chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Feb2022 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: No known allergies. COVID 19 Treatment was Paxlovid from 20Sep2022 to 25Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe shortness of breath, chest pain, dizziness, tachycardia, heart pounding, tremors, hives with whelps, itchiness, fever, night sweats, fear of doom, shoulder pain, nausea, headaches, all over body aches and tenderness. Medications included Benadryl, hydrocortisone cream, famotidine, Vistaril, Allegra, Tylenol. Most of these symptoms have been going on for 7 days.
Case number PHEH2015US003162, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 12 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 03 Feb 2015, the patient received MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly. It was reported that the patient received the vaccine that was frozen with excursions as follows: on 14 Jan 2015, the vaccine was at 0.4 degree Celsius for 1 hour and 16 minutes, on 26 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Missed 2nd dose of M; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Missed 2nd dose of M) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (Missed 2nd dose of M). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Missed 2nd dose of M) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Experiencing sinus issues; chronic neck pain; chronic back pain; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Experiencing sinus issues), NECK PAIN (chronic neck pain) and BACK PAIN (chronic back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sinus disorder (has history of sinus issues).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 17-Sep-2021, the patient experienced SINUSITIS (Experiencing sinus issues), NECK PAIN (chronic neck pain) and BACK PAIN (chronic back pain). At the time of the report, SINUSITIS (Experiencing sinus issues), NECK PAIN (chronic neck pain) and BACK PAIN (chronic back pain) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.  Patient said she is experiencing sinus issues and chronic neck and back pain side effects months after getting the two moderna doses. Patient  already went to clinic and was advised to get tested for covid.
Monday, 10/11/2021, I noticed a big red rash on both of my legs and my arms, then two days later I noticed a circular red rash on my upper left arm around the injection site.  Then, the next day I started with itching all over my body and inside my mouth, upper roof, tongue and throat.  I called the pharmacist, and told her what was happening, which I confirmed that Zyrtec would be considered an Antihistamine and I already had a bottle of this in my cabinet, so I took one Zyrtec pill around 2:00 pm. Around 4:00 pm, i realized it wasn?t subsiding and some different symptoms started, like blurred vision, headache, cold chills and light headedness.  So, I called my mother to come to my home and pick me up to take me to Urgent Care.  While there I started with Chest Pains.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    The case reported for 60 out of 189 patients. No concomitant medication was provided by reporter.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
EMS was called over to  patient information table  for a 33 year old female patient  not feeling well. EMS found the patient sitting in the  chair AOx4 ,  skin warm, pink and dry. Patient  complains of feeling light headed  with  slight shortness of breath. Patient  is not complaining of  any nausea or chest pain.  Patient  is not on any  medications at this time and only has a history of an ovarian cyst. Patient denies any allergies and  no known drug allergies.  Patient was transfered  over from  the chair to a wheel chair by standing and pivoting . Patient was then brought to a  back hallway 100ft  away  to be  further evaluated.  Patient blood pressure was 120/90, heart rate 80, spo2 99%. Patient was put on oxygen via nasal cannula  at 4lpm.  Patients said her breathing  started to improve.  Patient then started to say her throat was feeling dry and described a lump forming in her throat. Patient had sip of water to see if she could swallow.  Respiratory rate increased  to hyperventilating  40 breaths per minute.  Vitals were attempted to be reassessed, but then the patient began to experience nausea and dry heaving.  At this time  a paramedic  who is administering vaccinations  to patients stepped in  to help administer epinephrine 1:1,000 .3mg  intramuscular on the left thigh. Providence Fire/Rescue showed up  and patient was then transferred from wheel chair to  Providence Fire/Rescue stretcher with 2 EMT limb lift. Patient was then put on a Non-Rebreather at 15lpm of oxygen. Patient care was transferred over to Providence Fire/Rescue.  Personnel on Providence  Fire/Rescue names were not obtained and no signature was obtained.
Anaphylactic. Patients throat started closing up 10 minutes after vaccination.  Epinephrine given.   Patient responded and recovered.  Sent to hospital for further monitoring.
Left arm hurt Right after first shot, has continued to hurt still today.  Have been to my Docter and had a Corazon shot for pain in my shoulder no relief.
The pt developed redness, swelling and rashes at the site of the injection. She also had scratch marks due to itching.
This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On an unknown date the patients received improperly stored PEDVAXHIB (incorrect product storage). No adverse effects were reported. Outcome of the event, incorrect product storage was unknown. Reporting health professional considered product the event to be not related to PEDVAXHIB. This is one of several reports from the same reporter (MARRS # 1504USA004228 and MARRS # 1504USA004065). Additional information has been requested.
PT. had large knot on left thigh one day after she received shots.  Area was larger than a quarter, red, hard, and hot to the touch.  Did not seem painful for pt.  Was told to give antihistamine and use cold compresses as needed.
This 21-year-old member received her 4th anthrax vaccination on October 15, 2003, while stationed overseas.  She reports the vaccination site was red and swollen around the upper arm.  The rash began to her arms within 30-45 minutes after receiving shot then slowly spread over her body over the next 3-4 days. She describes the rash as "feeling like sandpaper", with pruritis and some axillary lymphadenopathy for one week. She denied any fever, nausea, vomiting, diarrhea, muscle fatigue or weakness, paresthesia, or headaches.  She sought out medical care 3-4 days later as the rash continued to spread and was given a shot of Benadryl. She was diagnosed with "atopic dermatitis after anthrax shot" and instructed in the use a hydrocortisone cream to the rash until resolution. Her rash lasted approximately 7-10 days.  She reports no further rashes or scarring noted as of August 27, 2004. She denies any past history of a similar reaction, any recent illness, exposure to new substances, or bites while overseas.
Onset pain approximately 39 hours after shot R arm induration 16x18mm, erythema 25x45mm.
16 year old patient received adacel shot before due date / No AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA314548 (same reporter).  This case involves a 16 year old patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] before due date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunization.  On 30-Oct-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6512AA (Expiry date 23-10-2021) via unknown route in the right deltoid.  It was actual medication error case due to inappropriate schedule of product administration.  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 holders 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.
2hr p/vax pt noted to have 1-2 red blotches on face;5-6hr later pt bedtime, pt was noted to have total of 5-6 red blotches on face & neck;woke up next AM was covered w/red blotches;c/o intense itching;pt seen by MD vax rxn suspected;
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced skin ended very badly, sick heart, and cannot even work, and patient was hospitalized (date unspecified). Number of days hospitalized was not reported. The patient reported that the vaccine almost killed the patient. The patient had 3 months sick heart and skin ended very badly. The patient cannot even work and did not leave hospitals. The patient said it was very bad decision to use the vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot even work, skin ended very badly, and sick heart. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20220407564-Covid-19 vaccine ad26.cov2.s-Sick heart, Skin ended very badly, Cannot even work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer or non-healthcare professional from medical information team. This consumer reported similar events for 37 patients. This report is for 33rd patient of 37 patients. A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 19Jan2021 (Lot Number: EL3249) and dose 2 via an unspecified route of administration on 09Feb2021 (Lot Number: EN5318); both as single dose for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. On 10Aug2021 (longer than two weeks after both doses), patient was tested positive for covid virus, after being fully vaccinated. On an unknown date, patient underwent body mass index test which showed 28.7. On 10Aug2021, NAAT Covid test resulted positive. Caller stated 15% of breakthrough cases were from one Pfizer Covid 19 Lot number: EN5318. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
This spontaneous report as received from a nurse refers to an 8 months 3 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
36 hours after vaccine, sudden onset tachycardia, shortness of breath, dizziness on the verge of passing out, called covid hotline, sent to ER due to resting heart rate of 130-150.  Lasted approximately 9 hours, was going to be kept for observation in ED. Resting HR came down to 90 and sent home, following day unable to perform normal activities and unable to work for two days as of now
Case number PHEH2013US022552 is an initial spontaneous report received from a pharmacist on 15 Oct 2013. This report refers to a patient of an unknown age and gender. The patient was vaccinated with seasonal flu vaccine (manufacturer and batch number unknown) on an unspecified date. It was reported that the patient received Flu vaccine that was expired on 20 Jun 2013. It was unknown whether the vaccine was FLUVIRIN or some other vaccine. Reporter enquired whether the patient could revaccinate with FLUVIRIN. No other information was provided.
Patient c/o of pain to his mother about 9:30am. Mom noted area (about the size of her palm) to bil legs red and swollen. Informed mom to apply cool compresses and apply Myoflex Cream to area q 3-4 hours. Give Ibuprofen or Benadryl for pain and/or inflammation.
did not experience any adverse events after taking doses of the vaccine as compared with her sister who experienced fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "did not experience any adverse events after taking doses of the vaccine as compared with her sister who experienced fever.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial report received from a pharmacist on 15 Jan 2010: The patient was vaccinated with FLUVIRIN (batch:104045P1) 0.5 ml once, intramuscular, stored at temperatures as low as 34 F and 35 F on an unspecified date. No adverse event was reported.
Side effects of flu shot. Muscle aches, headache, flu symptoms: ears and throat.
No additional adverse effects were reported; a patient received an expired dose of VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On 07-JAN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not reported) (dose, route of administration and anatomical site of vaccination were not reported; lot number R034584, expiration date 29-DEC-2019, and upon internal validation stablished as the same) as prophylaxis (expired product administered). No additional adverse effects were reported.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 60.70 for dose administered on 20 Mar 2021. No concomitant medications were reported.  Batch number 031A21A administered on 20 Mar 2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 AM . This vial was moved to fridge on 09 Mar 2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Discolouration; 3 circular macular rashes; a left arm rash; redness; pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SKIN DISCOLOURATION (Discolouration), RASH MACULAR (3 circular macular rashes), RASH (a left arm rash), ERYTHEMA (redness) and PAIN (pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (CIPROFLOXACIN).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Discolouration), RASH MACULAR (3 circular macular rashes), RASH (a left arm rash), ERYTHEMA (redness) and PAIN (pain). At the time of the report, SKIN DISCOLOURATION (Discolouration), RASH MACULAR (3 circular macular rashes), RASH (a left arm rash), ERYTHEMA (redness) and PAIN (pain) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Immediately after shot felt a tingly numbness all the way down arm to fingers. Then later in the day her legs, arms, & face was itchy & tingly. She said also felt lightheaded & nauseous. Has had previous flu shots & never felt this way. Did not report this to nurse until the next day. Never went to MD or took medication. Also felt weak.