chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose in series was received in the thigh (my son's choice). He did not even feel the injection and had no side effects at all. Not even regional soreness. For this dose, he chose left deltoid. I tried to get him to change his mind, but he was sure, so this is where they gave it. He was tense when the injection was administered and had some minor discomfort with the injection because he was tense. I gave him oral ibuprofen when we got home (maybe 1:15 p.m.), like last time, and he seemed fine through until the evening. He started touching his upper arm around  and acting grouchy. I repeated ibuprofen at 9 p.m. when he went to bed. At that time, I thought he felt hot, but didn't take his temperature as I knew there was nothing different I would do. He had a very restless night, with little sleep, and continued discomfort of his arm. This morning (6 a.m.) his temperature (temporal, taken many times and averaged) is 102.8 degrees F. I have dosed the ibuprofen again and will start Tylenol at the 3 hour mark in rotation with ibuprofen.
This spontaneous case report was received from a consumer (PVX2018-2956) on 11-Oct-2018. The report describes a female consumer who "had a protein drink before and after the administration of VAXCHORA". The consumer was receiving VAXCHORA for cholera vaccine. It was reported that the consumer took VAXCHORA on 10-Oct-2018 but she had a protein drink 30 minutes before and 5 or 10 minutes after the dose. The action taken with VIVOTIF with respect to the event "had a protein drink before and after the administration of VAXCHORA" was not applicable. The clinical outcome of the event "had a protein drink before and after the administration of VAXCHORA" was unknown. Company's Comment: The causality of the event "had a protein drink before and after the administration of VAXCHORA" was considered as not applicable.
Pregnant caller received the 1st dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the Moderna vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Jul-2021. On 01-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the Moderna vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that patient wanted to wanted to be in the Pregnancy Registry.
"Hot Flashes" twice a week.  Skin turned from white to cherry red on neck arms chest and thighs.  Was not painful but annoying like "pins and needles."  In 1997 started taking amino acid Arginine 500 mg daily.  Had no problems with it until the Shingles Shot.  Then the "hot flashes" started until 21 November 2009 when I quit the L-Arginine and the "hot flashes" immediatly stopped.  The Shingles Shot is a weakened virus.  Googling L-Arginine you learn it will react with viruses.  Since I've spoken to several people who have had shingles, I am foregoing L-Arginine.
itching pustules across her back; itching pustules; This case was reported by a consumer via call center representative and described the occurrence of pustular rash in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced pustular rash and pruritus. On an unknown date, the outcome of the pustular rash and pruritus were unknown.   It was unknown if the reporter considered the pustular rash and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and 10 days later she experienced itching pustules across her back. The reporter did not consent to follow-up.
Numbness on right side of face , numb tongue, water build up in ears, right nostril closed up right side of face sags and eye will not close can?t blink. Diagnosis Bell?s palsy nad viral infection
BLOOD CLOTS; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots (Dose number in series 2). Reporter stated that, "I got the blood clots too after one of the shots" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221237140-blood clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
The day after the shot he felt extreme fatigue. He said he required 1 week of sleep over the 2 days following the shot
Hive rash unresponsive to OTC ointments for 3 months; 6-inch radius behind each knee, right elbow 1-inch radius
As of 9/12 - A black and brown circular bruise about 3 cm diameter at the sight of injection. Pain. Getting better.   At the start, which pt says occurred the following day, there was an additional crescent shaped similarly colored bruise below the site of injection, although much larger.
After completing the Pfizer vaccine series in May (1st vaccine in April; 2nd vaccine in May), I stopped menstruating and had severe ovarian pain for many months. I was diagnosed with ovarian failure on July 30th 2021. I was in so much pain in August that I had to be prescribed pain medication to manage. The pain was in my ovaries, and it was excruciating. I will never have my own children, which is heartbreaking as I was only 32 years old when I got vaccinated and stopped menstruating. There are studies coming out now proving the vaccines affect women's menstrual cycle. I would like to come forward to have my adverse event and symptoms documented to help inform other women about side effects. I do not know where or how else to report this. I have spent thousands of dollars at a fertility clinic to try and get pregnant and nothing is working; nor are the prospects of pregnancy ever going to be promising for me and my husband. The doctors are not sure why this is happening to me, as I had never missed a cycle in my entire life. I menstruated every single month until I got the Pfizer vaccines. My fertility has come to an end because of these vaccines, which were mandated in order for me to continue working and pay our bills/live. I know I am not alone because I am encountering more and more women who are still also experiencing cycle irregularities due to the COVID-19 vaccines and are also going into menopause at an early age. I implore someone to please take this seriously and look into this. I am going through early menopause due to these vaccines. I am being told by my doctor that I will need to be on hormone replacement therapy to give my body the estrogen it needs in order to stay healthy.
Noticed injection site was itchy. Looking at my arm noticed large red area (approx. 4 inch circumference with a center darker red area of about 1 1/2 - 2 inch circumference).
This spontaneous report as received from a nurse refers to a male patient of unknown age. The nurse reported that the patient, who, on 11-DEC-2013, received his first dose of GARDASIL 0.5ml, intramuscular (lot # and expiration date were not provided), was in the office on 19-DEC-2014 to receive his second dose of GARDASIL 0.5ml intramuscular (lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Body aches; Fatigue; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced general body pain and fatigue. On an unknown date, the outcome of the general body pain and fatigue were unknown.   It was unknown if the reporter considered the general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced body pain and fatigue. The reporter did not consent to follow up. This case has been linked with case US2019AMR208449, reported by same reporter.
effecacy slowly decreases; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT INEFFECTIVE (effecacy slowly decreases) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC PRODUCT INEFFECTIVE (effecacy slowly decreases). At the time of the report, THERAPEUTIC PRODUCT INEFFECTIVE (effecacy slowly decreases) outcome was unknown.            No concomitant and treatment medication information was reported. Patient was fully vaccinated end of Feb. Patient would be going in for heart surgery and was worried about it.   Reporter did not allow further contact
Information has been received from a health professional concerning a 7 year old white female, with no known drug allergies, who on 09-OCT-2002 was vaccinated with a first dose of Varivax (Lot# 643118/0503M). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 22-APR-2006 the patient experienced 50 vesicles on her back and trunk. It was noted that there was no fever. Subsequently, the patient recovered. Medical attention was not sought. Additional information is not expected.
Information has been received 11/15/02 via legal complaint from an attorney concerning a male child who received series of Tripedia, and Engerix B vaccines as well as Tetramune, Acel-Imune, and Hib-titer vaccines from 4/22/93 through 9/15/94 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae." Legal complaint states that at approximately 18 months of age, the pt was "neurologically devastated by the accumulation of mercury in his body, and has regressed developmentally, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, and the loss of language skills." Legal complaint also states that the pt has incurred "expenses of hospitalization."
pt recvd vax 5FEB93 & exp local soreness @ inject site & warmth sl; 26FEB93 awoke in AM w/rt sided facial paralysis from eyebrow; seen 26FEB93 by MD; dx sl bell's palsy;
armpit was swollen and painful; swelling is closer to the top of his ribs/left armpit is swollen; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:00 as dose 1, single for COVID-19 immunisation. Medical history included pain and knee operation. Concomitant medication(s) included ongoing mometasone furoate (FLONASE [MOMETASONE FUROATE]); hydrocodone bitartrate, paracetamol (VICODIN) taken for pain from 19Feb2021 to 01Mar2021; marijuana (MARIJUANA). Consumer stated, on 09Mar2021 at 03:00 that a day and a half later, he noticed that his left armpit was swollen and painful/ hurts. He stated that the swelling was closer to the top of his ribs on the left side versus the bottom of the left arm, and says it looks like an oval and a "big ol' puff." Caller would like to know if this has been reported as a common side effect experienced by others. Consumer further added that it seemed to be getting better until he got up to do his morning routine, isting at the same level now. He was planning to receive the second dose of the vaccine on 28Mar2021. Mentions predating the vaccine he had surgery on his knee two weeks ago, and he was taking Vicodin daily until 01Mar2021. Added last night he drank a beer and he smokes medical marijuana. Adds there was nothing different from this daily routine going on except the Pfizer COVID 19 vaccine. AE(s) did not require a visit to physician or ER. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt vaccinated with MERUVAX developed generalized malaise & pain in both knees, rt wrist like it was sprained.
suffering, feels terrible; Hurts so bad, she never hurt that bad; bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking; Feels sick, can't get out of the bed; emotional and crying; Coughed; Can't walk but is getting better; feels anger and fury.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed) and CRYING (emotional and crying) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 032B21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM, AMLODIPINE, LAMOTRIGINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Blood pressure, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Coughing after drug inhalation.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed), CRYING (emotional and crying), COUGH (Coughed), GAIT DISTURBANCE (Can't walk but is getting better) and ANGER (feels anger and fury.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (suffering, feels terrible,), PAIN (Hurts so bad, she never hurt that bad), BONE PAIN (bones feel like they are in two when she tries to move, bones are breaking and not just achy, anything that touches her skin feels like her bones are breaking), ILLNESS (Feels sick, can't get out of the bed), CRYING (emotional and crying), COUGH (Coughed), GAIT DISTURBANCE (Can't walk but is getting better) and ANGER (feels anger and fury.) outcome was unknown.            The Albuterol was provided as treatment for a rescue inhaler.
Patient was hospitalized with pneumonia from 7/11/2021- 7/14/2021  related to COVID infection. COVID test positive 7/12/2021. Patient became symptomatic 7/8/2021. Patient was fully vaccinated at this time.
patient pregnant - due date 5/27/2021.  Single pregnancy.   C/O  hot flashes feeling faint   BP: 118/82  Pulse: 86  o2: 99%   Patient stated she always experiences same symptoms whenever she receives a vaccine and has blood work.    #21 went home
Rapid heart rate that hasn't stopped; Chills; Fever; body aches for 5 days; Swallen lymph node under left arm pit for 5 days and still there; This is a spontaneous report from a non-contactable consumer. This 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at arm Left on 02Mar2021 12:30 (at the age of 32-years-old) as a single dose for covid-19 immunisation. Medical history included thyroid disorder. Patient did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. In two weeks, Other medications used Birth control and thyroid medicine. Historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) dose 1 (Lot number and expiry date was not reported) via unspecified route of administration at Left arm on 09Feb2021 12:00 PM as a single dose for covid-19 immunisation. On 02Mar2021 16:30 the patient experienced rapid heart rate that hasn't stopped, chills, fever, body aches, swollen lymph node under left arm pit for 5 days and still there. The patient underwent lab tests and procedures which included heart rate: rapid on 02Mar2021. Treatment was not given for adverse events. Outcome of the events was recovered with Sequel on unspecified date in 2021  No follow-up attempts are possible; information about lot/batch number cannot been obtained
P began feeling weird, tired  and drained of energy on Saturday afternoon about 3pm and continued into Sunday.  On 3/8/21, approximately 10pm, patient began with nausea and vomiting and diarrhea  and continues today with same symptoms plus body aches, chills and fatigue.
4 month old boy seen on 12/23/04 for routine well child visit. Patient well; no history of illnesses. Received Pediarix, Prevnar, HIB #2 that morning. Later in evening, seized and hospitalized for 1 week. 60 Day follow up: Pt has a mixture of seizure types including myoclonic and absence. Is currently being followed by a pediatric neurologist and on antiseizure medications.
Initial unsolicited report received from a consumer on 14-Nov-2017. This case involves a 56-year-old male patient, who was vaccinated with 0.5ml dose at frequency once of FLUZONE QUADRIVALENT (batch number and expiration date was unknown), intramuscularly on an unknown site on 08-Nov-2017. Medical history included bilateral vascular necrosis in hips and herniated disc along with walking difficulty, pain and numbness right foot. Concomitant medication was not reported. On 09-Nov-2017, one-day post vaccination, the patient returned to baseline of walking difficulty, pain and numbness right foot i.e. walking without pain, able to touch toes, had feeling in right foot, able to move and walk well. It was reported that, the patient had relief of pain and ability to walk lasted for 5 days following vaccination (Nov-2017). Patient's lab test and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
Patient given Pneumovax IM in left deltoid on 5/22/06. Returned to clinic on 5/24/06 and observed a 5" area of warm erythematous skin around upper arm, approx. 1 inch below the injection site to the distal humerus. Tender to touch. Doctor instructed patient to use warm compresses and Advil 200 mg q 12hrs.
Headache, Myalgia, NauseaVomiting, injection site pain, chills Narrative: Employee reported injection site pain/discomfort, chills, headaches, body aches, nausea, and vomiting. Reports used Tylenol (no dose or frequency provided) for symptoms. Reports arm felt "heavy, sore."
Body aches; Fatigue; Headache; Loss of appetite; Fever-T-Max 101.2; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK3248), via an unspecified route of administration on 07Jan2021 15:30 in right arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with first dose of BNT162B2 on unspecified date. The patient was not pregnant. The patient experienced fever-T-Max 101.2, body aches, fatigue, loss of appetite and headache on 07Jan2021 20:00. No treatment was given to the patient for the events. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, nasal swab: negative on 04Jan2021.
Information has been received from a physician concerning a female who was vaccinated IM with a second dose of GARDASIL. Shortly after being vaccinated the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007.  Initial and follow-up information has been received from a physician concerning a 11 year old female with rhinitis and cough at the time of the vaccination who on 11-JUN-2007 was vaccinated with IM with a second dose of GARDASIL (lot # 655205/1426F). Concomitant therapy on 11-JUN-2007 included, IM first dose of MENACTRA (lot #C2559AA) and subcutaneously a seconde dose of VARIVAX (MED) (lot # "04434"). On 1-JUN-2007 the patient fainted wna collapsed in the hallway while going from the exam room to the waiting room. The patient was taken back to the exam room, evaluated, rested and did fine. On 11-JUN-2007, the patient recovered. Additional information is not expected.
6/11/13 9:45am RMA gave patient oral rotavirus, PREVNAR/IM (patient crying). She stopped crying, breathing - turned blue and closed eyes after the administration of Hib/IM. She immediately called for help with Dr., NP this under RN went into the room where mom was holding patient upright, she was awake - breathing, no discoloration (grey/blue) noted. Patient responded to her mom appropriately. O2 SATs R/A 100% - no oxygen given. Pulse 98. Incident lasted less than 1 minute. Pt recovered immediately. Kept in clinic x 20 min for further observation without any problems.