chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a 8 patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 15-FEB2-15, 25-FEB-2015, 03-MAR-2015, 24-MAR-2015, 16-APR-2015 and 21-APR-2015, the 8 patients were vaccinated with doses of (Merck) PROQUAD, (strength, dose, frequency, route and anatomical location were not reported) (lot # K021548, expiration date 06-MAY-2016) which were improperly stored. No adverse events were reported. Additionally, it was reported that the temperature excursion for (Merck) PROQUAD was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling in left armpit. Resolved 5 days after vaccination.; This is a spontaneous report received from a contactable consumer (Patient herself) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 56 years old non-pregnant female received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in left arm on 23Mar2021 at 13:30 (56-year-old at vaccination) as Dose 2, Single for Covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications included ascorbic acid, colecalciferol, nicotinamide, panthenol, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTI VITAMIN), calcium and ergocalciferol (VITAMIN D) within 2 weeks of vaccination. The patient was non-pregnant at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the Covid-19 vaccine. The patient did not had Covid prior to vaccination and was not tested for Covid post vaccination. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in left arm on 02Mar2021 (56-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. On 24Mar2021, the patient experienced swelling in left armpit. Resolved 5 days after vaccination. No treatment was received for adverse event. The clinical outcome of the event was recovered on an unspecified date in 2021. The reporter mentioned the seriousness of the events was non-serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
--Hives/rash on trunk (11/16 only) --Mild R ear bleeding & mild/moderate nose bleeding (11/16 only) --Hypertensive episodes (11/16-11/18) --Moderate to severe headache (11/16-current) --Malaise/ fatigue (11/16-11/28) --Leg weakness/ unsteadiness (~11/18- current)
Extreme fatigue, chills, nausea, headache for about two days. Sore arm, stiff neck, sore left underarm ongoing
Post vaccine pt felt light headed and was scared to stand up. Pt was transferred via wheelchair to med obs . pt was transferred to the stretcher  Per patient she experiences fainting episodes with hormonal changes  monthly. Pt was given water and apple juice.  Pt was released at 1100. Vitals as followed  1037 BP 177/94 HR 77 RR 20 SPO2 97 1040 BP 173/93 HR 74 RR 20 SPO2 98 1049 BP 167/99 HR 74 RR 18 SPO2 98 1059 BP 172/87 HR 74 RR18 SPO2 98
Patient got Kinrix instead of Pediarix; 3 year old pt received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2kl4k, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (had two doses of Pediarix ).   On 15th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 15th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 19-AUG-2022 Reporter's Comment: The patient was administrated with Kinrix instead of Pediarix.  No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was administrated with kinrix instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Noticed a raised red rash, oval in shape, about 2.5" diameter, around the site where my vaccine was injected 9 days ago. Rash area feels hot and firm, but not itchy or painful. I don't believe I need any treatment, as it is not bothersome.
Information has been received from a consumer concerning her 6 month old daughter who on 29-NOV-2007 was vaccinated with a 0.5 mL dose of COMVAX.  The patient was concomitantly vaccinated with a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and pneumococcal vaccine (unspecified) (manufacturer unknown).  On 29-NOV-2007, the patient experienced redness and a lump at the injection site.  The patient did not receive medical attention for the experience.  The redness subsequently went away, but the lump persisted.  At the time of this report, the patient was recovering.  No additional information is expected.
Patient received flu shot on 10/2/13 at about 730 pm. She said she noticed a rash around the injection site by 11:00 am then next morning. A red injection site reaction  "3 inches in diameter" present 10/4/13 PM when seen at the pharmacy. Site was aching per patient. Was to follow-up with PCP next day.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, Report about covid treatment: Yes, if vaccine received: Yes. Other medication in 2weeks was Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 16Jun2022, Treatment stop date: 19Jun2022, Indication: Treatment of COVID-19. covid vaccine details: Vaccine brand Pfizer/BioNTech, Vaccine administration date:27Apr2022. Adverse event: Rebound Covid 10 7 days post completion of Paxlovid, Adverse event country: Adverse event start date: 26Jun2022, Adverse event start time: 11:00 PM, ae resulted in: None of the above, If patient recovered: Recovering, If treatment ae: No.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events Drug ineffective , covid 19 and the suspect drug cannot be excluded
HEART ATTACK; This spontaneous report received from a consumer concerned a 49-year-old of an unspecified 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 administration, batch number were not reported, expiry: unknown) dose was not reported, (dose number in series 1), 01 in total was administered, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. The reporter had not reported any adverse events following vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine MRNA 1273 (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, (dose number in series 2) start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, following vaccination with MRNA 1273, the patient had heart attack. On the next day (after vaccination) the patient died due to heart attack (dose number in series 2). It was not reported whether autopsy was performed or not. This report was serious (Death).; Sender's Comments: V0: 20220100315-COVID-19 VACCINE AD26.COV2.S-Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
Arm soreness lasting 5 days Fever peaking 101.4 degrees F that started day 2 and lasted 3 days with general aches throughout the body with a little unsteadiness in the feet headache started after giving the shot and lasted 4 days
Roughly 27 hours after the vaccination I noticed pain and swelling in my left armpit. Morning of day two post vaccination, the lump has grown to the size of a small egg. It is painful to touch. There is no redness. No redness or swelling at the injection site either. Mild soreness only. I did experience fatigue the first day also but it has since subsided. Only symptom remaining is the lump in my left armpit.
Initially started as a small redish color rash on arm, that has now (14 days later) covered approx 50% of my body. Not sure if the maculopapular rash was caused by vaccine or not, but its the only "new" thing I have been exposed to. Rash is still present even after dose of prescribed steriods.
pt recvd vax 2SEP92-3SE92 area turned red, swollen & hot to touch; states took APAP; 4SEP92 began to hurt & hard infection in center; approx 3" induration w/infection in center; hot to touch;
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 16 week old male with no known drug reactions or allergies who on 06-FEB-2007 was vaccinated with the first oral dose of Rotateq (Lot# 654664/0726F). Concomitant vaccinations included Hib (unspecified carrier) and hepatitis B (unspecified). On the physician reported that on 09-FEB-2007 (he also reported the onset as two days after vaccination), the patient experienced vomiting 3 times and mucous in stool. The patient went to the emergency room but it was unknown whether the patient was admitted into the hospital. On 12-FEB-2007, the patient recovered from vomiting 3 times. It is  unknown whether the patient will receive the second and third dose of Rotateq. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007.  Information has been received from a physician concerning a 16 week old male with no known drug reactions or allergies who on 06-FEB-2007 was vaccinated with the first oral dose of Rotateq (Lot# 654664/0726F).  There was no illness at the time of vaccination.  Concomitant vaccinations included the first dose of ACTHIB, (Lot # L20306-2) on 06-FEB-2007 IM in the right arm, the first dose of IPOL, (Lot # L20306-2) in left arm and DAPTACEL, (Lot # L01813BA) in left arm both given on 22-JAN-2007.  On the physician reported that on 09-FEB-2007 at 11:45, the patient experienced vomiting 3 times and mucous in stool.  The patient went to the emergency room.  The patient's temperature was 97.4, respirations 22, pulse 20, weight 12 pounds and 12 ounces, and Hematocrit 24.  The patients physical exam was abnormal increased bowel sounds were noted.  The physician's impression was "AGa".  On 12-FEB-2007, the patient recovered from vomiting 3 times.  The patient's weight at the time of the report was 13.5.  It is unknown whether the patient will receive the second and third dose of ROTATEQ.  Additional information has been requested.
little bit red at the injection site; like bruises (in the arm of the injection); little spot, like chicken skin; really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), ADMINISTRATION SITE BRUISE (like bruises (in the arm of the injection)), SKIN TEXTURE ABNORMAL (little spot, like chicken skin) and VACCINATION SITE ERYTHEMA (little bit red at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ILLNESS (really sick). On 21-Mar-2021, the patient experienced ADMINISTRATION SITE BRUISE (like bruises (in the arm of the injection)) and SKIN TEXTURE ABNORMAL (little spot, like chicken skin). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (little bit red at the injection site). At the time of the report, ILLNESS (really sick), ADMINISTRATION SITE BRUISE (like bruises (in the arm of the injection)), SKIN TEXTURE ABNORMAL (little spot, like chicken skin) and VACCINATION SITE ERYTHEMA (little bit red at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication.  No treatment medication was reported.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Psoriatic arthritis (Started 40 years ago and Stable.), Interstitial lung fibrosis (Idiopathic Interstitial fibrosis of lungs. Stable) since 2021, Cholesterol and Thyroid disorder. Concomitant products included GUSELKUMAB (TREMFYA) for Psoriatic arthritis. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 05-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. It was also reported that patient took antacid and some medication for Cholesterol and Thyroid. Patient did not have any allergies from medications, food and other products. Patient is taking Tremfya for about an year. Patient was sick with fever and chills for 2-3 days after receiving the 2nd dose. Patient has experienced the similar event fever in the past. The patient was not tested positive or diagnosed with COVID. Treatment medication was not reported. This case was linked to MOD-2022-539509 (Patient Link).
Low grade fever (37.7); fatigue; achiness; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 26Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low grade fever (37.7), fatigue and achiness on 27Jan2021. The symptoms onset day after vaccination; symptoms resolved within 24 hours. The patient underwent lab tests and procedures which included Low grade fever: 37.7 on 27Jan2021. Outcome of the events was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.
Mother called clinic stating child has had temperature of 103, nausea, vomiting, and hives since 06/30/2000. Instructed mother to take child  in for treatment and notify clinic when she has returned from doctors office.
WOKE UP FROM SLEEP DUE TO PAIN; RIGHT ARM PAIN; RIGHT SHOULDER PAIN; This spontaneous report received from a consumer concerned an 80 year old female. 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 not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced woke up from sleep due to pain. On 05-JUN-2021, the subject experienced right arm pain. On 05-JUN-2021, the subject experienced right shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, right shoulder pain, and woke up from sleep due to pain. This report was non-serious.
Swelling on the face; Rashes, fine bumps on her face, neck, and arms; Itching on her right arm; Her arm was hurting form the vaccine; an allergic reaction; This is spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: ER8733, Expiry date: not reported) (age at the time of vaccination was 38 years), administered in Arm Left on 26Mar2021 at 10:15 as dose 1, single for COVID-19 immunization. The patient's medical history included anemic since Jan2021, Covid-19, allergies to penicillin. The patient's concomitant medication included Iron for anemic since Jan2021. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient reported that the patient had some allergic reactions after the first dose of the vaccine. On 26Mar2021, the patient had little bit of swelling on the face and rashes, fine bumps on her face, neck and arms, itching on her right arm. The patient was recommended by the facility when she went for her second dose last 16Apr2021 schedule for an allergy testing first. The patient should continue to get her second dose or not. The outcome of the event an allergic reactions was unknown and other events was recovered on 27Mar2021.  No follow-up attempts were needed. No further information was expected
This spontaneous report as received from a Healthcare Worker refers to a 4 month old patient of unknown gender. On 08-AUG-2013 the patient was vaccinated with a first dose of ROTATEQ 2 ml, oral (lot number was not reported). On 09-OCT-2013 the patient was administered an expired second dose of ROTATEQ 2ml, oral (lot number reported as: 0302AE; exp date; 03-OCT-2013). No adverse effects were reported. Additional information has been requested.
Hives outbreak on day 12 (Feb 4). On Feb 5 I experienced diarrhea and stomach pain. On Mon Feb 6 I went to urgent care and was prescribed prednisone. I took 4 tablets daily for 3 days, then 2 tablets daily for 3 days, and then 1 tablet daily for 3 days. I took Zyrtec on occasion after that to help with the itchiness and used a cortisone topical cream. I am still experiencing redness, itchiness, and dermatographia.
"polymyalgia rheumatica" (off label) as result of covid/coronavirus vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 59 year-old female patient received bnt162b2 (BNT162B2) (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: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as ""polymyalgia rheumatica" (off label) as result of covid/coronavirus vaccine".   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event polymyalgia rheumatica with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
4 hrs after shot - severe pain radiating cold chills and fever and headache. Next morning - more continuation of symptoms took ADVIL 48hr feeling better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "Other medical history: Limited circulation in right leg" (unspecified if ongoing), notes: Other medical history: Limited circulation in right leg; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid as treatment from 01Jan2023 to 06Jan2023 for COVID-19  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.