chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy". 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Experiencing numbness in lips; Hives after first dose; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history included severe allergy to grass (carries an EpiPen). Concomitant medications were not reported. The patient experienced numbness in lips and hives after first dose on unspecified date. Patient was not sure if she should get the second dose which is scheduled for 21Jan. Event took place after use of product. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
This spontaneous medically confirmed report (initial receipt 17-Jul-2014) concerns a 53 year old female patient. On 18-Jan-2013, the patient received one time dose of intravenous influenza virus vaccine (manufacturer and batch number not reported) at 0.5 ml. The outcome was not reported.
Patient reports that 2-3 days after receiving the vaccine her arm is fine, but after that she started to notice that it was painful and caused a burning pain in her arm. There is no redness or visible markings on the skin around the injection site. She says the pain is not constant but comes and goes, but can wake her up at night.
Pt recvd vax 430 & by 530 had t99.8; 630PM t101 by 1230 t103 & had nausea & vomiting x3; woke up next morning w/face swollen & red, feet also red; pain @ inject site; also had sore throat; also had t105 given APAP; seen by MD;
blood clots; headaches; diplopia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received BNT162b2 (COMIRNATY), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 2021, for COVID-19 immunization, reaction(s): "diplopia", "Headaches", "blood clots"; Comirnaty (Dose 2), administration date: 2021, for COVID-19 immunization, reaction(s): "diplopia", "Headaches", "blood clots". The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches". The events "blood clots", "headaches" and "diplopia" required physician office visit.  Additional information: During a routine phone call, he described various health issues following initial two-dose vaccine series and booster dose since 2021. Patient described symptoms of headaches, diplopia and blood clots that he recalls following vaccine doses and is actively being treated by his physician.  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-202201184241 same patient/product/event, different dose number;US-PFIZER INC-PV202200069596 same patient/product/event, different dose number;
Night of administration of inject, pt devel fever of 103, became as stiff a board; body was real red, vomited & uncontrollable crying for 2 hrs;
Information has been received from a physician concerning a 9 week-old female with acid reflux who on 30-AUG-2010 was vaccinated with ROTATEQ PO. The physician reported that the patient was given ROTATEQ and immediately vomited. The AE improved after stopping therapy. The patient recovered on 30-AUG-2010. The patient sought unspecified medical attention. Additional information has been requested.
Feeling stiffy; 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 77 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Feeling stiffy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is 1 of a cluster of 2 patients who experienced similar events following vaccination with ADACEL. The event for the first patient was captured in case number 2010-03334. Initial report was received from a health care profession on 09 June 2010. An unidentified patient, with medical history not provided, received an intramuscular injection on 01 June 2010 of ADACEL, lot number U3446AA, and on 02 June 2010 developed a temperature up to 100.5 with body aches, chills, lightheadedness and dry mouth. The patient had no illness at the time of vaccination and received no vaccinations within 4 weeks prior to the ADACEL vaccine. The outcome was reported as recovered. Documents held by sender: None.
Clear white line running through the deltoid muscle at the injection.; Ever since his booster shot his deltoid muscle has been hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Clear white line running through the deltoid muscle at the injection.) and MYALGIA (Ever since his booster shot his deltoid muscle has been hurting ) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01721A, 0481A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis (In his hands, feet, and back - not the arm.). Concomitant products included CELECOXIB (CELEBREX), TRAZODONE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Ever since his booster shot his deltoid muscle has been hurting ). On an unknown date, the patient experienced VACCINATION SITE REACTION (Clear white line running through the deltoid muscle at the injection.). At the time of the report, VACCINATION SITE REACTION (Clear white line running through the deltoid muscle at the injection.) outcome was unknown and MYALGIA (Ever since his booster shot his deltoid muscle has been hurting ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2022, X-ray: white line running through deltoid muscle (abnormal) There is a clear white line running through the deltoid muscle at the injection.         Patient's weight was reported as 170 with an unknown unit. Patients date birth was reported as 22 Oct 1900.  Patient had no reactions with his first or second shot.  No treatment medication details was provided.
Client c/o nausea and vomiting starting at 2:00 a.m. on April 19th, 2007.  He had received 2 vaccinations on April 18, 2007 around 8 a.m.
She arrived at vaccine clinic to receive her covid vaccine.  She reported this was her second vaccine and that she had forgotten to bring her vaccine card from first covid vaccine appointment.  When asked by check in staff what vaccine she was here for, she reported she was here to receive her second pfizer vaccine so new card was started at check in desk for pfizer.  She then arrived at vaccine station and reported to nurse that she was here for her second pfizer vaccine .  Once vaccine was given, it was noted in data base that she  had received moderna for her first vaccine.  This was reported to medical team lead and vax clinic manager.  Vax clinic manager spoke with patient and informed her of error.
Administred Moderna to <18 Y/O,  Dr ok"d dose 2
This spontaneous report as received from a pharmacist refers to an unspecified number of patients. The patient's medical history was not provided. On unknown dates, multiple unspecified patients were administered both ZOSTAVAX and PNEUMOVAX 23 together at the same visit (lot #, dose, route and site of administration were not reported for both). No adverse events were reported. Additional information has been requested.
Not feeling well; fatigued; This is a spontaneous report from a contactable consumer (who reported for herself) . A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number EW0150) on 30Mar2021 at 11:30 AM, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization, in left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history was not reported. The patient had no known allergies. Concomitant medications included: Birth control. On 03Mar2021 at 05:00 PM, the patient experienced she was "not feeling well" she means that she was fatigued and beat all the time. Reporter stated this event started within the first 24 hours of being administered the first dose but that now she is almost 100% recovered from feeling fatigued and feeling beat. The clinical outcome of the events was recovered.  Since the vaccination, the patient has not been tested for COVID-19.   Information on lot/ batch number has been requested.
Patient received Pfizer Bivalent but was in need of the  Pfizer Primary dose.
10/21 Onset of generalized pruritic rash 36-40 hours after receiving Fluzone vaccine, + fatigue, mild abdominal pain, No fever, chills, myalgias, headache. Rx with OTC Claritin and Benadryl. 10/22 patient saw her primary PCP - diagnosed with hives by PCP - Rx with Zyrtec QD and Benadryl PRN HS Cod tepid both PRN no signs of anaphylaxis.
Severe pain in my lower jaw. Doctor prescribed amoxicillin. Root canal done by endodontist on 4/12/2021.  Endodontist:
Moderna Bivalent was administered to patient looking to receive the first dose of the Moderna primary series. Patient experienced normal vaccine related side effects the day after the vaccination but was otherwise unremarkable.
Patient called 5/30 (3 days after receiving shot - After spending 15min in sun booth that are and only shot area got extremely warm and burnt.
Patient did not have any adverse reaction. Patient received dose of Pfizer vaccine which was not stored within the CDC guidelines.
Dark stool following the administration of her first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 22 year-old female patient received bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FAECES DISCOLOURED (non-serious), outcome "unknown", described as "Dark stool following the administration of her first dose". The lot number for the vaccine, Comirnaty, was not provided and will be requested during follow up.
Diarrhea; Vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 7-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 7 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset Jun2022, outcome "unknown", described as "Diarrhea"; VOMITING (non-serious) with onset Jun2022, outcome "unknown". Additional information: Reporter stated, "I am calling to report side effects of my son who received third COVID vaccine on Thursday." Reporter was informed about the role of Pfizer drug safety. Lot# and expiration date: Reporter stated, "I am sorry that one I do not have." The patient did not receive any other vaccines or medicine within four weeks prior to the vaccination. Reporter further stated, "I have a quick question, I wasn't aware that a third dose of the COVID vaccine was being recommended, is that correct?" You are taking about booster dose: Reporter stated "Yes." Reporter was informed about Pfizer information department for the question and offered the number. The information on the batch/lot number for [BNT162B2] was not provided and will be requested during follow up.
Ringing in the ears began after the vaccine. It has continued to this day. Some days worse than others. Self-treatment with decongestants doesn't help. Ringing is worse now. I am afraid to take a booster shot.
Red Rash covering the chest, right shoulder (injection site), and neck. Extreme fatigue for 24-48 hours.
Information has been received from a physician and a consumer (patient's mother) concerning a 7 year old female who on 09-MAY-2003, was vaccinated with first dose of VARIVAX (Merck) (route not reported, lot number 643082/0593M).  The patient's mother reported that her daughter received two doses, but the physician reported that patient only received one dose.  On 13-JUL-2009 the patient experienced chickenpox (the patient was diagnosed with chickenpox on 22-JUL-2009).  On 27-JUL-2009, the patient was seen again and she was diagnosed with impetigo.  On 02-AUG-2009, the patient was seen again and she was diagnosed with impetigo.  On 02-AUG-2009, the patient had a fever.  The patient current status was unknown.  The patient sought medical attention by contracting the pediatrician.  Additional information has been requested.
Patient received injection 24 hours after the vial was taken out of refrigerator.  Maximum, per guidelines, is 12 hours
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, after receiving the vaccine, the patient experienced severe swelling all the way down to elbow of the arm where injection was administered. The outcome of the event was unknown. Causality was not provided. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA004452.
I got the shot March 3, I had no problem for 2 to 3 days.   Then I woke up to a hard, solid,  red, lump at the vaccination site,  on my  upper right arm.   The lump was somewhat itchy, and at times sore. It was always hot to the touch. It was 2 inches wide and 1 inch high. As the days went on it got redder and bigger. I drew a circle around it and it grew past the circle. It was at it worst March 12. Finally,  March 13 the lump was not so hard and solid. It was still very red. March 15 there is still a red mark but no lump.   It is 3 inches wide by 1 1/2 high.
Signs/Symptoms: Urinary tract pain, WBC's in urine, bilateral epididymitis, 101.2 fever (1/30 to 2/3), chills, no bacterial/other infection identified on urinalysis or culture. Treatment: Rocephin, azithromycin, cipro
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2022-496015 (Patient Link).
Vaccination site pain; swelling or lump at the injection site (left arm); Hardness at the injection site; could not raise left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (swelling or lump at the injection site (left arm)), JOINT RANGE OF MOTION DECREASED (could not raise left arm) and VACCINATION SITE INDURATION (Hardness at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, Gabiscon advance and Famotodine for Reflux gastritis, Levothyroxine 25 mcg for Thyroid disorder, Vitamin D for an unknown indication.   On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (swelling or lump at the injection site (left arm)), JOINT RANGE OF MOTION DECREASED (could not raise left arm) and VACCINATION SITE INDURATION (Hardness at the injection site). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (swelling or lump at the injection site (left arm)), JOINT RANGE OF MOTION DECREASED (could not raise left arm) and VACCINATION SITE INDURATION (Hardness at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.
I woke up around 2am with a slight fever that got a little worse. Took Advil and it was gone a couple hours later
This case was reported by a healthcare professional and described the occurrence of throat burning in a 44-year-old female subject who was exposed to a strong odor (fumes released from BOOSTRIX, GlaxoSmithKline) packaging. On an unspecified date the subject was exposed to a strong odor, "fumes" released from BOOSTRIX packaging. It was reported that there was a very strong odor (product odor abnormal) that was inhaled by the subject (a nurse) and it caused her throat to burn. The odor also made the subject light headed. Additionally, it was reported that the odor resulted in an unpleasant taste. Product complaint was documented. At the time of reporting the outcome of the events was unspecified. It was reported that the pharmacy received a box of BOOSTRIX vaccine and when the pharmacist opened the box, strong fumes were released from the packaging. The odor was unusual and was so strong that they had to put the box outside and odor permeated the office. The smell was described as very strong plastic fumes. Lot number and expiration date were not available at the time of reporting. An investigational report received via GlaxoSmithKline Biologicals on 18 July 2011 indicated that according to the investigation performed and the sample received, this complaint was considered to be unsubstantiated.
Post vaccination reports tingling @ vaccine site/ left arm, denies any additional symptoms / complaints; denies any respiratory symptoms / none noted. Medical monitoring x 30 min w/ vital assessment: BP 130/84 O2 sat 99% RA. Symptoms resolve, released home w/ self
Pt. states that after receiving the 3rd Booster of Pfizer 11/05/2021, started experiencing symptoms 11/10/2021 of developing shingles. Primary visit 11/2021, prescribed Valtrex and Trecento Cream for confirmed Shingles.
Patient noted at around 0700 on 1/10/2021 what she described as "patches on her right side" which progressed to right side of back. Came in to clinic for evaluation on 1/11/2021-started on Valtrex and reviewed safety precautions until crusted over.  Patient with minimal pain at this time. Will follow up with patient on 1/19/2021
I noticed a lump on my right breast. My doctor also noticed it several days later during my well woman visit. She suspected it was a cyst. She referred me to a radiologist to have an ultrasound. I was diagnosed with a complex partial cyst on my right breast. I was not given any other treatment aside from continuing self-breast exams. It resolved on its own, but I have a follow up in 6 months.
Development of pityriasis rosea rash 1 week after Pfizer booster.