chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 13 month old white female with no relevant medical history except premature birth at 35 weeks who on 24Oct03 at 1:30PM was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. There was no concomitant medication. On 11Nov03, the pt presented with a vesicular rash of about 20 lesions in a generalized desemination on her torso, low grade fever, cough and nasal congestion. There was no prescription drug required. Unspecified medical attention was sought. No other information was available. Follow up information received from a certified medical assistant indicated that on 11Nov2003 at 08:00AM 19 days post varicella vaccination, the pt developed 1-2 pox like rash. At day 20 the pt developed 20 lesions. At the doctor's appt. the pt had irritability; runny nose,  chest congestion with cough; decreased appetite. At follow up visit on 18Nov2003 the pt was improved. The outcome was reported as recovered on 18Nov2003. There were no adverse events following prior vaccinations. No additional information is expected.
This spontaneous report was received from nurse pracitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-JUL-2014 patient received improperly stored MMR II [lot # lot J010933/exp. date 09/06/2015], exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The outcome of the event was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore). At the time of the report, PAIN IN EXTREMITY (Arm is really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This is a spontaneous report from a contactable physician. This physician reported for a 2-month-old patient, unspecified ethnicity, who was vaccinated with PREVENAR 13, PEDIARIX, ACTHIB and rotavirus vaccine liquid; all vaccines on unspecified date, at an unknown dose, formulation and indication. The patient had experienced questionable seizure twice witnessed by patient's mother. The second event required mouth to mouth resuscitation by the mother. At that point, the patient was taken to a facility. The patient was admitted for full work up including CT head and EEG with results all negative. No further events witnessed. Unsure at this point if events are due to vaccines. The patient is responding normally at this point in time. Follow-up (10Oct2014): Follow-up attempts completed. No further information expected.
non-toxic L sided goiter appearing after administration of 2nd dose of Pfizer vaccine; noticed unilateral swelling of neck, reported to PCP, US revealed goiter, goiter has since decreased in size to < half original size
PATIENT STATED HE WAS FEELING DIZZY IMMEDIATELY AFTER THE SHOT AND FAINTED FOR APPROXIMATELY 5 SECONDS AFTER THE SHOT. HE ALMOST FELL OFF THE CHAIR BUT WE WERE ABLE TO BREAK HIS FALL. HE PROCEEDED TO THROW UP AFTER RECOVERING CONSCIOUSNESS. I RECOMMENDED HE LIE DOWN AND ELEVATE HIS LEGS. HE FELT OKAY AFTER LYING DOWN FOR 10 MINUTES AND WAS ABLE TO GET UP AND LEAVE THE PHARMACY WITH HIS MOM
12/21/04 phone call from pt stating right upper arm is hurting, muscle is twitching with red, blue and purple bruising approx 1" wide and 23" long starting at injection site, denies memory of injury, states is working with use. Reviewed VIS, referred to family Dr.
vaccinated with Kinrix / 1st dose: 6-18-2019 / 2nd dose: 11-8-2019/ In between a Pediarix dose was administered on 10-07-2019.; vaccinated with Kinrix / 1st dose: 6-18-2019 / 2nd dose: 11-8-2019 / In between a Pediarix dose was administered on 10-07-2019.; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix) and DTPa-IPV (Kinrix).   On 8th November 2019, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. In November 2019, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Pediarix and an unknown time after receiving Kinrix, the patient experienced extra dose administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the extra dose administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional detais were provided as follows: The age at vaccination was not reported. The patient received first dose of Kinrix on 18th June 2019. On 7th October 2019, the patient received a dose of Pediarix. On 08th November 2019 the patient then receive second dose of Kinrix, which led to extra dose administered and inappropriate schedule of vaccine administration. No patient demographics was reported, no lot number and expiration of the vaccines were provided.. The patient received the doses in a different facility from where the call was made. The reporter did not consent to follow-up.
bad nose bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (bad nose bleed) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K2014 and 029k2074) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis (More coughing, increased inflammation.) since 1980, Seasonal allergy, Drug allergy, Coughing and Inflammation. Concomitant products included CELECOXIB for Arthritis, LOSARTAN POTASSIUM for Blood pressure high, NAPHAZOLINE HYDROCHLORIDE (ACONEX) from 24-Feb-2021 to an unknown date for Bone density abnormal, ATORVASTATIN for Cholesterol, CITALOPRAM for Depression and Hot flashes.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced EPISTAXIS (bad nose bleed). On 23-Jan-2021, EPISTAXIS (bad nose bleed) had resolved.            The patient reported that event stopped after nose packed with gauze.   This case was linked to MOD-2021-018400 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Patient demographics, medical history, concomitant medications and event start date updated.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Company assessed the event to be unlikely related to company product.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 at 03:30 as dose 1, single (Lot number: EN9264), in right arm, on 25Feb2021 at 10:00 as dose 2, single (Lot number: EN6202), in left arm and on 02Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 26Sep2016, stop date: 15Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: COVID tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medications were received in 2 weeks. The antiviral drug (COVID 19 Treatment) received from 16Aug2022 to 20Aug2022 for treatment of COVID-19. The event COVID tested positive with symptoms sneezing and coughing from 24Aug2022 at 3 PM (outcome: not recovered).
feels like his arm is heavy; injection site soreness; injection site soreness and redness; flu like symptoms; numbness in his entire left arm; tingling on the finger tips / tingling in the finger; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 22nd May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On 22nd May 2020, the patient experienced injection site pain and injection site erythema. On 24th May 2020, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the patient experienced heaviness in arm. On an unknown date, the outcome of the injection site pain, injection site erythema, influenza-like symptoms, numbness of upper extremities, tingling of extremity and heaviness in arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, influenza-like symptoms, numbness of upper extremities, tingling of extremity and heaviness in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced intensive injection site soreness and redness as soon as he got home after getting the vaccination. This lasted for a full week. The patient experienced flu like symptoms that lasted for a day.  About 2 days after the vaccination he experienced numbness in his entire left arm and tingling on the fingertips of the left arm.  This was episodic, it comes and goes daily and if he sits relaxed watching tv he feels like his arm was heavy and tingling in the finger comes back. No other details were provided.
Started to have chills in morning after shot. Took temp  was normal at 97.4. Took home covid test- negative. Laid down. Took temp an hour and a half later. It was 100. Drank fluids including Emergen-C. Went back to napping for another hour and half, temp was at 102. Went back to nap for another hour and temp had started to drop back to 100. It was back to regular temp by 5:30pm.
Itching on palms of hand started on Day 15 after booster shot (3rd shot) of Moderna. Quickly became body-wide itching, on chest, abdomen, neck, back, arms, etc. The severe itching moves rapidly from one site to another. There have been raised red welts. Currently taking antihistamine. I also had delayed side effects from Shot 1.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient said that she could tell after her shot that something was wrong, although she did not inform the pharmacist.  She said that she felt sick the next day after the shot. Now her arm has been hurting since 11/3/08 that she received the shot.  She saw a doctor on the 14 and he said that it was nerve pain.
both arms and both legs were extremely achy; hurt all inside; was so sore could hardly walk; difficult to breathe; felt like throat was swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both arms and both legs were extremely achy), PAIN (hurt all inside), GAIT INABILITY (was so sore could hardly walk), DYSPNOEA (difficult to breathe) and PHARYNGEAL SWELLING (felt like throat was swelling) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (both arms and both legs were extremely achy), PAIN (hurt all inside), GAIT INABILITY (was so sore could hardly walk), DYSPNOEA (difficult to breathe) and PHARYNGEAL SWELLING (felt like throat was swelling). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg. At the time of the report, PAIN IN EXTREMITY (both arms and both legs were extremely achy), PAIN (hurt all inside), GAIT INABILITY (was so sore could hardly walk), DYSPNOEA (difficult to breathe) and PHARYNGEAL SWELLING (felt like throat was swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter.
Severe chills and fever,  headache, nausea & vomiting  x 36 hours
mom phoned 5FEB93 to report rash on ear starting 26JAN or 27JAN that as of 1FEB92; red, bumpy, itchy, t101-102 seen by MD 2FEB93 ex w/bronchitis & inner ear infect; describes pt as lethargic w/dec appetite;
This infant had brief periods of hypo-responsiveness, paleness, and irritability. Continuous crying, difficult to console, localized erythema at the injection sites. Incidents occurred at home as per mom.
received  2nd Moderna vaccine 3/22/21 After receiving this vaccine pt started noticing dyspnea wjen walking Came to see Dr  4/1/21- was admitted to  hospital with Lg bilateral pulmonary emboli thought secondary to 2nd dose of Moderna COVID vaccine,
Headache; Jaw pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced headache, jaw pain and fatigue. On an unknown date, the outcome of the headache, jaw pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, jaw pain and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR094718   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient self-reported this case. She received Shingrix dose in an unknown arm. She had nothing else to report. The reporter consented to follow up. Additional supportive information: For tolerance of 2nd dose of Shingrix, refer case US2022AMR094718.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094110:Same reporter US-GLAXOSMITHKLINE-US2022AMR094718:Same Reporter, Same Patient, 2nd dose
The patient received a Janssen Covid-19 Vaccine at approximately 10:00 am on 04/07/2021.  The vaccine was drawn from a vial, stored in the refrigerator, that had been punctured on 04/06/2021 at approximately 1:30 pm.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 3 (booster) ,single at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: DULERA; MONTELUKAST; ALLEGRA; AZELASTINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Hive breakout, in various areas of body, extremely itchy at 10th day following 2nd vaccination on 4/2/2021 still present
Vaccine administered 8/19/11. Presented to clinic on 8/22/11 with swelling, itching and redness of rt arm. Administered methylprednisolone 125 mg IM x1. Discharged to home with prednisone taper and also instructed that he could use OTC diphenhydramine prn. Rash, Erythema Multiforme & Uriticaria Pruritus METHYLPREDNISOLONE 125 MG ONCE.
administered expired FLUZONE HIGH-DOSE QUADRIVALENT to patient with no reported adverse event; Initial information received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient who reported administered expired fluzone high-dose quadrivalent to patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ769AC ; expiry date: 30-Jun-2022) via unknown route in the right arm for immunization.  On an unknown date the patient reported a non-serious administered expired fluzone high-dose quadrivalent to patient with no reported adverse event (expired product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event expired product administered.   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.
Received flu and pneumonia on 11/15/05 clinic. By evening, redness, pain, swelling, SOB on Thursday. Antibiotic and Benadryl prescribed.
Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhausted) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (Exhausted). On 28-Jan-2021, FATIGUE (Exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-026568 (Patient Link).
Within 2 hours intense pain at vaccination site out of proportion to injection Within 5 hours, malaise and generalized body aches  Within 12 hours chills, rigors, headache All symptoms resolved within 18 hours post injection
Arm where vaccination given was swollen, red, sore to touch, with pruritus. Initial reaction continued for 1 week.
Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: DOSE 1-6/23-PAIN AT INJ SITE/NAUSEA;6/24- MYALGIA/N/V/D;6/25-HA/N/V/MYALGIA;6/26,6/27-HA/MYALGIA/FATIGUE; 6/28-HA/MYALGIA
Nausea and HA one hour after Pfizer vaccine. Fatigue and aches 6 hours to 36 hours.
Site of injection swollen to size of quarter, hard, itchy, painful. Redness spreading out 4 inches in diameter for 3 days now.
Patient missed his second dose (Second dose not administered within 42 days); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed his second dose (Second dose not administered within 42 days)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed his second dose (Second dose not administered within 42 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed his second dose (Second dose not administered within 42 days)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported. Concomitant medications were not reported.
Severe swelling; Redness; pain and discomfort; pain and discomfort; This is a spontaneous report from a contactable pharmacist received via a sales representative. An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe swelling, redness, pain and discomfort on Apr2018. The outcome of the events was unknown.  The information on the batch/lot number and expiration date has been requested.