chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer (patient's mother) and refers to her 17-year-old non-pregnant female daughter. The patient had no pertinent medical history. She did not have any known drug reactions or allergies. The patient's concomitant medications were not reported. On an unknown date in 2009 (reported as sometime in 2009), the patient was vaccinated with a dose of GARDASIL (dose, lot# and expiry date were not reported), via intramuscular route of administration for prevention of human papilloma virus (HPV). On an unknown date, the patient received second dose of GARDASIL. On an unknown date in 2009 (reported as sometime in 2009), the patient developed graves disease, lupus, had removal of her thyroids and developed hives after receiving GARDASIL. She saw multiple physicians and the events required multiple visits at the hospital. The patient received unspecified treatment for the events and multiple unspecified tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and vaccine was not provided. Upon internal review, the events of graves disease, lupus and removal of her thyroids were considered to be medically significant. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1810USA009407:
Quarter sized hives on  elbows, arm pits, and the side of torso.  My hands also felt swollen and hurt to use.  Symptoms appeared 20 hours after shot.
Student received H1N1 vaccine 12-10-09 around 2 PM. He came to the school clinic 12-11-09 at 8:22 AM stating he began having a headache starting the evening of 12-10-09 and it continues this morning. Took ADVIL 11/11 tabs 7:30 AM 12-11-09.
Patient woke up the day after vaccinations with fever of 103 degrees. She was very fussy and had quarter- sized red lumps on each thigh where vaccines were given. They were hot and warm to touch but redness not spreading. Lumps hard and painful. Patient seen in office 3/13/09, told to use TYLENOL and cold compress as needed.
pt states she had swelling and warmth in the left arm.  Two days later the arm is still red and swollen around the injection site.  Pt has taken 4Tylenol in the past 48 hrs for her symptoms.
Arm had been sore but noticed last night about a inch below the site of injection there was a red spot that was red and hot formed. It?s about inch wide and two inches long.
COVID; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: The patient wanted to know how long she needs to wait to get the Pfizer COVID-19 Vaccine 2nd booster dose after she had Covid 2 weeks ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & was brought in early this AM by mom found pt in bed w/sz; dx severe ear infect & treated w/ATB;
Started with HA, vomiting, Diarrhea, chills, profuse sweating on 11/1/09 @ 2:12 AM. TYLENOL x 2 nights. Nov. 2 MAXALT and TORADOL - Given TORADOL inject. x 5d.-6d. Went to ER on Nov. 8 @ 9-00AM - Given DILAUDID, PHENERGAN - Admitted. Home on Nov. 9th - Same Sx on 10th. -Given TORADOL and LORTAB, ATIVAN and Sx are continuing. Started Verapamil Nov 9. TID.  11/13/09: Patient summary report and CT head scan received for date of service 11/02/09. Diagnosis: Headache-Migraine  Patient presented with complaint of one day history of headache, which had worsened. Pain located at top and front of head. Orientated X3. Glasgow Coma Scale 15. Pain scale of 6. Treated withToradol and Maxalt and subsequently pain scale of 2. Patient discharged home./rem   11/13/09: Hospital records received for dates of service 11/08/09 -11/09/09. Diagnosis: Recurrent intractable headaches, Malignant hypertension, hypokalemia.  Patient presented with complaint of intense daily headaches staring in the evening and waking her up at night. The patient has experienced sweating, vomiting, nausea, diarrhea, chills and feeling shaky with the headaches. The patient's daughter noted that the patient seemed confused and seemed to contract the abdominal muscles and have difficulty breathing while sleeping. The headaches started two days after receiving H1N1 vaccine. Treatment with Toradol has been helpful. In the emergency room, the patient was bradycardic (HR 53) and blood pressure was 200/90 mmHg. The patient was treated with Latetalol and Dilaudid and admitted. The patient was orientated X4 and was alert. Neurology consult noted possibility of seizure disorder and also noted that symptoms occurred the day after receiving the H1N1 vaccine; whether this was associated with the H1N1 vaccine was not known./rem Hospital admission date 11-8-09. Hospital discharge date 11-9-09. Please update information include discharge date.
Client complained of swelling and redness  to site of injection and radiating down arm. She also complained of facial and legs swelling. Client received vaccine at 10:30am and symptoms started around 11pm that night. Symptoms resolved per client on Monday 5/31/2021. Patient did not seek medical care, symptoms resolved on its own.
Hives, itching, rash, swelling of the face and injection site, all presented about 4 hours after vaccination with rapid worsening. Went to ED. Treated with Benadryl and decadron.
Arm (from shoulder to elbow) itched, burned, swollen, flaming red. Was given prescriptions of famotidine and prednisone.
2 minutes after administration of GARDASIL, the patient developed dizziness, diaphoresis, cold clammy skin and hypotension (BP: 75/38 2 min / 2 min 79/48). The patient was continuously monitored until fully recovered. Last vitals.
received varicella inj 9-10-some local reaction started 9/11-this am arm very sore-4" area of erythema with cluster of blisters in the center-some brusing serrous fluid. "8cm x 7cm erythema and induration with 1 cm blistered area" Covered with Telfa and paper tape cold pack to area as often as able
Pain to left deltoid area/shoulder. Unable to elevate arm. Community ER - 11/25/18. X-ray done in ER - employee states was told were negative. Prescribed Ibuprofen 600 mg and FLEXERIL 5 mg.
My heart went into an irregular rhythm , felt like it was pounding out of my chest.  I have not had this problem since being placed on Metoprolol.  This continued for a week an a half coming and going at various times.  It got so bad I almost ended up in the ER  on 3 separate occasions.  Reported this to my primary care doctor.  The  events have ceased as of 8/21/21
Arrives to the ED c/o COVID-like symptoms of cough, congestion, dyspnea for the past 7 days. Txs zinc, singulair, antitussives and antipyretics,empiric doxycyline,supplemental 02.
Vaccine given outside of CDC recommendation for administration. Rcvd VARIVAX #1 on 3/17/08: the received VARIVAX #2 on 10/8/08. Patient experienced no known adverse effects. Error found on random chart audit.
pt recv vax ID inadvertently 0.1 ml;following vax,pt passed out;MD reported that pt was afraid of injections;no further details;
Patient was given the first dose of SHINGRIX on Saturday 5/12/18 around 12pm. Patient reports she noticed adverse reaction that same night. She had a fever that lasted around 24hr of 100F, itchy all over her body, really sore arm at injection site difficult to raise, red and inflamed at injection site. Patient came in Monday 5/14/18 around 3pm to report this incident and she stated that she hadn't taken anything for the reaction. I suggested BENADRYL and hydrocortisone OTC to help with her symptoms. Also recommended that she call her doctor to inform him of reaction and see if she needed any other therapy. She will call us to let us know the outcome of reaction.
Shingles right side of face; Shingles right eye; swelling left side of face; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles right side of face), HERPES ZOSTER (Shingles right eye) and SWELLING FACE (swelling left side of face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A29A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] and PREDNISONE for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced HERPES ZOSTER (Shingles right side of face), HERPES ZOSTER (Shingles right eye) and SWELLING FACE (swelling left side of face). At the time of the report, HERPES ZOSTER (Shingles right side of face), HERPES ZOSTER (Shingles right eye) and SWELLING FACE (swelling left side of face) outcome was unknown.
8/24/2021 I got vaccinated with MODERNA in Pharmacy at 9:30am. Side effects for the next hour. I could not feel my left arm (vaccine), body weakness, lack of strength mostly in my extremities. Sickness, feeling faint, cheek cramps, hot feeling running down my body, hot feeling in my head. Interference in the brain: I could not keep my thought straight, clumsiness speaking, words would get stuck, I was difficult to talk. Bad coordination, I was bumping in to everything in the house (wall corners, table, fridge etc.) I'm not hungry. I had a Enema and brain interference got a little better. I had some breakfast and my nausea  got better. Around 4pm pain started in the area of the injection. The other symptoms are getting better. 25/some/21=24 hours later. Sharp pain at injection site. Hot head and on the sides cold sensation. Some cramps on cheeks. Mild brain interference came back. Body cramps mainly in hands and abdomen.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pituitary gland removal" (unspecified if ongoing), notes: Pituitary gland removal , Caller states that she had this procedure done 25 years ago; "Has no pituitary gland" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE taken for hypopituitarism. Vaccination history included: BNT162b2 (Dose: 1, she had no issues with the first dose of the vaccine., Lot Number: EM9810, Anatomical Location: right arm), administration date: 11Feb2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, Lot Number: EN6199, Anatomical Location: right arm), administration date: 05Mar2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "Confusion", "falling". The following information was reported: CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "unknown", described as "Confusion"; FALL (non-serious) with onset Oct2021, outcome "unknown", described as "Falling". The events "confusion" and "falling" required emergency room visit. Additional information: The patient spent the day in the emergency room in Oct2021. She stated that she was instructed to, and did, increase her dose of Hydrocortisone each time she received a dose of the vaccine. For other medicines Hydrocortisone, she stated that she had been taking this medication for 25 years since her pituitary gland was removed. Stated that she had no issues with the first dose of the vaccine. She had problems after the second dose and both booster doses. She stated that after the second dose of the vaccine and the two boosters; the following day after all three them she experienced confusion and falling. Stated she was hospitalized twice and spent a day in the Emergency Room after her first booster. She stated that after her first booster dose on 20Oct2021, she spent the day in the emergency room, she was not admitted to the hospital.Sender's Comments: Linked Report(s) : US-PFIZER INC-202201049977 same patient/drug/event, different dose;
Regional erythema and edema 1 inch below injection site. TX: KEFLEX x 10d, Prednisone x 5d, cold therapy.
red ring around injection site; itchiness around injection site; headache; arm numb; arm pain; covid toe; This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP letter via follow-up letter. A 60-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0172) via an intramuscularly administered in arm right (upper) on 30Apr2021 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729) via an intramuscular route of administration in left arm (upper) on 09Apr2021 at 11:30 AM (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included bacterial infection from an unknown date and unknown if ongoing (prescribed with metronidazole, today she stopped taking it) and lymph nodes surgery under her left arm in 2004. Concomitant medication included metronidazole taken for bacterial infection. On 30Apr2021 at 12:30, the patient had covid toe, arm pain on 30Apr2021 at 20:00, arm numb on 01May2021 at 06:00. On 02May2021 at 06:00, the patient experienced red ring around injection site, itchiness around injection site and headache. Therapeutic measures were taken as a result of arm pain, arm numb treatment taken as Ibuprofen, red ring around injection site, itchiness around injection site, headache treatment taken as hydrocortisone cream. The outcome of events covid toe was recovered on Apr2021, arm pain and arm numb recovered on 04May2021, red ring around injection site, itchiness around injection site, headache were recovered on 10May2021.  Follow-up attempts are completed. No further information is expected.
Upon internal review significant correction was performed to update suspect product coding on 30 Oct 2015. Initial unsolicited report received from a nurse on 25 September 2015. This case involves a 37-year-old female patient who was vaccinated with a [dose not reported] intramuscular (dose series not reported) dose of FLUZONE (batch number UI443AA, expiry date was not reported) in left deltoid on 25 September 2015. On an unspecified date of 2014 "previous year" patient had received a dose of Fluzone. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as iodine. Other medical history and concomitant medications were not reported. On 25 September 2015, an hour following the vaccination patient had facial angioedema hive like. It was reported that, patient required emergency room (ER)/doctor visit. Patient laboratory investigation and corrective treatment was not reported. The outcome of event was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event facial angioedema hive like. List of documents held by sender: none. Addendum: 30 Oct 2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to change product coding. Sender's Comments: Angioedema is listed with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented and additional information including patient's medical history of allergy as well as results of investigation identifying the culprit allergen are needed to further assess the case.
Pt given shot Sat 830A. Returns at 930A with urticaria all over body, no difficulty breathing. Given 1/2cc CELESTONA IM and 1tsp BENADRYL PO. 1030A pt left office without difficulty breathing and redness not as bad.
Tuesday, the day after my shot I had afib, headache, fever, chills and abdominal pain.   Abdominal pain did no resolve.  Thursday,  April 8th my Dr. sent me for a CTScan.  I was told I had an appendicitis and that my appendix would be removed the next day.  on April 9th my appendix was removed.
Patient received immunizations Saturday afternoon, the next morning she was feeling feverish and pain in the arm below the injection site. She stated that it was swollen and red. Patient took two ibuprofen every six hours. Did not go into the clinic until Tuesday, the healthcare provider marked the size of swelling and redness, and received a 10 day course of doxycycline the same day. Started doxycycline that night and could see that the redness and swelling has gone down by referring to the outline the healthcare provider drew. Patient states that she has had cellulitis before, about 15 years ago, from a spider bite. Reported to pharmacy that she received cellulitis from a flu shot on Friday, 10/12/2018.
Pt was administered flu vax @ approx 1215 PM 20NOV91 VS-nl; pt had taken flu vax previously remained in the clinic for 15 to 20mins p/inject; pt passed out on the golf course @ approx 2PM to ER dx MI; no evidence of allergic rxn;
Patient's right arm swelled up. It became painful and red. It was severe enough that he could not sleep. It happened several hours after the shot's were given. Patient experienced chills and a fever of 100.8. He had not tried anything for treatment.
Information has been received from a 61 year old female with sulfonamide allergy and no pertinent medical history who on 05-Jan-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (lot# not reported) for prevention of shingles. Concomitant medication included MSD. On 06-Jan-2009 the patient experienced swelling on her arm at the injection site and bruising. The patient sought medical attention. "Routine labs" were performed. At the time of the report, 08-Jan-2009, the patient's injection site swelling on arm and bruising persisted. Follow-up information was received from a physician on 15-Jan-2009. It was reported that on 07-Jan-2009 the patient with allergic to erythromycin experienced redness at the injection site after receiving ZOSTAVAX (lot# 66280/1617X). As of 15-Jan-2009, the patient's outcome was unknown. Follow up information was received via medical records which indicated that the patient was a female with osteopenia who on 05-Jan-2009 at 10:54 am was vaccinated subcutaneously with a second dose of ZOSTAVAX (lot# 662860/1617X). Concomitant therapy included MSD, calcium (unspecified), chondroitin sulfate sodium + glucosamine sulfate and vitamins (unspecified). On 07-Jan-2009, the patient visited the office and stated having erythema at the site of injection and no nausea , vomiting short of breath and chest pain. The physician impression was cellulitis vs. localized shingles vaccine reaction, and "openia". The plan was to encourage the patient to do weight-bearing exercise and take bisposhate. Vitamin D and immunoreactive parathyroid hormone were checked. The cellulitis was treated with KEFLEX and the area was marked. the patient was advised to call the office if the event became worse or was not improving in the next 48 hours. Deep vein thrombosis was doubted as well. Additional information has been requested.
I had headache, vertigo, fatigue, and body ache that evening of the shot. These lasted for about 2 days. Then on Dec 28th, I started having headache, body ache, diarrhea, congestive, running nose, fatigue, sore throat and coughing.  I went on the Dec 29th and got tested for Covid-19, positive result.  Most of my symptoms are gone since Jan 4th but the others are still ongoing.
injection site pain; fatigue; chills; myalgia; abdominal cramps; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-years-old male patient received first dose of bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 50 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: AVELOX" (unspecified if ongoing), notes: AVELOX. Concomitant medication(s) included: ELIQUIS; LEXAPRO; LOSARTIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "injection site pain"; FATIGUE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "fatigue"; CHILLS (non-serious) with onset 04Mar2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "myalgia"; ABDOMINAL PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "abdominal cramps"; ANXIETY (non-serious) with onset 04Mar2021, outcome "not recovered", described as "anxiety". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, myalgia, abdominal pain, anxiety.  Additional Information: The patient had no other vaccine within 4 weeks. Other medications in two Prior to vaccination: ELIQUIS, LEXAPRO, LOSARTIN. Prior to vaccination, the patient was diagnosed with COVID-19 and was not tested for COVID-19 since the vaccination. Allergies to medications, food, or other products: AVELOX. No treatment was received for the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccine was administered post excursion to patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received via Pediatrician. Agency number: 01286178.  This case involves a 36-year-old female patient whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] vaccine was administered post excursion to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  This case is linked to cases 2022SA390611, 2022SA392303, 2022SA391393, 2022SA390948 and 2022SA392531.  On 19-Sep-2022, the patient administered post excursion suspect FLUZONE QIV at dose 0.5ml once via intramuscular route in the left upper arm (lot: UT7695JA, expiry: 30-Jun-2023) for immunization with no reported adverse event (poor quality product administered) same day latency.  It was reported that "Pediatrician reported the administration of FLUZONE QIV NP to 6 patients after it was not suitable to use post temperature excursion. Caller states she previously reported a temperature excursion and products were determined to be not suitable to use and the product was still placed back in the refrigerator. Caller states that another physician used the products and administered them to patients post excursion."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown.     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.
Within 2 hours of injection I began to feel achy in my joints. By 8 hours I had chills and fever.  Significant redness at injection site and hot to touch. Took ibuprofen for fever, which seemed to help reduce fever. Still redness and hot at injection site nearly 40 hours after injection. Continuing ibuprofen to reduce swelling with some success.