chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in left knee was completely gone/completely pain free when going up and down the stairs/not taking any pain medication, the only difference was getting the second dose of the vaccine; Soreness of left arm in the area of the injection; Headache; Body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3247) via an unspecified route of administration administered in left arm on 12Mar2021 at 12:30 (at 46 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included cardiomyopathy and pain in left knee both from unspecified date. The patient had no known allergies. Concomitant medications included metoprolol 150mg and candesartan 16mg both from unspecified date for unspecified indication. The patient previously took the first dose of BNT162B2 (Lot Number: EL3247) via an unspecified route of administration administered in left arm on 19Feb2021 at 12:30 (at 45 years old) as single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced soreness of left arm in the area of the injection, headache, and body aches; all non-serious on 13Mar2021. No treatment received for the events. The patient also added that for many years he had pain in left knee that would typically be felt when going up or down the stairs. However, over the past couple of days from the time of reporting on 14Mar2021, the patient noticed that the pain in left knee is completely gone. The patient was completely pain free when going up and down the stairs. The patient was not taking any pain medication, the only difference was getting my second dose of the vaccine on 12Mar2021. Outcome of the events was recovered on unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient states she was up all night "sick". She was chilled and felt she was running a fever. She has history of left breast cancer and has had mastectomy on that side. She woke up this morning with L arm swelling and redness. She has history of lymphedema. Injection was given in R arm.
Nauseous approximately 4 hrs after injection.  Vomiting 30 min-hr after onset of nausea, followed by chills.  Slight headache following a.m. and currently.
Stated "shaking" about 10 min after going to sleep, lasted about 20 min, was unresponsive to mom. Highest temp was 102, "didn't want to eat and was whining".
Case number PHEH2014US024677, is an initial spontaneous report from a consumer (patient) received on 08 Dec 2014. This report refers to a 73-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 06 Oct 2014. On 20 Oct 2014, she started experiencing diarrhea. She stated that she had experienced six or seven bouts of diarrhea since that date. She spoke to her doctor about her symptoms; doctor doesn't think it was related to vaccine. Outcome of the event was reported as condition unchanged. Seriousness and causality of the event was not reported.
body aches; chills; arm is sore; not feeling well; I feel kind of warm. I might have a low-grade fever.; I feel kind of warm. I might have a low-grade fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 16Sep2021, outcome "unknown", described as "arm is sore"; MALAISE (non-serious) with onset 16Sep2021, outcome "unknown", described as "not feeling well"; PYREXIA (non-serious), FEELING HOT (non-serious) all with onset 16Sep2021, outcome "unknown" and all described as "I feel kind of warm. I might have a low-grade fever". Additional information: The patient stated that she received her second dose of Pfizer's COVID vaccine on 15Sep2021 and on 16Sep2021 the patient had body aches and chills. The patient stated that she was not sure if she had a fever. The patient felt kind of warm. The patient thought she might had a low-grade fever. The patient arm was sore. The patient was wondering if she could take Tylenol or Ibuprofen. The patient would like to provide no personal information, but she didn't had any problem telling her symptoms. The patient stated that she would call back if she gets worse which she hoped she didn't.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 01-Oct-2018 regarding an unsolicited valid serious case received from Office-staff. This case involves female of an unknown age patient who experienced Guillain Barre, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, dose, route and site of administration were not reported). On an unknown date, patient developed a serious Guillain-Barre like symptoms, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. Relevant tests were not reported. Final diagnosis was Guillain-Barre syndrome. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none. Sender's Comments: This case involves a patient of an unknown age who experienced Guillain-Barre like symptoms post vaccination with FLUZONE QUADRIVALENT. Time to onset is unknown. Guillain-Barré Syndrome is a expected following FLUZONE vaccination. However, further information including patient's medical history, medical condition at the time of vaccination, clinical description of GBS, lab investigation reports result would be relevant for accurate assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report was received from a physician, via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-NOV-2014, the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 ml (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the (23-valent) PNEUMOVAX had temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported and "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
I get sick every time I take one of them; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 08-Dec-2020.  This case involves a patient who reported i get sick every time i take one of them (Illness), while the patient received INFLUENZA VACCINE.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced a non-serious event and reported that get sick every time when take one of them (illness) unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case
Patient developed redness, warmth, pain and a quarter sized knot at injection site 2 weeks post injection.
High blood pressure, rapid heart rate, hard to breathe for 3 hours, 5 hours after the shot.  Heart was beating so hard it was shaking my extremities.  Felt like I had the flu for one week with a sore right arm.
Advised ice to site, keep moving arm, avoid apap or NSAIDS unless significant symptoms
swelling in lt eye; itchy & pain 31AUG94; mins p/vax, pt's lt eye swelled up & itched MD advised pt to stay @ clinic for 1 hr; no tx given;
chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history provided).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). At the time of the report, CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Grabbed Adult Hep A in the bin where we keep Ped/Ado and gave to patient, there was no bad outcome or treatment course. Didn't realize it was given until almost 2 weeks after the fact.
Received H1N1 vaccine R thigh on 11-18-09 @ 1310. Came home from school @ 1530 11-19-09 complaint of itching and hives. Taken to ED tx'd with BENADRYL Q 6.
Pounding ,throbbing  headache so bad I did not want to lift head from pillow.  Chills 99.7 temperature  where as my normal temp is  nearer97.8. Sickness started almost 24 hour after shot and last about16 hour with aching head and neck..  till next morning
Died January 21 after she received an mRNA shot; A spontaneous report was received from a consumer via social media concerning a 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died two days later (death).   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 19 Jan 2021, per social media post, the patient received one of their two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that the patient was dead on 21 Jan 2021.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not applicable.  The patient died on 21 Jan 2021. The cause of death was reported as unknown.  An autopsy was done.  The reporter stated that the autopsy showed no other red flags, otherwise, no additional autopsy results were reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Chills, fever, nauseous, headache, sweating, pain at injection site and whole arm.. Sore muscles, sore joints.
Pt recvd vax 8SEP92 & exp nausea; @ the time of report nausea persisted; No further details were provided;
Twenty days after 4th dose vaccination, I started having a sore throat on May 22, 2022. Later that afternoon, I started coughing and had a headache. I took a home Covid test and it showed positive results. I continued having symptoms with a slight fever of 99.2 which is a little high for me. I was very restless and coughing thru the night. The next morning on 5-23, I spoke with the PA at my PCP's office and she told me to isolate at home, drink fluids and take Tylenol or other OTC meds to treat symptoms as needed. She suggested that I call back if symptoms were worse after 5 days. I am feeling better now. I am reporting a breakthrough case of Covid.
1-2 days after the vaccine patient very fussy and had balance problems. Resolved after 3-4 days.
I'm on my 3rd Mirena IUD and haven?t had a period or spotting in over 11 years, but started spotting about 24 hours after my first vaccine. The spotting lasted three days.
Currently spreading rash on torso, genitals, thighs, chest , and arms. Fungus like sores.
Information has been received from a legal firm regarding a case in litigation concerning a male child with measles virus vaccine jaundice who on 09/07/1995 was vaccinated with MMR vaccine second generation (lot #615320/0623B). Concomitant therapy included ActHib vaccine dose #1 07/29/1994, dose #2 09/22/1994 and dose #3 11/10/1994, hep B vaccine recombinant dose 31 05/18/1994, dose #2 06/24/1994, dose #3 11/18/1994, Tripedia on 11/07/1995, Orimune dose #1 07/29/1994, dose #2 09/12/1994, dose #3 02/14/1995 and varicella vaccine. It is alleged that the pt was born healthy and with normal APGAR scores. Beginning as early as 05/18/1994 through 12/07/1995, when the pt was approximately 18 months of age, he was administered not less than 14 vaccines at the office of his pediatrician with vaccinations containing the mercury-based preservative Thimerosal. It is a alleged that these cumulative doses of toxic ethylmercury were the direct and proximate cause of the pt's mercury poisoning and has sustaining devastating neurological injuries that are permanent in nature. It was reported that prior to completing the schedule of Thimerosal-containing vaccines, the pt had been developing normally and meeting his age-appropriate development milestones. He began to regress at 18 months of age and now suffers from disintegrative autism or resulting from his exposure to Thimerosal. The pt is currently receiving treatment to remove the mercury from his body. It was reported that as the mercury levels in his body have decreased, the pt's parents have noted some improvement in his symptoms. Despite this improvement, it is alleged that the pt's severe neurological and other related disorders are permanent in nature. Upon internal review, the pt's autism, neurological injuries, mercury poisoning and pervasive developmental disorder were considered other medical events. Additional info has been requested. *F/U report on 10/10/02: Upon internal review of report, it was deem necessary to make an amendment in the narrative section of this report. In the first sentence of the quoted narrative, the words "a history of possible" be added and the words "measles virus vaccine" be removed. The correct sentence is "Info. has been received from a legal firm regarding a case in litigation concerning a male child w/a history of possible jaundice who on 9/l6/95 was vax'd with MMRII."
approx 7 hrs p/vax pt awoke & cried cont for 1 hr; face, eyes & lt thigh very swollen; caregiver unable to console pt; 911 was called when breathing pattern changed to rapid rate; transported to ER; tx DPH & released in 1 hr;
Several small abceses around  the waist area and buttocks.  One larger abcess on the left calf.
patient developed pain and muscle spasm on the left anteriolateral aspect of the thigh, symptoms improving, occurrence after injection.  he was being treated for a few week prior for acute back pain with imaging showing degenerative disk disease
Approx 15 min post Varivax was given began scratching abdomen. Six lesions (papular with inflammation) were noted on his abdomen and one on the left thigh. Immediately sent to ER. See attached. 12/14/01-okay today per call from mom. Pt had chicken pox immunization and started breaking out. Pt has four pink small bumps on abd. and one on rt gm. No resp distress. 1/4 Prelone po, 1/4 Benadryl po.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, the multiple patients were vaccinated with a dose of improperly stored GARDASIL 9 lot# K026247, expiry date 29-JAN-2017, dose, site and route of administration were not reported No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient has a seizure and developmental disorder of unknown etiology. After a long admission to the hospital in which his anti seizures medications were adjusted, ketogenic diet started, gastrostomy tube with fundoplication placed he was discharged. On follow up visit to his pediatrician he got a dose of MMR. After the vaccine (within 24-48 hours) parents noticed changed on patients neurologic status that evolved from an ambulating child to a child with altered mental status and uncontrollable seizures. He required pentobarbital coma to control the seizures. He was again discharged home and since his seizures were very difficult to control (now he is on his second phenobarbital induction coma). Given the prior abnormal neurologic status it is difficult to prove cause of effect but parents believe that there is an association between the worsening of neurologic status and the vaccine. CSF studies done 20 days post vaccine showed 0 wbc, 0 rbc, protein of 10mg/dl, glucose of 74 mg/dl, negative titers (IgG and Igm) for measles in CSF with appropriate serologic response to measles 3/26/07 Received medical records from hospital which reveal patient experienced multiple seizures starting s/p MMR vax & lasting approx 3 weeks prior to admit on 10/28/06-12/12/06.  Transferred from floor to PICU & placed in pentobarb coma for 2 wks.  Extubated w/o difficulty. Weaned off drips & spontaneous increased motor movement noted thought to be related to mitochodrial movement disorder secondary to ketogenic diet patient had been on.  Consults by genetics, ID, GI & GI surg, neuro.  Received 5 days of IVIG for possible encephalitis & multiple IV antibiotics.  Developed secondary UTI, pneumonia & pancreatitis during hospital stay.  Transferred to rehab on 12/12/06 FINAL DX: Seizure disorder s/p status epilepticus; global developmental delay; medication induced pancreatitis; & motor regression. 3/31/201 Follow-up: Patient's seizures and loss of celibitone still a problem.
This case was reported by a nurse via call center representative and described the occurrence of febrile seizure in a 4-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number 4H5PT, expiry date 30th June 2019) for prophylaxis. On 26th October 2018 11:00, the patient received FLUARIX QUADRIVALENT 2018-2019 season .5 ml. On 26th October 2018, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced fever. On 26th October 2018 01:15, 2 hours 15 minutes after FLUARIX QUADRIVALENT 2018-2019 season,the patient experienced febrile seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the febrile seizure and fever were unknown. It was unknown if the reporter considered the febrile seizure and fever to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient was well prior to the vaccination. The patient was vaccinated on the morning of reporting date. The patient's mother called the office at 1:30 pm to report the seizure. A fever was also present. The patient was taken to the emergency room and was admitted for overnight observation.
Approximately two weeks after vaccination (11/26) began to exhibit hives on back, chest, abdomen, arms, and legs while out of state. Initially thought it was due to a bug bite or allergic reaction. Took a Benadryl the first day and returned home the following day. Upon return tested negative for COVID-19 (PCR administered on 11/29).  Hives continued to persist, resulting in scratching skin raw and reddened patches. Took Claritin non-drowsy (24 hour) daily. When hives reappeared before next dose treated with cortisone.   After two weeks scheduled an appointment with PCP. Earliest availability was 12/20. PCP diagnosed as a possible allergic reaction to food or environmental factor.  Referred to allergist for further treatment.  Allergist appointment was scheduled for 2/3. Hives continued to persist almost daily. After performing scratch test allergist diagnosed with chronic urticaria (hives), likely triggered by a viral or bacterial infection. No health concerns leading up to onset, so unknown what could have triggered. Allergist stated symptoms could last 6 month to 3 years or more from onset. Most go away on their own after one year. Recommended taking Allegra to suppress symptoms.  As of 3/9, symptoms mostly under control. Approximately 1-2 flare ups a week which can be treated with allergy medication.
Found down in PEA arrest  2/13/2022. ACLS provided and transferred to hospital.  ROSC was obtained but patient exhibited no cranial nerve reflexes or purposeful neurologic function. Brain death testing was performed 2/14 and patient's condition was consistent with brain death. declared dead 2/14/2022
This spontaneous report was received from a registered medical assistant refers, refers to a 17 year old female patient. Concurrent condition and medical history were not reported. On 09-JUN-2014, the patient was vaccinated with a dose of GARDASIL injection, lot # K00102, expiration date on 06-AUG-2015 (strength, dos3 #, dose, route of administration and anatomical location were not reported). On 25-AUG-2014 the patient received another dose of GARDASIL injection, lot # reported as K001502, expiration date on 06-AUG-2017 (strength, dose #, dose, route of administration and anatomical location were not reported). On 17-AUG-2015 the patient was vaccinated with another dose of GARDASIL injection, # reported as K001138, expiration date on 08-APR-2017 (strength, dose #, dose, route of administration and anatomical location were not reported). There was not concomitant medication reported. No adverse experience has been reported and there was no product quality complaint reported. Lot number K001138 is an invalid lot number for GARDASIL. Additional information has been requested.
jaw spasms on the left side of face near TMJ; Involuntary jaw closing; This is a spontaneous report from a contactable consumer (patient) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 29Jan2021 17:45 at a single dose for covid-19 immunization. The vaccine was administered at the Health Department. The patient also received the first dose of other vaccine (reported as Pfizer brand) via an unspecified route of administration on the right arm on 29Jan2021. Medical history included tinnitus from an unknown date, and allergy from quinoa. Patient is not pregnant at the time of the vaccination. Concomitant medications included ergocalciferol (VIT D), and fexofenadine hydrochloride (ALLEGRA). The patient previously took, neosporin [neomycin sulfate;polymyxin b sulfate] and experienced drug allergy. On 02Feb2021 08:00, the patient experienced jaw spasms on the left side of face near TMJ, and involuntary jaw closing when teeth were very close to each other. The reported events was resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.