chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A child received an expired dose of ACTHIB yesterday with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via nurse via regulatory authority (Reference number- 00678904) and transmitted to Sanofi on 12-Jul-2021.  This case involves a 2 months old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] yesterday (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination.  On 12-Jul-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ359AA, expiry date: 11-Jul-2021) (Diluent- Lot: U6872AA, Expiration date: 01-Feb-2022, dose of diluent 0.6 ml) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported that "Nurse called to report that an expired dose of a vaccine had been administered today (12JUL2021). The vaccine expired 11-Jul-2021. The caller would like to know if this dose is valid or if the child should be revaccinated?"  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swelling, hot, and progressing redness at site of injection. Swollen limb, numb at tips of fingers of affected arm, fever, chills, increasing redness, nausea, slight diarrhea.
Urticaria. Sub cut - epinephrine .03 cm. Benadryl 25 tid.
Following days: Fever, swollen eyes, lethargic (12/24/06) seemed to be getting better. 1/3/07: Wheezing, hives, fever. 1/5/07: Hives worse, wheezing. Lost skills after this. (Stopped eating solids, stopped talking, ultimately dx of Austim & Hypotonia). 01/29/2010 Autism dx, speech loss, sensory problems.   1/19/09 Reviewed PCP medical records which reveal patient was in good health on day of vaccination.   FINAL DX: mixed language delay; autism spectrum disorder RTC 1/3/07 w/rash all over.  Dx w/allergy & hives.  Tx w/antihistamine.  RTC 1/5/07 w/worsening of hives all over & bronchospasm.  Tx w/steroids.  RTC 5/14/07 w/fever, runny nose, cough & sneezing.  Dx w/URI & treated symptomatically.  RTC 6/29/07 w/irritability & pulling at ears.  Parent also expressed concern re speech & hearing.  Referred for speech delay to early intervention program & tx for bilateral OM & otitis externa.  RTC 7/23/07 continuing to pull at ears.  Dx w/cerumen impaction.  Early intervention evaluation done 7/25/07 revealed patient w/non-purposeful speech, not following directions, picky eater, inconsistent eye contact, toe walking & hand flapping.  Referred to ENT for recurrent OM.  Recommended BM & T& adenoidectomy.
Patient became diaphoretic, felt faint, felt nauseaous, felt hot, left arm tingling.
Case number PHEH2014US025902, is an initial spontaneous report from a nurse (patient mother) received on 23 Dec 2014. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was administered only MenCYW-135 liquid component of MENVEO (batch number: 14031) without being reconstituted with MenA, intramuscularly on 11 Nov 2014. No adverse event was reported following the administration error.
Headache for 7 days straight, ongoing headaches 2-3 times a week. Large blood clots in stomach fat. Significant bruising of stomach. Left with large knots that become inflamed and bruise. As small as peas but some as large as a small fist.
Patient received second Pfizer vaccine- no reaction to first vaccine. Patient placed on 30 minute observation for anaphylaxis to pistachio nuts. Received vaccine at 1440. At approximately 1450 patient complained of feeling bad and having a rapid heart rate; placed on pulse oximetry HR 103 (validated with radial pulse of 104/min) and O2 Sat 98%. Patient requested to void; patient stated he felt very anxious. Patient escorted to BR; became lightheaded enroute. Placed supine on sofa; legs elevated; encouraged slow deep breaths; with purse lips. VS- at 1455 = 184/80, 99%, 147 Reg/tachycardic. RR 24/min. Patient continued to feel more lightheaded with warm clammy skin. States his heart rate was worsening. VS at 1500 = 180/90, HR 145, RR 24 with unlabored breathing, o2Sat 98%. Arms tingling, lips pink, skin pale, no circumoral edema; no hives-speech controlled and unlabored. 911 called for further evaluation and clinical support. Patient agreed with plan of care. No LOC  throughout event.
This case was reported by a nurse and described a subject of unspecified age and gender who did not respond to immunization to hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date on  or before 9/27/2005, the subject received a dose of Engerix B. The dose number was nor provided, however, the nurse reported that, the patient received a series of Engerix B. At an unspecified time following the last dose of the Engerix B series, the nurse reported that, the patient failed to seroconvert. The subject was seen at a physicians office. Report received via manufacturer. Follow up will not be available.
Pt recvd series of 3 hep B vax on 0,1,6 months schedule & failed to respond to normal series of 3.Booster was given.
chills; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and HEADACHE (headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant Medication was Provided.
12/17/20 Received Pfizer COVID vaccine 12/18/20 Sore arm, no other side effects 12/20 Headaches refractory to ibuprofen, and vertigo 12/21 Worsening HA and vertigo 12/22 Feels lightheaded.  She has multiple sclerosis and has had vertigo as a part of her MS in the past. HA onset was about 72h after COVID vaccine. Currently been having HA, vertigo for about 2 days, seems to have peaked.
This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions of the patients were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored oral, ROTATEQ lot # L008057 (expiry date: 04-NOV-2017) or lot number # L008996 (expiry date: 02-JUN-2017). Concomitant medications of the patients were unknown. No adverse event reported. The outcome of the event incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Narrative:  No discharge summary reported, per patient, were transferred to hospital after receiving first dose of Moderna COVID-19 vaccine with possible seizure. Was kept overnight and then discharged.
Headache, Myalgia, fatigue Narrative: missed work following second dose due to symptoms
sensation of tunnel vision; blurred vision; Light headed; This spontaneous case was reported by a patient and describes the occurrence of TUNNEL VISION (sensation of tunnel vision), VISION BLURRED (blurred vision) and DIZZINESS (Light headed) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20/2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for Prevention.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced TUNNEL VISION (sensation of tunnel vision), VISION BLURRED (blurred vision) and DIZZINESS (Light headed). On 13-Jan-2021, TUNNEL VISION (sensation of tunnel vision), VISION BLURRED (blurred vision) and DIZZINESS (Light headed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: A follow up received on 04 JUN 2021 has no new information; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
High Fever 104°F. High Pitched Crying. Lethargic. Listless. Rash. Swelling at injection site.
This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis, there were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as case number 2009-01355.
Fatigue, neck pain, swollen lymph node in armpit of injection arm, severe sore throat, congestion, chills
my mother complained of pains all over her body the night of first shot.  She continued to have pain.  My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often.  She stayed in bed all day and had no energy to to do regular routine.  She was very itchy and vomited after 2nd dose.   the day after second dose she was unable to ambulate and continued throwing up.  When I called ambulance she could not even answer basic questions like how old she was.
About 5 minutes after vaccine administration patient had grand mal seizure lasting about 2-5 minutes.
SEVERE TINNITUS BOTH EARS; STOMACH PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; ARM PAIN ON INJECTION SITE; DIARRHEA; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 18-MAR-2021, the subject experienced arm pain on injection site. On 24-MAR-2021, the subject experienced severe tinnitus both ears. On 24-MAR-2021, the subject experienced stomach pain. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from stomach pain, diarrhea, chills, fever, arm pain on injection site, and nausea on 2021, and had not recovered from headache, and severe tinnitus both ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
After he received the vaccine, he had a headache, chills and body aches for 24 hours.  He had been having discomfort, so he went to the doctor. He was diagnosed with a large mass in his upper left quadrant (ULQ). He has had numerous tests and at this point we are waiting for the surgeon to schedule the surgery.
Pt given vaccine @ 11:26 am and seated on chair. Pt asked if dizziness is a reported side effect, nurse informed Pt not common. If any dizziness recommend not to drive. Pt reported he had a dizziness that lasted a couple seconds and went away. Pt stated never had dizziness prior. I stayed with Pt, another nurse informed provider NP. Provider instructed to have pt. wait 30 minutes and recheck vitals. Pt reported feeling fine, pt. had no further episodes. BP 136/80, P72, O2 97%. I spoke with provider cleared to leave at 12:00 pm. I informed Pt any questions call the clinic to schedule an appointment. I went over 911 precautions, pt. verbalized understanding. Translation RN
Patient hospitalized within 6 weeks of receiving COVID vaccination. Admitted on 4/1/21. Patient also presented to ED on 4/6/21 and was subsequently hospitalized for 2 days.
Nausea, retching, chills, headache, vision loss, dizziness.
severe left shoulder pain after vaccine, vaccine placed high up on deltoid, now with bursitis and rotator cuff tear
Patient vomited one time on 3/26/00, 36 hours after vaccine. On 4/7/00, patient developed a rash, redness, and burning in her neck. On 4/11/00, patient noted pain in her right arm and weakness. The pain in her arm and shoulder continues. Patient received physical therapy treatments.
Acute myocardial infarction, one day after the vaccine.  s/p cardiac catheterization, and stent placement X 2
HIVES; CONFIRMED COVID-19 INFECTION; LOW GRADE FEVER (100 F); This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient had unremarkable past medical history.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 2D5AZ1A, and expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced low grade fever (100 f). Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications included: paracetamol. On 21-MAY-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive (COVID-19), and COVID-19 virus test (NR: not provided) Positive (COVID-19). On an unspecified date, the subject experienced hives. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from hives, and low grade fever (100 f) on 28-APR-2021, and the outcome of confirmed covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000180784; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Information has been received from a healthcare worker referring to a 10 month old male infant. On an unknown date the patient was vaccinated with VAQTA (0.5 ml, frequency and lot# were not reported) intramuscularly, which was outside of prescribing information recommendations for age range, at an unspecified medical practice. No adverse effects to the infant. Additional information has been requested.
6x8 oval redness with taut skin, no cellulitis or streaks no treatment needed.
arm hot and sore/Notice my left arm aches/upper right arm aches and late at night it really starts aching; sick; arm hot and sore; hot to the touch where the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), FEELING HOT (arm hot and sore), VACCINATION SITE WARMTH (hot to the touch where the vaccines) and MYALGIA (arm hot and sore/Notice my left arm aches/upper right arm aches and late at night it really starts aching) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes in August 2018 and Asthma in 1975. Concomitant products included INSULIN, HYDROCODONE, PANTOPRAZOLE, DICLOFENAC and VITAMIN E NOS for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ILLNESS (sick), FEELING HOT (arm hot and sore) and VACCINATION SITE WARMTH (hot to the touch where the vaccines). On 01-May-2021, the patient experienced MYALGIA (arm hot and sore/Notice my left arm aches/upper right arm aches and late at night it really starts aching). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Pain in arm, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, PARACETAMOL (EXCEDRIN BACK & BODY) for Pain in arm, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), FEELING HOT (arm hot and sore) and VACCINATION SITE WARMTH (hot to the touch where the vaccines) outcome was unknown and MYALGIA (arm hot and sore/Notice my left arm aches/upper right arm aches and late at night it really starts aching) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received and updated Reporter information, medical history and outcome of event body ache to not recovered.
Was administered Varicella vaccine on 4/6/11 at 3:41 pm. Next day came in with little bit rash to chest area, was told to return end of day and did not. States on 4/9/11 started with itching took ATARAX. On 4/10/11 she had itching & rash throughout body and took BENADRYL. She went to MD on 4/11/11 and chickenpox were ruled out. She was prescribed a MEDROL pack (steroid) and ALLEGRA. 4-12-11 rash is better color changed. No fever.
pt recvd vax;had fever >102 at 1am;mild convuls x 8;PMD notified;watch t, coll compress,apap q 3 hrs;to MD 9dec;motrin given;no futher convuls;still swelling at inject site; t 101; fussy;
About 1 hour after immunization, arm began to hurt severely. So much so she went to ER. They said it was ok & sent her home. It has been almost one month and it still hurts so much she can't move it.
BLOODY NOSE; RED RASH ON LEGS; HEADACHE; ITCHY RASH; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient reported that she usually did not get headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 in total administered on 11-APR-2021 for prophylactic vaccination on Left Arm. No concomitant medications were reported.  On 07-MAY-2021, the patient experienced red rash on legs and headache. The patient reported that the rash was little pin point red round dots from above ankles to about the knees and a few small spots on hands as well. The patient further added that the rash was itchy and looked like an allergic reaction. On an unknown date the rash was starting to go away. On the fifth day of headache, on 12-MAY-2021, the patient experienced bloody nose and was hospitalized for 4 days till 15-MAY-2021. During her hospital stay patient underwent CT (Computerized Tomography) Scan and other test which were normal. The patient stated that her headache resolved while she was in hospital. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAY-2021, was recovering from itchy rash and red rash on legs, and had not recovered from bloody nose. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210535420 - Covid-19 vaccine ad26.cov2.s-Bloody nose.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
hasn't real felt well; cough; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (hasn't real felt well), COUGH (cough), PYREXIA (fever) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Gout, Arthritis and Cholesterol.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MALAISE (hasn't real felt well), COUGH (cough), PYREXIA (fever) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse reaction, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, MALAISE (hasn't real felt well), COUGH (cough), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101.4 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medicines for high blood pressure, gout, arthritis and cholesterol.
Kidney pain, Fatigue, Swollen eye lids, Severe dry skin, Itchy skin.
Patient received Fluarix vaccine, which is not approved for children under age 18.  No adverse reactions according to Mom.
This initial spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 09-SEP-2015, the patient received an unspecified dose in immunization series for (Merck) VARIVAX (dose and route of administration were not reported) that was improperly stored. While lot # for administered dose was not specified by reporter, lot # my include: lot # L016125 with expiration date 06-MAY-2017 or lot # L015046 with expiration date 29-APR-2017. No adverse effects were reported. Additional information has been requested.