chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness on the injection site; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Severe Headache; Fatigue; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Chills; Fever of 98.7 F; Body aches; Sweating; This is a spontaneous report from a contactable other hcp (Nurse, the patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 24Feb2021 as dose 1, single for COVID-19 immunisation and experienced no adverse events. The patient experienced body aches on and sweating on 17Mar2021 15:00; severe headache, fatigue, body aches/ severe bone aching from head to toe/ too painful to even move my legs or hands, chills and fever of 98.7 F on 18Mar2021, soreness on the injection site on 19Mar2021. It was reported that (18Mar2021) the patient woke up with severe headache, fatigue and body aches. Severe bone aching from head to toe, it was too painful to even move patient's legs or hands. Therapeutic measures were taken, which includes: Theraflu. By noon patient was having chills and fever of 98.7o F. Took Tylenol.  Symptoms all through the night. (19Mar2021): Woke up with no body aches or fever, only soreness on the injection site. The patient underwent lab tests and procedures which included body temperature: 98.7 F on 18Mar2021. Therapeutic measures taken as a result of the events included Theraflu and Tylenol. The outcome of the events body aches, body aches/ severe bone aching from head to toe/ too painful to even move my legs or hands and fever of 98.7 F were recovered on 19Mar2021, the outcome of other events were unknown.  No follow-up attempts are possible; No further information expected.
Patient received immunizations on 6-6-11. Mom noticed on the morning of 6-8-11 that her left thigh was red and swollen and warm to touch. The red swollen area was 12 cm by 16 cm measured by the pediatrician. BENADRYL 2 tsp every 6 hours and cool compresses were recommended. Will recheck if worsens.
within an hour i was dizzy and very very hot. I went home to rest, next day I could not hardly move without discomfort as my whole body was achy and I was disoriented most of the day.
This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (lot # N000238, expiry date: 25-OCT-2019) for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 50 degree Fahrenheit for 30 minutes. No data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009707:
Body aches, headache, light headedness, imbalance and left sided joint pain. Appointment with Dr.
NUMBNESS AND TINGLING IN MY RIGHT HAND AND PARTICULAR IN MY RIGHT THUMB, GETS WORSE AT NIGHT,  WAS WAITING FOR IT TO SUBSIDE OR GO AWAY BUT AFTER 3 WEEKS IT IS NOW A BIT CONCERNING AND WILL BE CALLING MY DOCTOR IN THE MORNING.
cellulitis or infection of skin: 4-5 inches in diameter, antibiotic treatment
a lot of body aches; headache; some shortness of breath; This is a spontaneous report from a contactable Other Health Professional (HCP) reported for herself. A 41-year-old female patient (pregnant: no) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 18Jan2021 at 12:15 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 41 years old on 28Dec2020 for COVID-19 immunisation (first dose, via intramuscular, administration time=10:00 AM, vaccine location=Left arm). After the second vaccine starting about 10 hours after it was given, the patient had a lot of body aches, headache, and some shortness of breath on 19Jan2021. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No other medications in two weeks. The outcome of the events was recovered on an unspecified date.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021067674 maternal, infant cases;US-PFIZER INC-2021068772 maternal, infant cases
expired Quadracel was administered to a patient inadvertently, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via  Medical Information (Reference number- 00326236) and transmitted to Sanofi on 21-Oct-2020.  This case involves a 5 year old male patient who was administered a 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA, expiry date: 09-Oct-2020) via intramuscular route in the left thigh for prophylactic vaccination on 20-Oct-2020 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was 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 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.
Approximately one day after I felt a severe itch on my back, I thought it was a mosquito bite. Approximately 48 hours after injection, break out in sweat, chills, stomach unhappy, diarrhea set in. Back itch spread and developed red scaly patches, could not see well and I live alone. Some pain experiences with the "rash" as well. Approximately 60 hours still sweat/chills/mild belly pain.  This subsided by hour 72. Back did not clear until 9/7/18.
4/25/2021-woke up sweating, could not stand up right felt as if I was in labor.  This lasted for several hours then I started my menstrual cycle.  Since I never experienced this pain outside of actual labor went to urgent care.  Thought could have kidney stones so walked next door to ER.   Luckily it was not stones and I was fine.  Went to ob and everything checked out fine.  I experienced this pain for roughly 6 hours prior to my menstrual cycle.  Once I would start the pain was better but I was bleeding clots (semi deflated grapes look).  This was 5/20/2021 and 6/14/2021.  When I started on 7/11/2021 the pain was gone.  So three periods after first dose extreme pain. Unable to move or do anything.
1 of 2 pts exp systemic reacts (arthralgias & myalgia) following Td vax; reacts began w/in 24 hrs post vax;
About 10 and a half hours after the vaccine I started feeling bad, fever, aches, chills, fatigue that increased over the next 8 hours and leveled off for 12 hours, arm was really sore and developed a rash 2 by 5 inches at the injection site, legs really ached and it was very difficult to sleep for more  than a hour or two at a time. 36 hours later after a decent sleep for 6 hours I started to feel better and by 3 days was pretty much fine and over it all.
Fever of 100 degrees, fatigue, chills, body aches; All lasted 10 hours
Approximately 12 hours after dose 2 of the COVID 19 Moderna vaccine patient began to feel body aches, joint pain, mild dizziness, headaches, sweating, intermittent nausea, increased appetite and thirst, chills, and rigors. Patient presented to clinic for evaluation on 28JAN2021 (day 4 after vaccine) with continued symptoms although noted very mild improvement overall. Vitals within normal limits, no immediate concerns that required ER intervention or referral.
After administration of the vaccine at 9:50 AM, the patient went out to the waiting area to wait the 15 minutes after the vaccine. About 10 minutes into the waiting time, patient became very pale, and stated that were having chest pain. Patient was given water and their blood pressure was taken, it resulted in a BP of 70/60. The patient was laid down on the ground, and legs raised, and after another 10 minutes the BP was taken again and resulted in 118/78, at this point the patient was feeling much better. However, to be precautious, the patient was rolled out in a wheel chair to make sure hypotension did not occur again. Patient stated that at 11:30 they had a scheduled appointment already with their doctor and said they would discuss with them the adverse reaction of the previous couple hours.
Patient c/o dizziness, palpitations, SOB. VS within normal limits blood pressure 100/60, pulse 71, 97-99% Oxygen saturation. Diaphoretic, responsive with GCS 15. Denies existing health conditions, medications, or allergies. Given 1 bottle of water. Patient asked to walk with nurse. After walking 15-20 feet, patient said "whoa" and nurse grabbed patient and lowered him to the ground.  Patient was placed supine and bag placed behind his head. Nurse unable to palpate carotid pulse and patient completely unresponsive.  Nurse instructed to call 911 at this time. Patient positioned for CPR and opened his eyes. Stated "I fell asleep while I was walking." Patient instructed to lie still and informed 911 had been called. At this time, RN positioned patient's legs upward to increase blood flow to chest and head. This nurse repeated blood pressure at this time 96/62. Nurse obtained heartrate 71-75 and oxygen saturation 98%.  Denied pain. Stated he used a push mower in his yard this morning.  Patient diaphoretic and chilled. Assisted into seated position to drink orange sports drink and a second bottle of water. Upon EMS arrival approximately 4 minutes after call, paramedics examined patient and took over his care. They measured a blood glucose level of 134. Nurses assisted patient into ambulance for paramedics to run an EKG. Patient later returned to his personal vehicle and remained on site for about an hour. He called his brother-in-law to assist him home. Nurses on site checked on patient every 10-15 minutes until his family member arrived.
it was rpt from med professional concerning pt vax & subsequently lab evaluation revealed lack of seroconversion
Rotavirus vaccine was administered first.  Then PENTACEL (IPV-DTAP-HIB) was administered IM in the right thigh, then PCV7 administered IM left thigh.  At 205am 5-1-09 mother stated child had fever of 103 degrees F.  Was advised by physician to give TYLENOL/MOTRIN every 4 hours PRN for fever or every 8 hours PRN for fever
Fatigue, body aches, cough, fever up to 102 lasted whole day so far, chills headache
Approx. 3 weeks after oldest brother broke out with chickenpox, 2 younger brothers now showing rash symptoms. Red rash, fluid filled vesicles, popping and itching. No fever.
visual disturbances and  severe headache started about an hour after vaccine.  This improved over night, then 24 hours after vaccine severe headache which lasted another 2 days, aches
injection site pain; flu-like symptoms; fev; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fev and chills. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fev and chills were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fev and chills to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced flu-like symptoms that lasted for 3 days and  injection site pain, fev and chills.  For tolerance after 2nd dose refer case US2020AMR034882.  This case is linked to the case US2020034256 and US2020AMR034880 wife's case.
Expired vaccine administered; First dose on 11 Feb 2022 and second dose on 02 Mar 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11 Feb 2022 and second dose on 02 Mar 2022) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11 Feb 2022 and second dose on 02 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11 Feb 2022 and second dose on 02 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.
irregular pap sear; Inappropriate schedule of vaccine administered; This spontaneous report was received from a pharmacist concerning a currently 32 years old adult female patient. No information about her current condition, medical history or concomitant therapy was reported.   In 2010 (at the age of 21 years old), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot# were not reported) for prophylaxis. In 2011 (at the age of 22 years old), she received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot# were not reported) for prophylaxis.   The patient stated that she had an irregular pap smear (unspecified date and result) and it was recommended that she got the shot. On an unknown date, the patient came into the pharmacy and stated to the pharmacist that she needed to get the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine per her "OBGYN" (inappropriate schedule of product administration). The series of vaccine was not completed previously. Now, the patient was 32 years old. The pharmacist wanted to know should the patient need to start over or not. The outcome of irregular pap smear was not resolved. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.   The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Itchy hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Itchy hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On 10-Mar-2021, the patient experienced URTICARIA (Itchy hives). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Hives, at a dose of UNK dosage form. At the time of the report, URTICARIA (Itchy hives) had not resolved.
Nausea, headache, fatigue, body aches, muscle aches, back pain 48 hours later.
Patient came into the clinic for a booster dose of vaccine (called ahead prior to coming), marked "yes" to immunocompromised, and no to at least 6 months from last dose of Pfizer vaccine. Immunization given. Per reason written on sheet patient does not qualify as immunocompromised, as reason put was smoking. No known adverse events/side effects at this time, tolerated well. Patient was notified of event, To call back with any concerns. Observed in office for 15 minutes.
Booster vaccine was given 4 months early. (Staff member had no adverse reactions.) I am just reporting the booster was given to early.
Swelling and pain under the left armpit (possibly swollen lymph nodes?) -- started the morning after vaccination and continues to persist  (3 days after)
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 10-JAN-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. Lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions once of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
No additional AE; Medical assistant reported ROTATEQ  was administered after temperature excursion. See full details below. No additional AE/no PQC.  ?    Names of vaccines involved ROTATEQ 1968393 05/24/2024 ?    Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 28-SEP-2023 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968393 and expiration date 24-MAY-2024, for prophylaxis (dose number, route and site of administration were not provided) (product storage error). On 14-AUG-2023, temperature excursion lasted for 12 hours 20 minutes 0 seconds in temperature 8.9 degrees Celsius (°C). On 28-AUG-2023, temperature excursion lasted for 8 hours 20 minutes 0 seconds in temperature 9.4 degrees Celsius (°C).
Foggy Brain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EX19581) via an unspecified route of administration in the left arm on 14Jan2021 at 11:00 (at the age of 70-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 04Feb2021 at 11:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient had no other relevant medical history and no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included hydrochlorothiazide, valsartan (DIOVAN HCT) and finasteride (PROSCAR); both for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 11:00, the patient experienced foggy brain and fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 06Feb2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events foggy brain and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a other refers to unspecified number of patients of unknown ages. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB for prophylaxis. No adverse event. Sender's Comments: US-009507513-1708USA013504: Original Case: 1708USA013476; US-009507513-708USA013505: Original Case: 1708USA013476; US-009507513-1708USA013476: Original Case: 1708USA013476.
Patient fainted and fell over on the bench she was sitting on and ammonia inhalant was used to arouse patient. She had no complaints of pain or dizziness after she woke up.
BOOSTER DOSE (NO REACTION TO ORIGINAL DOSE). 5 HR POST ADMIN PT DEVELOPED RASH/ITCH ON ARMS, BACK, POSTERIOR NECK (RESOLVED WITHIN 48 HR); BODY ACHE + FEBRILE SENSATION (HOWEVER (-) FEVER) DEVELOPED LATE EVENING (11 PM) POST ADMIN (@ 48 HRS SYMPTOMS SIGNIFICANTLY IMPROVED).
Lymph node swollen on left side of neck; This is a spontaneous report from a contactable healthcare professional. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 10:45 (at the age of 34-years-old) and received second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) and ethinylestradiol, levonorgestrel (PORTIA-28). The patient had no known allergies. Prior to the vaccination, the patient had not been 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 30Mar2021, the patient experienced lymph node swollen on left side of neck. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of this event. The clinical outcome of the event lymph node swollen on left side of neck was not recovered at this time of report.  No follow-up attempts are needed. No further information is expected.
chills, fever of 101  very sore L arm  stomach upset fatigue and general muscle pain  above reactions occurred 6 hours after vaccine I did take 400 mg Ibuprofen at 12 hours after vaccine to decrease fever and aches Next morning fever and chills were gone but milder flu symptoms of aches and fatigue remained and stomach upset I would estimate that reactions lasted 2 days and by day 3 I felt much better except for the sore arm. The sore arm lasted 3 to 4 days.