chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got a booster shot 2 days ago & have some redness at site of injection from approximately shoulder to elbow; is tender to  touch; have some fatigue, but so far no fever; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (got a booster shot 2 days ago & have some redness at site of injection from approximately shoulder to elbow), INJECTION SITE PAIN (is tender to  touch) and FATIGUE (have some fatigue, but so far no fever) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (got a booster shot 2 days ago & have some redness at site of injection from approximately shoulder to elbow), INJECTION SITE PAIN (is tender to  touch) and FATIGUE (have some fatigue, but so far no fever). At the time of the report, VACCINATION SITE ERYTHEMA (got a booster shot 2 days ago & have some redness at site of injection from approximately shoulder to elbow), INJECTION SITE PAIN (is tender to  touch) and FATIGUE (have some fatigue, but so far no fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medications were provided.   Reporter did not allow further contact
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 24Mar2021 as dose 2, single (Lot number: EP6955), in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary Sarcoidosis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Apr2003; METFORMIN, start date: Sep2021; LORATADINE, start date: May2012. Past drug history included: Ace inhibitors, reaction(s): "Known allergies: ACE Inhibitors". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; negative, notes: Tested negative for the next several days; Positive, notes: I tested Positive for COVID-19 with an at home COVID-19 test kit. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 15May2023 to 20May2023  Clinical course: Patient finished 5 days of Paxlovid. Tested negative for the next several days. Then stuffy nose and shortness of breathing. 6 days later patient tested Positive for COVID-19 with an at home COVID-19 test kit.
Severe hypertension- began almost immediately after vaccination snd is continuing to date of report. Normal bp range is 220/84. Blood pressure since vaccination has ranged from 162/94 to 194/100.
Client received all 3 vaccines. He was sitting at the time. About 2 min after administration. He stood up and came over to parent side while parent was speaking to me. I noticed him wobble a little and became pale and was weak in knees and going down - I caught him and lowered him to floor and laid him flat. He remained awake speaking slowly. Pupils reactive and round. Noticed sweating occurring to forehead after about 10 min parent help get him into chair prior to immunization administration I had asked if he at breakfast and he answered yes, I gave client a juice and granola bar to eat while he continued to recover. At about 20 min of event occurring he was speaking better, sweating continued. At about 30 min of event child was speaking and smiling explained "it just came on suddenly". Shared that he didn't eat all his cereal this morning. Child has never had this happen before. He is not diabetic - was unable to check his blood sugar at time of event. Client was able to walk out on his own at about 40 min since event occurred.
Chest tightness; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 16:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included uterine fibroids. Concomitant medications included vitamin B complex (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and D (unspecified), all taken from unknown dates for unspecified indications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 16:45 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 06:00, the patient experienced shortness of breath and chest tightness. The clinical outcome of the events shortness of breath and chest tightness were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient complaint of right eye numbness and slight headache 6 minutes after vaccination. Both symptoms resolved immediately. Vital signs within normal. Juice given and patient was placed in recumbent position and was observed for 14 minutes then discharged home.
4 expired doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Med Info Agent: Client**CROSSLINKED TO MOD21-164106** HCP calling to provide missing information about an incident where 4 patients received an expired vaccine. HCP confirmed there were only 4 Patients involved, all females, and that they all received booster doses. No more demographics were given.HCP said the Hospital received the shipment one week ago, and that vials were transported in a cold container and remained cold the entire time while being transported. HCP could not confirm the exact date the shipment was received, he said "about a week ago" but confirmed vials were immediately placed in the refrigerator. HCP also confirmed vials expired on November 13th. The following data was copied from CASE MOD21-164106: "We were administering the COVID booster vaccine and one of the lots ( 054C21A ) expired on the 13Nov2021 and 5 (five) patients received it earlier today 15Nov2021. I was wondering if there was any data on people receiving the vaccine that expired? Anything we need to monitor or effectiveness? o *Lot number(s) - 054C21A o Number of doses/vials - 5 patients o *Date the vial was initially stored in the refrigerator - Not sure, pharmacy manager in a meeting. o *Date(s) of administration of vaccine  15Nov2021 o Did the vial undergo any temperature excursions? No, once it's delivered it goes into the fridge into the vault."  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-386799, MOD-2021-387483, MOD-2021-387484 (Patient Link).
ERECTION WITH DISCHARGE WHILE SLEEPING; This spontaneous report received from a patient concerned a male of unspecified age. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the subject experienced erection with discharge while sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the erection with discharge while sleeping and erection with discharge while sleeping was not reported. This report was non-serious.
This spontaneous report was received from a physician, via a company representative, referring to a patient (encounter key # 158406) of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2016, the patient was vaccinated with a dose of RECOMBIVAX HB, "10Pk 5 mcg/0.5 mL SDLLokCap Ped", lot # L016959, expiration date: 12-MAR-2018, (dose number and route of administration were unknown), which was improperly stored. On unspecified dates, RECOMBIVAX HB had three temperature excursions of 0.55 Celsius degrees (33 Fahrenheit) for 96 hours, 1.11 Celsius degrees (34 Fahrenheit) for 528 hours and -0.55 Celsius degrees (31 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as in excursion and the type of excursion and storage criteria were reported as refrigerator (R). No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
pt recvd vax;c/o red swollen leg;painful to touch;fussy & crying throughout noc (nl cry);elev T,mom states unable to take T,pt too fussy, 17mar95 t102
No adverse event; PROQUAD administered post temperature excursion; This spontaneous report has been received from a liscensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications  were not reported.   On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella Virus Vaccine Live (PROQUAD) (lot # S031881 with expiration date 07-APR-2021; albumin status rHA) (0.5 milliliter) involved in temperature excursion outside of the recommended prescribing information range (date unspecified) (of -9 degree celsius (C) to 8 C (-2.8 C), during 5 hours and 2 minutes) as prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (STERILE DILUENT). The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The patient did not experience any adverse event.; Sender's Comments:  US-009507513-2009USA001227: US-009507513-2009USA001249:
Soreness at injection site; This is a spontaneous report received from a contactable consumer or other non hcp.   A 57-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Right on 04Feb2021 09:15 AM as single dose for covid-19 immunisation. Medical history included prehypertension, blood cholesterol increased and G6PD allergy. Concomitant medications included amlodipine Besylate (strength 2.5 mg) and rosuvastatin (strength 5mg) (list of medications the patient received within 2 weeks of vaccination). In Hospital the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. The patient experienced soreness at injection site on 05Feb2021 04:00 AM. The events assessed as non-serious. No treatment was received for the events. Since the vaccination, did not patient been tested for COVID-19. The outcome of the events was reported as recovering.   Follow-up attempts completed. No further information expected.
Tingling in extremities on occasion, lethargic, having migraines at least 3 times a week.
Lower extremity myalgia local reaction & induration 2cm/2cm marked tenderness, skin warm.
101° Temperature; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (101° Temperature) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome, Celiac disease and Hashimoto's disease. Concomitant products included MELOXICAM and LEVOTHYROXINE for an unknown indication.   On 26-Jan-2021, the patient received first 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) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Jan-2021, the patient experienced PYREXIA (101° Temperature). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (101° Temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 101 (Inconclusive) 101° temperature was given..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment generic extra strength 500 mg 2 cap every 6 hours.
Immediate headaches and dizziness difficulty breathing . Next day muscle aches fevers dizziness n constant headaches  and joint pain with diarrhea
Pain at injection site for about 3 days, headache for about 48 hours, chills and fever 8 hours, and diarrhea 4hours. They felt intense, but were short lived.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Flushed / Sweating-Mild
Headache, Myalgia, Arthralgia, Fever, Injection site pain and swelling. Fatigue Narrative:
Myalgia, Arthralgia, Fever, fatigue, chills, injection site pain Narrative:  adverse reactions subsided about 4am per employee report
Reports that she experinenced symptoms that started in the middle of the night after the first dose of vaccine,  She states she had chills , fever, body ache and headache.  These symptoms persisted until about 48 hours after the dose was given at the same level of intensity.  The fever spiked to 103.7 , this fever was with fever reducing medication ( tylenol).  On 2-4-21 The Rarm injection site is red with an induration of 2-3 inches of diameter redness and swelling 3 inches in diameter ( this had decreased in the amount of swelling in the past 24 hours.) The site remains warm to touch today 2-4-21.
had difficulty breathing so went to hospital. they discovered a blood clot in her lung and she was also in a rapid vetricular response atrial fibrillation. remained hospitalized for 5 days.
anaphylactic reaction .. she received the 2nd dose of the vaccine today around 10 AM at clinic and started feeling throat swelling, generalized itching, and trouble breathing. Patient reports having a mild allergic reaction after the first dose but was discharged from the ED.
Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional. This case involves a patient (age and gender not reported) who experienced broke out with a skin rash, round, red circles, white centers and sometimes in clusters so that they overlap, md described them as "granuloma", an immune system response and a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf, while he/she received vaccine YF-VAX. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 11-Aug-2017, the patient received a dose of suspect YELLOW FEVER VACCINE lot M51761V (expiry date: 28-Feb-2018, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious broke out with a skin rash (rash) (unknown latency) 48 hours following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious round, red circles, white centers and sometimes in clusters so that they overlap (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious md described them as "granuloma" (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious an immune system response (unknown latency) following the administration of YELLOW FEVER VACCINE. On an unknown date, the patient developed a non-serious a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf (tissue injury) (unknown latency) following the administration of YELLOW FEVER VACCINE. It was reported that lesions are not itchy, and there is no seepage. Generally they are not painful unless directly impacted by something with a sharp angle. Other relevant tests included Patient had been tested for sensitivity to poultry and eggs, with results being negative. Final diagnosis was a year later, visible tissue damage remains/ lesions seem to be primarily located on the arms and hands (i.e. below the elbow region), and on the legs, from the mid-thigh to the mid-calf, an immune system response, md described them as "granuloma", round, red circles, white centers and sometimes in clusters so that they overlap and broke out with a skin rash. The patient was treated with PREDNISONE. Topical steroid creams have no effect, and in some cases exacerbate the problem. Forty doses of oral prednisone eased some of the symptoms. The patient outcome is reported as Unknown for skin rash, as Unknown for "granuloma", as Unknown for an immune system response. List of documents held by the sender: None.
patient under 18 years old was vaccinated with first dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old was vaccinated with first dose of Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old was vaccinated with first dose of Moderna vaccine). On 20-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old was vaccinated with first dose of Moderna vaccine) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Information has been received from a physician concerning a 16 year old female who was vaccinated with a first dose of Gardasil (no lot # provided).  Subsequently the patient fainted after receiving the injection.  Subsequently, the patient recovered from fainting.  The patient sought unspecified medical attention.  No product quality complaint was involved.  This is one of the multiple reports from the same source (WAES# 0804USA00153).  Additional information has been requested.
while waiting after vaccine, patient c/o of light-headed while sitting, headache.  Then c/o dizziness coupled w/ bifrontotemproal headaches and extremity weakness,  Her skin becae increasingly mottled,  Pt. was given Dexamethasone and Benedryl. and then observed.  Patient was then able to go home.  Pt. had 3 days of gradually improving fatigue, Rash also gradually improved.  Pt. is now fully recovered.
Headache within 5 minutes - lasted 3 days Muscle aches about 6 hours after - lasted 2 days Fever and shaking chills about 10 hours after - lasted until next morning
This spontaneous report was received from an office manager concerning to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, and drug reactions or allergies was provided. Concomitant therapies included prednisone.  On an unknown date in the past, the patient was vaccinated with PNEUMOVAX23 for prophylaxis (the lot #, expiration date, route, dose, and strength were not provided). In April 2016, the patient underwent a kidney transplant which outcome was unknown. Upon internal review the event of kidney transplant was considered to be medically significant. The causal relationship between the event and the vaccine was not provided. Additional information is not expected because there was no consent to contact physician.
Now presents with erythemia to outer nasal area; nasal pharyngeal and anal discomfort. c/o of swelling and itching of nose. States 24 hours after injection had local redness and itching locally. Dis(?) within a few days.
ringing in his ears. Still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears. Still ongoing) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A2114) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (ringing in his ears. Still ongoing). At the time of the report, TINNITUS (ringing in his ears. Still ongoing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Left upper thigh with about 5-7 cm area of swelling and erythema with visible puncture mark.