chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had mild redness/itch first day or two and was suprised to notice afternoon of Day 8 (Feb. 7) that my arm was sore and a bit lumpy, pink.  By 11pm it was more red and itchy so I contacted urgent care nurse and was told to take Benadryl every six hours.  Redness over about 5 inch round area and itch continued at significant level for 5 days or so and was diminishing when I talked with my primary care physician at seven days of reaction and she advised to keep Benadryl going (I was at every 8 hrs then) until completely gone.  Stopped taking on Feb. 16 with only barest shadow of color remaining.  No further problems.
No adverse effects noted. Resident administered expired Moderna vaccine, expired on 10/13/2021.
vertigo; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness) and NAUSEA (nausea). On 17-Feb-2021, VERTIGO (vertigo), DIZZINESS (dizziness) and NAUSEA (nausea) had resolved.            Treatment and concomitant medications were not provided by reporter.
Increased pain, hardened tissue under skin at injection site, pinkish-red inflammation of the skin the size of my fist. The area also became hot.
Initial case was received on 28 June 2010 from a consumer who is also the patient. A 69 year old female patient received a left arm injection of Tetanus Toxoid Adsorbed Preservative-Free (lot number U2972AA) on 12 April 2010. She experienced severe joint pain of shoulders, hips and knees ever since. She saw a healthcare professional and treatment included "2 rounds of Prednisone." She continued to have joint pain and was treated with CELEBREX and ibuprofen. The patient reported no illness at the time of vaccination and she had no vaccinations within 4 weeks. Concomitant medications included FOSAMAX and SYNTHROID. She had an allergy to Sulfa, but no medical conditions were reported. The patient was referred to a Rheumatologist. As of this report she had not recovered from joint pain. Documents held by Sender: None.
Got very ill with this vaccine; Fever; Chills; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (husband). This is the second case out of two cases. A male patient of unspecified age had received BNT162B2 (Pfizer-biontech covid-19 vaccine, solution for injection) via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient's medical history included Covid-19 in the month of Oct 2020. The patient concomitant was not reported. Reporter stated that after receiving the dose of vaccine on an unspecified date in Mar2021 the patient got very ill with this vaccine and had fever and chills. The outcome of the events was unknown.   No follow up attempts are possible; information on Lot/batch number cannot be obtained.
had fever; extreme fatigue; was feeling very sleepy; did not feel well; This case was reported by a consumer via call center representative and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and GARDASIL for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and GARDASIL. On an unknown date, less than 3 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever, fatigue, sleepiness and feeling unwell. On an unknown date, the outcome of the fever, fatigue, sleepiness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue, sleepiness and feeling unwell to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was patient's mother. On 13th June 2019, the patient received the co suspect Meningococcal Vaccine by Sanofi Pasteur. The patient felt very sleepy, had fever, did not feel well and had extreme fatigue which all resolved in 2 days.  The reporter did not know if it was okay to get all the three vaccines on the same day.  It was unknown if the reporter considered the fever, fatigue, sleepiness and feeling unwell to be related to Gardasil  and Meningococcal Vaccine The reporter did not consent to follow-up.  The reporter did not want to provide her address or phone no. and also did not want to provide HCP information. This case has been linked with US2020AMR234292, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR234292:same reporter
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On 22-JUL-2015, the patient was vaccinated with an improperly stored doe of PROQUAD (Merck) (dose and route were not reported, lot# reported as L005296, expiration date 17-AUG-2016). There was no adverse effects reported. This is one of several reports from the same reporter. Lot number L005296 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
After completion of venipuncture, stated he felt "lightheaded", then fainted, was incontinent of urine. Was unresponsive for +/- 30 seconds, roused, vomited x2.
Patient calls 911 w/ anaphylactic reaction 45 MiNs s/p Moderna Covid-19 vaccine. x 4 0.3 mg Epi peNs given prior to ED arrival. Airway patent but difficulty speaky. Further ED treatments included IV MedicatioNs & breathy treatment.
We were conducting a booster clinic. We were told by medical staff that everyone showing up to the clinic was eligible for a booster, per their Medical Director. Individuals receiving boosters did not have access to their Covid-19 record cards for nurses to verify before giving the vaccine. Afterwards, when inputting doses , it was discovered that this individual had received their booster dose too early per CDC guidelines. They were monitored afterwards per CDC guidelines and no adverse events occurred. They were eligible to receive their booster on 1/30/2022, but received it on 11/18/21.
acute supparative parotitis, lt side headache, earache, parotid swelling
Cellulitis like rxn. Rx Augmentin 500 BID x 7 days. Medrol dose pak.
Headaches, dizziness, nausea and vomiting (w/dry heaving)
Allergic rash; pruritus; Diarrhea; Cough; Redness; Hypersensitivity reaction; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough) and ERYTHEMA (Redness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever, Urticaria and Hypersensitivity reaction (NOS). Previously administered products included for Diphtheria: DTP (Rash Around Injection site one week after shot) on 15-Oct-2013. Past adverse reactions to the above products included Injection site rash with DTP. Concurrent medical conditions included Drug allergy (oral Ferrous Sulfate tablet -Rash) since 1982, Cosmetic allergy (Chlorohexidine Gluconate Skin Cleaner - Rash) since 2014, Hypertension since 2005, Osteoporosis since 2017 and Glaucoma since 2018. Concomitant products included BIMATOPROST (LUMIGAN) from 2018 to an unknown date for Glaucoma, LOSARTAN from 2013 to an unknown date for Hypertension, IBANDRONATE SODIUM (IBANDRONATE) from 2017 to an unknown date for Osteoporosis.   On 19-Feb-2021 at 12:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 11:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough), ERYTHEMA (Redness), HYPERSENSITIVITY (Hypersensitivity reaction) and CHILLS (Chills). On 06-Mar-2021, DERMATITIS ALLERGIC (Allergic rash), PRURITUS (pruritus), DIARRHOEA (Diarrhea), COUGH (Cough), ERYTHEMA (Redness), HYPERSENSITIVITY (Hypersensitivity reaction) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: not reported (Inconclusive) result not reported.         Treatment medications not provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional infovaacine dose 2 added, facility details added, patient details added, concomitant added, other relevant tab updated, events added, and event date added. On 03-May-2021: Updated Patient Medical History Vaccination details, Demographics, Casualty of Primary Source Reporter, Event Outcome date, Concomitant medication details.
Left deltoid swollen, hard to touch, hot, elevated temp. Gave Tylenol. Mom took him to ER on 1/8. They told her was ok, to give Tylenol and notify the Health Dept.
Patient received the Janssen vaccine on 8/4/21.  When the administration documentation was entered into the  system, it was discovered that the patient received the Moderna Vaccine on 3/19/2021 and 4/21/2021.  The patient was transferred to a medical hospital with shortness of breathe.
Adverse effects: chest pain (pressure in center of chest - 5/10 severity), palpitations, shortness of breath, anxiety, numbness/tingling in hands & face.  Treatment: Benadryl 25 mg oral administered.  Outcome: Symptoms improved with treatment. Patient discharged home from ER to follow up with PCP.
Redness and swelling of arm for a week- Benadryl Possible cellulitis- Antibiotic
7 mm raised circular induration (R) arm. 5 mm raised circular induration (L) arm.
2 1/2 inch x 2 inch red edematous area Lt arm at site of Varicella vaccine given on 7-8-08
VACCINE GIVEN ON 17 MARCH.  ON THE 19 MARCH PT HAD EDEMA AND ERYTHEMA TO ENTIRE LEFT ARM ALONG WITH SYSTEMIC SX OF MALAISE AND FATIGUE.  RESOLVING BY THE 20TH AFTER TX WITH BENADRYL.
This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease Sojourn's disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced joint swelling in hands, fast heart beat, palpitation, body ache, muscle ache, and headache. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the joint swelling in hands, fast heart beat, palpitation, body ache, muscle ache, and headache was not reported. This report was non-serious.
Syringe did not deploy appropriately and patient did not receive full dose. Patient was given full dose after this was realized the same day.
dizziness; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age (reported as "72", unit not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 30Jan2021, at single dose, for COVID-19 immunization. Medical history included vertigo (reported as "vertigo real bad"). Concomitant medication included an unspecified blood thinner. On 30Jan2021, almost right away, the patient experienced dizziness. The patient was unsure if his dizziness was from the vaccine or from his history of vertigo. The patient also reported that he is taking a blood thinner and was not aware he needed to let his vaccination provider know until after he got his dose. He asked if he should be concerned. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
ActHIB vaccination was en. The powder is intact and within range and the saline is expired /No AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] with expired diluent.  Medical history, medical treatments, vaccinations and family history were not provided.   On 08-Nov-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (powder Lot number: UI918AA, expiry date: 05-Dec-2019 and liquid diluent Lot number: U6074AA, expiry date: 27-Oct-2019) via intramuscular route in the right thigh.  It was a case of actual medication error due to expired product administered.  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.
Child became limp, unable to hold head up, Refused to bear weight on Lower extremities. Awake and alert but "out of it" according to father. This lasted 10 days, but did not call to inform Pediatrician.
Got covid 7 months after vaccination, it turned into a bacterial sinus infection and required antibiotics.
felt a sharp pain in chest; This is a spontaneous report received  from a non-contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 06May2021 at 17:00 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to dairy. Concomitant medications included prazosin (MANUFACTURER UNKNOWN) and buspirone hydrochloride (BUSPAR) and hydroxyzine (MANUFACTURER UNKNOWN); all taken for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 06May2021 at 17:15,10 minutes post injection, the patient felt a sharp pain in chest that lasted for 2 hours before fading out. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event  felt a sharp pain in chest was recovered on unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Beginning at 6pm of evening after shot was given, Moderate to severe body aches, fever 101.3°, chills, fatuge, headache.  Ibuprofen taken at 8am following terrible difficulty sleeping. Continued to manage parking with that pain reliever at 1pm and midnight on May 8th.
Patient states normal arm discomfort for the first few days. About 2 days after, her arm continues to hurt and cause discomfort. It has continued fairly steadily since the vaccination. She has used Ibuprofen on and off. The Ibuprofen seems to help. She is going to try warm compresses to see if that helps in conjunction with Ibuprofen.
The hacking cough started about 2 and a half months after receiving the vaccine. It's an annoying, dry spot in the back of my throat. I told my doctor and he sent me to an EMT. Then that doctor said he couldn't find anything that would physically make me cough. The cough has been getting better but not gone away completely. I was prescribed a medication to help with the coughing. Before I had the vaccine I could work harder at a longer time period, but now when I work my heart rate goes up and I get sick, nauseas, and light headed so I have to sit down to let my heart rate go down.
Patient was given Pfizer 5 to 11 vaccine instead of adult vaccine.  Vaccine was mixed as if it were adult vaccine and 0.3ml was administered.
One week later started itching on my face and got hives on one side of face,  on arms , a little on chest , hands also itched terrible!  My forehead turned bright red. With little red bumps on it!
Extreme Shaking for 3 1/2 hrs.     Fatigue Diarria                                                         Running nose Fever 102                                                   Sore Arm Headaches                                                 Rash around site and half way down upper arm /itches and still hurts on day 4 Body aches Headaches
Patient experienced neck pain and diarrhea which then progressed to weakness.  On 10/16/19 daughter drove to hospital.  Patient was transferred to Medical Center. Patient with weakness starting in lower extremities, then upper extremities, areflexic bilateral upper and lower.   Dx w/Guillain-Barre Sysndrome.  Patient on ventilator support and receiving immunoglobulin
I felt like I had a head cold I tested on 28MAR2023 and I was positive, I m still positive and I still feel worst. I contacted my doctor and prescribed me Paxlovid, I have not felt so much better after but just a little but.
Left arm swelled about 2 1/2 inches at injection site arm very sore, had soreness in eyelid, cheek, neck, legs and hamstring in left side.
2 1/2 x 3" lump in arm warm and Swollen left arm.
Big lump at injection site that is very painful and feels bruised. Lump appeared a month after injection.
8/18, 19, 20, 23, 26, 31/2021 - my heart began racing - beating fast - some chest pain - but mostly heart racing. This has never happened before. I felt I should've called 911 - but did not bc concerned about covid in ambulance, hospital.
Diagnosed with Temporal Arteritis inflammation. Pain in eyes, jaw, teeth, tender temporal  areas.
Swelling of face, fingers, feet & lips upon awaking. BENADRYL at home, went to E.R.
4 month old male patient administered ADACEL rather than Daptacel with no adverse event; 4 month old male patient administered ADACEL with no adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00819220).  This case involves a four month old male patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] rather than DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 19-Oct-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported, Frequency: once) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of ADACEL and DAPTACEL) and inappropriate age at vaccine administration (with respect to use of ADACEL) (latency on same day).  It was reported "Caller states that today her sister took her 4 month-old son to the doctor for his 4 month immunizations, but he was given ADACEL rather than the indicated Daptacel".  At the time of reporting, 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 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.
inadvertently administered frozen vaccine / frozen temp ranging -8.2 to -13.4 C for 7 hrs; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the incorrect storage of drug to be related to Havrix.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The patient was administered with frozen vaccine Havrix which was kept on temp ranging from 8.2 to 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. The vaccine details were available. The reporter consented to follow up. This case is one of the several cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100521:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter
Patient came in to the pharmacy on 12/28/2018 and complained that he has been having pain in his left arm since he got the flu shot on 11/05/2018. He has tried pain medication but it did not help him. He also said that his left arm is painful and he has to use the right arm to lift his left arm. When asked if he has seen his doctor, he said that he has high deductible and did not see his doctor.
Couldn't see after receiving HPV vaccine approximately 2 minutes after. Felt lightheaded. Felt like she had to go to the bathroom c/o headache.
the patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, drug allergies/reactions concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (one dose, lot # S009757, expiration date 27-SEP-2020, strength, frequency and route were not reported) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature 32.5 Fahrenheit for 8 hours. There was no previous temperature excursion and the call was because of a data logger.