chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called and stated that after she took yellow fever vaccine on 3/2/05, she started with itching and burning at injection site. Was swollen and hot to touch on 3/3/05-3/6/05. Patient had yellow fever vaccine given in that arem Rt. arm. Advised to f/u with pmd.
SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT.  Initial report received 26 June 2008 from a listserve inquiry which had been submitted by a health care professional.  A 21-year-old female patient with no significant medical history, had received a Yellow Fever vaccination (manufacturer, lot number, route/site of administration not reported) 12 days prior to the reporting of the event on 26 June 2008, and within two hours of vaccination, she experienced shaking chills, nausea and visual disturbances.  She also experienced several episodes of fever and chills in the ensuing week along with two near syncopal episodes.  The patient contacted her physician on 25 June 2008, 11 days following vaccination, to inform them of her symptoms.  She had gradual improvement, but still did not feel 100%.  She was evaluated by her physician on the morning of 26 June 2008.  She looked well, in no distress, no rash, no hepatomegaly and no abdominal pain.  Basic laboratory tests and LFTs were run (results not reported) and the patient was discharged.  Later that afternoon, the patient returned to the physician after laying in the sun because she developed a macular rash which covered only sun exposed areas.  The rash spared her hands and feet and had a halo of blanching around the macules.  The patient had no other complaints and the remainder of the examination had been normal.  Corrective treatments included XYZAL.  At the time of the report, the physician was awaiting the results of the laboratory studies.  The physician consulted listserve to obtain additional information pertaining to the patient's symptoms and to inquire if the events experienced by the patient might be associated with yellow fever vaccination.  The physician also requested guidance for the management of the events to prevent further complications.
Vaccination with varicella (?live virus?) in 2006 was first ever, requirement as part of application. Did not have chicken-pox or shingles previously.  Adverse event began on Monday, December 10th, 2018 (began to be unwell), and later that same week rash began on right shoulder and arm, spread from there to neck and up the back of head and over the head, and over right chest and upper back near right shoulder, and upper right arm. Diagnosed on Monday,  December 17th, 2018, as a severe case of shingles - PA said, "the worst she had seen". Lasted until mid-February, 2019, and then I resumed doing exercise again. Did not scratch the blisters and they healed without scarring.
Seriousness criteria other medically significant (OMIC). From initial information received on 11/21/06 from a literature report. A report of three cases, it was reported that three pts were evaluated at the neuromuscular clinic from 2001 to 2005, All pts underwent detailed history, general and neurological examinations, electro diagnostic and lab studies, including spinal fluid, complete blood count, metabolic panel, serology for autoimmune disorders, Lyme serology, VDRL, serum immune fixation, thyroid studies glucose and HBA1C, and MRI for brain and spine. The other two pts from this literature report are reported in cases 200603299 and 200603300. A healthy 84 year old female had received a dose of Influenza vaccine sometime in 2001 to 2005. The date of vaccination was not specified. The trade name, manufacturer, lot number, route and site of administration were not reported. The pt did not have any acute illness or systemic infections prior to the vaccination. He did not have any history of diabetes mellitus, alcohol abuse, exposure to any known neurotoxins, and there was no family history of neuropathy. Twenty one days post immunization, the pt experienced severe pain in a band like distribution in the mid thoracic region. Four days later, she experienced progressive weakness and numbness which progressed over 6 weeks, in her legs and hands. She was able to take a few steps with a walker, and she had marked weakness in proximal and distal muscles of upper lower extremities. Muscle stretch reflexes were absent in the legs and diminished in the arms, vibration was absent in the feet, but proprioception and pin sensation were intact. Gait was broad based and ataxic. Her CSF was 136.0. The pt did not improve with a 5 day course of IVIG. She was then treated with weakly oral prednisone starting at 150 mg/wk for 2 months followed by a slow taper to 20 mg/wk, At 14 months follow up, the pt is able to ambulate without assistance, and she has mild weakness (grade 4 MRC) in deltoid, intrinsic hand muscles, and hip flexion. Reflexes remain absent in the lower extremities. The pts status at the last follow up indicated that she could ambulate independently, and had mild weakness in her arms. The authors conclusion is that this pt , who was other wise health, developed CIDP with rapid onset in close proximity to influenza vaccinations, suggesting a plausible relationship between the immunization and the induction of CIDP. It is possible that antecedent events such as immunization are more likely in such pts,  but has not been systemically evaluated. In contrast to GBS, which is a monophasic illness, how a single event such as immunization may trigger induction of a relapsing or chronic immune mediated disorder such as CIDP is not known. The reporter for this case is the same as for cases 200603299, and 200603298.
a patient that regained hearing after experiencing hearing lost from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (a patient that regained hearing after experiencing hearing lost from the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (a patient that regained hearing after experiencing hearing lost from the vaccine) (seriousness criterion medically significant). At the time of the report, DEAFNESS (a patient that regained hearing after experiencing hearing lost from the vaccine) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (medically significant) event of Deafness; onset latency unknown after receiving a dose of mRNA-1273.222 bivalent vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event was available in the report. The patient regained hearing. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714609 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714609:Same reporter
Vaccinator gave this adult the pediatric Pfizer vaccine dose. Client is an adult and should have received the adult dose and formula.
Admit for COVID-19 infection with bronchitis. Found to have bilat PE; 2/2 COVID-19. Fully vaccinated. Started on Eliquis, steroids, Singulair and zinc. Did not require O2. Improved. Discharged home.
Onset of hives.  Began slowly on upper legs.  Followed by random larger outbreaks over body.  Have had hives every day since.  Antihystamines provide little relief.  Doctor prescribed Ranitidine.  No additional relief.
Moderate to severe fatigue, headache, nausea, muscle weakness, muscle jitteriness/shaking, leg numbness, feeling of hand weakness, leg paralysis (states she can't "feel" her legs at times), glossy/glazed eyes, arms and legs feeling "heavy", bone and joint pain, "not good" feeling all over.
Childcare worker stated that the child was sitting in the floor and she just passed out. She picked her and up and brought her downstairs to the nurses. She was alert, HR 92, and she was pale. Mother notified and stated that she always passed out with needles and shots when she was younger. The nurses monitored the child for 45 minutes adn then mom took her home. No rash, SOB, or any other s/s.
This spontaneous report as received from a medical assistant refers to a currently 23 year old male patient. On an unknown date in the past the patient was vaccinated with M-M-R II (dose and lot# not reported). On an unknown date, the patient was tested positive for measles and rubella titers and negative for immunity to mumps. Therefore the patient was advised by his physician to receive another dose of M-M-R II. On 07-MAY-2014, the patient was vaccinated with (Oka/Merck) PROQUAD instead of M-M-R II, due to an error of the facility. The Medical assistant confirmed that this error was not due to medication confusion but it was due to the products being placed in the incorrectly labeled spot in the storage compartment. The patient had not reported or demonstrated an adverse effect, he was otherwise healthy. Additional information has been requested.
It was reported in a published article that a female patient, who is HIV positive and who had a miscarriage in 1993, who on 11/11/95 was vaccinated with a dose of MMR (second generation) while nearly three months pregnant. It was reported that the patient was placed on a protocol which mandated MMR (second generation) every 2-3 years. It was noted that the patient had a miscarriage in 1998. The author noted that vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins. It was unknown if medical attention was sought.
Severe joint and muscle pain 12-24 hours after shot unrelieved with use of ibuprofen that has since disappeared. 48 hours after shot generalized maculopapular rash covering entire body including scalp/face/throat down trunk to calves and down arms to tops of hands. No change with 50mg of benedryl x2
itch on his back and arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch on his back and arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced PRURITUS (itch on his back and arm). At the time of the report, PRURITUS (itch on his back and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Within 5 minutes of receiving the COVID vaccine, patient experienced face numbness, flushing  of face, lightheadedness, nausea, elevated heart rate, elevated blood pressure. Patient had premedicated with 25mg benadryl 25 minutes prior to receiving the vaccine due to having had previous adverse reactions to vaccinations.  At 1010, 15 minutes after receiving the COVID vaccine, patient was given Benadryl 25mg PO. She was then evaluated and monitored by her primary care physician.
Sore arm; This is a spontaneous report from a contactable consumer reporting for a patient.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), and the second dose of BNT162B2 (Lot number EL1283), both via an unspecified route of administration on unknown dates as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date the patient experienced sore arm post vaccination and it was more sore with the second dose. The clinical outcome of the sore arm was unknown.
Sudden onset of heart palpations that lasted for 1 hour.  Went to ER and BP was very elevated.  CXR, EKG, blood work ok.  Followed up with physician and cardiologist.  Placed on additional medicine for SVT and BP.   Had stress test, ECHO and nuclear heart scan.  Also had a 48 hour holter monitor placed
Patient passed out after injection for about 2 minutes gave pt ammonia inhalant, water, propped leg in chair, cold cloth to neck.
Patient was taken to daycare following vaccine adminstration and about 1 hr. after arrival spiked a fever and experienced a seizure.  Patient was then brought in to clinic by father where his temp. was 102.4 and he was still somewhat lethargic/post-ictal.  Pt. was then transported to our Ped. ER wher blood and urine cultures were obtained and were eventually neg. A rapid flu test was also done and was neg. WBC was 23.4 K.  Pt. was given Rocephin and was followed up in our clinic the following day where a repeat flu test was positive. Pt. was afebrile then and had been afebrile for the previous 12 hrs. Pt. was then placed on Tamiflu. There was no further seizure activity and the febrile illness resolved.
Case number PHEH2014US003805, is an initial spontaneous report from a pharmacist received on 24 FEB 2013 with a follow up information received from a pharmacist on 21 MAR 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with first dose of FLUCELVAX (batch number: 004011A, expiry date: JUN 2014) at a dose of 0.5  ml intramuscularly in the left deltoid on 11 JAN 2014 approximately at 5 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up information received from a pharmacist on 21 MAR 2014: Updated reporter information, dose number, batch number, expiry date, dose and site of administration of suspect vaccine).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 31 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Headache and fatigue within 2 hours after shot. Body aches following day. Headache everyday, nearly all day. Rash on belly and back 1 week after rash on entire body the next day.
This spontaneous report was received from a 74 year old female patient, referring to herself. The patient had no medical history, concurrent conditions nor concomitant therapy. On an unknown date (reported as several years ago), the patient was vaccinated with ZOSTAVAX (reported as "unspecified shingles vaccine") (dose, route, lot# and expiration date were not provided) for prophylaxis. On an unknown date, 5 years after the vaccination, she developed shingles rashes. The reporting patient mentioned that she developed rashes in her mouth, her back, and her vagina; the rashes lasted for an unspecified amount of time (The patient recovered from herpes zoster and genital herpes zoster on unknown date). Thereafter on an unspecified date, she developed post herpetic neuralgia in thoracic discs 8, 9 and 10, which she still had at the time of the report. Unspecified treatment was administered for the adverse events. The causal relationship between the above mentioned events and ZOSTAVAX was not provided.
Racing heart started about 5 hours after second Moderna vaccine.  Heart rate 143-145 for about 4 to 4 1/2 hours.  Did not go to hospital or call doctor.  Waited it out.  Drank a lot of water, took deep breaths.  After 4 to 4-1/2 hours heart rate started to return to normal.
got the flu after a shot; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient's child via social media.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294166, 2020SA294167, 2020SA294173, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294144 , 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves2  patients of unknown demographic for whom it was reported that patients had got the flu for a shot (influenza) while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, it was reported that the patients had got the flu for a shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Patient received vaccination at 8:00 am and returned to work after finishing the 15 minute monitoring period.  At approximately 0845 am the patient began to feel nauseas, tightness in throat, diaphoretic, short of breath.  In the Emergency Department patient was given Epinephrine 0.3 mg intramuscularly and methylprednisolone 125 mg intramuscularly.
Patient with erythema 4x4 area left deltoid area, swollen and warm to touch.
80-year-old male with a history of coronary artery disease, CABG, mitral valve replacement surgery, hypertension and hyperlipidemia was brought to the ED by an ambulance for the complaint of a weakness that he noticed when he woke up in the morning.  The patient states that he felt too weak to get up from his bed.  He has been having a nonproductive cough for the last 1 week.  The patient also states that he was exposed to a family member who tested positive for the COVID-19 infection 2 days ago.  He denies any shortness of breath.  However, he is tachypneic.  He denies any fever, chills, diaphoresis, chest pain, abdominal pain or urinary tract infection like symptoms.
Patient contacts clinic 1 week after vaccination to report 2 hrs after getting the vaccines she developed fever, chills, delirium, nausea and vomiting, muscle aches and spasms, kidney pain, fast heart rate. No injection site swelling or tenderness, no swelling of the face or neck. No respiratory symptoms associated with fever. She did report weakness and dizziness.
Extreme muscle pain in my hips,knees,groin,and lower back. Basically the lower extremities of my body. I kept thinking that it would go away after a couple of days. It?s been almost three months. I also have stiffness in my neck and shoulders many days. But the lower extremity pain is every day, all day. It is difficult to go up and down stairs.
Pt is a hospitalized breakthrough case but is not hospitalized for non COVID-19 reasons. Was admitted to Hospital on 6/5/21 for diabetic ketoacidosis and was there diagnosed a second time with COVID-19. His inital was positive was on 1/22/21. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination: bamlanivimab, aspirin, calcium carb and citrate-vitD3, finasteride, pantoprazole, pyridostigmine, ramipril, vitamin B-12, vitamin D3, insulin.
Large erythematous, painful, swelling from shoulder into right forearm and beyond elbow.  Clearing slowly on antibiotic and prednosone.  Brachial Neuritis 12/6/07.
27NOV95 pt had diff in breathing;EMS called pt taken to ER & placed in ICM;sz activity present;temp 98.7;14 days in ICM;pt appears to have some complications from attack i.e. eyesight,motor problems;
Intern pharmacist vaccinated patient with Moderna vaccine left outside of refrigerator greater than 24 hours.
Upon waking up on 02/13/2021, the day after the injection, I experienced severe dizziness and loss of balance.  This continued for the next 2-3 hours.  I went to the Emergency Dept. due to these concerns.
On the same day, some headache and chills.  Next day, dizziness, sleepiness, some nausea, and arm tenderness. On the next day and about 26 hours after receiving the injection, swollen lymph nodes (armpit) were noticed and lasted through the next day.
This 72  year old male received the Covid shot on  2/26/21    and went to the ED on 3/11/21     and was admitted  on 3/11/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome)
Redness, swelling, hot to touch from shoulder to elbow. Treated with Ice, Ibuprofen.
Ongoing dizziness, whole body aches & pains, headache, sore throat, irritation in eyes from thimerosal, overall weakness, cough & nausea. No treatment.
Lack of drug effect; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included leukaemia from 2014 to an unknown date. The patient's concomitant medication includes ibrutinib (IMBRUVICA) taken for leukemia. The patient experienced lack of drug on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 05-APR-2022; Vaccine expired on 02-Apr-2022 and vaccine administered on 05-APR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 05-APR-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 05-APR-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 05-APR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 05-APR-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 05-APR-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. BUD date 02-APR-2022 and vaccination was removed from the fridge on 05-APR-22. No treatment information were provided.   This case was linked to MOD-2022-569375.
PATIENT SAID ARM IS STILL SORE EVEN ONE MONTH AFTER VACCINATION; DESCRIBES IT AS "TRAVELING PAIN" FROM ARM DOWN TO WRIST; SHARP PAIN FROM ELBOW TO WRIST, SOME DAYS BAD, SOME DAYS GOOD, UNABLE TO PICK UP THINGS- HOWEVER STILL HAS NOT GONE TO SEE A DOCTOR AS SHE DOES NOT HAVE A PRIMARY PHYSICIAN.