chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced paralyzed legs; Broke his nose; Hypoglycemic; Caused a fall,fell few times after; This spontaneous case was reported by a health care professional and describes the occurrence of MONOPLEGIA (Experienced paralyzed legs), FACIAL BONES FRACTURE (Broke his nose), HYPOGLYCAEMIA (Hypoglycemic) and FALL (Caused a fall,fell few times after) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044H21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG), LISINOPRIL, GABAPENTIN, CYCLOBENZAPRINE, ATORVASTATIN, OXYCODONE, OMEPRAZOLE and GLUCAGON (BAQSIMI) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-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 MONOPLEGIA (Experienced paralyzed legs) (seriousness criteria medically significant and life threatening), FACIAL BONES FRACTURE (Broke his nose) (seriousness criteria medically significant and life threatening), HYPOGLYCAEMIA (Hypoglycemic) (seriousness criterion life threatening) and FALL (Caused a fall,fell few times after) (seriousness criterion life threatening). At the time of the report, MONOPLEGIA (Experienced paralyzed legs), FACIAL BONES FRACTURE (Broke his nose), HYPOGLYCAEMIA (Hypoglycemic) and FALL (Caused a fall,fell few times after) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) his blood sugar is going up and blood glucose is around 500 after using his insulin.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported.  Patient  experiencing insulin resistance, feels like his insulin was not working and  his blood sugar was going up. He stated that his blood glucose was around 500 after using his insulin which never used be like that until he got his second dose of the Moderna COVID-19 Vaccine  and still ongoing as of today. He had hypoglycemic emergency and  fell few times after second shot, Patient also experienced paralyzed legs which caused a fall and  broke his nose. Patient never went to hospital and taped his nose since it was  not  extreme. Concomitant medications included Insulin Novolog  1-30 units on sliding scale.  Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded   This case was linked to MOD-2021-115467 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Chills, shaking, 99.7: Could not get warm with 2 hot water bottles, 2 quilts, 3 blankets, 2 aspirin body aches
Patient had fever, left deltoid intramuscular reaction: swollen, redness by DTaP vaccination.
Hospitalized abdominal pain and hematemesis and hematochezia new O2 requirement
muscle aches; very hot rose cheeks; headache; upset stomach; pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced muscle pain, red confluent rash cheeks, headache, upset stomach and pain. On an unknown date, the outcome of the muscle pain, red confluent rash cheeks, headache, upset stomach and pain were unknown.   It was unknown if the reporter considered the muscle pain, red confluent rash cheeks, headache, upset stomach and pain to be related to Shingrix.  Additional details were provided as folows: The age at vaccination was not reported. The patient was having muscle aches, very hot roses cheeks plus a headache and upset stomach. The patient asked should they call their primary care physician (PCP). The patient asked could they take anything for the pain.
joint pain was in her jaw on the left side; This is a spontaneous report from a contactable consumer (patient's husband). A 66-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EM9809, NDC number, expiry date: unknown) via an unspecified route of administration in deltoid right (shoulder) on 10Feb2021 at 13:30 (at the age of 66-years-old) as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included ongoing breathing problem. She had for about 3 years and uses a nebulizer machine. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history relevant to adverse events were reported as none. There were no concomitant medications. The patient experienced joint pain in her jaw on the left side on 10Feb2021. It started that night but the next day she was fine, it was gone. Duration of event was 0 day. The patient did not require emergency room or physician office visit. Investigation assessment was not reported. Relevant tests were reported as none. The outcome of the event at the time of last observation was resolved on 10Feb2021.  Follow-up attempts completed. No further information expected.
Pt with 3 day historry of rash and tactile fever for 1 day.
Covid-arm - the 8th day after vaccine at the injection site my arm became hard, blotchy red circle, inflamed, sensitive to touch - as of this day 2/23/21 it has lessened in severity  - i applied lavender essential oil a couple of times since the 21st and it appears to be disappearing and less sensitive - I received the vaccine at pharmacy - I have reported the adverse effects to my doctor's office; and will inform pharmacy at my 2nd vaccine appointment on March 13, 2021 at 12 noon.
A spontaneous report was received from a consumer concerning a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash spreading near injection site, dizziness, headache, body aches in upper arm and legs, feeling very tired, left arm hurting near injection site and left arm being red and itchy at the injection site.  The patient's medical history report were not included. No relevant Concomitant medications reported included.   On 12 Jan 2021 , approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot no# 012L20A) for prophylaxis of COVID-19 infection.     On 13 Jan 2021, she experienced rash spreading near the injection site and it got worse. She also felt dizzy, had headache, had body ache in upper arm and legs and was feeling very tired. On 19 jan 2021her left arm was hurting and was red and itchy. On 20 Jan 2021 it got worse.    Treatment for the events included Hydrocortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome for the events headache and dizziness were reported to be recovered/resolved around 15 Jan 2021. The outcome for the events rash spreading near injection site, body aches in upper arm and legs, feeling very tired, left arm hurting near injection site and left arm being red and itchy at the injection site were unknown.
pt recvd vax & w/in 36hrs p/vax exp hives & a rash;tx w/DPH;sx resolved;
patient was accidentally given just the adjuvant for AREXVY; patient was accidentally given just the adjuvant for AREXVY; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G2MG3, expiry date 24-FEB-2025) for prophylaxis.   On 13-OCT-2023, the patient received Arexvy. On 13-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient was accidentally given just the adjuvant for AREXVY) and inappropriate dose of vaccine administered (Verbatim: patient was accidentally given just the adjuvant for AREXVY).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 13-OCT-2023, 16-OCT-2023 Reporter is the HPC (pharmacist). He states that a patient was accidentally given just the adjuvant for AREXVY. The patient was then administered a full dose of AREXVY which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. Arexvy administered on 13th October 2023 (full dose and adjuvant only administered on 13th October 2023) Permission granted for Safety Team follow-up with Healthcare Professional.
RESIDENT PASSED AWAY ON 12/4/2021 ON HOSPICE SERVICES.
Generalized rash, approximately 2 inches in diameter at location where subcutaneous injection was given in right arm.  Rash slightly raised, soreness at location of rash, and rash warm to the touch. Varicella vaccine given on 7/14/08 and did not notice rash until 7/15/08 per patient.
BLURRY VISION; STRONG AWFUL SMELL; STOMACH ACHE; NAUSEA; MIGRAINE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced migraine. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced blurry vision. On 07-APR-2021, the subject experienced strong awful smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, and nausea on 06-APR-2021, and had not recovered from blurry vision, strong awful smell, and migraine. This report was non-serious.
Information has been received from a nurse referring to a female patient of unknown age who was also a nurse. The patient's relevant medical history, concomitant medications and past drug history were unknown. On 11-NOV-2017, the patient was administrating RECOMBIVAX HB (lot# N006321, expiration date 08-NOV-2019; dose, strength, route unknown) to a newborn baby. The patient accidentally got a finger stick and stuck herself after giving the baby the injection (occupational exposure to product, accidental exposure to product and injury associated with device). In November 2017, the patient had testing done after the finger stick but didn't have the result back yet. As of 12-NOV-2017, the patient would no longer got RECOMBIVAX HB because of it was accidental, and the outcome of the finger stick was unknown. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1711USA005222:
Written by the patient and guardian:  " 8-10 minutes after shot, complaints of light head an throat closing up.  Removed mask for fresh air, no relief.  Went to get up for water, immediately for light headed, pale face, checked-out look in eyes.  Body went limp, set 17yo in chair, still was light headed and lethargic.  Laid 17yo down on floor, administered water.  Vision came back dizziness went away.  remained seated for another 15minutes.  Continued hydrating w/ water, other symptoms diminished."  From Dr.:  "Witnessed patient pass out in chair, within 10-20s was helping caregiver lower patient to the floor and patient had come to.  Increasingly alert.  Endorses above narrative, as well as not having eaten or drinking much today, "maybe an apple".  She does not have a history of vasovagal syncope.  Patient Pulse at 65, normal breathing, no distress, no signs of injury.  Overall episode appears to be vasovagal syncope.  Patient asked to drink water and remain at the vaccine center an additional 15-20 minutes for observation.  After 15 min patient feeling back at baseline.  No further medical intervention.
9 days after treatment, red swollen rash appeared at injection site. Have seen doctor for followup and was told it is common side affect known as ?covid arm? from vaccine .
Patient received GARDASIL number 3 on 3/21/15 mother states patient has swelling and tingling of the face after immunization.
recipient of vaccine reports decline in health starting end of January 2022 lasting for eight weeks. Recipient was diagnosed with COVID 19 in January after receiving vaccine in April 2021. recipient reports onset of upper respiratory infections, heart failure, exacerbation of arthritis, diverticulitis, strep related infections, conjunctivitis, hallucinations and nightmares
Pt had no reaction with first dose. Pt walked into clinic seven days post second dose with red, raised hives on trunk and back and anterior thighs. No swelling of throat.
I felt tired and weak. I had chills and that I was coming down with something. Pain in my left arm.
Pt received anthrax 3 Oct 11 in (L) arm. Did not start having a side effect until 5 Oct 11. Pt has redness down (L) arm and hot to touch.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick after first dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick after first dose). At the time of the report, ILLNESS (felt sick after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-395893 (Patient Link).   Reporter did not allow further contact
The first night following the vaccines, I woke up around 1:00AM crying from excruciating pain. I had pain in my lower back radiating down the back of my legs. It was painful to walk, lay down, anything. The pain lasted for about 2 weeks. Did not seek medical attention due to financial reasons.
Initial unsolicited report received from a pharmacist on 09-Oct-2017. This case involves a seven patient (onset age and gender not reported) who were vaccinated with a single dose of FLUZONE QUADRIVALENT (batch number: UI838AA, expiry date: 30-Jun-2018 and site of administration were not reported) via intramuscular route on 04-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed injection site reaction, rash with warmth and erythema below injection site extending to elbow region. No tenderness or itching reported. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patients were recovered from events. List of documents held by sender: none.
Cellulitis and secondary lymphangitis and 1 cm tender axillary lymph nodes. Vaccine site revealed major type reaction. concurrent wound right hand between 3rd and 4th digit. Treated with Levaquin.
Upon sitting down in observation area, client became pale, diaphoretic, and reported feeling dizzy. Client assisted into cot to lie down. Provided water and granola bars. Advised to report adverse effects to primary care provider and VSAFE. Advised client to call 911 or seek emergency medical services if side-effects worsen or severe side-effects develop. Client observed for 30 minutes and vital signs taken every 5 minutes. Adverse effects completely resolved after 30 minutes and client left site unassisted with steady gait.
10/27- right neck and shoulder pain, sudden short headache on right side at right temple and behind the right eye, pain went around the right ear but not consistent; pain as base of skull on right that seemed to go through back of head; mild urgency to urinate  10/28- all of the above, right side of tongue felt gummy/numb; mild headache; no pain behind ear 10/29- shoulder and neck pain not as bad; right side of tongue is numb; mild loss of taste on this side  10/30- a.m.- right side of tongue is completely numb, cant feel part of lips; 10/30-p.m- right side of face going numb, cant feel myself blink, lips not working properly when smiling or pursing lips, sudden urgency to urinate  10/31- all of right side of face is numb and almost immobile, pain at base of skull; mild headache, diagnosed w/ bells palsy at  ER.  Prescribed prednisone and valtrex for 7 days
swollen lymph nodes; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Onset of pain at site of Pneumococcal vax, immediately. Area of redness was noted 24 hrs. after shot, non-puritic, involving right deltoid area, approx. 19.5x5cm. Vital signs-normal, including normal temp., 11/5/99. Symptoms gone by 11/8/99
Flu-like symptoms at onset. By 12/20, disorientation & confusion. Went to emergency room, suspecting stroke. After 2 hrs, ER said no stroke, but admitted to ICU to continue tests. That is last I remember - until early AM 12/24. In interim was conscious but non-responsive and apparently in acute distress and unable to bear any sensory stimulation. Diagnosis: Encephalitis of unknown origin.
This spontaneous report as received from a physician via a company representative refers female patient of unknown age. On an unspecified date the patient was experienced vaginal pain with was diagnosed as a herpetic lesion after receiving her second dose of GARDASIL (lot# unspecified) (dose, frequency and location unspecified) on an unspecified date. The date of the first and second dose of GARDASIL were both unspecified. The patient would not receive the third dose of GARDASIL. Unspecified topical ointment was given to treat the event. The patient had sought medical attention via saw the physician. No lab diagnostic studies were performed. On an unspecified date, the patient recovered from the event. Additional information has been requested.
tested positive for Covid; This is a spontaneous report from a contactable consumer via. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that her roommate, received the first dose of Covid-19 vaccine on 10Apr2021 and tested positive for Covid today on 13Apr2021. Reporter asked if they need to wait to get the second dose of the vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416340
Patient received his first COVID vaccine on 3/2 and then passed away 3 days after receiving Moderna vaccine.  Provider presumed he died from sudden heart attack, this occurred at home.
Note: I took this same vaccine 6 years ago with no reaction at all. This is the second time I have had this vaccine in my life.  With the initial pill Wednesday, just irritable bowel,   Second pill on Friday, waves of nausea and GI pain, cramping and heartburn like pain Third dose, Sunday, continued nausea in waves and cramping, epi-gastric "ulcer" like pain, some generalized itching,  Hives on the morning of the last dose that I didn't notice until I had already take the last dose.  So they must have developed on back between the last two doses. Hives from buttocks up to mid back and some appearing on back of thighs. Day after last dose some itching and nausea still and doesn't seem to be resolving.
On 20DEC began a fever of 103.6 had seizure; taken to ER; 21DEC had sl ear infect given Ceclor by MD; devel red raised itchy rash on entire body; seen by MD (hives);
Mom reports in the early afternoon following his morning vaccines listed above, patient began complaining of headache, nausea and malaise so he went to his room to lay down.  She heard him making strange noises, so she went to check on him.   He was laying on his bed moaning with b/l arms flexing and extending at elbows and shoulders shrugging - she spoke to him and he was awake and able to respond, so she went to him and held him and his arms stopped moving.  She reports his arms were moving for ~1 minute while she was there but was unsure how long they'd been moving prior to her entering the room.  She asked him if he was moving his arms because his head hurt, and he denied moving his arms intentionally.  He complained it felt like someone was "kicking him in the head," and indicated his forehead.  She noted his temperature was 100.8 at this time.  She reports she gave him ibuprofen prior to the episode listed above, but timing is not quite clear.  Mom put a cool cloth on his forehead, his fever came down and he was able to sleep a bit throughout the night.  He continues to have b/l upper arm and shoulder twitching that is involuntary.  He still has headache this morning, but it is less severe.    Patient reports headache last night was 8/10, today is 4/10.
Pt recieved vaccination on 26Mar10 and returned to clinic on 6April10 with c/o redness and swelling to injection site. Was dx with vaccine reaction and treated with cold compresses and home care.
Information has been received from a physician concerning 5 cousins who on an unspecified date were vaccinated IM with a dose of MMR II respectively. Subsequently in all patients' arm that vaccine was given, the arm locked up. The arm released after 2 day to 4 weeks in all patients. As of 12-APR-2011, the patient had recovered. It was unspecified if the patients sought medical attention. Arm locking up was considered to be disabling by the reporter. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
FLU LIKE SYMPTOMS MOSTLY AT NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the patient experienced flu like symptoms mostly at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms mostly at night on JUN-2021. This report was non-serious. This report was associated with product quality complaint.
About one hour after receiveing flu shot developed rapid heart rate, feeling "shakey", SOB, heaviness in her chest, and general not feeling well.  Followed up in ED for evaluation and treatment of symptoms that resolved over about 4 hour period.