chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia, Fever, Diarrhea, NauseaVomiting, arm soreness, bloated feeling,  Narrative: Fever, myalgia, nausea, diarrhea, arm soreness, feeling bloated. Resolved in 48 hours
Welty rash on her left and right thigh/welty rash on her belly button; dizziness; itching welty rash; Headache; Soreness in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness), PAIN IN EXTREMITY (Soreness in arm), RASH PRURITIC (itching welty rash) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and HEADACHE (Headache). On 15-Feb-2021, the patient experienced URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness) and RASH PRURITIC (itching welty rash). At the time of the report, URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness), PAIN IN EXTREMITY (Soreness in arm), RASH PRURITIC (itching welty rash) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: rare (Inconclusive) It was a drug reaction and rare esoinophils..         Patient went to dermatologist and had a biopsy , the result was that it was a drug reaction and there was a rare  eosinophil.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD21-041652 (E2B Linked Report). This case was linked to MOD-2021-017202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Follow up was received on 01 March 2021. Primary dosage regimen was changed from first to second dose and action taken changed from unknown to not applicable.; Sender's Comments:  MOD21-041652:CROSS-LINKED
Pt recv vax on 10/1/97; within 1 min post vax pt exp throat closing, lip swelling, asthma attack w/ wheezing; tx=Epinephrine & breathing treatment
1/18/06 C/O HA, red bumps, itchy, 30-40 water-filled blisters scab.
This spontaneous report was received from a nurse via a company representative and refers to an 18 year old female patient with seizures. The patient had a history of anxiety with injections. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot #, dose and route were not provided). Concomitant therapies included MENVEO and BEXSERO. Prior to receiving the vaccine, the patient did not eat or drink anything. On an unknown date, the patient passed out after receiving GARDASIL 9. Food and sweet tea were given and after that, the patient recovered from the event. The patient sought unspecified medical attention. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of loss of consciousness was considered to be medically significant. Additional information is not expected, as the reporter refused any further contact.
Two weeks after my first vaccine, I noticed a rash/raised area at the injection site on right arm.
Reporter indicates that 10 (?) pts did not respond to Hep B; some of thers non-responders did have very low titer levels;
Information has been received from a nurse practitioner concerning a patient who was "vaccinated with the first dose of VARIVAX (Merck) when they were a child (age unknown). The patient did not receive a booster dose of VARIVAX (Merck). The patient was now a teenage and had shown symptoms of chickenpox." The patient received unspecified medical attention. At the time of the reporting, the patient's status was unknown. Follow up information received from a nurse practitioner concerning a 12 year old male with ZITHROMAX allergy, who 28-JUL-2000 was vaccinated with a dose of VARIVAX (Merck) (lot # 634839/1864J) at another health department. The patient did not receive a booster dose of VARIVAX (Merck). On 24-MAY-2010 the patient was presented to clinic with a rash, his mother was concerned it was chickenpox. The patient was diagnosed with varicella on 25-MAY-2010. There were no labs or diagnostic tests performed. The outcome was unknown. Follow up information had been received from a licensed practical nurse indicating that the patient was not seen in office since 25-MAY-2010. No other information could be provided at this time. No further information is available.
Patient is a 78 y.o. female who presented on 3/8/2023 with ongoing nausea, vomiting and weakness found to have COVID-19 viral illness and acute hypoxia. Also treating for CAP.  Patient clinically improved to room air and was discharged with antibiotics to complete a course for community-acquired pneumonia.  She was also found to have bacteria in her urine culture and will receive simultaneous treatment for that as well.   Acute Respiratory Failure with Hypoxia - suspect due to below - room air sat 88% in ER - placed on 3L NC (not on O2 at baseline), down to 2L - CT chest show "tree in bud nodules in bilat upper lobes, no evidence of PE", suspect should be able to wean off o2 in next 24-48 hrs -Patient was able to wean off of oxygen by the time of discharge.   Fever Sepsis due to CAP - Tmax 102.8 temp 3/8 but has remained afebrile since - suspect due to COVID-19 viral illness, pneumonia  - CT chest show "Tree-in-bud nodules in the bilateral upper lobes, which is nonspecific and may be infectious or inflammatory. No evidence of PE."\ -Patient received Rocephin and azithromycin.  Was reduced down to Rocephin and then discharged on cefdinir.   Asymptomatic bacteriuria -Patient noted to have positive urine culture with greater than 100,000 E. Coli -Patient was receiving ceftriaxone in the inpatient setting -We will complete treatment course with cefdinir. -She does follow with urology in the outpatient setting, would recommend continue to follow-up with them.   COVID-19 viral illness - Presented with: Fevers, nausea vomiting, weakness - Positive COVID-19: 3/8 at Hospital - Vaccination status: Vaccinated with Moderna with last dose 2022 - CT Chest on admission showed Tree-in-bud nodules in the bilateral upper lobes, which is nonspecific and may be infectious or inflammatory. No evidence of PE. - Oxygen status: 2L NC - Decadron: Yes. Expected end date 3/19 - Remdesivir: No. - Note: she tested positive for covid on 2/25/23 (had minimal sx - chest congestion at the time so did not receive any tx and symptoms resolved completely).  She tested "negative" for covid at ECF on 3/7. Dtr notes "GI bug" is going around at her ECF     Nausea and Vomiting--resolved Dehydration - Suspect due to Infectious process, n/v PTA - Denies nausea, but has poor appetite - PRN zofran available    Seizure Disorder - tonic-clonic seizures, last seizure was 6/2015 - On multiple agents (Onfi, Keppra, Lamictal), will continue home regimen - Follows with Neurology (Dr), saw her 2/23/23 - seizure precautions   Type 2 Diabetes with long term insulin use - Home regimen includes Lantus 16 units twice daily, Jardiance -Given known incidences of UTI, feel that Jardiance is contraindicated and recommend to the patient to discontinue this on discharge. -Would recommend trialing metformin XR, Januvia, or a GLP-1 like Trulicity.
Productive cough; Dry skin in hands and feet; Pain in hands and feet; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4159996-00 (Agency).  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Oct2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous from 2020 (Batch/Lot number: unknown) to 2020 at 150 mg (150 mg, 1 in 1-2) for psoriasis. Relevant medical history included: "Alcohol Use: Whiskey or screw drivers every night", start date: 1969 (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "L4 and L5 was Broken" (unspecified if ongoing); "Broken Wrist" (unspecified if ongoing); "Fell" (unspecified if ongoing); "Non-Smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Humira, notes: Patient was on Humira previously. The following information was reported: PRODUCTIVE COUGH (non-serious) with onset 28Oct2021, outcome "recovering", described as "Productive cough"; DRY SKIN (non-serious) with onset 28Oct2021, outcome "recovering", described as "Dry skin in hands and feet"; PAIN IN EXTREMITY (non-serious) with onset 28Oct2021, outcome "recovering", described as "Pain in hands and feet". The action taken for risankizumab was temporarily withdrawn on 2020. Therapeutic measures were taken as a result of productive cough.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of PRODUCTIVE COUGH, DRY SKIN IN HANDS AND FEET and PAIN IN HANDS AND FEET with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
developed a reaction to spandex; it burns like fire or like somebody taking knife a knife and sticking into his skin; spandex rash around his pelvic area; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (developed a reaction to spandex), BURNING SENSATION (it burns like fire or like somebody taking knife a knife and sticking into his skin) and RASH (spandex rash around his pelvic area) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (developed a reaction to spandex), BURNING SENSATION (it burns like fire or like somebody taking knife a knife and sticking into his skin) and RASH (spandex rash around his pelvic area). At the time of the report, HYPERSENSITIVITY (developed a reaction to spandex), BURNING SENSATION (it burns like fire or like somebody taking knife a knife and sticking into his skin) and RASH (spandex rash around his pelvic area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Reporter's information, patient information, vaccine information, and events were added.
Localized soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Localized soreness in right arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Hay fever, Pollen allergy (Runny nose, eyes sneezy), Type 2 diabetes mellitus since February 2001, Macular telangiectasia since 2017, Allergy to molds, Dust allergy and Allergic to cats. Concomitant products included LISINOPRIL, FUROSEMIDE, ALLOPURINOL and INSULIN DEGLUDEC, LIRAGLUTIDE (XULTOPHY) for Diabetes.    On 05-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Localized soreness in right arm). At the time of the report, PAIN IN EXTREMITY (Localized soreness in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-261624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received included no new information.
3 days after receiving FLUMIST child presented to ER knee pain bilateral, knees warm to touch, swollen, unable to extend l leg. Child admitted overnight to hospital pain resolved next day.
nausea; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 20Sep2021 11:15 (Lot number: FC3182) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: 2020; LORAZEPAM taken for anxiety; ASPIRIN 81 taken for anticoagulant therapy. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 20Sep2021, outcome "unknown", described as "arm soreness"; NAUSEA (non-serious) with onset 21Sep2021, outcome "unknown", described as "nausea". Therapeutic measures were taken as a result of limb discomfort, nausea.  Additional information: Patient wants to know if nausea can be a side effect of the vaccine, and what she should do to treat it. Reporter says she called to query a question about one side effect that she had after getting her first dose of the Pfizer COVID-19 vaccine, which was nausea. She says she got her first dose yesterday and she only had soreness in her arm, it was just the nausea bothering her this morning. She says she got up and drank some Pedialyte, which she drinks that if she was nauseated. She says she got the dose around 11:15-11:20 in the afternoon, and her right arm started to be sore in the evening. Reporter says she put alcohol on it, and it was about the same soreness as yesterday. She says when it gets sore she puts alcohol on it. Reporter says she got nauseated for the first time early this morning when she got up, so she drank some Pedialyte and water and it calmed down for a little while, but then it came back. Reporter says she takes medications concomitantly, but she was not sure if they would be relevant to the report or had anything to do with her arm soreness and nausea. She says she takes Losartan 25mg, 0.5 Lorazepam, and Aspirin once a day. She says that she goes off the Losartan for 2-3 years when her blood pressure goes down, they keep her blood pressure under control, she doesn't had really high blood pressure. She says she her blood pressure will go down and then it will come back up again after a while off of the medication so then she goes back on it. No further details provided about her Losartan. She says she had been taking medicine for quite some time. She says that she had been taking the Lorazepam off and on for a long time. No further details provided about this. She says she was prescribed the Aspirin because they do that as people get older to prevent stroke as a blood thinner type medication. She says she doesn't take it every day, sometimes she skips some days.  No follow-up attempts are possible. No further information is expected.
Patient was given MCV4 and Var #2 in her left arm.  Mom stated that patient had a history of feeling light headed with any type of procedure/lab test.  Approx 40 sec. after shots were given and covered with a bandaide, I asked the patient if she felt okay.  She and her mother stated she did much better than she did when she was younger.  I had her stand up from the table before she left, at that time I noticed her color changing.  I immediately sat her in a nearby chair and was getting a cool cloth when her body stiffened and eyes rolled back into her head.  Her arms were contracting, back was arched and she did not respond to verbal or tactile stimulus.  She had loss of consciousness for about 15 - 20 seconds.  After waking, she responded appropriately to questions from Dr.  We had her drink some fruit juice and wait another 10 minutes, then I walked in the hall with her.  She and her mother left, she was feeling fine.
6 days after vaccine, patient experienced lower back ache which spread over next 24 hours down to back of thighs. It worsens with rest and when lying down. It is waking her up at night and is an achy, cramping feeling.
Patient with initial low grade fever which resolved but then developed 3 days after shot developed acute myopericarditis with elevated troponins requiring intensive care unit and therapy.
Light rash developed on left arm near the injection site. Not raised and no itching. First noticed when dressing on 11-23-21 at 7:00 a.m. By 1:00 p.m. on 11-23-21 the rash has spread (about double size) on top of left arm and is raised and itching. Called pharmacy to report and was told that CDC recommends Benadryl. Not taken yet at 1:57 p.m.
rash on eye, mouth, chin and leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on eye, mouth, chin and leg) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-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 RASH (rash on eye, mouth, chin and leg). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash on eye, mouth, chin and leg) outcome was unknown.            No concomitant medications were reported by the reporter.  Additional treatment medications included unspecified steroid and itch cream.
Persistent daily chronic headache started approximately 36 hours after 2nd injection.  Pain level ranges from 4-8 on a 10 point scale.  Tests come back normal with no specific treatment plan that can be determined.  Headache does not respond well to Ibuprofen, Tylenol or Divalproex. Perhaps 30 minutes of muted relief when taken. PT can not attend school.
Fever 101.6, diarrhea, fussy, decreased appetite, "hard" breathing.
This spontaneous report was received from a company representative's neighbor regarding his co-worker who is a female patient in mid 20's years of age. On an unknown date, the patient was vaccinated with what they believe was a dose of PNEUMOVAX 23 and had quite a bit of swelling post vaccination. The outcome of swelling post vaccination was reported as recovered/resolved. Causality was not reported. Additional information has been requested.
patient was given 0.5ml of the liquid component of Pentacel, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 6 months old male patient who was given 0.5ml of the liquid component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6629AA and expiration date:02-May-2021) via unknown route in the left thigh for prophylactic vaccination on 28-Sep-2020 (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE ; PNEUMOCOCCAL VACCINE 13V ; ROTAVIRUS VACCINE and INFLUENZA VACCINE for prophylactic vaccination..  It was an actual medication error case due to inappropriate reconstitution technique (same day latency), as the only the liquid component of the Pentacel vaccine was given and not the powder part.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Joint pain, skin pain, muscle pain, fever, headache, migraine, eye pain, eye discharge, vaginal discharge
Patient noticed numbness/weakness in both arms/hands and legs/feet and finally resolved after 1.5 months.
This spontaneous report was received from a Nurse refers to a 4 year old patient. On 20-MAR-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX Lot # h014074 (dose, route and frequency were not reported). The nurse reported that the on 24-OCT-2013, (Oka/Merck) VARIVAX was stored for -13.9 C for 8 hours. On 29-OCT-2013, the (Oka/Merck) VARIVAX was stored for -12.8 C for hours. On 14-NOV-2013, the (Oka/Merck) VARIVAX was stored for -11.4 C for 1.5 hours. On 26-MAR-2014, the (Oka/Merck) VARIVAX was stored for -14.7 C for 1.5 hours. On 14-MAY-2014, the (Oka/Merck) VARIVAX was stored for -13.8 C for a total of 5 hours. Since the overall average for (Oka/Merck) VARIVAX was below -15 C, these cumulative excursions of -11.4C for 20 hours is supported. No adverse effect has been reported. No further information was provided. This case is linked to the case 1405USA015822, 1405USA015834, 1405USA015835, 1405USA015836, 1405USA015837, 1405USA015838, 1405USA015839, 1405USA015840 and 1405USA015841, 1405USA015842 (same reporter link). Additional information has been requested.
Describes it similar to a torn tendon pain, lifting arm was painful, twisting an object such as a door was painful.
pt recv vax & devel inj site rxn characterized by redness & induration 49 to 72hr p/vax;pt also devel fever ranging from 103 to 104;this is one of six patients from this site w/the above rxn;
Pfizer bivalent booster was incorrectly administered for the second dose of the primary series.
This case was reported by a nurse and described a 46 year old male subject who had a decreased response to vaccination with Engergix-B. The subject's medical history included non smoker and non drinker. On 04 August 2005, the subject received the third dose of Engerix-B (lot AHBVA077AB). On 21 October 2005, a hepatitis B surface antibody test revealed a titer "below two." The nurse considered the decreased therapeutic response to be related to vaccination with Engerix-B.