chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with a dose of ROTATEQ orally, lot number M035456, expiration date: 01-MAY-2018 or Lot # M038208, expiration date: 04-MAY-2018 or lot M040267, expiration date 14-MAY-2018 or lot M041181, expiration date 03-MAY-2018 (strength and dose were not reported) for prophylaxis. The temperature of excursion with dose of ROTATEQ was between 47 to 77 Fahrenheit degrees for 192 hours. No previous temperature of excursion was performed. The temperature of excursions were detected by a data logger. This is one of two cases from the same reporter.
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 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:32 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 22.17 for dose administered on 07-Jan-2021.  No concomitant medications were reported.  Batch number 025L20A was initially moved to fridge on 05-Jan-2021 and it underwent temperature excursion  with temperature 34 degrees Fahrenheit from 09:00 AM to 10 AM. Beyond use date for the vial was 27-Jan -2021. Product moved to clinic on 07-Jan-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).
I do not remember if it was the 23rd or 24th  but I noticed a little red/pink area. I have watched it everyday and it has gotten larger. It kind of itches but not a lot. It doesn't hurt when I touch it.  As of today it is several inches across.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.  Patient did not reported any adverse event.  No treatment medications were provided.
NO NEGATIVE OUTCOME AFTER RECEIVING VACCINE RESIDENT DIED IN HOUSE UNDER HOSPICE CARE SERVICES
No side effects at time of injection.   5 days later on 3/28, my lymph nodes on right side of face/neck became swollen.   Today is 3/30 and they remain the same, swollen.
My cardiologist had worse side effects than me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My cardiologist had worse side effects than me) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My cardiologist had worse side effects than me). At the time of the report, VACCINATION COMPLICATION (My cardiologist had worse side effects than me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  The first physician is documented in case MOD21-167776 The second physician is documented in case MOD21-167783 The patient's husband is documented in case MOD21-167784 This case has been created for the patient's cardiologist who she claimed had worse side effects than her. The patient did not expand on the type of side effects and did not give any further information on this adverse event.
1,000 mg of acetaminophen taken 90 minutes after. Developed diarrhea 2 hours after.  Then feverish, headache, and body aches from 9 hours through 11 hours after.  Took another dose of acetaminophen  9.5 hours after  vaccine, and again  17 hours after vaccine. At 12 hours through 23 hours after,  body aches,  chills,  and lethargy. Took a 4th dose of acetaminophen 24 hours after vaccine.  At 33 hours after vaccine,  took 400 mg of ibuprofen. Sleep through the night of 3/14/21 - the morning of 3/15/21 symptom free.
This spontaneous report was received from a nurse practitioner refers to a 19 years old patient who on 22-AUG-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
RN attempted to administer pfizer covid-19 vaccine using a 1mL, 25 gauge x1" VanishPoint syringe (0.5mm x 25mm; LOT either G294A or G210308). Upon administration the dose "spilled" out around the needle hub. RN confident no vaccine was administered to patient, and administered a full dose using a separate syringe.
Areas appeared on face and neck that are red, swollen, and irritated dry skin.  Describes as the same but much worse than her allergic reaction that she has to some foods
7/19/04 mild chicken pox in a vaccinated child, no treatment, symptoms: clear and then white blisters with red base per mom, afebrile.
Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with a dose of Gardasil. Subsequently on an unknown date the patient experienced syncope. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
HCP stated that they have diluted the vaccine and stored at room temperature but it went up to 80F.; HCP stated that they have diluted the vaccine and stored at room temperature but it went up to 80F.; This case has been considered invalid as Unspecified number of patients.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. A patient (no qualifiers provided) 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: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "HCP stated that they have diluted the vaccine and stored at room temperature but it went up to 80F." Additional information: HCP calling for temperature excursion of the Pfizer-BioNTech Covid19 Vaccine. HCP stated that they have diluted the vaccine and stored at room temperature but it went up to 80F. She is not sure about the duration of the excursion, she gave a estimated duration of 1 hour. HCP stated, "we gave it to them quickly within 1 to 2 hours we gave it, we were done". HCP is asking for viability information of the vaccine. She just wanted to make sure that she doesn't need to revaccinate them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: case re-assessed to invalid.
This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 74-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Lot Number: EW0153), dose 1 via an unspecified route of administration in right arm on 24May2021 16:40 (at the age of 74-years-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included had her thyroid removed in the 90s, patient stated she has been on medication since 2002. Concomitant medication included Armour Thyroid taken from 2002 and ongoing. The patient previously took Armour thyroid as she had her thyroid removed in the 90s. On 26May2021, the patient experienced horrible dizziness which lasted for a week and a half and just ended recently. She did not understand what it was for a while and thought it could be dehydration but she drank plenty of water and that did not stop. On 24May2021, the patient experienced dehydration. On an unspecified date in May 2021, the patient had abdominal comfort. No treatment was given for the events. The outcome of the events was reported as recovered on an unspecified date in June 2021. No follow-up attempts are possible. No information about lot/batch number cannot be obtained.
Diarrhea x12 days,  Bloody diarrhea x3 days. Weak, sleeping all day, Diarrhea has slowed now. Am taking him to the emergency room in the a.m.  No way to get him to the hospital until now.
My uncle tested positive for COVID-19 five days after being exposed to his COVID positive daughter (she was not positive at the time of exposure), who was also fully vaccinated with the Pfizer vaccine; My uncle tested positive for COVID-19 five days after being exposed to his COVID positive daughter (she was not positive at the time of exposure), who was also fully vaccinated with the Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp.   A 63-years-old male patient (reporter's uncle) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unknown date in Mar2021 (Batch/Lot number was not reported) as dose 1, single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unknown date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 63-years-old). The patient medical history and concomitant medications were not reported. Facility type vaccine was unknown. It was unknown if patient had any known allergies. Patient had no covid prior vaccination. The reporter stated that on 06Aug2021,  the patient tested positive for Covid-19 five days after being exposed to his Covid positive daughter (she was not positive at the time of exposure), who was also fully vaccinated with the Pfizer vaccine. The patient underwent lab tests and procedures which included Covid nasal swab rapid test which result was positive on 06Aug2021. The outcome of the events were unknown.   Information about Lot/Batch number has been requested.
24MAR92 c/o cough, t99.4-CXR-neg; 1125AM albuterol 1/2 strength nebulizer-clear; sent home on Ventolin syrup dx acute Bronchitis; 24MAR92 diff breathing, t98;
Induration/Erythema to left thigh. Induation since vaccination with erythema 2-3 day after.
pain in her chest; weakness in her upper back; her ears started to hurt; she felt sore in her body; 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 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 01Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Patient didn't even feel the needle.), for COVID-19 immunisation. The following information was reported: EAR PAIN (non-serious) with onset 02Feb2022, outcome "unknown", described as "her ears started to hurt"; PAIN (non-serious) with onset 02Feb2022, outcome "unknown", described as "she felt sore in her body"; CHEST PAIN (non-serious) with onset 03Feb2022, outcome "unknown", described as "pain in her chest"; ASTHENIA (non-serious) with onset 03Feb2022, outcome "unknown", described as "weakness in her upper back".  Additional information: It was reported that when the patient received the second dose two days ago, someone told her that she might feel some adverse reactions. Yesterday (as reported) her ears started to hurt and she felt sore in her body. Today (as reported) she felt pain in her chest and weakness in her upper back. She was wondering if these were normal symptoms and if they would pass.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200204095 Same patient and drug, different event separated in time
Patient fell from exam table right after administration of those 3 vaccines when MA turned to put the syringe away. Brief (few seconds) LOC. Gain back consciousness within few seconds. Rx- Kept patient laid down on the floor for 10-15 minutes, she states feeling normal and transferred to exam table, drunk water. rested for another 15 minutes before d/c home with mom, f/up apt next morning  Pt came back for f/up this morning and doing well, no c/o dizziness or anything else. Ate breakfast. No concern at all today.
no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related.    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Patient is stating they are having pain behind left knee that caused limping. Has gotten better but still hurts going up and down stairs. On a scale of 1 to 10 where 1 is no pain and 10 is the worst pain, patient stated it was a 10 originally but now is a 5 as of 2/15. Patient stated they did nothing to hurt it outside of getting the vaccine on the 10th.
A small knot developed on the bicep of the same arm injected. It appears to be on/near a large bicep vein. It is slightly painful. It is still present 1 week after vaccination
Breakthrough case admission after 3 vaccines Pfixer 3/7/21 Lot# EL3248;  Pfizer 3/28/21 Lot# EN6200;  Pfizer 1/14/22 Lot# 330308D
This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 24-JUL-2007, the patient was vaccinated with the first dose of VARIVAX (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis. The second dose of VARIVAX was on 27-MAY-2011. It was reported that on 24-JUL-2007, the patient received the first dose of M-M-R II (strength, dose, frequency, Lot# and expiration date were not provided) for prophylaxis, and the second dose was on 17-MAY-2011. No adverse events were reported.
This spontaneous retrospective pregnancy report as received from a consumer refers to herself, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The patient reported that she received GARDASIL 9 while she was pregnant in 2016 (date was unspecified)(exposure during pregnancy)(lot # and expiry date were not reported) for prophylaxis. The Last Menstrual Period and Estimated Date of Delivery were unknown. Other suspect therapies included sterile diluent. The patient reported that the nurse inadvertently gave her the vaccine while she was pregnant. The pregnancy outcome and fetal outcome were unknown. No PQC involved. No further AE information provided.
1/19/2021 developed mild chills, sore throat & itchy arm at injection site, no fever; able to perform normal daily tasks & work. 1/20/2021 chills worsened & developed headache, arm not as itchy, no fever; able to perform normal daily tasks & work. 1/21/2021 rash developed at injection site spanning the arm about 3 inches wide and 2 inches long, red, itchy, & injection site a bit swollen, eyes puffy & watery, chills continued, congestion started, headache worsened, body aches; able to perform normal daily tasks & work most of the day; developed low grade fever around 3pm 100F, ibuprofen and benadryl then 101F at 7pm, another dose of 400mg ibuprofen temp stable at 100F through the night. 1/22/2021 fever seemed to have broken through the night 98.4F morning then 100.7F at 10:30am , congestion worsened, headache & body aches continued; unable to perform daily tasks or work.
Beginning 1 day after vaccine I developed a red, raised, hard, and hot rash at the injection site about the size of a softball
shortness of breath; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unknown date, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date in Mar2021, as a single dose for covid-19 immunization and felt unwell. The patient reported that I got your Covid 19 vaccine in Mar2021. I had been exercising an hour a day prior to the vaccine for the past several years. However, after the vaccine when I felt unwell I stopped exercising. After the second vaccine I tried to start exercising again and had shortness of breath while doing so. I went to the doctor who sent me for a nuclear stress test. The results are that I have a "fixed defect" in my heart! I never had any heart problems with my heart prior to the vaccine. Outcome of the event was reported as unknown.  Follow-up attempts are possible. Information on the lot/batch number has been requested.
Redness, swelling, ache at injection site. Itching (2 days post injection). Still with some erythema in right upper arm.
Client has had an extremely sore arm since 2 days after the vaccination. She cannot move it or use it due to the amount of pain.
Diarrhea; Constipated; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and CONSTIPATION (Constipated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and CONSTIPATION (Constipated). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and CONSTIPATION (Constipated) outcome was unknown.            Concomitant product information was not provided.  Patient was recommended from doctor to remove dairy from diet.
I'm still verrrrrry tired all the time and have reoccurring cold sores on lips.