chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warmness at the injection site; Hives at top torso; Headache; Nausea; Swelling at the injection site; Turned red at injection site; uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (uncomfortable), VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache) and NAUSEA (Nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DISCOMFORT (uncomfortable). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Turned red at injection site). At the time of the report, DISCOMFORT (uncomfortable), VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Turned red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Patient stated that about 2-3 days after vaccination she began to experience numbness and tingling in her arm. It has progressed since to severe shoulder pain and patient is unable to lift or use left arm at all.
Nausea, slight headache, general malaise, body aches, itching/hive a few inches to left of the injection site noted the following day
painful, tender and swollen lymph nodes in right arm.  swelling is gone now but still tender.  Boobs up 2 cup sizes.  Not a desired affect for me.  What the hell is in this to make such a response?  Covid is the new flu.  Don't force people to take this.
A hard, tender lump/rash formed on my left arm where the injection was administered. When it first formed it was itchy but that subsided by the following morning. It developed 7 days after the injection. There have been no other side effects.
allergy; runny nose; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0171), administration date: 22Apr2021, when the patient was 29-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EP7533, Route of Administration: Intramuscular), administration date: 31Mar2021, when the patient was 29-year-old, for Covid-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 11May2022, outcome "recovering", described as "allergy"; RHINORRHOEA (non-serious) with onset 11May2022, outcome "recovering", described as "runny nose". It was unknown if therapeutic measures were taken as a result of drug hypersensitivity, rhinorrhoea.  No follow-up attempts are possible. No further information is expected.
This spontaneous retrospective pregnancy report was received from a physician and refers to a 1-day-old male neonate. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient's mother medical history included 1 prior pregnancy with one full term delivery and allergy to CECLOR. On an unknown date, the patient was exposed transplacentally to the dose of GARDASIL 9 administered to his 29-year-old mother on 19-OCT-2016 at 11:30, first dose, 0.5 ml, lot# reported as M021407 with an expiration date 30-APR-2018 in the left deltoid for prophylaxis. The patient's mother received also other suspect medications included PRENATE (since 05-JUL-2016, tablet daily, orally for pregnancy), MACROBID (since 14-SEP-2016, for urinary tract infection (UTI)), DICLEGIS (since 22-06-2016, tablet in am, tablet in the afternoon, 2 tablets at bed time (HS) orally), TYLENOL (325 mg, as need (pm) for headaches) and was vaccinated with a dose of influenza virus vaccine (unspecified), on 19-OCT-2016. On 31-MAY-2016, the patient's mother had ultrasound examination performed. The pregnancy was confirmed with last menstrual period (LMP) on 13-APR-2016, estimated date of conception on 26-APR-2016 and estimated date of delivery (EDD) at 19-JAN-2017 (it was a twin pregnancy). The patient's mother was exposed to the therapy with GARDASIL 9 in the third trimester of pregnancy (27 weeks and 1 day). The earliest exposition of the other suspect therapies was in the first trimester of pregnancy (all captured in MARRS# 1611USA003674). On 30-DEC-2016, the patient was born at the 37 weeks of gestation (type of delivery was not reported). The baby's weight was 6 lbs and 3 oz (length was not provided). The infant was born normal, no congenital anomaly was reported. The APGAR score assessment was reported as 4 in a 9 grade scale. The outcome of the APGAR score 4 in the 9 grade scale was unknown. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review the event of APGAR score 4 in the 9 grade scale was determined to be medically significant. Additional information has been requested. Sender's Comments: US-009507513-1611USA003674.
Pt called and had spine pain, chills and body pain after shot called day after Fri 1/29 and feeling better and called Mon 2/3 and feeling good.
Patient guardian gave consent for dose #2. Nurse told by facility consent given for patient dose number two, but upon entering into system after shot was given, it was discovered that dose three had been administered. dose one 6/12/21, dose 2 7/16/21, dose 3 9/16/21. Patient did not experience any reaction.
No adverse event reported. The vaccine was given out of manufacturer guidelines. (child was too young to receive vaccine)
Patient brought in to the ED by EMS on 10/30 for shortness of breath and weakness. EMS found patient to have 90-92 SpO2 on room air and was placed on 3L O2 by nasal cannula. In the ED, patient tested positive for COVID-19 by PCR. She was admitted 10/30-10/31 and diagnosed with hypoxia related to COPD exacerbation/COVID-19 infection. Her O2 requirements gradually ame down and was able to be on room air by 10/31.  She has received the primary COVID vaccine series and one booster.
Patient admitted to the hospital with a CVA with right sided weakness and chest pain. Chest pain radiated to her right arm and had significant shortness of breath. Symptoms started one week prior to seeking emergency care.
Severe illness; This is a spontaneous report received from a non-contactable Consumer. A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The consumer was calling about the Pfizer COVID-19 vaccine. She mentioned that she completed her shots and never had COVID because she takes vitamins. She added that she lost her twin nephews due to a severe side effect and a heart attack after getting the vaccine (AER# AER#202300045329 and PV202300017123) and her niece got a severe illness from taking bad shots of the vaccine. She also said why we are giving this to people and it's having side effects because it was not tested. Outcome of the event was unknown.   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-PV202300017123 same reporter, drug and different patient, event;
have blisters near the area where the injection was made; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose number unknown (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 23Sep2022, outcome "unknown", described as "have blisters near the area where the injection was made".  Additional information: Patient had the Pfizer booster (Further vaccine name could not be clarified over the call hence captured as Unspecified Vaccine) and that was yesterday and today patient had blisters near the area where the injection was made.   No follow-up attempts are possible. No further information is expected.
mild tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL3247) via an unspecified route of administration in right arm on 05Mar2021 13:00 as 1st dose, single dose for COVID-19 immunization. The patient was 62-years-old and was not pregnant at the time of vaccination. Patient did not had COVID prior to vaccination. Patient was not tested for COVID post vaccination. Vaccine facility type was reported as workplace clinic. Patient did not receive any other vaccine in four weeks. Patient medical history included osteoporosis, acid reflux and had no known allergies. The concomitant medications included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), alendronate sodium (FOSAMAX). On 05Mar2021 at 13:30, patient experienced mild tiredness. Patient did not receive any treatment for the adverse events. On an unspecified date in Mar2021, the outcome of the event was resolved.   No follow-up attempts are possible. No further information is expected.
my arm became sore a few hours after receiving the second dose of Moderna COVID19 vaccine. When I laid down to sleep,approx. 12 hours after receiving the injection, I experienced a headache and shaking/chills. I woke this morning to a headache and exhaustion.
severe itching all over the body and getting more intense as time goes by. Doctors office advised to delay 2nd dose and will see an allergist soon.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
The patient's husband motioned for me to come out to the post vaccination area.  This was about 10 minutes after the patient received her first Moderna Covid 19 vaccine. Patient's husband motioned for me to come out and help with his wife who had received a COVID vaccine about 10 minutes earlier.  He said she's about to pass out.  He said we knew this was going to happen that's why I came with her.  He said she always passes out.  Said she did every time she received a flu shot and therefore she was expecting it.  Technician announced code white and another tech brought an ice pack out for us.  He held her head and I held her torso up in the chair so she wouldn't slump down in the chair and slide out.  She felt a little clammy so we got an ice pack for the back of her neck and we asked her if she felt hot and she said yes.  She had her eyes closed but she would always respond when we spoke to her.  She slumped over again and them came back to but was just too weak to really open her eyes or hold herself up.  She responded to us whenever we would ask her any questions.  Her husband asked her if she wanted a drink of water so we gave her an unopened bottle of water and she could hold it herself and drink herself.  She started perking up after that and even started eating her hot balls from her purse.  She stayed with us for about 30 to 45 minutes and said she felt okay now.  Two associates in the store (-claims associate) walked out with the patient and her husband to make sure didn't have any spells on the way to the car.  The patient hugged me before she left and said that was the best shot she ever got and said she really appreciated us tending to her and she would be back to get her 2nd shot here.
2 pts recvd 3 doses of Engerix-B & it was determined that both exp a lack of effect; no seroconversion confirmed by their neg titer reports;
A nursing assistant reported temperature excursion under case #01697141 for vaccines that were administered to patients after excursion occurred.; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 13-AUG-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T002846, which has been verified to valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis, that experienced a temperature excursion (product storage error). The administered dose of the vaccine was stored temperature of -10.2 degrees Celsius, for 1 hour and 53 minutes, as recorded by a data logger. No previous temperature excursion was reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014951: US-009507513-2008USA014950: US-009507513-2008USA014803:AE case # 01697210 US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014888: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869:
about 6PM began crying non-stop;mom took to ER & pt adm for observation;cried until about MN;had fever up to 102-was afeb by 6OCT96;was given IV ATB 3OCT-6OCT96;discharged 7OCT96 w/no meds;
My left leg from knee down is half numb, odd sensations. I developed weakness and a drop foot. I have decreased muscle strength. I went to the doctor and he tested me and said it is definitely weaker.  I never had this before. I have nothing else that would cause this.
Patient broke out in hives. Dose admin on 8/29/11 (Mon) broke out in hives (Wed) 8/31/11 swollen joints, pt took BENADRYL.
She received one anthrax vaccine that was administered on 28 Apr 2007. Other than slight arm redness and swelling she denied any problems with her immunization. About one year later she noted she would occasionally get some small bumps, similar to a pimple that would get dark around her vaccination site. The darkness persisted but would have episodes of a red ring of bumps surrounding area. Stated it looked like a ring worm but it was not. She reports a hx of sensitive skin and only uses natural products on her skin. She did report that she notices site irritation more when she has to take her fluconazole and sometimes ibuprofen. Suspect Systemic contact dermatitis. Symptoms: Rash and Oth Nonspec Skin Eruption (R21).
No additional AEs reported.; patient received an expired dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 1-year-old male patient. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.     On 17-DEC-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA (recombinant Human albumin) (PROQUAD) 1 dose (strength, route of administration and anatomical site of vaccination were not reported, lot # S012472, expiration date reported and validated as 20-OCT-2020) for prophylaxis (expired product administered). No additional adverse events reported.
Pt was given 1st dose of moderna at 17 years of age.  Since 1st dose was administered, we went ahead and gave him the 2nd dose today 4/20/21 lot #032B21A
starting from 10/13/21 evening at 3 pm, patient felt swollen arm so took a tylenol at that night and 10/15/21 at 2:30 am patient had left arn, left side of the neck and left side of the face swollen. ANd arm felt hard and hot. Felt pain when touch or move  the arm.
Information has been received from a physician concerning a memo from their cooperate office regarding a nine year old patient who had received a varicella virus vaccine live (Oka/Merck) booster. It was reported that the patient developed a possible anaphylaxis reaction with wheezing, shortness of breath, facial edema, facial mottling, was stabilized and transported to the hospital. It was not specified if the patient was admitted. Current patient status was not reported. No product quality complaint was reported. Further information was not available. This is one of three reports from the same source. Additional information has been requested.
approx Juyl 2021, patient noticed busitis of the right shoulder.  Around 2/2/22 she develope iridocyclitis, with a working diagnosis of systemic lupus erythematosis.
Fever; chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (patient) reported for herself. A 60-years-old female patient received first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, in left arm, on 05Jan2021 13:00 at single dose for COVID-19 immunization. Reason why batch/lot is unknown was misplaced/discarded. The patient was not pregnant at the time of vaccination. Medical history included known allergies: Penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced fever, chills, headache, fatigue on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the events was recovering. Since the vaccination, patient hasn't been tested for COVID-19.   No follow-up attempts are possible, information about lot/batch cannot be obtained.
I developed vitiligo.  After receiving booster on 11/3, the next morning, more vitiligo spots appeared.  This vaccine definitely causes vitiligo.
She said that she could barely see from her left eye, then she started blinking profusely on both eyes and she does this every 10 seconds. She has been doing this ever since and has not stopped.
This case involves adult and unknown gender patient who experienced flu (influenza) while receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. It was reported "When I do not, I typically do not get the flu. Same as Covid. Get the shot and you might get covid, you might not, just about the same chance as the flu. Sorry, no". It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on the batch number for this case.
Sore Right Arm (After First Vaccine); Could not move Right Arm (After First Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Right Arm (After First Vaccine)) and MOBILITY DECREASED (Could not move Right Arm (After First Vaccine)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Right Arm (After First Vaccine)) and MOBILITY DECREASED (Could not move Right Arm (After First Vaccine)). On 15-Apr-2021, PAIN IN EXTREMITY (Sore Right Arm (After First Vaccine)) and MOBILITY DECREASED (Could not move Right Arm (After First Vaccine)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-138860 (Patient Link).
Presented to ED with N/V, weakness, feer and diarrhea; + covid & DKA; CXR clear; Tx: Vit C, rocephin, Vit D3, lovenox, zinc; initially on 2lpm O2; down to room air at time of d/c
"Screaming all day after receiving her DTaP, IPV, Hep B-Hib, Prevnar, and Rotateq
Had febrile seizure. In ED temp was 102. Per mom seizure lasted about 3 mins.  No h/o previous seizure.  No further seizures since then.