chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GAGGING; SHORTNESS OF BREATH; BACK HURTING; NOSEBLEED; GETTING HOT AND COLD; LEG PAIN / SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female patient. The patient's weight, height, and medical history were not reported.  The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: not reported) dose was not reported, administered on 01-APR-2021 to the left arm as prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the day after vaccination, the patient experienced chills, hurting back, feeling hot and cold, headache and sore arms. The patient administered TYLENOL (acetaminophen) for headache. She stated the lower part of back was hurting so that she increased her water intake but the pain did not go away. On 03-APR-2021, third day after vaccination, the patient experienced blood clot came out of nose and nose started bleeding, described as dark red (subsumed under nosebleed).  At the same time on 03-APR-2021, patient experienced gagging, pain in legs, and shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nosebleed, leg pain / sore arm, and shortness of breath, and the outcome of chills, back hurting, gagging and getting hot and cold was not reported. This report was non-serious.
Mother noticed redness and swelling 11/21/2013 one day after getting flu vaccine. Local erythema with warmth, tenderness and induration, no streaking left arm 19x31 cm.
Patient stated she developed an elevated, raw, scaly rash under her left armpit that extends around to spine.
pt recvd vax 7OCT93 & 24 hrs later pt exp ear ache & h/a behind the rt ear; 8 days later devel Bell's palsy;
Pleuritic chest pain in middle of night, presented to ED, anti-inflammatory meds, steroids, arrhythmia
Lightheaded, vomiting, passed out, tingling in fingers and toes, body numbness
A serious spontaneous report of trouble breathing, heavy congestion, and wheezing has been received from a consumer concerning a 32-month-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 15-Oct-2010. On 25-Oct-2010, the patient experienced trouble of breathing, heavy congestion, and wheezing. He was seen by paramedics and oxygen was administered, per reporter, oxygen level was only at 80%. The patient was not hospitalized. On 26-Oct-2010, an x-ray was performed, the results of which were normal. The patient was treated with albuterol and prednisone. The events were not completely resolved.
Patient stated he was feeling very faint and dizzy.  He also stated that he does not do well with vaccines.  When asked to explain, he stated that he always feels like he is going to faint.  I placed a cold ice pack on the back of the patient's neck and we stayed with him until he felt better, which was approximately 20 to 25 minutes.  We asked patient to remain for a total of 30 minutes, after which he stated he felt fine to leave.
Accidentally administered a full dose of vaccine 0.5 mL instead of a half dose for the booster 0.25 mL which was what they were needing.
Restless sleep night of vaccination. Morning after vaccination developed severe chills, light headed, temp 101, body aches, extreme fatigue remainder of that day and evening.  Tylenol helped lower temp. Slept thru night. Next day felt well enough to drive home. Fatigue main symptom that day.
EMS reported patient with increased BP, paleness and sweating about 30 minutes after injection. Doctor's office called and said she was fine. I called later and the father said she was doing fine.
Pt. got lightheaded, and felt tingly all over about 10 minutes after shot (12:10).  About 10 minutes (12:20) letter started feeling "Chest tightening".  She denied not shortness of breath, and no other symptoms.  About 2 minutes after that all symptoms were resolved.  She denied BP check, & EMS.  Reports when she got home felt yucky & whoozy but was still able to do chores.  Around 9:00 pm started feeling short of breath and real tight chest.  She put vicks vapor rub on chest and in nose and about 20-30 minutes felt a little better.  She was able to sleep her normal amount.  She reports she is back to her baseline this morning.
Injection was given to a 7 year old and requirement for vaccine is 4-6, patient parent has been notify.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, strength, route and lot# not reported) that was stored improperly. The nurse did not have the temperature and the time period the RECOMBIVAX HB was out of range. No adverse effects were reported. No PQC involved. Additional information is not expected.
I woke up and my lip was quite swollen, and I had some hives. I went to urgent care, and they thought it might have been a reaction to medication. They put me on steroids or antibiotics I do not remember, and it seem to help somewhat. I continued to get it, so I went to my PCP and explained my symptoms. She put me on antihistamine, Allegra in the morning and Zyrtec at night. At least I don't itch but I am still getting the hives. When I went to see an allergist, I was told to stop taking the antihistamine for 3 days and I got swells, it was horrible. They did a urine analysis for UTI and the results where I did have a UTI. As soon as I saw her on the next 3 days, I took an antihistamine and it helped but I am still having hives.
Follow up information received on 4/26/04, provided demographic information, medical history, administration of initial dose of Flumist and subsequent dosing information and date, lot number and site of herpes lesion. Information regarding Flumist was received from a physician regarding a 6 year old female patient who received a first dose on 12/11/03, and developed herpes. The patient's concurrent illness includes food allergy. Indication for Flumist was immunization. Product was administered on 12/11/03. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 12/16/03, a 6 year old female patient developed herpes on top of lip, under nose, after receiving her first dose of Flumist on 12/11/03. Zovirax ointment was prescribed, and patient recovered. On 2/19/04, the child received a second dose of Flumist, and the reporter stated, no herpes outbreak, but 7 days later mom called to report that mom had herpes outbreak. The reporter also indicated that the mother received Zovirax and recovered.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FISH OIL from 12-Feb-2021 to an unknown date and PRENATAL MULTIVITAMIN + DHA from 12-Feb-2021 to an unknown date for an unknown indication.    On 24-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 17-Dec-2020 and the estimated date of delivery was 23-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Pregnancy test: positive (Positive) Positive. On 12-Feb-2021, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  The patient's positive pregnancy test was on 15-Jan-2021 and estimated date of conception was 23-Sep-2021.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician at the same medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt recv vax & devel flu-like sx characterized by nausea,vomiting,myalgia,& loss of appetite lasting more than 24hrs;
Patient presented to RPh with swollen, red bicep, warm to touch and was instructed to call provider (8-6-15) had office visit.
This spontaneous report was received from a consumer refers to her first brother as a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with MMR II (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bad reaction after a dose of MMR II. The reporter was unspecified what type of reactions. The reporter states she was a young child when this occurred. The reporter also stated that her mother told her the rest of the MMR II was not administered to her brother. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the several reports from the same source. Additional information has been requested.
on August 11, 2021 pt was cleaning out a horse stall and began having pain to his back and stabbing pain in his right side with breathing. Pt unable to lay down due to difficulty breathing. Pt was seen in the clinic on 8/14/21 and prescribed Flexeril 10mg  prn, Toradol 60mg IM and Depomedrol 80mg IM. Pt was instructed on risk of PNA and PE and instrcuted to go to ER with worseing symptoms. Pt presented to my office on 8/20/21 with continued symptoms as above. I ordered a CXR which was negative adn a D-Dimer which was elevated at 1.5. Pt was instructed to go to the ER for further eval for a CTA chest to r/o PE and was found to have RLL PE and PNA. Pt was started on Eliquis 5mg BID, Norco 5/325mg QID prn pain, Mucinex DM 1 BID prn cough, Decadron 4mg daily for 10 days, Levaquin 500mg daily for 10 days and to f/u with PCP. I saw the pt in the office on 8/23/21 and ordered at BLE venous doppler and hematology referral
Narrative: Patient tested positive for COVID-19 and was hospitalized despite full vaccination (received 2 doses of Pfizer [04/20/2021; 05/11/2021] no booster received up to date). Patient was initially positive on 12/30/20021 but was only admitted on 01/04/2022 due to worsening symptoms. Patient was re-tested on 1/17/2022 and remained COVID-19 positive.
Lower-than-authorized dose volume administered; needle broke; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Lower-than-authorized dose volume administered) and DEVICE CONNECTION ISSUE (needle broke) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Lower-than-authorized dose volume administered) and DEVICE CONNECTION ISSUE (needle broke). At the time of the report, UNDERDOSE (Lower-than-authorized dose volume administered) and DEVICE CONNECTION ISSUE (needle broke) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Patient received Pfizer vaccine 1/14/21 for dose one, and Moderna vaccine 3/25/21 for dose 2.
Noticed slight redness one-inch below injection site on 2/24/2021.  At 5 AM on 2/27/2021 there was a three-inch warm, red, hard, swollen circle around the injection site.  Spoke virtually to PCP's Urgent Care weekend nurse practitioner who told me to outline the red area, call back the next day if it extends beyond line and ordered IC Cephalexin 500 mg capsule, three times a day for 7 days.  On 2/28/2021 the redness had extended beyond the ink line so I called the Urgent Care and the covering nurse practitioner told me to continue the antibiotic and to see my PCP the next day.  On 3/1/2021, I saw my PCP.  The redness had extended down my arm to almost my elbow.  I was told to finish the antibiotic and
Mom contacted and informed her child should be given another MMRV vaccine in 4 weeks.
Information has been received from the registered  nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 10-MAY-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
On 9/4/01, pt developed a fever (100F-103F), slight cough and sneezing.
expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z3YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: An expired dose of pediarix  was given to the patient. The reporter consented to follow up. Additional Supportive Information:  The patient received vaccine after it's expiry date, which led to expired vaccine used. This is one of three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066909:Same reporter US-GLAXOSMITHKLINE-US2022066911:Same reporter
Our patient came in to receive her second dose of SHINGRIX, and the vaccine was inadvertantly given SQ. Patient came in to show us her arm the next day. I first noticed of course it was done SQ and so her arm was extremely swollen, red and warm to the touch. I told her to take some Ibuprofen if she was able to too and maybe use some cool compresses to help with swelling and absolutely go to urgent care or ED if it became worse. I called to follow up to see if she did receive medical treatment or if the arm got worse and was not able to reach her.
Mom called b/c child started having "tantrum" behavior. (Behavior occurred approx 1 hr after vaccine administered). - Rolling on floor, crying; Mom did not feel this was "typical behavior for child." No treatment given to child. Parents consoling child.
Dizziness; Difficulty standing; TThis is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4546313.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Eye shaking" (unspecified if ongoing), notes: Eye shaking; "Confusion" (ongoing); "Hand Tremors" (ongoing), notes: Hand Tremors; "Dizziness" (ongoing); "Difficulty standing" (ongoing), notes: Difficulty standing; "Unstable" (ongoing), notes: Unstable; "Buzzing" (ongoing), notes: Buzzing. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DYSSTASIA (non-serious), outcome "unknown", described as "Difficulty standing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Difficulty breathing (hospitalized at ICU); Turned very red (hospitalized at ICU); Severe headaches (icy pick) (hospitalized at ICU); Fever of 105 degrees (hospitalized at ICU); This case was reported by a consumer via market research programs and described the occurrence of difficulty breathing in a adult male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Concurrent medical conditions included asthma (Severe). Concomitant products included salbutamol (Albuterol Neb).   On an unknown date, the patient received the 1st dose of Hz/su + AS01B. On an unknown date, 1 hr after receiving Hz/su + AS01B, the patient experienced difficulty breathing (serious criteria hospitalization), erythema (serious criteria hospitalization), headache (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the difficulty breathing, erythema, headache and fever were recovered/resolved.   The reporter considered the difficulty breathing, erythema, headache and fever to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 22-DEC-2022 Reporter's comments: The patient had reported that, in 2019 he does not remembered in which month, while he had severe asthma was given the first shot of Shingrix vaccine and within 1-2 hours after taking the shot, the patient had experienced difficulty breathing, had a fever of 105 degree Fahrenheit, he had turned very red and had severe headaches to which he had referred it as ick prick headaches.  He was hospitalized in the ICU and was Intubated. He was then discharged after 10 days and the issue was fully recovered. He did not remembered any other details during his hospitalization. The reporter had consented to follow-up. Additional supportive information: Concomitant products included  Oral and topical corticosteroids.
Loss of taste; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included known allergies to sulfa. The patients concomitant medications were not reported. The patient previously took Zithromax and experienced drug allergy. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. It was unknown if the patient has been tested for COVID-19 post vaccination. On 05Mar2021 at 07:00, the patient experienced loss of taste and no treatment was received for adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Positive for Covid-19; Positive for Covid-19; Moderna - Dose number: 5 ... Pfizer / BioNTech - Dose number: 3; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Lot number: El9266), in right arm, on 25Mar2021 at 12:00 as dose  2, single (Lot number: Er8732), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: Ff2587) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09May2022 as dose 4 (booster), single (Lot number: 049l21a), in left arm and on 27Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7163B CUS9951), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Feb2021, stop date: 30Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Positive for Covid-19 "; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna - Dose number: 5 ... Pfizer / BioNTech - Dose number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (07Oct2022) Negative; (11Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested positive for Covid-19 on an unknown date and was treated with Paxlovid from 30Sep2022 to 04Oct2022. The patient tested positive again for Covid-19 on 11Oct2021.
outside of 6 month window for second dose, yet to receive it; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comments: The reporter was the patient.  The reporter reported the patient was outside of the 6 month window for their second dose of Shingrix and had yet to receive the second dose. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Appendicitis which led to an Appendectomy  CT scan revealed  appendicitis  All happened on April 20
Muscle weakness, altered mental status, numbness of feet x 2 days, patient transferred to hospital. Was hospitalized x 3 days & discharged home.