chrisvoncsefalvay/vaers-outcomes huggingface dataset:
almost had syncopal episode from weakness; almost had syncopal episode from weakness; after my second dose, I had no until hour 12. I woke up middle of night to severe fatigue; myalgia; low grade fever; headache; swollen lymph node in L armpit; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; This is a spontaneous report from a contactable physician reporting for herself.   A 27-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not reported) on 08Jan2021 14:00 via an unspecified route of administration in the left arm for COVID-19 immunization. There was no other relevant medical history. No unknown allergies. The patient previously received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 12:00 pm in the left arm for COVID-19 immunization and experienced some arm pain which lasted several hours and mild. Concomitant medication included sertraline, ascorbic acid (VIT C), ergocalciferol (VIT D), zinc, cetirizine hydrochloride (ZYRTEC). No other vaccine was received in four weeks. The patient had not had COVID prior vaccination, and COVID was not tested post vaccination.   After the second dose on 08Jan2021 at 02:00 pm, the patient had no symptoms until hour 12. On 09Jan2021 at 12:00 am she woke up middle of night to severe fatigue, myalgia, low grade fever, headache, swollen lymph node in left armpit (injected left arm). On 10Jan2020, the patient was 36 hours out and she still had these symptoms but slowly improving, relieved more with ibuprofen vs paracetamol (TYLENOL). She also reported she did not receive treatment for the events. She stated that the myalgia, fatigue, headache were severe and she almost had a syncopal episode from weakness. The events were non-serious as reported. The outcome of the events was reported as not recovered.
Her symptoms began with dizziness in the morning. The following week she developed an ongoing headache with extreme fatigue.  I took her back and forth to the doctor told she needed more sleep and water. Her next symptom was shortness of breath and fast heart rate with increased headache. We were sent to a cardiologist who then sent us to a neurologist. After ER visits, rheumatology, endocrinology, and two more neurologist we still had no help for my daughter who cannot think anymore her muscle and joint pain is crippling and her head hurts so bad she cannot open her eyes.  The symptoms just keep coming we are not faced with gastric issues adding to her pain. We received a POTS diagnosis from two neurologists. My daughter cannot play, read, think, stand up, take a shower.  She just lays and cries all day every day.  My straight A student is now a shell of who she used to be.  In pain and not able to care for her basic needs.
Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reportedly, 102 doses or vials were initially stored in the refrigerator on an unknown date. It was reported that vials had not undergone any temperature excursion. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU was received with reporter address updated.
Moderna Covid -19 vaccine EUA  My arm HURT when given the covid 19 moderna vaccine.   It is still hurting now,  which is 13 days later.  Day number 8, after I received the  covid 19 moderna vaccine, I developed a red RASH about 2 1/2 inches wide and long where the injection was given.  Day number  9, after receiving the covid 19 moderna vaccine,  the RASH turns into a 2 1/2 inch RED circle on arm where the injection was given.    Twelve days after vaccine, I have a faint red circle.     HEADACHES EVERYDAY SINCE VACCINE.      PAIN still in arm.
Pt stated that he had not received the Bivalent booster shot and last Covid vaccine was in March 2022 at his doctor's appointment. Verified by RN administering shot, later, clinical staff obtained state documentation which proved that patient had in fact already received the Bivalent booster dose in 10/2022. Second dose of Bivalent Booster administered in error based of pt's reported history.  There have been no adverse reactions reported by patient.
Local allergic reaction with redness, swelling and intermittent itching around injection site approximately 8cmX8cm-treated w/ Benadryl, cool compress
Information has been received through the manufacturer registry from a physician and the spouse of a 27 year old Indian with no concurrent medical conditions, no known drug allergies and a history of having had a therapeutic abortion in her first trimester who on 10/02/02 was vaccinated with a dose of varicella virus vaccine live. There were no concomitant medications. The pt's spouse reported that the pt was pregnant around 10/29/02.  The pt's LMP was on 09/30/02.  Subsequently, the pt developed gestational thrombocytopenia during her pregnancy. There were no local reactions at the vaccination site nor any varicella or herpes zoster symptoms post vaccination.  On 05/10/02 the pt had been tested for varicella antibodies before vaccination and the results were negative.  On 12/20/02 the pt had an ultrasound performed for dating purposes with an EDC of 08/04/03.  On 03/05/03, 04/02/03 and 07/07/03 the pt had an ultrasound performed which were reported as normal.  On 07/30/03, 39+ weeks from her LMP, the pt delivered a liveborn, normal, 7lb, 12 oz. female.  The infant had no congenital anomalies, complications, abnormalities, or features of congenital varicella zoster syndrome. There were no complications during labor or delivery. The pt had no infections or other illnesses during her pregnancy. Additional information has been requested.
Soreness, redness, swelling at injection site; Fever 101.6 degrees on 3-22-2019 at 5:30 pm; Body aches, tiredness throughout 3-22-2019.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 13-OCT-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 6876 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mother of child notes pt had mild swelling on (R) thigh Saturday. On Sunday (R) thigh appeared a little red. She did not touch his thigh. No fever. Possible that child, scratch site of injection. Now skin appears blotchy no warm to touch no induration no treatment.
fatigue, diarrhea, stomach cramps, nausea, pain in joints especially in knees, muscle pain
Patient got confused...received RSV 08-28-2023...counseled on typical vaccination reactions
got her first / injection early last March but has not received her second dose / March 2020 Is the correct date of the vaccination; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient did not consented to follow- up. No further information were provided by the patient.
redness; soreness; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were recovered/resolved.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced redness and soreness that resolved quickly. Reporter did not consent to follow-up.
She has abdominal cramping now; Chills; she develops joint pain /They were sore and stiff; she develops joint pain /They were sore and stiff; This is a spontaneous report from a contactable consumer patient via a Pfizer-sponsored program. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685, Lot Expire Date: unknown), intramuscular injection in left deltoid on 30Dec2020 07:15 AM at single dose for COVID-19 immunization (reported as "Why was the patient taking COVID19 Vaccine (Verbatim): healthcare worker "). Medical history included ongoing allergy to sulfa antibiotics since 1998 (diagnosed within her first year of life) and allergic to the cold from 2011 and ongoing. She has an allergy to the cold and people sometimes confuse it with Raynaud's. It is not Raynaud's. Concomitant medication included etonogestrel (NEXPLANON) from May2019 and ongoing for birth control. The patient received the vaccine on 30Dec2020 and developed symptoms 4 days ago (10Jan2021), she was experiencing joint pain and chills, also reported as "just over the last 2 days she develops joint pain and chills". Patient experienced chills on 13Jan2021. Patient just called about possible side effects and she was wondering if she should get the second dose. Her side effects were minor. They were joint pain and chills. Joint Pain started in the hips and felt like something was wrong. They were sore and stiff. She has abdominal cramping now and she was not sure if that is from the joint pain or regular period. She just finished her menstrual cycle and normally she has cramps afterwards. She does not have a fever. Patient has checked her temperature three times. 30Dec2020 was when she received her first dose. Vaccination Facility Type was health center . The events did not require a visit to emergency room and physician office. No prior vaccination within 4 weeks but patient reported that events following prior vaccinations was "the worst was swelling and tenderness with HPV vaccine. HPV vaccine manufacturer: unknown". Outcome of the event chills was not recovered (ongoing) while for other events was unknown.
sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 70, Unit: Unknown, as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included chronic rhinitis and other allergies, both from an unknown date. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The patient was scheduled to receive the second dose on 15Mar2021. The patient was also scheduled to have allergy testing on 23Mar2021 and she  was asking if she should do this after her second dose or if she needs to put the testing off for a while. 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.
p/vax pt exp chickenpox on face, back, arms, legs, scalp & ears;pt had an elevated temp & lesions all over body;
March 16, 2021; Pfizer Covid 19 Vaccine EN6204 (2nd Shot) caused itching, dark and red rash on body.  I called Dr. to prescribe a medication for itching.  My whole right arm was in pain. I had to scratch body in all location with red spots.  October 17, 2021; Pfizer Covid 19 Vacc MDV, Pharmacy After my 1st Booster shot 10/17/2021, I had very bad itching with dark spot and red rash.  All my problems happen at the same time. I saw my primary care doctor for dark spots and red rashes. He referred me to the dermatology Dr.   My right ear drain fluid along side with pain. Dr., dermatology diagnosed it with infection Chondrodermatitis nodularis helicis.  He  performed a biopsy after the problem continue to drain with pain. I saw Dr. for arms and leg rash and dark spots, and finger nail turned dark.   Dr. referred me  to Dr. hand specialist. He diagnosed my right thumb finger nail with infection and removed my nail plate.  It cracked half across finger nail.  Neoplasm of uncertain behavior of skin.  I had to see Dr., a foot specialist for red spots on ankle and pain, contact dermatitis.  He performed a biopsy of the red spot on my ankle bone because it looked suspicious.  He gave me a medication to use.   Dr. is a Foot & Ankle Specialist. I woke up in February 2022 with vision problem.  My right eye blinked half close then open again had turned red.  I became cross eyed.  Dr. optometrist and Dr. neurology diagnosed me with Diabetic 6th nerve cranial palsy.  I could not drive and looked like cars were meeting us head on. It was months before my vision returned to normal. I had to see Dr. (hematologist) who recognized my ear and eyes as soon as he walked into the treatment room,  He ordered an MRI of my head to make sure I did not have a tumor on my brain. He performed lab work
R34 - Oliguria R79.89 - Elevated serum creatinine N17.9, N18.9 - Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC)
Evening of vaccine: nasal congestion and rhinorrhea, ongoing (30 days) nasal itching.  Wheezing next morning, dry cough  that has lasted one month.  Fever (vs. hot flashes?), chills.  Also, change in bowel movements : diarrhea/constipation (varies).  "Brain fog" for past month.  Nausea.  Mesntrual irregularity week (has Kyleena  IUD - normally only every few months - but had spotting one week after vaccine, and then next week menses  with more bleeding than usual, lasted 2 days).  Feels like has improved in past week, but wants a CXR to rule out pneumonia.
This initial spontaneous case, was received from pharmacist on 01-Nov-2017, concerning a 15-year-old, adolescent female patient. The patient's concomitant medication included CEFTIN (since 24-Oct-2017). On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml route of administration: intramuscular, anatomical location: left deltoid, batch number: 195229 expiry dates: May-2018. On the same day of vaccination, the patient had hyperthermic response (stated as then passed out prior to leaving pharmacy). She was conscious and immobile for 2 minutes. EMS (emergency medical support) came and assessed the patient and found blood pressure was found to 108/67 and heart rate (47) was low. It was reported that total time was 15 to 20 min before cleared to go. At the time of this report, patient recovered from the events. The reporter assessed the case as non-serious.
diarrhea; cough; today cant hold food down; vertigo; ear pressure; legs feel like rubber; doesn't feel strong; nausea; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (legs feel like rubber), VERTIGO (vertigo), MUSCULAR WEAKNESS (doesn't feel strong), EAR CONGESTION (ear pressure) and DIARRHOEA (diarrhea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma (D-cell lymphoma of the spleen).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced MUSCULAR WEAKNESS (legs feel like rubber), MUSCULAR WEAKNESS (doesn't feel strong), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (tiredness). On 06-Apr-2021, the patient experienced VERTIGO (vertigo) and EAR CONGESTION (ear pressure). On 07-Apr-2021, the patient experienced ASTHENIA (today cant hold food down). On an unknown date, the patient experienced DIARRHOEA (diarrhea) and COUGH (cough). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (legs feel like rubber), VERTIGO (vertigo), MUSCULAR WEAKNESS (doesn't feel strong), EAR CONGESTION (ear pressure), COUGH (cough), ASTHENIA (today cant hold food down), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown and DIARRHOEA (diarrhea) had resolved.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. Patient used inhaler for coughing.
Patient initially had muscle soreness in the left arm for about 4 days which did subside.  2 days later he developed an enlarged axillary lymph node which continues to be painful and a 3" x 2.5 inch erythematous patch at the injection site.  All symptoms are slowly dissipating but do continue at this time.  No constitutional symptoms.
Full-body hives that began on the thighs and spread beginning 5 p.m. April 15 and ending approximately 10 a.m April 18. Did not seek a doctor but instead self-medicated with OTC Benadryl, hydrocortisone cream, and oatmeal baths.
Patient received vaccine at 2:30 pm and when she got up she fainted. She came to quickly & sat in pharmacy for 10 min. Was given water. Pt was fine and it has happened before. Stated by mother.
Dx with ITP.  6/10/08 Reviewed PCP medical records of 5/27-6/6/08. FINAL DX: Idiopathic thrombocytopenic purpura; mononucleosis Records reveal that on day of vaccination patient experienced low grade fever, decreased appetite, nausea, hands itching x 1 day.  Exam revealed excoriated area of left hand between thumb & 1st digit appearing like eczema. Returned to office 5/30 w/petechial rash all over except hands & feet & diarrhea.  Referred to hematology.  Tx w/IVIG.  Returned to office 6/2 w/improved purpura. Returned to clinic 6/4 w/continued improvement but new erythematous exudate & enlarged tonsills & cervical lymphadenopathy. Referred to heme for additional IVIG.  By 6/6 platelets & rash had improved considerably.  To continue f/u in 10 days for labs.  7/4/08 Reviewed heme/onc  clinic medical records of 5/30/08 FINAL DX: immune mediated type thrombocytopenia. Records reveal patient experienced fever, achiness, nausea & diarrhea approx 8 days prior to onset of symptoms which resolved; gum bleeding & lower extremity petecchial rash on day of consult.  Seen by PCP & referred emergently to heme/onc.  Tx w/IVIG while in clinic & serial labs followed.
Emanthema; Herpes Zoster - Information has been received from a physician concerning a 4 year old female who in approximately 1997 was vaccinated with one dose of varicella virus vaccine live.  There was no concomitant medication.  On approximately 28 Mar 2000 the patient experienced a chickenpox like rash with approximately ten lesions.  in april 2000 she experienced a zoster like rash that was red and inflamed with some cantral clearing and blistering.  The zoster like rash was located to the left upper thigh.  she was administered cetirizine dihydrochloride zyrtec and triamcinoline acetonide kenalog.
tired; splitting headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 14:15 (Lot number: EW0162) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic fatigue" (unspecified if ongoing); "insilun resistance" (unspecified if ongoing); "peanut" (unspecified if ongoing), notes: known allergies: peanuts; "known allergies: chocolate" (unspecified if ongoing), notes: known allergies: chocolate. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1,, Lot number: ER8727,, Administration time: 02:30 PM,, Vaccine location: Left arm), administration date: 20Mar2021, for COVID-19 Immunization, reaction(s): "extremely exhausted", "tummy upset", "general malaise", "extremely aggitated". The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "tired"; HEADACHE (non-serious), outcome "recovering", described as "splitting headache". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: Other vaccine in four weeks was reported as no and Other medications in two weeks was reported as Trazadone. Covid prior vaccination and covid tested post vaccination was reported as no. After the first vaccine, she was extremely exhausted for about two weeks after the vaccine with tummy upset and general malaise. she was also extremely agitated and needed to be left alone so as not to offend others. After the second vaccine (Dose 2 administration time; 02:15 AM), she had a splitting headache everyday for 18 days. Today was the 19th day and she have a slight headache today. she've also been sleeping 9 hours per night and she have been tired and not able to do anything, but she was not as exhausted as with the first dose. She have been unwell for over a month now because of the vaccine and never want to get another one. Adverse event start date: 20Mar2021. Adverse event start time: 06:00 PM.  No follow-up attempts are possible. No further information is expected.