chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed diffused erythematous blanching urticarial lesions on upper arms and neck approximately 16 hours after Hep A vaccination number 2.  No immediate reactions were noted after vaccine administration. Pt tolerated first Hep A, given 19Nov2004, with no reported adverse reaction.  No c/o oropharyngeal or tongue swelling.  No c/o dyspnea, wheezing, difficulty swallowing or speaking.  She has not changed her medications and could not relate the onset of lesions to any new or temporally associated recent food ingestion.  Pt was seen by doctor, who diagnosed acute urticaria and prescribed loratidine 10mg daily and diphenhydramine 25mg q4-6h prn.  Fexofenadine 180mg daily was added by Allergist if diphenhydramine use is limited by too much sedation effects.
No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003334: US-009507513-2108USA003248: US-009507513-2108USA003331: US-009507513-2108USA003332: US-009507513-2108USA003333:
Had a some sort of blockage; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Had a some sort of blockage) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a some sort of blockage). At the time of the report, VACCINATION COMPLICATION (Had a some sort of blockage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Pt came today 7/19/21 at 9am complaining of patch liked rash around her body that's itching. Noticed ones on her leg , one on the left arm, and pt said one just formed on the side of the forehead. She stated that it started the day after the vaccine and that it keeps popping up. I recommended pt to see the doctor as soon as possible. Pt states they do not have insurance and cannot afford to go. I recommended a clinic near by that could help with uninsured pts. I offered to make an appt for them. They said they would call me if they need help.
Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from a physician by phone. This case involves a 6 months old patient who was vaccinated with an expired third dose of IPOL (Batch number, expiry date, dose, route and site of administration were not reported) on 11-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. Documents held by the sender: none.
Pentacel was not reconstituted properly with no reported adverse event; Lyophilized portion was not given with no reported adverse event; Initial information received on 07-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who experienced pentacel was not reconstituted properly with no reported adverse event and lyophilized portion was not given with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ580AA via intramuscular route in unknown administration site. First time product used : No   On 07-JAN-2022 the patient developed a non-serious pentacel was not reconstituted properly with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. On 07-JAN-2022 the patient developed a non-serious lyophilized portion was not given with no reported adverse event (incorrect dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported "from reporting manager office that PENTACEL was not reconstituted properly, and the lyophilized portion was not given. It was questioned that what should be done now. This was an potential AE because of medication error. The patient has been Still using product".  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Pentacel was not reconstituted properly with no reported adverse event, Lyophilized portion was not given with no reported adverse event).  At time of reporting, the outcome was Unknown for the event pentacel was not reconstituted properly with no reported adverse event and was Unknown for the event lyophilized portion was not given with no reported adverse event.   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 the 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 has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored measles, mumps and rubella (Wistar Ra 27-3) virus vaccine live (V@05C) (lot # K008202, EXP date: 05-JUNE-2016, dose and route not reported. No adverse effects was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Received COVID-19 Moderna Vaccine and "had side effects".; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Received COVID-19 Moderna Vaccine and "had side effects".) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Received COVID-19 Moderna Vaccine and "had side effects".). At the time of the report, IMMUNISATION REACTION (Received COVID-19 Moderna Vaccine and "had side effects".) outcome was unknown.            Concomitant medications were not reported.  Patient received COVID-19 Moderna Vaccine and had side effects.  Treatment information was not reported.
tested positive again; tested positive again; Symptoms are worse; congestion; cough; body aches; chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 11:00 as dose 1, single (Lot number: ER8735), in left arm, on 22Apr2021 at 11:00 as dose 2, single (Lot number: Ew0170), in right arm and on 14Dec2021 at 11:00 as dose 3 (booster), single (Lot number: 3303BD) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT, start date: 25Apr2022. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 07May2022, outcome "not recovered", described as "Symptoms are worse"; PAIN (non-serious) with onset 07May2022, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 07May2022, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 07May2022, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 07May2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took Paxlovid for 5 days after 1st day of positive test; Negative, notes: tested negative, on day 7; Positive, notes: came down with symptoms of covid again on day 10 and tested positive again. Therapeutic measures were not taken as a result of drug ineffective, covid-19, condition aggravated, nasal congestion, cough, pain, chills. Clinical course: Patient was received other medications in two weeks.
raised hot/red area  about 5cm in diameter appeared yesterday (07/19/21) . Pt said it had an internal burning sensation. Pt was ibstructed to use diphenhydramine and hydrocortisone 0.1% cream. If symptoms persist for > 7 days pt should go to a clinic for further tx.
I woke up with shortness of breath, aches, and an upset stomach. I just didn't feel like myself. I felt really weird. I also had a headache. The doctor confirmed I had the flu. I was in bed for four days. Urgent care gave me albuterol, ondansetron, and oseltamivir. The oseltamivir made me dizzy.
On 6/18/19 back of rt arm given VARIVAX sq pt re-visited clinic on 6/20/19 and vaccine site appeared red swollen about 7 am at 9 am. Pt referred to office at 11:30 am on 6-20-19. They were rx for cellulitis with cephalexin 250 mg 4 x daily/one wk.
At bath time last night mom noticed that left lat. thigh/hip swollen, hot to touch and red in lg area. Here for PPD V, notified RN. Area as described above measuring roughly 5" long x 3 1/2 - 4" wide. Pt active in NAD. Told mom to give Tylenol/Motrin for c/o pain, hot/cold compresses if needed.
This spontaneous report as received from a consumer via Pfizer refers to a 17 year old female patient. The patient's medical history, concurrent conditions, concomitant medication were not reported. On an unknown date (also reported one or two years ago) when the patient was 15-16 year old, she was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (lot, expiry date, dose, route of administration were not reported) (or) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) (lot, expiry date, dose, route of administration were not reported) for prophylaxis. When she had the initial HPV vaccine, she had a really bad reaction that included tennis ball size lymph nodes under her arms (lymphadenopathy). On an unknown date of June 2018, the patient experienced upset stomach, which was worst on 10-JUN-2018, syncope and swollen lymph nodes (lymphadenopathy). The patient stated that as long as she is not super active, she seems to be feeling better. The reporter stated that the patient's lymph node under her left arm is worse than the right. The outcome of abdominal discomfort was reported as recovered. The outcome of all other adverse events were reported as unknown. The causality assessment was not provided by the reporter.
Felt like I would faint; also nausea and diarrhea (I was just buying lift tickets on a ski slope...not pretty!!!)
Intestinal gurgling, heavy sweating, palor, general malaise occurred within 10 minutes of receiving vaccine. Symptoms persisted for 5 hours until bedtime. Next morning had fatigue, headache and feeling of scalp tingling but other symptoms had lessened or subsided.
experienced a fever; experienced a fever and mild illness; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and feeling unwell. On an unknown date, the outcome of the fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever and feeling unwell to be related to Shingrix.  Additional details were reported as follows:  The age at vaccination was not reported. Pharmacist reported the patient experienced a fever and mild illness following dose one of Shingrix. HCP did not provide lot number and expiration date for dose one of Shingrix.  HCP did not provide patient initials and date of birth. HCP describes fever following dose one as mild, almost not even a fever.  The fever and mild illness went away, no resolution date provided.  For tolerance after 2nd dose refer case, US2020AMR075347.
2 hours after vaccine developed persistent blurry vision  and   8 hours after vaccine have developed some shortness of breath . Neither of which has resolved as of 12:35 am  1/26/21
Fatigue and headache started about 12 hours after vaccine was given, lasted throughout the day on and off, fatigue and malaise progressed throughout the day. Nausea started about 24 hours after vaccination. Then overnight about 30 hours later developed chills and hot flashes alternating through the night, difficulty sleeping, headache and fatigue continued.
Sudden onset RLE pain (behind right knee) with difficulties walking.  Hx DVT, venous duplex negative.  Arterial duplex completed, showing proximal aortoiliac occlusive disease with occlusion of popliteal and infrapopliteal arteries.  Not on anticoagulants prior to pain.
Randomized red blood petechiae like spots under skin appearing on abdomen and back, then spreading to chest, arms, legs and neck over next several days.  Severe lower back pain, fatigue, general muscle pain
Pt recv 2 doses of Recombivax & 1 dose of Engerix-B; also given booster Engerix-B and titer is still 3.9.
Tingling in left arm moving up to neck area. Throat felt funny. Pale appearing.
Went on vacation, scuba diving in early June.  Very crowded airport.  Wore my mask the entire trip.  Became sick three days after arriving home.  Symptoms were very similar to the malaria I caught.  Tested positive for Covid-19.  Went to hospital and received the monoclonal antibody treatment.  My symptoms improved rapidly after that. I received the booster shot on 12/18/2021.  For three weeks after, I was easily fatigued and had frequent headaches and muscle aches.  I tested negative for Covid-19 with a home test kit.  The symptoms gradually resolved.
first dose / on an unknown date (more than six months ago); This case was reported by a pharmacist 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 first dose on an unknown date more than 6 months ago).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient had not yet received second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented follow up. This case has been linked with case US2021153987 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021153987:Same reporter
4 days after 2 nd dose on 3/18/2021 my father/patient has growing rash, unusually large swelling of injection site arm, left arm. increasing sensitivity to shot, soreness.
Patient hospitalized for 2 days. 83 y/o male HX of COPD on 2L at baseline who presented with acute hypoxic respiratory failure due to COVID-19. He had symptoms for about 2 weeks prior to presentation. He ultimately presented to urgent care and was sent to the ER. He required 4 L of oxygen to maintain his saturations in the ER and was started on Decadron due to his hypoxia. CT thorax with contrast showed no PE. He was weaned to his home baseline 2L easily. He was able to ambulate with minor desaturations but recovered quite quickly. Physical therapy and occupational therapy cleared him for home without services. He was discharged to home in stable condition. He was found to be hyperkalemic on admission so his potassium supplements were stopped. He remained mildly hyperkalemic, will need this rechecked outpatient.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 09-SEP-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Within 15 minutes of influenza vaccine, given in left arm, right arm started itching. Progressed to scalp, neck and torso. Tight feeling in chest. Dr. notified, vitals taken, PFT done and injected in left arm with epinephrine by Dr.
Evanescent, pruritic urticarial papules on extremities and face. No involvment of oropharyngeal mucosa. No associated shortness of breath, pooling of secretions.
Rash and pruritis started after vaccine FLUZONE. Initially rash started on hands and wrists bilateral, spread to bilateral ankles, feet and thighs. Applied cortisone cream(had at home) w/ little relief. Appointment in Employee health w/ nurse practitioner today.
my hemoglobin dropped from 11.4 to 8.1.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I am on dialysis" (ongoing), notes: I am on dialysis and severe asthma; "severe asthma" (unspecified if ongoing), notes: I am on dialysis and severe asthma; "insulin dependent diabetic" (ongoing), notes: as well as being insulin dependent, diabetic. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HAEMOGLOBIN DECREASED (non-serious), outcome "unknown", described as "my hemoglobin dropped from 11.4 to 8.1.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient was on dialysis and severe asthma, as well as being insulin dependent diabetic. The week after my COVID mixed variant booster #3, my hemoglobin dropped from 11.4 to 8.1. Patient was struggling.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.