chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOSS OF BLOOD; LEGS STARTED BUCKLING; PALE OR YELLOW; This spontaneous report received from a consumer concerned a 73 year old female with unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included anemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced loss blood. On JUN-2021, the patient was pale or yellow. On JUL-2021, the patient experienced legs started buckling. Patient went to see her PCP, from there patient went to emergency room and had 2 pints of blood administered. Patient had a repeat transfusion with 2 pints and now patient was on the way to the emergency room as doctor recommended for patient to have another 2 pints. Patient was getting treated for anemia in every 6 months.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pale or yellow, and loss of blood, and the outcome of legs started buckling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210810877-covid-19 vaccine ad26.cov2.s -loss of blood . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastational Diabetes" (unspecified if ongoing); "Para Thyroid Precancerous" (unspecified if ongoing); "Optic neuritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Diabetes type II" (unspecified if ongoing); "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Acid-GERD" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Low Vitamin D" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Low White Blood Count" (unspecified if ongoing); "Peanut allergy worsened" (unspecified if ongoing); "Weight gain" (unspecified if ongoing); "Relapsing Remitting Multiple Sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; LEVOTHYROXINE; LISINOPRIL; SERTRALINE; CHLORDIAZEPOXIDE; NEXIUM 1-2-3; VITAMIN D 3; TRULICITY; CRANBERRY; ATORVASTATIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm".  Additional information: Patient's concomitant medication included: Blood Booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The mother gave birth to a premature baby; The mother gave birth to a premature baby; This is a spontaneous report from a contactable consumer (mother). This consumer reported information for both mother and fetus/baby.  This is a baby report. A female patient of an unspecified age was exposed to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), transplacental on 11Mar2021 (Lot Number: EN6204) as dose 1, single, and transplacental on 08Apr2021 (Lot Number: ER8734) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the mother gave birth to a premature baby (the patient) via vaginal delivery with epidural anaesthesia. The patient was hospitalized and stayed in intensive care for 19 days. The patient weighed 5.9 lbs ozs and measured 50 cm long. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021416982 mother case
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, unspecified number of patients were vaccinated with VAQTA (lot# unspecified) (dose, frequency and route were not reported) which were exposed to temperature range:-0.7C Time frame: 15 minutes Temperature Range:-0.5C Time frame: 15 minutes. No adverse effects were reported. No concomitant medications were reported. No adverse events or Product quality issue (PQC) were reported. This case is linked to case # 1401USA000286, 1401USA000288, 1402USA010744, 1402USA010745, 1402USA010746 and 1312USA011848 (same reporter link). Additional information is not expected.
Hospital 5/22 thru 5/24/2021   Dx:  UTI/ Weakness/ Right Pleural Effusion         Covid Positive (5/22/2021) ED to Hosp-Admission Discharged  5/22/2021 - 5/24/2021 (2 days)  Treatment team UTI (urinary tract infection) with pyuria Hospital Problem List   Generalized weakness Resolved  Pleural effusion on right Resolved  UTI (urinary tract infection) with pyuria Resolved  Lack of appetite Resolved  UTI (urinary tract infection) Resolved  Constipation Resolved  Intractable vomiting with nausea Resolved
Patient who received the Pfizer-BioNTech COVID-19 Vaccine first dose last 28Dec2020. While waiting for the second dose, Patient contracted COVID-19; Patient who received the Pfizer-BioNTech COVID-19 Vaccine first dose last 28Dec2020. While waiting for the second dose, Patient contracted COVID-19; had to recover first and it is now past the 6 weeks after the first dose; This is a spontaneous report via a Pfizer sponsored program CEP/PSP: 159558 (Pfiz-er COVID-19 Vaccine Call Center) from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 28Dec2020 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient who received the pfizer-biontech covid-19 vaccine first dose on last 28Dec2020 while waiting for the second dose, patient contracted covid-19 on an unspecified date. The patient had to recover first and it was now past the 6 weeks after the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and Covid-19 cannot be totally excluded.
local erythema and rashspreading medially from site of injection, worsening over the ensuing 48 hours.
tested positive for Covid-19; tested positive for Covid-19; overweight; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date Jul2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single and (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: DRUG INEFFECTIVE (medically significant) with onset 26Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 26Dec2021, outcome "recovering" and all described as "tested positive for Covid-19"; OVERWEIGHT (non-serious) with onset 2021, outcome "unknown", described as "overweight". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive. Clinical courses: Symptoms were moderate for approximately 3 days and are now subsiding. While the patient is considered overweight he is otherwise in good health.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received vaccine in left upper arm for both doses. In early stages of pregnancy; second dose of vaccine administered after excursion; first dose of vaccine administered after excursion; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (received vaccine in left upper arm for both doses. In early stages of pregnancy), PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine administered after excursion) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine administered after excursion). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (received vaccine in left upper arm for both doses. In early stages of pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (received vaccine in left upper arm for both doses. In early stages of pregnancy) outcome was unknown and PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine administered after excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not provided.  No treatment medications were not provided.  Date of LMP not provided.   This case was linked to MOD-2021-250555 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received  contains no new significant information.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-JUL-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Some of her symptoms started to dissipate and her inflammation markers are coming down/unexpected benefit: inflammation markers have started to come down and symptoms are starting to dissipate; Some of her symptoms started to dissipate and her inflammation markers are coming down/unexpected benefit: inflammation markers have started to come down and symptoms are starting to dissipate; This is a spontaneous report from a contactable consumer (Husband). Follow-up received on 08Jun2021 from a contactable consumer was processed together along with initial information.   A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiration date: unspecified), via unspecified route, administered in right arm on 23Mar2021 02:40pm (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes rheumatoid arthritis and covid-19 positive in Jan2020. It was reported that before getting covid, her hands would sweat, but after having covid they stopped sweating. Concomitant medications include Prednisolone which started from Jan2021 and started with a dose of 15mg which is then reduced to 10mg and 5 mg. Lab investigation includes inflammatory markers which is 2 on unspecified date and 0.8 on unspecified date. History of all previous immunization with the Pfizer is none. On an unspecified date in Mar2021, after the vaccination, the patient had unexpected benefit where her inflammation markers have started to come down and her symptoms are starting to dissipate. The inflammation markers started going down after the first Pfizer vaccine. She had an appointment with her doctor at the end of the month. Her marker level was 2 then it went down to 0.8. Caller reported an unexpected benefit from the Pfizer Covid vaccine. She usually has a lot of inflammation of her joints and typically had sweaty hands. After her covid infection in jan2020 her sweating in hand stopped. Because of the joint inflammation she was tested for rheumatoid arthritis which was negative. After second dose the doctor wants to start her on Xeljanz still thinking it is RA but before she does, she needs to get her Shingrix vaccines. All his family got the Pfizer covid vaccine and no one had any major side effects. Reporter also asked about whether the prednisone reduce the efficacy of the vaccine. The events did not result in emergency room/physician office visit. And Will being on Xeljanz reduce the efficacy of the vaccine. The outcome of event was unknown.      Follow-up attempts are needed. Further information is requested.
Pt received vaccines on 09/10/03, on 09/11, father noticed swelling with redness on right arm. Father brought child to clinic on 09/12/03 for increased redness, warmth, swelling, no fever.  Pt started on Keflex for 10 days, follow up in ER for increased swelling, redness.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with ROTATEQ (2 MLS, orally, Lot:1807AA, Exp:24-Aug-2013) on 16-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-JUL-2012 the nurse called to report that ROTATEQ that was stored under conditions that merck could not support and was administered that day and no adverse effects reported. No treatment information was reported. It was not reported whether the patient had sought medical attention. Additional information has been requested.
patient received Quadracel given in error instead of Daptacel, no AE; 18 month old patient received Quadracel, no AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2020SA025963. [same reporter]  This case involves an 18-month-old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered  and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  On 09-Jan-2020, the patient received a 0.5 mL fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA, expiry date: 13-Aug-2021 via an intramuscular route at the left outer thigh for prophylactic vaccination.  It was a case of actual medication error due to Wrong product administered and Inappropriate age at vaccine administration.  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 Directive and Module VI of the 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.
Her head and scalp felt inflamed; Her neck was killing her; It felt like a massive migraine; Head and scalp felt inflamed and puffy; She couldn't get out of bed; Head was hurting unbearably; Shoulders were killing her; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy) and MALAISE (She couldn't get out of bed) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fall (Patient was walking in the dark, misstepped and hit her head on a wall) on 31-Oct-2021.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy), MALAISE (She couldn't get out of bed), HEADACHE (Head was hurting unbearably) and ARTHRALGIA (Shoulders were killing her). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 07-Nov-2021, INFLAMMATION (Her head and scalp felt inflamed), NECK PAIN (Her neck was killing her), MIGRAINE (It felt like a massive migraine), SKIN SWELLING (Head and scalp felt inflamed and puffy), MALAISE (She couldn't get out of bed), HEADACHE (Head was hurting unbearably) and ARTHRALGIA (Shoulders were killing her) had resolved.            No concomitant medications were provided.  Treatment medication also included Ice for head.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 9:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 52.65 for dose administered on 03-Apr-2021.  Concomitant medication was not provided  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 9 am. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Instantly had a metal taste in my mouth, became very dizzy/lightheaded, skin paled, nurses observed "glassy" eyes, low blood pressure. Sores developed on side of tongue later at night, took Benadryl.
The pt received a flu vaccine on 11/5/99 without incidence. On 10/18/01 or 10/19/01, the pt received a Fluvirin vaccine on her deltoid muscle. Within 48 hours, 10/20/01, the pt was dx'd with a cerebral thrombosis and was admitted to a hospital. The pt experienced cerebral thrombosis, MCA with right hemiparesis and aneurysm on the left carotid artery. The pt was discharged on 10/29/01 and at the time of the report was undergoing rehabilitation therapy. The reporter has stated that the pt's family doctor believed that there was a possible relationship with Fluvirin. The pt did not have a risk factor for stroke per her family physician. The left carotid aneurysm found on exam was a risk factor already present, although unknown. Also, the concomitant use of Premarin would have increased the pt's risk of cardiovascular events. It is more likely that the combination of the aneurysm and the use of Premarin resulted in this event rather than the vaccination with Fluvirin. Further information regarding the other risk factors will be requested from the reporter.
Swollen lymph node in armpit on side of injection as well as sore shoulder on side of injection as well. Both appeared  approximately 32 hours after injection