chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 1APR93 & 2APR93 a local react consisting of warmth, swelling, pruritus, erythema & induration of 8 1/2 cm by 7 1/2 cm;
June 11- appendicitis occurred. I was hospitalized for 24 hours and received IV antibiotics while in the hospital. Discharged with oral antibiotics. Then had C.Diff 24 hours after hospital discharge and given additional antibiotics.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 4/28/2023 PYELONEPHRITIS
SM RECEIVED THE INFLUENZA INTRAMUSCARLY VACCINE VIA INTRANSASAL ROUTE
She also mentioned that her stepmom received the vaccine and was really sick for a couple of days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She also mentioned that her stepmom received the vaccine and was really sick for a couple of days".  Additional info: She also mentioned that her stepmom received the vaccine and was really sick for a couple of days. Consumer also mentioned that she could not get the shingles vaccine before since she has other health problems.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within five minutes of taking the shot "my" neck starting swelling (cervical lymph node) and was having problems swallowing.; Within five minutes of taking the shot "my" neck starting swelling (cervical lymph node) and was having problems swallowing; Also experienced extreme cotton mouth; face and body turned red.; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 17Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The medical history included thyroid disorder. 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 4 weeks prior to the COVID-19 vaccine. The concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 17Apr2021, within five minutes of taking the shot, the patient's neck started swelling (cervical lymph node) and was having problems in swallowing. The patient also experienced extreme cotton mouth, face and body turned red. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and treated it as an allergic reaction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events neck swelling (cervical lymph node), problems swallowing, extreme cotton mouth, face and body turned red was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
3/30/05 Doctor phoned clinic advising this child was admitted to hospital for fever, vomiting, and diarrhea on 3/29/05. Reported 4 ounce weight loss.
Bell's Palsy.  Started feeling the numbness from the tongue on 5/15. On 5/16, back of the ear started hurting, and feeling the differences of blinking between left and right eye at night.  On 5/17, the left of the face paralyzed and unable to lift the left side of the lips or eyebrow completely, but still have can move a little bit. At evening on 5/17, went to Emergency Room. The ER did not run any diagostic test, only gave steroid and antivirul medicine.  On 5/18, the symptoms got worse. Left eyebrow, lips are not moving any more.
Rash with redness, swelling, warmth L deltoid (site of injection). Low grade temp.
Nausea, pain, fever, redness and swelling at injection site (left arm?Shingrex), upset stomach, headache, muscle ache
Within 30 minutes of the moderna vaccine , first shot , I had racing heart , nausea and dizziness. Heart beating excessively. Lasted 3 hours . Woke the next morning with a red area at injection site . Over the course of last 10 days , spot has whelped , itched , fever in arm at Red spot. Went to unspecified clinic and have cellulitis in arm , on steroid and strong antibiotics . So allergic reaction to meds in vaccine after 30 min and lasted 3 hours .  The next day red area about size of quarter, then an egg , now the size of a grapefruit at day 10
partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 patients. This is a 2nd of 2 reports.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The physician reported the patient with symptoms partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination. The most recent, the physician was considering trying to get IVIG treatment. The event outcome was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event capillary leak syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101324800 same product, reporter and event, different patients.
Patient reports an area of redness and swelling on her right deltoid, which started the day after she received the first dose of her Maderna vaccine, on 12/31/2020.  She also had pain in this area, but it resolved within 2 to 3 days.  Her primary symptom is itchiness in the area.  Denies any other symptoms, no body aches/fever/chills, no headache, no SOB, hives, or swelling of lips/tongue.  She has not been reporting her symptoms to V-safe.  No past medical history of vaccine reaction.  No known allergies.   Exam: R deltoid, 3 cm circular area of erythema, well-circumscribed, slightly raised, not particularly indurated.  Warm to touch.  Not tender to palpation.  No evidence of ascending lymphangitis.  No lymphadenopathy. Assessment:  Localized reaction, no treatment provided, encouraged Pt to try cold compress & oral antihistamine for symptomatic relief
Well appearing at time of appointment with ongoing stridor assoc with laryngomalacia (CXR obtained with normal cardiopulm finding). 3 days later lethargic with decreased PO intake. Seen in ED with RLQ mass and intussusception on U/S. Failed enema, failed Lap reduction, open surgery with ileocolectomy with re-anastomosis.
Fever 100.5, shortness of breath, heart racing, wheezing, fatigue
numbness, tingling, parathesias in Right arm, the arm the vaccine was given for a month after first Maderna vaccination
When I woke up I was dizzy, nauseous, I had a migraine, and I felt like I was going to pass out. I was about to go to class but I felt like it would be a bad idea if I did. I went back to my dorm and threw up immediately. I felt a bit better after that. I took a nap before my next class and when I woke up I felt better.
Patient was erroneously given a third dose of the Pfizer Covid-19 vaccine, instead of the recommended 2 doses.
I got my vaccine in the morning after work. I went to sleep and when I woke up that evening I was violently ill with fever, sweating, chills, my muscles hurt, my bones hurt to where I thought they were disolving, breathing was difficult, and I began having chestpain and palpitations. All symptoms went away except for the chestpain. The chestpain escalated in Nov'22 that lead me to an ED where they referred me to a cardiologist for follow up.
A report was received from a health care professional on 11/14/03 concerning 6 vaccinees of unknown demography who inadvertently received two 0.5ml doses of Fluvirin, one on 11/07/03 and another on 11/10/03. On 11/07/03 and on 11/10/03, 6 unidentified vaccinees inadvertently received a 0.5ml dose of Fluvirin. The vaccinees had not experienced any adverse reactions at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Longer than recommended time from first vial puncture to vaccination. Vial was punctured between 3&5pm on 6/6 and patient was vaccinated 6/7 between 1&2 pm. Vial  remained refrigerated. Patient contacted 6/8, administration details were disclosed. Patient asymptomatic. CISA consult requested, awaiting results from Janssen safety team regarding viability of vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 10Dec2021 at 01:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (13May2022) 70/40, notes: 13May - 3rd day the Blood pressure dropped to 70/40 with Paxlovid taken with Azithromycin & Prednisone; SARS-CoV-2 test: (26May2022) Posiitive, notes: 26May The throat cough and Positive COVID continues unabated. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
could taste the medicine, face went numb, lips and nose swelling, brain bulging against skull
Nausea/vomiting Low grade fever- gave Motrin Fatigue- rest Facial rash-Beanadryl
Information has been received from a registered nurse concerning a 55 year old female who on 07-NOV-2006 was vaccinated with Pneumovax 23 (lot #651406/0620F), 0.5 ml, SQ. Concomitant therapy included influenza virus vaccine (unspecified) which was given during the same visit but the vaccine was given at a different site. In November 2006, the patient was hospitalized for treatment with IV antibiotics because she developed a cellulitis shortly after her recent Pneumovax 23. The cellulitis was not responsive to oral antibiotics. On 16-NOV-2006, the nurse reported that the patient was discharged from the hospital. The outcome of the event was not reported. Cellulitis was considered to be serious due to hospitalization and other important medical event. Additional information has been requested.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 05-MAY-2015 the patient was vaccinated with the first dose of VAQTA (dose, route, lot# and expiration date were unknown). On 13-OCT-2015, the patient was vaccinated with the booster dose of VAQTA (dose, route, lot# and expiration date were unknown). Concomitant therapies were not reported. No adverse effects were reported. Additional information is not expected as we have no consent to contact the physician.
I woke up with a weird headache. I had COVID-19 before and I knew what this headache felt like. I was sick to my stomach and I had diarrhea. I did a home COVID-19 test and it immediately came back positive. When the doctor's office opened, I called and asked for the prescription Paxlovid. They sent that in yesterday morning and I had someone pick it up. I started taking that yesterday. My headache has subsided. I'm still nauseous and have a sore throat and some diarrhea. I'm feeling weak and tired, but no where near the first time I had COVID-19.
No additional AE reported; patient was administered improper stored dose of PROQUAD; This spontaneous report has been received from a registered nurse concerning 12-months-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 22-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously, in the left arm, lot number T012419 had been verified to be a valid number; expiration date reported and validated as 06-OCT-2021, for prophylaxis (dosage and frequency were not provided) (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA002212:
I began bleeding and ovulating out of my normal cycle.  I have been bleeding non stop for about 2 weeks now.  One being my regular cycle and then it was over.  About 2 days later after the shot, I began bleeding again.  Today, I am having heavy cramping and discharge.  I have always had a regular period so this is abnormal.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose: 1, 2, 3; Moderna, Dose: 4, 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL2747), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL1283), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Sep2022 as dose 4 (booster), single (Lot number: AS7163B), in left arm and on 23May2023 as dose 5 (booster), single (Lot number: AS7180B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ongoing valley fever infection (onset Aug2022)", start date: Aug2022 (unspecified if ongoing), notes: ongoing valley fever infection (onset Aug2022). The patient's concomitant medications were not reported. The patient did not received other medication in 2 weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown", described as "Pfizer / BioNTech, Dose: 1, 2, 3; Moderna, Dose: 4, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: I am strongly positive; (03Sep2023) Negative, notes: tested negative on day 5; (08Sep2023) Positive, notes: strongly positive. Therapeutic measures were taken as a result of Treatment of COVID-19 included Paxlovid from 30Aug2023 to 03Sep2023.
Fluzone HD was inadvertently administered to 5 patients shipped on 06Nov2019 and not received until 11Nov2019, no AE; Lab tech reports delayed shipment of Fluzone HD, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (lab technician).  This case is linked to case 2019SA316735 (same reporter).  This case involves 5 patients who inadvertently received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number, expiry date, route and site of administration were not reported) after shipment delay on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and product shipment delay.  Lab technician reported delayed shipment of Fluzone HD which was shipped on 06-Nov-2019 and not received until 11-Nov-2019 at 1308. Caller reported that Fluzone HD was inadvertently administered to 5 patients.  At the time of report no adverse event was reported.  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.  Information on the batch number was requested.
Mom called at 1545 and said pt had varicella vaccine at 1330 and when got home pt was itchy and broke out in hives. Told mom to do 2 tsp of Benadryl Q 6 h prn and 10 mg Claritin daily for 1 wk. Call for worsen symptoms.
audible hallucination; Paranoid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 13:00 as dose 3 (booster), single (Lot number: gh9694) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing), notes: htn; "sleep apnea" (unspecified if ongoing); "depression" (unspecified if ongoing); "kidney disease" (unspecified if ongoing), notes: kidney disease. Concomitant medication(s) included: MECLIZINE HCL; CITRACAL [CALCIUM CITRATE]; MAGNESIUM; AMLODIPINE; MICARDIS; MYRBETRIQ; ZETIA; BUPROPION; LASIX [FUROSEMIDE]; POTASSIUM; SOLIFENACIN; GABAPENTIN; ATORVASTATIN; VENLAFAXINE; COQ10 [UBIDECARENONE]; BABY ASPIRIN. Past drug history included: Codeine, reaction(s): "known allergies: codeine"; Lidocaine, reaction(s): "known allergies: lidocaine"; Quinapril, reaction(s): "known allergies:quinapril"; Beta blockers, reaction(s): "known allergies: beta blockers", notes: beta blockers. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: PARANOIA (non-serious) with onset 24Sep2022 at 11:00, outcome "not recovered", described as "Paranoid"; HALLUCINATION, AUDITORY (medically significant) with onset 24Sep2022 at 11:00, outcome "not recovered", described as "audible hallucination". Therapeutic measures were not taken as a result of hallucination, auditory, paranoia.  Clinical Course: Patient had injection on Friday afternoon. By Saturday around 11am patient had been having audible hallucination. Hearing storys told about her hearing her family's voices in the hallway talking about her family was not present. Paranoid people are listening to her, monitoring her phone and ipad, recording her conversations by having recorders in ceiling vents.afraid she was being drugged by her food. Extremely emotional about the events she was hearing. Confrontational about what she was hearing. Afraid her money was being taken afraid items were being taken from her house.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Hallucination, auditory cannot be excluded for the suspect drug BNT162B2. the case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
No adverse efects reported; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 01-OCT-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S012246 and expiration date: 10-FEB-2020 (exact dose, frequency and route of administration were not reported) for prophylaxis. No adverse effects were reported.  The vaccine was stored in 68 Fahrenheit (F) for 8 hours. There was a previous temperature excursion in 57 F for 2 hours. The improper storage was recorded by Digital Data Logger.
Rash on his legs that was itchy; Rash on his legs; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on his legs that was itchy) and RASH (Rash on his legs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash on his legs that was itchy) and RASH (Rash on his legs). At the time of the report, RASH PRURITIC (Rash on his legs that was itchy) and RASH (Rash on his legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-080613.