chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really bad sore throat; bad body ache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (really bad sore throat) and MYALGIA (bad body ache) 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 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (really bad sore throat) and MYALGIA (bad body ache). At the time of the report, OROPHARYNGEAL PAIN (really bad sore throat) outcome was unknown and MYALGIA (bad body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.
This report was received from manufacturer research (control number HQWYE5096909JUN03) for pneumococcal vaccine 23 polyvalent. It was reported that a 47 month old male was vaccinated on 10/4/02 with a dose of pneumococcal vaccine 23 polyvalent. On 4/21/03 the pt experienced pneumococcal bacteremia (serotype 9F strep pneumoniae) dehydration and otitis media. Subsequently, the pt was hospitalized. The outcome was reported as recovered. This was originally reported by a physician. Additional info has been requested.  A 15-day follow up report received 7/15/2003 adds: The child was given no other vaccinations that day and was not taking any concomitant medications. The reporter indicated that the child received the first dose of Streptococcus pneumoniae vaccine (Prevnar) in July 2002 at a local health department, but had not received a second dose. It was reported that the child had a history of chronic otitis and had tubes placed. Due to deterioration of his inner ear from the recurrent infections, he was eventually given cochlear implants. On 04/21/2003 the pt experienced pneumococcal bacteremia (serotype 9F strep pneumoniae) dehydration and otitis media. Subsequently, the pt was hospitalized. The outcome was reported as recovered. Follow up info received from a physician indicated that on 04/21/2003 the child was taken to the ER and admitted to the hospital with pneumococcal meningitis, pneumococcal bacteremia, dehydration and otitis media. Blood cultures and CSF cultures grew strep pneumoniae, serotype 19F not 9F as previously reported. The child was initially treated with ceftriaxone sodium (ROCEPHIN) and IV fluids. The child improved and was discharged from this hospital approximately 4 to 5 days later. The child recovered completely. The physician noted that he had spoken to an infectious disease specialist who suggested that they revaccinate the child with pneumococcal vaccine 23 polyvalent and Streptococcus pneumoniae vaccine (PREVNAR) and place the child on penicillin prophylactically for one year. This was originally reported by a physician. Additional info has been requested. Additional follow up received on 8/8/03 indicated that the onset of hte adverse event was 4/15/03 in the PM. The child was admitted to the hospital on 4/21/03 and transferred to another hospital on 4/22/03. He was hospitalized for 10 days. The child was diagnosed with sepsis and meningitis. The child was treated with vancomycin and Rocephin for several days. He was discharged in good health with resolved sepsis and meningitis. The outcome was reported as recovered on 4/30/03. The reporter indicated that the sepsis and pneumococcal meningitis were considered to be life threatening and other important medical events (OMIC). This was originally reported by a physician. No further info is expected.
Patient presented to the vaccination site on 2/1/2022. The client reported that she received a 1st dose of Janssen, COVID vaccine on  04/07/2021. Client reported itching, redness, and swelling at vaccine site that lasted around a week. Client stated that her PCP was made aware and prescribed a medication for the itching. PHN submitted a medical consult via teams to Clinical Project Coordinators requesting to switch to a different COVID vaccine. Per Dr, approval to proceed with Pfizer was obtained from medical consult team via Teams, Clinical Project Coordinator. Client received COVID vaccine Pfizer Lot FK9896 on 2/1/2022 at 2:40PM. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and to seek medical care immediately if shortness of breath or angioedema occurs. The client left the vaccination site at 1515 with stable gait.
Patient had a slight seizure (passed out and had jerking movements of arms) that lasted approximately 10 seconds.
Lethargy and emesis upon arrival at home.  Parent notified the office and returned arriving at 11:51 AM.
Guardian brought child to clinic with reports of rash on 3/14/17. Rash on 3/15/17 Rash gone, Mild diarrhea.
During 15 wait, after inoculation, I noticed some muffled hearing in my left ear, that I wrote off to head congestion.   Later that evening, I noticed the effect was sustained.  Woke up the next morning, 4/27, with some ringing in my left ear, and muffled hearing.  Worked on computer all day with no improvement, and no noticeable change.  Decided to report what may be a side effect. About 5 years ago, I had Ramsay Hunt Syndrome, with left side of face paralyzed, and very painful aural nerve attack in left ear, and loss of sense of sweet taste.  After about 8 weeks I had recovered 90%, or more.   No problems since then, as my sweet taste slowly returned.
Moderate headache with mild nausea, started within ~30 mins or so of receiving vaccine. Took 2 OTC ibuprofen ~2 pm which provided some mild relief. After evenings rest, the next morning there was a trace of a headache after waking up. Took 2 OTC extra strength Excedrin that has been successful in keeping the headache at bay so far.
pt devel joint pain, myalgia, h/a, t103, vomiting, & nausea approx 1 wk p/flu vax; in addition noted a burning sensation in muscles, bones, eyes, & head; sx persisted for approx 2 wks during which time pt was unable to work & lost 11 lbs;
Fever of 101.9F; Muscle aches accompanied the fever but were mostpresent in the first 24 hours.; Soreness in the left arm where vaccine was administered; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 15Apr2021 at 14:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not applicable. 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 did not have any other medications in two weeks. The patient had no known allergies. On 16Apr2021, 16 hours after the vaccination, the patient experienced fever of 101.9 degree Farenheit (degF), which lasted for approximately 48 hours. Also experienced the muscle aches which accompanied the fever but were most present in the first 24 hours and soreness in the left arm where vaccine was administered. On 16Apr2021 at 06:30, 16 hours after the vaccination, the patient underwent lab test which included body temperature and result was 109 (degF). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 101.9 (degF), muscle aches and vaccination site soreness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Unusually fussy, worsening sleep x 4 nights, Tylenol no help, no fever. Tx: continue Tylenol, observe.
Patient reported experiences a rash on the face and swelling in the arm at injection site that lasted a few days
Wheezing, very congested in chest area, hard to take a full breath. Pale in color approximately 4.5 hours following the vaccine.
stomach issues; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues) and DYSPNOEA (shortness of breath) in a 77-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. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach issues) and DYSPNOEA (shortness of breath). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    Concomitant medications were not reported.  Patient received Moderna original 0.5ml doses instead of the bivalent booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Live follow up received is significant. Patient details were added.
Pt. received TYPHIM VI vaccine on 6/18/12 on 6/21/12 she developed hives on her back per her report. She visited her dermatologist & was given a topical corticosteroid, symptoms began to improve on 6/23/12.
Pneumonia, unspecified organism Non-ST elevation (NSTEMI) myocardial infarction Gastrointestinal hemorrhage, unspecified Thrombocytopenia, unspecified
Stillbirth at 37 weeks gestation due to undetected massive perivillous fibrin deposition/maternal floor infarct, leading to severe IUGR.
Opposite of adverse event: since getting vaccinated I have stopped having migraines. I can even ingest limited amounts of trigger foods without getting sick. I have had severe migraine since my late teens, averaging 2-3 severe migraines per week (aura, vomiting, severe pain, photophobia/phonophobia,  one episode of aphasia, neurological diagnosis of complex migraine). After menopause (2 decades ago) the frequency dropped to 4-6/month on average. I have not needed migraine medications for over 6 months. This was a noted drop-off in severity after the first two shots. Since my booster (over 4 months ago) I have not had any migraines of any type. Is this a possible outcome of the covid vaccine? Are there other reported cases? Since getting vaccinated I have gone from a patient who gets headaches from everything (in addition to migraines) to not needing any medication for headache.
pain in left heel; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left heel) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in left heel). At the time of the report, PAIN IN EXTREMITY (pain in left heel) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD21-087920, US-MODERNATX, INC.-MOD-2021-114322 (E2B Linked Report).; Sender's Comments:  MOD21-087920:cross linked id US-MODERNATX, INC.-MOD-2021-114322:Wife Case
The evening of receiving vax the pt developed a fever, nausea and vomiting. She also developed induration at the site of Pnu-Imune-23 administration. She recovered. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune-23 lot 470-592. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of Td vax.
Extreme tinnitus beginning the day following vaccine and lasting about 48 hours. Within two days, tinnitus reduced but has remained persistent for now well over a month. For last 3 weeks, experiencing intermittent extreme tinnitus in left ear followed by muffled hearing/hearing loss. Overall tinnitus volume now seems to be increasing/worsening.
Pt recv vax on 12/14/98; on same day pt exp irritability  x 8-10 hr
About 36 hours later had tachycardia - heart rate of around 140 that awoke me.   Called 911, ekg was normal, bp normal, heart rate came down.  Followed up with bloodwork at urgent care that day.   On 1/21 or 1/22 heart rate in 140s again - went to primary care doctor, ER 3 times over next several days.   Tachycardia happened frequently during day, usually accompanied with nausea.   Saw cardiologist on 1/25 and obtained 24 hr monitor- preliminary diagnosis is SVT.
inconsolable screaming lasting about 3hr;no fever;no swelling or redness @ inj site;
Breakthrough bleeding after booster started with spotting at about 4pm and then by 7pm; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Breakthrough bleeding after booster started with spotting at about 4pm and then by 7pm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 008C21A and 039A21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE (PIRMELLA) for Birth control.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced INTERMENSTRUAL BLEEDING (Breakthrough bleeding after booster started with spotting at about 4pm and then by 7pm). At the time of the report, INTERMENSTRUAL BLEEDING (Breakthrough bleeding after booster started with spotting at about 4pm and then by 7pm) outcome was unknown.            Patient received the booster at 2pm today and was given a slip of paper with Spikevax information on it and She had not experience break through bleeding for her first two doses of the Moderna vaccine and she was expecting her period to only begin this Sat or Sunday also she have been on the pill on a long time and no missed doses recently. She is not taking any other medications, although she also mentioned that she stopped her supplements one week prior to the Moderna vaccine. No Treatment information was reported.
Patient received DTaP #4, Hib #4, PREVNAR #4 on 3/4/13 and after vaccinations pt is not able to walk.
Dizziness, fever, malaise Took an ambulance to ER Followed up with PCP on 10/14/20
2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well; The initial case previously was missing the following minimum criteria: [Unspecified product]. Upon receipt of follow-up information on 29Jul2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CORONARY ARTERY THROMBOSIS (death, medically significant), outcome "fatal", described as "2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well". The patient date of death was unknown. Reported cause of death: "2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well (Further not clarified)". It was not reported if an autopsy was performed. Clinical course: 2 other people that I used to catch the bus with, they died. They couldn't make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201004865 same reporter/drug/event, different patient;; Reported Cause(s) of Death: 2 other people /They couldnt make to the hospital on time because the blood clot reach to their heart, they took the Pfizer vaccine as well (Further not clarified)
Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  vial didn't undergo any temperature excursions.
Both sides experience but the left side is much worse numbness/tingling (pins & needles sensations) in face, eyes, lips, cheeks, tongue, temples, shoulders, arms, hands, feet, & legs from feet up to knees. My speech was/is slurred, cognitive difficulties, memory recall difficulties (especially when tingling is in the temple region), burning sensations on upper left side of back, pin prick burning sensations on right side of head mostly temple region. Vision changes, tripping, dropping objects, muscle weakness primarily left side, blood pressure fluctuated between high and low as well as my heart rate, eventually breathing issues started. I went back to Dr.'s office for treatment several times, a neurologist, and to a Clinic out of state. No one wanted to say it was Guillain-Barre Syndrome caused by the nurse giving me the Influenza - IIV3 High 65+ vaccine. I eventually was lucky enough to get back in to see the primary doctor I had had previous to current Dr. He diagnosed me immediately with Guillain-Barre Syndrome. The only treatment given was Clinic gave me 600 mg Gabapentin. Left arm at injection site. Very painful; couldn't lift arm or move it across body, to dress, put on deodorant, etc.; continues to be painful.
PMHx significant for Interstitial lung disease/pulmonary fibrosis followed outpatient by doctor, Chronic respiratory failure on 2L O2, hypothyroidism, PMR on chronic steroids who presented to the ED with complaints of increased cough, shortness of breath x2-3 days, she is positive for COVID-19.
Severe Vertigo/dizziness, rapid heart rate, chest & back pain, sweating, pain and sensitivity in lower calf  Being tested for blood clots  Results unknown at this time
Patient presented to ED because of R sided weakness. Brain MRI revealed L thalamic infarct.  Because of her deficits, she will be discharged to facility.  She will remain on statin, plavix (21 days total) and ASA for life. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
mostly unknown, but partner said patient was unresponsive the next morning the day after receiving her Covid vaccine
The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA767A, expiry date 31-DEC-2023) for prophylaxis.   On 27-MAR-2023, the patient received Menveo. On 27-MAR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 Nurse reports a staff member administered a dose of Menveo. The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent.  At the time of reporting, the dose has not been repeated.  The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments: Nurse reports a staff member administered a dose of Menveo to a 16 year old female patient on 27Mar2023 from lot number AMVA767A (expiration date 27Mar2023).  The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent.  At the time of reporting, the dose has not been repeated.  ~~~~~~~Consented to follow up. "The Vaccine Administration Facility is the same as Primary Reporter", Call Notes:Reporter gave permission for follow-up
PT EXPER AN INJECT SITE REACT, GENERALIZED ACHES AND PAINS AND VOMITING WITHIN 24 HRS AFTER IMMUN.
9-4: had red, swollen thigh around MMR vaccine site, noticed two days after shot. Treated with cold/ ice compress, Motrin or Tylenol. Mom called back 9-6, 9-9, 9-10 with rash on legs, red spots, + blanching. Treated with Benadryl. Called 9-12 with red leg (varicella vaccine 9-2) red, swollen, hot. Seen, treated with Keflex.