chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got sick for a day; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported. The patient took lot of fluids as treatment.   This case was linked to US-MODERNATX, INC.-MOD-2021-296473 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-296473:Cross linked case
injection site soreness lasting aproximately 24 hours, diarrhea lasting about 48 hours, metalic taste in mouth lasting about 24 hours
for first week has malaise and soreness and fever, but approximately a week later started to experience nerve pain on the left side of the body, fluctuating at different points. also felt like her lymph nodes were swollen under the armpits and breast area. That has subsided, but the nerve pain still remains and fluctuates on the left side of the body(same side she received the shot on).
This case was reported by a healthcare professional and described the occurrence of swelling of legs in a subject of unspecified age and gender who was vaccinated with (INFANRIX, GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of INFANRIX (.5 ml, unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter could not recall any other details, but strongly felt there was a quality issue with INFANRIX. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events probably related to vaccination with INFANRIX.
Experienced Tinnitus in both ears. First noticed on Tuesday, February 23rd. By a week later the Tinnitus was only in my left ear. Consulted with my General Practitioner prior to second vaccine dose. The doctor  on Tuesday, A that I receive the second dose. Received the second vaccine dose on March 20th, one month after the first. The Tinnitus persisted after the second dose. Referred me to an ENT Specialist. There has still been no improvement in the Tinnitus!
2 weeks after his first COVID vaccine on 3/20/2021, patient developed a rash, located on the dorsal/lateral feet, legs and arms; red and bumpy but not itchy.  He was seen on 4/9/2021 at which time he had small ~2-3 mm purplish macules and slightly elevated papules on the thighs, lower legs and very faint on the right flexor forearm.    A biopsy of the skin was done on 4/9/2021 and he was treated with Triamcinolone 0.1%  cream pending biopsy results.  The patient had his second COVID vaccine on 4/10/2021 and patient reported his rash spreading on his arms on 4/12/2021.    biopsy results returned on 4/14/2021 and showed urticarial hypersensitivity reaction.  He was continued on Triamcinolone 0.1%  cream and Zyrtec 10 mg po qhs and Claritin 10 mg po qam were started.    He was seen on 4/21/2021 and exam showed: Arms and legs have small erythematous papules, monomorphic and less than 3 mm each, on the distal arms and legs. The most numerous are on the dorsal wrist and lateral feet bilaterally. His palms and soles are clear. The more proximal lesions present on the lower legs and forearms are not as erythematous and appear to be fading; previously affected area on the R flexor forearm at last visit is clear today. The ones on the thighs also appear to be fading with mostly post inflammatory hyperpigmentation remaining. The mid to low back, flanks and abdomen are clear except for two similar erythematous papules on the left flank  He was continued on Triamcinolone 0.1%  cream and Claritin 10 mg po qam; zyrtec was discontinued due to sleepiness.  On 4/22/2021 and 4/23/2021 patient sent patient portal messages showing new linear purplish plaques developing.  Labs were sent which were unremarkable.  Felt to be dermatographism and zyrtec restarted at lower dose of 5 mg po qhs.
Chest pain, feeling of tightness, heaviness, difficulty breathing  the following night (01/01/2022) especially when laying down. Symptoms resolved by next morning
Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at 5:15 pt was sweating through shirt, put on fan took bp1:80/60 pulse 70, had pt elevate legs, also had visual changes bp2: at 5:25pm 195/126 pulse 73, bp3: 185/124 pulse 79, pt has history of high bp, told pt to follow up with md if bp is elvated later today and tomorrow
nauseated on way home; could not see then tunnel vision; fell bruising hip; wen to be p/5-10 mins was nl; also felt faint @ time was not taken to MD; pt recovered w/in 10 min; bruise occurred due to fall fr tripping over vaccum cleaner;
had all the symptoms of the coronavirus; sick; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In February 2020, less than 6 months after receiving Shingrix, the patient experienced coronavirus infection and sickness. On an unknown date, the outcome of the coronavirus infection was unknown and the outcome of the sickness was recovered/resolved.   The reporter considered the coronavirus infection and sickness to be unrelated to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. At the end of 2019, the patient received Shingrix. In the first week of February 2020, the patient had all the symptoms of the coronavirus and was sick for two weeks. The reporter specified that the symptoms had nothing to do with the Shingrix vaccine. The reporter consented to follow up.
102.5 fever; Body aches; fatigue; This is a spontaneous report from a contactable Other Health Professional. A 41-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 27Jan2021 15:00 (Batch/Lot Number: EL9262) as single dose for covid-19 immunization.  Medical history included anxiety. The patient's concomitant medications were not reported. The past drug included bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 15:00. The patient experienced 102.5 fever, body aches, fatigue on 27Jan2021 03:00 with outcome of not recovered. No treatment was given for the events. The facility type vaccine was Public Health Clinic/Veterans Administration facility. The patient reported that her fever got high (102.5) and was unwell for several days. The patient underwent lab tests and procedures which included body temperature: 102.5 on 27Jan2021.The outcome of the events was not recovered.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 12:00 as dose 4 (booster), single (Lot number: EJ4989), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 DM" (unspecified if ongoing); "PRN" (unspecified if ongoing). Concomitant medication(s) included: INSULIN ASPART subcutaneous. Past drug history included: Moxifloxin, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as oral Paxlovid from 21Aug2022 to 26Aug2022.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
Pt is having pain in muscle and had shot on 8/24/10. Had initial pain which went away, but then had pain come back about 3 days ago and is having pain and muscle weakness which just started about 3 days ago.
Pt recvd vax & 6 hrs later pt fussy & crying; temp was taken R & found to be 103; pt taken to ER for eval;
Anti-body blood screen was non-reactive; This spontaneous case was reported by a nurse and describes the occurrence of ANTIBODY TEST NEGATIVE (Anti-body blood screen was non-reactive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Anti-body blood screen was non-reactive). At the time of the report, ANTIBODY TEST NEGATIVE (Anti-body blood screen was non-reactive) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
Period came a week and a half earlier than normal; nose virus before and still has the virus after the vaccination; Vaccination caused early periods; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Period came a week and a half earlier than normal), NASAL CONGESTION (nose virus before and still has the virus after the vaccination) and MENSTRUATION IRREGULAR (Vaccination caused early periods) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Nasal congestion. Concomitant products included Nasal Spray for Nose Virus for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Period came a week and a half earlier than normal), NASAL CONGESTION (nose virus before and still has the virus after the vaccination) and MENSTRUATION IRREGULAR (Vaccination caused early periods). At the time of the report, MENSTRUATION IRREGULAR (Period came a week and a half earlier than normal), NASAL CONGESTION (nose virus before and still has the virus after the vaccination) and MENSTRUATION IRREGULAR (Vaccination caused early periods) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Cramping/Spasms; Coughing; Just felt terrible; Mybody hurts so bad/Muscle Aches are just all over and generalized to her whole body; Soreness at the site; Throwing up Mucus; She has asthma and has taken her rescue (albuterol) inhaler more frequently; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping/Spasms), COUGH (Coughing), FEELING ABNORMAL (Just felt terrible), ASTHMA (She has asthma and has taken her rescue (albuterol) inhaler more frequently) and MYALGIA (Mybody hurts so bad/Muscle Aches are just all over and generalized to her whole body) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient started INFLUENZA VACCINE (FLU) (unknown route) left arm. In October 2021, the patient experienced ASTHMA (She has asthma and has taken her rescue (albuterol) inhaler more frequently) and VOMITING (Throwing up Mucus). On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (Cramping/Spasms), COUGH (Coughing), FEELING ABNORMAL (Just felt terrible), MYALGIA (Mybody hurts so bad/Muscle Aches are just all over and generalized to her whole body) and VACCINATION SITE PAIN (Soreness at the site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramping/Spasms), COUGH (Coughing), FEELING ABNORMAL (Just felt terrible), ASTHMA (She has asthma and has taken her rescue (albuterol) inhaler more frequently), MYALGIA (Mybody hurts so bad/Muscle Aches are just all over and generalized to her whole body), VOMITING (Throwing up Mucus) and VACCINATION SITE PAIN (Soreness at the site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: negative (Negative) Patient states her daily COVID tests have been negative..         It was reported that patient used to take COVID tests daily since she received her booster shot.   This case was linked to MOD-2021-377004 (Patient Link).
Given vaccines (TDap, HPV and MCV) and said she felt weird. After vaccines went limp, eyes rolled back and got stiff and was laid down by Medical Assistant. Had one jerk and then eyes opened and were dilated.  Came to after that and vitals stable.
Wealth formed; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE URTICARIA (Welt formed) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). On 21-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (Welt formed) and had extreme itchiness at injection site. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE URTICARIA (Welt formed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Seizures; High blood pressure; Patient was not strong enough to take the phone; Patient couldn't use hands and arms; Patient didn't speak coherently; Violent chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), HYPERTENSION (High blood pressure), ASTHENIA (Patient was not strong enough to take the phone), HYPOKINESIA (Patient couldn't use hands and arms), SPEECH DISORDER (Patient didn't speak coherently) and CHILLS (Violent chills). At the time of the report, SEIZURE (Seizures), HYPERTENSION (High blood pressure), ASTHENIA (Patient was not strong enough to take the phone), HYPOKINESIA (Patient couldn't use hands and arms), SPEECH DISORDER (Patient didn't speak coherently) and CHILLS (Violent chills) outcome was unknown.            No adverse events were experienced after the first dose of COVID-19 vaccine, which was "all ok". No information provided about the first dose of the vaccine.  No concomitant medication, treatment received or medical history was provided.  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.; Sender'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.
Syncope; This spontaneous report was received from an unspecified reporter via company representative referring to 9 to 18 years old patients of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  It was a rapid-fire poster presentation.  Vaccination was associated with syncope in adolescents. However, incidence of vaccine-associated syncope and resulting injury, and how it compared to syncope incidence following other medical procedures, was not known. Therefore, it was describing the incidence of syncope and syncope-related injury in adolescents following vaccination and routine venipuncture.  There were identified all Center for Health Research members ages 9 to 18 years with a vaccination or routine venipuncture and a same-day International Classification of Diseases (ICD) diagnosis of syncope and collapse from 2013 through 2019. All cases were chart reviewed to establish chronology of events (vaccination, venipuncture, syncope, and injury, as applicable) and determine whether the event was attributed to vaccination or venipuncture. Incidence rates for vaccine- and venipuncture associated syncope were calculated overall and by sex and age group. Incidence rates for vaccine-associated syncope were also calculated by vaccine type (Human Papillomavirus (HPV): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown)/ Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) vs. non-HPV).  The results showed: Of 197,642 vaccination and 12,246 venipuncture events identified, 549 vaccination and 67 venipuncture events had same-day codes for syncope. Chart validation confirmed 59/549 (10.7%) and 20/67 (29.9%) as vaccine-associated and venipuncture-associated syncope, respectively. Overall rates of syncope were 2.99 per 10,000 vaccination events (95% CI: 2.27- 3.85) and 16.33 per 10,000 venipuncture events (95% CI: 9.98-25.21), yielding an incidence rate ratio of 0.18 (95% CI: 0.11-0.31). The incidence of vaccine-associated syncope increased with each additional simultaneously administered vaccine, from 1.51 (95% CI: 0.93-2.30) following a single vaccine to 9.94 (95% CI: 6.43-14.67) following 3 or more vaccines. When stratified by the number of vaccines received, rates of syncope were similar following vaccination events with and without the HPV vaccine. Among those with syncope events, documented injury occurred in about 15% of both vaccine and venipuncture events. It was concluded syncope occurred more commonly following venipuncture than vaccination. A higher number of simultaneously administered vaccines was a risk factor for post-vaccination syncope in adolescents.  The outcome of syncope was not reported. The reporter considered syncope to be related to vaccine type (Human Papillomavirus (HPV).  This is a non-valid report due to the lack of patient's identifiers.   Upon internal review, syncope was determined to be medically significant.; Sender Comments: Keywords : MUL
The initial spontaneous case, received on 17-Oct-2017 by other non-health professional (consumer), concerning a female patient of an unspecified age. On an unspecified date, the patient was administered with influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination the patient experienced injection site soreness. On an unspecified date, the patient had recovered from the event. The reporter assessed this case as non-serious.
Patients received on the 7th Dec 2021 doses from 2 vials that were first punctured on the 30th Nov 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received on the 7th Dec 2021 doses from 2 vials that were first punctured on the 30th Nov 2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received on the 7th Dec 2021 doses from 2 vials that were first punctured on the 30th Nov 2021). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patients received on the 7th Dec 2021 doses from 2 vials that were first punctured on the 30th Nov 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
No adverse event.  Expired # 2 HPV immunization given.  Re-given 7 days later.
Fever, chills, body aches, swollen lymph nodes, diagnosed with non Hodgkin's lymphoma on June 21st.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 09-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot# L039095, expiry date 08-JAN-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
chills twice, body aches, nauseated 4 times twice with vomiting, weakness, tired, soreness at injection site