chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt describes sensation of needle "hitting some thing" on entry. 6 hrs later developed pruritis with mild generalized "almost" "rash, GI upset". Denies fever, vomiting, diarrhea. Generalized s/s resolved 12/15/09 noc. L arm now hurts when lifted or rotated. Shoulder area and "pops". PHN advised rest and ice this pm with F/U phone call 12/17/09. 12/17/09 08:10 Pt reports pain to arm "popping" noise gone.
dizziness; soreness at injection site; This is a spontaneous report received from a contactable reporter consumer or other non HCP.  A 37 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Mar2021 11:00 (batch/lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient, prior to vaccination, was not diagnosed with COVID-19. Concomitant medications included: HCG. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: DIZZINESS (non-serious) with onset 25Mar2021 11:30, outcome "recovering", described as "dizziness"; VACCINATION SITE PAIN (non-serious) with onset 25Mar2021 11:30, outcome "recovering", described as "soreness at injection site". The patient, since the vaccination, has not been tested for COVID-19. Therapeutic measures were not taken as a result of dizziness, vaccination site pain.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 years old adolescent and unknown gender. On 10-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot number J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt. had seigure like activity and was sent to women and children's ER. 10/23/08-records received for DOS 10/8-10/9/08-DC DX: Seizures. Presented with seizures in ER. No fever. Loss of consciousness.
2-3 days later pt devel bronchocongestion, pneumonia, fever, flu-like sx, fatigue, vomiting, anorexia; recvd chiropractic therapy & PCN for x 10 days;
Death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Death) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant products were not provided.  Treatment medication were not reported.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Rash began 3/23/04 mostly trunk , a little in arms and legs with 1 episode of vomiting without URI or GI symptoms. There is no itch or pain. The rash increased significantly around 3/27-3/29/04 and resolved completely on 3/30/04. There was no fever. 3/29/04 exam. T 9. Maculo-papular non confluent pink. 2-3nmm on trunk (to groin area). Small amount on area. None on legs, palms, soles. Small amount bimalar. Eyes without erythema.
This study case was received from the investigator in a trial on 01 July 2011. A 23-year-old male subject, with no significant medical history, received an injection with ACAM2000, lot number not reported, on 04 February 2011. On 22 February 2011, the subject had a normal troponin I, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 22 February 2011, a diagnosis of unspecified disease of pericardium was made. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Covid test result= Positive; Covid test result= Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 at 09:30 as dose 1, single (Lot number: EL3247), in left arm, on 16Feb2021 at 11:00 as dose 2, single (Lot number: EL3247) intramuscular, in left arm and on 14Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 53 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. It was reported that the patient had no known allergies and no other medical history. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "Covid test result= Positive". On 12May2022 at 13:00, the patient reported having symptoms of congestion and very mild cough. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: Nasal Swab Covid test type. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021169419 Same patient and drug, different event separated in time
Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: had fever 103F, stomach pain, unable to get out of bed, headache, muscle pain in arms and legs, fatigue. takes 2 capsules of advil every 4 hours to manage symptoms. fever/chills is now gone. adverse effects lasted 1 month after the first dose and 2 weeks after the second dose. pt states she has not seeked medical care for any of this and has not notified her provider. previously had covid march 2020 and was hospitalized 4 times. states benefit of vaccine outweighs risk for her.
I have been experiencing the subjective sensation internally of heat on the top of my ears and scalp. My ears also feel warm to the touch compared to my fingers.  Sometimes it makes me feel like the room is hot when I know it is not.  This has been happening on and off for 6 weeks since shortly after my first shot.
WRONG VACCINE GIVEN. WAS GIVEN A TDAP INSTEAD OF A DTAP.
Total body rash appeared on the third day post-vaccination.  treatment with Benadryl and cold compresses
After client waited for observation 15 min.  and he left clinic.  He then returned a few minutes after from the parking lot and complained of feeling hot and lightheaded.  He appeared pale and diaphoretic.  He did not lose consciousness.  He was taken to an exam room, evaluated by an MD who was working in the Clinic.  The MD stated he felt he had a vasovagal reaction. He was observed for approx. 30 min. and evaluated again by the Dr. prior to leaving.  Upon leaving the Clinic the client did not appear pale and was not diaphoretic.  He stated he felt fine other than being a little tired.
Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129934, 2014SA129941, 2014SA129950, 2014SA129951, 2014SA129955, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were unknown. On 15 September 2014, same day after vaccination, the patient presented with elevated heart rate, low grade fever and increased respiratory rate. Corrective treatment and laboratory details were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none. Follow-up information was received on 12-Nov-2014 from the healthcare professional. It was reported that a 25-years-old patient, since vaccination, his lungs are not fully recovered that patient had more breathing issues and has more asthma attacks than usual. The patient had asthma as previous history. The patient had not received any other vaccine within 4 week prior to influenza vaccine. The patient had received multivitamin, albuterol and PZN concomitantly. The patient had no illness at the time of vaccination. It was reported that the event elevated heart rate and low grade fever was resolved.
Pt showed up for second pfizer vaccine this morning, she was already very anxious about receiving vaccine, she has a phobia of needles. I went out and spoke to her about the vaccine and administered. She immediately said she felt hot/dizzy and needed something cool. I gave her an ice pack and instructed her to do deep breathing exercises. We continued to talk and take her mind off the vaccine. She said she was feeling better and I told her I wanted her to wait to make sure she was okay. She continued with the ice pack and resting in the booth. After her time was up waiting I checked in with her and she said she felt much better and was going to head home and then said this happens all the time after receiving vaccines.
Sudden symptoms of severe vertigo occurred 03 May when repositioning during sleep. The room spun for 5-10 seconds followed by severe nausea on at least 6 different occasions. Saw PCP 04 May thinking I had a migraine, was diagnosed with vestibular neuritis and prescribed meclizine and zofram to control dizziness and nausea. Dizziness/vertigo continued to be severe for 48 hours from first instance.
A few minutes after receiving the vaccine, the patient began to feel dizzy.  After sitting in a chair for a few minutes she felt too weak to remain seated, at which point the patient was moved to the floor.  The patient said she experienced some tightness in her chest, and 911 was called.  EMS arrived within a couple of minutes.
This is my 3rd time filing this form because their is an error. Hopefully it takes this time Severe SOB, numbness and tingling of hands, legs, and feet. Cramping of thumbs where they are claw like and cannot move. This lasted for 4hours Severe dizziness/vertigo with intractable nausea and vomiting  Took 2 meclizine and zofran at home ER gave 1L NS, zofran, toradol, and valium
P/last dose of Rabies vax 17NOV90 devel muscle aches, h/a, fatigue & nausea on 25NOV90 & 19NOV90; Also had urticarial rash; As of 28NOV90 pt still feeling tired;
Pain at injection site as soon as vaccine administered and has not abated. Shoulder pain. Physical therapy ordered.
Friday afternoon, felt mildly feverish. Friday evening, fever 101; Motrin took fever away. 6 PM Sunday, 11/21/04, fever 100.5; successfully treated with Motrin.
The evening of the vaccination on 10/4/17, the patient states she had a lot of pain which kept her awake. The following morning, she experienced a high fever and headache at 5:00 AM and her arm became red with bumps and slight itching. When she presented at the pharmacy at 3:30 PM she had a 2.5" x 2.5" red splotchy patch where the vaccination was given and stated it was somewhat itchy. Patient was advised to take BENADRYL and contact her doctor. I marked the area with pen and told her if it got any bigger than the area, was hot to the touch or she saw any red lines, to call her doctor immediately or go to the ER.
The afternoon after receiving the injection, pt reports redness around injection approx. the size of a softball and pt c/o itching. She did use BENADRYL OTC cream. The morning after pt notes that the redness had spread down to her elbow. States the itching improved and the redness may have improved slightly. Minimal edema noted. Pt using BENADRYL OTC cream. Encouraged pt use oral BENADRYL, continue cream, apply cold packs and an NSAID.
(Left arm) swelling, redness, itching in arm.  Just above injection site to the elbow, inside of arm is very itchy.  Mild fever & very tired.  Slept for 12 hours straight, the next night.  Large lump at injection site.
Headache- lasted 12 hours; 24hrs after injection Tachycardia at rest (hr 106); chest pain; flushing/feeling very warm; flushing/feeling very warm; elevated BP 136/96; This is a spontaneous report from a contactable Nurse reporting for himself. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 17Dec2020 10:45 AM at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included mild coronary artery disease (CAD), Migraine, Psoriasis, and allergy to Sulfa Medications. Concomitant medication included atorvastatin (LIPITOR), finasteride, cetirizine hydrochloride (ZYRTEC]), aspirin, melatonin, biotin, zinc, ergocalciferol (VIT D), ascorbic acid (VIT C), ubidecarenone (COQ10), fremanezumab (AJOVY), and adalimumab (HUMIRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache- lasted 12 hours, 24hrs after injection tachycardia at rest (heart rate (HR) 106), chest pain, flushing/feeling very warm, elevated blood pressure (BP) 136/96 on 18Dec2020 10:30. Symptoms lasted for about 2 hours. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event headache was recovered on 18Dec2020 22:30 (lasted 12 hours), the outcome of the other events tachycardia at rest (heart rate (HR) 106), chest pain, flushing/feeling very warm, elevated blood pressure (BP) 136/96 was recovered on 18Dec2020 (lasted about 2 hours).
55 patients received a dose of a vial after 12 hours of initial puncture; Vial stored in refrigerator once punctured, in freezer prior to puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture). On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications provided.
This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 10-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
neck and shoulder ache; neck and shoulder ache; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Support. A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced neck and shoulder ache on an unspecified date in Mar2021. He asked if the events were symptoms from the vaccine. No unaddressed medical questions referred or forwarded to medical information. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Migraine, nausea, muscle fatigue, vomiting, fever, dizziness. All symptoms started at 4am (12 hrs after shot) and continued to get worse throughout the day where I could not sit up or move my body. The sickest  I ever felt in my life. I was also dehydrated and could not swallow from the nausea and vomiting.  I could not open my eyes from the pain in my head.  Taken to the ER at 4. Left the ER with an excruciating headache still but was able to stand and get into the car.
Narrative: A 49yo female w/ PMH of Rectal Bleeding, Carpal Tunnel Syndrome, Migraine. PTSD, Guillain, Barre Syndrome, Pain in joint shoulder region, Low Back Pain and Hypothyroidism. On February 7, 2022 the patient present to healthcare facility to reestablish care. It's documented she was last seen in 2009. Healthcare facility reported the patient had a historical ADR of Moderna Covid-19 vaccine induced fatigue described as extreme fatigue and sleepiness. No other information was provided. ( vaccine lot#, exp date, where administered, administration site and who administered the vaccine-are not on patient's immunization record and were not provided by the reporting physician)
This spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 10-JUN-2014 was vaccinated with (Oka/Merck) PROQUAD lot# J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Mild sz w/fever 101F lasting less than 20sec; Has sz in afternoon & was hospitalized;
Patient stated that she stated experiencing  dizziness and extreme weakness and she was very disoriented. Patient also stated that she was off balance. 911 was Called and transported patient to the ER. Patient stated that she is very tired and weak.
Chills that developed to a fever, high fever, lethargy, pain at injection site, numbness of digits on injection arm, Neck pain on side of injection, dizzy spells for 24 hours after injection, Lethargy for 72 hours afterward.
This spontaneous report as received from a certified Medical Assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On 06-SEP-2016, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot no. M023383/expiration date- 11-MAY-2018, lot no. M019642/expiration date- 20-APR-2018, lot # L026412/expiration date- 15-JUL-2017, lot # L019126/expiration date- 27-MAY-2017, (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of event was unknown. No PQC(product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Loss of sensation of taste  Generalized body aches/ joint pains which became increased from moderate to severe.  Severe Lower back pain( without any prior strain/ any injury)  this lower back pain was followed with left sided knee pain, the pain was on the scale of 8.  The lower back pain and knee pain started on 20th May 2021.   These symptoms started a few days after the vaccine but progressed over the next two weeks.
Left side of face paralysis, primarily noted in mouth and left eye.  Can not blink left eye, continues to tear up.  Left side of mouth does not move while trying to smile/eat/talk.  Emergency Room visited 1/24/20.  MRI, CT Scans run to determine if stroke occurred.  Diagnosis  is Bells Palsy with seven days of steroids prescribed (Prednisone 20mg - two tabs once per day).
I had/have swollen glands in my arm pits that sill is persisting on 9/27/21.  The glands hurt when being touched as well as when when not.
Initial information received on 20-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional via other company (Pfizer). This case involves a consumer of unknown age where temperature was out range going to 1.7 MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect storage. It was unknown whether vaccine was used or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.