chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to mass vaccinating event today, reports received 1 dose of Moderna COVID19 Vaccine only this year. Our staff verified on MIIC - misread MIIC and did not see 2nd dose on there. Patient received his "2nd" dose of Moderna today. However, towards the end of the day during documentation, we noticed that today we may have given patient a 3rd dose of Moderna. Called his clinic to verify - they manually entered in the 2nd dose in his chart. Tried connecting with patient as well, but unable to connect with him today to verify information again. Unsure if documentation at doctor's clinic is incorrect or patient did not disclose info correctly. Unsure if patient is experiencing SE from additional Moderna COVID Vaccine.
Initial report was received on 22 December 2011 from a health care professional. A 63 year-old female patient (date of birth not reported) had received on 15 December 2011 an intramuscular injection of ADACEL (lot number and site of administration not reported) and six days later on 21 December 2011, experienced a "little knot" above the injection site that was slightly tender. Concomitant medication included ASPIRIN. The patient was not seen in the office. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 24 February 2012. The patient did not receive any treatment. The patient's outcome was reported as recovered. Documents held by sender: none.
Arm has red patches near site and arm is sore whereas has not had any issues until today.
Rash below my neckline (hives), diziness, loss of appetite, and fever of more than 102F.
Patient seen on 11/10/10 noted for 1 day of clear fluid filled vesicles bilaterally on posterior arms and few scattered on upper thighs. Lesions not pruritic. Patient with no history of fever = normal activity. No ill contacts.
TREMORS; FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced tremors. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle pain and tremors was not reported. This report was non-serious.
Initial case was received from a health care professional on 16 OCTOBER 2013. An adult female patient (age unknown) had no medical history reported, received a dose of FLUZONE vaccine in right arm on 15 OCTOBER 2013. (Route, batch number not reported). Patient had not reported concomitant medication. IT was reported that on 15 OCTOBER 2013 patient had injection site pain. No corrective treatment was reported. At the time of report the outcome of event was not recovered.
2 1/2 inches by 2 1/2 inches, slightly raised circular area of induration, red.
Patient developed COVID after vaccines.  There was an outbreak at her facility   .  She ended up with pneumonia and expired on 03/07/2021
The first 3 Covid vaccines were from Moderna. The 4th was Pfizer.  Within 24 hours after vaccination, my breathing began to be a little more difficult. The 5th day after vaccination, I am having considerable trouble breathing and have begun Amoxicillin 875 to stop inflammation in my lungs. I hope that works. The tightness in lungs feels like bronchitis without the cough. My voice is weak and different from normal.
Developed shingles-like rash on chest and back.  Next day developed the same rash on right arm.  Two days later, developed more shingles-like rashes on other areas of chest and back.  Had headache on 8/3/2012 & on 8/4/2012 prior to developing a rash.
Within 1 hr following vaccine, noticed mouth felt weird and tongue slightly swollen (took benedryl as precaution, no further swelling) Within 14 hrs of vaccine, felt all over general aches and joint pains, loss of appetite, trouble focusing on tasks but still able to complete them After 30 hrs, suffered insomnia (1 night), with shooting aches and pains and headache At ~ 40 hours the pains included loss of concentration, unfocus on tasks and unable to complete them,  total loss of appetite, nausea, severe headache, tinnitus, severe body and joint aches and lethargy. At this point I cancelled my work day because I couldn?t function.  The pain was miserable.  Day 3 after vaccine - a little sore,  aches in places that don?t usually ever hurt and usual spots hurting about double, a little tired, smaller appetite than usual but eating.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient passed out minutes after the injection, went atonic and then started to shake, EMS was called, the paramedicas came, patient regained consiousness and stated that they always pass out after a shot, paramedics stated that patients can sometimes tense up when they faint and that can look like seizure, pt left on own  mobility
she started to get a rash on her both legs above the ankles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (3rd dose (1st booster dose), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 11May2022, outcome "unknown", described as "she started to get a rash on her both legs above the ankles".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
found to be confused and cyanotic and hypoxic, brought to ED and found to be severely hypercapnic (pCO2 102.5, pH 7.219),  requiring BiPAP pt tested postive for COVID PTA, around holidays, tested postive for COVID on 1/1 started on decadron,, given 5 days of remdesivir PCT elevated (0.40) so stared on Unasyn
chills; fever; body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had covid" (unspecified if ongoing), notes: I had covid slightly over 90 days ago. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 2022, outcome "unknown"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got a covid booster shot earlier this morning (at time of report) and woke up in the middle of the night with chills, fever and body aches and headache. The patient's thermometer broke in the first few seconds of turning it on, but the temperature was at least 100. The patient had covid slightly over 90 days ago so perhaps the patient's immune system was already high for covid. The event took place after the use of the product.  The lot number for BNT162b2, BNT162b2 omi ba.4-5 was not provided and will be requested during follow up.
pt recv vax 16OCT96 & that same day pt exp pain radiating down arm causing numbness in hand & pain in neck;
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # M022400 with expiration date of 01-NOV-2017; lot # reported as M036294 with expiration date of 13-FEB-2018; doses and routes of administration were not provided). No adverse symptoms were reported. Administered doses of vaccines experienced temperature excursions of: > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 10 hours and 15 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 2 hours; > 5 degrees Fahrenheit but < 14 degrees Fahrenheit for 1 hour; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 1 hour and 30 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 3 hours and 30 minutes; > 14 degrees Fahrenheit but < 46 degrees Fahrenheit for 6 hours and 15 minutes. Digital Data Logger was involved. This is one of two reports received from the same reporter. Additional information is not expected because there was no consent to contact physician. Sender's Comments: US-009507513-1701USA011718.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 25-NOV-2015 at time- 20:10, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
general aches/aches; side effect of the booster; low grade fever/low fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (general aches/aches), ADVERSE DRUG REACTION (side effect of the booster) and PYREXIA (low grade fever/low fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (general aches/aches), ADVERSE DRUG REACTION (side effect of the booster) and PYREXIA (low grade fever/low fever). At the time of the report, PAIN (general aches/aches), ADVERSE DRUG REACTION (side effect of the booster) and PYREXIA (low grade fever/low fever) outcome was unknown.            No concomitant drugs provided. No treatments were reported.
lungs feel like they're closing; Shortness of breath; wheezing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (lungs feel like they're closing), DYSPNOEA (Shortness of breath), WHEEZING (wheezing) and COUGH (coughing) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included TESTOSTERONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced CHEST DISCOMFORT (lungs feel like they're closing), DYSPNOEA (Shortness of breath), WHEEZING (wheezing) and COUGH (coughing). At the time of the report, CHEST DISCOMFORT (lungs feel like they're closing), DYSPNOEA (Shortness of breath), WHEEZING (wheezing) and COUGH (coughing) outcome was unknown.            Treatment of the events were not reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
01/08/2020 1:00AM injection site pain,  chills, nausea,  temp 102. headache
TIREDNESS; NECK PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included right leg broken, and concurrent conditions included leg nerve ending pain, and right leg pain, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced neck pain. On 07-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on MAY-2021, and had not recovered from neck pain. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history was not reported. On 18-DEC-2014, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (frequency, anatomical location, route of administration and lot # were not provided) which expired on 12-JUL-2014. No adverse event was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt exp irritability 1 hr p/vax, vomited x 1 12 hrs; exp high fever 4 hrs fever cont w/APAP; 8-10 hrs post vax pt exp muscle weakness, pt unable to sit or stand; Refused to eat 29FEB92;
Nose bleed - started around 6:15 am and lasted around 15 minutes.  No history of nose bleeds or other bleeding problems.
Anthrax booster administration in R deltoid subcutaneously on 11June.  Within few hours of administration, developed nausea, bitemporal HA.  Continued increased erythema around site of injection x72hr, and continued systemic sx.  Seen on 14June initially w/ 8" erythema, toward elbow, no swelling, + pruritis. Treated w/ hydrocortisone 1% and Zyrtec, w/ improvement by next day, and + resolution of systemic sx w/in 24hrs of that as well.  Pt reports similar local reaction after 2nd dose of anthrax, but did fine w/ all subsequent doses until this one.
This medically confirmed spontaneous report (initial receipt 18-Feb-2015) concerns a 36-year-old male patient. The patient received TB vaccine in the past four weeks. On 27-Jan-2015 at 17:06, the patient received intramuscular AFLURIA pre-filled syringe, (batch number: T51808), that was kept at 21.2 degree C on for 1-2 days (administration of temperature excursion vaccine). It was reported the patient was fine and there was no adverse event. Outcome was reported as unknown. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as unrelated.
Approximately 20 minutes later started feeling tightness numbness on right side of face. About 2 hours later started feeling extremely faint, shaking, pounding heart, sweating and numbness. Called the doctors office to report. Went to ER same day. Started having pounding heart at night, panic attacks, anxiety attacks, unable to sleep. At times feel jittery, racing pulse like nerves is off. Right side of face at times is still tight tingly.
Pt said her arm was red with a lot of swelling she saw her doctor and he gave her cephalexin and the redness and inflammation went away.
Apprx. 10-15 minutes after immunization, Pt developed welts. Pt was at hospital to get blood test- went to ER. Paremed told it was hives and to give Benadryl.
Four weeks post vax, the pt experienced pain. It started like a muscle pull/strain; saw his physician who felt it was musculoskeletal rather than IZ related. Pt saw chiropractor and acupuncturist for treatment. They felt the arm was cold and damp.
Immunocompromised (AIDS) patient received a dose of Moderna which is not currently authorized by written Agency/CDC guidelines as of 1/6/22. Janssen Dose #1 in April 2021. Janssen Dose #2 in November 2021. Received a full dose (0.5mL) of Moderna with Team on 01/04/2022. Current guideline for Janssen schedule is 1 dose only for Primary Schedule, no immunocompromised dose, and a booster dose 2 months from Primary Dose. Moderna Dose given by Team falls outside of this current guideline.  I telephoned patient in the afternoon of 1/6/22, and he reported only moderate side effects. Soreness at injection site, myalgia, & vomiting. Did not have to visit PCP, UC, or ED. Otherwise felt decent.
Patient reported severe body ache; Out of energy; Very tired; Sleepy; Sore arm; Runny nose; when patient received this dose, vaccine vial had been at room temperature for about 31 hours; when patient received this dose, vaccine vial had been at room temperature for about 31 hours; This is a spontaneous report from a contactable reporter (pharmacist).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 11Feb2022 at 15:30 (lot number: FK9729) at the age of 60 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were reported as none. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FJ6369; Route of administration: Intramuscular; Anatomical site: Right arm; Administration time: 18:00), administration date: 19Jan2022, when the patient was 60 years old, for COVID-19 immunisation.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) and PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious); both with onset 11Feb2022 at 15:30, outcome "unknown", described as "when patient received this dose, vaccine vial had been at room temperature for about 31 hours"; PAIN (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Patient reported severe body ache"; ASTHENIA (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Out of energy"; FATIGUE (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Very tired"; SOMNOLENCE (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Sleepy"; PAIN IN EXTREMITY (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Sore arm"; RHINORRHOEA (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Runny nose". Therapeutic measures were taken as a result of pain, asthenia, fatigue, somnolence, pain in extremity and rhinorrhea.  Additional Information: The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. It was reported that when the patient received the second dose, the vaccine vial had been at room temperature for about 31 hours and it was also mentioned this was the reason for reporting these events even though they were generally seen in patients. Treatment received for reported events included Tylenol and Benadryl. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Swollen and very painful lymph node on left armpit area &  fever of 101°. After receiving the vaccine 4 days prior. Had to go to urgent care facility.
Pt nervous. Pt skin became blotchy after injection and M.D. was called into the room. Skin had almost cleared by the time dr entered. Pt. calmed and was d/c with mom et dad.
I had severe numbness and tingling of my hands and feet as well as in my arms legs and torso.  I became uncomfortably cold and had to sit in the 90*F sun with a heavy sweatshirt to warm myself.  I then experienced an excruciating headache that lasted over 2 hours and was only relieved by an nsaid and sleep.
Sympotms were body aches and chills. Advil and rest helped them go away in about 36 hours.
Few hours after PNEUMOVAX injection into deltoid - patient developed severe nausea, muscle pains, prompting visit to ER. Symptoms controlled with ZOFRAN and PERCOCET.
started out with a rash around injection site and is now full blown on left arm from top to wrist and under to arm pit area of arm.  rash is a burning sensation and very itchy.
After dinner around 7pm I started feeling a rapid heartbeat. It became extremely rapid. I generally check my heart rate and blood pressure. My heartbeat was so fast the monitor registered an "error" message. I tried to do breathing and bare down but that didn't help. My sister is a nurse she came over to check on me and she told me I should go to the ER. I called the on-call doctor in the ER and he called me back 3 hours later he instructed me to go to the ER. When I got to the ER they were prepared for me and took me back to do a EKG. They gave me a 12 lead EKG and IV. The doctors the told me to take a deep breath and bare down and they lifted my legs high in the air but it didn't work after two trials. They gave me adenosine treatment that brought my heart rate down. I stayed for observation for a few hours and then I left the following, I was not admitted. I went to follow up with my cardiologist and he told me the situation I had was benign and it should not increase my risk of heart attack or stroke. He told me that the event could happen again so he prescribed me metoprolol titrate and that it should help if not then I am to go to the ER again.
Immediately after administration the patient had a lump that formed at injection site. At 15 minutes the lump was still palpable and had not reduced in size. Patient called at 1630 reporting that the lump was still there and the same size. Patient was advised to take a pain reliver and use a warm compress and call back if not improved. The patient did not call back by end of day 1/5/22. Follow-up call was made 1/6/22 in AM. Patient reported that there was no visible lump put the injection site was had a large bruise and hard lump that was below the surface. Also, she reported that her left arm was very sore. Patient was advised to call and check-in with her PCP and call the pharmacy to inform of her progress.
Initial report was received on 30 March 2011 from a health care professional. A two year-old male patient who had no known allergies and had no illness at the time of vaccination, had received on 17 September 2010 a "booster" dose of DAPTACEL, lot number C3474AA (route and site of administration not reported) and within 24 hours, experienced a fever of 100.4, had difficulty breathing, was lethargic and "in distress". The patient was diagnosed with Croup. The patient had a similar reaction after receiving Merck's HEPATITIS B (date of administration, onset date of adverse event and specific description of event not reported). No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.