chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm is still quit sensitive; left arm turned real red, hot, inflamed and a burning sensation; left arm turned real red, hot, inflamed and a burning sensation; left arm turned real red, hot, inflamed and a burning sensation; localized rash then started spreading from shoulder to the elbow area; left arm turned real red, hot, inflamed and a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation) and VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, METFORMIN and tresiba insulin injection for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) and VACCINATION SITE PAIN (left arm turned real red, hot, inflamed and a burning sensation). At the time of the report, VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) and VACCINATION SITE PAIN (left arm turned real red, hot, inflamed and a burning sensation) 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.   Treatment includes Neosporin, hydrocortisone cream, Ice and antibiotics.
pt recvd vax on 18NOV93 & 20NOV93 devel a fever of 102; No further details were provided;
patient received 1st dose on 11/3/2022 at 45 years old, and 2nd dose on 5/17/2023 at 46 years old. Also, 2nd dose was given at 6 months after 1st dose instead of the rec; patient received 1st dose on 11/3/2022 at 45 years old, and 2nd dose on 5/17/2023 at 46 years old; This spontaneous report was received from a pharmacist and refers to a 46-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-NOV-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiration date, and route of administration were not provided).  On 17-MAY-2023 at 46-years old, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml  (strength, lot #, expiration date, and route of administration were not provided) (Product administered to patient of inappropriate age). The 2nd dose was given at 6 months after 1st dose instead of the recommended 2 months after first dose (Inappropriate schedule of product administration).
Information has been received from a 45 year old female patient who was vaccinated with two doses of GARDASIL vaccine (no lot number was provided). Subsequently the patient experienced unspecified problems. At the time of this report, the outcome is unknown. It is unspecified if the patient sought medical attention. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of an improperly stored RECOMBIVAX HB (lot #, expiration date, route and dose were not reported). No adverse effects were reported. This is one of several report received from the same reporter. Additional information has been requested.
I noticed my arms where the shots were given was itching, and swelling. When I woke up on 07/04/2014 both arms had a rash in the area of the shot. The rash spread down my arms, and 3 of my fingertips felt numb.
Patient started experiencing an itching rash all over body the evening after receiving the vaccine. She is treating with over the counter antihistamines and topical creams (Benadryl, aveeno)
pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program .  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 12MAR96 11AM & devel gen fussiness;13MAR fever of 99 ax,constant crying & screaming for over 3hrs,inability to nurse (breastfeed),inability to sleep;given APAP;d/t inability to suck breast a sleep period of 6hrs followed;
Pt. states that after receiving the 2nd dose of Moderna 12/08/2021, started experiencing symptoms 12/10/2021 of headache, low-grade fever, pain at the injection site, fatigue, and nose bleed with clots (15mins). Symptoms have subsided, tenderness at the injection site continues. No noted Primary visit/communications.
Information has been received from a registered nurse concerning an 8 year old white female student who has a twin sister and a history of having been treated for reactive airway disease in the past who on 7/9/96 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 616867/0243D). There was no illness at the time of vaccination. On 1/2/04 the patient broke out with lesions of chicken pox, had vomited one time, had a decreased appetite, and on and off fevers. The patient was seen in the office with 20-30 lesions with areas of cellulitis. The patient was prescribed cefadroxil. Subsequently, the patient recovered. Chicken pox, vomited one time, decreased appetite, and cellulitis were considered to be other important medical events (OMIC). No further information is expected. It was also reported that the patient's twin sister was vaccinated with a first dose of varicella virus vaccine live (lot # 616867/0243D) and also developed chicken pox, vomiting and cellulitis.
Itchy arm for 1 week following first covid vaccine (Moderna) with no redness.  8 days following vaccine, large, red and hot area appeared on same arm as vaccine, lasting longer than 1 week.
Pt received ZOSTAVAX yesterday, then last night both feet were red, itchy, swollen and "blotchy".
When mom arrived home p/working evening shift, noted pt's lt thigh swollen & stiff; brought pt to hosp noted pts lt thigh more swollen (asymmetrical) than rt, even sl below knee; no erythema or induration;
Mom noted few itch spots on abd 4 days ago. Spots increased over next few days.
24hr p/vax pt devel rash on face, neck, chest, T100 for 2 days then rash persisted for 2-3 more days;
A week after second dose pain  in Fingers in both hands especially around joints. Painful to grip things. Stinging pain sometimes on side of certain fingers. Two weeks later burning sensation in both hands intermittently and painful to the touch. It has been three weeks since I had this reaction and now I feel the burning sensation on tops of both feet. It is uncomfortable. I am also feeling the sensation in my arms now.
14 minutes after injection I had a heat rise up to my head and I became extremely dizzy,  nausea, headache, extremely high blood pressure/ heart rate, I was rushed o er to the Er and kept there for observation and until the dizziness wore off around 330pm. EKG was normal and blood work looked fine so thegg ugh said nothing was wrong and let me go.
No adverse symtoms reported; was inadvertently administered a dose of ZOSTAVAX via the intramuscular route rather than the recommended subcutaneous route on 08/07/2019; This non-valid spontaneous report was received from a pharmacist regarding an unspecified patient of unknown age and gender. Information about the patients' pertinent medical history, concurrent conditions, drug allergies or reactions, and concomitant therapies were not reported.  On 07-AUG-2019, the patient was inadvertently vaccinated intramuscularly, instead of the recommended subcutaneous route (incorrect route of product administration), with a dose of zoster vaccine live (ZOSTAVAX)(lot # S000618 with expiration date not reported, but upon internal validation was establish as 06-APR-2020) as prophylaxis (strength, dose number, and anatomical site of vaccination were not reported). The vaccine was reconstituted with sterile diluent (DILUENT MRK INJ)(lot # and expiration date were not reported). No adverse symptoms reported.  This is a non-valid case due to lack of patient identifiers.
Deep muscle pain in both arms and across chest. Fever, dizziness, Fainting.
Patient passed out and was unresponsive. She was breathing and had heart rate. Epinephrine was administered. Patient became coherrent. EMS transported patient to hospital for evaluation
No adverse rx noted. Mother was contacted (the same day as vaccinations provided) in the afternoon and stated that the child was happy and doing fine. Second contact attempted the next day.
pt recv vax & pt devel granuloma @ the inj site;pt was advised to apply warm packs, move the legs a lot & massage;the granuloma lasted for 1 to 4wk;
pt recv vax; presented to er, c/o sore lt arm; 5cm area of erythema around site of inject; sl warm & tender to touch; Keflex, dph, tylenol tiq ordered by MD;
I usually walk 2 miles and go up a hill,a couple of days felt short breath.; I started to feel dizzy.; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The medical history was reported as none. The concomitant medications of the patient included vitamin b complex (MANUFACTURER UNKNOWN), vitamin c (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), and biotin (MANUFACTURER UNKNOWN). The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, the patient experienced the events dizziness, vertigo.The patient used to walk 2 miles and go up a hill and on 22Mar2021, she felt shortness of breath for a couple of days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events dizziness, vertigo and shortness of breath was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 72, via an unspecified route of administration, in right arm, on Apr 14, 2021, at 17:30, single dose, for COVID-19 immunisation. The patient's medical history included known allergies to fruits and dairy; all from an unknown date and unknown if ongoing. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced palpitations, PAC (premature atrial contraction), PVC (premature ventricular contractions) and atrial trigeminy on May 14, 2021, 12:30 pm. Treatment received as a result of events: Propranolol. The outcome of the events: not resolved. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No follow-up attempts possible.
heart rate would increase to 110per BP cuff; oxygen woulddecrease to 90% per oximeter.; This is a spontaneous report from a contactable pharmacist. A 73-years-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: EP7534) via intramuscular route of administration in the arm left on 13Mar2021(at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes and palpitations on an unspecified date. Other medications in two weeks received by patient included metoprolol (MANUFACTURER UNKNOWN), budesonide; formoterol fumarate (SYMBICORT), hydrochlorothiazide (HCTZ), and fluticasone propionate (FLONASE), all taken from an unspecified date for unknown indications. The patient previously took Aspirin and experienced allergy. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown if the patient had been tested for COVID-19, since the vaccination. On 14Mar2021 the patient experienced heart rate increased and oxygen saturation decreased. The patient felt fine at the day of vaccine. Next day if she was sitting, patient felt fine. However, if she stood up and took a few steps her heart rate would increase to 110 per BP cuff and her oxygen would decrease to 90% per oximeter. She continued to feel this way for 2 weeks and suddenly felt better after 2 weeks. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of heart rate high and oxygen saturation decreased which included treatment with albuterol via nebulizer per pt. The clinical outcome of the events heart rate high and oxygen saturation decreased were recovered on 28Mar2021.  No follow-up attempts are needed. No further information is expected.
itchyness at  the site of the injection Fever or 103 and higher Cellulitis inflamation of the muscle continued muscle damage since event - treated symptomatically  for 2 days - doctor called on both occasions- saw doctor on day 3 -she suggested trying an anitbiotic for 1 day - if no imporvement then go to the ER the next day - went to the ER the next day - IV antibiotic and pregnisone
Nosebleeds/have had 11 episodes since then. Mostly from the left side, last 20 min to 65 min; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration in left arm on 12Mar2021 at 12:45 (Batch/Lot Number: EN6208) as (At the age of 68-years) dose 1, single for covid-19 immunisation. Medical history included hypothyroidism and glaucoma, known allergies: Sulfa. Concomitant medication(s) included levothyroxine 0.088mcg; latanoprost 125 mcg and vitamin taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, at 07:30 the patient experienced nosebleeds. Began 25Mar2021 and has had 11 episodes since then. Mostly from the left side, last 20 min to 65 min. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received no treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Soreness/tenderness at injection site. Vomiting and diarrhea, chills, fever, headache, body ache, fatigue.
It was reported that a pt (10 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested.
Headache, Fever, inj site pain, chills, body aches, fatigue, night sweats, disorientation  Narrative:
fever; shivering/could not get warm; headache; knocked down/ sickness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune system disorder.   On 4th December 2019, the patient received the 1st dose of Shingrix. On 4th December 2019, less than a day after receiving Shingrix, the patient experienced fever, shivering, headache and feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, shivering, headache and feeling unwell were not recovered/not resolved.   The reporter considered the fever and headache to be related to Shingrix. It was unknown if the reporter considered the shivering and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter  The last night before the time of reporting, she started experiencing a fever, shivering, could not get warm, and headache. The reporter could not find the heating pad last night to keep her warm. The patient was knocked down. The patient was not recovered.  The patient treated with Tylenol. The reporter did not know if her mother received the shot intramuscularly or not. The reporter did not have the lot number of the Shingrix which was administered in front of her she said that her mother may have that information but she did not want to disturb her as she was resting/sleeping. The reporter stated that she called the pharmacy where her mother got the injection to let them know that her mom was sick and they said that every once in a while people will be knocked down for a few days after getting injection with Shingrix.  The reporter wanted to find out what was in Shingrix that was making people sick for days. She wanted to know if it had preservatives in it.  The reporter was upset because her mother was supposed to go away but now that she is sick she cannot travel.  The pharmacist informed her that the median duration of side effect was 2-3 days. This case has been linked to the case US2019AMR232958, reported by same reporter.
This spontaneous report as received from a pharmacist refers to 4 patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates the patients were vaccinated with ZOSTAVAX lot # M042851 for prophylaxis, which were exposed to temperature excursion of 15 to 46 (28) degrees Fahrenheit for 45 minutes. There were no previous temperature excursions. Data logger was involved. On unknown dates the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. The pharmacist confirmed that the DILUENT (unknown lot#/exp. date) used to reconstitute the ZOSTAVAX was properly stored. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009030.
Patient is fully vaccinated.  Tested COVID + on 12/4/2021. Admitted on 12/3/2021 for 5 days.  Admitting dx altered mental status and COVID 19.  Encepalopathy, debility, UTI with possible sepsis.  51-year-old white male, who apparently was brought to the emergency room because of change of mentation.  The patient is debilitated with advanced multiple sclerosis.  The patient is immobile with contractures.  The patient has indwelling catheter as well.  The patient was found to have severe UTI with possibility of sepsis, empirically was covered with IV antibiotics.  I was unable to get history of the patient due to his confusion.  The patient was getting very restless.  He was having legs cramps on screaming, I had to give him Ativan IV in the ER.  When I saw him, the patient looks in a very poor condition. The patient is being discharged home with home care today to the care of his family in a stable clinical condition
light headed and feel like faint; chest feels heavy; fainty breathless; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed and feel like faint), CHEST DISCOMFORT (chest feels heavy), DYSPNOEA (fainty breathless) and NAUSEA (nauseated) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLESTIPOL, PENCICLOVIR, AMBROXOL, SERTRALINE, OXYCODONE, TOPIRAMATE, ONDANSETRON and GABAPENTIN for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (light headed and feel like faint), CHEST DISCOMFORT (chest feels heavy), DYSPNOEA (fainty breathless) and NAUSEA (nauseated). At the time of the report, DIZZINESS (light headed and feel like faint), CHEST DISCOMFORT (chest feels heavy), DYSPNOEA (fainty breathless) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included, an anti nausea pill was provided.
Post vax the patient developed swelling and reddening of the right deltoid. The patient was treated with cold compresses.