced "swelling" and "neurology was called" (adverse event NOS (not otherwise specified)) to treat the patient while in the hospital. The patient received unspecified treatment and sought medical attention. Information on lab diagnostics/studies were unknown. At the time of the report outcome of the events were unknown. The causality of the event adverse reaction following immunization was considered to be related to the suspect therapy, however causality of the other events were unknown. Product quality issue was not involved.
feeling bad/she is still "feeling crappy"; has swollen lymph nodes; is lethargic; has a low-grade fever; feels like she doesn't have the energy to take a shower.; 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 female patient received BNT162b2 (BNT162B2), on 11Aug2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, DOSE 2, Primary Immunization series completed, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 13Aug2022, outcome "not recovered", described as "feeling bad/she is still "feeling crappy""; ASTHENIA (non-serious) with onset Aug2022, outcome "unknown", described as "feels like she doesn't have the energy to take a shower."; PYREXIA (non-serious) with onset Aug2022, outcome "unknown", described as "has a low-grade fever"; LYMPHADENOPATHY (non-serious) with onset Aug2022, outcome "unknown", described as "has swollen lymph nodes"; LETHARGY (non-serious) with onset Aug2022, outcome "unknown", described as "is lethargic". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
administering dose post temperature excursion with reported adverse event; vaccine had multiple temperature excursion with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 years old female patient who was administered dose post temperature excursion with reported adverse event and vaccine had multiple temperature excursion with no reported adverse event ,while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA); HEPATITIS A VACCINE INACT (HEP A IN VAC); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 22-Jul-2022, the patient received a 5th dose of suspect IPV (VERO)( lot U1A452M and expiration date: 20-Feb-2023) at a dose of 0.5ml once via intramuscular route in the right arm for immunization.  On 22-Jul-2022, the patient was administered doses post excursion (poor quality product administered) (latency: same day). It was also mentioned  that the vaccines had multiple excursions (product storage error), the first on unopened MDV on 05-APR-2022 a high of 8.63C for 15 minutes, reporting a dose was administered post excursion but the MDV was sealed at the time of the excursion at 8.63C for 15 minutes and the second excursion occurring on 05-JUL-2022 at a high of 11.22C out of range for 10 hours, and on 18JUL2022 a low of 1.17C for 45 minutes, on 29JUL2022 at 10.93C for 12 hours, and on 06AUG2022 at 1.6C for 1 hour.   Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both 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.; Sender's Comments:  01226710: 01226726: 01226027:
Speech issues, speech problems; This spontaneous case was reported by a pharmacist and describes the occurrence of SPEECH DISORDER (Speech issues, speech problems) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced SPEECH DISORDER (Speech issues, speech problems). At the time of the report, SPEECH DISORDER (Speech issues, speech problems) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had intermittent speech problems. Reporter stated that he think it could be something neurological.  No concomitant medications were reported. No treatment medications were reported.
On day 10 after the injection, I developed cellulitis at the injection site where the skin was hot, red, and swollen. Also very painful. I developed a low grade fever (highest was 100.2) day 11. Day 12 I now also have moderately severe arthralgia to the affected arm, in the side of my neck as well as my shoulder, elbow, and wrist. I feel horrible and had to leave work.
Headache, body aches, cough - began 1/10/21 - 3 day s/p Pfizer 1st dose vaccine WAS NOT TESTED for COVID - his dr said not necessary - "his wife had it, he had it!"
Approx 6-7 min after receiving vaccine in left arm. Patient's mother expressed concern about her daughters reaction. She complained of headache, stomachache, weakness in her legs and her eyes rolled back in her head and her head dropped.
10/18/2001 5 PM resident vomiting, temp 101.3 RD had 5 cm raised area. Blotchy areas on thighs and groin. Ran a temp through 10/20/2001, vomiting noted only on 10/18/2001.
I've managed my Trigeminal Neuralgia without any pharmaceutical medication for over a year & half with medical marijuana. After my first vaccine shot I started having intense random flare ups. After my second shot my flares up were incredibly intense & were all day long.
Patient developed sore shoulder and adhesive capsulitis of (L) shoulder after Tdap injected in (L) deltoid 6/9/14.
Breakthrough infection began with mild cough led by fever, chills, headache and congestion.
IM injection in left arm/deltoid. Left arm erythematous, warm, sl. swollen. Elevated BP 200/120.
Slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Slight fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 003A21A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], GUAIFENESIN (MUCINEX), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), AZELASTINE HYDROCHLORIDE (AZELASTINE HCL), VITAMIN C [ASCORBIC ACID], ZINC, COLECALCIFEROL (VITAMIN D3), ASPIRIN [ACETYLSALICYLIC ACID], PROPRANOLOL, EZETIMIBE, SIMVASTATIN (EZETIMIBE/SIMVASTATIN), MONTELUKAST, ZALEPLON, CYCLOBENZAPRINE, HYDROXYCHLOROQUINE and AZITHROMYCIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (Slight fatigue). At the time of the report, FATIGUE (Slight fatigue) outcome was unknown.            It was reported that after their second dose the patient traveled Internationally and Nationally extensively.  No treatment medications were reported.   This case was linked to MOD-2021-411362, MOD-2021-411494 (Patient Link).
Per mother, on 2nd day of pneumococcal vaccine administration, pt had redness and swelling to right deltoid area and had a "low grade fever", did not measure temp increase, and slight pain to arm. On 3rd day of vaccine administration, 12/11/03, swelling and redness diminishing and fever resolved, no more pain to left deltoid area. Used warm compresses as instructed on day of vaccination.
ANGIOEDEMA AND ANAPHYLAXIS. 4/6/202021- SWELLING OF LEFT EYE- WENT AWAY IN 2 DAYS. 4-9-21 SWELLING OF ENTIRE FACE TOOK TO URGENT CARE AND GIVEN SHOT OF SOLUMEDROL AND A PREDNISONE PACK. 4-16-21 SWEELING OF EYES AND FOREHEAD GIVEN PREDNISONE PACK. 4-23-21 ANAPHYLAXIS ON A VENTILATOR FOR 43 HOURS AND ICU
Within about 15 minutes I experienced numbness in my shoulder, then clavicle into neck, it felt odd. About 20 mins after the shot the numbness spread into the left side of my face. It was extremely numb as if I had novacaine. The numbness lasted intensely for about an hour. Then it was periodically for  about 36 hours after the shot. I was very tired about 2 hours after giving the shot and that lasted about 24 hours. I could not pick up my left arm for 24 hours at all. It wasn?t until 3 days later that I could pick my arm up.
pt recv vax 13NOV97 & 30NOV97 pt devel vesicles & crescent lesions all over body w/itching;pt had greater than 50 lesions;pt was afeb;
Pt recv vax on 2/17/99; on 3/1/99 pt exp fine macular rash on torso & legs
Unilateral anterior uveitis, left eye.  Rapidly resolved with topical corticosteroids, with no sequelae.
slightly raised rash on upper chest on breasts and just below xiphoid process, also noted at base of back of neck: noticed 2/3/21 at 0830 at on neck but no further investigation until noticed at 1230pm that day before shower
This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On 09-JUL-2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 29-JUL-2013, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse event was reported. Additional information is not expected.
Has had right arm pain since first vaccine on 1/27/2021 with worsening pain when she lifts her arm, had second vaccine on 2/17/2021 without any adverse reactions
Diagnosed with COVID-19 on December 25.  Presented with sinusitis and fever.
nausea; muscle spasms in arms, legs, thumb, felt like collapse; Injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash.   On 18-APR-2023 09:30, the patient received Shingrix (intramuscular, unknown deltoid). On 18-APR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). On 18-APR-2023 16:30, the patient experienced muscle spasm (Verbatim: muscle spasms in arms, legs, thumb, felt like collapse). On 19-APR-2023, the patient experienced nausea (Verbatim: nausea). The patient was treated with ibuprofen (Motrin). The outcome of the injection site pain, muscle spasm and nausea were not resolved.   It was unknown if the reporter considered the injection site pain, muscle spasm and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, muscle spasm and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-APR-2023 The reporter was the patient, received vaccine yesterday at 9:30 am at her pharmacy. Seven hours after vaccination at 4:30pm the patient experienced muscle spasms in her arms and legs and felt like she would collapse due to the spasms. On the day of reporting the patient had muscle spasms in her thumb. In the evening, prior to the GSK receipt date, the patient had pain at the injection site which was not recovered. On the day of reporting, the patient had nausea, which was not recovered. The pharmacist advised the patient to take treatment with Motrin for pain. No more details was report. The reporter consented to follow up. This case is linked with US2023057558, for the same reporter.; Sender's Comments:  US-GSK-US2023057558:Same reporter