chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Menactra Vaccine as per request. About 5 minutes post immunization, she had a syncopal episode and had jerking movements. She was assisted to supine position and vital signs obtained. EMS 911 was requested. Orthostatic BP performed. 92/58 mm Hg BS 100 mg/dl. Recovered spontaneously after 2 - 3 minutes.
I got the shingles shot / I got shingles/ Suspected Vaccination failure; I got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got the Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Attendee was found laying on his back on the floor of the observation area and appeared pale skin, eyes open. breathing effortlessly.   Attendee was assessed by me and I asked him his name. No response. Said Hello,  can you hear me? Attendee responded "yes".   I asked patient to tell me how he was feeling and he said I feel dizzy.  Blood pressure was taken 152/ 66 pulse 76 SpO2 98%. Attendee informed he appeared to have fainted. Stated he did not have any symptoms or problems like this after first dose. States he did have breakfast.  Remembers walking to chair after shot and was watching Anime on his phone and then I asked him if he could hear me. Patient denies SOB, chest pain, no S/S of swelling, itching , redness, denies headache. Sat up with assistance on floor. Offered saltine crackers and Nestle sugar water which he drank. Patient stood with assistance back to chair. No symptoms of nausea, vomiting, headache or dizziness. Second BP taken 132/66 Pulse 66, SPO2 99%. Attendee rerported he drove himself to clinic. Advised to call for ride home. Patient called his father who arrived and identified to pick him up at 11:58. Observed patient until father came and answered questions from father. Home care instructions reiterated. Attendee walked to exit by me.
chills, nausea, headache.  Chills lasted several hours, nausea and headache over 24hrs
she had a miscarriage; was pregnant when got the vaccine; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (she had a miscarriage) in a 34-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3915B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (1st Dose, Lot number: 012L20A) on 14-Jan-2021, Moderna (2nd Dose, Lot number: 031M20A) on 05-Aug-2021, Moderna (3rd Dose) on 22-Oct-2021, Moderna Bivalent (4th Dose and Lot number:  AS7140C) on 06-Sep-2022; for Product used for unknown indication: Flu Shot (one week ago). Past adverse reactions to the above products included No adverse event with Flu Shot, Moderna, Moderna, Moderna and Moderna Bivalent.    On 29-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (was pregnant when got the vaccine). On 01-Nov-2023, the patient experienced ABORTION SPONTANEOUS (she had a miscarriage) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 29-Sep-2023, MATERNAL EXPOSURE DURING PREGNANCY (was pregnant when got the vaccine) had resolved. At the time of the report, ABORTION SPONTANEOUS (she had a miscarriage) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a 34-years-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Abortion spontaneous, which occurred approximately 1 month after SPIKEVAX 2023-2024, administered as fifth dose within COVID-19 vaccination schedule, at unknown weeks of gestation. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live significant follow-up received contains historical vaccines added, suspect drug information updated, event added.
8-30-19 hives on palms, fingers, moving to scalp . I carry a prednisone burst RX due to previous allergic events, started the burst 60mg for 5 days, famotidine daily and Benadryl 25mg at night to help with itching. After burst completed, still have uticaria , another burst course following the same routine.  At completion of 2nd course, took OTC loratadine antihistamine for 2 days to manage symptoms at physician's suggestion.  9-15-19 experienced  angioedema in the mouth, hives on feet and scalp, went to ER. BP and pulse rate were WNL, ER physician placed on long prednisone taper  60mg daily for 5 days, 30mg for 3 days, 20 mg for 3 days, 10 mg for 3 days. After finishing the taper, 24 hours later angioedema occurred in mouth and throat took 25mg Benadryl, adm EPI PEN, famotidine. Went to Urgent Care clinic, adm 125mg Prednisone IM injection. RX prednisone 40 mg taper, hydroxyzine HCL 50 MCG and famotidine.
Immunizations administered on Monday 3/27/06. On Tuesday 3/28/06 noted small red area in right deltoid. By Wednesday 3/29/06 site larger, hard, warm to touch. Area 9 cm X 8 cm.
Had tightness in chest about 30 minutes after he left the health department. EMS reported this to me. I called him later that day and he said he felt fine and did not go see a MD.
Severe fatigue, body aches and head aches. Swollen lymph nodes under arm and in neck. Low grade fever. Sore throat. Insomnia.
anaphylactic reaction/ Anaphylactic shock; Initial information received on 03-Feb-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via Agency.  This case involves a 90 years old male patient who experienced anaphylactic reaction/ anaphylactic shock (anaphylactic reaction), after receiving TETANUS TOXOID.  Reported that earlier in life, he received a Tetanus vaccine and did not have a reaction.  Past medical treatment, concomitant medication, family history not reported.  Before vaccination, the patient had car accident and was hospitalized.  On an unknown date in 2002, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. It was also reported that he was not sure of the exact name of the Tetanus vaccine because it was given to him after he was in an accident and his wife informed him that they gave him a vaccine.  On an unknown date in 2002, the patient developed a serious anaphylactic reaction/ anaphylactic shock (anaphylactic reaction) (latency unknown) following the administration of TETANUS TOXOID. This event was assessed as medically significant.  The reporter wanted to know that if he could get the Covid-19 (Coronavirus disease) vaccine because of the above stated.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event anaphylactic reaction.  Information on the batch number to be requested.; Sender's Comments: This case concerns a 90 years old male patient who had anaphylactic reaction, after vaccination with TETANUS TOXOID(produced by unknown manufacturer).The time to onset is unclear. Also reported that at the time of vaccination patient was in the hospital due to having a car accident. Previously, he received a Tetanus vaccine and did not have a reaction. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Child received MMR and Varicella vaccine and 1 hour later rash began to develop.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: blurry vision-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported leg weakness and blurred vision and dizziness/slight difficulty breathing upon getting ready to leave observation area. Said she hadn't eaten in a while and felt cold due to A/C in the store as well. BP was low and HR high, so called 911 to get her emergency help as she didn't feel like she could walk out of store safely. Felt strange and that her legs might give way. EMS arrived, vitals looked good, pt refused ambulance.
pt recv vax MAR96 & APR96 sx of shoulder & neck pain w/weakness LUE;clinical atrophy of supraspinatus, scapular spine, upper lt arm muscle masses;EMG/NEV acute partial denervation c-6 myotome vs upper trunk of brachial plexus
This spontaneous report as received from an office manager via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL series (lot # and route not reported). On an unknown date, "recently", the patient had an abnormal pap smear. At the time of the report, the patient's outcome was unknown.
With both doses of the Moderna Covid Vaccine, I developed a cough and nasal congestion the day the fever began, (the day after the dose in both cases) and lasted for one day after the fever left. I had a fever for one day with dose 1 and for 2 days with dose 2. The cough was minimally productive. With the second dose, I  felt as if I would cough with a deep breath. When I took a big breath in, the coughing could be induced, but was also spontaneous. The nasal discharge was clear. I have no cardiopulmonary disease, have never had Covid, and have had no Covid exposure. I have never had anything like this before. I am completely well now. I think this was vaccine induced.
This spontaneous report was received from a registered nurse concerning a currently 19 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot# N024567, expiration date: 07-SEP-2019; lot# N022995, expiration date: 23-AUG-2019 or lot# N017701, expiration date: 09-JUN-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of VARIVAX was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682: US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007505: US-009507513-1805USA007506.
Sweating; Throbbing headache; Soreness in left injection site arm; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Throbbing headache), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness in left injection site arm), PYREXIA (Fever) and FATIGUE (Tiredness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Throbbing headache), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness in left injection site arm), PYREXIA (Fever) and FATIGUE (Tiredness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of 7 Advil day.. On 23-Mar-2021, HEADACHE (Throbbing headache) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness in left injection site arm), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.    This case was linked to MOD-2021-302399, MOD-2021-028030 (Patient Link).
Fever, blood curdling screaming that evening.  Excessive sleeping for days afterward.  Fever on & off.
Injection site pain 4-36 hours after dose. Headache 12-36 hours after dose. Joint pain 12-36 hours after dose. Fatigue 12-36 hours after dose. Chest tickle 24-36 hours after dose. Tooth ache 4-36 hours after dose.
ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a health care professional 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 not reported, batch number: 1802070, and expiry: 25-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210808029, 20210811045 and 20210807548.
After getting my 1st dose of the Pfizer COVID shot, the very next morning, i noticed i could no longer bend my ring finger on my right hand.   I have had some "arthritis like symptoms" in my hands since about last summer 2020, and they seemed like they were getting somewhat better, but since getting the Pfizer first dose, those symptoms have gotten worse (like sometimes either of my hands fall asleep for no reason; pain in my hands; very stiff and cannot bend them to make a fist; other wierd feelings or symptoms in my hands).  In addition, i have not been able to bend the ring finger on my right hand anymore since the first dose on 4/11/2021.  This is completely new and the symptoms i have described have not gotten better since the first dose.   I was hoping this would all get better but since it has now been over 2 months, i thought i should report it.    i got the 2nd Pfizer shot on 5/1/2021. Thank you
A patient came in to receive his booster dose of Modera. He was administered the correct vaccine and dose, but it hadn't been exactly 6 months after the last shot of his primary series. His primary series was also Moderna, but he received his second dose on 6/3/2021. He still had 4 days to wait before reaching the required 6 months after for his booster shot. A nurse administered the dose. He waited his required 15 minutes and seemed fine at checkout.
Rash covering both hands, arms, left knee, both heels and feet with dry cracking/peeling skin on hands and feet with clear drainage noted by mom.
Pt went unconscious walking to the sitting area immediately after receiving their vaccine. Pt came to and recovered quickly. Pt reports this happens every time he gets a vaccine of any kind and is due to anxiety, not allergies.
The patient passed out while sitting in the waiting area about 15 minutes after the vaccine was given. They were pale but became responsive very quickly after the fall. After about 20 more minutes the patient was able to stand up and felt "all better". The paramedics were called and assessed the patient before the patient left.
I put my asthma in overdrive. Had to go the doctor and get meds and miss a few days a work. Two weeks later I have still having breathing problems and can't do normal activities.
This spontaneous report as received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. Since 04-JAN-2016, an unspecified number of patients were vaccinated with doses of ROTATEQ, oral, lot # L004453 expiration date 27-MAY-2016 (dose was not reported), which were exposed to temperatures outside of the recommended range, were given to unspecified patients. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt received 3rd booster covid vaccine on 12/27/21. Her LMP was 12/3/21, and she found out she was pregnant. Then on January 30th she started passing large clots. Ultrasound imaging on 2/1/22 showed patient was experiencing miscarriage.
Patient was a fine and healthly baby , up until the age of 8 yrs old , his feet started turning in he has had to date 4 surgerys on both feet and leg's , 1 eye surgery on all muscles on his eye's and he can not get up from the floor (laying down) nor bend over . his hands are so bad. he falls with out warning. We have been seen by several doctors and no one knows what is wrong with him. He has been tested over and over again, never and musle bio, they have told me that his mylan is beening ate away by his own body. And after reading about vaccine's , This the only thing that makes since. I have all info on everything that has had done to him for the last 6 years. I can make copies of all plus all doctor's cards of who we have seen and been, Also he was seen in several clinics. He is weak, cannot walk, falls, hands are bad. Legs hurt very bad.
Tiredness followed by chills and fever of up to 102.3 for 5 days.   After 5 days developed cough but no longer had fever. Started antibiotics prescribed by oncologist after 4 days of fever.    Arm is still sore after 7 days.
STILL PAINFUL HAND; SWOLLEN FEET; ZERO PERCENT TASTE BUDS; NAUSEATED; EXTREME EXHAUSTION; SLEEPY; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 06-AUG-2021 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 06-AUG-2021, the patient experienced sleepy. On 06-AUG-2021, the patient experienced headache. On 07-AUG-2021, the patient experienced swollen feet. On 07-AUG-2021, the patient experienced zero percent taste buds. On 07-AUG-2021, the patient experienced nauseated. On 07-AUG-2021, the patient experienced extreme exhaustion. On an unspecified date, the patient experienced still painful hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme exhaustion, and still painful hand, and the outcome of sleepy, headache, swollen feet, nauseated and zero percent taste buds was not reported. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose Number: 1, 2, 3 ; Pfizer/BioNTech, Dose Number: 4, 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Lot number: 047A21A), in left arm, on 16Apr2021 as dose 2, single (Lot number: 036B21A), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 045C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27May2022, described as "Moderna, Dose Number: 1, 2, 3 ; Pfizer/BioNTech, Dose Number: 4, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
She completed the series of Pfizer vaccines on 4/14/21. She was tested covid positive as outpatient on 6/21/21. She developed chest pain, dyspnea, dry cough watery diarrhea, and she was admitted to the hospital on 7/3/21. She is currently still hospitalized.
Pt exp vertigo & tinnitus 2 wks p/adm of Typhoid & plague vax; 50% fluctuating hearing loss appeared to be improving; ENT specialist believed may have been autoimmune response, not related to vax;
Acute tinnitus starting in the right ear within seconds of receiving the injection in my right arm. Within 1 week it moved to both ears.