chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; Polymyalgia; Taking everything and still having migraines and polymyalgia; This is a spontaneous report from a contactable reporter (other healthcare professional-nurse) received from a Pfizer-sponsored Program. The reporter is the patient.  A 75- year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history included: "pericarditis," start date: Jan2021 (unspecified if ongoing); "migraine," start date: Jan2021 (unspecified if ongoing); "polymyalgia," start date: Jan2021 (unspecified if ongoing); "fibromyalgia," start date: Jan2021 (unspecified if ongoing); "stomach issues," start date: Jan2021 (unspecified if ongoing); "diabetes" (ongoing); "COVID," start date: Jan2021 (unknown if ongoing), notes: She added in January she had Covid. The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (first dose (batch/lot number: unknown) as DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "blood sugar was below 50 the whole night," "fibromyalgia," "polymyalgia," "heart problems," "high blood pressure," and "had issues with her appetite."   The following information was reported: MIGRAINE (non-serious), outcome "not recovered," described as "Migraine"; MYALGIA (non-serious), outcome "not recovered," described as "Polymyalgia." Therapeutic measures were taken as a result of migraine, myalgia.  Additional information: The patient had a migraine every day since the second dose. She wanted to know if there was something she can do. She experienced migraine every day and had been taking a Z-Pak, had Prednisone already, and it's not subsiding. She still has migraines and has been going on for two weeks now. The patient also experienced polymyalgia on an unspecified date. Patient further reported she has been bedridden since the second dose and this has been for two weeks. Patient clarified she had been bedridden for longer than two weeks. She mentioned she is bedridden now and was bedridden two weeks prior to that. She is trying to find some things out. She has nothing against the vaccine but has medical reactions to things. She is wondering and trying to find out if other people have had this. She wanted to know if there is any other way to help the situation. She is on oxycodone three times a day, on delta 8 gummies. She had spoken to her health care provider and they don't know what to do. She is taking everything and still having migraines and polymyalgia. She has tried Prednisone and it did nothing. Patient wanted to know if other people are having reactions to the Comirnaty vaccines.   The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101651160 same reporter/patient/drug, different dose and AE.
CHILLS; FEVER; LIGHT-HEADED; Feeling ill; SLIGHT REDNESS IN SITE OF INJECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068) dose was not reported, administered on 05-MAR-2021 at 9:45am, to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced chills, fever, light-headed, feeling ill, and slight redness in site of injection. Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed on 05-MAR-2021, had not recovered from chills, and fever, and the outcome of feeling ill and slight redness in site of injection was not reported. This report was non-serious.
pt recv 1st dose of hep b vax 19APR95 pt dx on 17OCT97 w/JRA;pt had a convuls @ MD office p/1st dose of vax;  Per follow-up, juvenile rheumatoid arthritis still active, stiffness and pain.
Patient notified 2nd dose scheduler that she did not feel well. 2nd dose scheduler notified EMT, who notified Paramedic and, EMT. Paramedic  Supervisor notified that Patient at 940 am c/o chest pain discomfort radiating to middle back; 4 lead done, BP. Patient refused to go to hospital, was awake, alert and oriented x4 and able to sign refusal paperwork." Supervisor Report.
At site of Pneumonia shot, hurt on administration. Started to be inflammed until about 6" up arm & almost encircling arm. Arm very painful to move last night. Took Tylenol daytime for 3 days. After 1 wk, redness gone, but painful to touch.
Follow-up information was received that provide additional information on recovery status and emergency room or doctor visit. Information regarding Prevnar was received from a nurse regarding an 11-month-old female patient who received the fourth dose of Prevnar that appeared to be inadvertently administered in tradermally in right forearm but believed to have been administered deeper on 05-Jul-2006. On the same day the child became itchy at the injection site and developed a possible local delayed hypersensitivity reaction or possible reaction to aluminum in the adjuvant characterized by a red lump on the injection site. On 12-Jul-2006, the child became cranky. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 05-Jul-2006. Dose regimen was 1 dose 1 time per day (intradermal). Concomitant medications were not reported. On 05-Jul-2006, the patient received a dose of Prevnar that appeared to be inadvertently administered intradermally in the right forearm (drug administered at inappropriate site) but believed to have been administered deeper (incorrect route of drug administration). The reporter noted that no indruation was immediately observed and could "not even tell the child received a vaccine." Later, on the same day, the child was itchy at the injection site (injection site pruritus). The nurse suggested Tylenol (acetaminophen), Motrin (ibuprofen), Benadryl (diphenhydramine) and hydrocortisone treatment. At 5:00 pm, the child developed a small red bump on the injection site (injection site erythema) (injection site swelling) that grew to 2.5 by 3.0 cm. The reporter noted that these events were the result of a possible local delayed hypersensitivity reaction (type IV hypersensitivity reaction) or possible reaction to aluminum in the Prevnar adjuvant (hypersensitivity). On 12-Jul-2006, the injection site swelling decreased to a size "smaller that a marble" and the child was described as cranky (irritability). The reporter noted that the events required an emergency room or doctor visit. On an unspecified date in 2006, the patient recovered from the events. No additional information was available at the time of this report.
I experienced jittery, nervous, heart palpitations, trouble breathing, brain fog, and fatigue.
Moderna COVID-19 Vaccine  Itching, redness, rash 6 post vaccination
Received DTaP #5 for kindergarten physical. The next day parents noticed injection site with 5 1/4" x 4" erythematous patch, warm to touch. No nodule, no pain.
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONTRAST MEDIA ALLERGY (Contrast media allergy), DERMATITIS ALLERGIC (Allergic rash), DIARRHEA (Diarrhea), PERIPHERAL SWELLING (Swelling arm) and DRY MOUTH (dry mouth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication. The patient's past medical history included Lymphocytosis and Estrogen receptor positive status ER. Concurrent medical conditions included sulfa antibiotic and Iodine allergy. Concomitant products included ANASTROZOLE (ARIMIDEX), COLECALCIFEROL (COLECALCIFEROL D3), CYANOCOBALAMIN, FLUTICASONE PROPIONATE, PROBIOTICS NOS and LORATADINE (CLARITINE) for an unknown indication. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On an unknown date, the patient experienced CONTRAST MEDIA ALLERGY (Contrast media allergy), DERMATITIS ALLERGIC (Allergic rash), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Swelling arm), DRY MOUTH (dry mouth) and PERIPHERAL SWELLING (swelling in legs and feet worse). At the time of the report, CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHOEA (Diarrhea) and DRY MOUTH (dry mouth) outcome was unknown, DERMATITIS ALLERGIC (Allergic rash) and PERIPHERAL SWELLING (Swelling arm) had resolved and PERIPHERAL SWELLING (swelling in legs and feet worse) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-086818, MOD-2021-086711, MOD-2021-086996, MOD-2021-085006 (E2B Linked Report). This case was linked to MOD-2021-087217, MOD-2021-087217. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: new events updated; Sender's Comments: MOD-2021-086818:Case received in same source doc email; MOD-2021-086711:Case received in same source doc email MOD-2021-086996:Case received in same source doc email; MOD-2021-085006:Case received in same source doc email.
2 days after the 2nd dose vaccine, I had a pain in my left rib cage around 4pm and at 9pm it had moved to the breast bone and became more severe.  I took nitroglycerin for chest pain and my SOB.  I drove myself to the ER (Hospital).   The ER did  boodwork, chest x-ray, ultrasound with contrast-every normal.  I stayed in the hospital for 2 days for monitoring and was diagnosed with periocarditis and discharged with prescription for colchicine and aspirin for 2 weeks and the pain did go away. 1 week after discharge, I followed up with cardiologist.  On 6/1/2021 I had another flare up and now taking colchicine for 3 months.
Multiple episodes of seizure on one day (at least three episodes) on 04/06/2021
Information has been received from a nurse concerning a "young lady" who on 02-APR-2010 was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL. 48 hours later, on 04-APR-2010 the patient presented with a systemic rash (all over the trunk of her body). The patient sought medical attention. The patient was told to take BENADRYL (manufacturer unspecified). At the time of the report, the patient was recovering. Additional information has been requested.
One week after vaccination some itchiness at site of injection. Eight days after vaccination large, red swollen circle/rash around injection site, about 3 inch diameter.
Full body hives. Treatable by zyrtec. Lasted at least a week.
Some patients  / received / 1st / doses / in 2020 and due to covid are / coming / to finish / series; This case was reported by a nurse via call center representative and described the occurrence of social problem in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients received 1st dose of Twinrix in 2020 and due to covid they were not coming back in to finish their series. The reporter consent to follow up via email. This case has been linked with case US2021149566 and US2021AMR150416 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149566:Same reporter. Only pt identified. US-GLAXOSMITHKLINE-US2021AMR150416:Same reporter. "Some patients" who only got 1st and 2nd dose.
This non-serious medically confirmed report received via a sales representative (initial receipt 10-Jun-2014) concerns a female patient. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and PNEUMOVAX 23 (batch number not reported). The vaccines were given in opposite arms. On an unspecified date over one year ago, the patient's whole arm turned red after the administration of the PNEUMOVAX 23. The patient did not report any respiratory issues. The patient saw her primary care physician. Outcome was not reported.
three in red and swollen area around injection site.  topical benedryl was applied one time.  Still red as of 12/11/22, but swelling has resolved itself.
Information has been received from a consumer concerning a 15 month old white female pt with no allergies who on 10/18/00 was vaccinated with the 1st dose of MMRII, IM, in the left thigh, a Hib conjugate vaccine and streptococcus pneumoniae vaccine (Prevnar). There was no illness at the time of vaccination. On approx. 10/18/00, the pt's mother reported that the pt developed a bad rash all over her body which appeared as "red, dark site". On 10/25/00, the pt saw her physician. The pt's rash subsequently, persisted. Follow-up has been received from a physician who reported that on 10/25/00, the pt developed a fever and a rash. The physician noted that the pt required no treatment and recovered. Additional information is not expected.
pt resides in a local health and Rehab Center; in the HCF pt had a positive COVID test on 9/19/22;  pt to ED via EMS 9/22/22 with worsening SOB and hypoxia; O2 supplementation and nebulizer tx; worsening hypoxia and SOB; ABX given; DNR/DNI; comfort measures; pt's condition declined and pt passed away in the hospital
No adverse event; Pharmacist reported that an expired PNEUMOVAX 23 was administered to a patient.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report has been received form a pharmacist, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-MAY-2023, the patient was vaccinated with an expired Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX23) injection, as prophylaxis (lot number: U022984, which was determined to be valid as syringe, with an expiration date on 29-JAN-2023) (strength, dose, scheme, route and anatomical location of administration were not reported).  No additional adverse event was reported.
That night following vaccine, I had chills.  The next day, I had injection site soreness and a headache. As the day progressed, I experienced a fever of 101, headache, nausea, muscle weakness. Tylenol was required around 4p. That evening, I continued to have all symptoms.  Fever came back up around 11p. Addition Tylenol was taken.  Sunday, I had a headache.  Muscle weakness was better.  Injection site pain was better.  Still had a fever.  I was very dizzy all day Sunday.  On Monday, I felt much better but was fatigued.
Vomiting for 48 hours starting 24 after vaccination received; Fever; Cold; Muscle aches; Fatigue; Pain continuing; Dose 1 and 2: Moderna; booster dose: Pfizer; Dose number: 3; This is a spontaneous report from 2 contactable reporters, consumer (patient) and consumer (Pfizer employee).  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 16Dec2021 (Lot number: FE3594) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot number: 006B21A, Anatomical site: Right arm, Route of administration: Intramuscular), administration date: 02Apr2021, when the patient was 45 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot number: 039B21A, Anatomical site: Right arm, Route of administration: Intramuscular), administration date: 30Apr2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 16Dec2021, outcome "unknown", described as "Dose 1 and 2: Moderna; booster dose: Pfizer"; IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "Dose number: 3"; VOMITING (non-serious) with onset 17Dec2021, outcome "recovered with sequelae" (19Dec2021), described as "Vomiting for 48 hours starting 24 after vaccination received"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Fever"; NASOPHARYNGITIS (non-serious) with onset 17Dec2021, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Cold"; MYALGIA (non-serious) with onset 17Dec2021, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Muscle aches"; FATIGUE (non-serious) with onset 17Dec2021, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Fatigue"; PAIN (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Pain continuing". Therapeutic measures were taken as a result of vomiting, pyrexia, nasopharyngitis, myalgia, fatigue and pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that muscle aches lasted longer. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for events included Tylenol and Advil.
Mom reports noticing swelling on right thigh. No rash noted but tender to touch, redness at site, and hard knot palpated.
Over a week of feeling dizzy, foggy-headed, upset stomach, exhaustion, sometimes ringing in ear, sometimes feelings of heart racing and trying to catch breath.
Diarrhea that came on quickly (though I had taken some Gas-X the hour before as I was feeling unusually gaseous), the diarrhea lasted 30 minutes, and emptied a lot of my digestive tract. I drank plenty of fluids after this, slept OK, and ate well in the morning. So it was a short, but significant event. No noticeable fever or other symptoms.
Nausea then vomiting for a full 24hrs after receiving vaccine.  It started approx 24hrs after receiving vaccine.
Pt developed cellulitis after smallpox administration.  Treated with Dicloxicillin and improved.
pt inadvertently recv TRIHIBIT & HIBTITER;no adverse exp had occurred at that time;
Following vaccine administration at 12:45pm, patient described dizziness and "throat pressure" to pharmacist at 1:00pm.  Blood pressure was measured using an automatic cuff at 1:05pm with result of 144/101.  Patient described this as an elevated reading from her normal blood pressure.  Patient was monitored and blood pressure was taken again at 1:20pm with a result of 138/103.  At this time, patient stated the throat pressure was no longer present and the dizziness was still present in waves, but better.  At this time, patient stated that she felt better and requested to leave.
Administration error: patient had already completed primary series of Shingrix given on 6/19/2018 and 8/18/2018 which at the time was unknown to the pharmacy. Patient was administered an additional dose on 04/11/2022.
Information has been received from a pharmacist concerning a child who in November 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of a dose of varicella virus vaccine live (Oka//Merck). It was reported as a medical error administered by the nurse. A product quality complaint was not involved. No further information is available.
Staff had her 2nd dose on 01/12/2020 yesterday.  This morning 6am wake up with bad headache.  Went to work, 3:30 had blood pressure checked 174/102 and pulse was 98.  Took Tylenol.  Not dizzy.  Monday covid negative
Dizziness/nausea, migraine headache, loss of appetite, itchy throat, ear pain
Information has been received from a registered nurse concerning a 62 year old male pt with an allergy to penicillin who on 2/13/97 in the AM was vaccinated IV in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Concomitant medication included Norvasc. It was reported that "at least five years had passed between doses." On 12/13/02 at "6-7" PM the pt developed a local reaction described as chills, shakes, sweats, arm swollen and erythematous and a "high fever" of 102 and ended up in the ER. A chest x-ray revealed atelectasis of the right base. It was noted that the pt had recovered. Upon internal medical review it was determined that atelectasis was an other important medical event (OMIC). The nurse also reported that two other patients had local reactions, one of which developed a fever and aches (WAES0212USA01473 and WAES0212USA01989).  Follow up on 07/09/2003: "Follow up information recorded on 06/23/2003 stated that on 12/16/2002 the patient called the office and reported taht he "felt better" on levofloxacine.  There were "no residual effects" reported.  It was also noted that no follow up chest x-ray was done. The patient recovered without further incident.  There was no further treatment.  Upon internal medical review, it was determined that atelectasis was an other important medical event (OMIC).  The nurse also reported that two other patients had local reactions, one of which developed a fever and aches (WAES # 0212USA01473 & WAES # 0212USA01989)."
4/26/2021 patient came in to inquire if people have been complaining about arm pain from the flu shot.  He said his has hurt since the shot, and is still hurting.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: she experience mild tongue swelling that went away within 10 minutes. she declined to wait for ems
Pt had a breakthrough case of COVID 19 in August 2021 required hospitalization, mechanical ventilation and then he expired on 8/29/21
sore arm; sore lymph nodes in armpits,; temp. 99.5; fatigue and racing heart; heart rate fluctuates but up to 165; chest pain/fluttering,; racing heart; This is a spontaneous report from a contactable consumer (patient's mother).  A 18-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 23May2021 15:00 (at the age of 18-year-old) as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. It was unknown if patient had other vaccine in four weeks. It was unknown if patient was tested post COVID vaccination. Reporter was not sure if patient had other medications in two weeks. It was unknown if prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. On 23May2021 the patient experienced sore arm, sore lymph nodes in armpits, temp. 99.5, fatigue and racing heart, chest pain/fluttering, heart rate fluctuates but up to 165. The patient had the physician office visit for the reported events. The patient underwent lab tests and procedures which included body temperature (temp) 99.5 and heart rate up to 165 both on 23May2021. Outcome for the all reported events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.