chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin reaction; allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "food allergies" (unspecified if ongoing), notes: Has food allergies; "external allergies" (unspecified if ongoing), notes: external allergies.; "allergic to antibiotics" (unspecified if ongoing), notes: allergic to antibiotics and sulfur; "allergic to sulfur" (unspecified if ongoing), notes: allergic to antibiotics and sulfur; "allergies to medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SKIN REACTION (non-serious) with onset 2021, outcome "unknown"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergy". The events "skin reaction" and "allergy" required physician office visit. Therapeutic measures were taken as a result of skin reaction, hypersensitivity. Additional information: Has a lot of allergies to medications, amongst other things. Also had allergist for majority of the time. Treatment: Lots of things. Patient doesn't want to take another shot if, it is going to bring back the allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse concerning multiple patients. Medical history and concurrent conditions were not reported. On an unknown date, patients were vaccinated with RECOMBIVAX HB (dose, strength, route, lot number and expiration date were not reported. Secondary and concomitant therapies were not reported. Nurse reported that one of their health care providers has stored vaccines incorrectly from November 2013 to 03-MAR-2014. Multiple patients, ages pediatrics up to less 18 years of age, were vaccinated with improperly stored vaccines. No adverse event was reported on the original call. This is one of 5 reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 19 year old female patient who in 2007 at the age of 16 years completed the vaccination with the series of GARDASIL (Lot number not provided). The physician reported that currently the patient had and abnormal (papanicolaou) PAP test, positive for 13 types of high risk HPV including types 16 and 18; and positive for 5 types of low risk HPV including types 6 and 11. At the time of the report the patient's outcome was unknown. The patient sought medical attention by an office visit. Additional information ha been requested.
This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said that after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she developed a lump in her neck in Apr2021. She said she is scared and has not been able to eat since then in Apr2021. She wants to know if this is a common reaction to the vaccine. Consumer is also seeking advice on how to treat the symptom. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Dizziness, Myalgia, Arthralgia, lightheaded, groggy, warm & cold Narrative:
pt recv flu vax & exp pain @ the inj site;pain radiated to shoulder & elbow, was unrelieved by APAP & advil & caused to have limited ROm of lt arm;this is 1 of 2 pt from this site to exp inj site pain p/vax;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Other medical history: Diabetes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Mar2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large rash area below injection site.   About 4-5 days later, more spread out rash on forearms and legs.   Large rash has subsided. Moderna Covid-19 Vaccine EUA
-yellow and green bruising -lump under the skin -warmth to touch -itchiness  Treatment is ice packs twice a day for 15 minutes at a time. Also, taking Ibprophen.
Shortly after he developed high fevers and screaming. Followed by full body rash. My son has never been the same. He is currently in weekly private OT, speech, and PT. He is in a multi disability kindergarten. There he receives the same services. He mentally acts like a 3 year old. Is unable to function like other children his own age. He is given life skills and sign language classes.  Days after the vaccination he lost all capability for learned things. He was completely unintelligible and became angry and enraged over every little thing.
Started to experience dermatographia about two weeks after the vaccine. Started to take Zyrtec daily to avoid near constant itching. Still experiencing today 9/17/22 but can stretch Zyrtec doses to every 2-3 days.
Information has been received from a registered nurse concerning a 5-month-old male who on 24-OCT-2006 and February 2007 was vaccinated PO with the first and second doses, respectively, of Rotateq. Unspecified medical attention was sought. Additional information has been requested.
Developed tremor, rapid heart rate, nervousness, breathlessness, and fatigue. Had thyroid lab values checked 3-4 weeks later and was hyperthyroid after being normal. Lowered medication and retested 8 weeks later and labs were much better though not completely back to normal. Symptoms have mostly resolved.
heavy period with blood clots; headache; tired; muscle spasms and pulls; muscle spasms and pulls; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (09:00 AM) (at the age of 33years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization and experienced fever, chills, body aches, headache, nausea, lethargic, extremely tired, period (two weeks early) and heavy. The patient's medical history and concomitant medications were not reported. The patient previously took Codeine and Duricef and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Mar2021 (18:00), the patient experienced headache, tired, muscle spasms and pulls, heavy period with blood clots. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  Information about lot/batch number has been requested.
swelling of the wrist; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling of the wrist) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swelling of the wrist). At the time of the report, JOINT SWELLING (swelling of the wrist) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided. It was reported that the swelling subsided after 4-5 months.   This case was linked to MOD21-117465, MOD21-168413, MOD21-168423, MOD21-168424 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-117465: MOD21-168413: MOD21-168423: MOD21-168424:
Nine days after vaccine the arm I received the shot in had a large red rash.   It was not itchy but was very warm and did not go away for 48 hours.  Doing some research on side effects, it seems like "Covid Arm".
Patient received their first dose of the Gardasil vaccine on Friday, 8/1/2014 and developed an unusual rash on 8/2/2014. The rash was petechial, periorbital, but only around the left eye, asymptomatic: non-painful, non-pruritic, no associated swelling, and not present anywhere also on the patient's body. The rash had mostly resolved 2-3 days later. No treatment was given.
Woke up at 0300 next morning and got up to bathroom. Ended up getting dizzy, passing out and dislocating shoulder. Husband found her on floor. As day continued, still was shaky, nauseated, lightheaded and had headache. Finally passed by Thursday evening.
2nd dose not yet administered, also due for the 3rd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included TWINRIX (1st dose received on 7th December 2021, batch number A955S, Expiry date 22nd May 2022).   On an unknown date, the patient did not received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 28-July-2022 Reporters comment: The pharmacist reported the patient was late for Twinrix 2nd dose, the second dose not yet administered and also due for the 3rd dose. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not received the 2nd dose, which led to incomplete course of vaccination.
Myocarditis; Chest pain; Pain in jaw; Neck pain; Dizziness; Hyperhidrosis; Impaired work ability; Malaise; This case was received. (Reference number: 1423608) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain), PAIN IN JAW (Pain in jaw), NECK PAIN (Neck pain), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), IMPAIRED WORK ABILITY (Impaired work ability) and MALAISE (Malaise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054czia) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Hypothyroidism, Hypercholesterolemia and Arthritis. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), OMEPRAZOLE, MICONAZOLE and ROSUVASTATIN for an unknown indication.    On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), PAIN IN JAW (Pain in jaw) (seriousness criteria hospitalization and life threatening), NECK PAIN (Neck pain) (seriousness criteria hospitalization and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization and life threatening), HYPERHIDROSIS (Hyperhidrosis) (seriousness criteria hospitalization and life threatening), IMPAIRED WORK ABILITY (Impaired work ability) (seriousness criteria hospitalization and life threatening) and MALAISE (Malaise) (seriousness criteria hospitalization and life threatening). At the time of the report, MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain), PAIN IN JAW (Pain in jaw), NECK PAIN (Neck pain), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), IMPAIRED WORK ABILITY (Impaired work ability) and MALAISE (Malaise) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Catheterisation cardiac: abnormal (abnormal) abnormal. On 14-Jun-2021, Electrocardiogram: abnormal (abnormal) abnormal at Urgent Care and abnormal (abnormal) abnormal in Emergency Room. On 16-Jun-2021, Echocardiogram: confirmed myocarditis (abnormal) Confirmed myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications were listed as armor thyroid. No treatment was reported for these events. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was reported by a nurse and described the occurrence of tight feeling in arm in a subject of unspecified age and gender who was vaccinated with infanrix for prophylaxis. There were no concurrent medications. On an unspecified date on or before 24 April 2006 the subject received a dose of Infranrix in an unspecified arm (dose number not provided). The nurse reported that the lot number of Infranix was "either lot AC14A007BA or lot AC14A008AA." At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 24 April 2006, the subject experienced "tightness in the arm," injection site redness and swelling injection site. The subject was seen at a physician's office. The outcome of the events was not reported. The nurse considered the events to possibly be related to vaccination with Infanrix.
arm still hurts, pain travels down the arm; pain travels down the arm; Can't sleep very well; This case was reported by a consumer via interactive digital media and described the occurrence of painful l arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2022, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced painful l arm, radiating pain and sleeplessness. On an unknown date, the outcome of the painful l arm, radiating pain and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the painful l arm, radiating pain and sleeplessness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the shingles shot 15 days before the date of reporting. The patient stated that the left arm still hurts and sometimes the pain travels down the arm and also could not sleep very well. No further information was provided.
have not been able to work; cough; having breathing issues  with asthma s/s; having breathing issues  with asthma s/s; fever; chills; This is a spontaneous report from a contactable other hcp (Patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: En5318), via an unspecified route of administration, administered in Arm Left on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history included cold and exercise induced asthma. The patient had no known allergies. Concomitant medications received within in two weeks of vaccination included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); biotin (BIOTIN); magnesium (MAGNESIUM); cyanocobalamin (B12 [CYANOCOBALAMIN]); fexofenadine hydrochloride (ALLEGRA). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EJI686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 (at the age of 51years) as SINGLE DOSE for covid-19 immunization. The patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination.  On 28Jan2021, the patient reported that the first two days she had fever, chills, etc. and on day 4 cough started and would not stop. Patient saw doctor and was having breathing issues with asthma. Patient was having couple years ago with cold and exercise induced asthma, however never had issues with having to take steroids or breathing treatments. Patient was now on nebulizer every 4 hrs, have not been able to work, on steroids and other medicines. Patient said it was unknown if it would be a permanent issue with her lungs. Therapeutic measures were taken as a result of having breathing issues with asthma, fever, chills as medicines and nebulizers. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt vax w/2nd dose of varivax subsequently laboratory evaluations revealed pt failed to seroconvert.  pt sought unspecified MD attention
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 19-year-old patient of an unspecified ethnicity and gender received 3 doses of TRUMENBA (Lot # R65027, exp Sep2017) via an unspecified route of administration at single dose: the 1st dose on 17Aug2016, the 2nd dose on 25Nov2016 and the 3rd dose on 21Mar2017 (Lot R65027 Exp Sep2017) for immunisation. The patient medical history and concomitant medications were not reported. The patient returned on 22Mar2017 with cellulitis at injection site with streaking with outcome of unknown.
vertigo; hardly walk; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), GAIT DISTURBANCE (hardly walk) and DIZZINESS (dizziness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient is taking allergy pill) and Depression (Patient is on antidepressant drug).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced VERTIGO (vertigo), GAIT DISTURBANCE (hardly walk) and DIZZINESS (dizziness). At the time of the report, VERTIGO (vertigo), GAIT DISTURBANCE (hardly walk) and DIZZINESS (dizziness) outcome was unknown.            Treatment included Neosporin for the rash, Valium for vertigo and a pill for nausea. Also cold medicine for cough. Upon internal review on 04-Aug-2021, the age was corrected to 76 years.
received an expired dose of fluzone qiv,with no reported adverse event; Initial information received  on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], with no reported adverse event.   The patient's past medical history, medical treatment(s), Concomitant medication,  vaccination(s) and family history were not provided.  On 25-OCT-2022 the patient developed a non-serious event of received an expired dose of fluzone qiv (dose, strength, formulation, route, administration site, batch and expiry date was unknown for prophylactic vaccination),with no reported adverse event (expired product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken : not applicable.  Outcome: Unknown  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.
Nausea,  lightheaded, then fainted and was unconscious for approximately 1 minute followed by profuse sweating for several minutes. Was helped to bed and feeling mild headache, body aches, and low grade fever. After 3 hours still feel like a fall risk.Injection area sore and itching. No further treatment sought.
Pt received DPT vacc. @ 11 a.m. 24Jan90, 25Jan90 child discovered not breathing & CPR was administered.  MEDEVACed to Stormont-Vail Medical Ctr, Tokepa, pronounced dead, only symptom noted periods of "blank staring" exhibited by the child.
swelling, itching, dizzy & woozy; on 2 1/2hr p/vax;BP 136/88
On Tuesday at 12:20 PM Johnson & Johnson Vaccine was received in my left arm After Vaccination until bedtime (around 11 PM) was sleepy but no other symptoms presented themselves. On Wednesday at 01:07 AM woke up to a terrible migraine, nausea, and cold sweats. Could not go back to sleep. On a scale of (least)1-10(most) was a pain level of 6 or 7.  I also could not stop shaking.  At 2:03 AM  developed a fever of 101.3 F. Sat in a cold lukewarm shower until the fever broke.  Was able to go back to bed.   Spent all of Wednesday inside. Migraine and nausea still present. Intensified with bright lights.