chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; CHILLS; FEVER; RASH; This spontaneous report received from a patient via a company representative concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 19:15 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021 16:00, the subject experienced rash. On an unspecified date, the subject experienced body aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, chills, rash, and fever. This report was non-serious.
migraines, ringing in left ear, arm sore 3 days, vomiting, nausea, tender breasts
Patient is experiencing pain in the left arm at the injection site.  There is no redness or marks at the site.  She notices the pain five to six times daily and the pain last for approximately 3 seconds.  She has not been able to identify and pattern that triggers the pain.  The pain is located about 5 inches down form the top of the shoulder.
patient had headache about 20 minutes after vaccination. No further interventions, patient does have a history of migraines.
a little itchiness on the same arm of injection; experienced chills; very bad headaches; felt like she had the flu; bone pain; stay in bed all day; feel very anxious; her hands started to sweat; numbness on face and tongue; tingle on face and tongue like she had anesthesia; tingle on face and tongue like she had anesthesia; tongue was bigger and dryness; tongue was bigger and dryness; thirsty; pressure on chest; dizziness; This spontaneous case was reported by an other caregiver and describes the occurrence of ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia) and PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia), PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia), SWOLLEN TONGUE (tongue was bigger and dryness), TONGUE DRY (tongue was bigger and dryness), THIRST (thirsty), CHEST DISCOMFORT (pressure on chest) and DIZZINESS (dizziness). On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), BEDRIDDEN (stay in bed all day), CHILLS (experienced chills), BONE PAIN (bone pain) and HEADACHE (very bad headaches). On 20-Jan-2021, the patient experienced INJECTION SITE PRURITUS (a little itchiness on the same arm of injection). On 16-Jan-2021, ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia), PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia), SWOLLEN TONGUE (tongue was bigger and dryness), TONGUE DRY (tongue was bigger and dryness), THIRST (thirsty), CHEST DISCOMFORT (pressure on chest) and DIZZINESS (dizziness) had resolved. On 17-Jan-2021, INFLUENZA LIKE ILLNESS (felt like she had the flu), BEDRIDDEN (stay in bed all day), CHILLS (experienced chills), BONE PAIN (bone pain) and HEADACHE (very bad headaches) had resolved. At the time of the report, INJECTION SITE PRURITUS (a little itchiness on the same arm of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Per pt's uncle: This is the second time the pt was taken to the ER after receiving her immunizations. She has a fever of 103F, continuous crying, can't walk. The uncle claimed the ER doctor & the pediatrician told him the reaction was caused by receiving 5 shots at one time.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 504 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a literature article concerning a 16 year old female patient developed uveitis, keratitis and conjunctivitis following administration of GARDASIL. 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 ADR's was 30 days (range 0 - 476 days); time to onset was unknown in this case. There was one reported rechallenge 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 vaccination 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.
Patient had flu vaccine given on Tuesday, 10-23-07.  Phoned 10-25-07 and spoke with someone.  Symptoms are headache, sore throat, stopped up (stuffy nose, neck stiff) but had an appointment to doctor's office at 3:00 pm, 10-25-07.  I phoned back, no answer.  Called 10-26-07 am.  Client stated she saw the doctor.  She had an ear infection, sinus problems and sore throat.  Doctor told her it probably came from flu shot.
pt recvd vax 22AUG95 & 24SEP95 pt devel a gen vesicular rash w/about 100 lesions associated in lymph node enlargement w/fever, resembling a case of chicken pox;most of the lesions were on the trunk;had no oral lesions;
Subsequent to receiving vax, the pt developed colicky pain. It was noted that the pts mother changed the infant formula. The outcome is unknown. Please note case number 1999021841 for the pts twin sister.
COVID 19 Treatment/Covid Test: positive; COVID 19 Treatment/Covid Test: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022 at 08:30, outcome "unknown" and all described as "COVID 19 Treatment/Covid Test: positive". Other medication in 2 weeks. AE resulted in: [None of the above]. Known allergies: No Known Allergies. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Client incorrectly received Men B (Trumemba) formulation instead of Men B (Bexsero) formulation for 2nd dose.
Patient received INFLUENZA vaccine 10:45 am in right deltoid. At 10:55 am patient began demonstrating symptoms of anaphylaxis. At 10:55 am EMS was activated. At 11:00 am patient began showing signs/symptoms of respiratory distress. At 11:05 am 0.3 mg epinephrine was administered via auto-injector to lateral aspect of right thigh. 11:20 EMS arrives & care transferred.
After 24 hours right arm was sore, swollen with large amount of redness around injection area, could not raise it above the shoulder. Entire body was weak and fatigued.  48 hours everything seemed back to 'normal'.  Roughly 80 hours later from the vaccination, suddenly body cramped up and had trouble speaking and pronouncing words. Fell to the ground and had hand spasms similar to bells palsy or cerebral palsy. Could not speak fluently or get up on my own. After 45 minutes to 1 hour, when paramedics were called and came they sat me up. Within a few minutes, like a switch, I could speak normally again and could walk on my own. Walked out to the ambulance and waited for 15 minutes or so, and everything seemed fine and back to 'normal'. Declined to go to hospital, and since that episode things are still 'normal'.
This spontaneous case, initially received from other health professional (nurse) on 15-Oct-2018, concerns a 58-year-old, adult female patient. The patient's current condition included seasonal allergies. The patient did not administered any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019). On the same day (reported as same evening), after the vaccination, the patient experienced systemic itching which lasted for 24 hours. The patient took over-the-counter (OTC) allergy medicines (drugs unspecified) as a treatment measure for the event. On 10-Oct-2018, in the evening, the patient had recovered from the event. The reporter assessed the case as non-serious. Follow up received from the reporter on 12-Nov-2018: New event 'rash' was added in the event tab. It was reported that the reporter was not aware of any skin diseases that the patient might have. The only medications that the patient took were the over the counter allergy medicines. Follow-up received from other health professional on 21-Nov-2018: The reporter confirmed that the patient experienced systemic itching and took OTC medicines. Hence, the event- rash was deleted from the event tab. The narrative was amended accordingly.
No additional AE reported.; PROQUAD expired and was administered; PROQUAD has had one temperature excursion in the past; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 17-AUG-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, recombinant human albumin (rHA), lot # S003866, expiration date was reported as 08-AUG-2020, and upon internal validation established as 08-AUG-2024 (route of administration was not reported) for prophylaxis.  The administered vaccine experienced one temperature excursion in the past on 10-AUG-2020: 74.8 degrees F for 15 hours. No additional Adverse Event reported.
Small pox shot has a discoloration on skin around the shot, seems to be getting bigger.
pt recvd vax; on 21sep94 showed swelling & red rash rxn in am; lt anterior deltoid area & gradually inc; P/E (on 22sep94) 6-7cm erythema swelling red tender area; no fever; able to move hand freely p/ P/E; rx po keflex;
sick from the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick from the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick from the vaccine). At the time of the report, ILLNESS (sick from the vaccine) outcome was unknown.            no concomitant medications and treatment details reported.   Consent for follow up - unknown
CONSTANT SHORTNESS OF BREATH; LOW BLOOD OXYGEN; WEIGHT LOSS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 77 year old female. The patient's height and weight were not reported. The patient's past medical history included covid-19 positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, frequency once total, administered on left deltoid on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After the vaccine, on 13-MAR-2021 the patient experienced chills, fever and headache. The headache goes go from the left to right side of her head. On an unspecified date, the patient experienced constant shortness of breath, low blood oxygen, and weight loss. The shortness of breath was severe and patient had to take a break every couple 100 steps for rest. On 15-MAR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: COVID-19 (nr: not provided) positive, oxygen saturation (nr: not provided) low, and weight loss (nr: not provided) 5 pounds and she is down to 86 pounds. The patient was prescribed steroids and nebulizer treatment. The patient had low blood oxygen level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills, constant shortness of breath, low blood oxygen and weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210442930-covid-19 vaccine ad26.cov2.s -Constant shortness of breath/low blood oxygen/weight loss. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Low WBC's, down to 1.8. Autoimmune type adverse event. Evaluated by hospital. He has been hospitalized. He is disabled.
Experienced minor muscle aches one day after first Covid-19 injection injection; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Experienced minor muscle aches one day after first Covid-19 injection injection) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Experienced minor muscle aches one day after first Covid-19 injection injection). At the time of the report, MYALGIA (Experienced minor muscle aches one day after first Covid-19 injection injection) 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.  No treatment information was provided.
Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4435587-00 (Agency).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 06May2021 as dose 1, single (Batch/Lot number: unknown), on 27May2021 as dose 2, single (Batch/Lot number: unknown) and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (ongoing) (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history included: "Bypass surgery", start date: 09Feb2021 (unspecified if ongoing), notes: Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant) with onset May2022, outcome "unknown". The action taken for risankizumab was dosage not changed.  Causality: The reporter's causality for the event (s) of pneumonia for skyrizi (risankizumab) was not provided. Agency's opinion is that there is a reasonable possibility that the event of pneumonia is related to skyrizi (risankizumab).   The reporter's assessment of the causal relationship of "pneumonia" with the suspect product(s) BNT162b2 was not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported event and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
More than 35 days passed since the first dose and patient did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and patient did not get the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and patient did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and patient did not get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and Treatment information were not provided.
Hospitalized nite of 21AUG91 for probable pertussis-related atonic reaction; Told ER MD unable to awaken pt while sleeping;
peeling of the skin; swelling area was warm to the touch; injection site is still swelling; redness of the skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (peeling of the skin), VACCINATION SITE WARMTH (swelling area was warm to the touch), VACCINATION SITE SWELLING (injection site is still swelling) and VACCINATION SITE ERYTHEMA (redness of the skin) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 24-Apr-2021, the patient experienced VACCINATION SITE WARMTH (swelling area was warm to the touch), VACCINATION SITE SWELLING (injection site is still swelling) and VACCINATION SITE ERYTHEMA (redness of the skin). On 08-May-2021, the patient experienced SKIN EXFOLIATION (peeling of the skin). At the time of the report, SKIN EXFOLIATION (peeling of the skin) and VACCINATION SITE SWELLING (injection site is still swelling) had not resolved and VACCINATION SITE WARMTH (swelling area was warm to the touch) and VACCINATION SITE ERYTHEMA (redness of the skin) had resolved.            No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
From PCP note: per pt sick, hurted all over, legs aches, burning sensation, sore throat, ha for 10 day.
the next day very tired, 2nd day sniffles aching muscles above knees-stiffness all over;3rd day dizziness very odd all of above;p/10 day MD appt vertigo given rx;nausea, no appetite, vision-h/a, forehead;
For 6 days after second Pfizer shot I had low fever 100.4 and body aches.   Injection arm has ached from my shoulder to my elbow since the injection.  Continually taking aspirin is the only thing that will help.   Since about a week after injection both hands go numb all the time.  Eating and sleeping is the worst times.  I?m continually waking up since the vaccine with my hands numb and hurting.
pain in gums/teeth right side only; right side ear aches; Swollen glands in right side of neck; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (pain in gums/teeth right side only), EAR PAIN (right side ear aches) and LYMPHADENOPATHY (Swollen glands in right side of neck) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced GINGIVAL PAIN (pain in gums/teeth right side only), EAR PAIN (right side ear aches) and LYMPHADENOPATHY (Swollen glands in right side of neck). At the time of the report, GINGIVAL PAIN (pain in gums/teeth right side only), EAR PAIN (right side ear aches) and LYMPHADENOPATHY (Swollen glands in right side of neck) outcome was unknown.            No concomitant products and treatment medication were provided by reporter.   Reporter did not allow further contact
urticaria that started 2 days after the second dose and has continued intermittently for the last 3 and a half weeks. treatment is cetirizine 10 mg PO Q24. Referral to Pediatric Allergist placed.
pt recvd vax; swollen face; unilateral b/w ear & chin;
I started to have some problems with my Asthma. I started coughing and sneezing and my doctor suggested a Covid-19 test. I tested positive on 08/08/2021. My symptoms progressed to a lot of wheezing and I was very weak. I had trouble walking up the stairs. I lost 9 lbs in 7 days. It has been four weeks and I still have low appetite and no energy. I have to use my rescue inhaled twice daily and I usually only use it twice a month. I had no loss of taste or smell. I was prescribed Albuterol twice daily and my Advair doubled. I had a Regeneron infusion on 08/11/2021. I started to feel better after about 12 days from the time of my first symptoms. My Oxygen levels and blood pressure also improved at that point.