chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a headache, fever and sore throat. Took a home COVID-19 test and it was positive. Called my interim doctor and was prescribed Paxlovid. Had to call Cardiologist because I would have to stop taking some of my other medications before I could take Paxlovid. Wasn't able to get them to call me back until about 5 days later. Finally talked to them and was told to stop taking Plavix and Atorvastatin. At that point I was starting to feel a little better, so I never did take Paxlovid. I retested for COVID-19 and still showed that I was positive. Doctor said I don't have to take another test because it may show positive for a while. Still feel fatigued.
Vials were stored in the fridge for more than 30 days; No adverse event; HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge), PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 18-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Apr-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge), PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge) and PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days).    No concomitant information was reported.  Suspect product dosage text was reported as initial booster.  It was unknown if patient number 3 experienced any adverse events.  No treatment information was provided.   HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge.   This case was linked to US-MODERNATX, INC.-MOD-2023-720530, US-MODERNATX, INC.-MOD-2023-720479 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720530:same reporter US-MODERNATX, INC.-MOD-2023-720479:same reporter
I have a big pink hot area where I got my shot; I have a big pink hot area where I got my shot; 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 VACCINATION SITE WARMTH (I have a big pink hot area where I got my shot) and VACCINATION SITE ERYTHEMA (I have a big pink hot area where I got my shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (I have a big pink hot area where I got my shot) and VACCINATION SITE ERYTHEMA (I have a big pink hot area where I got my shot). At the time of the report, VACCINATION SITE WARMTH (I have a big pink hot area where I got my shot) and VACCINATION SITE ERYTHEMA (I have a big pink hot area where I got my shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
No adverse effect reported; Pharmacy intern states that dose of M-M-R II was administered the intramuscular route; This spontaneous report was received from a pharmacy intern and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent condition, medical history, concomitant therapies and drugs or allergies reactions were reported.  On 19-APR-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) by intramuscular route, for prophylaxis, lot # R001658 and expiration date of 17-JAN-2020 (strength, dose and anatomical route were not reported).  On the same date, the patient experienced incorrect route of product administration. No adverse effects reported.   The outcome for the event was not reported.
When I take deep breath my chest hurts; Chills; Pain in the arm where I got the shot; Feeling cold; This is a spontaneous report from a contactable consumer. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185; Expiration Date: 01Aug2021, at the age of 22-year-old), dose 2 via an unspecified route of administration, administered in Arm Right on 19May2021 as dose 2, single for covid-19 immunisation. The patient medical history included pneumonia and covid both on an unspecified date in June2020 (Last year like around June. I did get COVID like the actual COVID and that gave me pneumonia but that was back in June. I was admitted to the hospital and they prescribed some medicines to take but I dont remember those. I am not taking those medication anymore) and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0170; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 28Apr2021 as dose 1, single for covid-19 immunisation. The patient stated, she got second dose of Pfizer vaccine today, during the day she was fine but had some pain in the arm where she got the shot but right now when she took a deep breath her chest hurts. She had lot of chills and wanted to know if that was normal? She stated, she was around 160 pounds, she thought she gained weight, it's around there 160, 161. It's one of that two. Stated, no just a pain reliever for this, Acetaminophen, 500 mg, this is the first time that she took it today. She did take it around 4 pm, so this was her second one. The outcome of event for when I take deep breath my chest hurts was not recovered and for the other events it was unknown.  Follow up needed, further information has been requested.
On 09/02/2000 the patient developed shingles on the right arm with severe pain, 7 on a scale of 1-10. The patient's entire right arm was covered with red and painful pox. It was also reported that the patient was afebrile. A sibling had an unusual rash 2 weeks prior to this occurrence. It was noted that the varicella zoster was confirmed by a visit to the dermatologist. Additional information has been requested.
Sore arm at injection site. Brachial neuritis, fever, body aches, and headache.
Day 6 post vaccine patient began complaining of bilateral anterior ankle pain, and L hip pain.  She had a low grade fever of 99.8 at that time.  The following day Day 7, she had general fatigue, bilateral angle pain, and malaise.  On Saturday, Day 8 she was unable to stand for periods of 15 minutes or longer due to pain in both ankles, and her knees, and elbows began to hurt.  On this day she was given advil 400mg without relief, she then took Tylenol 650mg and the joint pain decreased from a 9 to a 6.  We have had to continue alternating tylenol and advil since Saturday and she is unable to stand or walk for prolonged periods.
Patient presented to office on 05/19/15 with complaints of right arm pain, tenderness, swelling and erythema at injection site of right deltoid, post-PREVNAR 13 vaccine administered on 5/11/15. Advised to apply cool compress and to return to office should condition not resolve itself.
about half a dose was administered; leaked onto the patient's skin; leaked onto the patient's skin; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On 27th November 2021, the patient received the 1st dose of Shingrix. On 27th November 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: Pharmacist was administering first dose of Shingrix to the patient and due to a needle malfunction, only about half a dose was administered and the other half leaked onto the patient's skin which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact.  No other symptoms were reported. Pharmacist was asking if an additional dose was to be given to make up for the underdose. The reporter consented to follow up.
On all four injection sites I had knots underneath my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 at 14:00 as dose 2, single (Lot number: El8a82) at the age of 66 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Retinal vein occlusion", start date: 01Aug2018 (ongoing), notes: eyelea injection every 4 to 6 weeks; "High blood pressure" (ongoing), notes: Onset date: 10 years ago, metoprolol succinate 100 mg 1x a day; "Thyroid" (ongoing), notes: Onset date: 10 years ago, Levothyroxine sodium 25 mcg. The patient's family history included: "stroke" (unspecified if ongoing); "Alzheimer's" (unspecified if ongoing); "Arthritis (RA)" (unspecified if ongoing); "eye disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM taken for thyroid disorder (ongoing); METOPROLOL SUCCINATE oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EL0142; Route of administration: Intramuscular; Anatomical Site of injection: Right upper arm; vaccination time:10:00), administration date: 04Jan2021, for COVID-19 immunization, reaction(s): "pain that radiates down my arm to my right thumb/ pain on occasion traveling down my arm into my right thumb", "My right upper arm where two of the injections were given stay sore", "knots underneath my skin". The following information was reported: VACCINATION SITE NODULE (non-serious), outcome "unknown", described as "On all four injection sites I had knots underneath my skin".  Additional information: the patient did not received any prior vaccination within 4 weeks of suspect vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200104772 Same patient, different dose/ AE;US-PFIZER INC-PV202200089180 Same patient, different dose/ AE;US-PFIZER INC-202201304975 Same patient, different dose/ AE;
TDAP given IM, R deltoid 5/31/06. Pt developed hard raised spot at injection site on 6/1/06. Slowly progressed to enlarging area of swelling and erythema, no pain. Became 4" X 2" area and pt was treated 6/6/06 with Cephalexin and topical cream.
21JUL pt recvd vax irritable, crying, lt thigh became red & swollen; fussy & wakeful during day w/much crying; @ noc screaming sounds;  had fever; 24JUL 330 mom nursing pt stopped sucking eyes closed & rolled back, shaking 10-15sec;irritabl
the fingers and hands are tingling; she feels very numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization, reaction(s): "soreness in the arm"; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 Immunization, reaction(s): "soreness in the arm". The following information was reported: PARAESTHESIA (non-serious) with onset Dec2021, outcome "unknown", described as "the fingers and hands are tingling"; HYPOAESTHESIA (non-serious) with onset Dec2021, outcome "unknown", described as "she feels very numb". The events "the fingers and hands are tingling" and "she feels very numb" were evaluated at the physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He feels uncomfortable and worried. Always says that he feels like head ache. Also he is abnormal and afraid that he has covid-19.
her legs were red, the back of neck, stomach and arms; a little swelling under eyes and middle of back; rash all over the body; This is a spontaneous report from a contactable consumer.A 96-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL9264), via an unspecified route of administration on 02Feb2021, 6PM as single dose at left arm for covid-19 immunisation. The patient medical history included scoliosis, skin problems off and on prior to the vaccine and have dermatitis and other skin issues which had been diagnosed for years. the patient concomitant medication was not reported. on her legs were red, the back of neck, stomach and arms and a little swelling under eyes and middle of back and chest had some rash, states it is a dry rash. States that on Monday prior to the vaccine, one of her cheeks was red, that by yesterday she had a rash all over. the patient was is shrinking from scoliosis. On 03Feb2021, the patient had a rash come over her body . the outcome of event rash was not recovered. outcome of events her legs were red, the back of neck, stomach and arms and a little swelling under eyes and middle of back was unknown.  No follow up attempts are possible. No further information is expected.
had Pfizer vaccine then was exposed to a person that hasCovid. Now is the 1st day that the patient is showing symptoms; had Pfizer vaccine then was exposed to a person that hasCovid. Now is the 1st day that the patient is showing symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) for a program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome unknown. It was reported that caller doctor, is asking specifically for Paxlovid because he has a patient that was treated with cancer and had Pfizer vaccine then was exposed to a person that has Covid. Now is the 1st day that the patient is showing symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up. Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Vial stored >12 hours post puncture; vaccine has now been expired because it was after 12 hours, Dose administered >12(US) hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine has now been expired because it was after 12 hours, Dose administered >12(US) hours post puncture) and PRODUCT STORAGE ERROR (Vial stored >12 hours post puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine has now been expired because it was after 12 hours, Dose administered >12(US) hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored >12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine has now been expired because it was after 12 hours, Dose administered >12(US) hours post puncture) and PRODUCT STORAGE ERROR (Vial stored >12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that it was the patient's second booster dose. No concomitant medications was reported. No treatment medications was reported.  The vial was initially stored in the refrigerator on 22-Jun-2022. The vial was first punctured on 22-Jun-2022 7:45 AM. The vial was stored in fridge post puncture. The vial does not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celcius= 46 to 77 degree Fahrenheit ) was 2 minutes.
I started a period on 23 Oct 21 and I barely bled for 2 days. It started again on 5 Nov 21 and hasn't stopped! I've been put on Progesterone and Tranexamic acid to stop my excessive bleeding. Nothing has helped and it is still going strong. My periods have always lasted about 5 days tops, so this is extreme for me!
Pain in the arm; This is a spontaneous report from a contactable Nurse. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Information on the Batch/Lot number has been requested. The patient's medical history and concomitant medications were not reported. The patient stated that the first injection (Pfizer vaccine) was great, besides pain in the arm for 12 h pain in the armours. It was also informed that she was scheduled to have a computerized tomography scan (CT scan) with IV (Intravenous) contrast 5 days before the second dose of the Pfizer vaccine. The outcome of the event was recovered on an unspecified date.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
6/23/04 swelling and redness at sight. Called- 2X (Ice-Motrin-Benadryl).
2/2/2021 8:15 vaccination By 10PM, fever of 100.7. When woke up, my temp was around 103.7. I felt horrible.  Took motrin, went back to bed. Took Motrin prior to vaccine and took every 5 hours till i went to bed and still woke up with that fever. Extreme fatigue, lymph nodes swollen under right arm; lasted about 2-2.5 days.  Temp lasted approximately 4-4.5 days.  *COVID + 10/2020; temp lasted for 14 days.
Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient presented to the emergency department with impaired vertical gaze and dizziness. Vital signs within normal ranges except pulse 49 beats per minute. Diagnosed with CVA, administered tPA, admitted to the hospital. Discharged two days later to home in good condition.
Patient complained of itchy rash on right arm, very pruritic.  Patient tried hydrocortisone cream.  Saw NP in office on 9/29/2015.  NP suggested a cold pack/ aloe and to contact us if the injection site becomes develops signs of infection such as drainage, pain, increase redness.
Patient became increasingly lethargic, sleeping excessively, having poor balance and coordination/increased ataxic gait and refused to walk starting on 8/16/2012.  On 8/28/12 patient was hospitalized for the complete inability to walk or bear weight.  Partial ability returned in a few days but full ability did not come back for three additional weeks.
anxiety state, unspecified; chest and neck feel intense which comes and goes; patient received intravenous migraine medication; not herself; lost 5 pounds; lower left back pain which feels internal; chest and neck feel intense which comes and goes; pressure tingly feeling in her head; weak; thirsty; food aversion, couldn't eat, felt hungry, tasted disgusting; headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (patient received intravenous migraine medication) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced ASTHENIA (weak), THIRST (thirsty), FOOD AVERSION (food aversion, couldn't eat, felt hungry, tasted disgusting), PARAESTHESIA (pressure tingly feeling in her head) and HEADACHE (headache). On 18-Aug-2021, the patient experienced CHEST DISCOMFORT (chest and neck feel intense which comes and goes). On an unknown date, the patient experienced MIGRAINE (patient received intravenous migraine medication) (seriousness criterion medically significant), FEELING ABNORMAL (not herself), WEIGHT DECREASED (lost 5 pounds), BACK PAIN (lower left back pain which feels internal), MUSCULOSKELETAL DISCOMFORT (chest and neck feel intense which comes and goes) and ANXIETY (anxiety state, unspecified). The patient was treated with IBUPROFEN ongoing from 18-Aug-2021 for Head pressure, at a dose of 1 dosage form. At the time of the report, MIGRAINE (patient received intravenous migraine medication), ASTHENIA (weak), THIRST (thirsty), FOOD AVERSION (food aversion, couldn't eat, felt hungry, tasted disgusting), FEELING ABNORMAL (not herself), PARAESTHESIA (pressure tingly feeling in her head), WEIGHT DECREASED (lost 5 pounds), BACK PAIN (lower left back pain which feels internal), CHEST DISCOMFORT (chest and neck feel intense which comes and goes), MUSCULOSKELETAL DISCOMFORT (chest and neck feel intense which comes and goes), ANXIETY (anxiety state, unspecified) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Computerised tomogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant information was provided by reporter. They gave her an IV of a migraine medication. she thinks it was Toradol but was unsure.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.