chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized redness, warmth and induration at the site of the injection beginning about 20-22 hours after vaccine injection. Patient evaluated talked with doctor on call around 6 pm on 4/02/19, was instructed to give diphenhydramine and observe overnight. Patient seen in the office at 2pm on 4/03/2019. Parent and patient reported that redness had increased since the evening before. Patient had redness, swelling and increased warmth in the upper anterolateral L arm, with an area of induration at the medial margin. Patient prescribed hydroxyzine, (told to discontinue diphenhydramine), cool compresses, and pain control with acetaminophen or ibuprofen with instruction to follow up the follow day. Patient instructed to seek immediate medical care if fever/chills/sweats occur.
Sore arm; headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (Tired) 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 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 PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (Tired) had resolved.            Concomitant medications were not provided. Treatment information was not reported.
Patient said he felt fine the day of the vaccination. Day after he felt off, no specific symptoms, just not quite right. Day 2 after vaccination, he felt worse. Finally in June, he was feeling back to normal. He reported having no COVID symptoms during this time.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2016, the patient was treated at a physician's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
pt recvd vax; c/o heavyness in chest; c/o lump in throat; c/o h/a; c/o "full headed feeling" & cough;
Vaccine given 9-2-15. On 9-7-15 at 1600, pt developed severe (R) side facial edema from jawline into eye socket. Went to urgent care on 9-7-15, went to ER on 9-8-15. Began KEFLEX, steroids, NSAIDS.
even when I did use to get the flu shot I always ended up with it; Initial information received on 06-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of unknown age and gender who reported even when i did use to get the flu shot always ended up with it after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength; formulation; lot number; expiry date not reported) via unknown route in unknown administration site for flu vaccination.  On an unknown date the patient reported even when i did use to get the flu shot i always ended up with it (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was reported by patient "So I choose not to anymore".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
patient experienced a small, pin point rash over the body which resembled poison ivy. it was a little itchy as the patient described but went away on its own.
Lymphadenopathy of right axilla; localized, mild, 5 cm diameter rash and redness at site of injection.
Tired, wife was sick, Tested for COVID-19 and came back positive (July 29, 2021), quarantined for 2 weeks, has recovered.
Patient was under the age of 18 when he received his first dose of Moderna COVID vaccine  on 03/15/2021 shortly after 9:30am at clinic. No adverse reactions where witnessed at the time of administration or during his 15min of observation, although the vaccine is has not been approved for anyone under 18 years of age.
Nurse noticed that COVID vaccine syringe was empty while she was injecting . She alerted the patient that he must get another vaccine since the previous syringe might have been empty. The nurse asserted that everytime she uses a syringe she retracts the needle before putting it in the sharps container and she demonstrated the procedure to the patient.  Patient was worried that he was injected with a used syringe.
Large red itchy circular rash at site of vaccination (left arm). Started over a week after vaccination. Was solid red and hard for three days. Now it is a red circular outline and the middle is back to flesh colored.
Awoke at 3 am the following day with uncontrollable shivering, fever, and chills. The shivering intensified with every exhale and lasted about 30 minutes. The fever and chills lasted longer. Awoke about 6 am with mild fever, body aches, and head ache. Took Tylenol about 6:30 am which helped alleviate the head ache.
Tinnitus, exhaustion, diarrhea, and Vertigo.  Vertigo is still present 4 days after onset
This spontaneous prospective pregnancy report was received from a consumer referring  to herself a 28 year old female patient. On 13-JUL-2017, the patient was vaccinated with VARIVAX 1 shot one time in arm muscle, for prophylaxis.  It was reported that in August 2017 (reported as last week), the patient took a pregnancy test which showed positive for pregnancy. The LMP and EDD weeks not known. The patient stated that she was 2 weeks preganant.
Higher resting heart rate/ high 70s to 80s; feeling heart pounding against chest; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient).   A 29-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an un-specified route of administration on 09Jul2021 (at the age of 29-year-old) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 09Jul2021, the patient experienced higher resting heart rate, and feeling heart pounding against chest. her resting heart rate was usually around 50s to low 60s. After 2nd dose (Pfizer Vaccine) on the day of this report (reported as today), she kept having these symptoms. her resting heart rate is now in the high 70s to 80s. Heart rate was measured using a  Watch in the same settings (sitting down, at rest, no movement). Patient was not hospitalized for the events. The outcome for the event was reported as not resolved. Device Date was 09Jul2021.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Encephalitis vaccine inactivated doesn't have clear markings for 0.25 ml dose for 2 month to 35 month old child dose.  Patient received full dose of syringe 0.5 ml.
Bilateral breast ultrasound exam was performed. There is dense fibroglandular tissue with benign features. There are a few benign-appearing cysts in both breasts. The patient indicates the palpable area of concern at the right breast 10:00 position 3 cm  from the nipple, which corresponds to a benign-appearing 2.4 cm cyst.  An oval 1.3 x 1.2 x 0.6 cm circumscribed mass at the right breast 2:00 position 4 cm from the nipple and an oval 8 x 7 x 4 mm circumscribed mass at the left breast 3:00 position 2 cm from the nipple have benign features and may represent a fibroadenoma.
Lower back pain; Right Hand pain; Neck pain; Knee pain; expressed excessive from her normal pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Right Hand pain), PAIN (expressed excessive from her normal pain), NECK PAIN (Neck pain) and ARTHRALGIA (Knee pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and OXYCODONE for Pain.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (expressed excessive from her normal pain). On an unknown date, the patient experienced BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Right Hand pain), NECK PAIN (Neck pain) and ARTHRALGIA (Knee pain). At the time of the report, BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Right Hand pain), PAIN (expressed excessive from her normal pain), NECK PAIN (Neck pain) and ARTHRALGIA (Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
This spontaneous report was received from a pharmacist regarding two unspecified infants of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 12-JUN-2015, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp.  Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose.   Lasted x3 days then pressure on right side of head eye for a month.  Elected not to do 2nd shot due to above s/s.
Three days after second dose, began experiencing heart palpitations, chest pain, and shortness of breath.  I woke up feeling very tired with chest tightness/pressure. I was unable to accomplish daily tasks like making my bed, due to those symptoms. Presented to local ED. They ran electrocardiogram, blood tests/labs, and CT with contrast.
very alert; confused; jittery; always moving; only slept in 2-3 hour intervals; hyper; This spontaneous case was reported by a consumer and describes the occurrence of HYPERVIGILANCE (very alert), CONFUSIONAL STATE (confused), FEELING JITTERY (jittery), DYSKINESIA (always moving) and SLEEP DISORDER (only slept in 2-3 hour intervals) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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 OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HYPERVIGILANCE (very alert), CONFUSIONAL STATE (confused), FEELING JITTERY (jittery), DYSKINESIA (always moving), SLEEP DISORDER (only slept in 2-3 hour intervals) and ENERGY INCREASED (hyper). At the time of the report, HYPERVIGILANCE (very alert), CONFUSIONAL STATE (confused), FEELING JITTERY (jittery), DYSKINESIA (always moving), SLEEP DISORDER (only slept in 2-3 hour intervals) and ENERGY INCREASED (hyper) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not  consent for safety team to contact her HCP
Threw up; Diarrhea; literally defecated water while standing up showering; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea; literally defecated water while standing up showering) and VOMITING (Threw up) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced DIARRHOEA (Diarrhea; literally defecated water while standing up showering). On 19-May-2021, the patient experienced VOMITING (Threw up). At the time of the report, DIARRHOEA (Diarrhea; literally defecated water while standing up showering) had resolved and VOMITING (Threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment details provided. Patient was concerned whether to take 2nd dose or not.   This case was linked to MOD-2021-225646, MOD-2021-225646 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Event(vomiting) was added. On 24-May-2021: Follow-up information received on 24-MAY-2021 contains non-significant information. On 17-Jun-2021: Initial Additional-1 : 2nd dose and AE details On 23-Jun-2021: date of events diarrhea and threw up occurred and outcome of event updated. On 23-Jun-2021: batch number added.
IRRITATED UNDERARM; THREE RED DOTS ON THE SIDE OF THE VACCINE ADMINISTRATION SITE; TENSE SHOULDER; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced tense shoulder. On 11-APR-2021, the subject experienced irritated underarm. On 11-APR-2021, the subject experienced three red dots on the side of the vaccine administration site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irritated underarm, and tense shoulder, and the outcome of three red dots on the side of the vaccine administration site was not reported. This report was non-serious.
Patient was asked to wait 30 minutes as she stated she has a history of reacting to medications. At the 30 minute mark, she approached me complaining that she had tingling in her face, throat and lips. VSS, BP WNL, SaO2100% on RA, LS clear. Patient able to swallow and take water. Rapid response MD gave her 3 puff MDI Albuterol and 25 mg Benadryl. Transported to ER for observation and released at 5:30 with no further events. MD states patient had a panic attach.
Shoulder joints started aching. Felt sick to stomach. Went to bed. Woke up middle of the night. Very hot sweaty, disorieanted. Asked husband to get cold cloth. While husband was out of bedroom, unbeknown to me I called 911. Per husband: I was convulsing when medical personnel arrived. Taken to hospital by ambulance. I don't recall anything after my husband left the bedroom. I woke in the E.R. Hospital put me in hospital. Long term effects have been neck surgery do to convulsions, constant headaches, numerous time missed from work.
pain in one toe constantly/terrible pain in one toe/ It is burning pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNISATION SERIES COMPLETE;  UNKNOWN MANUFACTURER), for COVID-19 immunization, reaction(s): "No problems"; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "No problems". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "not recovered", described as "pain in one toe constantly/terrible pain in one toe/ It is burning pain".  Additional information: Caller mentioned she got her shot yesterday, and a pedicure but the pain was nothing she did, but she wanted to know if it was the vaccine as it was pain in one toe constantly. Patient had COVID shots and the booster shots and had no problems. Yesterday she went to get the new COVID vaccine shot that was out. Last night she started getting terrible pain in one toe and it was still going on. It was burning pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
maternal vaccine exposure with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 25 years old female patient who was exposed to vaccine influenza quadrival A-B vaccine [Fluzone QIV] in context of maternal vaccine exposure with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure with no reported adverse event occurred at 17 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine at 17 weeks of pregnancy, during second pregnancy trimester for influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 10-Jun-2022. The estimated due date is 04-Apr-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient previous pregnancy.   On 06-Oct-2022, the patient received a dose 1 of suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot UT7682KA, expiry date: not reported) via intramuscular route in the left deltoid for prophylactic vaccination(immunisation).  On 06-Oct-2022 the patient developed a non-serious maternal vaccine exposure with no reported adverse event (exposure during pregnancy, latency: same day).  Action taken: Not applicable.  Outcome: Unknown. Additionally, at time of reporting, the pregnancy is still ongoing.
This spontaneous report was received from a pharmacist concerning an adult female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 28-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 expiration date: February 2017, as prophylaxis (Strength, dose, route of administration and lot # were not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected as there was no consent to contact the reporter.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: pt sat 30 mins after inj as per protocol, but returned to store 10 minutes after (40 total mins elapsed), pt complained difficult to catch a deep breath, pt complained was not getting better, administered epi pen mid left thigh, pt felt better, 911 was called prior to epi injection after a few minutes pt reported difficulty breathing ems now on seen, epi adm 728 pm, pt to hosp with ems at 741 pm
I had a servere skin rash (red spots, itchy) al over the body for 3 weeks. There was no professional medical help received, just used over the counter allergy medication -Benadryl and hydrocortison oinment-topically.
Developed vesicular erythematous skin eruption over left flank in dermatomal distribution, onset "several days" following receipt of SPV left arm given 18 Aug 2008 (exact date of onset unknown).  Received AVA #1, typhoid vaccines on 15 Aug 2008, & AVA #2 29 Aug 2008; IZ record indicated exempt status for varicella 2/2 non-susceptibility.  Seen by allergist 15 Sep 2008, diagnosed with herpes zoster - no treatment indicated at time.
Pt had local erythema and swelling at 24 hours, post vax, with 7cm X 7cm area on anterior thigh (L). Was given Cephalexin po X 10 days for cellulitis vs local reaction.
I read the patient's obituary in the newspaper, please refer to primary care physician for more details. I never received any call regarding any adverse event regarding actual vaccines.
Vaccine was injected into subacromial space instead of deltoid.  Severe subacromial bursitis symptoms developed rapidly.
Information has been received form a registered nurse concerning a 13 year old female student who on 20-JUL-2009 was vaccinated with the first dose of HEP A (Lot: 663683/1715X) intramuscularly in the left arm and the second dose of VARIVAX (Merck) subcutaneously in the right arm at 2:45 pm. On 22-JUL-2009, 48 hours post vaccination, at 1:15 pm the patient developed a 3 x 3.5 cm area of a light pink induration with surrounding blanching. A 5 x 7 cm area of moderate erythema. There was no streaking and no axillary nodes. The patient went to the physician and was prescribed KEFLEX for 5 days. Subsequently, on an unspecified date the patient recovered. No further information is available.
Patient complains of increase heart ate (on her watch) and feeling very anxious.  BP 155/75.  HR 98