chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever (max. 102.8F) lasted two days; Headache/ Headaches continued for four days; nausea; dizziness; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself (patient).  A 24-years-old female non pregnant patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation:  solution for injection, lot number: EN6204, expiry date: unknown) via an unspecified route of administration in Left arm on 02Apr2021 as dose 2, single and bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP6955, expiry date: unknown) via an unspecified route of administration in left arm no known allergies. Concomitant medications included lamotrigine, quetiapine, bupropion, escitalopram taken for unspecified indication, start and stop date not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and was not tested for it post vaccination. On 14Mar2021, the patient experienced fever (max. 102.8f) lasted two days, headache/ headaches continued for four days, nausea and dizziness. The patient underwent lab tests and procedures which included body temperature:102.8 fahrenheit on an unknown date in 2021. No treatment was received by the patient for AEs. The outcome of event was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
on 3/11/2020 patient had Varicella titers drawn after VARIVAX was administered on 8/28/2019.; Information has been received from a licensed practical nurse referring to a 13 years old female patient. The patient had no pertinent medical history, no drug reactions or allergies and no concomitant medications.  On 28-AUG-2019, the patient was administered with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis (reported as for routine school vaccination).         On 11-MAR-2020, the patient had varicella titers drawn. Titers were positive. The patient sought medical attention and there was no treatment given for the event. The outcome of the event was recovered in March 2020. The causality between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005659:
BRUISING BEGAN 2 DAYS AGO WITH SINGLE BRUISE, INCREASING TO MODERATE BRUISING ON HIS ENTIRE BODY. 9/27/2016 DX WITH ITP.
pt recv vax; to er; er dx as inflammation or swelling of brain w/ numbness of tongue, causing partial paralysis of rt side of face
Bones were hurting, but the pain was gone the next morning; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 27Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient received the 1st dose of Pfizer Covid-19 vaccine last Saturday (27Feb2021) during the night on 27Feb2021 after the 1st dose her bones were hurting, but the pain was gone the next morning on 28Feb2021. Her 2nd dose is scheduled on 27Mar2021. The outcome of the event was recovered on 28Feb2021.  Information on the lot/batch number has been requested.
Left arm soreness began on day of vaccine.  Left arm extreme weakness with inability to raise arm above chest level, severe fatigue and headache on day 1&2 following vaccination. Also had lymph node swelling and pain in the left armpit.  Headaches have been recurrent since vaccination.
Suspected vaccination failure; I broke out the very next day oñ the left chest area....hello shingles; The pain before the break out was terrible / ended up in the E.R; I got a rash to come back right away; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. The patient was treated with calamine + zinc oxide (Calamine Lotion). On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient stated that, the pain before the breakout was terrible and he/she ended up in emergency room. They ran tests to saw if the patient was having a heart attack. The patient was told to see his/her P C D the next day and he could find nothing and said he thought, might be the patient was going to break out with shingles. He/she got a rash to come back right away. The patient broke out the very next day on the left chest area. The patient went back and was given some medications that he said would give the patient a lighter case. The patient stated that, from what he/she had saw from other people's cases of the breakout phase, he/she was very lucky, it was very light. The patient used calamine lotion on them and once they broke out. The pain was about over. The patient suggested to get the shot and said might be you be one of the lucky ones that it would work for. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151406:Same reporter. Cousin's case. US-GLAXOSMITHKLINE-US2021AMR151421:Same reporter. Other people's case.
PATIENT HAS NOT SEEN A DOCTOR FOR ANY OF THE ADVERSE REACTIONS. SHE SAID THEY STARTED AROUND 2 & 1/2 WEEKS AFTER VACCINE AND HAVE GOTTEN BETTER.
Doctor ordered a Tdap to be given to a 5 year old as the 5th dose at a health center. Doctor should have ordered a DTaP. Patient given Tdap as ordered. Error was discovered when the new stock was to be ordered and the report indicated an error. Upon reviewing the chart, the error was confirmed.
24 hrs post first dose 1 lymph node last side of neck swollen, hard, immobile, and painful.  48 hrs post first dose lymph nodes through left armpit and left proximal upper arm swollen, hard, immobile, and painful.  60 hrs post first dose lymph nodes throughout  left arm swollen, hard, immobile, and painful.  Arm generalized +1 edema. Pain 3 on scale of 1-10. Currently 13 days post dose.  Arm remains unchanged.
This patients medical history, concurrent diseases and concomitant medications were not reported. On 02-DEC-2013 the patient was received nasal FLUMIST but the vaccine was expired. As of the time of reporting, the outcome of the event of gave expired FLUMIST was unknown. The report was considered to be non-serious by the reporter.
Pain at injection site immediately after. 8 hours later developed fever of 100°. Overnight had fever of 102.5° for a few hours. Migraine this entire time. Still have headache and low grade fever two days after receiving injection.
when it was dropped on the floor it broke; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 27Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 26Jan2023 as dose number unknown, 0. 5 ml, single (Lot number: FY2475, Expiration Date: Dec2024) for immunisation, Device Lot Number: FY2475, Device Expiration Date: Dec2024. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious) with onset 26Jan2023, outcome "unknown", described as "when it was dropped on the floor it broke".  Additional information: There were two syringes have broken. According to the reporter no patient got the broken vaccines. The second one broke on 26Jan2023, when it was dropped on the floor it broke.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300046183 same reporter/drug/event, different patient;
This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 22-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose, route of administration were not reported; lot # M026306, expiry date: 30-APR-2018) for prophylaxis. The dose was exposed to the temperature of 32 degrees Fahrenheit (F) for a time frame of 26 days (from 05-NOV-2016 to 30-NOV-2016). There were no prior temperature excursions. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA011310.
Received vaccine then slept for four hours, fever 101 degrees developed continued x 3d. Parents report he seems excessively tired, fussy.
Swelling in armpit and feeling pain in my heart.  Felt like something was very messed up with my heart.  It hurts to move my left arm any.
No additional AE information provided; lhe patient was administered an improperly stored dose of MMRII; This spontaneous report was received from a medical assisstant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 17-DEC-2019, the patient was administered an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S006647 and expiration date 05-MAR-2021; strength, dose and route were not reported) for prophylaxis (product storage error) with sterile diluent was properly stored. No additional adverse event information was provided. The vaccine underwent temperature 9.4 Celsius for a duration of 25 minutes. There was no previous temperature excursion. The call was because of data logger.
2nd dose administered with a vial that had been punctured for more than 12 hours; 2nd dose administered more than 1 month after first; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered with a vial that had been punctured for more than 12 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 1 month after first) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 006D21A) for COVID-19 vaccination.     Concomitant products included SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), TRAMADOL, ESCITALOPRAM OXALATE (LEXAPRO) and ALPRAZOLAM for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered with a vial that had been punctured for more than 12 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 1 month after first). On 24-Jul-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered with a vial that had been punctured for more than 12 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 1 month after first) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drugs were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Batch number and Anatomical location provided for first dose.
Patient brought to attention of staff that he was feeling nauseaus and proceeded to bathroom. Patient reports that he vomited 2 times each a small amt. Patient came out of bathroom and reported that he was feeling short of breath and that the muscles in his neck were tight. He was also feeling itchy and warm throughout body. Brought patient to room for observation and immediately gave epipen to the L quad. This was approx 30 min after administration of Moderna Vaccine 2nd dose. Patient did not have any reactions to the first dose. Patient reported that he felt better almost instantly. Per NP on duty lung sounds were clear to auscultation and with good airflow. VS checked then after epipen admin they were as follows: BP 168/90, HR 80, )2 99% RA. Patient then began to c/o 10/10 headache. Ibuprofen 200mg 2 taps PO were administered with small glass of water. Patient tolerated well.  Vitals rechecked 5 min later and were as follows: BP 146/88, HR 77, O2 97% RA. Per facility protocol patient was transferred to ER for further evaluation.  EKG taken in ER and was found to be normal. Patient observed for 1.5 hours with no adverse events. Patient discharged home with cetirizine and epipen, education provided by ER staff.  Follow up with patients PCP within 1-2 days.
Developed erythema and swelling of eyelids, bilaterally, plus purulent discharge from eyes.  Mild pre-septal cellulitis plus R otitis media present on 12/7/2009.
Nurse reporting a temperature excursion for PROQUAD. Information obtained for vaccines that were administered to patients.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose (Product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml, subcutaneous (SQ), lot # T016990 with expiration date 11-NOV-2021, for prophylaxis.   On 25-JUL-2021, a temperature excursion was occurred from 6°F to 14°F (7.3°F) during a time frame of 37 minutes. This temperature excursion was not previously reported.  On 06-AUG-2021, the product storage error was identified.  On 14-SEP-2021, a temperature excursion was occurred from 6°F to 14°F (9.9°F) during a time frame of 2 hours and 11 minutes.  On 15-SEP-2021, a temperature excursion was occurred from 6°F to 14°F (6.6°F) during a time frame of 59 minutes.
Left arm and its joint still hurts; Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm and its joint still hurts), ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) and FATIGUE (fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm and its joint still hurts), ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (ACETAMINOFEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Left arm and its joint still hurts) and ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) was resolving and FATIGUE (fatigue) outcome was unknown.            No concomitant medications was given.   This case was linked to MOD-2021-324333 (Patient Link).
pt recvd vax & had difficulty breathing, itching all over & red blotches 5 hrs p/vax; rx'd in ER w/DPH; 7MAR laryngitis & congestion (lungs); 8MAR fever 102.8; MD reprots pt w/rash, dyspneic, tachycardic, apprehensive;
A report has been received from a Health Professional concerning, pregnant female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter reported that patient received FLUMIST QUADRIVALENT and later found out she was pregnant which was also considered as drug exposure during pregnancy. The outcome of the event of patient received FLUMIST QUADRIVALENT and later found out she was pregnant and drug exposure during pregnancy is unknown. The report was considered to be non-serious. Outcome of the pregnancy was unknown.
diffficulty gripping things; The joints appear to larger than now; Arthritis worsened; CRSP worsened; CRSP worsened; Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened) and CONDITION AGGRAVATED (CRSP worsened) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022b21a and 002c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulpha), Drug allergy (Diluadi), Drug allergy (Percocet), Asthma, Avascular necrosis, Seizures, Arthritis, Complex regional pain syndrome, Pain, Cancer, Depression, Blood pressure high and Sleep disorder. Concomitant products included AMLODIPINE for Blood pressure high, LETROZOLE for Cancer, FLUOXETINE HYDROCHLORIDE (FLOXETINE) for Depression, PARACETAMOL (TYLENOL) for Pain, TRAZODONE for Sleep disorder NOS.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened), CONDITION AGGRAVATED (CRSP worsened) and VACCINATION SITE PAIN (Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm). At the time of the report, GRIP STRENGTH DECREASED (diffficulty gripping things), JOINT SWELLING (The joints appear to larger than now), ARTHRITIS (Arthritis worsened), COMPLEX REGIONAL PAIN SYNDROME (CRSP worsened), CONDITION AGGRAVATED (CRSP worsened) and VACCINATION SITE PAIN (Pinkie finger and the one next to it started hurting and is getting worse/began feeling pain in my right hand finger joints/Sore Arm) had not resolved.            After second vaccination the patient began to feel pain in right hand and finger joints. It started with the pinkie finger and progressed to the four other fingers on that hand. The joints also appeared larger. She woke in the morning unable to use her right hand and fingers were in extreme pain. The patient used little exercises which decreased joint stiffness, but she now had difficulty gripping things, especially without pain.  No other treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Medical history updated, concomitant drugs, suspect dosage regimen and new events were added.
103.5 fever, fatigue, headache, muscle soreness & pain, Cough, sore throat.
1 week after 2nd vaccine I developed severe joint pain, caused a lupus flare-up still dealing with joint pain, and I am unable make full fist on right hand
Patient received the flu shot, and about 10 AM on Thursday, Oct. 9 2008, she claims she developed sore throat at 1 AM next day with swelling on the left cheek. She went to local hospital and was given oral BENADRYL, and she was released after evaluated.
"Severe pain and inflammation" at injection site (left deltoid). Pt went to urgent care referred to orthopedics, received x-rays, states "no range of motion.
pt was symptom free Narrative: Pt given first dose Pfizer and 3 weeks later 2nd dose Moderna. No side effects noted
This spontaneous report was received from a nurse regarding a 1 year old female patient. No medical history and concurrent conditions were reported. On 01-JUL-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (dose 1), subcutaneously in the left thigh for vaccination against chicken pox. On 21-SEP-2015 the patient experienced vesicle like rash at injection site of (Oka/Merck) VARIVAX (injection site rash, injection site vesicles) (reported by the patient's mother). At the time of reporting the patient was without rash (recovered approximately on an unknown date in September 20155). It was unspecified whether the patient sought medical attention or not. The causality assessment was not provided. No product quality complaint was reported. Additional information has been requested.
This spontaneous reprot has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients had been administered unspecified doses of RECOMBIVAX HB, (lot #, strength, route of administration and dose were not provided), that underwent temperature excursions. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Shingrix was given subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st April 2021, the patient received Shingrix (subcutaneous). On 21st April 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The shingrix was given subcutaneously to a patient instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow-up.
Migraine intense, lasted 5 days.  Vessel fragility, spontaneous, painful hematomas in fingers that occurred a week after the first dose of the CoVid Moderna vaccine.
Pt received FLUZONE HD at 11:30 AM on 10/14/14 - at 5:00 PM, pt experienced sweating, nausea and vomiting. At about 6:15 PM, pt is chill. She calls to the pharmacy and ask the pharmacist pt was advised to go to ER.