chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details were provided and no additional AE's were reported; An HCP is reporting an AE on behalf of a patient. The HCP reports that a patient was administered a dose of VARIVAX after it expired. The HCP did not wish to be contacted so no letter is being sent. No additional AE details were provided and no addit; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 24-JAN-2023, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), administered subcutaneously (strength and anatomical site of vaccination were not reported; lot number U002400, expiration date reported and validated as 22-JAN-2023) as prophylaxis (expired product administered). No additional adverse events were reported.
Pt. was given Flucelevax on 10/6/2022 and a repeat dose was given on 11/17/2022.  Pt. reported some mild aching in arm but denied any other symptoms.
UNSPECIFIED ADVERSE REACTION; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20220243783.
Sudden hearing loss on 02/28/2021 in the left ear. First saw family doctor on March 5 , who then referred me  get hearing test and then to ENT specialist. right away. Dr gave me steroid injections for three consecutive weeks after audio tests every time. there was no regain of hearing. There was none found. . loss. I was asked to report back after 2 months to see if there was any improvement . There was no improvement.
experiencing some pain and do not know if its from the vaccine or previous condition from his stroke.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "experiencing some pain and do not know if its from the vaccine or previous condition from his stroke.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
very mild cold like symptoms; chills; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is 2nd of two reports.   A male patient (mid 40s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced 14 days after injection very mild cold like symptoms, chills, nasal congestion no congestion. The patient had not being tested for COVID. The pharmacist was not entirely sure if they were related to the vaccine. Wanted to know if there was any data on delayed onset side effects. The outcome of the events was not reported. Serious criteria for this case was no.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021005612 same reporter/drug, different patient
TESTED POSITIVE; This spontaneous report received from a patient concerned a 42 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: IVP dye allergy (Intravenous pyelogram dye). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: Unknown) dose was not reported, 1 total administered in left arm on 08-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). Age at time of vaccination 41 years old. The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 Vaccine) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered in left arm on 22-NOV-2021 for prophylactic vaccination. The patient received non-company suspect drug Pavloid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 05-MAY-2022 for Covid-19 treatment, therapy stopped on 07-MAY-2022. Concomitant medications included azelastine, beclometasone dipropionate, calcium carbonate, cetirizine, escitalopram, lisinopril, paracetamol and salbutamol for an unknown indication. On 24-MAY-2022, the patient tested positive (COVID-19 virus test) (Dose number in series: 2). Laboratory data included: COVID-19 virus test Positive. On an unspecified date, Laboratory data included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with Pavloid was discontinued. The patient was recovering from tested positive.  This report was non-serious. This report was associated with product quality complaint number: 90000234315.
pt states when she got the 2nd dose she got so tired she had to lay down and take a nap.   A few weeks later she states when she gets up from laying down she has to get up slowly because she gets so dizzy.  She says her head feels like it is spinning going around and around.  She had such a bad vertigo episode on 5/8/2021 she had to have someone help her to keep from falling down.  She is still having these episodes so will see her PCP on 5/25/2021.
Mother reports child developed fever of 104.7 not responsive to Ibuprofen. She took him to ER and they treated him with Tylenol with some improvement. Mom alternated tylenol and ibuprofen until 9/1/12 when fever finally normalized. On 9/1/12 child developed diffuse rash which lasted until 9/3/12.
Urticaria, facial swelling, with wheezing within 2 hours of receiving the influenza vaccine.
Pt had developed a blotchy, red rash, no hives, no itching. Pt did not take any medications. Rash has improved within the last 24 hours.
Per mom right arm became very red & swollen, oozing, spiked a 104.0 fever on 6/4/11. Went to E.R. Transferred to hospital admitted x 3 days, treated with I.V. antibiotics, dx cellulitis (vs) allergic reaction.
Itchy rash with redness of skin that started on the site of the injection, and spread to involve almost the entire body. Took Benadryl tablet, without relief. Came in to the office for evaluation on 7/11/16 with the same symptoms. Treated with 3 day course of oral prednisone, Cetirizine and Benadryl.
2 hrs following vax pt became blue in color, & began having seizure activity; pt was taken to ER given Adrenalin;
IM given in left arm 3rd dose. (Booster). Moderna Covid-19 Vaccine Lot 045C21A given was removed from freezer on 10/6/21 @ 11:45 am. Given on 11/5/21, out of time range. Patient contacted that evening. Moderan manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them. Called patient today 11/17/21 and let him know that Moderan let us know the vaccine was viable, no additional booster vaccine is required.
This spontaneous report received from a patient concerned a male of unspecified age. 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:unknown) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced brownish and scaly rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brownish and scaly rash was not reported. This report was non-serious.
Extremely painful period. The worst pain I have ever felt. I almost fainted from the pain and I was sick a few times. This lasted for about 3 hours when my period first started.  My period was one day late and the flow was normal.
Patient was instructed to wait 15 minutes before leaving the pharmacy.  During the 15 minutes, a team member on the store floor witnessed the patient faint and hit the floor.  Within 30 seconds, the patient regained consciousness and got up and sat back in the chair.  911 was called and EMS arrived within 10 minutes to evaluate the patient.  EMS determined that all his vitals were normal and allowed the patient to leave the pharmacy.
10/09/12 lightheaded, nauseated. 10/10/12 lightheaded, nauseated. 10/11/12 lightheaded, nauseated, tongue developed rash and dry mouth. 10/12/12, blisters around mouth, ran fever, lips began swelling. 10/14/12 began taking Benadryl for swelling. 10/15/12 went to private physician.
16JUN92 woke @ 3-4AM w/chills, h/a, dizziness, aching was severe lasted 24-48 hrs; 17JUN92 same sx but redness, less dizziness-some tenderness @ inject site, no swelling or redness;
I got the injection around 8:45 and felt fine until around noon, where my arm started to get very sore and I started to get a headache. I felt very fatigue for a few hours and my head was out of it. Around 7:00 PM I started to get nauseous like I was going to be sick. All the symptoms were gone by the next day except for the soreness in my arm.
This spontaneous report was received from a licensed practical nurse and refers to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection, lot number L031272, expiry date 19-NOV-2016, (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of -3 degrees Celsius for 6 months. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This resident sustained 2 seizures, 45 minutes apart, and an elevated temperature of 101 F  on 2-19-21. The first seizure occurred at approximately 8:45 am and the second at approximately 9:30 am.  The resident does not have a seizure disorder or history of seizure activity other than 1 day after receiving the first dose of the same vaccine on 1-20-21.
Left arm pain that felt like I had been punched in the shoulder... lasted 2 days. Started 2pm Friday. Took 600mg Ibuprofen made pain slightly better. Nausea, fatigue, chills, headache... started 5pm Saturday lasted to Sunday morning.
Monotone mood; not eating; No ambulation/ still ambulation altering; Lethargic; Patient had a fever, but didn't check the degree/ 07/21/2022-that evening temp 104/ 07/22/2022-103 temp; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2396334-1. The original narrative from the sender is as follows:  07/20/2022-mom stated patient had a fever but didn't check the degree 07/21/2022-vaccinations give that morning-that evening temp 104, lethargic, not eating and no ambulation 07/22/2022-monotone mood, 103 temp, still ambulation altering Ibuprofen and Tylenol 07/23/2022-playing, no walking till that evening, no fever 07/24/2022-fever free, acts normal per mom.  When asked if child felt okay, no fever-guardian said yes. When the family called back with reaction, the child had been fevering the day before.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Monotone mood, not eating, no ambulation/ still ambulation altering, lethargic and patient had a fever, but didn't check the degree/ 07/21/2022-that evening temp 104/ 07/22/2022-103 temp".  No further information is expected.
Started off as aches and pains about 4 hours after vaccination then led to chills with shakes and shivering followed by flu like symptoms which lasted approximately 36 hours.
Breakthrough case admission after 2 vaccines Pfizer x2; Pfizer 2/15/21 Lot# EL9267;  Pfizer 3/8/21 Lot# En6199
Rash on abdomen and back. 5:03pm. Pt stayed 30 min. BENADRYL, steroids per Dr. ordered.
Local skin reaction from IMZ injection on left thigh (1" x 1" induration with 2" x 3" erythema).
Difficult breathing; fast heartbeat /pounding heart. Tingling of arms and hands; numbness of arms and fingers; tingling of face; Tingling of ears; Tingling of jaw; Tingling of throat; Dizziness; Could not swallow; Nurse took blood pressure and it was at 171; heaviness feeling of legs (as if they were being pulled down); Lips were swelling up (upper lip); I received Epi Pen in right thigh by center; Got a allergy pill with a bit of water after Epi Pen was injected into thigh/ I could swallow the pill and the water w difficulty; felt numbness even after epi pen was given in arms & hands; Went to ER by ambulance; At home, felt very fatigued; had rash in throat area skin and face (reddish/pinkish); My right arm has a pink hive at injection site; Soar Arm and heaviness & achy; headaches; Sensitive to light; Chills; muscles aches; my taste buds changed; Use inhaler more; heaviness feeling in legs; itchy skin all over hands and face and feet even more; currently very dry skin as if I went to the sun and got sun burned;  lymph nodes under arms are swollen; a bigger swollen lymph node under right arm is bigger; Very tired/ sleepy as if I have not slept / under eyes puffiness; Very forgetful; Joints hurt/hands & feet, shoulder area/legs; Heart pounds as if I were sacred; fast beating at times; tired when I walk; out of breathe even on short distance walk.
Wore up extremely tired,took temperature and had a fever of  99.4  couple of hours later I had a a headache that continued though the day.  Stayed in bed all day fever got higher by 4:00 p.m. took Tylenol
Developed sharp debilitating toothache in Molar #31 starting in the afternoon of 10/4/2022. Doctor visit, then dentist visit, then Root Canal specialist visit, finally terminating in tooth extraction on 10/11/2022. Dentist agrees that the abscess was likely there previously, but the vaccination probably overwhelmed the body's ability to deal with it setting off the sudden deterioration.
Initial report received 23 February 2009 from a consumer, who is the patient's parent.  A 14-year-female patient had received a first dose intramuscular right deltoid injection of MENACTRA on 20 February 2009 and she experienced an instant migraine with blurred vision post vaccination.  The patient was evaluated by her physician and treated with MAXALT X2 and Ibuprofen.  The patient also developed redness and swelling at the injection site.  The patient had a past history of mitral valve prolapse and had been receiving BICILLIN injections every month.  Her last BICILLIN injection had been on 20 February 2009, the same day as MENACTRA vaccination.  The patient had no concurrent illness at the time of vaccination and received MENACTRA vaccination as part of her routine well child visit.  The patient's recovery status was not reported.   This is a follow-up for report(s) received on 03/04/2009.  Follow-up information was received from a healthcare professional on 23 March 2009.  The patient had a history of migraine headaches, and had been hospitalized in January 2008.  MENACTRA Lot number was reported as U2639AA.  Per the reporter, the injection site inflammation had not been reported to the physician's office or to the emergency department.  The patient recovered.
Systemic: Fainting / Unresponsive-Severe, Additional Details: IMMUNIZERS WITNESSED PATIENT FALL OUT OF HER CHAIR AND LOSE CONSCIOUSNESS. THEY CALLED 911 AND MONITORED HER. LETTING HER STAY LAYING THEN HELP UP SLOWLY TO SEATED POSITION.  TRIED TO MONITOR BP, BUT AMBULANCE ARRIVED BEFORE THEY COULD GET CUFF ON.  PATIENT DECLINED GOING TO HOSPITAL.  FOLLOWED UP VIA PHONE CALL.
Soreness in R thigh above patella developed in mid March Acute Flaring of R knee in late March 3/31/2021 with pain, heat, and swelling that progressed over two days to inability to flex knee, raise leg against gravity when supine. Symptoms in leg resolved over 2 weeks with PT.  R-foot began to swell 2 weeks later with pain over and below base of R toe that progressed with heat, swelling, and redness over lower R-foot. Physician thought knee problems may be due to gout because of presentation so a prescription for a methylprednisolone was made available (6 day taper  (21, 4 mg tabs) instituted within 24 hrs of severe foot symptoms). Pain, swelling, and temp. elevation of foot began to resolve within 8 hrs or steroids.
Initially I felt agitated after injection almost immediately. That evening and every evening since I have had but I am going to call insomnia. Unable to fall asleep unable to stay asleep.  In addition my arm still aches at day 13, sort of the touch and I would describe it adult ache.
Dizziness, Myalgia. NauseaVomiting, "whoozy/weak" in his legs Dizzy, nausea, myalgia, "whoozy/weak" in his legs.
Pt was in the waiting room.  Approximately 5 minutes after getting the vaccine, pt's mother called out and said that her daughter is passing out.  Pt was found slump on the chair, slow to respond to my questions and diaphoretic.  Pt stated she feels hot.  Pt did not lose consciousness. Pt assisted to a room where she laid down.  Mother stated she's never had this reaction to vaccines in the past.  About 40 minutes later, pt sat up.  Pt c/o feeling cold and shaky for a little while, but stated she feels better.  Pt waited another 5 minutes and then discharged home accompanied by mother, in stable condition
It was reported that a 67 year old female pt received a Fluzone SV '00-'01 vaccination on 10/19/00. Reportedly, 24 hours post vax, the pt developed lack of mobility in both legs, also abdominal pain under her ribs. Dx'd as a mild case of Guillain-Barre Syndrome. Further information requested. From followup correspondence receivedon 12/18/2000 it was reported to ignore pt has had EMG that ruled out Guillian Barre. From the follow-up correspondence received on 05/14/2001, it was reported that the pt recovered from this experience.
This spontaneous report as received from a physician refers to a male patient of unknown age. On 03-JUN-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (L) subcutaneously. No concomitant medication was reported. The physician reported that, on 03-JUN-2014, the vaccine that have been administered to the patient that was kept out of range of temperature log. Additional information has been requested.
This spontaneous report was received from a pharmacist via a company representative and refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates in June 2017 (reported as within last month), the patients were vaccinated with PNEUMOVAX 23 (dosing details, route, lot/batch# were unknown) for prophylaxis. On unknown dates in 2017, the patients experienced redness and soreness (pain) that extended beyond the injection site which lasted for a couple of days. The events have usually resolved after a couple of days (unknown date in 2017). Causality assessment was not provided by the reporter. No product quality complaint was involved.
Patient was given an expired vaccine that was left out from the day before. He has reported no side effects except for a sore arm.
For the 24 hours after the injection, I felt like I had the flu--headache, bodyaches, chills, felt really bad. My left arm hurt from the injection site down to my fingertips.
Bleeding side effects; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 (mRNA-1273) vaccine and developed bleeding side effects/haemorrhage.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On a unknown date, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Within 24 hours of receiving the second Moderna vaccine, the patient experienced bleeding side effects.  The reporter stated that their physician did not know about the bleeding side effects. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, bleeding side effects, was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Pt presented to the pharmacy on Wednesday afternoon after receiving a PNEUMOVAX 23 on Monday. He had a red rash on the lower part of the upper arm. It was warm to touch. He also had a small rash on the upper trunk. He reported running a fever of up to 101F the night before.
Patient here for 1st dose of Pfizer. Has concerns of lightheadedness, nausea and anxiety after getting vaccinated. Juice provided. EMS called. Medics took over care for the patient, vital signs were reported to be stable. Patient was escorted to the post-vaccination observation area after reporting that he felt better and was okay to walk. Was able to discharge independently with family member following the adverse event.
Reports left shoulder pain. Started 9/30/21 when getting 2nd covid vaccines. At first it was localized soreness. He had COVID 10/25/21. Weakness in LUE started in first week of November that has progressively worsening. Now has pain radiating to left shoulder blade and difficulty lifing left arm. Needs R arm to guide left arm. Cramping in L scapula. He works maintenance and he is left handed. Pain was severe and constant muscle cramp last night 10/10. It is going numb. Had soreness in the past but no known injury to left shoulder. Had parethesias to bilat hands in the hands
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 17-APR-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot number and expiry date reported as 671416/1241AA and 12-APR-2013 respectively, dose and route unspecified) as the first dose. No concomitant medications were reported. No adverse event was reported. Additional information is not expected.
PATIENT HAD BEEN VACCINATED WITH PFIZER VACCINE IN APRIL 2021. PATIENT DID NOT DIVULGE INFORMATION AND RECEIVED JANSSEN VACCINE. WHEN ENTERING INFORMATION IN TO IT WAS SHOWN THAT SHE HAD BEEN VACCINATED WITH PFIZER. PATIENT THEN ADMITS SHE WAS VACCINATED WITH PFIZER PREVIOUSLY AND HAD WANTED JANSSEN THEREFORE SHE ASKED FOR IT. PATIENT INFORMED THIS WILL BE REPORTED FOR SAFETY PURPOSES.