chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning an 82 year old female who on June 23 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (lot 647028/0564N) (IM). Concomitant therapy included an unspecified medication. On June 24 2004 the patient developed injection site rash. Unspecified medical attention was sought. No product quality complaint involved. Follow up information from the medical assistant reported that there has been no adverse reaction. No further information is expected.
I had a bad sore throat, bad headache, and bad cough, then developed:   Costochondritis (kos-toe-kon-DRY-tis) is an inflammation of the cartilage that connects a rib to the breastbone (sternum). Pain caused by costochondritis might mimic that of a heart attack or other heart conditions.
Arm had large red area- about 6 by 6 inches, started small and enlarged by the 2nd day Sunday, 7/22/2018, warm to touch per patient. Patient states he has no other symptoms.
Vaccines given 5/26/2009.  Left leg appeared red, warm to touch and painful when touched.  Mom noticed this on 6/9/09.  Subsequent appt. 6/6/09.  On 6/5 area involved = 1 1/2 inches 6/6 area 3 cm X 3 cm child also had temp on 6/5 - 6/6 : (101. degree) ax. 6/6/09 started on axb. for 10 days
Left arm suddenly went tingly, numb, weak.  EMT to Hospital.  Ultrasound imaging showed acute arterial embolus in left axillary and proximal brachial artery segments. Surgery to remove clot was performed within 3.5 hours of hospital admittance. Was discharged from Hospital next day (11/09/2021). Surgery site is healing.  Follow up treatment includes Warfarin blood thinner.  Determining correct dose is progressing.
Marked swelling, erythema and induration of left arm from axilla to wrist. Pt reports pain with arm movement. Dx: Heat, elevation, Zyrtec.
Initial and follow up information has been received from a medial assistant concerning a 58 year old white male with benign prostatic hyperplasia (BPH), elevated cholesterol, "onychotic" toe nails, sciatica and an allergy to sulfa, rosuvastatin calcium (CRESTOR), cefuroxime axetil (CEFTIN), trees, grass, mold and dust who on 20-SEP-2005, AT APPROXIAMTELY 10:30 am was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P).  Concomitant therapy included terbinafine (LAMISIL) ans saw palmetto.  On 22-Sep-2005 the patient called the physician's office and reported that he had developed a swollen, red spot, the size of a fist, at the injection site.  In follow up, it was reported that on 20-SEP-2005, the patient developed huge red spot, the size of a fist, where the shot was given and the patient had experienced very bad headaches.  On 21-SEP-2005, the injection site swelling was smaller.  Subsequently, the patient had recovered.  The reporter expressed concern regarding the lot.  No further information is expected.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
I have experienced nerve pain since the shot was administered.  At over a month post-injection, I still have intermittent nerve pain in my limbs, hands, and feet.  So far the nerve pain has not improved.  My sleep began to worsen as time went on post-injection.  I have developed insomnia for the first time in my life after never having sleep problems before.  This has not improved.  I had pain in my left eyeball.  I have had joint and muscle pain.  I have experienced intense PVC?s and an elevated pulse.  I had no preexisting conditions before taking the COVID vaccine.
Lower extremity weakness, difficulty walking, difficulty lifting leg or self from sitting upright position. Per follow up report recieved on 06/23/2005:  Patient's recovery status is unknown.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse practitioner regarding a 43-year-old female patient who experienced headache, nausea, tachycardia and erythema on her cheeks, forehead, and neck. At 43 years of age, the patient received her first dose on 07-Oct-2003. Medical history: The patient's concurrent illnesses include seasonal allergies and a "serum-sickness like allergy" to penicillin and sulfa. The reporter indicated that the patient had no history of adverse reaction to "TIV flu vaccines." Product details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 07-Oct-2003. Dose regimen was 0.5 mL (intranasal). Concomitant therapy: Concomitant medications were not reported. Event details: Three hours post-immunization, she experienced headache, nausea, tachycardia and erythema on her cheeks, forehead and neck. She returned to the physician's office where her vital signs were reported to be normal. She left the physician's office after lying down for a period of time. A the time she left the office, "everything had resolved except the erythema." No additional information was available at the time of this report.
shivers, fever (107 degrees), headache, body aches, slightly disoriented (lost track of time, but that could be due to fever), seriously sore arm, stomach upset
patient presents to Occupational Health to receive Adacel Vaccine -- returns 2 days later with erythema/fever at site, complains of fatigue, chills, feeling shaky -- given Keflex 500 bid x 10 days to rule out infection
37yo M with 6 days of diffuse, constant chest pain after receiving J&J vaccine on 16JUN.  Patient reporting SOB and increased symptoms when laying flat.  Patient hypertensive on exam, otherwise vitals wnl.  CV/PULM exam unremarkable.  EKG nsr.  Concern for possible post vaccination pericarditis vs myocarditis vs much lower concern for PE.  Patient counseled on findings and escorted to the ED for further evaluation and treatment.  Patient will f/u after clearance from ED.  Pt was sent to Medical Center. Pt was given a cardio referral. Had a full lab work up, and x-rays. Pt has been seen in clinic  multiple times for follow up and continued chest pain.  Pt also reports extreme fluid retention.
11-6-09-child had red spots on face in AM-1 hr later T-99.4-2 hr. later-lips-eyes had whelps then spread to whole body. PM-to ER-cause unknown-given BENADRYL IM-fever 103 degrees. 11-7-09-face swollen-large whelps-(size of hand) on trunk and legs-on prednisone 5mg/ml-2 tsp. BID. 11-8-09-whelps starting to resolve. 11-9-09-splotchy-areas flat. 11-10-09-has sm. dots on trunk and legs-none on face, resolving.
Pt came in for her 2nd dose of the moderna vaccine. Patient reported headache and dizziness after 5 minutes of vaccine administration (10:37 am). Pt able to ambulate to the monitoring room, tolerated activity. Pt laid down, Rn dim the lights and let the patient rest. VSS, HA = 8/10 but after 15-20 minutes, pt reported 5/10 HA and dizziness went away. Per pt she has migraine but usually goes away after resting and taking Excedrin. Pt felt better and discharge @ 12 noon.
Admin IM Hep B dose # 2 of 3 at approx 11:30 AM 6/30/09 w/o incident mom called at about 16:40 reporting that his ears turned bright red and swollen and a flat red rash was spreading cephalocaudally.
Sept 24th I started getting migraines and took my migraine meds and it didn't really help much. I continued on my day and took another dose that night. Same thing the 25th and migraine got worse. Took medication and didn't help. Sunday same thing. Monday I went to the Urgent Care and they could only give me a dose of Toradol which did nothing. Later that night I went to the ER and they gave me Decatron, Benadryl, Omnipack, Magnesium, Reglan, Sodium chloride, another dose of Sumatriptan and those meds took the edge off. They did tests and let me go. The next day I went to my DR and they gave me a dose of Toradol and promethazine and since then I continued taking my regular medication Sumatriptan and Fioricet. Yesterday was the first day I woke up without the migraine and with just a regular headache.
Information has been received from a 51 year old female consumer with (BACTRIM DS reported as BACTRUM DS) allergy, bronchitis and heavy smoker who on 01-OCT-2010 came-down with shingles because of her daughter's vaccination in 21-SEP-2010 with a 0.5 ml (also reported as 0.5 mg) dose of VARIVAX (Merck) (Lot# unknown), IM. There was no concomitant medication. The patient reported that on 01-OCT-2010, she developed chickenpox. The patient said "is had bronchitis and is a heavy smoker, which is believes is why she developed shingles". On an unspecified date, annual check-ups tests and blood work test were performed (results not provided). At the time of the report, the patient had not recovered. No further information is available.
atypical varicella w/fever, vesicles & ovoid macules typical of erythema mult w/onset 12 days p/vax;
Patient received a dose that was not needed. According to local records at the time of appointment, patient was due for her 1st booster but patient had already had on 2/2/2022. Patient was given an extra dose. She did not have any adverse reaction, but also should not have received this dose.
Vaccine was given at incorrect interval (7 weeks instead of 8 weeks). Pediatric Pfizer Bivalent (maroon cap) vaccine should have been given per standing order as the third dose.  Patient was given Pediatric Pfizer Monovalent (maroon cap) vaccine.  Physician on call was consulted and advised that Pediatric Pfizer Bivalent (maroon ca) dose should be administered at 8 weeks.  Parent was notified and advised to have dose repeated 2/14/2023 with Pediatric Pfizer Bivalent (maroon cap) vaccine.  Parent verbalized understanding and plans to schedule an appointment at that time.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, unspecified number of patients were vaccinated with improperly stored oral, ROTATEQ suspension 2 (lot # K016311, expiry date: 26-MAY-2016) (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
she is dying; her toes are turning black; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "she is dying"; NAIL DISCOLOURATION (non-serious), outcome "unknown", described as "her toes are turning black". The patient underwent the following laboratory tests and procedures: Protein total: Unknown results, notes: now every tissue in her body is riddled with spike proteins, her toes are turning black. Clinical course: she was dying in pieces because she got covid after she had the vaccines and now every tissue in her body was riddled with spike proteins, her toes are turning black. She was a perfectly healthy woman when reporter met her, had no problems until she got covid after she got the vaccine and now she is dying.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300147151 same patient and product, different dose and event;US-PFIZER INC-202300147865 same patient and product, different dose and event;
Shoulder joint & muscle pain at injection site. Unable to lift arm or lift weight with hand/ Arm
Rash on arm of injection, pimple like spot just above injection, itchy all over, and general icky feeling.
After waiting for 20 minutes at the parking lot, I drove home and started to have symptoms that included throat closing, a lot of congestion. This subsided after taking Benadryl. Dull headache for a couple of days; only slight pain at injection site.  On 4/4, I began feeling sick with headache, weakness, nausea. On 4/6, the symptoms were worse and finally dissipated later that day enough to work. These symptoms continued for several more days and now feel better.
pt recvd vax & later that mo presented to er w/ fever; severe weakness & tiredness; pt dx w/ neutropenia;
This spontaneous report was received from a registered nurse concerning a 33 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date the patient was possibly vaccinated with a dose of M-M-R II (dose, route and lot# not provided). On 25-JUL-2015, the patient received an unspecified type of blood test for serological testing of immunity for MMR. The blood test determined the patient to be seronegative for MMR titers. The primary reporter stated that it was unknown whether or not the patient received M-M-R II in the past. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Patient reported feeling faint as soon as she was injected then she fainted in the chair she was sitting in. Seconds later she had a seizure lasting approx. 7 to 10 seconds. When she woke up she said she'S had seizures before ?but not for a while?. She also said she hadn?t eaten that day. She rested in our facility's Clinic until she felt well enough to go home. In the Clinic she was given some glucose tablets and water and the NP checked her blood pressure. The patient consulted with her doctor by phone . When I spoke with the patient on 6/4/21 she had plans to see her doctor and possibly be referred to a neurologist.
Pt noted to have Syncopal episode, pale skin and diaphoretic, unable to arouse at this time, verbal stimuli attempted with no response, sternal rub successful ( patient responded with a audible groan). MD notified for evaluation. Paramedic summoned, 911 EMS summoned on scene for transportation. Pt alertness increased,  pt  became combative when onsite staff attempted to escort to ambulance, . Pt agreed to be evaluated. Hospital contact made by medic. Pt refused care. Scene cleared by vaccine site.
Moderna COVID-19 Vaccine EUA Occurring seven days after vaccination, redness and itching at injection site, spreading out to cover approximately 3-4inches circular pattern.
This spontaneous report was received from a licensed vocational nurse (LVN) and refers to a patient of unknown age and gender. There was no information about the patient;s concurent donditios, concomitant therapies or medcical history provided. On 23-MAY-2017 the patient was vaccinated with improperly stored dose of PROQUAD recombinant human albumin (rHA) lot # M036158 with an expiration date 12-FEB-2018 for prophylaxis (dose and route of administration were not reported). No adverrse effect was reported. Administered dose of PROQUAD experienced temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 6 hours and 48 minutes.  There was no previous temperature excursion. A digital data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA005346:
MILD FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 25-MAR-2021, the subject experienced mild flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild flu like symptoms on 29-MAR-2021. This report was non-serious.
Patient was given a 2nd dose of PVC13 instead of receiving PPSV23. Patient tolerated this well, no reaction.
REDNESS ABOUT 6 INCHES ROUND BELOW INJECTION SITE OF SHINGRIX VACCINE.
Sore arm, tiredness, every joint ached including my head - a screaming headache., and even my skin hurt.  Also my kidneys hurt but could have been from the fall when I fainted. Chills & fever, weakness and fainted. Better by noon but still have a headache and no energy.  Sickest I?ve been in 30 years. Won?t get a 2nd dose!!
given an expired ACTHIB vaccine,with no reported adverse event; Initial information received on 04-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was given an expired acthib (HIB (PRP/T) VACCINE) vaccine,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 03-Nov-2022, the patient received a first dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot UJ600AAB, expiration date: 29-Oct-2022 via intramuscular route in the left thigh as Immunization    On 03-NOV-2022 the patient was given an expired acthib vaccine,with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  A nurse looked at the actual powder component which expires on 30Nov2022. This was realized after the injection. Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (given an expired ACTHIB vaccine,with no reported adverse event).  At time of reporting, the outcome was Unknown for the event     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
scheduled for second dose 18 Feb 2021 but delayed due to snow storm; new appointment is now 12 Mar 2021, past the 36 day mark; headache; nausea; myalgia; chills; injection site pain; severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain), PRODUCT AVAILABILITY ISSUE (scheduled for second dose 18 Feb 2021 but delayed due to snow storm), PRODUCT ADMINISTRATION INTERRUPTED (new appointment is now 12 Mar 2021, past the 36 day mark), HEADACHE (headache) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history is provided. concomitant is provided.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach pain), HEADACHE (headache), NAUSEA (nausea), MYALGIA (myalgia), CHILLS (chills) and INJECTION SITE PAIN (injection site pain). On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (scheduled for second dose 18 Feb 2021 but delayed due to snow storm) and PRODUCT ADMINISTRATION INTERRUPTED (new appointment is now 12 Mar 2021, past the 36 day mark). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach pain), PRODUCT AVAILABILITY ISSUE (scheduled for second dose 18 Feb 2021 but delayed due to snow storm), PRODUCT ADMINISTRATION INTERRUPTED (new appointment is now 12 Mar 2021, past the 36 day mark), HEADACHE (headache), NAUSEA (nausea), MYALGIA (myalgia), CHILLS (chills) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received no treatment for the events.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.