chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful burn / rash all over hands; Painful burn / rash all over hands; He has brown spots on the tops of his hands.; The burn are did go to his other pointer/index finger and across his other fingers; Everywhere he had the sores it's been peeling and he has these bright pink spots all over his hands; he couldn't even lift his arm up; sleeps on his left side and he couldn't sleep the night he got the vaccine; his arm was super painful; He felt so mad; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 13Apr2021 (at the age of 32-year-old) as dose 1, single for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021, he reports he sleeps on his left side, and he couldn't sleep the night he got the vaccine. On 15Apr2021 the patient experienced painful burn / rash all over hands, he has brown spots on the tops of his hands, the burn are did go to his other pointer/index finger and across his other fingers, everywhere he had the sores it's been peeling and he has these bright pink spots all over his hands, he couldn't even lift his arm up, and on unknown date in Apr2021 his arm was super painful and he felt so mad. It was reported that, he's left-handed and the day he received the COVID 19 vaccine was the worst day, he couldn't even lift his arm up. His arm was super painful. He tried to sleep on his back, and he'd roll over onto his arm and wake up in pain. He took pictures of his hands every day. He has pictures to show. He took pictures of his hands to a friend of his who was an emergency room doctor and his doctor friend told him that he's definitely having a reaction to the COVID 19 vaccine. He went back to the facility that gave him the COVID 19 vaccine and the person at that facility told he should not get the second vaccine and that he should see his primary care doctor. He sent these pictures to his doctor friend. The clinical outcome of the event painful burn / rash all over hands, was not revered and while the outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.
10/10 Pt. states having localized redness in an area on her deltoid muscle approximately 1 inch in diameter - some itching at site noted as well. S/S appeared the day after the vaccination. Denies S.O.B. and any breathing problems. Call back next day - pt. states all better - no further problems. All clear 2 days after vaccination.
Vaccines given, declined OJ, pt states had big breakfast, observed for 15 min, while observing pt felt light headed, muffled hearing, states "vision started to become blurry." Pt placed in supine position, cool compress to forehead, OJ provided. BP taken 10:47 AM 92/63 HR 93. Pt states vision has cleared, provided OJ and lollipop, 10:52 BP 91/68 HR 80, Pt states hearing is now normal.  10:58 AM 93/60 HR 83, pt verbalizes feeling normal.  Pt sitting up and standing w/no problems. Pt and mom feel comfortable heading home--discharged to home w/mom.
Irritation/redness/swelling - around injection site - 2 1/2 inch diameter. Warm to the touch. Itchy. Treated with PRELONE TAPER dose and ZITHROMAX.
Information has been received from a literature article concerning a 12 year old female patient developed uveitis, retinal hemorrhage and vitreous floaters following administration of GARDASIL and tetanus toxoid vaccine. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in 1 case; the time to onset in this case was of 58 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
loss of some taste; Throat felt sore; blister inside of her lips, swollen lips; swollen lips; itching on entire left  arm/Arm felt itchy; Sore blister in her mouth on the inside of her lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced LIP SWELLING (swollen lips). At the time of the report, LIP SWELLING (swollen lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Sender's Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Had hives and they are lasting for over 7 months/it was going away but two weeks ago she had another flared up and it felt like when it first started again; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Had hives and they are lasting for over 7 months/it was going away but two weeks ago she had another flared up and it felt like when it first started again) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), LEVOCETIRIZINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Had hives and they are lasting for over 7 months/it was going away but two weeks ago she had another flared up and it felt like when it first started again). At the time of the report, URTICARIA (Had hives and they are lasting for over 7 months/it was going away but two weeks ago she had another flared up and it felt like when it first started again) had not resolved.            Treatment for the event included antihistamines.   This case was linked to MOD-2021-354823 (Patient Link).
Initial report received from a physician on 06 Jul 2010: It was reported that on 02 Jun 2010, the patient was inadvertently received an intramuscular dose of MENVEO (batch number 027011) instead of GARDASIL in her left arm. The patient complained of burning, swelling and warmth at the injection site that spread down to her arm on 02 Jun 2010. The patient also received varicella injection and TDAP vaccine on 03 Jun 2010. The outcome of the events was reported as complete recovery on 04 Jun 2010. The seriousness and causality were not reported.
First started experiencing body aches in left arm then whole body.  Very tired and nauseous.  Unable to sleep during night due to being nauseous.  Next day spent sleeping woke up feeling a bit better still very tired, not much of appetite.  Following day feeling better but still get lightheaded and tired.
The glands in my neck swelled on the left side and were very tender. They lasted for about a month. I was going to have a sonogram of the neck but by the time the appointment they went away.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. In March 2014 - reported as within the past 10 days - the patients were vaccinated with PNEUMOVAX 23. Indication for use, route of administration and anatomical location of the vaccination, dose number and dose were not reported. The administered vaccines were expired, the reporting pharmacist believed that the vaccines had been expired as of the end of February 2014, though he could not confirm the exact expiration date. No adverse events or outcome were reported. Additional information has been requested.
Vial of Pfizer was not diluted and patient received a full vial of pfizer vaccine undiluted
Per client:  redness at site, fever by noon and fever next day.  Firmness to site, hives extending outward from site down to left elbow; mid chest pain to left shoulder (left arm flu shot).
10/21/09 - Injection site (left arm) sore, left arm numb to hand; pain in left chest and throat; insomnia 10/23/09 - 8:00AM; Fatigue; stuffiness; 1:00 PM - Fever, cough, extreme fatigue and stuffiness 10/24/2009- Morning all previous symtoms worse
pt recv vax 23APR97 & 7MAY97 pt devel a rash;
Temperature normally is 97.6 I went up to 98.6; I would be hot one moment and cold next; My hands and feet were extremely painful because they felt so cold to me; Raynaud's was triggered my hands and feets were extremely painful because they felt so cold to me which has never happened before; I woke up with the worst migraine; Chills feeling like I was going to vomit; Chills feeling like I was going to vomit; My hands and feet were extremely painful; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the second of 2 reports. A 46-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular, administered in right deltoid on 20Mar2021 11:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Ehlers-danlos since birth, Hashimoto's from 1989 and ongoing, ongoing Raynaud's, thyroid disorder and blood pressure abnormal. No prior vaccination. Concomitant medications included levothyroxine taken for thyroid disorder from an unspecified start date and ongoing; metoprolol, losartan and amlodipine all taken for blood pressure from an unspecified start date and ongoing. The patient took first dose of BNT162B2 on 27Feb2021 at 11:45 AM (Batch/Lot number: EN6202) via intramuscular administered in right deltoid for covid-19 immunisation in which patient had a mild headache for 4 days then it went away. Upon receiving the second dose on 20Mar2021 patient was fine until 2 am (21Mar2021) and woke up with the worst migraine patient had ever had and chills feeling like patient was going to vomit. Patient's body temperature normally was 97.6 and it went up to 98.6 which was normal but patient would be hot one moment and cold the next. Patient had Raynaud's, Hashimotos and third autoimmune disorder tat they had not given a name to yet. But even being cover with blankets patient's Raynaud's was triggered patient's hands and feets were extremely painful because they felt so cold to patient which had never happened before and by 9 AM Monday morning (22Mar2021) it stopped. The migraine stopped at 7 PM and from that point on patient had felt fine no other symptoms or issues. The outcome of events Chills feeling like patient was going to vomit, Temperature normally was 97.6 went up to 98.6, hot one moment and cold next was unknown, of other events was recovered on 22Mar2021.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021335589 same patient, same product, different dose, different events.
DTaP #4 was ordered on 6-11-08,PCV7 was inadvertently administered instead of DTaP. The  mistake was discovered soon after administration, the mom was informed and the fourth dose of DTaP was also administered.  The child had already received 4 doses of PCV7, appropriatly spaced, on 5-2-07, 7-3-07, 9-12-2007, & 3-10-2008.
STEMI secondary to  mid LAD spontaneous coronary artery dissection (SCAD).  Most likely due to post-partum condition.  Reporting for documentation.
1st dose 24Jun2019, 2nd uncertain; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th June 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The medical assistant reported that a patient received the 1st dose of Shingrix and believed she received a 2nd dose.  The HCP did not had record of 2nd dose and might give her another dose (potential late dose or 3rd dose). The reporter consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This case was reported by a pharmacist via sales rep and described the occurrence of swelling in a 62-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date unknown) for prophylaxis. Concurrent medical conditions included Sjogren's syndrome. Concomitant products included TWINRIX. On 4th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced swelling, erythema and injection site burning. On an unknown date, the outcome of the swelling and erythema were recovering/resolving and the outcome of the injection site burning was not recovered/not resolved. It was unknown if the reporter considered the swelling, erythema and injection site burning to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. On 4th October 2018, the patient received last dose of TWINRIX (batch number: 53AT5) on left arm. No complaints were observed with TWINRIX. Swelling, redness and burning were experienced after receiving SHINGRIX and the redness and swelling was disappearing at the time of reporting. Burning feeling persisted at the time of reporting and it started at injection site but felt like it was spreading down the right arm, right shoulder and neck area. The patient had not seen a physician prior to reporting this case, pharmacist would advise patient to follow up with physician provider. The reporter agreed to be followed up from GlaxoSmithKline.
Patient vaccinated at 10 am at 6 pm had fever, chills, body aches, nausea and vomiting  today low grade temp, headache and body aches
Next day at noon developed severe vertigo, sweating, nausea, and vomiting.  Went to local Hospital emergency room.  ECG and lab work normal. Two days later, woke up with sweating, vertigo, and vomiting.  Went to local Urgent Care.  Given meclizine and anti nausea med.
tip of her nose and tongue were numb; fully incontinent of urine; unable to lift her arms; throat hurting; could not swallow; feeling cold; shaking; weakness in legs; difficult to stand up; Initial information was received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves 79 years old female patient who experienced unable to lift her arms, throat hurting, could not swallow, feeling cold, shaking, weakness in legs, difficult to stand up, tip of her nose and tongue were numb and fully incontinent of urine after receiving vaccine Influenza Quadrival A-B high dose HV Vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included Tetanus Vaccine after which she did have a bad reaction 25 years ago. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Drug allergy and Sjogren's syndrome.  On 05-Oct-2022, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (with lot UJ875AC, expiry date: 30-Jun-2023, strength, formulation: unknown) via unknown route in unknown administration site for prophylaxis.  On 05-Oct-2022 (latency: same day) the patient developed non-serious events of unable to lift her arms (limb discomfort), throat hurting (oropharyngeal pain), could not swallow (dysphagia), feeling cold, shaking (tremor), weakness in legs (muscular weakness), difficult to stand up (dysstasia) following the administration of influenza quadrival A-B high dose HV vaccine.  On 06-Oct-2022 (latency: 1 day) the patient developed non-serious events of tip of her nose and tongue were numb (hypoaesthesia) and fully incontinent of urine (urinary incontinence) following the administration of influenza quadrival A-B high dose HV vaccine.  No lab data was reported.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Information has been received from a pharmacist via a field representative referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route unknown). The patient might currently have shingles (start date unspecified). The reporter did not provide the causal relationship of shingle and ZOSTAVAX. Additional information has been requested.
blotchy skin near injection site of DTaP.  Fever next day.  Started day after fever.  Children's Motrin and Tylenol given.
Covid arm after two days.  Rash, red, swollen, hard, HOT.  At injection site and below injection site.  Not above.
diarrhea; first 24-48 she was feeling horrible; loss of apettite; myalgia; fever; vomiting; headache; rash in the back; This spontaneous case was reported by a health care professional and describes the occurrence of DECREASED APPETITE (loss of apettite) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DECREASED APPETITE (loss of apettite). At the time of the report, DECREASED APPETITE (loss of apettite) 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.   Patient took Tylenol and Benadryl as treatment.
Pt. reported a skin reaction at injection site that was 2" around red, hot area. Looked like red circle around injection site surrounded by pink circle with dot in center of red circle. Dr. prescribed Keflex after 6 days of antibiotic, area started to improve.
Developed fatigue, joint pain and severe headache 8-10 hours after injection.  Symptoms became worse from 10 to  35 hours after.
Information has been received from a health worker referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, strength, route and lot# were not reported). No adverse experiences were reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 13-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K021030, expiry date 22-JUN-2016 (strength, dosing details, anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
AFib; Lightheaded; Pain in the right rear back and couldn't bend over to tie shoes; A spontaneous report was received from a male consumer 75-year-old who experienced, a sore Arm/Pain in Extremity, Afib and lightheadedness.  The patient's medical history was not provided. Products known to be used by the patient within two weeks prior to the event was simvastatin, tadalafil, androgel, prevision, magnesium, vitamin D3, vitamin B12, calcium and fish oil.  On 04-Feb-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 Intramuscularly for prophylaxis of COVID-19.  On unknown date, the patient experienced sore arm, lightheadness, lasted for 3-4 days and went away.   On unknown date, the patients vitals were checked and the heart rate was elevated to 148 and was admitted to the hospital. EKG and pulse rate was irregular. The patient was diagnosed with A fib. Treatment included apixaban, metoprolol and fluids.  The patient received both doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome for the events, sore arm, lightheadness and A-fib was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
numbness & weakness of lt face, arm, leg & chest pressure lasting 30 sec to 2 mins (10-30 times/day); no improvement on ASA, ticlid, phenytoin, phenobarbital, procardia;
rt leg became stiff, area of hard redness around inj site size of a coffee cup; pt does not want to bear weight; daycare called mom to pick up child;
Patient had well child exam 1/22/07, received Influenza vaccine, Hepatitis A, Menactra.  1/24/07 patient returned to clinic with complaints of  dizziness, headache, chill, green/yellow nasal drainage, bodyaches. Sites free from any s/s of infection or irritation/ VSS no temp.  Patien informed by PA-C to increase fluids, take tylenol/motrin for the bodyaches, RTC if sx increase or any other complication arise.
Left deltoid swollen, hot to the touch. Redness covers upper (L) arm, starting just above the acromion process to just above the elbow (6.5 inches), continues around the entire arm. The reaction is confined to the upper (L) arm. This reaction noted on 3-6-19.