chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications.  On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 27-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Patient had micro-cephalic osteodysplastic primoidal dwarfism type I, a lethal genetic disorder with DNR/DNI status. Per parent request, vaccine given 10/18. Fever developed 10/19 PM. Other symptoms began 10/22, including vomiting, diarrhea, rash and continued fever. Seizure one time in afternoon. Dyspnea developed about 12 AM. 10/23 Patient transported to hospital; patient died about 0830 on 10/23. Medical record received on 11/22/2004 states pt experienced gastroenteritis and respiratory failure. Death Summary & ER Record received on 12/01/2004 states pt experienced Beach Disease and respiratory failure. Death Certificate received on 12/02/2004 states pt experienced respiratory failure, Majewski's micro-Cephalic osteodysplastic Dwarfism Type 1.
Right upper ext. warm, red, slight induration 18 X 20 cm at vaccine site 2 days after vaccine.
Systemic: numbness shooting down arm occasionally-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reported numbness shooting down left arm after the vaccine that comes and goes occasionally. He did not see a healthcare provider or complained of any medications taken to relieve this. He reported that it does not bother him but he wants to let us know
Information has been received from a physician concerning a 12 month old female with no pertinent medical history and no drug reactions/allergies who on 29-MAR-2007 was vaccinated with ProQuad (Lot # 656647/0101U). Concomitant vaccinations included Prevnar. On 05-APR-2007, the patient experienced fussiness and fever. The fever started out at 102 F and climbed to 103-104 and lasted for 48-72 hours. On 09-APR-2007, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous retrospective pregnancy report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with two doses of RECOMBIVAX HB (dose, route, lot# and expiration date not provided). It was reported that the patient did not receive a third dose of RECOMBIVAX HB, because on unknown date she had become pregnant. Her last menstrual period (LMP) date and delivery date were not provided. The pregnancy outcome was unknown. The reporter stated that on an unknown date the patient experienced negative titers for Hepatitis B. The outcome of negative titers for hepatitis B was unknown. The relatedness between the events and RECOMBIVAX HB was not reported. Additional information has been requested.
All dairy products, especially milk, have a carbonated almost sour taste. This has been present since the taking of the vaccine.
Red hive-like rash all over upper body, face, and upper part of thighs; appeared about 20 hours after injection; gradually went away after four days; did not itch;
Diarrhea, muscle aches, low-grade fever (99.8), itchy chest felt like a rash but no visible rash
patient started having headache Chills Body aches sore throat 1 month after having her second dose of Moderna Vaccine.
Fatigue, neck, shoulder and back pain, chills,l ightheadedness, muscle soreness and stiffness.
Shaking, Fever, chills, sweating, sore throat, body pain. Symptoms ongoing as of 36 hours after booster. Experienced exact same symptoms after moderna second dose. Feels like a horrible flu case. But worse.
Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 11 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 11 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 11 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 11 Feb 2022) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 2:46 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-Feb-2022 at 2:46 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 11 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 11 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 11 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 11 Feb 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient ethnicity was reported as Black or African American. No concomitant medications were reported. Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown. Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021. On 11 Feb 2022 at 02.46.41 PM, the patient received second dose vaccine past its 30 day expiry date. No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Gout flare up. Got medication. Still hurts. 5/23/21 stroke like symptoms in the morning. 5/30 more stroke like symptoms in the morning. After a week I felt better.
Patient reported 11/30/2016 her Left arm was swollen and painful from the elbow up to the injection site. Edema traveling down to her wrist and hand.
Bordeline Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Orthostatic Intolerence; Autonomic Dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 36-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), autonomic nervous system imbalance, orthostatic intolerance, headache, dizziness and fatigue. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007498: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Tinnitus; This is spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient himself) reported that an unspecified aged male patient received second dose of BNT162B2 COVID vaccine (formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2 for COVID-19 immunization. Patient developed Tinnitus after 2nd Covid 19 vaccine on unknown date. After researching it online, I found that many others have experienced the same issue. It might be something you look into. It's a horrible condition. The outcome of the event was recovered in 2021.  Lot/Batch number has been requested.
Pt recvd vax & 1 day p/vax exp fatigue, h/a, achy, nausea; treatment ASA;
FLARE UP OF SYMPTOMS WHICH REQUIRED RESTART OF STELLARA THERAPY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ustekinumab for drug used for unknown indication. On an unspecified date, the patient experienced flare up of symptoms which required restart of stellara therapy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flare up of symptoms which required restart of stellara therapy was not reported. This report was non-serious.
Macular rash over abdomen within 5-10 minutes of injection. Claritin 2.5 Q D x3.
The night of my second shot (around 8pm PST) I experienced extreme warm sensations in both feed, almost able to feel the contours of the nerves in my feet.  My toungue also felt cold later that night, and the nerves in my legs felt cold, despite my skin feeling warm.  I continued feeling warm sensations across both feet in the evenings and when sleeping throughout the following 2 weeks.  Beyond that I've continued to have a warm/swollen sensation in the nerves in my legs below my knees, concentrated in shins.  I've had a similar sensation in my forearms.    It should be noted that after my first shot (on 3/30), about a week later I started developing intermitent headaches, and then around mid april developed intermitent facial numbness and and some pain in my left jaw and around my teeth, but the proximity to my first shot wasnt as close, so didnt report that in this form.
Tested positive for COVID-19 four months after dose 5. Had teleconference with doctor and was prescribed PAXLOVID. Has completely recovered.
severe arm pain, swollen lymph node in armpit, chills, shortness of breath, tightness in chest. All started the morning after the booster and subsided within 24 hours.   I had no side effects at all for first 2 doses (Pfizer as well)
Hard stinging electric like pain in the left side on my lower back close to my spine; it was so shocking that forced my whole body to move; Paresthesia; Severe pain in my left arm; problems with the angle of vision. Vision was modified; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 15:00 (Lot number: FJ1611) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: 33130BA, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 24Dec2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Hard stinging electric like pain in the left side on my lower back close to my spine"; DYSKINESIA (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "it was so shocking that forced my whole body to move"; PARAESTHESIA (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Paresthesia"; VISUAL IMPAIRMENT (non-serious) with onset Jan2022, outcome "unknown", described as "problems with the angle of vision. Vision was modified"; DIZZINESS (non-serious) with onset Jan2022, outcome "not recovered", described as "dizziness"; PAIN IN EXTREMITY (non-serious) with onset 15Jan2022 12:00, outcome "unknown", described as "Severe pain in my left arm". The events "hard stinging electric like pain in the left side on my lower back close to my spine", "it was so shocking that forced my whole body to move" and "paresthesia" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of back pain, dyskinesia, paraesthesia, visual impairment, dizziness, pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. After the 2nd dose of the Covid vaccine shot, the patient suffered of constant dizziness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Tenderness, swelling and redness on rt deltoid for three days followed by small lump, non-tender reported by phone from mom.
Did not make antibodies; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Did not make antibodies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung transplant and Chemotherapy. Concurrent medical conditions included Immunocompromised.    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 SARS-COV-2 ANTIBODY TEST NEGATIVE (Did not make antibodies). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Did not make antibodies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
metals (coins, spoons, mobiles) are sticking all over his body; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (metals (coins, spoons, mobiles) are sticking all over his body) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (metals (coins, spoons, mobiles) are sticking all over his body). At the time of the report, IMMUNISATION REACTION (metals (coins, spoons, mobiles) are sticking all over his body) outcome was unknown.            Concomitant medication of the patient was not reported.   It was reported that the patient just got vaccine of Moderna for COVID-19 and for some reason metals (coins, spoons, mobiles) were sticking all over his body. He tried it prior to obtaining the shot.  No treatment information was provided by the reporter.
Severe nose bleed approximately 90 minutes after vaccine. I just began a workout when the nosebleed began. It took approximately 15 minutes to resolve. I also experienced a nosebleed the following day and the day after.
Headache and 99.6 temp for 1 day followed by migraine on 11/08/2009 at 6:00 AM.  OTC meds taken, symptoms subsided.  11/12/2009 Migraine at 10:00 AM to 6:00 PM OTC meds again.  No further issues.
Post vaccine 1 I experienced fatigue and nausea constantly and headaches. At second vaccine I started getting shooting body pains from head to toe within an hour of getting second vaccine. Nausea increased and I began getting migraines. Fatigue, body pains, muscle weakness, feet turning black and blue, left side of my body not working as well, nausea, dizziness, and brain fog. Symptoms have continued over a month post vaccination. Not able to be managed alieve, tylenol, steroids, or chloroquine.
Realized that the dose of Vivotif that she took yesterday had expired back in November; Spontaneous report received on 29DEC2020.  A 31-year-old female pharmacist "realized that the dose of Vivotif that she took yesterday had expired back in November" (PT: Expired product administered). She was receiving Vivotif (expiry date: NOV2020) for immunisation. On 28DEC2020, she took her first dose of Vivotif. Later, she realized that the dose of Vivotif she took had been expired back in NOV2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first dose of Vivotif and the next day, she realized it was expired about a month ago (expired product administered). Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and the next day, she realized it was expired about a month ago (expired product administered). Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable to Vivotif.
Initial report received on 10 February 2012 from the investigator under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 4 doses of DAPTACEL; lot number C2934BA received on 03 June 2008, lot number C2934AA received on 05 August 2008, lot number C2955BA received on 06 October 2008 and lot number C3081AA received on 07 July 2009 (route and site of administration not reported). The subject developed cold-like symptoms on 08 December 2011, approximately 2 years and 5 months after the last dose. On 21 December 2011, the subject developed a paroxysmal cough. Laboratory testing included positive PCR on 21 December 2011. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 21 December 2011. The subject was not hospitalized. At the time of final contact on 13 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Migraine with pain level of 9; nausea, joint aches to where moving is difficult and extremely painful.  hand swelling; chills and low grade fever.
Female patient presents to EMS observation area post vaccine with complaint of leg numbness. Patient reports baseline anxiety and became extremely agitated requesting transport to hospital.
Severe chills/shaking cold Severe body/muscle aches Day of/could not walk unassisted  Severe nausea/throwing up Fever No appetite
Patient started 08/28/2003 with fever and pruritic rash all over body had DTaP and MMR 08/26/2003.  Covered blanching, hot erythematous urticarial rash.
Pain in arm and Bruised in area of vaccine of right deltoid. Was hard to even hold anything that night. Took Tylenol and had slight fever/body temp felt warm. Fever lasted day and a half. Arm pain getting better able to drive on 8/27 (3 days later) and able to lift and talk on phone now today (8/30-6 days later). Still slight bruise but not warm to the touch or infection. Still sore when lifting arm but getting better as well.
evening p/vax had t103, high pitched crying for 15min & shaking x 2sec
Severe shivering until about 3:00 am; 100 deg, F. fever until about noon when 2 x tylenol, 500mg administered; feeling tired until about 2:00 pm; headache ongoing but sespect it will disappear after a good night's sleep.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), in the left arm, on 23Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NYQUIL, start date: 03May2022, stop date: 05May2022. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: I was tested positive with COVID-19 on 04May2022; (14May2022) Negative, notes: I was better and was tested negative with antigen at home test on 14May2022; (21May2022) Positive, notes: I started having some COVID-19 symptoms today 21May2022 and tested positive for COVID-19 with an at-home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient stated she was tested positive with COVID-19 on 04May2022 and started taking Paxlovid on 05May2022. She was better and was tested negative with antigen at home test on 14May2022. She started having some COVID-19 symptoms today 21May2022 and tested positive for COVID-19 with an at-home antigen test.  No follow-up attempts are possible. No further information is expected.
(L) leg, redness, tender, irritable (12pm) TYLENOL (1:30 pm) crying, inconsolable, BENADRYL (5 pm).