chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trigeminal neuralgia s/p R microvascular decompression who presents with subacute neuromuscular weakness on 10/1. Per family she had new onset dizziness and back pain around 9/20/17 about 2 weeks after receiving flu shot for first time in life. Developed progressive weakness, nausea, diarrhea emesis and had been unable to take PO when initially presented to ED on 9/25/17. Symptoms thought to be 2/2 hypothyroidism and uncontrolled HTN so sent home at that time without documented neuro exam. Returned to the hospital on 9/27 c/o not being able to get out of bed due to weakness. Neurology consult 9/29 notes mild trouble breathing, absent reflexes, neck flexor extensor weakness and proximal >Distal, upper> Lower weakness. Also noted patchy sensory loss. MRI C/T/L w/wo significant for subtle enhancement of conus medullaris and cauda equina. LP with WBC 0, RBC, 1, glucose 72, Protein 49. Started on IVIG 0.4g/kg/day with dose given on 9/29 - 30. On 9/30 she developed  increased work of breathing, hypophonia, hearing loss, and left LMN facial weakness. Intubated d/t increased work of breathing and transferred to MC for further care.
sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Mar2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore right arm and shoulder. Flu-like exhaustion requiring sleep through the day following the vax. Very achy joints in addition to the right shoulder.
Administered Fluzone vaccine to patient around 2:30 pm on 11/12/02.  Patient left health unit and returned to office.  Approximately 30 minutes later, a co-worker of the patient entered health unit and stated "I think one of my co-workers is having a seizure."  Entered patient's office around 3 pm and found him sitting in his chair, A&Ox3.  No apparent seizure activity.  Answered all questions appropriately.  +PEARRL.  Gait steady.  MAE x4.  BP 136/96, HR 80's.  States he had taken his medication as usual today (for seizure disorder).  Also states he believes he did have a seizure prior to my arrival.  Co-workers state there was no physical activity, but a change in LOC and orientation.  No seizure activity noted by nurse upon arrival.  No treatment needed.  Discussed possible relation between flu vaccine and seizure with patient.  Unable to determine if there is a correlation.
My daughter was given her year old vaccinations late in the day on 9/6/13. She'd been fatigued all day 9/7, then around 11 pm 9/7/13 we found her having a grand mal seizure in her crib. I called the pediatrician at home, who said go to ER. She was evaluated at ER until well after midnight, she was NOT running a fever, not a febrile seizure. She was sent home. We followed up with PCP on 9/9/13. She had following multiple tests including EEG, ambulatory 24 hour EEG, and MRI. Pediatrician states that it was a reaction to the vaccination, to never give her pertussis again. She has developed petit mal seizures from the time of this vaccine forward. Prior to 9/6/13 she had never had any signs or symptoms of seizure like activity. Fast forward to her 5 year old vaccinations, on 8/8/17 the nurse erroneously gave her the pertussis vaccine again - even though it was clearly marked in the chart for her, as well as discussed in detail between myself (mother) and the pediatrician as well as the nursing staff twice - during this visit and during her physical on 8/3/17 where they specifically ordered pertussis free vaccine JUST for patient. Her reaction this time was a high fever lasting 4 days. Per Dr we had to do TYLENOL/ibuprofen alternating and BENADRYL for 72 hours. Dr states that he consulted with pediatric specialists in hospital for a treatment plan. We watched her around the clock for the 72 hours, and her fever even with the TYLENOL/ibuprofen was in the 99-100 range. I documented hourly how she was reacting, and we called Dr routinely to discuss the situation. The office claims that the incident was reported to the nursing board, but both of the nurses are still employed there. The nurse tried to claim she didn't know there was a reaction, but it was clearly listed in the chart under both allergies and under every single office note from the original incident, as well as having been discussed in detail the week before. As well as the fever, she has had an increase in absence seizures and seizure activity, and the seizures have become noticeably more frequent and more lengthy. She went from having them a few times a month to a few times a week after the August incident.
Rash arm pit pain, felt like lymph nodes were swollen-left arm Narrative:
Initial unsolicited report received from a physician via Pfizer-sponsored interventional study on 10-Dec-2015. Manufacturer Report Number: 2015378599. The case involves a 65-year-old female patient who was vaccinated with a 0.5 ml intramuscular injection single dose of FLUZONE on 16-Oct-2015 at approximately 14:00 hours. The patient also received blinded therapy with non company drug however this product was not coded as it a non sponsored study. Patient's medical history included hypertension and hyperlipidemia both since Jan-2008, coronary artery disease (CAD) and atherosclerosis since 23-Mar-2009, herniated lumbar disc since 1990, insomnia since 1969 all were ongoing, a myocardial infarction with stenting on 23-Mar-2009, cholecystitis with cholecystectomy in 1989, alcoholism from 2000 to 2002 and hemorrhagic stroke from 11-Sep-2015 to 15-Sep-2015 and intermittent bilateral lower extremity edema from 27-May-2015 to 20-Sep-2015. The patient also had oedema peripheral from 27-May-2015 to 20-Sep-2015. Concomitant medications included Atorvastatin since 24-Oct-2013 from hyperlipidemia, Ibuprofen since 1990 for herniated lumbar disc, acetaminophen and diphenhydramine both since 1990 for insomnia, Trazodone since 22-May-2015 for insomnia, Lisinopril since 08-May-2015, Amlodipine since 13-Sep-2015 and Metoprolol tartrate since 14-Sep-2015 all three for hypertension, Furosemide since 11-Jun-2015 for intermittent bilateral lower extremity edema, and aspirin since 14-Sep-2015 for atherosclerosis all are ongoing. On 16-Oct-2015, at approximately 16:00-16:30 hours, the subject developed epigastric abdominal pain, nausea and diarrhea and was hospitalized on the same day. The event term was reported as acute pancreatitis. On 16-Oct-2015, upon arrival to the emergency room blood was collected and she was noted to have elevated lipase level at 2165 IU/L and 941 IU/L on 17-Oct-2015. On 17-Oct-2015, no acute findings were noted on the abdominal ultrasound and CAT scan. Patient received treatment with ZOFRAN 4 mg and Fentanyl 25 mg on 16-Oct 2015 and Famotidine 20 mg on 17-Oct-2015. The patient was discharged from the hospital on 17-Oct-2015 considered recovered on the same date. There was no action taken with the study medication in response to the event. The investigator reported there was not a reasonable possibility that the event, acute pancreatitis was related to the study medication or clinical trial procedure but was related to the concomitant drug, influenza virus vaccine polyvalent. Case Comment: In agreement with the investigator the company considered there was not a reasonable possibility that the event acute pancreatitis was related to the study medication or clinical trial procedure. The concomitant drug, influenza virus vaccine polyvalent, may provide a plausible explanation for the event. The follow-up information received does not alter the previous company clinical evaluation. List of documents held by  sender: none.
Felt small palpable, movable, round lump under skin in left anterior shoulder area near base of neck surrounded by puffiness in skin. Nodule tender when palpated. Injected site without any bruising, redness or swelling but deltoid sore with movement. Denies that lump was previously present. PMD labeled incident as "allergic reaction to TD" per pt. Symptoms resolved after 1 week.
I received the flu vaccine, working on health care. I developed chills, body aches, Headaches, diarrhea, mild fever. I took Tylenol to alleviate the symptoms.
Information has been received from a registered pharmacist concerning a female patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed hardness and redness at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Pt experienced a large swollen area of warm erythema on both outer thighs. Both approximately 6x6 cm. These appeared 1 day post vax. Pt prescribed Keflex. Resolved before 3/7/00.
30 minutes after pt. was itchy, continued 72 hrs, swelling, redness at injection site. Pt. took diphenhydramine & daily OTC antihistamine.
Fatigue, headache, muscle pain, chills, fever.  Started 12 hrs after 2nd shot and lasted 18 hrs.
After having the standard side effects of the vaccine (low-grade fever, chills, muscle aches) the evening following the administration, I started having severe chest pains the next morning/afternoon that I attribute to heartburn/GERD related issues. The pain was debilitating and the worst I have ever expereinced relating to heartburn. Taking over-the-counter medications did little to help, and I had to let the pain run its course. At one point, I thought I was having cardiovascular issues due to the intensity of the pain. Any heartburn/GERD related pains I've had in the past only last several minutes (5-15 min), but this pain lasted longer than 30 min. After this event, my chronic heartburn worsened and I had to be treated with prescription dose medication for GERD symptoms, including Clonezepam and Famotidine, which I continue to take daily. I also suffer from general anxiety, and this event caused that to worsen too.
w/in 10min of vax pt devel an inj site rxn characterized by a palm sized area of redness, swelling & warmth;pt was seen in ER where nurse mad a dx of an allerg rxn;17OCT97 rxn was resolving;this is 1 of 2 reports from this facility;
Hives on arms, chest, and back starting within 2 hours of injection. No respiratory symptoms, mild site irritation to first dose. Treated with benadryl at home
pt recvd vax & approx 2PM 1FEB93 mom stated noted approx 6PM a diaper change, noted excessive swelling to inject site approx 6cm & swelling to hip & groin of rt leg;
Tinnitus in right ear.  Some loss of hearing in right ear.  Tight upper back and neck muscles.  Sharp headache pain.
2 days p/vax (w/in 48hr) starting, limp, non responsive-pink-warm;awoke w/in seconds-happy-2nd spell similar-4 days later;
Information has been received on 3/4/02, from a physician concerning a 32 year old male who "recently" was vaccinated with 1 dose of varicella virus vaccine live. On that same day, post vax, the pt had shortness of breath, difficulty breathing and nausea. It was noted that the pt's adverse reactions caused him to go to the ER. It was reported that the pt did not experience wheezing and therefore did not have an anaphylactic reaction. Upon internal review, the pt's difficulty breathing was determined to be an "Other Important Medical Event". Additional information has been requested.
At site of DTaP/IPV (left thigh) mild red, flush 5 cm:not indurated. Slightly warm, mildly tender. RX: cool compresses and ibuprofen.
Fluzone received at 9:00am on 12/14/07. Onset of swelling of hands, face and eyes with fever at 7:00pm.  Benadryl given.  Parent did not take to MD until 12-17-07.  Currently on Clarinex and Benadryl. Parent states still has "blotches" on hands and feet.  Previously (2 months prior) similar symptoms after eating food from concession stand.  Allergy testing done on 1-7-08 at Hospital. MD does not want child to receive 2nd dose of flu vaccine during this season. Follow-up Information 22-APR-2008: SC0726 - We are only aware of one filing of this report- E20331. Followup required - none. No contraindication to future flu & Td. SC0727 - no future flu vaccine unless MD approves. SC0728 - no followup required. No contraindications for future immunizations. SC0801 - no followup required.
No adverse event; Patient got a Moderna COVID19 vaccine bivalent as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient got a Moderna COVID19 vaccine bivalent as a second dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient got a Moderna COVID19 vaccine bivalent as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient got a Moderna COVID19 vaccine bivalent as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient got a Moderna COVID19 vaccine bivalent as a second dose).    No concomitant medication details was reported. Date of administration of the primary series dose1, 08-Oct-2022 and lot number was unknown. Patient received COVID-19 vaccine bivalent as a second dose. Prior to this the patient only received one dose of the primary series. No treatment medication details was reported.
moderna vial was first punctured on 2/3/22 6pm and was accidently adminstered to patient on 2/4/22 at 11:16 am.
Pt developed thrombocytopenia to 8000. she was on cellcept and plaquenil at the time.
I was outdoors for an event talking and engaged with people, completely outdoors and very windy. In the afternoon I started feeling scratchy throat and a bit tired. On Saturday I was a bit tired and had a lot to do, had a busy day. Sunday was probably the same but because I had a lot to do I continued. Sunday evening I started feeling chills and body ache and went to bed. In the morning I got the rapid Covid test and one that was sent and it came out positive. I spoke to my Dr. on virtual appt and sent me Paxlovid. I took it for 5 days. The symptoms continued to be the same on Monday I had stuffy nose. Tuesday was terrible stuffy nose and body ache. 3-4 days I didn't feel well at all but never really had a fever, though I was feverish in the evening. By the weekend I walked a bit and felt tired. For 2 weeks I wasn't very energetic but by the time I finished taking Paxlovid I was ok without much congestion and now I'm pretty ok. Monday/Tuesday April 27th I felt very very bad. On the 5th of May I took another Covid test and it was negative.
Symptoms started on 8-22-21. 101 fever, runny nose, fatigue, cough, and shortness of breath. Was hospitalized on 8-28-21 with pneumonia due to COVID 19 virus and acute respiratory failure with hypoxia. Expired on 9-2-21.
Stiffness; Swelling; Big hard lump; Itching; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), MASS (Big hard lump), PRURITUS (Itching) and MUSCULOSKELETAL STIFFNESS (Stiffness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VITAMINS NOS, PREGABALIN and BIOTIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced SWELLING (Swelling), MASS (Big hard lump) and PRURITUS (Itching). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, SWELLING (Swelling), MASS (Big hard lump), PRURITUS (Itching) and MUSCULOSKELETAL STIFFNESS (Stiffness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-044320 (Patient Link).
Patient given Pneumovax 23 prior to discharge, the following day developed 106 fever, flue like symptoms and 4 x 8cm red area where received shot,
Developed swelling, redness and pain in her left deltoid where injection was given. Also started to run a fever. Given oral atbx, did not respond. Dx of cellulitis at injection site, poss adverse reaction to pneumo vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. During 2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (route, dose, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. Later in 2016, the patient was treated by a family medicine physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown.  The lawyer felt that vaccination failure and herpes zoster were related to ZOSTAVAX. Additional information has been requested.
P stated "was given both flu and pneumo vac. in left upper arm". Arm swelled and became very reddened with red streaks per patient. went to ER.
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (got sick with COVID) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Hydrocortisone and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced COVID-19 (got sick with COVID). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency. At the time of the report, COVID-19 (got sick with COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   IV fluids, Solumedrol used as a treatment medication
after 2 years of 1st dose could take 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received 2 years prior to the report).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
Paient had tachycardia, loss of consciousness, and also clammy wet skin. Also patient had labored breathing for about 15 seconds. Per CDC guidelines, epinephrine was administered and EMS was activated. The patient was okay after been seen and left on foot.
Itching both arms, and lower back, Benadryl 25mg PO administered by NP. Resolution of symptoms at 3:00 pm. Pt discharged home, advised to premed before next injection with the same- Benadryl 25mg PO.
DIZZY; LOW GRADE FEVER; FREEZING COLD; FEEL EXTREMELY HOT; SLEEP LESS; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight was 120 pounds, and height was 160.02 centimeters. The patient's concurrent conditions included penicillin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included no medical history and had no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, Laboratory data included: Blood test (NR: not provided) Low progesterone level. On APR-2021, the subject experienced sleep less. On 09-APR-2021, the subject experienced feel extremely hot. On 09-APR-2021 20:00, the subject experienced freezing cold. On 10-APR-2021, the subject experienced dizzy. On 10-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.2 or 99.3. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel extremely hot, and freezing cold on 09-APR-2021, and low grade fever on 10-APR-2021, and the outcome of dizzy and sleep less was not reported. This report was non-serious.
Symptoms began around 8 pm with sudden fatigue and continued throughout the night, with something new every time I woke up: chills, then fever, severe left leg cramp. Tachycardia was the last, starting just before 3am; resting pulse rate around 115 (measured with a home pulse oximeter) whether lying down or sitting up, throughout the rest of the night and into the next morning. Note, I had COVID-19 (symptom onset 12/07/2020), relatively mild.
Post vaccination. No other symptoms lightheaded. Refused transport. blood pressure 163/98, 104