chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant, referring to a patient of unknown gender and age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 19-JUN-2017, the patient was inadvertently vaccinated with one expired dose of GARDASIL 9 lot # L004014 with expiration date on 04-MAR-2017 (strength, anatomical location and administration route were not reported) for prophylaxis, however no adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA000704.
The patient received FLUZONE QUADRIVALENT, but the patient was requesting Fluzone High-Dose quadrivalent no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via agency (Reference number- 00806883) and transmitted to Sanofi on 11-Oct-2021.  This case involves a patient (unknown demographics) who was received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], but the patient was requested for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry not reported, formulation: solution) via unknown route in unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was a case of actual medication error due to wrong vaccine administered (latency same day).  It was reported "pharmacist reporting that during a flu clinic the patient received FLUZONE QUADRIVALENT, but the patient was requesting Fluzone High-Dose (HD) quadrivalent. The pharmacist wanted to know if the same composition was in both formulations and if a person could receive more that one Fluzone inoculation to meet the Fluzone HD."  No other adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Around 8 or 9 pm - 10 hours after receiving the 2nd shot, I nearly collapsed.  Somehow I manage to fall on the bed instead of the floor and then for about 15-20 minutes I was shivering, sweaty, heart racing up and down - and overall a very bad reaction.
This is a 51y.o. male with a history of ESRD on HD MWF, DM II, HFpEF, HTN, HLD, PVD and GERD who presented to Hospital with a complaint of cough and fever.  Patient states that he has had a nonproductive cough for the past 2 days.  He admits to chest discomfort with coughing. He also reports 5-6 watery stools per day for the past 2 days. He states he went to dialysis today but was sent home early because symptoms were worsening. Patient denies lightheadedness, dizziness, headache, shortness of breath, abdominal pain, nausea, vomiting, lower extremity edema or chills.  He denies any sick contacts.
Patient complains  of painful red, warm, swollen  area  on left arm .  Patient went to medical facility and was given antibiotics.
pain; This is a spontaneous report from the Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration on 11Feb2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pain on 03Mar2021. The caller (patient)sated that "had her first dose 11Feb2021 and experienced pain after 20days from the 1st dose. She is also scheduled to have her 2nd dose on March 11 which is more than 21days from the 1st dose." The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Left arm is in pain three months later and it is currently disabling and handicapping my arm actions and I took Tylenol to relieve the pain but that does not help and I just started experiencing these arm disabling handicaps.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-AUG-2017, the patient was administered an expired dose of PNEUMOVAX 23 injection (lot # L036437 with expiration date at 18-MAY-2017; dose, route of administration and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
At the time of vaccine the patient indicated they get warm and sweaty from blood draws but not with vaccinations or shots, as he has had allergy shots before.  He came with his mom, just in case he had any issues.  All indications point to his fear of needles and a vasovagal syncope response.  He was given and bottle of water and an icepack.  He and his mom waited 30 minutes and he was feeling fine and back to himself.
PAIN ON RIGHT KIDNEY AREA; MUSCLE CRAMPS ON RIGHT FOOT AND LEFT UPPER THIGH; HOT FLASHES; BACK PAIN; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced hot flashes. On 08-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain on right kidney area. On 09-APR-2021, the subject experienced muscle cramps on right foot and left upper thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on 09-APR-2021, and had not recovered from hot flashes, pain on right kidney area, and muscle cramps on right foot and left upper thigh. This report was non-serious.
5 hrs p/vax pt c/o h/a, later in evening t>102, delirium, sore site; temp persisted until morning of 14MAY92;
The patient stated that while the vaccine went into her arm it burned, then the next day she experienced fatigue, shakiness, joint pain, bruising and nausea.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 09-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not provided), on 11-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not provided) and on 06-AUG-2013, the patient was vaccinated with the third dose of GARDASIL (dose, route, and lot number were not provided). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Received the vaccine past the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the vaccine past the 6 hour vial puncture expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the vaccine past the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the vaccine past the 6 hour vial puncture expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Four male patients were receiving their first dose when the event occurred. No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012A21A)  with no associated AEs.
pt recvd vax 28OCT93 & that day devel severe pain & swelling around the inject site, fever of 100.5, nausea, vomiting, was hypotensive; the following day was adm to hosp dx w/cellulitis;
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 71-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in right arm, single dose, for COVID-19 immunization. The patient had no medical history. Concomitant medication included Vitamin C (ascorbic acid). The patient developed fatigue (tired) and pain (a lot aching), with outcome of unknown. No therapeutic measures taken as a result of fatigue and pain. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Client states she had  a headache, fever, and shivers.  Could not get warm all night.  Started around 10:00 p.m. and lasted all night.  Client called around 11:00 am 08/06/2019 and said that she just started feeling warm.  Headache was gone after she took something for it that morning.
Headache, Myalgia, Fever, UrticariaPruritus, pain & swelling injection sight; fatigue Narrative:
This spontaneous report as from a consumer via social media who obtained the information from a third party, who reported that a female patient of an unknown age, on an unknown date was vaccinated with a dose of GARDASIL (dose, lot number, expiration date and route not reported). The patient stated that she was newlywed and always wanted to become a mom. On an unknown date, the patient was diagnosed with premature ovarian failure. At the time of the report, the patient's outcome was unknown. The patient stated that because she received GARDASIL there was one less mom in the world. The patient reported that premature ovarian failure was not a coincidence. This is one of several reports received from the same source.
I did not have an adverse event after receiving the vaccine. I tested positive for COVID-19 in 03/2023. I had a stuffy and runny nose with a cough. I contacted a provider and got a prescription for Paxlovid. I tolerated the medication, but it changed my sense of taste with a metallic taste. As of today, I do not have any lingering symptoms of COVID-19.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  It was reported that offender were called back to the clinic and vital signs were taken and were normal. No signs of any distress was present and when offender was asked if he had signs he denied any at that time.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Reporter added. Patient demographic updated.
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1758. Patient reported itchy tongue and dry mouth, itching at injection site at 1809, she was given Benadryl 25mg po.  At 18:20 itchiness and dry mouth resolved, but patient then developed chills and felt cold and clammy, visibly shivering. At 18:35 still had chills. 18:43 chills/shivering resolved but felt ?less cold?. 18:45 patient returned to the hospital to finish shift and give sign-out. Clinic RN gave another Benadryl 25mg to the patient and asked the patient to return to the vaccine clinic after the end of her shift to reassess. 19:36 Patient returned to clinic, all symptoms resolved.
neurological deficit during sleep eyes rolling back in head, no recognition, staring-arms jerking, legs twitching (fingers) mouth, limbs jumping changes in breathing;
After patient received Pfizer covid vaccine she sat down in the observation area. she informed pharmacy staff that she felt dizzy, light headed and sweaty and seeing spots. 911 was called but patient refused to go to the hospital. patient walked out with ems personnel
Experienced shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number J352N, expiry date 11th December 2021) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix. In November 2019, 20 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter consented to follow up.
This spontaneous report as received from a medical assistant refers to unspecified patient of unknown age. An unspecified number of patients received RECOMBIVAX HB that was improperly stored by being exposed to 34F for 3 days, 33F for 2 days, 34F for 2.5 days, 32F for 0.5 days, and 30F for 30 minutes. The medical assistant stated the vaccines dropped down to 32 F and 30 F for a total of 13 hours on 02-AUG-2012. The temperatures listed for 34 F and 33 F were prior to 02-AUG-2012. RECOMBIVAX HB (lot number reported as 0020AE, expired date 10-JUN-2014) administered on 03-AUG-2012, 06-AUG-2012, 07-AUG-2012, 08-AUG-2012, 09-AUG-2012, 15-AUG-2012, 20-AUG-2012, 22-AUG-2012, 27-AUG-2012, 28-AUG-2012and 29-AUG-2012. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
pt exp syncope, dizziness p/recvd MMR vax; pt was not hospitalized & subsequently recovered; no further details were provided;
lips felt numb; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 15Apr2021 at 09:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergy (unspecified). The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, 30 minutes after vaccination at 10:00 the patient experienced lips felt numb like she had Novocain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event lips felt numb was recovered on 15Apr2021, after the duration of one hour.   No follow-up attempts are needed. No further information is expected.
FEVER, CHILLS, MYALGIA, ARTHRALGIA, HEADACHE Narrative: Reaction started in the evening of the am dose. Employee missed the following day of work
Received 2nd Moderna vax dose on 6 May 2021 at Church.  By 13 May 2021 I began feeling pain in my neck.  By 16 May 2021 the pain had increased significantly, from my neck, to left shoulder, and down to my left hand.  On 16 May, due to the incredible pain, I sought treatment at the ER of Hospital.  I was given valium and muscle relaxants to get me through the night.  The pain didn't lessen at all.  I was then seen on 27 May by Dr (Sports Med/Orthopedics) at the Health Center.  He had x-rays taken (negative) and determined pain was likely caused by nerve inflammation.  Administered shots for pain, which reduced pain for a few hours.  He also prescribed Motrin and additional muscle relaxants.  He also provided a referral for physical therapy.  I began physical therapy on 8 June.  For the next month I was in constant pain...on a 1-10 scale, about a 7...didn't sleep much, going for 60 minute walks 2-3 times a night  between 2200 in the evening-0500 in the morning.  By mid-July, the pain began to lessen to about a 3.  My last physical therapy session was 12 Aug, at which time the pain was about a 1.  Since then I have continued light exercises as per Dr instructions.  At this time (30 Sep), the pain is between 0-1, but always there.
Generalized itching with upset stomach, mild wheezing, flushing and localized 7cm erythema at injection site.
Patient received immunizations and immediately began coughing, developed cyanosis, severe respiratory distress, and oral and facial edema. Oxygen sats at first assessment 55-60 percent, BP 120/90, HR 160. Was alert and able to talk with difficulty. Lung fields decreased aeration bilaterally. Oxygen cannula and Albuterol nebulization administered. Epi pen applied (lot 7EM841, exp 07/09). Pt responded immediately, pulse ox increased to 100%. Patient transferred to ER by ambulance.  11/11/2008 MR received for ER visit 10/22/08 with DX:  Allergic Reaction-serum, anaphylactic shock. Immediately after receiving vax pt began coughing, became SOB, fell to the ground and turned blue. TX with epipen and nebs and transferred to ER via EMS. Upon arrival in ER sx had resolved.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding concurrent conditions and pertinent medical history was not provided. On 12-AUG-2014 the patient was vaccinated with an expired dose of MMR II (injection, lot # H013042, expiration date 17-JUL-201, dose, route, and frequency were not provided). Concomitant medications were not provided. No adverse effect was reported. Additional information is not expected.
pt recvd vax 12JUN95 & 17JUL95 pt devel chicken pox;pt was exposed to a child w/chickenpox 3wks p/vax; pt recovered by 26JUL95;
On 30DEC2022 right after lunch I got really sick and dizzy and I got dizzy because my blood pressure went real low my smell was fine but my tasted was so metallic I kept trying things because I knew I needed to eat and peanut butter on a spoon and honey was fine sodas were ok as well water was foul and this lasted several weeks water again was like rusty metal my husband is deceased and the next day I managed to get to urgent care, my home test was positive very quickly when I got there my blood pressure was really low and I knew this because I took it at home I could not walk from kitchen to bedroom cause I was so weak. My oxygen level was fine but I was sick for well over a week and even now I am tired all the time I used to have trouble sleeping as now I sleep at all time.
antibodies are still negative; This is a spontaneous report from patient.   A female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route, the first dose on unknown date and the second one on 20Jan2021 both at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 26Jan2021 the patient had a blood drawn and her antibodies were still negative. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Per patient/employee: 5-6 minutes after her dose was administered, she felt her throat tightened, she was monitored in the clinic initially then taken to the ED.  Treatment was fluids via IV.   Patient/employee then followed up with her PCP & allergist; it was determined at that time that she should not receive her second dose.
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours.  Fasting glucose was 89 in the morning.  by 1400 hours my glucose was 250.  By bed time it was 300.  I did not eat dinner and adjusted my insulin and took an extra 500mg metformin.    I had  chills and fever through the night and all the next day.  Fever 99 to 101.  Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also.   I woke up on Jan. 6, 2021 with a hemorrhage in my right eye.  I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021.,  He asked that I report this advers reaction.
Narrative:  Patient developed stroke like symptoms 1 day s/p Janssen vaccine 2nd dose administration including incoherent speech, drooling, inability to drink fluids. She was transported to local ER, CT + for stroke and airlifted to trauma level 1 hospital. She currently remains in neuro ICU there.
Vaccine was administered in my physician's office on 6-28-07. three days later I experienced pain in and around the area of the vaccine-Saw my Dr. on 7-3-and was diagnosed with Shingles
Swelling and bumps; Double stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Double stroke) in a 79-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.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Double stroke) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SWELLING (Swelling and bumps). The patient died on 20-Jul-2021. The reported cause of death was double stroke. It is unknown if an autopsy was performed. At the time of death, SWELLING (Swelling and bumps) outcome was unknown.            Patient passed away after getting Moderna COVID-19 Vaccine. No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 75 year old male with no relevant medical history who experienced serious unexpected fatal event of CVA approximately 2 months after the first dose of the vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Double Stroke
Have had 4 Moderna shots, and within 8 hours, after each shot-- fever of 101+, chills, body aches, headache. Last 48-72 hours