chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 week male who on 06-JUN-2008 was vaccinated with the first dose of ROTATEQ (Lot number not reported). Concomitant therapy included the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), the first dose Hib conj vaccine (TET Toxoid) (ACTHIB) and the first dose of (PREVNAR). On 23-JUL-2008 the patient developed rash. The patient sought medical attention. The outcome of the patient was unknown. On 13-AUG-2008 the patient was vaccinated with his second dose of ROTATEQ, diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) (PEDIARIX), (ACTHIB) and (PREVNAR). No further information is available. This is in follow-up to report(s) previously submitted on 10/13/2008. Additional information was received from a nurse who reported that conflicting information was reported. The nurse reported that she received paperwork from the company regarding an adverse event report indicating that the patient developed a rash after he received his ROTATEQ. The nurse reported that she called the patient's mother, who said that the baby never had a rash. The nurse stated that the report was false, and that there was no way to tell which vaccine caused a rash anyway as babies usually get multiple vaccines on the same day. No further information is available.
LPN gave .5 ml for a second booster Covid- 19 vaccine.  Also LPN, gave this as a subcutaneous shot.   Arm was red and swollen. and hurt to the touch lasted for 3 days after.
slight headache; yawning; all he just wanted to do is sleep  ; it just he is sleeping a lot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Jun2021 10:15 (Lot number: EW0178) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Lot Number "EW0171"), for covid -19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "slight headache"; YAWNING (non-serious), outcome "unknown", described as "yawning"; HYPERSOMNIA (non-serious), outcome "unknown", described as "all he just wanted to do is sleep; it just he is sleeping a lot".  Additional information: Caller stated that her husband received the second dose of the Pfizer covid 19 vaccine today. Caller reported that he had a slight headache, and it went away as fast as it came. Caller stated that 1/2 hour to 1 hour after the vaccine he started yawning and could not stop and then went to sleep when he got home. Caller stated she woke him up to eat and he then went back to sleep.  No follow-up attempts are possible. No further information is expected.
1) Heart Palpitations.  I developed episodes of prolonged heart palpitations 12 days after my second Pfizer shot.   Sometimes I have an irregular heartbeat (80 BPM); sometimes I have a racing sinus heartbeat (120-130 BPM).  My normal resting heart rate is slightly below 60 BPM.  The palpitation episodes occur 2-3 times/week, and last from 2 minutes to 2 hours.    I contracted Covid-19 in March 2020 and had mild cold-like symptoms that lingered for around 6 weeks.  In June 2020, I began to experience the palpitation symptoms I am feeling now.  My symptoms subsided and disappeared from December through April of this year.    I am undergoing tests to determine what is causing my palpitations.  EKG and Echocardiogram came back normal.  I wear an Apple Watch that has confirmed Possible AFib / High Heart Rate during my episodes of Palpitations, using the ECG feature.  2) Migraine Headaches.  3 days after the second Pfizer shot, I began experiencing daily headaches on the left side of my head.  The headaches typically begin around the mastoid area, but alternate in other areas including above my left eye, left temple, left sinus, and back of head.  The headaches come and go, and are varying severity, but I've had some form of headache on same side of head every day since April 8, three days after my second shot.
FEVER; 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, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
On 04/14/05 mother brought child into county Health dept. to receive immunizations needed for child to start school. At approximately 10:00 am the child was seen in clinic room 1. RN administered immunizations, DTaP 0.5cc IM LA, IPV 0.5cc SQ LA, MMR 0.5cc SQ RA, and PCV7 booster 0.5cc IM RA. The child got down off her mother's lap and was standing by the mothers chair. RN had given the child a sticker to place on her shirt. RN asked if child wanted a coloring book, the child stated "yes". RN left the room to get book and heard pt mother yell out "NURSE"!! RN and another RNC Supervisor responded to the call for help.  10:10 AM, On arrival RN's observed the child laying on the floor of the clinic where her mother had placed her. No seizure activity was noted, the pt was assessed for airway, breathing, and circulation. The child was breathing, crying softly with eyes shut. Vital signs were assessed with BP 100/70, Pulse-100 and regular, and Respirations 24. Skin was pale, warm and dry to touch. When RN called the childs name, she responded by opening her eyes and looking about calling for her mother. Pt pupils were equal and reactive to light. No involuntary urination noted. Pt face was bathed with cool compresses and pt mother and nursing staff provided reassurance to pt. Pt eventually wanted to get up and sit back in her mothers lap. RN's assissted pt to standing position and she and her mother were assisted back to clinic room 1. 10:25 AM- vital signs were checked again, BP was 84/56, Pulse 96- regular and Respirations-22. Skin was warm, dry and pink in color. There were no visible signs of injurt to child upon assessment. 10:45 AM- Pt mother and Pt left HD stating that they were on their way to lunch. 3:00PM RNC tried to contact the pt at the home to check on pt several times prior to finally reaching them at 3:00PM and Pt mother stated that pt was "doing fine and no more problems" mother gave the following account to RN: " After the nurse walked out of the room pt was sitting in my lap and asked me what the sticker said that the nurse had given her, I told her and then she eased out of my lap ato stand up. When she stood up, holding on to the stickers, her eyes shut and her head fell back. I reached out and grabbed her to keep her from hitting the floor and then hollered for the nursed and ya'll were right there" RN instructed mother to seek medical attention of her personal physician or local ER if any further problems arose. Mother verbalized understanding and thanked the nurse for calling to check on her child.
The pt experienced erythema and vesicles at the site of injection along with a single erythematous papule on back.
pt devel low grade fever, blood tinged diarrhea day following shots; was hospitalized overnoc; no tx other than routine blood work; (CBC, SMA-6) & IV fluids;
Mental Issue (confusion,senility) after the 1st dose of the vaccine; The patient missed his scheduled 2nd dose due to the hospitalization; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (Mental Issue (confusion, senility) after the 1st dose of the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 CONFUSIONAL STATE (Mental Issue (confusion,senility) after the 1st dose of the vaccine) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (The patient missed his scheduled 2nd dose due to the hospitalization). At the time of the report, CONFUSIONAL STATE (Mental Issue (confusion,senility) after the 1st dose of the vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (The patient missed his scheduled 2nd dose due to the hospitalization) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CONFUSIONAL STATE (Mental Issue (confusion,senility) after the 1st dose of the vaccine) to be unlikely related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (The patient missed his scheduled 2nd dose due to the hospitalization).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is Unlikely as the event of Confusional State was pre-existing.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is Unlikely as the event of Confusional State was pre-existing.
Cough  ? Fever ? Shortness of Breath ? Generalized Body Aches ? Headache Pneumonia due to COVID-19 virus  monoclonal antibody infusion IV remdesivir and dexamethasone and also received 1 unit of convalescent plasma.
the dose administered to patient was 0.25ml instead of 0.5ml, because it was a first dose. After consulting my Health Care Supervisor, the patient returned next day, before 24 hours of administering the first dose, and I administered a second dose of 0.25ml, in order to complete a full first dose of 0.5ml
pt recv vax & devel a mild rash that cont to spread for 6 days until; pt was covered;pt had a low grade fever & some nausea;
neurological reaction; This is a spontaneous report from a contactable dentist (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Feb2021 (Lot number was not reported) as dose 1, single for CVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced neurological reaction after the first dose, on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
10 minutes after the first dose, I developed a severe headache and a sharp increase in blood pressure. My blood pressure returned to normal within 40 minutes but I had a persistent headache for 19 days. After second dose, the headache returned with greater severity and my PCP had to prescribe a course of prednisone to help reduce the pain. There was no blood pressure change with the second dose. I also had profound fatigue and was in bed for 48 hours after both doses. My current condition is that the headache and swelling has resolved on right side of temple after 3 days on prednisone but I still have selling and pain, though reduced on left side. I also had typical pain at site injection and received both doses in my right arm.
By Wednesday, before Thanksgiving I had itchiness all over body, and it took off as Thanksgiving progressed. During Friday and Saturday had the worst of it during the evening, and later that week the bumps as rash became more pronounced in all areas. Persistent up until today 12/03/2021 and will be seeing a dermatologist at end of this month. Have yet to visit with a doctor and have been trying to reach someone all week.
patient received 0.25ml of dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milligram. On 25-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose). On 25-Mar-2021, INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose) had resolved.            No treatment medication was reported.  This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.
Headache, Myalgia, Diarrhea, Nausea Vomiting, UPPER LIP TINGLING, METTALIC TASTE, CRAMPS, CHILLS
Starting on 05/17/2022, he woke up with a cough, nasal congestion, sneezing, raspy voice, nasal drainage, sore throat and one episode of vomiting. A day later he had diarrhea. We did a rapid COVID-19 test at home on 05/22/2022 which came back positive and then we did a PCR test on 05/23/2022 which came back positive. The symptoms that persisted were nasal congestion, cough and nasal drainage and they lasted until about 06/03/2022; however, he was testing negative by 05/28/2022 with a rapid COVID-19 test.
Itchiness at injection site on day 6 followed by 3 inch raised rash on days 7-9. Axillary tenderness and lateral breast tenderness from day 5 to present. At first did not associate the axillary tenderness with injection.
Sudden ringing ears with intense headache and dizziness. Sudden strange taste in mouth with difficulty swallowing.  Disorientation. Close to passing out.  About 3 hours after vaccine I was intensely nauseous.
Patient returned to the pharmacy today asking if it was normal for her arm to still be in pain. She stated that second dose was administered high on her arm near shoulder. She complained of persistent pain and limited range of motion.
Pregnant patient received the first dose; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-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 09-Sep-2020 and the estimated date of delivery was 12-Jun-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 01-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment information provided.
I started to feel the PVC's happening and so I went to the emergency room. They did an EKG and stated that I needed to see a cardiologist. I went to the cardiologist, and he did an echocardiogram and it showed that over 10% of my heart beats are PVC's. I was placed on CAM monitor for a week. I was placed on a beta blocker called sotalol. I still feel the PVC's which included pounding in my chest and head. The do not feel like they happen as often.
legs start hurting so bad; knees were hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs start hurting so bad) and ARTHRALGIA (knees were hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (legs start hurting so bad) and ARTHRALGIA (knees were hurting). At the time of the report, PAIN IN EXTREMITY (legs start hurting so bad) and ARTHRALGIA (knees were hurting) outcome was unknown. Not Provided          no concomitant medications reported. no treatment details reported.
No additional AE/PQC; HCP called to report inadvertent administration of PROQUAD after a temperature excursion that occurred on 10/12/2023 and the patient received the dose of PROQUAD on 10/19/2023. Limited patient demographics provided. .         ?; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient"s pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 12-OCT-2023, a vial of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot number: X007087, which was determined to be valid, with an expiration date on 04-SEP-2024) underwent a temperature excursion of -12.4 degrees Celsius for 18 minutes.  Then on 19-OCT-2023, the patient was vaccinated with a the improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, as prophylaxis (lot number: X007087, which was determined to be valid, with an expiration date on 04-SEP-2024) (strength, dose, scheme, route and anatomical location of administration were not reported).  No previous temperature excursion was reported.  No additional adverse event was reported.
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster on 03-APR-2022 and 2nd booster on 14-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Relapsing-remitting multiple sclerosis, Drug allergy and Drug allergy. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster on 03-APR-2022 and 2nd booster on 14-JUL-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster on 03-APR-2022 and 2nd booster on 14-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No treatment details were reported. This case was linked to MOD-2022-620991 (Patient Link). Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow-up document contains no new information.
Tinnitus started shortly after the first shot, continued for approx. 2 weeks and subsided. the Tinnitus started again approx. 2 weeks after the second shot and still has not subsided (over a month).
Expired. Hep B #3 given to patient. New vaccine and/or titer offered
I.P.V. Joint pain monthly, possible herpes. Dx / psoriasis, chronic scabies on face.
Fatigue, nausea, vomiting, diarrhea, fever, severe headache, body aches.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the pharmacist administered PNEUMVOAX 23 (expiration date, dose and route not reported) to the patient. The patient experienced severe soreness (onset date unknown). This particular shot was from lot # M036161. The outcome of the event was unknown. The causality between PNEUMOVAX 23 and the event was not provided. Additional information has been requested.
In-consolable crying for 1 1/2 hour on 8/23/2010.  Whimpering and crying when site touched.  8/24/10 noticed a red circle at injection site with a white ring around it, and a bump underneath the injection site.
Day after the shot tenderness, redness, hard lump, tiredness muscle aches, chicken pox like, dizziness,  ears feel full and won't pop, hard to hear.
approx 1/3 of the pts treated w/Engerix-B failed to respond or had borderline titer levels produced p/the 3rd dose; 60 to 70 pts have been treated to date;
Face swelling; lips were all swelled up; eyes were all swelled up and my cheeks; Face swelling; lips were all swelled up; eyes were all swelled up and my cheeks; Face swelling; lips were all swelled up; eyes were all swelled up and my cheeks; Hives all over my body; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0176, Expiry Date: Unknown) via an unspecified route of administration on 26Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534, Expiry Date: Unknown) via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization. The patient experienced face swelling, lips were all swelled up, eyes were all swelled up and patient cheeks and hives all over patient body on an unspecified date in Apr2021. No treatment received for the events. The clinical outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected.
Serious Dizziness / Vertigo when moving from a laying down position to sitting or standing, and when moving from sitting or standing to laying down. Visual "room spinning" and some nausea as well. Symptoms began 3/17/2021. Still ongoing.
102 Temperature  for 2 days, Pain in the chest( between the ribs) Chills Body aches Headache  Went to Emergeny and tests came out -ve. Took Advild every 6 hours and it took 3 days to get back to normal