chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; Extremely fatigued; Unexplained bruises I noticed 2 on my left arm Saturday and one on my stomach/Monday 2 more bruises on my left arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 10Nov2021 at 15:30 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), migraines controlled with medication, ischemic colitis episodes, anxiety and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient received unspecified concomitant medications (reported as yes my normal medications) within two weeks of vaccination. On 13Nov2021, the patient experienced unexplained bruises, noticed 2 on left arm and one on stomach then on 14Nov2021 and 15Nov2021, the patient experienced, migraine, was extremely fatigued and, 2 more bruises on left arm on 15Nov2021. The patient did not bump anything or injured self. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events unexplained bruises, noticed 2 on left arm and one on the stomach, migraine, extremely fatigued and 2 more bruises on left arm was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
From Monday night to Friday - Headache, fever, chills, congestion, and fatigue On Monday night only - sore throat  On Tuesday only - loss of smell and taste Ongoing - Congestion
missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .; 14 years of age and received the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years of age and received the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years of age and received the Moderna vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .). On 22-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years of age and received the Moderna vaccine) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This report refers to a case of Product administered to patient of inappropriate age and Inappropriate schedule of product administration,  for mRNA-1273, lot # unknown,  with no associated AEs.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age and Inappropriate schedule of product administration,  for mRNA-1273, lot # unknown,  with no associated AEs.
Father called day following immun c/o high pitched cry 1 hr p/inject, little rash on inject site; doing fine today; no treatment given;
Information has been received from a physician concerning a 65 year old female who on 19-DEC-2006 was vaccinated SC with a dose of Zostavax (Merck) (lot # 652965/0622F). One week later on approximately 26-DEC-2006, the patient was diagnosed and treated for shingles at the injections site. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 3/14/2007. Additional information from the physician indicated that on approximately 26-DEC-2006, the patient developed a rash. She presented to an urgent care center and was diagnosed with shingles. The patient was treated with an unspecified prescription therapy. The duration was reported as one week. No further information is expected.
losing weight/lost 30 pounds; lost his taste; he's not eating; was sick; it just may kill him; Very very bitter taste in his mouth/Nothing taste good; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good), WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating) and ILLNESS (was sick) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good). On an unknown date, the patient experienced WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating), ILLNESS (was sick) and FEELING ABNORMAL (it just may kill him). At the time of the report, DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good), WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating), ILLNESS (was sick) and FEELING ABNORMAL (it just may kill him) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: 30 Patient stated that he lost 30 pounds of his weight as he was not eating as he couldn't taste anything..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported. Patient stated that he tried home remedies to relieve the symptoms and has spoken with his doctor and has an appointment fixed on 12-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received: added new events and updated events outcome to not recovered/not resolved
Became itchy on extremities. Developed rash but chest and throat.  Started to have swelling to forehead and eyes. Denies SOA but states chest feels heavy. PT sent tp ED via Ambulance.
pt recv vax 12JUN95 & it was noted that pt was exposed to chickenpox in daycare;22AUG96 pt exp chickenpox;pt had a fever & multiple pox on the scalp, chest, back, hands & feet;
Systemic: Seizure-Mild, Additional Details: short episode with sudden change of awareness followed by convulsions. patient griped onto pharmacist's arm fimly and knocked head against wall. Patient broke his glasses. Parmacist called out to tech for assistance. Patient monitored for 5 mins. EMS offered but declined. follow up calls made at 2pm and 7pm . messages left. no return call received.
Initial vaccine dose one of Moderna was administered on 08/11/2021. On 09/16/2021 I administered Pfizer. The patient was monitored and denied any symptoms. He was educated of potential side effects including injection site reaction, fever, chills, tiredness, body aches, headache, muscle pain and nausea. I advised the patient to report any symptoms to his primary care provider and to seek emergent care as needed.
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
unusual behavior; throat pain/tightening; excessive salivation; runny nose; change in pitch of voice; paleness; fast heart rate; elevated blood pressure.  Onset of symptoms approximately 10-15 minutes after administration of DTaP 5, IPV 4, and MMR 2 vaccines.  Immediate treatment with oral Benadryl and Epinephrine injection; follow up treatment of Prednisolone.
Consumer passed 49 days since the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer passed 49 days since the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer passed 49 days since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer passed 49 days since the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
slight injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight injection site pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 017C21A and 014J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (flu shot given 2.5 weeks before the vaccination. Patient had side effects) in 2021. Past adverse reactions to the above products included Adverse reaction with Flu shot. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergic to the drug Mucinex), SLE (Patient is in remission, mild and not on immuno suppressant drugs for years), Gout (Pseudo gout), GERD and High cholesterol. Concomitant products included OMEPRAZOLE for GERD, ATORVASTATIN for High cholesterol, MAGNESIUM and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (slight injection site pain). At the time of the report, VACCINATION SITE PAIN (slight injection site pain) 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 did not provide any causality assessments.   Patient was never tested positive for COVID-19.  Patient had no acute illnesses at the time of injections.   This case was linked to MOD-2022-438826, MOD-2022-437114 (Patient Link).
On  11/4/20 at 2 am and then 6:30 am, he had difficultly swallowing, throat pain, swelling on one side of the face, tongue and throat.
8/26/99 woke up w/cramps in stomach;1/2hr later had severe cramps& vomiting in AM of 8/26/99;tx w/phenergan;
Symptoms developed 07/10/2021. Puritic rash noted s/p varicella vaccination. Not classic in appearance to varicella (no true vesicles, papules, and crusting lesions). Small papules noted with some on larger red base. Small scab noted in center of lesion. + Itchiness.
When mixing the next vial of Pfizer covid vaccine I mistakenly grabbed the old vial that had already been reconstituted and which 6 doses had already been withdrawn. I added the 1.8ml of sodium chloride and proceeded to draw up the dose for the patient. After it was administered I saw the new bottle on the counter and realized the error. I properly mixed the new vial and the patient was given another injection from the correctly mixed vial. I followed up with the patient 5/13/21. She experienced a headache and some nausea on the day she was given the vaccine but has fully recovered.
24 hours after vaccine Pt had swollen red arm. (From armpit to mid forearm). Pt saw Dr.
Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse event This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 74 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported. Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
no adverse effects; Patient have been administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 13-MAR-2020 at 09:33, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # S023219, expiration date on 03-MAR-2022, at a dose of 0.5 mL, intramuscular on the left thigh (LT). On that same day, the patient also received pneumococcal 13v conj vaccine (CRM197). Administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported. The outcome was provided as "supported". No adverse events reported.   This is one of several reports received form the same reporter.; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008889: US-009507513-2008USA008876: US-009507513-2008USA008883: US-009507513-2008USA008885: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933:
15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report received from a contactable Physicians. This Physicians reported similar events for 15 patients. This is the 5th of 15 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received COVID vaccine reconstituted with 1.3 ml instead of 1.8 ml and they reported significant body aches on an unspecified date. Many had GI symptoms (nausea, vomiting and diarrhea) they have reported this to VAERS and have reviewed how to avoid this issue going forward. The seriousness of the events was reported as non-serious. Outcome of significant body aches was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Left arm pain, limited range of motion unable to raise left hand above head Treatment: ADVIL with food, ice.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Heat at the site of the vaccination; Itchiness at the site of the vaccination; Reddness at the site of the vaccination; Swelling at the site of the vaccination; Severe Pain at the site of the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Heat at the site of the vaccination), VACCINATION SITE PRURITUS (Itchiness at the site of the vaccination), VACCINATION SITE ERYTHEMA (Reddness at the site of the vaccination), VACCINATION SITE SWELLING (Swelling at the site of the vaccination) and VACCINATION SITE PAIN (Severe Pain at the site of the vaccination) outcome was unknown.            Treatment also included ice pack for adverse events.   This case was linked to MOD-2021-322203 (Patient Link).
Patient was asymptomatic 4 hours after vaccination given at 10a, then in the evening started to develop chest pain, shortness of breath, nausea, and abdominal pain. Patient came to ED for evaluation. She received epinephrine IM 0.3 mg, Benadryl 25 mg, Pepcid 20 mg, 1 L NS bolus, Toradol and PO Tylenol for pain management. Patient is now feeling better.
Patient went walking at local gym after receiving flu vaccine and felt a sudden spasm and trouble turning neck B/C of tightness at SCM muscle. Was treated with stretches/muscle relaxer.
severe dizziness on arising from bed; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1686; expiration date: unknown) at 77-year-old vaccination age via an unspecified route of administration in the left arm on 31Jan2021 13:15 at a single dose for covid-19 immunization. Medical history included allergy to artificial crabmeat, NIDDM (non-insulin-dependent diabetes mellitus), HBP (high blood pressure), GERD (gastrooesophageal reflux disease) and BPH (benign prostatic hyperplasia). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but has other medications the patient received within 2 weeks of vaccination. On 04Feb2021, the patient experienced severe dizziness on arising from bed at 0800 hours. The dizziness subsided approximately 6 minutes later with no recurrence. The event did not require treatment. The event was considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on 04Feb2021 0806 hours.  No follow-up attempts are possible. No further information is expected.
right arm pain, fever of 100.9 and Achy.  Tylenol taken on 1/13/21 no improvement.
pt recvd vax 16DEC92 & exp nausea, vomiting, lightheadedness & weakness; presented to MD; all blood work was reportedly nl; pt reported that the sx were similar to those exp w/mononucleosis;
Patch of erythema with itchy left leg approx. 8x10cm sized patch.