chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain/a little worse; It feel sore every time I move from one side to another/Sore/Hurts when he coughs; It hurts when I cough; Short of breath; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old male patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solu-tion for injection, lot number: Solution for injection, lot number: EW0164, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in left arm on 19Apr2021 18:00 (at the age of 58-year-old) as single dose for COVID-19 immunisation (for Covid-19). The patient had no medical history. There was no family history. The patient did not take concomitant medications. There was no previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date as the Pfizer vaccine. Patient did not receive prior vaccinations (within 4 weeks). Patient experienced chest pain/a little worse on 19Apr2021, It feel sore every time I move from one side to another/Sore/Hurts when he coughs, It hurts when I cough, short of breath on an unspecified date in Apr2021. Patient stated he have received the first Pfizer shot and experienced chest pain. It feel sore every time he move from one side to another. It hurts when he cough." It was informed to patient that chest pain has not been reported with the vaccine. However, muscle and joint pain has been associated with the vaccine. Please seek medical advice if your symptoms persists or get worst. Chest pain is a symptoms that should not be ignored. Chest pain started late last night and its still sore, it hurts, the same, it was a little worse this morning, but he's laying down not moving around, so it still feels the same, verified as persisting. He did not treat the symptoms in any way. States he said he is going to take some Advil. Any adverse event did not require a visit to emergency room or physician's office. There were no relevant tests. The outcome of event for chest pain/a little worse was not recovered and for other event it was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
VR appeared to pass out, stiffened up and had seizure like activity, VR was sweaty and pale. Vitals were taken, pt presented hypotensive. VR regained consciousness. A&Ox4. Ambulance called and transported pt to hospital for further evaluation.
Patient received her shot and felt very weak within 24 hours.  The week of 4/4/2021 began to feel dizzy and stated she felt unwell.  Her blood pressure and heart rate were taken and she was having an elevated heart rate.  Her normal heart rate is around 50 BPM and her heart rate jumped to over 100 BPM.   This continued on and off for a couple of weeks.  The week of 4/18/2021, began having shortening of breath.    On 4/25/2021, was found in her home unresponsive. Suffered a stroke and was taken to a hospital.  She was transferred to a hospice unit on 4/26/2021. She passed away on 4/28/2021
Left arm has bruises at injection site. Irregular shape (2 inches length x 1 inch wide). No fever or any s/s complained. The bruise occurred next day after injection.
This spontaneous report was received from an unspecified reporter concerning a 20 year old patient of unknown gender. On an unknown date in June 2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On an unknown date in November 2011, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, and dose unspecified), intramuscularly. The third dose was never administered. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
blotch as red / blotch does not hurt or itch, but visible; Blotch is hot / producing heat; is bothersome; blotch near the injection sit; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (blotch as red / blotch does not hurt or itch, but visible), FEELING HOT (Blotch is hot / producing heat), IRRITABILITY (is bothersome) and VACCINATION SITE RASH (blotch near the injection sit) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jul-2021, the patient experienced RASH MACULAR (blotch as red / blotch does not hurt or itch, but visible), FEELING HOT (Blotch is hot / producing heat), IRRITABILITY (is bothersome) and VACCINATION SITE RASH (blotch near the injection sit). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (blotch as red / blotch does not hurt or itch, but visible), FEELING HOT (Blotch is hot / producing heat), IRRITABILITY (is bothersome) and VACCINATION SITE RASH (blotch near the injection sit) had not resolved.            Concomitant medication was not reported. The event blotch was 2 inches by 3 inches in oval shape.
My arm was sore and hurting for about a week. I took an ibuprofen. 2 weeks later I was sniffling and sneezing. I had a lot of snot. I had covid. About 2 weeks later after that I was negative. The coughing I had never went away. I have uncontrollable coughing that makes me puke. When I lay down it'll feel like I have heart burn. I would get a random wave of congestion. I also couldn't hear out of my right ear. I went to an urgent care and they said I have an ear infection and asthma. I also had irritation in my throat. They had gave me a prescription for asthma medication. They also said my lymph node is swollen on the right side. I was prescribed a 10 day course of antibiotics and a 2 week course of prednisone. I was prescribed Symbicort and a back up albuterol inhaler. They gave me a shot of antibiotics and shot of steroids. My ear is still a little achy, and my throat keeps hurting. I got an appointment on August 15, 2022.
This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 13May2021 (15:30) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included sulfa allergy. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient previously took hydrocodone, acetaminophen (VICODIN), and had drug allergy. On 14May2021 (20:30), the patient had a feeling of heart pain; and heart was beating fast. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Covid rash about 3 days after injection lasting for 2-3 days and tender, swollen axillary lymph node lasting about 5 days.
First muscle and joint pain of body and redness at injection site. Next morning, injection site was hard and redness grew to size of quarter, then half dollar. Muscle pain, itching and burning and pain of injection site continued throughout the day. Called doctor around 3pm was told it was my body's immune system reacting how it should. Took 800mg ibuprofen throughout day and night, also 60mg fexofenadine every 12 hours. Also applied ice as directed by doctor. Sunday morning, woke up worse pain and injection site size of a baseball and very painful, less itchy but still hard and hot. Plan on calling doctor Monday morning for further advice.
patient did not have any type of reaction; freezer went out of range after being checked on 11/19/2020; This spontaneous report was received from a nurse and refers to a 4 year old female patient. There was no information about the patient's concomitant therapies or medical history provided. The patient's concurrent condition included congenital metatarsus adductus (reported as Q66.22).  On 19-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot # T013540 and expiration date 17-OCT-2021) subcutaneously in the left thigh (LT) and diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL) (lot # C5656AA and expiration date 13-AUG-2021 ) intramuscularly in the right thigh (RT) for prophylaxis. It was reported, that on that day the freezer went out of range and wasn't checked again until the afternoon of 20-NOV-2020. The manufacturer was notified and all vaccines were labeled with an excursion sticker. The patient's mother was notified of the event and she was understanding. The patient did not have any type of reaction. A data logger was used to capture that temperature excursion, but no further details regarding the temperatures were available.; Sender's Comments:  US-009507513-2011USA013282:
Ever since the vaccine I experience anxiety at night. It can last anywhere from 3 hours to 5 hours.
Fever of 101.2. Would go down with MOTRIN. Highest was 102. Lasting from Friday until Sunday. 8 days after shots, he started with seizure like episodes that last anywhere from 5 to 15 secs and happen multiple times a day. Could happen once a day or happen 6x a day.
Called medical center 9/5/19 to report "since receiving Tdap vaccine  on 4/419 Has not been feeling well" Reports  "Fatigue, Brain Fog, Nausea & dizzyness" Reports under care of private HD who suggested he  "report Tdap possible reaction".
chills; tired; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 22nd January 2022) for prophylaxis.   On 2nd November 2019, the patient received the 1st dose of Shingrix. On 2nd November 2019, immediately after receiving Shingrix, the patient experienced chills and tiredness. On an unknown date, the outcome of the chills and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and since receipt had chills almost every day and was feeling tired.  The reporter consented to follow up.
Brief period of unresponsiveness about 75 seconds right after receiving nasal H1N1 (had received HPV several seconds previously), palor and nausea upon spontaneous recovery, followed by vomiting after drinking water
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history and did not had any known allergies. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 16Apr2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with inhaler.   Clinical course: It was reported that adverse event 2 to 3 days after finishing treatment, patient got a severe cough. Much worse than before treatment. All other covid symptoms were managed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
didn't receive her second dose until JUN-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (about four years ago, received first dose).   In JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: didn't receive her second dose until JUN-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 The reporter was a patient. The patient received first dose of Shingrix about four year ago from reporting time and due to cost she did not received her second dose until June 2023. The reporter did not consent to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Patient reported fevers as high as 105 at rehab and myalgias along with weakness, She was subsequently admitted to the hospital for these symptoms.
Receipt of invalid dose of vaccine. Pt did not meet age criteria for EUA product. It is anticipated that patient will receive second dose of Moderna to complete the series.
I was exposed on 12/25/2022 and symptoms started @ 12/26/2022 with upper body and skeletal aches, my fever started around 8PM the same day and it reached a high of 103 degrees. I tested positive for COVID-19 with a home rapid test. I contacted my doctor through my portal and due tome being high risk from Diabetes I was prescribed PAXLOVID, I took a five day course. Fever remained through day six. I tested negative on January 3 2023.
sick to my stomach; head hurt; fever; threw up once; felt nauseous; arm was sore; went up to my neck and lower shoulder; went up to my neck and lower shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), NECK PAIN (went up to my neck and lower shoulder), ARTHRALGIA (went up to my neck and lower shoulder), ABDOMINAL DISCOMFORT (sick to my stomach) and HEADACHE (head hurt) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0178B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), NECK PAIN (went up to my neck and lower shoulder) and ARTHRALGIA (went up to my neck and lower shoulder). On 05-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to my stomach), HEADACHE (head hurt), PYREXIA (fever), VOMITING (threw up once) and NAUSEA (felt nauseous). On 05-Apr-2021, VOMITING (threw up once) had resolved with sequelae. At the time of the report, PAIN IN EXTREMITY (arm was sore), NECK PAIN (went up to my neck and lower shoulder), ARTHRALGIA (went up to my neck and lower shoulder), ABDOMINAL DISCOMFORT (sick to my stomach), HEADACHE (head hurt), PYREXIA (fever) and NAUSEA (felt nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient started excessively blinking very hard on the ride home from the doctor's office.  I knew that she was very nervous about receiving the shot so I didn't worry so much until the next morning when she was still blinking hard.  I called her doctor in the morning and reported the situation with her.  She recommended I see an eye doctor, of which I did the same day.  She does have allergies but the hard blinking is not from that.  My daughter never did this. EVER.  7/25/13 I called the doctor again and told her that the blinking was still happening.  She suggested I call a neurologist and make an appointment.  7/26/13 Friday I called the doctor's office again and reported still the excessive blinking happening.  I took patient and my 3 year old, who also developed a cold 2 days after the shot, back to the doctor at 1:15 pm.The doctor examined patient and she told me it was a tic. Just a nervous reaction from getting the shot but probably not an allergic reaction. My husband and I believe that unusual behavior is an allergic reaction.
Day following vaccination at 7:00 a.m., I expreienced a nose bleed while blowing my nose - lasted about half an hour.  Never had this happen before.
Patient has been experiencing extreme fatigue (including excessive daytime sleepiness), difficulty awakening, bilateral leg muscle pain, nerve pain (pain shooting down his right leg that he explains as "throbbing"), nausea, headaches and abdominal pain that radiates to his back. Symptoms have slowing been progressing and getting worse over the course of the summer.
Storage unit did not record temperature of vaccine. Could not verify for a period of time, vaccine may have been ineffective; no treatment or adverse reaction.
GOT COVID FIVE MONTHS AFTER THE SHOT; This spontaneous report received from a patient via a company representative concerned an 86 year old of unspecified 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced got covid five months after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid five months after the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20211238440. This report was associated with product quality complaint: 90000207487.
Information has been received from a pharmacist concerning a 27 year old male with no medical history or drug allergies reported, who on 13-OCt-2008 was vaccinated with PNEUMOVAX 23 (Lot # 660718/0551X). Concomitant therapy included influenza virus vaccine (unspecified). The patient was admitted to the hospital because he developed tachycardia along with aspiration pneumonia and vomiting after receiving PNEUMOVAX 23. Laboratory tests performed included comprehensive metabolic panel, hepatic enzyme and cell blood count (results not provided). At the time of this report, on 14-OCT-2008, the patient was not recovered. Tachycardia along with aspiration pneumonia and vomiting were considered to be disabling. Additional information has been requested.
Pt received vaccine on may 8th pt began to have itching in left upper back on may 11th on May 22nd itching turned to pain- and shingles like rash (painful rash with vesicles) developed.   culture obtained- but due to lab error- unable to confirm shingles dx  The shingles rash was in left upper back from neck link to bra line- in multiple dermatomes, and crossed midline-- so would be atypical shingles case--
I take shots easily, but I experienced pain with this vaccine. I heard a pop when she put the needle in and then she pushed it in even further and it was painful!  I had pain in my arm all week after that and up into my shoulder and neck.  I had a headache that lasted about 3 days. My arm was warm/hot for about 3 days for the whole arm and then just localized to the injection site and surrounding areas at the top of my arm for 5 days after the injection. I have also been nauseous and queasy ever since the injection.
pulled muscles in abdomen; Had mild tempreture,around 99-100F; felt pretty rotten for 2 days; felt very run down/I just didn't want to do anything for a couple of days; pretty strong body aches; sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (pulled muscles in abdomen), BODY TEMPERATURE INCREASED (Had mild tempreture,around 99-100F), MALAISE (felt pretty rotten for 2 days), FATIGUE (felt very run down/I just didn't want to do anything for a couple of days) and MYALGIA (pretty strong body aches) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced BODY TEMPERATURE INCREASED (Had mild tempreture,around 99-100F) and VACCINATION SITE PAIN (sore arm at the injection site). 08-May-2021, the patient experienced MALAISE (felt pretty rotten for 2 days), FATIGUE (felt very run down/I just didn't want to do anything for a couple of days) and MYALGIA (pretty strong body aches). On an unknown date, the patient experienced MUSCLE STRAIN (pulled muscles in abdomen). On 09-May-2021, MALAISE (felt pretty rotten for 2 days) had resolved. At the time of the report, MUSCLE STRAIN (pulled muscles in abdomen), BODY TEMPERATURE INCREASED (Had mild tempreture,around 99-100F), FATIGUE (felt very run down/I just didn't want to do anything for a couple of days), MYALGIA (pretty strong body aches) and VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Body temperature: mild temperature of 99-100f (High) mild temperature of 99-100F.         No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-455486, MOD-2022-455756 (Patient Link).
migraine type h/a began 4 1/2 hrs p/inject lasted 2 days, had fatigue, nausea hot & cold;
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 11-APR-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an outbreak of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter considered the event of outbreak of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of outbreak of shingles was considered to be disabling.