chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
heart rate; light headed; This case was reported by a other health professional via sales rep and described the occurrence of heart rate increased in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 40 min after receiving Bexsero, the patient experienced heart rate increased and light headedness. On an unknown date, the outcome of the heart rate increased and light headedness were unknown.   It was unknown if the reporter considered the heart rate increased and light headedness to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After 40 min of Bexsero administration, the patient felt light headed and experienced heart rates between 78 to 118 beats per min.  Clinic stated they did report this to VAERS as well. The reporter agreed to follow up from GlaxoSmithKline.      Lab Comments: on an unknown date, lab test was done
Took two doses on consecutive days; Spontaneous report received on 30JAN2020.  A nurse reported that a consumer "took two doses on consecutive days" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. The consumer took the first dose of Vivotif on 28JAN2020 and then took the second dose on 29JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first and second Vivotif doses on consecutive days (Inappropriate schedule of product administration) instead of taking on every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first and second Vivotif doses on consecutive days (Inappropriate schedule of product administration) instead of taking on every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
After my second shot of the COVID19 Pfizer vaccine, I did get the fevers, chills, body ache, stiff neck/back soreness/pain, major headache, fatigue, and nausea/lightheadedness when standing. These started 15 hours after the vaccine was received.  Along with soreness of the right arm injection site. Some of these symptoms where for 24 hours.  So fevers, chills, and nausea/lightheadedness resolved first. I continued to have the sore right arm, body ache, stiff neck/back soreness/pain, and major headache for a few days after.    Two days after the vaccine,  I also noticed that my right armpit was sore and tender to touch. No lump or redness noted. It took a few days but that pain when away.  Along with the right armpit soreness, I noticed I had some numbness and tingling of my left arm and hands. It was intermittently to my left leg and foot. Felt like pins and needles.   Yesterday, I notices it also intermittently to my right leg and foot. I have never had  this prior to the vaccine. It still remains, but  feels like it may be more dull feeling today than yesterday.   I took Extra Strength Tylenol and Extra strength Excedrin headache for most of the pain. I added ibuprofen 4 days in to see if will help me feel better faster.
had mild case of rash p/1st dose;but had severe rash, hives all over the body & T101;saw MD (dermatologist) who recommended never to have hep b vax again;
a patient who received the 2 doses of the vaccine 4 days apart; a patient who received the 2 doses of the vaccine 4 days apart; Usual side effect of arm soreness, tenderness; Usual side effect of arm soreness, tenderness; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, NDC number, Expiry Date of Pfizer COVID-19 Vaccine: unknown), via an unspecified route of administration, administered in arm on 29Jan2021 13:30 (Batch/Lot number was not reported) as 1st dose, 30 ug, single, [30mcg injection to unknown arm] and received BNT162B2 via an unspecified route of administration on 02Feb2021 09:45 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient age at time of vaccination was 35 years. Medical history included ongoing depression and anxiety and looks like the patient has been getting treatment for depression and anxiety, further details unknown. Family history reported as none. Concomitant medications were not reported. HCP said that the patient had who received the 2 doses of the vaccine 4 days apart on 02Feb2021 and experienced usual side effect of arm soreness, tenderness on an unspecified date in 2021. The adverse events do not require a visit to emergency room and physician office and not hospitalized. No relevant tests performed. Prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The report assessed as non-serious. Outcome of the events arm soreness, tenderness was recovered on an unspecified date in 2021. Relatedness of the events was reported as unrelated.  Information about lot/batch number has been requested.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Felt tired the day of booster (11/11/2021).  The following day (11/12/2021) I felt very weak.  I went for a nap and when I got up I had great difficulty walking.  I finally made my way to the bathroom where I could no longer keep myself on my feet.  My legs felt paralyzed.  I slid down to the floor.  Had to call 911 for help.  I believe (as did the EMT's) that this was a result of the booster shot.
Redness/swelling at site of injection. Contacted MD -> pt. advised to visit urgent care. Was prescribed cephalexin 500 mg, #20 (twice a day) x 10 days. Follow up with pt. later today and Thurs 12/3/15.
After a month, I noticed that my arm muscle was still sore and hurt worse as the day progressed.  I continue to have difficulty raising my arm /elbow above shoulder height.  I often  reach up to pull something off a shelf and will lose ?support? of my right arm.   I am awakened at night by a throbbing pain if I lay on my while sleeping on my side.  My arm often feel ?limp?, as if I need to support it with a sling.  I can no longer type on the computer keyboard for any length of time before I have to stop and try to stretch my arm.   The pain is constant, but at different levels.  It ranges from a 3 to a 9 depending on how much activity I?ve engaged in throughout the day.   Believe it or not, I can press on the upper arm muscle and one spot feels bruised!    Since I?ve had neck and shoulder problems in the past,    so I first brushed it off as muscle spasms, but as time progressed, I began to believe that the pain is associated with the shot.   My left arm doesn?t have any of the problems AND it is still sore in one area of the muscle .    I?ve given the sore arm almost 4 months to correct itself, but am now seeking a doctor?s help.   I?m seeing my Family Doctor in a week and my back/pain doctor in April.   I am requesting that tests be run to see why the muscle continues  to throb and the arm has limited mobility.    I did get a Shingle shot the month prior to my Co-Vid shot, but didn?t have this issue until C-Vid shot.
Severe nausea and vomiting June 1-5, 2021 and July 22-24, 2021.
Fever 101.8, Tachycardia, dizziness, Severe malaise, Severe Right sided abdominal pain with peritoneal signs and tenderness in right upper and lower quadrant. Symptoms started approx 12 hrs after the injection and persisted till 50 hrs post injection. Symptoms were so intense that I had to take 3 days off from work
Pediarix vaccine expired 3/5/2023. Dose given 3/8/2023..
Feeling achey; Feeling tired; This is a spontaneous case, initially received from other non-health professional via Agency (reference number: SEQ19-03665) on 01-Oct-2019, concerning a 76-year-old, female patient.   The patient's relevant medical history, drug reactions or allergies were not reported.  The patient's concomitant medications included amlodipine, latanoprost and escitalopram.  On 23-Sep-2019, the patient was administered with administered Fluad vaccine [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, batch number: 260668, expiration date: 30-Apr-2020, dose, route of administration and anatomical location: not reported] for influenza prophylaxis.   On 25-Sep-2019, the patient started feeling achey and tired.  On an unspecified date, the patient stated she got back to her old new self. The patient wanted to know whether the adverse reaction would go away in two weeks.  At the time of the initial reporting, the outcome of the events of feeling achey and tired was recovering/resolving.  The reporter assessed the case as non-serious but did not provide causality assessment.  Non-significant follow-up reported by Agency (reference number: SEQ19-04469) on 11-Oct-2019: Additional Agency reference number added. No changes in narrative.; Sender's Comments: A 76-year-old, female patient has experienced pain and fatigue associated with Fluad (TIV). Chronology seems plausible. The patient's relevant medical history, drug reactions or allergies were not reported. The patient's concomitant medications included amlodipine, latanoprost and escitalopram. Causality may be confounded with concomitant drugs however, information regarding starting date use and duration is needed in order to establish a proper casual relationship. Considering chronology, causality is assessed as possible related for both events.
Pt recvd 1st & 2nd dose of Hep B vax on 19OCT91 & 23NOV91 & 2 days following the 2nd vax pt devel Bell's palsy of the rt side; @ the time of the report, pt exp was still being treated; No further details were provided;
Patient is a 82-year-old female with past medical history of hypertension, neuropathy, restless legs syndrome, asthma presents to the ED for confusion that started today.  Patient states that she lives alone, she has aide assistant Monday through Friday.  Patient reports right knee surgery status post Knee fracture about a month ago and was discharged home after 3 days.  Patient states that she started vomiting blood and was admitted at a local hospital with hemoglobin of 5 and received 2 units hospitalize for 3 days and sent to a Rehab for 11 days.  Patient states on the way to his PCP for scheduled regular appointment today she was unarousable after falling asleep in the car.  Patient states that al Past medical history Asthma CHF? Back pain Bronchitis hyperlipidemia Heartburn High blood pressure IBS (irritable bowel syndrome)  Neuropathy Nocturia OA (osteoarthritis) Restless leg syndrome Seasonal allergies Cataract Glaucoma   Currently in hospital on 06/09/2022.
increased severe menstural cycles with clotting and pain that I never had before. Tinnitus in both ears.  Chest pain intermittently.
administering expired pediatric dose of Engerix-B on 4/19/2021 / vaccine was expired on 02/27/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 97LJ2, expiry date 27th February 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 19th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information provided were as follows: The age at vaccination was not reported. The patient was administered an expired pediatric dose of Engerix B. The reporter asked for how long it was good for after expiration. No other details given. The reporter consented to follow-up
SHOOK SEVERELY ALL THAT NIGHT; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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, multiple subjects received vaccine and shook severely all that night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shook severely all that night was not reported. This report was non-serious.
I was extremely tired, experienced weakness in my legs low grade fever up to 100.8 which last for a few hours, I took tylenol and it went away.  I had a headache and lightheadedness and soreness and a lump at the injection site. This all started around 24 hours after the injection, and feeling got worse as the day went on. Many of these has subsided 24 hours after onset. I am currently only experiencing fatigue and a headache and soreness with luno at the injection site.
This spontaneous report was received from a 72 year old female patient (registered nurse) referring herself. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection in an unspecified arm (strength, dose, frequency, lot #, expiration date were not reported) for prophylaxis. On an unspecified date, the unspecified arm in which the vaccine was administered became swollen with associated redness, significant pain and throat tightness. Treatment was given to treat the adverse events. The patient seek medical attention and contacted the physician's office. The outcome of peripheral swelling, throat tightness, pain in extremity and erythema were reported as recovering/resolving. The relationship between the events peripheral swelling, throat tightness, pain in extremity, erythema and PNEUMOVAX 23 were not provided. There was no product quality complaint (PQC) reported.
No additional adverse event.; administered a dose of PNEUMOVAX 23 that was expired; This initial spontaneous report was received from a pharmacy student and refers to a 51-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided. The report concerned 1 patient and 1 combination product.  On 11-MAR-2020, the patient was inadvertently vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R012632, expiration date 15-JAN-2020 (exact dose, frequency and route of administration were not reported) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
3 days after the 2nd dose my right arm become extremely itchy. The injection site is swollen and painful. This did not happen with the 1st shot.
Developed pertussis illness after 2 doses of DTAP (partially immunized) (3/26/08 and 5/29/08).
Welts and blisters (up to 1"), red hives and itching. The last outbreak 4/24/02. Dx: Urticaria.
HYPOTENSION 1/10/2022 METABOLIC ENCEPHALOPATHY  HYPOTENSION 1/10/2022 ALTERED MENTAL STATUS, UNSPECIFIED
This spontaneous report was received from a nurse and refers to unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported that Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a 83 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT COPLAINED OF DRY FEELING IN THRAOT. SHE HAS KXOF ANXIETY VITALS 108/76 100% O2 PULSE 76.  LISTENED TO HER SOUNDS WERE CLEAR.  SHE WAS SHAKY HAD NINITIALLY REFUSED CRAKERS OR GINGER ALE. RESTED THEN HAD GINGER ALE AND CRAKERS FELT BETTER LEFT WITH MOM.MUCH BETTER 2ND VITALS 118/64 100% O2
02/03/2023 I was having dinner and I started having chills, fatigue and felt not well. On 02/04/2023 I contacted my physician via a telehealth visit. I took a home COVID-19 test and was positive and I  was prescribed a course of Paxlovid. I was feeling better after 5 days.
I was walking out of my apartment building to my car inside the garage on Friday at 6:00 pm. As I was walking, my arms & legs began to feel heavy. By the time I reached the garage I was feeling extremely fatigued. I got inside of my car and thought to myself that I've never felt this tired in all of my life. I then felt very cold and decided it was best to go back upstairs.  When I into my apartment unit - my cats greeted me as if I was gone for an extremely long time - and I noticed the sun coming in through my windows when the sun should have been on the other side of the building at 6:00 pm. Both the cats & the sunshine told me something was very wrong. I looked at the clock - it said 8:08. I put on the tv and discovered it was 8:08 A.M. on Saturday morning. I had fallen asleep (or passed out) in my car from 6pm Friday evening until 8am Saturday morning.  I have no sleeping disorders & do not require naps during the day. Today I still feel fatigued, but only slightly.  From the time I entered my car at 6pm Friday - until the time I exited my car at 8am Saturday - it felt as though only moments had passed. I had no idea I had fallen asleep or passed out.
Starting 06/16/2022, I test positive for COVID. I went to urgent care and was prescribed antibiotics. I had very minimal symptoms: headache, nasal congestion and chest congestion, and very fatigued. These symptoms lasted for about 4 days then resolved.
An hour after taking the H1N1 vaccine, my throat was raw and I lost my voice. I have not had a voice since that day. I am a singer for my church and most importantly a teacher. I can barely talk most days and still have no voice. I called the doctor the day after I received the vaccine to report my symptoms. They said they would make a note of it. I was told I should get my voice back to normal once I have the baby. He is now over 6 weeks old and I continually have no voice. It is very scratchy and hard for others to understand me. It is very hard to teach! I was told to drink warm liquids to soothe it, and suck on cough drops. Nothing helps.
Pt. received MMR vaccine on 12/12/09. On 12/22/09 developed macular rash on chest. Which spread to back, groin and face. Also developed mild URI sx including low-grade fever and mild diarrhea. In office on 12/22 pt. febrile. Mother very concerned this was adverse reaction to vaccine.
Fetal Demise inside the pregnant mother at 5 weeks and 3 days, less than two months after taking the vaccine. Was alive on 12/30/2009 and discovered no heart beats on 01/05/2010
PT PRESENTED WITH RIGHT UPPER ARM REDNESS AND SWELLING X 1 DAY. NO FEVER NOTED IN CLINIC AND MOM DID NOT REPORT ANY FEVER TO US. EVALUATED BY ARNP AND WAS DIAGNOSED WITH POSSIBLE CELLULITIS OF THE RIGHT UPPER ARM. GIVEN SAMPLE OF BENADRYL 12.5MG EVERY 8 HOURS AND CEPHELAXIN 250MG BID X 7 DAYS. RETURN TO CLINIC AS NEEDED.