chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unkonwn dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. On 23-JUL-2014 the 2 years old patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees Fahrenheit for 51 minutes and on 18-JUL-2014 to 48 degrees Fahrenheit for 24 minutes. This is one of several reports received from the same reporter. Additional information is not expected as no follow up was obtained.
Pt reports nausea, "shaky" feeling, weakness. Also states her heart rate was elevated over 100bpm throughout the night.
On 2/23/2023, my husband and I took three commercial flights to an out-of-state destination. We attended a wedding on 2/24/2023. We masked on the flights and in the airports, except when we were eating. We did not mask for the wedding, though, and it was an indoor event. On 2/26/2023, we flew back home. After my husband developed symptoms suggestive of COVID-19, I took a PCR test at a clinic and got a positive result on 2/27/2023. At that point, I didn't have symptoms. However, I did develop symptoms on 2/28/2023. I woke up with irritation at the back of my sinuses. I was starting to get a headache. I developed a low-grade fever and a cough. During my illness, my temperature never went above 101. I began taking PAXLOVID on the evening of 3/1/2023. By 3/4/2023, I felt fine. I still had a cough, but it was less intense now. I took a home antigen test on 3/4/2023 and got a positive result. On 3/9/2023, I took another test and got a negative result. At this point, I still felt fine. On about 3/15/2023, I began having symptoms again. I had sinus irritation, a worsening cough, throat irritation, headache, and fatigue. However, I didn't develop a fever. I took another home antigen test on 3/16/2023 and got a positive result. I had a telehealth visit with my doctor on 3/17/2023, and she gave me information about the isolation protocols. She did not prescribe another round of PAXLOVID. At the time of this writing, I don't feel 100%. I've been kind of tired and have had a bit of a headache, but they haven't kept me from doing anything. Also, the cough is gone. However, I plan to test myself again on 3/25/2023, as I am caring for my elderly mother, and I don't want to risk infecting her.
The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I went to bed. The day after my second vaccine, the entire day I felt extreme arm pain, full body aches, chills and had a fever. It was hot in my room and I was wearing multiple layers of clothing and laying under my blankets, shivering. It was very uncomfortable and lasted much longer but I had heard the second vaccine was a bit more intense so I figured this was to be expected. The following morning I woke up feeling like brand new.
anaphylactic reaction upon receipt of the vaccine; This is a spontaneous report from contactable pharmacist via a Pfizer Sales Representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in Dec2020 at a single dose for COVID-19 immunization. The patient was reported as a healthcare worker. Medical history included latex allergy. The patient's concomitant medications were not reported. The patient experienced an anaphylactic reaction upon receipt of the vaccine in Dec2020. The reporter called to confirm to confirm the lack of latex in the vaccine and also to inquire about the latex content of the 0.9% sodium chloride (NaCl) used to dilute the vaccine. The clinical outcome of anaphylactic reaction upon receipt of the vaccine was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylactic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Tennis ball circumference hardened swelling around injection site (upper left arm), significantly swollen left armpit lymph node.  Feeling as if blood is cut off to the left arm.  Significant neck pain and headache.  General lethargy. Reporting this issue 4 days after injection, still a significant issue, symptoms remain.
Pt noticed redness and swelling in injection site when woke up. Proceeded to then get severe joint pain, neck pain, headache, fatigue and nausea. Severe on 3/13 and 3/14 - staring to improve today.
Shaking chills for 2 hours, nausea and vomiting x1, body aches for 36 hours, temp as high as 103.2,  and lightheadedness after aforementioned symptoms subsided.  Did not seek medical treatment, they would not have done anything for me I wasn't doing at home.
Patient reported red rash on upper arm(Left) 12-14hours after PNEUMOVAX administered. Patient states Rash is not itchy, or painful; not warm to the touch; He is not allergic to any vaccines/drugs or foods; takes a baby aspirin daily will monitor.
Headache, Myalgia & Fever Narrative:  Missed one day of work following second dose due to above symptoms
2 weeks after vaccine patient experience eye discomfort followed by face and tongue numbness, dx with Bells Palsay 7/24 experience difficulty swallowing food resulting in a torn esophagus.
Post vax, the pt developed joint pain, redness, swelling of toes, ankles, wrists, and fingers. Severe pain in tendons of feet, shins/ankles, palms with swelling. Major exacerbation of pain in right lumber, buttocks, and thigh.
MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen.; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with This case is linked to cases 2019SA193300, 2019SA193301, 2019SA193307, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193306 and 2019SA158240 (same reporter).  This case involves 12 years old male patient with who was vaccinated with 0.5 ml first primary dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 30-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  It was unknown if any adverse event occurred.  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 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.   List of document held by sender: none.
Late Sunday evening, I was having severe pain in the back of my shoulder, radiating from there to my elbow, then into my thumb and first finger. I was treated in ER with pain medicine and told to take anti-inflammatory medication. After about a week, everything returned to normal.
03/25/2021 Was tested for Covid before leaving the country and tested positive. Very confused as to why I am not immune!
his spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not reported.  It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received vaccine past the beyond used by date. Treatment medication was not reported.
Pt stated she saw spots and later stated it felt as though her throat was trying to close. She was given liquid benadryl 25mg PO and was monitored. Pt. began to feel better and was driven home by friend that accompanied her.
Said after both doses, no longer needs glasses for being near sighted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "near sighted" (unspecified if ongoing), notes: wears glasses. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Said after both doses, no longer needs glasses for being near sighted".  Additional information: The patient wanted to know if anyone else has called regarding their vision. The patient reported that after both doses, she no longer needs her glasses for being near sighted.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
102 temperature,; This case was reported by a consumer via interactive digital media and described the occurrence of high temperature in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced high temperature. On an unknown date, the outcome of the high temperature was unknown.   It was unknown if the reporter considered the high temperature to be related to Shingles vaccine.     Additional Information: GSK receipt date :23-NOV-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received first dose of shingrix vaccine and had 102 temp. The patient asked if he/she should get the follow up booster dose.
Patient experienced allergic reaction at 15 minutes post vaccine.  Complained of itching on palms and spreading up her arms.  Given 50 mg Benadryl immediately.  Vital signs were normal and stable:  BP = 104/62 to 118/60; P = 75-80 regular rate; T= 98.3; PO2 = 99%.  Patient discharged to family member/home at 12:10pm with instructions to contact doctor/clinic to report incident.
Slight irritation at injection site for shingles within 24 hours. Itchy, blotchy skin. Began to fade two days later. Six days after injection, experienced severe burning top of left shoulder blade. Burning off and on that evening. Next night had red streak and few dots - they disappear by morning, severe itching, low grade burning for about 3 weeks. Shingles injection site and reaction area on T2 dermatome.
Prolonged Menstruation; This is a spontaneous report received from a contactable consumer or other non hcp. A 35-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 21Mar2021,at the age of 35 years old,as Dose 2, Single for covid-19 immunization.The patient medical history was not reported.Concomitant medication(s) included collagen taken for an unspecified indication, start and stop date were not reported.The patient experienced prolonged menstruation on 05Apr2021.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Apr2021 Nasal Swab.The patient didn't receive any treatment for the event.The patient had not received any other vaccine within 4 weeks.The patient was not diagnosed with covid19 prior to vaccination.The outcome of the event was recovered.The patient previously received her 1st dose of Pfizer covid19 vaccine on 27th feb2021.The event resulted in patient visit to physician clinic visit.
Fever 7/3/21 Cough and Mucous - green mucous 7/3/21  to 7/13/21 Sore Throat 7/3/21 - 7:00am Lost voice 7/3/21 - 8:00pm. 24 hours Hoarse voice - 7/5/21 to 7/13/21. 9 days Dizziness 7/5/21 to Present. Treatment over the counter dizziness medication.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (2.777777778 Celsius) for 216 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
BLOOD CLOTS; This spontaneous report received from a consumer concerned 3 women with unknown race and ethnicity . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry was unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date,3 women died from blood clots after getting (Janssen) covid 19 vaccine. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 : 20210530454-COVID-19 VACCINE AD26.COV2.S-Blood clots . This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: BLOOD CLOT
Flu like symptoms,  achy and really tired for 2-3 days--treated with rest and Tylenol.  Toughed out itchy skin which is still present
The patient received Pfizer on 01/16/21 and 02/06/21, Moderna on 06/09/21 and Janssen on 09/09/21
Faint, eyes opening, mild stiff, no shaking lasted<15 sec. No other treatment.
pain on his arm; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (Wife) reported for a male patient (Husband). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on unspecified date (lot number: not reported), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced pain on his arm after the first dose of the covid-19 vaccine. The outcome of the event was unknown.  Information on the Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Breakthrough case admission after 3 vaccines Moderna 1/27/21 Lot# 007M20A;  Moderna 2/24/1 Lot# 010A21A;  Moderna 9/23/21 Lot# 043B21A
the patient found deceased in bed (death); This spontaneous report was received from a physician via Sanofi (manufacturer control # 2020SA294858) on 15-MAR-2021, referring to a 13-month-old male patient. The patient's medical history included seizure and coronavirus disease of 2019 (COVID-19). He had no pre-existing physician-diagnosed allergies and birth defects and at the time of reporting. It was known if the patient had any additional medical history, concomitant disease or risk factor. Past medical treatment(s), vaccination(s) and family history were not reported.  On 23-SEP-2020 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA) (lot # S038146, expiration date was not reported, upon internal validation established as 25-MAY-2021, strength was not reported) 0.5 milliliter, subcutaneously in the left thigh for prophylactic vaccination. On the same date, the patient was also vaccinated with hib conj vaccine (tet toxoid) (ACTHIB) (lot # UJ185AA, expiration date, strength and route were unknown) 0.5 milliliter in right vastus lateralis for prophylactic vaccination. On 14-OCT-2020, the patient was vaccinated with influenza virus split virion 4v vaccine inactivated (FLUZONE) prefilled syringe (lot # UT7081JA, expiration date was 30-JUN-2021, strength was not reported) 0.5 milliliter intramuscularly in left vastus lateralis for prophylactic vaccination. Either on 14-OCT-2020 or 15-OCT-2020, the patient received a dose (once) of acetaminophen (PARACETAMOL) (lot #, expiration date, strength and route were not reported) 4 ml for an unknown indication and then the patient was put to bed at usual time. At that time the body temperature of the patient was 97.7 degrees Fahrenheit.  In the morning of 15-OCT-2020, the patient was found deceased in bed. No other illness and symptoms were reported. At the time of reporting, it was unknown if the autopsy was conducted, and the cause of death was not determined. The cation taken with acetaminophen(PARACETAMOL) was not applicable.   The causality assessment between death and all suspect therapies was not provided.; Reported Cause(s) of Death: unknown cause of death; cause of death was not determined
Rash in all over the hand; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash in all over the hand) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced RASH (Rash in all over the hand). On 25-Dec-2020, RASH (Rash in all over the hand) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient was administrated with only the diluent; Patient was administrated with only the diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo (unknown). On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 16-Jun-2022 Reporter's comment: The pharmacist reported that a patient was administrated with only the diluent of Menveo. No adverse event was reported. The reporter consented to follow up. The patient's identifiers, vaccination date, no lot number and expiration date were not provided. Vaccine was administrated on another facility. Additional Supportive information: The patient was administrated with only the diluent of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient developed rash on left thigh-warm, erythematous 12 x 22 cm-began approx 24 hrs post vaccination.