chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Developed severe joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced ARTHRALGIA (Developed severe joint pain). At the time of the report, ARTHRALGIA (Developed severe joint pain) outcome was unknown.            Patient walks with a cane due to arthritis. No relevant concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Injection site area became very large and puffy and lots of itching. Started sometime last night (hours after injection).
Went on 10/25 to Employee Health for annual evaluation, was given TDaP vaccine per facility requirement.  Had an allergic reaction to the vaccine, that night, arm became swollen, achy and warm to touch, next day, had numbness of left side of face and shortness of breath, became severe and was taken by ambulance to hospital and treated for allergic reaction with steroids, Benadryl and oxygen.  Was released.  On Sunday became feverish and achy, run temp for three days, On Tuesday, 11/1/11 noted numbness of lips, face.  Went to see Dr. on Wednesday and he told me my arm was still indurated and I was continuing to have an allergic reaction to the vaccine.  I am now on Prednisone X 5 days to treat the reaction.  Fever gone and back to work on Friday, November 04, 2011.
Rash, upper extremity, itching, joint pain, migraine, diarrhea.
Hands started deforming/Hand deformity; Pain in eyes/Eyes were hurting; General body pain/Pain in body; Joint pain/Joint pain in hands, elbows, wrist, toes and spine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HAND DEFORMITY (Hands started deforming/Hand deformity), EYE PAIN (Pain in eyes/Eyes were hurting), PAIN (General body pain/Pain in body), ARTHRALGIA (Joint pain/Joint pain in hands, elbows, wrist, toes and spine) and HEADACHE (Headache) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concomitant products included PREGABALIN (LYRICA) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form, first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. On an unknown date, the patient experienced HAND DEFORMITY (Hands started deforming/Hand deformity), EYE PAIN (Pain in eyes/Eyes were hurting), PAIN (General body pain/Pain in body), ARTHRALGIA (Joint pain/Joint pain in hands, elbows, wrist, toes and spine) and HEADACHE (Headache). At the time of the report, HAND DEFORMITY (Hands started deforming/Hand deformity) outcome was unknown, EYE PAIN (Pain in eyes/Eyes were hurting), PAIN (General body pain/Pain in body) and HEADACHE (Headache) had resolved and ARTHRALGIA (Joint pain/Joint pain in hands, elbows, wrist, toes and spine) had not resolved.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of joint pain in hands, elbows, wrist, toes and spine, headache, eyes were hurting and pain in body with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of hands started deforming was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Live Follow up: Added suspect and Co-Suspect product information and event (Hand deformity) was added.
Information has been received from a female with allergic reactions to environmental, paints, cleaning supplies, perfumes, phenol and sulfur containing drugs, CELEBREX and morphine (manufacturer unknown) who in 2000 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (dose, route, and lot# not reported). The patient had severe reaction to the RECOMBIVAX HB. At the time of the report,  the patient's outcome was unknown. Additional information has been requested.
Syncope, vomiting, weakness, dizziness, temp over 103, low blood pressure, cellulitis.
Started with normal sore shoulder but within days, should got worse (couldn't raise arm), soreness and stiffness spread across shoulder blades, other shoulder then became affected (couldn't get dressed or sleep at night). Then about 2-3 weeks later, spread into neck (much stiffness). I have lived with this for 11 months now and condition is slightly better, but still bad. Doc 204222, 60-Day follow up states that patient seems to be recovering slowly, but still do not have full mobility, still has stiffness in both shoulders, cannot do certain movements like lifting slightly heavy objects. Patient honestly thinks that she is getting better.
Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a female patient, received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.
Case number PHEH2014US024992, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 67-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Pt recv vax on 12/13/96; on same day pt exp red/ swollen vax site; dx=sterile abscess
Exactly 12 hours after the shot, I experienced a severe wave of nausea, dizziness, faintness, and body sweats that lasted 15 minutes. It gradually subsided.
pt recv vax 14FEB97 & 17FEB97 pt devel light rash under skin w/no blisters present;reported that the rash devel predominately on the trunk & palm of the lt hand;the rash was tender to the touch, but not fluid filled;50 or more lesions;
congestion; cough\gaged up because of the excessive cough.; feeling tired; This is a spontaneous report from a contactable Consumer (patient) via Medical information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on an unspecified date as a SINGLE DOSE for covid-19 immunisation. The patient's Medical history and concomitant medications were not reported. The patient experienced congestion, cough\gaged up because of the excessive cough and feeling tired on an unspecified date. Question: Caller stated "patient was in between doctors. Her doctor has gone away and she just got a new doctor. She did not want to go the emergency. Patient received the first dose of the Pfizer vaccine last Friday. Patient have a congestion, cough and feeling tired since she got her shot. It's getting worst then before. Patient gaged up because of the excessive cough. Patient read these symptoms can go away within few days. How long does the symptoms typically last. Response: Informed caller these symptoms have not been reported with the vaccine beside the tiredness. Please discuss this with your HCP for more information. The onset and duration of symptoms may vary from person to person currently we have limited information in regards to the specific time frame. For events, outcome was not recovered.  Information on the lot/batch number has been requested
PATIENT REPORTED FEVER, RASH, AND ATAXIA (poor muscle control that causes clumsy voluntary movements).
PATIENT RETURNED TO PHARMACY ON 10/29 REPORTING THAT HE HAD A RASH. HE STATED HE HAS HAD A RASH LIKE THIS BEFORE BUT WANTED TO KNOW IF THE FLU SHOT COULD HAVE CAUSED IT. I TOLD HIM YES AND THAT HE SHOULD CALL HIS DOCTOR TO MAKE THEM AWARE AND THAT BENADRYL SHOULD HELP.
No adverse effects reported.; patient received improperly stored PROQUAD; This spontaneous report was received from a nurse referring to an female children. Information about  pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 17-APR-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant Human albumin (rHA); lot # R024020 with expiration date 19-FEB-2020; lot # R022574 with expiration date 04-FEB-2020; strength, dose detail and route were not provided) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 9.1 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 15 minutes. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA010534: US-009507513-1904USA010535: US-009507513-1904USA010533: US-009507513-1904USA010531: US-009507513-11904USA010532:
LOOKED LIKE BLOOD CLOTS; BRAIN BLEED; BIG BLOTCH ON INNER THIGH; DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported 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 an unspecified date, the patient got shot and within 5 days, she had big blotch on inner thigh that was black and blue, her daughter took her to the clinic (physician office) and they said it wasn't blood clots but looked like little blood clots, she also had a brain bleed.  On OCT-2021, The patient was died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on OCT-2021, and the outcome of looked like blood clots, big blotch on inner thigh and brain bleed was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220332164-COVID-19 VACCINE AD26.COV2.S-Death,looked like blood clots, Brain bleed. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Vaccine Clinic Coordinator received a phone call from patient's mother reporting that her child's left arm where the KINRIX shot was given on 9/18/18 was swollen, tender, red and warm to touch. Itching was also noted. Mother was instructed to apply ice to site and give age appropriate dose of ibuprofen. Notified patient's family physician, to inform her of the above report. NP did not have any further orders. Called patient's mother back to let her know that I had contacted her family physician. Instructed her to take patient to Urgent Care if the swollen site became enlarged, hard or child developed a fever. Spoke with the patient's mother on 9/21/18 early in the day to check on patient. She reports that the injection site had spread and patient developed a "hard lump" which became hot to the touch. Urgent Care prescribed Amoxicillin TID X 10 days. Family gave her a dose of BENADRYL also. She was instructed to bring her back in today if the lump didn't start to subside.
Patient reported new onset diarrhea, nausea, vomiting and dizziness. These symptoms last for about 2 weeks.
extreme dizziness making it difficult to stand or move, severe vomiting, bowel movements, chills/shivers, hot/flushed feeling.  No treatments, just lay down and try to wait for it to pass and vomiting to stop.  After several hours (4-6) I was able to go to sleep.  When I got up during the night to pee, I was still dizzy, but not as severe.  When I awoke this morning, most of the dizziness was gone and my stomach felt good enough to have cereal.
This spontaneous report was received from a 78 years old male consumer reporting on himself. The consumer was vaccinated with ZOSTAVAX in August 2009, route reported as injection, dose as 1 shot (site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. In May 2010, the consumer developed shingles. LYRICA treatment was commenced. The consumer also stated that he had knee surgery (medically significant) just before getting shingles. The patient sought unspecified medical attention. Upon internal review, knee surgery was considered to be an other important medical event. The outcome of shingles and knee surgery was reported as recovered/resolved (date unknown). The relatedness for shingles and knee surgery is unknown for ZOSTAVAX. Additional information has been requested.
has been flaring terribly since; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 20220114000484.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "has been flaring terribly since".  Additional information: Patient's age and gender was unknown. Doctor has a patient who has been on 200mg dose for over a year. Patient was doing great until 4 months ago the patient received the Pfizer Covid vaccine and has been flaring terribly since. It was questioned if it could be from the vaccine. The patient has an appointment to see the doctor on Saturday - and requested to send the information soon so the patient has it for the appointment.   Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 25-SEP-2104 the patient was vaccinated with (Merck) VARIVAX (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt had Varivax on 6/6/03, broke out with chickenpox on 5/24/06.
The day following my first COVID vaccination, I had pain in my upper arm for 36 hours and could not lift it above my shoulder. I also experienced 6 hours of constant chills throughout my body, which came on suddenly around 1PM (24 hours after my vaccination) and was sent home early from work. During the 6 hours at home I believe I experienced body chills, I experienced what I believe to be brain fog. My coworkers described my motor skills (walking down a hallway) as slow and lethargic, and my thoughts being delayed. I do not consciously remember the 6 hour timeframe when I experienced these symptoms. Around 7PM that evening, I remember having a "coming to" moment where I remember the chills subsiding, and being able to think again.  The following day I felt back to normal other than pain at the injection site.
pt recv vax 12JAN96 & pt exp 4 separate outbreaks of vesicles on lt side resembling varicella;the vesicles were located on upper lt arm & lt buttock down to lt knee;each outbreak was about 6wk apart;pruritus persisted;
patient came to office for second Gardasil injection on 9/25/07 at 11:00 am. The injection was administered to the patient IM Left deltoid without difficulty by Registered Medical Assistant. Patient was advised to wait 10 minutes in the waiting area after the injection as per protocal after receiving the gardasil injection. Five minutes later triage nurses were paged to the front desk by office staff, patient was found on the floor awake but slightly disoriented, diaphoretic and stating that she felt lightheaded. Front desk staff reports that patient was in the process of checking out and asked for orange juice because she felt a bit dizzy but then immediately passed out, fell forward onto front desk and then fell to the floor. At which time front desk staff called nurses for help. Nurses and Medical Assistants immediately used ammonia salts to help awaken patient and monitored vital signs, which were stable at BP-100/70 P-80 office staff  also immediately called 911. Ems arrived less than 10 minutes later and patient was transported to the ER. Information has been received from a Registered nurse concerning a 23 year old female student who on 24-JUL-2007 was vaccinated IM with a first dose of GARDASIL lot #654539/0742U, with no reaction noted. On 25-SEP-2007 at 11:00 a.m. she was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot #654539/0742U). The nurse reported that the patient fainted after receiving the second injection, passed out about 5 minutes after the vaccination, and hit her head on the wall. Treatment included administration of "smelling salt". She was sent to an emergency room for evaluation for a head injury. Follow up information indicated that the patient was "awake, oriented, anicteric and conversational," with mo photophobia. The treating physician noted that the patient "needs something to eat. She had a vasovagal epidode." and added that there was no indication for laboratory tests or studies. Vital signs were as follows: temperature 97.8, pulse 93, respirations 20, blood pressure 131/67 mmHg. an electrocardiagram was ordered (results not provided). At the time of this report, the patient had recovered from the events (duration not specified). Additional information is not expected.
Expired vaccine used; Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received which included patient details (initials, age, gender) and vaccine information ( date of vaccination, dose number).
8/24/08 Developed T 100.7 Ax 2 hours after injections. Complained of body aches, chilling. T104.1 at 3 AM today 8/27/08
HPV vaccine used for disseminated warts (flat warts); This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 45 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, imiquimod (ALDARA) and cimetidine. The patient's current conditions included T-cell immunodeficiency. His concomitant medications were not reported.    On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for disseminated warts (flat warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   A copy of the published article is attached as further documentation of the patient's experience.   This is one of several reports received from the same literature.   Sender's Comments: US-009507513-1912USA001729: