chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED; SORE ARM/ARM PAIN; 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had a sore arm/arm pain, and later on died. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of sore arm/arm pain was not reported. This report was serious (Death). This case, from the same reporter is linked to 20210329044.; Sender's Comments: V0: 20210353764 - COVID-19 VACCINE AD26.COV2.S - Died. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Severe body aches, in bed next day severe body aches, sick to stomach. Sunday felt a little better. Ok Monday about 10pm.
Dizzy, nausea, lightheaded, tightness in chest, trouble breathing, dry mouth.
Information has been received regarding a case in litigation which concerns a male pt who during the period from the time of his birth through 9/99, was unknowingly injected with hepatitis b vaccine recombinant (yeast), Hib conjugate vaccine, diphtheria toxoid/pertussis vaccine/tetanus vaccinations containing the highly-toxic mercury-based preservative thimerosal. The alleged result of these vaccinations is that the pt suffers and will continue to suffer the toxic neurological and physical effects of mercury poisoning, extensive pain and suffering, emotional distress, substantially reduced ability to enjoy life, diminution of future earning capacity and his injuries will cause future expenditure on medical, hospital and related care. Upon internal review, toxic neurological and physical effects of mercury poisoning were determined to be "Other Important Medical Events". No further information is available.  Reported on 05/14/2003: "Follow up information received on 05/01/2003 indicated that the patient received injections of vaccines allegedly containing thimerosal on the folowing dates:  06/10/1998, 07/02/1998, 08/05/1998, 09/04/1998, 11/02/1998, 01/11/1999, 05/08/1999, and 08/16/1999.  Upon internal review, toxic neurological effects, toxic physical effects, mercury poisoning, extensive pain and suffering, emotional distress, substantially reduced ability to enjoy life, diminution of future earning capacity, and his injuries were determined to be other important medical events.  No further information is available.  Other business partner numbers include U2002-00125, F2002-00536 and MA2002-0080.
I received an influenza vaccination on October 27, 2003; I broke out in hives the following day.  I have been sporadically breaking out in hives during the past 2 months; specific reason for outbreak unknown.  I had no known allergies prior to the breakout.  Appears I may possibly be allergic to chocolate now, though not confirmed.  I saw a doctor and was prescribed prednisone and diphenhydramine.  Medication has had little effect.
Same day post vax, the pt experienced itching and whelps on left arm and right side of neck. Mom called ER and they recommended Benadryl. Itching and whelps resolved in one hour. Reappeared 4 days later and mom called ER, they recommended Benadryl again and it went away in one hour. One week later, the pt's lips swelled up and was given Benadryl and the swelling went away in about 2 hours.
On my ringer finger I have one of those little blisters/A little dot/Another spot is growing; Sometimes the elbow burns; The elbow itches on the side; Tiny little black thing above my wrist; I had bright red where they gave me the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (On my ringer finger I have one of those little blisters/A little dot/Another spot is growing), SKIN BURNING SENSATION (Sometimes the elbow burns), PRURITUS (The elbow itches on the side), SKIN DISCOLOURATION (Tiny little black thing above my wrist) and VACCINATION SITE ERYTHEMA (I had bright red where they gave me the vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced VACCINATION SITE ERYTHEMA (I had bright red where they gave me the vaccine). On an unknown date, the patient experienced BLISTER (On my ringer finger I have one of those little blisters/A little dot/Another spot is growing), SKIN BURNING SENSATION (Sometimes the elbow burns), PRURITUS (The elbow itches on the side) and SKIN DISCOLOURATION (Tiny little black thing above my wrist). At the time of the report, BLISTER (On my ringer finger I have one of those little blisters/A little dot/Another spot is growing), SKIN BURNING SENSATION (Sometimes the elbow burns), PRURITUS (The elbow itches on the side), SKIN DISCOLOURATION (Tiny little black thing above my wrist) and VACCINATION SITE ERYTHEMA (I had bright red where they gave me the vaccine) outcome was unknown.            No concomitant mediation was provided.  No Treatment medication was provided.
1/13 I received Dose #1 of the Moderna COVID-19 vaccine on 1/13 at 9am. I experienced no pain or other adverse effects at the time of injection. As the day progressed, I noticed mild pain and swelling at injection site.  1/13 At approximately 7pm, I noticed chills and fever. I took my temperature, which is normally at baseline around 97.6 F, and it was 99.0 F. I also noted mild fatigue and mild joint pain. I went to bed. 1/14 I awoke after approx. 8 1/2 hours of sleep feeling some tiredness and otherwise fine. Mild to moderate pain and swelling at injection site. Worked until 9pm. Around 7pm, I noticed mild lightheadedness,  mild fatigue, and mild muscle pain. When I got home, I ate, and began experiencing mild to moderate chills and fever with mild joint pain.  My temperature at approximately 10pm was 99.6 F.  1/15 I slept and have felt fine today. It is 6pm
Fever of 100 Chills Night sweats  Exhaustion and tiredness  Bruised injection site - quarter sized bruise  Sore arm from shoulder to fingertips - 3 days  Rancid and sensitive smell - start date 2/18/21
I broke out in rash that started on my right hip, small red bumps, and also itching on my back. The rash spread to my left side of my back and my inner left and right thighs. The rash leaves and returns. I have applied hydrocortisone; alcohol and itching lotion. I am still itching and the rashes have been worse once I am sweating or in the heat.
mild anaphylactic shock; Tachycardia; deep Flush; Missed dose; A spontaneous report was received from a nurse concerning a female patient of 27 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced tachycardia,deep flush and anaphylactic reaction.  The patients medical history was not provided.No relevant Concomitant medications were reported.   On 09 jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A ) vaccine for prophylaxis of COVID-19 infection.  On an unknown date,patient experienced mild anaphylactic shock to vaccine and developed tachycardia and deep flush. No Treatment information for the event was provided. At the time of the report it as 42 days since the first dose, and patient has not received the second dose.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event tachycardia,deep flush and anaphylactic reaction was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
5/17 This is a 92-year-old female with history of hypertension presenting with altered mental status.
Left wrist began to hurt and swell around mid April 2021. I went to Medical Office Building where it was discovered through ultra sound I had blood clots in my left wrist. I was immediately sent to the Advanced Care where I was told that I would not be able to go home and to call a family member because I had to remain for treatment which was an intravenous treatment then had to start immediate injections and medication. My wrist is in constant pain and I am unable to work due to the adverse reaction to the COVID 19 vaccine. Follow up appointment with Oncology 5/19/21, Follow up appointment with Primary Care Physician 6/17/21, US DVT Bilateral with Ultrasound-7/19/21
Information has been received from a health professional concerning a 9 year old female with an amoxicillin allergy who on 11/09/1995 was vaccinated SC with a first dose of varicella virus vaccine live. There was no concomitant medication or illnesses at the time of vaccination. On 02/06/2002 the pt developed a varicella rash. It was noted that the pt was not seen in the office. The outcome was not reported. Additional info has been requested.
PT had redness / swelling left arm (inject site) with pain. 4/1/03 - much improved. Minimal local pain.
Arm became red over a large area of the right arm. A red line extended under the arm pit causing a lump and pain. Fever for 1 day 102. Given methylprednisolone 4 mg x 21 for 6 days. Cephalexin 500mg x 21 for 7 days.
Parent reported Now-stop, high-pitched crying approximately 2 1/2 hours after vaccine administration. Patient evaluated in office. Afebrile 97/9 (R). Tylenol 80mg q 4h. Parent reported crying had stopped approximately 8 hours after vaccine administration.
severe violent  projectile vomiting of foam & bile; stomach spasms; arm pain; nausea; general weakness; headache; urticaria on abdomen & thighs; general muscle spasms; severe abdominal pain; This is a spontaneous report from a non-contactable consumer (patient).   A 52-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:30 (at the age of 52-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation, administered at Hospital.  Medical history included: breast cancer stage III Stage 3C breast cancer survivor, renal impairment chemo induced lower kidney functioning, obesity, asthma, Hashimoto's hypothyroidism, Known allergies: multiple antibiotics with anaphylaxis reactions, multiple foods tree nuts, melons, tomatoes, pork, etc. many with anaphylaxis reactions, environmental allergies like pine, grasses, pets, etc. various reactions. Patient was not pregnant. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); bupropion hydrochloride (WELLBUTRIN); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); ropinirole hydrochloride (REQUIP); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported.  The patient experienced severe violent projectile vomiting of foam & bile (medically significant) on 15Apr2021 20:00 with outcome of not recovered, stomach spasms (medically significant) on 15Apr2021 20:00 with outcome of not recovered, arm pain (non-serious) on 15Apr2021 20:00 with outcome of not recovered, nausea (non-serious) on 15Apr2021 20:00 with outcome of not recovered, general weakness (non-serious) on 15Apr2021 20:00 with outcome of not recovered, headache (non-serious) on 15Apr2021 20:00 with outcome of not recovered, urticaria on abdomen & thighs (non-serious) on 15Apr2021 20:00 with outcome of not recovered, general muscle spasms (non-serious) on 15Apr2021 20:00 with outcome of not recovered, severe abdominal pain (non-serious) on 15Apr2021 20:00 with outcome of not recovered. The clinical course of events was as follows: Day 1-3 minor, arm pain, nausea, general weakness, headache. Day 3-4 severe, headache, urticaria on abdomen & thighs, general muscle spasms, severe abdominal pain followed by 6-7 hours severe violent projectile vomiting of foam & bile needed Emergency Room treatment to stop stomach spasms. Therapeutic measures were taken as a result of events: patient received treatment with I.V. Zofran, Ativan, Compazine. COVID was not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced throat swelling, difficulty breathing and chest pain on inspiration just after leaving the office where she had received Gardasil and Adacel. Symptoms gradually resolved over 48 hours. She did not pursue any medical treatment until 48hrs later and did not take any medications.
Approx. 2 weeks after vaccine  on 3/26/2021 I start having itching, then having rash on my face, both hands, very little on my body . My hands and face were more serious. The others I did not scratch do much. It took almost to weeks to be gone. I did not take anything or put anything on it.  Approx. 2 weeks after 3rd does on 12/24/2021  I started having knee pain,  and feel cold. Nut no rash.   3rd dose - DOV: 12/24/2021  COVID 19 Moderna  Lot # 068H21A  at pharmacy.  4th dose - DOV: 10/20/2022  COVID 19 Pfizer Lot#  GH9691  at pharmacy.  I went to doctor after this vaccine reaction and was tested there.  Family Doctor seen Dr. visit  12/1/2022  Orthopedic Dr.  visit 11/29/2022
Had a vaccine attenuated no thimerosal in Jan 2010- Had flare of fibromyalgia symptoms- pain in back, legs and arms. Took anti-viral supps.
Patient was given Moderna vaccine but should have been given Pfizer vaccine based on patient age of 14.
Hives on arm and chest. Itchy throat. Settled several minutes later. Patient pre-medicated with oral benadryl (dosage unknown) prior to clinic. No further treatment required.
My son has his 11 year old immunizations yesterday and woke with fatigue severe nausea and high fever. Flush looking appearance. He is very sleepy as well. He received meningococcal vaccines and a Dtap.
Pt had infection under right arm. Doctor prescribed KEFLEX 500mg 1 capsule every 6 hours for 10 days.
I have been sick on and off since getting the vaccination and now have a 5-6 inch red welt on my left arm 1/21/21  at the insertion site of the vaccination.  I have extreme exhaustion at times and mild nausea, body aches, headaches, dull sore throat just like I had the 2nd day after the vaccination.  The symptoms don't last longer than 12 hours as long as I rest but then they come back.  I seem to have to rest much more than I ever have.  I usually can go from morning till night but every since getting the vaccine I feel like I'm getting the flu if I push myself just to work a normal work day.; has Hx Hashimotos
Itchy rash on arms, thighs, stomach, and neck. Swollen eyelids. Itchy throat. Worn down.
Rash/red spot left after 5-6 days. It?s now day 9 and my rash/red spot is back, hot to touch, itchy, raised and feels like there is a knot the size of a half dollar under skin.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 months old male patient who was vaccinated with a 0.5 ml fourth dose of PENTACEL Lot #C5409AA (DTap-IPV), lot:C5550AA (carton); lot:C550AA (HIB) via intramuscular route in the left thigh on 19-Sep-2018. The patient's past medical history, medical treatment(s) and family history were not provided. The patient had no other vaccinations. It was a case of actual medication error due to inappropriate reconstitution technique. On 19-Sep-2018, the patient had a visit to the doctor. 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 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. Documents held by sender: none.
sore throat; couldn't sleep well; UTI; dry hacking cough; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), INSOMNIA (couldn't sleep well), URINARY TRACT INFECTION (UTI), COUGH (dry hacking cough) and HEADACHE (headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), INSOMNIA (couldn't sleep well), URINARY TRACT INFECTION (UTI), COUGH (dry hacking cough), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). At the time of the report, OROPHARYNGEAL PAIN (sore throat), INSOMNIA (couldn't sleep well), URINARY TRACT INFECTION (UTI), COUGH (dry hacking cough), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Wrong Booster provided due to patient age. Patient received two Pfizer vaccines. Moderna given in error. No adverse symptoms that the clinic is aware off. Caught by audit.
Vial diluted incorrectly. Patient received 42 mcg of Pfizer vaccine. No adverse reaction reported by patient.
This spontaneous report as received from a approximately 90 years old male patient of unknown age reporting on himself. The patient had allergy for sorbitol and azithromycin (ZITHROMAX). The patient had no medical history. In February 2010 the patient was vaccinated with ZOSTAVAX (dose and route of administration were not reported). Concomitant therapies included simvastatin(ZOCOR), lisinopril(manufacturer unknown), furosemide(LASIX), dorzolamide hydrochloride (+) timolol maleate(COSOPT), latanoprost(XALATAN) and aspirin(manufacturer unknown). In May 2016, the patient developed shingles in his eye and forehead. The patient saw his ophthalmologist, who prescribed something expensive for the shingles infection. Lab diagnostic studies were not performed. The patient's condition was unresolved at the time of the report.     Additional information has been requested.
RED HOT ITCHY AREA ON ARM APPEARED ABOUT 1 WEEK AFTER SHOT RECEIVED. LAST ABOUT 1 WEEK AND WENT AWAY TEMPORARILY THEN REAPPEARED FOR A SHORT TIME. DID NOT REQUIRE ANY MEDICAL CARE. PATIENT APPLIED ICE AS NEEDED.
RECEIVED LESS THAN 0.5ML OF VACCINE AS THE INITIAL DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) (Dose number in series: 1) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced received less than 0.5ml of vaccine as the initial dose (0.3ml). On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as the initial dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked.
Hurt like heck; product preparation error; intercepted medication error; This case was reported by a nurse via call center representative and described the occurrence of pain in a 22-year-old female patient who received Rabies NVS (RabAvert) (batch number SWQK49AA ?, expiry date 31st October 2022) for prophylaxis.   On 4th June 2019, the patient received the 3rd dose of RabAvert. On 4th June 2019, immediately after receiving RabAvert, the patient experienced pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain to be related to RabAvert.  Additional details were provided as follows: The patient received only diluent portion of the Rabavert vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that it hurt like heck. The nurse will reconstitute the powder with 1 mL of sterile water for injection and administer to the patient.
This spontaneous report refers to a 17 month old female patient. The patient did not have any pre-existing physician-diagnosed allergy, birth defects, medical conditions or illness at time of vaccination. Historical vaccines included ROTATEQ, RECOMBIVAX HB,  PREVNAR 13, and FLUBLOK. On 18-SEP-2018 the patient was vaccinated with VARIVAX lot # N035940, expiration date: 18-DEC-2019; M-M-R II lot # N025894, expiration date: 19-SEP-2019; VAQTA lot # R006210, expiration date: 22-APR-2019; PREVNAR 13 lot # W11304, expiration date :31-MAY-2020; FLUBLOK lot # UT6259KA, expiration date: 30-JUN-2019; QUADRACEL, lot # C5254AA, expiration date: 18-SEP-2019; ACTHIB, lot # UI899AA, expiration date; 17-SEP-2019 (dose number, route and anatomical location were not provided). All the vaccines were administered for prophylaxis and purchased with public funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which ocurred at the time of storage in clinical practice. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002765: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1809USA010598.
Significant local swelling of arm from shoulder to hand. Swelling now resolving and patient able to use arm again.