chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A family friend advised that he recently had a stroke; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (A family friend advised that he recently had a stroke) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (A family friend advised that he recently had a stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (A family friend advised that he recently had a stroke) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received care at a medical institution. The neurologist advised that he knew exactly what was happening and that he was seeing many of these cases in vaccinated individuals. The patient recovered in a few weeks.  Reporter also stated that he heard another report of a co-worker that had a mild stroke with no prior history. Reporter searched literature related to prevalence of stroke in vaccinated individuals and found that numerous studies are underway. Reporter had no idea what type of vaccines were administered to any of the aforementioned individuals.   Company comment: This is a  spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced serious (medically significant), unexpected event of cerebrovascular accident. Event onset date and vaccination date were not provided; hence, latency cannot be assessed. The reporter stated that a family friend had a stroke and he received medical care at Medical Institution. Patient´s neurologist advised that he knewexactly what was happening and that he was seeing many of these cases in vaccinated individuals. Patient recovered in a few weeks. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a  spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced serious (medically significant), unexpected event of cerebrovascular accident. Event onset date and vaccination date were not provided; hence, latency cannot be assessed. The reporter stated that a family friend had a stroke and he received medical care at Medical Institution. Patient´s neurologist advised that he knew exactly what was happening and that he was seeing many of these cases in vaccinated individuals. Patient recovered in a few weeks. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Feb2023) Negative, notes: tested negative on day 6; (2023) postive, notes: retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as treatment from 22Feb2023 to 27Feb2023.
bump close to the clavicle; Trouble in the throat; Throat is closed; Not able to swallow; Felt like a ball inside her throat from the moment she received the vaccine; Closure of the throat in the left side; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Trouble in the throat), THROAT TIGHTNESS (Throat is closed), DYSPHAGIA (Not able to swallow), OROPHARYNGEAL DISCOMFORT (Felt like a ball inside her throat from the moment she received the vaccine) and THROAT TIGHTNESS (Closure of the throat in the left side) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pollen allergy (.), Grass allergy, Asthma (Caller is allergic to pollen, grass, cat, dogs and due to this has border asthma.), Osteoporosis and High cholesterol. Concurrent medical conditions included Allergy to animals (Cats) and Allergy to animals (Dogs). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis, MULTI VITAMINS & MINERALS, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Trouble in the throat), THROAT TIGHTNESS (Throat is closed), DYSPHAGIA (Not able to swallow), OROPHARYNGEAL DISCOMFORT (Felt like a ball inside her throat from the moment she received the vaccine) and THROAT TIGHTNESS (Closure of the throat in the left side). On an unknown date, the patient experienced SWELLING (bump close to the clavicle). At the time of the report, OROPHARYNGEAL PAIN (Trouble in the throat), THROAT TIGHTNESS (Throat is closed), OROPHARYNGEAL DISCOMFORT (Felt like a ball inside her throat from the moment she received the vaccine) and SWELLING (bump close to the clavicle) outcome was unknown, DYSPHAGIA (Not able to swallow) had resolved and THROAT TIGHTNESS (Closure of the throat in the left side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter contact information, outcome of events, new AE added.
Right Fifth Cranial Nerve, second branch distribution, burning and tingling , no rash.  Presumed to be mild herpes zoster (shingles).  Treated with Valacyclovir 1000mg TID for 7 days with resolution.
Client received Moderna vaccine that had an expiration date of 7/9/2023, administration of vaccine was on 7/12/2023. Client did not exhibit any immediate adverse reactions.
Overnight, after receiving vaccines, Emile stopped speaking...no words, not even Mama or Dada, for just over 2 weeks.  After this period he began slowly to regain lost vocabulary.  Now he is learning new words and expressing himself more, but has been recommended for some speech therapy by a speech therapist.  He also experienced sleep disturbance beginning the night following the injections, and lasting for 2 months.  During this time he, who previously had been sleeping through the night without waking, woke up screaming in a very unusual way and would stay awake crying and screaming uncharacteristically from 1 to 3 hours each night at first, then gradually getting back to his normal sleep pattern after several weeks.  He did not seem to wake due to hunger, and had no other sickness or teething.  He had a moderate fever (101) beginning the day of the vaccines which lasted for 7 days afterward.  He had also experienced a fever after previous vaccines at 4 months of age.  He received Tylenol and Motrin as needed.  While all of this was occurring, he was very clingy, often did not respond to his name, and was observed several times crawling into into walls/doorjams, as if he had missed the door opening, something he had never done before.  Both of these symptoms resolved after a few weeks.  A physician examined him, but found no cause for his sleep problems, behavior or cessation of speech.  Parents were told by pediatrician that a fever is normal after receiving Prevnar vaccine.  It appears that he is recovering, but we do not know if he will have permanent disability or developmental delays.
This medically confirmed spontaneous report (initial receipt: 05-Nov-2014) concerns a 57 year old female patient. On 04-Oct-2014, the patient received intramuscular AFLURIA (batch number T50307). AFLURIA was stored correctly. On 04-Oct-2014, during the vaccine administration, the needle became loose and the patient received less than the recommended dose of AFLURIA from a pharmacist (did not get the full dose). The outcome was unknown. Reporter comments: The reporter insisted that the reason the needle was not in place was due to a technique issue only and not due to the fault of the vaccine product. The reporter assessed the events as non-serious.
Vaginal bleeding; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (Felt tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-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-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (Felt tired). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and FATIGUE (Felt tired) outcome was unknown.            Concomitant products included Blood pressure medications.   Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUN-2021, contain significant follow up information including outcome of events not resolved. contact information updated
marked elevation of bad cholesterol; This spontaneous case was reported by a patient and describes the occurrence of LOW DENSITY LIPOPROTEIN INCREASED (marked elevation of bad cholesterol) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Flu vaccine in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Lovenox), LDL cholesterol and Thyroid disorder (have had the problem for 15 plus years ,out of control in June 2020 but after adjusting the medications, it was under control.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 20-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced LOW DENSITY LIPOPROTEIN INCREASED (marked elevation of bad cholesterol). At the time of the report, LOW DENSITY LIPOPROTEIN INCREASED (marked elevation of bad cholesterol) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2022, Low density lipoprotein: 188. On an unknown date, Low density lipoprotein: marked increase noted during most recent blood work.         On 13-Jan-2021 patient received the first dose of vaccine lot number 011L20A. On 10-Feb-2021 patient received the second dose of vaccine lot number 038L20A. On 09-Nov-2021 patient received the first booster dose of vaccine lot number 032F21A. On 02-Jun-2022 patient received the second booster dose of vaccine lot number 049L21A. The patient did not experienced a similar event in the past. Concomitant medication included Thyrosterol once a day. No treatment information was provided.
Fever; headache; This is a spontaneous report from a contactable consumer. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW00153) via an unspecified route of administration in the arm left on 13Apr2021 at 10:30 (at the age of 28-year-old) as a single dose. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. After the first dose of vaccination the patient had been tested for COVID-19.  On 07Apr2021, the patient underwent nasal swab test and the result was negative. On 14Apr2021 at 08:00 the patient experienced fever and headache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever and headache was recovering at the time of this report.   No follow up attempts are needed. No further information is expected.
aching everywhere; nausea; fever; chills; Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   The patient's past medical history included spinal laminectomy (Laminectomy and fusion on L3,4,5 vertebrae).   On 31-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and the 1st dose of Hepatitis B vaccine (intramuscular, left deltoid). On 31-JUL-2023, 6 hrs after receiving Shingrix and Hepatitis B vaccine, the patient experienced general body pain (Verbatim: aching everywhere), nausea (Verbatim: nausea), fever (Verbatim: fever), chills (Verbatim: chills) and pain in arm (Verbatim: Sore arm). The outcome of the general body pain, nausea, fever, chills and pain in arm were unknown.   It was unknown if the reporter considered the general body pain, nausea, fever, chills and pain in arm to be related to Shingrix and Hepatitis B vaccine.     It was unknown if the company considered the general body pain, nausea, fever, chills and pain in arm to be related to Shingrix and Hepatitis B vaccine.   Additional Information: Receipt date: 01-AUG-2023 The Consumer reported that he received his Shingrix and his Hepatitis B (unknown manufacturer) the day before reporting, both in the left deltoid. He had experienced arm pain that began about 4 hours after his vaccination, and chills, fever, nausea and general aches which started about 6 hours after the shot.
Information has been received from a nurse practitioner. The nurse practitioner reported that "she was sent an email by one of her patient's mothers who received it from another mother stated that a 15 year old female patient, who was not patient of the nurse practitioner, on 23-JUL-2008 was vaccinated with the first dose of GARDASIL and then two days later the patient almost passed out and was weak for hours. Through the rest of the summer and school year the patient complained that she could not run as fast and was weak. Then on October 17, 2008 the patient received her second dose of GARDASIL and on October 21st the patients mother received an urgent message from the school nurse to take her daughter immediately to her pediatrician. The patient was experiencing confusion, was disoriented, barely could stand, had no reflexes in her feet, and couldn't remember anything that happened that day. The patient was then taken to her pediatrician's office who advised her to see a neurologist. A week later when she saw the neurologist they did a EEG and a MRI because they thought she had a brain tumor, and the patients memory was slowly coming back. Then a second MRI was done which showed she had a demyelination that usually occurs either with GUILLAIN BARRE or with multiple sclerosis. Then later on the patient was diagnosed with GUILLAIN BARRE. The patient was given a spinal tap which showed no permanent damage, inflammation of her brain is going down, she has no debility". GUILLAIN BARRE was considered to be disabling by the nurse practitioner. Additional information has been requested.
Chest pain began within 24 hours of the booster dose.  The pain lasted about 24 hours, and was mitigated with ibuprofen.  More chest pain returned about two and a half weeks later, but more severe with pain associated with movement or laying down.  Went to the emergency room and was given an anti-inflammatory injection.  Also had some back pain right between my shoulder blades.  Anti-inflammatory injection combined with OTC anti-inflammatories relieved symptoms.  It's now almost exactly two and  a half weeks after the second round of symptoms, and they're returning again.  No chest pain at all before booster shot.  No heart conditions, low blood pressure, low cholesterol.
No adverse effect reported; temperature excursion / temperature: 11.1 C, 8.8 C; This spontaneous report was received from a nurse and refers to a 12-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, lot # T024831, expiration date 18-NOV-2022 (route of administration and anatomical location were not provided). The administered vaccine was stored in a temperature of 11.1 degree Celsius (C) for 1 hour 17 minutes and 8.8.C for 1 hour 17 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Reported on the 3rd day after receiving an IM H1N1 vaccine experienced tenderness at injection site which then moved to intense pain and swelling of arm. Did seek treatment on 11-11-09 and was placed on Mobic. Was given Decadron IM in ER.
02/22/23 presents to EC ED for "altered mental status". PMHx of "HTN and dementia"
pt recv varivax 17DEC97-nurse thought she was giving inactivated polio virus (IPV) & 28JAN98 pt was on ATB for ear infect, fever & cold sx;
I got a rash the day after my second booster.  It was about 3 inches long and 2 inches wide.  This did not happen with the first 3 and all were Moderna.
Very drowsy 6 hours after injection until 48 hours after injection. Diarrhea 18-26 hours after injection. Feel normal48 hours after injection.
Apprix 2 min after seasonal flu vaccine and after watching mom get her flu vaccine. Pt had syncope episode which resulted in fall to floor loss of consciousness for a 10 secs. When pick up from fllor noted to be diaphoretic, pale and have bloody bottom lip/ BP 89/64 EMS called pt HR 106 transported to hospital on follow up 11/19 mom stated patient was observed a few hrs in ER and he is ok.
A few minutes after receiving the HPV vaccine, the patients mother came out screaming her daughter was having a seizure. The nurses went into the room to check on the patient, and a provider was called into the room until Dr. could arrive. Patient was upset upon waking and coming out of it when the nurses entered the room.  Dr. could not rule out a seizure since she was not in the room, but it was believed to be syncope. Patient was sent to the hospital. Per Dr. "She was due for 2nd HPV in office today and was calm at the time of injection but then passed out and mom reports seizure like activity. When nurse arrived in the room she was lying still on the stable. When provider arrived, she was alert and upset. She has no sleepiness post event. EMS called and she was much calmer when they arrived and had normal vital signs. She has some cramping of her hands and feels abnormal so I am going to send her to facility for further assessment and reassurance."
ADACEL administered (L) deltoid 8/17. Intense (L) upper deltoid pain 8/18 - current.
Seen in office on 1.22.15 1:30 pm for generalized hives. No fever or other illness noted. BENADRYL 12.5mg/5ml, 2.5 ml every 6 hours given. Hives resolved 1.23.15 in evening.
A non-serious unlabeled spontaneous report of mycoplasma pneumonia and accompanying symptoms has been received from a nurse concerning a 33 month-old female; 33 days after the infant received FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The only medical history reported was a language delay, the patient is on no concomitant medications.  The patient received FLUMIST nasally on 25-Sep-2008 for flu vaccination.  On 23-Oct-2008 the experienced a fever up to 101 degrees Fahrenheit.  On 28-Oct-2008 the patient was seen by her pediatrician, she had cough and stuffy nose with nasal discharge.  Her pediatrician diagnosed probable mycoplasma pneumonia, no lab testing or chest x-ray was done.  The physician also noted crackles in the infant's chest.  She was treated with ZITHROMAX for 5 days.  According to the infant's mother the infant is doing better.  The event of mycoplasma pneumonia and the accompanying symptoms are resolving as of 06-Nov-2008.
This almost five year old child had fourth DPT, MMR and hepatitis vaccine done 8/15/02 and has developed a fairly large erythematous rash surrounding the injection site on the left thigh. I do not know which of the immunizations was given there, but it is presumed to be the DPT shot. There has been no associated fever, and the reaction began approximately four days ago. It occurred almost immediately after it was given. Review of systems: otherwise negative. There has been no prior history of reactions to any of the immunizations. Pt was given Keflex 250mg po and sent with a bottle of 100cc suspension. Probable DPT immunization reaction left thigh at the injection site vs. cellulitis. The pt was discharged and given routine aftercare instructions for cellulitis vs. immunization reactions, cephalosporin antibiotics, and instructed to follow up with primary care physician to use one teaspoon bid. I also explained to the mother that this may in fact not be an infection, but we are going to cover that possibility, and if it is an immunization reaction, she should certainly have a conversation or consultation with her primary care physician before the child receives any more DPT immunizations.