chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little dizzy after the second dose; not feeling myself after the second dose; Feeling very weak after the second dose; terrific headache after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a little dizzy after the second dose), FEELING ABNORMAL (not feeling myself after the second dose), ASTHENIA (Feeling very weak after the second dose) and HEADACHE (terrific headache after the second dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004121A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Heart disease, unspecified and Thyroid disorder NOS. Concomitant products included CLINDAMYCIN PHOSPHATE (DIVANON) for Blood pressure, METOPROLOL for Heart disease, unspecified, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced DIZZINESS (a little dizzy after the second dose), FEELING ABNORMAL (not feeling myself after the second dose), ASTHENIA (Feeling very weak after the second dose) and HEADACHE (terrific headache after the second dose). On 19-May-2021, DIZZINESS (a little dizzy after the second dose), FEELING ABNORMAL (not feeling myself after the second dose), ASTHENIA (Feeling very weak after the second dose) and HEADACHE (terrific headache after the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-406393 (Patient Link).
Information has been received from a physician concerning a female who was vaccinated IM with a first dose of Gardasil. The patient developed sting at injection site. Unspecified medical attention was sought. The patient was recovering as of the report date. Additional information has been requested.
Student had gotten a flu vaccine on 12/16/20. He came to the campus flu clinic on 1/26/21 and received another flu vaccine, his first dose being unbeknownst to the flu clinic staff.
shakes; cough got worse for those couple days; fever; full body fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), COUGH (cough got worse for those couple days), PYREXIA (fever), FATIGUE (full body fatigue) and MYALGIA (body aches) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced TREMOR (shakes), COUGH (cough got worse for those couple days), PYREXIA (fever), FATIGUE (full body fatigue) and MYALGIA (body aches). On 19-Jan-2021, TREMOR (shakes), COUGH (cough got worse for those couple days), PYREXIA (fever), FATIGUE (full body fatigue) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment included Advil.
No additional AE reported; HCP called to report that an expired vaccine PNEUMOV AX 23 was administered to a patient today; This spontaneous report has been received from an office manager, concerning 70-year-old female patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions, and concomitant therapies was not provided  On 30-SEP-2021, reported as today, the patient was vaccinated with a expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (lot number T017385 has been verified to be valid, expiration date reported and stablished as 01-SEP-2021) (dose number, dose, strength, vaccination scheme frequency, route and anatomical location of administration, lot number and expiration date were not reported) as prophylaxis (expired product administered). The reported wanted to know if the vaccine was still viable; no additional adverse event (AE) was reported.
Patient hospitalized for angiogram on 5/12/2021. Patient hospitalized for CVA on 5/13/2021. These visits are within 6 weeks of receiving COVID vaccination.
Next day after receiving vaccine pain noted in shoulder area and was unable to lift arm. Used massage and yoga with some improvement but pain returned approximately 1 hour later.
administered an expired pentacel with no reported ae; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 months old female patient who administered with an expired diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [PENTACEL] with no reported ae.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine for Prophylactic vaccination (Immunisation); and pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination (Immunisation).  On 08-Dec-2022, the patient received a dose 1 at dosage 0.5 ml once of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, Suspension for injection, (strength: not reported) (lot number: UJ625AA, expiry date: 07-Dec-2022) via intramuscular route in the thigh nos for Immunization with no reported ae (expired product administered) (Latency: same day).  It was reported as: Nurse called to report that they have administered an expired PENTACEL to a patient and is requesting some guidance what to look for and what to do moving forward."  Action taken was not applicable.  The outcome was Unknown.   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.
Vaccinated on 2/20/08.  Sore rt. side 2/22; 5 red spots under rt. arm on 2/23.  Pain deep in body beginning 2/24 and extensive rash.  Diagnosed with Shingles on 2/26/08.  Started medications on 2/26:  Gabapentin, Prednisone, Acyclovir.  Rash from center of chest to under rt arm; also on back.
This spontaneous report was received from a vaccine office coordinator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-MAY-2017, the patient received an unspecified dose of improperly stored VARIVAX in immunization series, lot # M040138 with an expiration date of 28-SEP-2018 (dose, anatomical location and route of administration were not reported). Diluent used to reconstitute VARIVAX was properly stored. The administered dose of vaccine underwent a temperature excursion of 8.2 degrees Fahrenheit for 6 hours and 12 minutes which was detected by a data logger. There were no previous excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a female patient of unknown age. Patient is diabetic with previously good blood glucose control on an insulin pump. On an unknown date, the patient was vaccinated with GARDASIL injection. Dose, route and frequency were unspecified. Concomitant therapies included insulin pump. On an unknown date, after administration of GARDASIL the patient presented with sky high blood glucose level. The patient sought medical attention and visited the office. The outcome of sky high blood glucose level and causality assessment was not provided. Additional information has been requested.
Pt received flu immunization right deltoid IM approximately 5 PM on 11/15/2001. Friday night 11/16/2001, developed "itchy red spot" right deltoid area. by Saturday AM 11/17/2001 developed itchy all over both arms. By 8:30 PM Saturday 11/17/2001, has itching and red blotches which pt calls hives over entire body. Took honey and oatmeal solution bath, applies ointment an this called itching. Seen 11/18/2001 4:45 PM itching and blotches reappeared. Repeat Bath and ointment helped very little. At 10 PM pt went to ER. He was given Prednisone 20 mgm bid PO for 5 days. He has appointment with PCP on Friday 11/23/2001. Pt reports he continues to have breakthrough itching and blotches between doses of Prednisone. Has occasionally taken Benadryl for itching. Pt works in a lumber yard: is exposed to wood products, insulation, paints, stains, chemicals and concrete building products. Pt also works at building construction.
FIGHTING COVID; This spontaneous report received from a patient via a company representative concerned a 60 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 was not reported, administered on JUN-2021 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 fighting covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fighting covid. This report was non-serious. This report was associated with product quality complaint: 90000209189.
COLITIS ATTACK; CONFIRMED CLOT IN EACH OF HER TWO LUNG'S LOWER LOBES (1 CLOT IN EACH LUNG); DEEP VEIN THROMBOSIS IN THE RIGHT ARM; DIZZINESS; PAIN IN THE RIGHT ELBOW; PAIN IN THE RIGHT ARM; SWELLING IN THE RIGHT ARM; SWELLING IN THE RIGHT ELBOW; FEELING COLD; This spontaneous report received from a patient concerned a 53 year old white female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient experienced swelling in the right arm, swelling in the right elbow, pain in the right elbow, pain in the right arm. On 14-AUG-2021, the patient experienced feeling cold due to the thin blood due to the Eliquis treatment. Laboratory data on 14-AUG-2021 included: Sonogram (NR: not provided) Confirmed blood clot in the right arm. On 16-AUG-2021, the patient experienced confirmed clot in each of her two lung's lower lobes (1 clot in each lung), deep vein thrombosis in the right arm and dizziness. The patient stated she went to emergency room on 13-AUG-2021, 14-AUG-2021, 16-AUG-2021 and 21-AUG-2021. On 21-AUG-2021, computed tomography of the chest confirmed blood clot in each lung in each of the lower lobes and patient was admitted in hospital due to colitis attack and because of the severity of the clots and got discharged on 26-AUG-2021. The patient was hospitalized for 6 days.  The patient was treated with an injection in the hospital (unknown medication) and Eliquis for blood clots after discharge. Eliquis was given orally at 10 mg in the morning and 10 mg in the evening and after 7 days switched to 5mg in the morning and 5 mg in the evening. The patient was on a special diet as per Gastroenterologist. The action taken with covid-19 vaccine was not applicable. The patient was recovering from pain in the right arm, pain in the right elbow, swelling in the right arm, swelling in the right elbow, confirmed clot in each of her two lung's lower lobes (1 clot in each lung), colitis attack, and deep vein thrombosis in the right arm, and had not recovered from dizziness, and feeling cold. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0: 20210857614-Covid-19 vaccine-Confirmed clot in each of her two lung's lower lobes (1 clot in each lung), Colitis attack, Deep vein thrombosis in the right arm, Swelling in the right arm, Swelling in the right elbow, Dizziness. This event(s) is considered unassessable. The event(s) 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(s).  20210857614-Covid-19 vaccine- Pain in the right arm, Pain in the right elbow. This event(s) is labeled per RSI and is therefore considered potentially related.
developed a UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "developed a UTI".  Additional Information: Patient was due to receive second dose of the Pfizer BioNTech Covid 19 vaccine tomorrow but developed a UTI over the weekend and was prescribed antibiotics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7 days after admin of Adacel Tdap, developed 4X6 cm area induration and redness. c/o of severe headache, body aches. No documented fever but did report night sweats 2 nights previous.
Itching, redness , bruising ,raised area at site of injection that was one week delayed
Client felt hot and tingling sensation up right arm. given 5ml benadryl PO. 120/70, 80 Pulse, 4 quad lungs clear upon discharge.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 2/25/09 with Urinary tract infection - bacteremia. Vaccination took place on 4/14/08. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
Initial unsolicited report received from a physician on 30 October 2015. This case involves a (age unknown) female patient who was vaccinated with a intramuscular [dose series not reported] dose of DAPTACEL (batch number C4887AA, expiry date was not reported) in left gluteal area on an unspecified date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications was not reported. On an unspecified date, same day following the vaccination patient experienced cellulitis at injection site on left gluteal area, fever, tachycardia, nausea and dizziness. It was reported that, patient required emergency room (ER)/doctor visit. Laboratory investigation and corrective treatment was not reported. The outcome of event was not recovered. List of documents held by sender: none.
Because of a mistake on the the birthdate, a 7 year old child was written as a 5 year old. and was given pediarix instead of Td. Was noticed after child left that day.
Patient received initial dose on March 3rd, 2021 and claimed after injection, noted significant amount of clear fluid leaking from injection site immediately following. Was observed, experienced no side effects. After discussing the scenario at length, decided to give partial Moderna Dose on 3/7/2021 at medical site. I personally adminsiterred 0.3 ml of Moderna vaccine IM to deltoid.
Covid-19; Covid-19; Loss of appetite; stomach pains; This is a solicited report based on information received by Pfizer from AbbVie (Mfr. Control No.: 21K-163-4143656-00).   A contactable consumer (patient) reported that a 14-years-old female patient received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose (Citrate free), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe pediatric crohn's disease. It was unknown if patient was enrolled in a COVID-19 vaccine trial. She received dose of COVID-19 vaccine manufactured by Pfizer BioNTech. Primary reporter did not have the lot number information, because the packaging was discarded. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 on an unspecified date with outcome of recovered, loss of appetite (decreased appetite/ appetite lost) on an unspecified date with outcome of unknown, stomach pains (abdominal pain upper) on an unspecified date with outcome of recovering.  The action taken in response to the events for adalimumab was permanently withdrawn. Case was reported as non-serious. The reporter's causality for the events with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events with PFIZER BIONTECH COVID-19 VACCINE was possible.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The events of drug ineffective, suspected COVID-19, decreased appetite and abdominal pain upper are related to the suspect product BNT162B2 based on plausible temporal relationship. The confounding factor for decreased appetite and abdominal pain upper is underlying medical condition of Crohn's disease.
Received Vaccine in left arm on 10/27/2021. On 10/28/2021 developed rash to right axillae. No other symptoms.Given Prescription for topical medication
Patient was inadvertently administered Moderna Covid-19 Bivalent Vaccine despite patient having never received any primary series doses of Covid-19 vaccine.
Headache, nausea 2 Aleve and 3 Tums Headache started the day after the shot when I woke up. The nausea started at the same time.
Patient developed thrombocytopenia with a platelet count of 13,000,  found on routine blood test on 3/10/2021.  Patient asymptomatic with no bleeding.
Information has been received from a physician's staff and the patient's wife concerning a father with no pertinent medical history of a female child who had been vaccinated at 8 weeks of age on 09-JUL-2007was vaccinated with the first dose of ROTATEQ (route unspecified and lot numbers: 656386/0031U). On 24-SEP-2009 and on 09-NOV-2007, the baby received the second and third dose, respectively of ROTATEQ (lot numbers: 657660/0972U and 657656/1153U respectively). The baby had no adverse event. Approximately one week after the first dose (approximately on 16-JUL-2007), the father, began having "a whole host of medical problems", including diarrhea, vomiting, arthritis and he last over 40 pounds ("about 2 or 3 years ago"). The patient's wife believed that the problem started when the patient was exposed to the ROTATEQ virus while changing this child's diaper. The patient did not ingest or came into contact with the vaccine itself". The doctor's staff reported that the patient "was sick for months and months". The patient was admitted to the hospital (no information available) and he eventually saw a rheumatologist (non contact information available), who felt the symptoms were related to an exposure to the vaccines virus. The father had recovered /date unspecified. The health care professional contacted during telephone follow up could not supply the following information: date of birth, hospital name and health care provider name and contact information. No further information is available.
soreness lasting 6 days, red patch on arm at site from 12/18  and continues today. The red patch was itchy for approximately 3 days.  NOTE: This was a booster shot.
painful to raise her arm; pain at site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful to raise her arm) and INJECTION SITE PAIN (pain at site of the injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concomitant products included ATORVASTATIN, METOPROLOL, DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), BRIMONIDINE TARTRATE (ALPHAGAN), BIMATOPROST (LUMIGAN), NETARSUDIL MESILATE (RHOPRESSA), DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE HCL + TIMOLOL MALEATE) and DABIGATRAN ETEXILATE MESILATE (PRADAXA) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (painful to raise her arm) and INJECTION SITE PAIN (pain at site of the injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 500 mg three times a day. On 04-Feb-2021, PAIN IN EXTREMITY (painful to raise her arm) and INJECTION SITE PAIN (pain at site of the injection) had resolved.            Action taken with mRNA-1273 in response to the drug was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received. Added the Fax number of the reporter.
Received chicken pox vaccine on 7-90-08. Started with redness the same day, afebrile with swelling to the arm. In office, area of redness measured 3.5cm x 4cm. Symptomatic treatment advised.
Several minutes after receiving Moderna COVID-19 vaccine, patient's face started to become flushed, swollen, and she had trouble breathing. This anaphylaxis reaction started at 3:40 PM . First dose of epi was given at 3:43 PM. After first dose of epi was given, patient's breathing normalized and swelling was reduced. EMS was called during this time period. At 3:49 PM, patients lips and mouth started to swell and patient couldn't breathe. At 3:50 PM, a second epi pen was given and patient could breathe easier. EMS arrived shortly after and was taken to emergency room.
30OCT93 malaise, aching, low back pain;02NOV93 rx'd w/rimantidine, keflex;03NOV93 tingling lower extr; admitted to hosp;07NOV93 transferred to regional hosp w/dx post flu vax GBS;09NOV93 on ventilator;
PATIENT WALKED IN STATING ARM WAS SWOLLEN,WARM, AND PAINFUL AT INJECTION SITE. PT DID NOT TAKE ANY PAIN MEDS PRIOR TO WALKING IN REQUESTING TO BE SEE BY PROVIDER. PROVIDER PRESCRIBED HC CREAM, TYLENOL AND KEFLEX.