chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This patient reports pleuretic chest pain after MMR injection (reported 1 + month later to the doctor). The patient did not call sooner, states left arm "sore", no rash, no fever, flu symptoms, no obvious deformity of limbs.
Within 5-10 minutes (actual time not recorded) after receiving MMR and VARIVAX, 12 month old patient exhibited a severe shaking, convulsion-like reaction to immunizations.  Full body convulsions lated approximately 30 seconds.  Physician was not in room at the time of incident but was called back into the room immediately during episode.  Physician did not see reaction however both parents were present at the time and noted reaction to the physician.  Physician did not record episode in his notes and did not file a VAERS.  TC with Mom who states child has regressive autism. 06/18/2007 Comprehensive MR received from PCP beginning age 2 months (8/3/1999) to present. Initial visit shows a healthy 2 mon. old with hydrocele.  After 4 mon. vax (10/7/1999) child had a brief shaking episode in the office (see VAERS 281070).  Again-healthy 4 mon old with hydrocele.  Multiple sick visits. 6 and 9 mon vax given w/o incident.  First developmental issues noted at 12 mon WCC-not saying 3 words or cruising. No mention of any rxn to vax. "Good development" noted at 15 mon WCC, only exception not saying "mama/dada", however noted to be vocalizing alot. Speech delay noted at 18 months.  Febrile seizure noted 3/28/2001. Multiple sick visits. At 2.5 yr visit-variable receptive language skills noted, hearing tested ok. Developmental delays noted. Refered to specialty facility-DX: PDD. Question of absence seizures noted at 3 yr WCC.  Autism Spectrum Disorder noted at 4 yr WCC. Progress noted in speech. 1/11/2010 Autism is still present. Seizure disorder still present.
Case number PHHO2011US07292, is an initial report received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was enrolled in a study. The subject's medical history included hyperlipidemia and cancer of left breast. Concomitant medications included Simvastatin. The subject received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was taken to the hospital for evaluation of dizziness and headaches. The same day, the subject experienced botulism and quadriparesis. The subject was unsteady on their feet and was weak in the upper extremities. The subject experienced progressive weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist. The subject underwent an MRI scan which showed spinal stenosis and multiple levels of degenerative disk with diffuse bulging and osteophyte formation. The investigator stated that per the neurosurgeon, did not cause the quadriparesis. An MRI scan of the brain revealed moderate microvascular disease. A CT scan of the head showed no evidence of acute cranial or intracranial abnormality. The subject was treated with Aspirin and DECADRON and some improvement in status was noted. The subject was placed on 'JV' for atypical presentation of Guillain-Barre syndrome. The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar puncture and their antibody cultures were collected. The patient's protein was normal. In the subject's CSF fluid it was noted that their glucose level was increased (assessed as not clinically significant by the investigator). On 21 Apr 2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The subject refused to be intubated and refused a N16 and foley catheter placement. The subject's condition deteriorated with desaturation 100% and blood pressure dropped. The subject was started on a dopamine drip, maximum dose. The subject experienced respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An autopsy was performed, and results are pending. The seriousness for botulism as life threatening and fatal, quadriparesis was disability and respiratory muscle paralysis was fatal. The outcome of the quadriparesis was condition deteriorating. The investigator suspected a relationship between the botulism, quadriparesis and respiratory muscle paralysis and the study vaccine. Follow up received on 04 May 2011: Patient's sex corrected, lab tests updated, events updated, death details updated, treatments provided, causalities updated.
9/16/03-afternoon, temp 103 R. R leg red, swollen, seemed painful at injection site. 9/17/03 sleeping more than usual. Temp 102.8 R pale, eyes droopy w/ dark circles, leg swell less.
4/27/11 Vaccines received on HD no symptoms noticed. 4/28/11 My mother noticed patient's leg when she was getting ready for school. I noticed it after school being red, swollen, warm & sore.
Patient got the vaccines, one in each arm, in the morning of 9/10/18. He presented to the pharmacy on the morning of 9/12/18 to show me that he had redness down his right arm which was the arm he received the PNEUMOVAX 23 in. It was not warm to touch, and the patient said it didn't hurt. He said he had a little soreness right at the injection site. There was no swelling compared to his other arm. He had no redness on the side where he got his flu shot. He also mentioned that he woke up this morning wet from sweat overnight. I counseled the patients on what signs/symptoms to look for that would warrant visiting a doctor.
"I" began having side effects that included headaches muscle pain fever and soreness of injection site.; "I" began having side effects that included headaches muscle pain fever and soreness of injection site.; "I" began having side effects that included headaches muscle pain fever and soreness of injection site.; "I" began having side effects that included headaches muscle pain fever and soreness of injection site.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 24Apr2021 at 15:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure and asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 25Apr2021 at 14:00, the patient began having side effects that included headaches, muscle pain, fever and soreness of injection site. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, muscle pain, fever and soreness of injection site were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine was placed in refrigerator on 18-Nov-2021. There was no temperature excursion. No adverse event was reported.
10-5-12 patient presents with fever at site of injection and rash. Patient said started 10-4-12.
Narrative:  patient COVID positive despite 2 doses of COVID vaccination. patient admitted to hospital 2/1/2022 - 2/3/2022
The day after receiving the TDAP shot I experienced serve body aches, chills, and fever. The following day I experienced fever, dizziness and nausea. I am 31 weeks pregnant and called my doctor to tell them of my symptoms. They informed me I may have contracted a simple cold and that more than likely the symptoms had nothing to do with the shot.  The symptoms finally decreased by the 4th day. On the 6th day after the shot I was seen by my doctor because the injection site was still large, swollen, hot and beat red. My doctor told me to file this adverse reaction report as they have not seen this type of response to the TDAP before. I have no history of reaction to vaccines. I have no history of allergies to anything. I am not taking any type of medication. I felt 100% fantastic before receiving that shot.
No additional AE/; HCP reported AE for inadvertently administering an expired dose of GARDASIL 9. No TEs reported. No symptoms reported. Obtained consent to contact HCP. MIR Filed (Case #02498538). No additional AE/PQC.; This spontaneous report was received from a medical assistant and referred to an 11-year-old patient of unknown age. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.   On 26-OCT-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/dose, lot #U034201, expiration date: 21-OCT-2023, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (expired vaccine used). No additional adverse event.
Swollen, erythemic thigh. Warm to touch. No definite cellulitis noted. Afebrile.
Itchy Indurated red skin below injection site on right thigh and around injection site left thigh.
Headache, Arthralgia, Fever, "mental fog" Narrative:  still mild fatigue and injection site tenderness
This spontaneous report was received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL. 35 doses were administered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
eventually broke out into massive rash of armpits and torso; skin irritation itchiness; skin irritation itchiness; This is a spontaneous report from a non-contactable consumer (patient). A 50-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 26Jan2021 at 12:00 hours as dose 1, single (at the age of 50-years-old) for COVID-19 immunisation. Medical history included hypothyroid from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no other vaccine in four weeks. Concomitant medication(s) included metronidazole benzoate (Flagyl) and doxycycline (both taken for an unspecified indication, start and stop date were not reported). Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19 post vaccination. On 26Jan2021 at 15:00 hours, patient had skin irritation, itchiness which eventually broke out into massive rash of armpits and torso. Patient had doctor or other healthcare professional office/clinic visit for the events. Therapeutic measures were taken as a result of all the events and treatment included fluconizole oral and hydrocortisone topical. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sore arm; Body aches/ Muscle aches/ Pain; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches/ Muscle aches/ Pain) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches/ Muscle aches/ Pain) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches/ Muscle aches/ Pain) and HEADACHE (Headache) outcome was unknown.            Patient received 2nd Moderna vaccine 01Mar2021 on left arm. She had body aches, pain, muscle aches, a sore arm, and a headache. She wanted to know if she could take an aspirin.
Approximately a week to ten days following flu shot, I developed severe joint and muscle aches (all over the body), a 104 degree temperature, chills, stiff neck and headache.  This lasted for four days and was gone just as quickly as it started.  I assumed I had the flu!  Two weeks later, the same exact symptoms returned, and I've had them several times since then.  Went to see my doctor on the third bout, and had blood work done.  My white blood cell count was elevated to over 18,000.  He put me on antibiotics and when I didn't get better in two days I went back.  Still had a very stiff neck so he referred me to another physician.  I was hospitalized and checked for meningitis, Lyme's disease, STD's, Hep C, familial mediterranean fever, lupus, several other types of diseases.  (Had a positive ANA and elevated CRP).  I am now under the care of a rheumatologist and taking Plaquenil for Rheumatoid arthritis, although I don't think he's positive that's what I have, and I also take methylprednisolone when I have a "flare."  My last flare was in September 2005 and lasted 3 days. Information from 60 day follow-up report states: Sporadic episodes of all over body aches, chills, above 100 degrees fever, neck pain, headaches, weakness. This lasts anywhere from 3-5 days. I really don't know if all of this is stemming from th flu shot, but it just seemed odd that after the one and only flu shot I ever had, I now get these recurring flu-like symptoms. 12/31/09 I am currently taking Plaquenil and havent had any flu-like episodes recently . The last on was in March '06-achy joints and muscles and a fever. So I am not sure if I am recovered or just waiting for the next episode.
This spontaneous report as received from a registered nurse refers to a 23 year old male patient. On 06-JAN-2014 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB injection (route, strength, lot number and expiration date not provided). No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a Register Nurse refers to a ten unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 20-NOV-2014 (dates of administration were unspecified), ten unspecified patients were vaccinated with a dose of VARIVAX (Merck) which underwent a supported temperature excursion, lot number reported as K007973, expiry date 03-JUN-2016 and lot number K005182, expiry date 10-APR-2016 (dose and route were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of two reports received from the same reporter. Additional information has been requested.
Pain in arm, swelling, chills, very weak. Unable to sleep, sweating, unable to get up.
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and demographics. The patient's concurrent conditions, medical history drug reaction/allergies, and concomitant therapies were not reported. In September 2016, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided), and the second dose of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided) was administered on 23-MAR-2017 both for prophylaxis. No adverse effects were reported. Additional information has been requested.
pt recv vax & felt tightness in throat;severe pain in arm & couldn't lift arm;JAN97 call MD still couldn't move arm;MD felt probable rotary cuff tendinitis;pt to physical therapy;arm & shoulder getting worse;still painful;
Patient complained of numbness of both sides of her face, tingling of her lips and tonged. Patient was treated with IM Benadryl. Symptoms resolved after 20 minutes.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a not specif patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles).   At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.      Reporter did not allow further contact
Immun. on 10/2/09, illness about 10/15, URI, subsequent angioedema 12/10/09.
Soreness at injection site: Started about 6 hours after the injection and lasted for about a day. Less serious than the first dose.
Patient discovered 2 blisters and drainage at the site of flu shot injection when bandage was removed. Wound is currently 0.9 x 0.5 inches. Antibiotic ointment and a bandage applied.  Patient instructed to keep aerea clean with gentle soap and water and keep it open to air.  Advised to ise ice pack in case of itching. Patient encouraged to take OTC Tylenol or Aleve for pain as needed.
Patient was in the observation room after receiving his 1st covid vaccine. He became dizzy, nauseated. He vomited multiple times and had a syncopal episode. The observing EMT and nurse were present during this and assisted the patient obtained vital signs and called 911. Patient was taken to the hospital accompanied by his wife .
I contracted COVID-19 on 06/20/2022 with symptoms of nausea, vomiting, sore throat, cough, runny nose, and low grade fever of 100.5. I was not prescribed any medications. I was ill for 3 days before my symptoms began to resolve. I have had a lingering symptoms of tickle in the back of my throat and occasional cough.
starting 12 hours after shot, fever of 100.4, muscle aches, chills, sweating, joint and spine pain and chest tightness. Increased in severity up to 24 hours after shot and continued for 24 hours. Was unable to do anything but lay in bed. 48 hours after shot, joint, spine and muscle aches continue as well as sweating and chills on and off. Extremely fatigued and have to lay down frequently. Continuing to improve, but not fully recovered at time of reporting, so marking unknown in Item 20.
sz (afeb) 6 hr post vax rigidity, head back, grimace, strange strangler cry, loss of conscious & stopped breathing, turning blue; regained consciousness but ashen & unresponsive; taken to ER:
pt recvd vax & w/in 1minute exp syncope;no treatment was given;sx resolved;
This spontaneous report as received from a medical assistant refers to 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 29-SEP-2016, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # L050956 with expiry date on 17-DEC-2017; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported.  This is one of several cases received from the same reporter.   Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA010748: US-009507513-1610USA004609:Original Case : 1610USA004609
Took the flu vaccine on 12/1/04 at 10:00 AM; went back to work. Had a slight soreness in the left arm where vaccine was given. Same day at 3:00 PM, had a static noise in right ear. Lost hearing in this ear. Later had vomiting and dizziness. Follow up 03/07/05: Patient was seen in the emergency room on 12/04/04. Chief complaint was vertigo and hearing loss. Patient reported felt a little dizzy and heard staticky sound in right ear. By next am pt had severe vertigo with nausea, requiring compazine and Bonine, and noted severe hearing loss in right ear. Over the next 48 hours vertigo is lessening but hearing loss has not improved in right ear. No further tinnitus reported. Patient denies aural fullness. Patient received flu shot this week, just prior to onset of symptoms. Upon ears were found to be clear with normal appearing tympanic membrane. Eyes: no nystagmus vertical or horizontal gaze. CT of head showed not Focal Lesions and Labs normal. Impression: Acute right Labyrinthitis, prob viral, affecting both cochlear and vestibular nerves. ER summary states labyrinthitis. msv
shingles; Information has been received from a lawyer regarding a case in litigation, concerning a currently 70-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On approximately 14-FEB-2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot number and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster) at the local Pharmacy.  Subsequently, the patient was treated for singles resulting from Zoster Vaccine Live (ZOSTAVAX) use. The reporter considered the event of shingles to be related to suspect therapy. At the time of the report, the patient's outcome was not provided.
Patient complaining  of skin rash located on the anterior arms, anterior and posterior upper legs and anterior and posterior lower legs. Patient describes the rash as red, raised and itchy. The rash has been occurring/present for 1 day and has been unchanged. Patient notes exposure to A flu shot.
Vaccine was administered beyond the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the expiration date) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the expiration date). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.  The patient was doing fine and was not worried about it.