chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 11-year-old male, who was vaccinated in the leg with a dose of hepatitis A virus vaccine inactivated. Suspect vaccination included a dose of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that the patient developed cellulitis and swelling in the leg which the vaccines were administered. He could not put weight on the effected leg. He was treated with steroids and diphenhydramine hydrochloride (BENADRL) and fully recovered. No product quality complaint was involved. This information is one of several reports from the same source. Additional information has been requested.
I experienced headaches, sore throat, fever, diarrhea, and vomiting for two days along with feeling very weak. I am still feeling very sick after receiving the vaccine.
On my left shoulder I had a reaction to the anthrax shot. This was my third shot. When I take off or put on a shirt it hurts to lift it. It itches sometimes. 9 x 11 cm area of erythema, pruritic, tender. Zyrtec, Motrin, HC 1%.
Rash (dermatitis) break out on chest; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0171) via an unspecified route of administration in the in the right arm on 26Apr2021 (at the age of 34-years-old) as a dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN) from an unknown date, for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 the patient experienced rash (dermatitis) break out on chest. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with hydroxyzine. On an unknown date, the patient underwent rapid COVID-19 test and the result was negative. The clinical outcome of the event of rash was recovered an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Patient tested positive for COVID-19 on 9/6, presented to ED on 9/14 and found to be hypotic. Patient transferred here and is currently undergoing inpatient treatment.
pt recv vax 15FEB97 & devel nausea which lasted throughout the next day & required best rest;no emesis or other sx;
Red rash on breasts and sides of chest, resolved 1 d later. Took cetririzine.
pt recv vax & devel sz assoc w/fever;body stiff, eyes rolled back in head;dx febrile sz;pt had another sz & cyanosis, apnea, emesis x2;vesicular pharyngitis;WBC 18.6;pt fussy, jaw shaking up & down, lethargic;pt recv OPV & 3 other unk vax;
Patient received first dose of COVID Pfizer vaccine. Approximately 10 minutes later, patient started complaining of an itchy throat. Rapid response nurse was called and patient was taken to the ED. Per ED note, patient also had chest tightness and cough. In the ED patient received famotidine IV, diphenhydramine IV, Duoneb, and IV methylprednisolone. Patient was later discharged from the ED. According to rapid response nurse and documentation in MAR, epi was not given during the situation. Patient has food allergies listed (shellfish, nuts), and codeine in Epic.
Arm (both), chest and leg. Hives; This is a spontaneous report from a contactable consumer, the patient. A 74-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in left arm on 18Mar2021 at 15:30, (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure. The patient was allergic to medications, food or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in left arm on 25Feb2021 at 15:30, as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient experienced hives over arm (both), chest and leg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient not received treatment for the reported events. The clinical outcome for event hives were recovering.   No follow-up attempts are needed. No further information is expected.
had a marked increase in depression; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included major depressive disorder (MDD), generalised anxiety disorder (GAD), post-traumatic stress disorder (PTSD), cervical cancer, multiple/recurrent lung infections and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included loratadine (CLARITIN) and ascorbic acid; herbal nos; levoglutamide; lysine; magnesium; manganese; retinol; riboflavin; selenium; tocopherol; zinc (AIRBORNE), both from unknown dates for unknown indications and unknown if ongoing. On 11Apr2021 at 08:00, for the next three days following the vaccination, the patient had a marked increase in depression. On 14Apr2021 morning, the patient woke feeling balanced. The patient reported that it was a dramatic difference, like a switch. However, the depression did come back the following week with even greater intensity. The patient believed that the first bout of depression was directly related to the vaccination, but was not certain if the second bout of depression correlates to the vaccine. Also, the patient was concerned to receive the second vaccine dose for fear of increased depression at an even greater rate. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event marked increase in depression for the next three days following the vaccination that came back the following week with even greater intensity was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a 66 years old male patient concerning himself. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route unspecified) on an unknown date. Concomitant medications included prednisone (manufacturer unknown), INDERAL, PERIACTIN, amitriptyline hydrochloride (manufacturer unknown) and pravastatin sodium. Patient stated that he was administered ZOSTAVAX and developed severe hives, welts, red hands, hot spots, tongue swelling and a lot of itching on an unknown date. Lab diagnostics studies of blood work was performed on 10-DEC-2012, 2 weeks ago, with no results provided. The events were not improved and the outcome of all events were reported as not recovered/not resolved. Additional information is not expected.
Temp of 103.7 within 24 hours of vaccine administration. Also developed headache, fever resolved the next day.
This spontaneous report as received from a licensed practical nurse refers to multiple patients' of an unknown age and gender. No information regarding the patient's concurrent conditions and medical history was provided. On an unknown dates, the patient were vaccinated with an unspecified number of doses of improperly stored VARIVAX (Merck) lot # K021484, expiration date: 03-NOV-2016 (dose, route of administration were not reported). The patient's concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
fairly severe rash; shortness of breath; not feeling at my best; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash, shortness of breath and feeling unwell. On an unknown date, the outcome of the rash, shortness of breath and feeling unwell were unknown.   It was unknown if the reporter considered the rash, shortness of breath and feeling unwell to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported  The patient had an adverse reaction to 1st dose of Shingrix. The patient nearly 3 weeks at the reporting date into a fairly severe rash shortness of breath generally not feeling at best since the injection. Any ideas as health care provider, the patient had seen and not witnessed this kind of reaction before. The only advice, the patient was getting is give it another two or three days.
Pt fainted after receiving second dose of Gardasil.  This also occurred after the first dose given with Menactra 11/16/07.
Complaining of stomachache, sore throat, congestion, cough  with several episodes of posttussive emesis.  Today she has had continuation of  symptoms.  Mother denies any fever, diarrhea, rash, lethargy, increased work of  breathing, chest pain, joint involvement, chills, bodyaches or ill contacts.  Medications: Benadryl and Tylenol last night at bedtime.  Her appetite has been  decreased but she is drinking well with good urine output.
Patient received Vaccine Booster (Dose 3) which had hindsight was expired past 10 weeks in refrigerator temperatures.  (10 Days Past)
Case previously recorded as MA2009-4287. Initial case report received from a pediatrician via agency, on 05 NOV 2009. A 9-month-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 100813) i.m., on 02 NOV 2009. No adverse events was reported. Agency reference no.: NA09-007607.
Patient received 3rd pfizer dose as requested. Pt presented to event, which only utilize paper consents, medical form from Dr was presented to vaccine coordinator and was allowed through event for a 3rd vaccine. This was not presented or discussed with staff.  Was found upon entering consents into state system. Note from physician states pt did not develop any antibodies after her first two vaccinations  per lab results.
fullness in throat when swallowing noticed within weeks of receiving 2nd Moderna Vaccine. Suspected thyroid nodules- when investigated further (2/2022) Internal jugular DVT on left side was discovered.  Vaccine cause is suspected because this is the only new change.
The patient experienced a syncopal episode approximately 10 minutes post-vax. The patient hit her head on the door and wall, and about 5 seconds later the patient came to and stated she's fine. The patient was reevaluated with a normal ultrasound and neurological exam.
facial swelling, nausia, vomiting and hives. treated with steroids and zofran
Low-grade fever began about 12 hours after vaccination. Pain in vaccine site (right arm) became intense. Arm was nearly immobile, pain radiated throughout the whole arm into the hand. Patient went to sleep, woke at 6:00 am, and was unable to go back to sleep because of arm pain. Patient got out of bed at 6:45 am, urinated, and went into the cabinet to retrieve Advil. Patient suddenly became very nauseous and went towards the kitchen to try to vomit in the trash can. Patient's roommate was in the living room and reported the patient was breathing heavily and stumbling towards the kitchen. Patient then collapsed on the kitchen floor. Roommate helped the patient sit up and the patient vomited for 1 minute. Patient began to recover and called her doctor. Patient has no history of fainting or vaccine/needle anxiety.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned 3 patients.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patients were previously treated with covid-19 vaccine (dose number in series 1) for prophylactic vaccination. No adverse events associated with pervious covid-19 vaccine were reported. (unspecified manufacturer)  The patient received an additional company suspect covid-19 vaccine ad26.cov2.s (dose number in series 2)(suspension for injection, intramuscular, batch number was 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 following vaccination with covid-19 vaccine ad26.cov2.s, three doses of expired vaccine were given to three patients as booster. (dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of expired vaccine used was not reported.  This report was non-serious.
Dizziness, burning up, tiredness, sore arm, diarrhea (started 05-05-21 and 05-06-21
Red rash ( no itch ) at axilla ,groin, *forearms, and neck Eyes are slightly puffy with slight pink face * Have some pictures of  representative rash area
I had a sore arm for about two days after receiving the vaccine. On 05/02/2023, I began not feeling well with a cough and congestion. I had a telehealth visit with a provider and was diagnosed with an upper respiratory infection. I got a prescription for an antibiotic. As of today, I am feeling a little better. I'm coughing less and the congestion is better.
Information has been received from a female who on 23-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot number, route and site not reported).  Concomitant therapy included ALVESCO.  On 31-JAN-2009 the patient had a burning sensation in the middle of her back that extends around in a ban pattern at her bra line.  The patient called her physician and was diagnose with shingles over the phone.  The physician told her to come in for an office visit if she developed a rash.  No rash at the time of this report.  The patient reported that the burning sensation improved when she stopped using her ALVESCO inhaler.  Additional information has been requested.
Breakthrough COIVD 19 infection in fully vaccinated individual resulting in hospitalization and ventilator use
feeling kind of beat up after; Consumer states he was knocked out; Neck pain; everything ached; all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (feeling kind of beat up after), FALL (Consumer states he was knocked out), NECK PAIN (Neck pain), MYALGIA (everything ached) and ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (was intubated). Concomitant products included APIXABAN (ELIQUIS), ROSUVASTATIN CALCIUM (CRESTOR), DOFETILIDE, COLCHICINE, PREDNISONE and LOSARTAN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling kind of beat up after), FALL (Consumer states he was knocked out), NECK PAIN (Neck pain), MYALGIA (everything ached) and ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (feeling kind of beat up after), FALL (Consumer states he was knocked out), NECK PAIN (Neck pain), MYALGIA (everything ached) and ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Consumer says he experienced side effects after 3rd Dose which was similar to 2nd Dose. Consumer says he took ibuprofen and Tylenol to alleviate the pain. But person in background says "u did not take ibuprofen"   This case was linked to MOD-2021-299897 (Patient Link).
She got the vaccine and immediately she had brain fever that came on immediately, her brain feels like it is swollen and  nothing she does help it.  She has an extreme splitting headache to where she feels her brain is going to go out of her head.  She has also had numbness and tingling down the right side of her body and into her tongue.   She cannot get to feeling better, she just keeps feeling worse.  She has taken Tylenol/Ibuprofen, and dr. put her on prednisone and gave her a Z-PA to see if this will alleviate symptoms.   Nothing she has taken has helped with it.   She feels as though her brain is swollen and that she going down hill.  She is a cancer survivor and cannot determine if having that has made her worse.   The pressure has gone to her ears, feels like it is going to burn her ear drums up.  She also has tinnitus with it as well.   She also has tinnitus and the headache that will not go away.   She has called her doctor many times and hasn't gotten any results back.
Patient has received 2 doses of Pfizer COVID19 vaccine (1st dose 3/20/21, 2nd dose 4/10/21) per PA Registry.  Patient has tested positive for COVID19 today, 5/20/21.  She presented w/ c/o chest pain x 2 days.  Admitted for observation on Telemetry unit.
pt recv vax;12 hr p/ recv both vax, devel hives;tx w/ DPH; recovered;recv 3rd dose, no problems;
Started feeling like kind of small lumps in that muscle or little below; redness; Muscle soreness; itching; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201, expiry date: unknown), via an unspecified route of administration on 06Feb2021 (at the age of 77-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included DILTIAZEM. Patient stated I take Tiadylt and it is, I think maybe to dilate blood vessels and rest of the stuff is over the counter. The patient received the vaccine on 06Feb2021 and experienced some muscle soreness. Patient stated, I just wanted to report that I received a Pfizer Covid vaccine on February 6th and experienced some muscle soreness. But on the 12Feb2021, I started feeling like kind of small lumps in that muscle or little below and some redness and by Saturday, redness was about three and a half inches in length and two inches wide and lumps are still there, you could see the lumps. Also, I could feel that knot, it is probably like an inch and a half big knot. I am just thinking if it was reaction. It itched a lot but I didn't really have any pain or discomfort with it, it just was red and little warmer to touch. No treatment was received for the events. The outcome of redness and vaccination site lump was reported as recovering, while the outcome of itching and muscle soreness was unknown.   Follow-up attempts are completed. No further information is expected.
Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, batch and expiration date not reported), via an unspecified route of administration, administered on the left arm on 26Jan2021 07:00 (at the age of 51-years-old) at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Workplace Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The patient experienced sore arm and diarrhea on 26Jan2021. Events were assessed as non-serious. Treatment was not received for the events. The outcome of the events reported was unknown.
Developed redness and swelling at injection site within 2-3 days of administration. Treated with warm compresses.
Headache, Myalgia, Fever, SORE ARM; SORE THROAT Narrative:
when they count the vaccines in the box, the number of lyophilized vials and diluent vials do not match; Hiberix was reconstituted with another diluent and administered to a child; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Hib (Hiberix) for prophylaxis.   On 17th October 2022, the patient received Hiberix. On 17th October 2022, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-OCT-2022 Reporter's comment: The administrator had stated that, it was possible that the Hiberix was reconstituted with another diluent and was administered to a child patient. She stated that when they had counted the vaccines in the box, the number of lyophilized vials and the diluent vials does not matched. The nurse who had administered the vaccine also does not remembered, if she had used Normal Saline (NS) or another diluent. No lot number or expiration date was available at time of call. The reporter consented to follow-up via mail. Additional supportive information: The patient was administered the Hiberix vaccine with another diluent, which had led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
headache, joint pain, muscle tenderness, dizziness, nausea, eye pain, ear ache,extreme tiredness, slept for over 24 hours. redness at site, with itching, and swelling.