chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Might not get 2nd dose between day 25-35 of 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Might not get 2nd dose between day 25-35 of 1st dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     no medical history was provided by the reporter.     On 23-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Might not get 2nd dose between day 25-35 of 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Might not get 2nd dose between day 25-35 of 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no Concomitant products were provided. no treatment medications were provided
After approximately one hour following the immunization in the right deltoid he experienced dull constant aching sensation in the posterior shoulder behind the right shoulder joint line. Pain is worse with lifting or pulling. Rates pain at rest 1/10 and 6/10 with movement. Denies shortness of breath, rash, dyspnea, dizziness, or numbness or tingling in right lower arm or fingers. Recommend ice, and Ibuprofen 600mg with food every 6 hours as needed. Seek medical attention if condition worsens.
Patient fainted after the covid shot, she was feeling hot and fell off the chair onto the floor. She hit her left eye and left temple resulting in a bump and a bruise.  Patient opened her eyes when I called her name and she was not aware of were she was. Her blood pressure was 95/64 65 bpm laying down and 70/54 114 bpm when sitting. We laid her back down because she was feeling dizzy and the Ambulance arrives 45 mins after called. Because of her bump and her low BP she was taken to the hospital.
stress fracture in her foot; Initial information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 70 year old female patient who had a stress fracture in her foot (stress fracture), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant medications   On 15-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) once via intramuscular route in unknown administration site for prophylactic vaccination.  On 18-Sep-2020, the patient developed a non-serious stress fracture in her foot (stress fracture) 3 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data was provided.  The physician gave the patient methylprednisolone, a daily tapering dose, starting at 24 mg and then decreasing by 4 mg daily for 6 days, to treat the stress fracture. The patient picked up the methylprednisolone over the weekend, but has not started taking it yet, because she read that there can be an interaction between Fluzone High-Dose vaccine and methylprednisolone, that if methylprednisolone is taken within 2 weeks of getting the flu vaccine, in could decrease the effectiveness of the flu vaccine.  At the time of report, the outcome of events was unknown.  There will be no information available on lot number
pt recvd vax; devel fever & subsequently devel 6 scattered lesions;
Low blood pressure; Swelling on lymph nodes; Fever; Sore arm; Chills; Fast heart beating; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm) and CHILLS (Chills) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and TACHYCARDIA (Fast heart beating). At the time of the report, HYPOTENSION (Low blood pressure), LYMPHADENOPATHY (Swelling on lymph nodes), PYREXIA (Fever), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and TACHYCARDIA (Fast heart beating) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2019, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Urgent adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Urgent adverse effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Urgent adverse effect). At the time of the report, VACCINATION COMPLICATION (Urgent adverse effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
child under age 5 received a dose of Covid vaccine intended for use in 5-11 year olds
pale, nausea, vomiting and sweating. patient stated,  "needles/shot make him nervous, as well as he has not eaten any food today" He also drank an energy drink this morning
Patient began to feel throat tightness about 30 min to one hour after going home. Patient took 2 Benadryl tablets.
This spontaneous report as received from a registered  nurse refers to a patient of approximately 1 year old. On 08-OCT-2014, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported) in the right leg for and a dose of (Oka/Merck) VARIVAX (dose, route and lot # not reported) in the right leg and influenza virus vaccine (unspecified) in the left leg.  The nurse reported that on an unspecified date in October 2014, the patient developed a pretty impressive rash where the M-M-R II was given in the right leg.  There were no lab diagnosis or studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
The patient felt like her throat was swollen and like her temperature had spiked.  It was not an allergic reaction but she was very anxious and became very upset about what could possibly happen.  We offered to call 911 and she refused but let us escort her to the local health center.  After speaking with a nurse there, I was told that her blood pressure was high at first but eventually became normal.  They saw no signs of an allergic reaction and feel that this was due to anxiety and a panic attack.  I spoke with the patient around 5:30pm and she said her throat still felt swollen like a balloon was there but felt ok otherwise.
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 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 52 years, 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zoloft, reaction(s): "Known allergy: Zoloft". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid from start 30Aug2023 to 03Sep2023 as treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295333 same patient, different drug/event;
Nine days after receiving my first COVID-19 vaccine, I developed a rash on my right arm and hand.  By day ten it had spread to both arms, hands and fingers.  On day 11 post-vaccine, it spread to my feet, toes, ankles, legs, hips and rear.  The rash was very red and swollen and itchy.  I visited my primary care doctor's office Monday, Jan. 25, 2021 and saw NP.  She was perplexed at the rash and wanted me to see my dermatologist.  The following day I went Epiphany Dermatology and saw Brenda Lane, NP.  She identified the rash and wanted to rule out any infection.  She did a biopsy and swabbed my throat for strep and requested that I get a rapid COVID-19 test, which was negative.  Drugs prescribed too.
Mother of child noticed swelling & increased redness of left upper lateral arm. MOC noticed child scratched injection site approximately 4 hrs after receiving MMR. Outer Left arm (lateral aspect) is erythematous, mildly edematous, and increased warmthness with central area of avulsion Acute cellulitis prescribed KEFLEX 250/5-->5ml PO Q 6 hours x 10d. & advised warm soaks.
Information has been received on 12/05/2001 from a mother concerning her 8 year old son with no past medical history and no allergies who "five years ago," in approximately 1996, was vaccinated with a dose of varicella vaccine. There was no concomitant medication or illness at the time of vaccination. On approximately 12/03/2001 at 8pm, the pt developed a slight fever and tiredness for one day and had about twelve chicken pox bumps on his body over the next three days. It was reported that the bumps itched. The mother reported that there was "no other lethargy or fever after the first night that we knew of." The bumps were originally thought to be bug bites, then they remembered that the pt had played with a child with chicken pox. It was reported that the pt recovered. No further info is expected.
Right arm had extreme itchiness and rash 6-8inches  from injection site down right arm covering entire arm. Patient claimed she had no shortness of breath and no pain other than normal soreness in arm, but did feel warm to touch.  She did say the rash covered the entire area on arm.
Red, warm, tender at injection site. Continuing to enlarge. Approximately the size of an orange at 1800. Have had flu shots every year for past 15 years without any reaction.
I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests.  TIMELINE:  The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR.  The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26.   The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?.  I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made.
DIARRHEA; 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 vegan. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 210A21A, and expiry: 27/JUN/2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 044B21A) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and MIRTAZAPINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, 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 experienced MYALGIA (soreness). At the time of the report, MYALGIA (soreness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Medical History information was reported.  Vitamins used as a Concomitant medication.  Ibuprofen prior to receiving 2nd dose of Moderna COVID-19 Vaccine.  Tylenol 500mg (2 tabs) after receiving 2nd dose of Moderna COVID-19 Vaccine.   This case was linked to MOD-2021-083384.
Nausea followed by severe vomiting, chills, followed by severe shaking, and high fever which lasted two hours.
Vomiting "all night" and next half of morning = 8 hrs after H1N1 administration - No treatment.
presents to ED with chest pain occurring at waking on same day.   troponin elevated at admission, decreased ejection fraction. Patient is evaluate and cardiac cath performed, negative for acute findings.  Symptoms had fully resolved at discharge.  Patient is started on aspirin and atorvastatin.
COVID-19 positive; COVID-19 positive; fever; tired; poor appetite; ache; 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-163-4426706-00 (Company).  A 12-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160991) at weekly (unk, weekly), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 positive"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "poor appetite"; PAIN (non-serious), outcome "not recovered", described as "ache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On an unknown date, the patient experienced covid positive. The action taken for adalimumab was unknown.  The reporter considered "covid-19 positive", "fever", "tired", "poor appetite" and "ache" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
circumoral numbness 3-4 days p/2nd shot on 9NOV or 10NOV; was due on 20NOV for 3rd but still had numbness of tongue & abdo discomfort, nausea & h/a on the rt sie; will see pvt MD:
Right thorax- rash and pain. Treated with BACRIM DS initially and changed to Acyclovir treated x 1 week. Treatment started 4/09- 4/24/09. Folliculitus / Herpes zoster.
103 Fever, pain (at injection site, across shoulders and chest into opposite arm), swelling at injection site (area was about 7"x4" welt), headache, watery eyes, unable to take deep breath without coughing, unable to move arm and difficulty breathing by night time. Same symptoms next day, 10/04/2015, with slightly lesser intensity. Treated with Motrin and Benadryl at home.
7 hours after the shot was injected, I began to run a high fever, chills, nausea, dizziness and severe pain in my left arm. I had the most severe pain throughout the night, unable to move my left arm and nausea from the pain. The fever and chills continued into the next day. Ibuprofen relieves the pain and fever, but it all returns when the medicine wears off. I have a high pain tolerance, and this pain was worse than natural childbirth, and I have given birth twice without any pain medication.
This case was reported by a consumer via call center representative and described the occurrence of pimples in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 23rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pimples, sinusitis, nasal flaring, rash and erythema. The patient was treated with benadryl (nos) (Benadryl) and ambiguous medication nos (Cortisone (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pimples, sinusitis, nasal flaring, rash and erythema were unknown. It was unknown if the reporter considered the pimples, sinusitis, nasal flaring, rash and erythema to be related to SHINGRIX. Additional details were reported as follows: The spots on patient face got 100 percent worse. The spots appear all over her face and appear as huge red pimples that did not itch, but they did hurt. The patient had seen her family doctor, an allergist and an infectious disease physician, but none of them know what condition she had. The patient had been taking Benadryl orally and has had a cortisone shot, but neither was providing long-term relief. Please refer case US2019017437, for tolerance of 2nd dose. This case has linked with case US2019017451, reported by same reporter.
Fever for more than 24 hours straight, 102 fever; Extreme body aches; anything that touched 'me' was painful, even the air was physically causing pain; Could not even move; Chills; Cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 20-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 right arm on 21Apr2021 at 08:30 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 31Mar2021 at 08:30 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 15:00, the patient experienced fever for more than 24 hours straight, 102 fever, extreme body aches-could not even move, chills, cold sweats, anything that touched her was painful, even the air was physically causing pain. On 21Apr2021, the patient underwent lab tests and procedures which included body temperature test and the result was found to be 102 (unspecified units). The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever for more than 24 hours straight, 102 fever, extreme body aches- could not even move, chills, cold sweats, anything that touched was painful, even the air was physically causing pain were recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalization for left leg cellulitis and COVID-19 on dates 1/13/23- 1/16/23. Treated with  vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
got the shot and got shingles / Suspected vaccination failure; got shingles; This case was reported by a consumer  via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shot and still got Shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.