chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore/dry patches; sore/dry patches / some turn sore; Pink spots under the skin turn brownish almost like sun spots /  some turn brownish; was unable to get her second shot of Shingrix until August 2020 Due to sheltering in place for COVID-19; rash from neck to bottom of toes / heavy rash under the skin / Eruptions seems to be coming from under the skin; This case was reported by a consumer via call center representative and described the occurrence of rash in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January).   In August 2020, the patient received the 2nd dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced dry skin, skin pain, skin discoloration and social problem. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the rash, dry skin, skin pain, skin discoloration and social problem were unknown.   It was unknown if the reporter considered the rash, dry skin, skin pain and skin discoloration to be related to Shingrix.  Additional details were provided as follows: Due to sheltering in place for COVID-19 the Patient was unable to get her shot of Shingrix until August 2020 in left arm.  The patient had a rash from neck to bottom of toes. It's a heavy rash under the skin then after a month a few broke out and are sore/dry patches.  Pink spots under the skin turn brownish almost like sun spots, some turn sore and some turn brownish.  Eruptions seems to be coming from under the skin.  The breakout on her back was terrible.  Cortisone cream did not help. She went into ocean water and it seemed to help.  The patient was waiting for biopsy results. The reporter consented to follow up.
STARTED ANTIBIOTICS THE DAY AFTER THE FIRST DOSE OF VIVOTIF; This spontaneous case (PVX2019-1655) was received from a caregiver on 25-Jun-2019. It describes a female consumer who "started antibiotics the day after the first dose of Vivotif". She was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis and oral amoxicillin (500 mg capsule; three times a day) for dental procedure.  Case report: The consumer took a dose of Vivotif and a day after, she started taking amoxicillin for a planned dental procedure.  Action taken with Vivotif and amoxicillin was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "started antibiotics the day after the first dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "started antibiotics the day after the first dose of Vivotif" was considered as not applicable.
Thought I needed to give the patient vaxelis.  Misunderstood the NP orders.  Child didn't have no reaction or distress after the vaccine was administered. Pt mother was aware of the vaccine given
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Feb-2021 and the estimated date of delivery was 21-Nov-2021. On 17-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 17-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Pregnancy test: positive (Positive) Positive.         The concomitant medications were not provided. The Treatment Information was not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 37 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (13Sep2023) Negative, notes: was testing negative 13Sep; (Sep2023) Positive, notes: then positive again a couple days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: yes. Patient received COVID 19 Treatment with Paxlovid. Treatment start date was 08Sep2023 and Treatment stop date was 12Sep2023. Patient had no known allergies.
Patient received third dose of Rotarix after recommended age of 6 months per manufacturer . No adverse reactions noted by parents.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot# K006921 is an invalid lot number for PNEUMOVAX 23)), Exp date 09-AUG-2014, (strength, dose, frequency and route unspecified). No adverse effect was reported. Additional information has been requested.
Hurting a little bit after administration; This spontaneous case was received on 21-Sep-2020 from other non-health professional (consumer) (reference number: SEQW20-02087) and concerned an elderly male patient.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2019, reported as in the previous year, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration, anatomical location, indication: not reported). It was unknown if the vaccine was Fluad Quadrivalent or other influenza vaccine. The batch number was not reported.  On an unspecified date in 2019, after administration, the patient had problems with the influenza vaccine hurting a little bit.  The outcome of events was not reported.  The reporter did not provide causality assessment.  This case is linked to case 202004579 (the same patient).  Case updated on 23-Nov-2020: Correction made to information received on 21-Sep-2020:  Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. No change in the narrative.  Company comment: The patient was vaccinated with the suspect product, influenza virus vaccine polyvalent. Reportedly, on an unspecified date after administration, the patient had problems with the influenza vaccine hurting a little bit (coded as pain). Although onset date was not provided, reported term of the event suggested plausible chronology. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship is assessed as possibly related. (defaults to 'related' in the safety database for reporting purposes).; Sender's Comments: The patient was vaccinated with the suspect product, influenza virus vaccine polyvalent. Reportedly, on an unspecified date after administration, the patient had problems with the influenza vaccine hurting a little bit (coded as pain). Although onset date was not provided, reported term of the event suggested plausible chronology. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship is assessed as possibly related. (defaults to 'related' in the safety database for reporting purposes).
Information has been received from a consumer concerning her daughter with no pertinent medical history who on 12/17/02 was vaccinated with a dose of Hib conj-hep B vaccine (643885/0829M). There were no concomitant medication. The reporter indicated that "her doctor told her that the vaccines were not working." She did note that her child had not contracted hep B. She could not provide any additional info. Unspecified medical attention was sought. The pt also received a dose of hep B vaccine recombinant (640329/0818L-dose given on 7/15/03; lot # for dose given on 4/1/03 not reported) on 7/15/02 and 4/1/03 (WAES0304USA00271). Additional info has been requested.
This initial spontaneous case, was received on 23-Oct-2017, from a pharmacist, concerning an adult male patient of unspecified age. The patient had no relevant medical history and concomitant medications. On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular, anatomical location: left deltoid). It was reported that, vaccine was at a maximum temperature of 55F overnight and it was administered. The pharmacist stated that the refrigerator was at 40.6F last night, but that morning the temperature was 55F and that was the first-time excursion. It was reported that, the patient did not experience any adverse events after the administration of the vaccine. The outcome of the events was not reported. This report was assessed as non-serious. Follow-up report received on 27-Nov-2017: Patient's initial was changed. Gender of the patient was added as male. Date of birth was updated. Route of administration (intramuscular), anatomical location (left deltoid) was added. It was reported that, the patient did not experience any adverse events after the administration of the vaccine. Amended narrative accordingly.
Pfizer-BioNTech COVID-19 Vaccine EUA Beginning one week after receiving the injection, the site has a red spot about the size of a quarter and feels slightly irritated.  It has been this way for approximately 24 hours.
vomiting after each dose; This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received shingrix and experienced vomiting. No further information was reported. The reporter consented to follow up. For tolerance of 2nd dose, refer link case US2021AMR141814.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR141814:same patient
pt recvd vax & became red, swollen & developed a knot; right arm noted to have swelling & redness beginning at shoulder & extending 1/2 to 3/4 distance to elbow; sent to PMD; tx w/DPH & cold compress; imp was local rxn to vax;
Developed allergies to certain foods and on/off heart palpitations ventricular anomalies that still persist.
I was fatigued for a couple days, more fatigued than with shots #2 and #3. The fatigue was similar to my first COVID-19 shot. No other issues until Tuesday, June 28, 2022. About a month after the booster shot. On that day, I developed petechiae (small red spots of internal bleeding) on the insides of both calves after an afternoon of walking. My doc's office advised that I go to urgent care before a flight later that week, so I saw an urgent care MD on Thursday, June 30. He had no idea what caused the petechiae, which I've never had before, and blood testing came back showing normal platelet levels. The petechiae turned yellowy-purple and disappeared within a week. I have no idea if they are related to the booster shot, but I've seen concerns that repeated shots could trigger immune reactions, such as thrombocytopenia.
headache; developed on left side of their face, on the temple area of their forehead, there's been a numb; eyelid felt really heavy, like weigthed down; extremely shaky (arms, shoulders, hands); This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (neurological issue), TREMOR (extremely shaky (arms, shoulders, hands)), HYPOAESTHESIA (developed on left side of their face, on the temple area of their forehead, there's been a numb), EYELID IRRITATION (eyelid felt really heavy, like weigthed down) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition were reported.). Concomitant products included PRAVASTATIN, Botox injections and Prolia vaccine.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced TREMOR (extremely shaky (arms, shoulders, hands)). On 24-Jan-2021, the patient experienced NERVOUS SYSTEM DISORDER (neurological issue), HYPOAESTHESIA (developed on left side of their face, on the temple area of their forehead, there's been a numb) and EYELID IRRITATION (eyelid felt really heavy, like weigthed down). On an unknown date, the patient experienced HEADACHE (headache). On 08-Jan-2021, TREMOR (extremely shaky (arms, shoulders, hands)) had resolved. At the time of the report, NERVOUS SYSTEM DISORDER (neurological issue), HYPOAESTHESIA (developed on left side of their face, on the temple area of their forehead, there's been a numb), EYELID IRRITATION (eyelid felt really heavy, like weigthed down) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included,tylenol   Reporter did not allow further contact
Temperature of 103, vomiting, chills, body aches, joint pain, head ache, joint swelling.  Tylenol and fluids. It lasted approximately 48 hours.
Post vax, the pt developed severe lymphadenopathy and an area of diffuse redness which extended from the injection site to the right groin. He recovered within one week.
the injection site is swollen.; injection site has like a big red circle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2023, outcome "unknown", described as "injection site has like a big red circle"; VACCINATION SITE SWELLING (non-serious) with onset Mar2023, outcome "unknown", described as "the injection site is swollen.". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema.  Additional information: Patient got the bivalent booster on 30Mar2023 and she was fine but the injection site has like a big red circle and it's swollen, she was fine but it's just that her arm is swollen, wondering if she should put an ice pack or something or what she can do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site pain; Feeling more tired than usual the day off and after; headache; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender (reported as the front-line physician) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got COVID-19 vaccine and reported some injection site pain, feeling more tired than usual the day off and after. The patient also mentioned having a headache on an unspecified date. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
The patient is a 4yo who received MMRV, Dtap and IPV. He developed severe nausea, emesis, irritability, low grade fever 6 hours after receipt. The MOP provided video of a crying, ill child which shows local reaction of erythema at both thigh injection sites and an abnormal gait, which resolved by next morning. He developed diarrhea the next day, which has continued intermittently since Apr 12 through when seen yesterday on April 27 2016. This alternates with normal stool and a sibling also has diarrhea symptoms starting a few days ago. The MOP c/o behavior regression. She was counseled the initial symptoms were likely vaccine related, the abnormal gait is most consistent with pain from local reaction, as it fully resolved by the next morning and the continued diarrhea and behavior changes are likely unrelated to vaccine.
Patient stood up and felt lightheaded, collapsed onto floor shortly after. Pharmacist and technician went out onto sales floor to assist. Patient given water and a chair to sit in. Patient became pale, started sweating and stated he is cold. Took him into immunization room to monitor patient.
tooth infection in his upper right side of the mouth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (tooth infection in his upper right side of the mouth) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TOOTH INFECTION (tooth infection in his upper right side of the mouth). The patient was treated with AMOXICILLIN ongoing since an unknown date for Infection, at a dose of UNK, tid. At the time of the report, TOOTH INFECTION (tooth infection in his upper right side of the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Treatment details included Amoxicillin tid and patient was unsure about the interaction of amoxycillin with the vaccine.
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 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:37 PM, 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 43.32 for dose administered on 03-Apr-2021  No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 31-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021 . Product moved to clinic on 30-Mar-2021.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 03-Apr-2021 and beyond use date for the vial was reported as 29-Apr-2021 . Product moved to clinic on 30-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 Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
aches, chills, fever developed approximately 24 hours post vaccine.  Unable to work 48hours post vaccine.  Symptoms resolved
itching - on face, no rash noted. Onset of symptoms - under 1 hour. Patient reported itching to face. No redness or rash noted anywhere on face. Benadryl 25mg PO given. No other issues noted. Stable to release home.
No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T018892 with an expiration date on 02-JUN-2022) for prophylaxis  (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursión of above 9°C Celsius degrees (18.9°C) for  18 hours, 0 minutes and 0 seconds (product storage error).    No previous temperatura excursions were reported.  No additional adverse effect were reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003904:Original Case : 2108USA003819 US-009507513-2108USA003903:Original Case : 2108USA003819 US-009507513-2108USA003905:Original Case : 2108USA003819 US-009507513-2108USA003819:Original Case : 2108USA003819
Pt is 32 wks pregnant, was given H1N1 nasal spray. 11/24/2009 OB records , patient 32 weeks pregnant, reports no side effects from vaccine given 10/29/2009.