chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Made sounds like she had shortness of breath at some point; Stomach ache; Very tired; Knees hurt a lot, particularly the left knee which is very painful; Stayed for 2 days in bed; Nodule on the left side next to the clavicle; Rash in the right arm and under the breasts, where it is very itchy; Lot of pressure in the head; Strong flu; Sore throat; Difficulty to walk; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy) and HEAD DISCOMFORT (Lot of pressure in the head) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful). On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Made sounds like she had shortness of breath at some point), ABDOMINAL PAIN UPPER (Stomach ache) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at a dose of Every 6-8 hours. At the time of the report, BEDRIDDEN (Stayed for 2 days in bed) had not resolved and NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk), ABDOMINAL PAIN UPPER (Stomach ache), FATIGUE (Very tired) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful) outcome was unknown.            It was reported that the patient didn't go to work.   This case was linked to MOD-2021-336022 (Patient Link).
dizziness, lightheadedness and nausea lasting approximately 90 minutes. Symptoms occurred around 10 p.m.  Vaccine given around 2 p.m.
Arm/shoulder/back pain despite mult. analgesics and interfering w/ ADL's >lmo.
lump in her breast; a lymph node; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (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: BREAST MASS (non-serious), outcome "unknown", described as "lump in her breast"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "a lymph node". The events "lump in her breast" and "a lymph node" were evaluated at the physician office visit.  Additional information: Female child (unknown age but 5 through 11y) had first Pfizer-BioNTech Covid 19 vaccine. An unknown time after child had a lump in her breast thought to be a lymph node. Parent was taking child to the pediatrician.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "oral allergy syndrome" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "known allergies: Soy and nickel" (unspecified if ongoing); "known allergies: Soy and nickel" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received vaccine Thursday evening & she said she noticed her arm swelling & it was sore Friday morning. She said it was swollen to about the size of a small fist. She said she would take BENADRYL & go see her doctor. If did not clear up.
Foggy brain; fatigue; inability to concentrate; episodic racing heart; episodic breathing difficulty; muscle cramps in legs & feet despite drinking a lot of water; This is a spontaneous report from a non-contactable consumer (Patient). A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6201, Expiry date was not reported), via an unspecified route of administration on 22Feb2021 09:30 (at the age of 68-years-old) in Arm Left as dose 1, single for COVID-19 immunization at hospital. The Patient Medical history and concomitant medications were not reported. Patient had no known allergies. The Patient did not receive other mediation in two weeks and in four weeks. Patient had no COVID-19 prior vaccination and tested COVID-19 post vaccination. On 22Feb2021 16:30, the patient experienced Starting 7 hours after vaccine & lasting for 2.5 more days. Foggy brain, fatigue, inability to concentrate, episodic racing heart, episodic breathing difficulty, muscle cramps in legs & feet despite drinking a lot of water. The patient did not take the treatment for the events and took the treatment for the event muscle cramps in legs & feet despite drinking a lot of water. The patient underwent lab tests and procedures which included saliva (sars-cov-2 test) : negative on 05Mar2021. The outcome for the events Foggy brain, fatigue, inability to concentrate, episodic racing heart, episodic breathing difficulty, muscle cramps in legs & feet despite drinking a lot of water was recovered on 25Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient developed diffuse hives about 5 hours after getting the vaccine. Reported some lip swelling (possible anaphylaxis) but was not seen until next day and all symptoms were completely resolved that that time.
Received vaccine 5/22/21 - had some local arm swelling & pain which resolved that night. 5/23 had fever, chills, nausea, diarrhea x2 days with complete resolution. On 5/29, developed urticarial rash on legs & arms - no improvement with OTC Benadryl. No new foods/obvious exposure to other allergens other than family had tried a new scent of their brand of fabric softener. 5/31, developed nausea, vomiting, hand/feet swelling, & had a pre-syncopal episode. Presented to ER; tachycardic with symptomatic orthostatics though vitals otherwise normal. Received IV fluids, Pepcid, Decadron with improvement in HR/symptoms. Continued to be orthostatic with some extremity swelling so received IM Epinephrine - subsequent improvement in rash, nausea. Hospitalized for monitoring. Orthostatis/nausea resolved, vitals remained stable. Some intermittent itchiness/hives present that came & went still present at the time of discharge from hospital.
lymphadenopathy on left side of neck.  It happened 5 days after first dose and has stayed swollen since first vaccine, but otherwise had no other issues.  After she received her second vaccine, it has doubled or tripled in size and is painful.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 09-NOV-2015, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contact a persistent strain of shingles. On or about 16-OCT-2016, the patient was treated at a medical center for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 21-OCT-2016, the patient received subsequent treatment at a medical center for ongoing and worsening symptoms which was diagnosed as severe herpes zoster accompanied by occipital neuralgia. Occipital neuralgia is a condition characterized by chronic pain in the neck, head and behind the eyes at the occipital nerve and artery and is a secondary condition to herpes zoster infections. The patient has been prescribed tramadol, VOLTAREN EMULGEL topical gel and VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
the evening the immun were administered pt had t104 & unconsoleable cry for > 3 hrs; MD stated pt was irritable & not back to nl routine until 6 days later;
This spontaneous report as received from two pharmacists (one vial field representative) refers to a patient of unknown age. On 06-NOV-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 11 of several reports from same reporter. Additional information has been requested.
Severe headaches, hallucinations, occasional confusion, short term memory loss, delusions, and paranoia of unclear duration. The pt also experienced loss of control of left foot. The pt experienced bleeding from the rectum (bright red). Annual FU: pt died. no other info provided.
patient received the vaccine  from vial  12 hours after the vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the vaccine  from vial  12 hours after the vial was punctured) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the vaccine  from vial  12 hours after the vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the vaccine  from vial  12 hours after the vial was punctured) 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.   No concomitant medications reported. No treatment information was provided.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 22-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On unspecified date(s), the subject received the series of three doses of hepatitis B vaccine.  At an unspecified time after completion of the vaccination series with hepatitis B vaccine, the subject experienced decreased therapeutic response.  The reporting nurse stated that the subject's hepatitis B antibody titers were "currently lower than what they should be and may need further immunization".  At the time of reporting the outcome of the event was unspecified.  Follow up information was received from the healthcare professional on 04 May 2007.  The healthcare professional indicated that she did not report this case to a regulatory authority.
THE DAY AFTER THE VACCINE I AWOKE WITH A LUMP ABOUT 1/4 INCH BELOW THE INJECTION SITE. THE LUMP LOOKED LIKE (IN SHAPE AND SIZE) AN EGG CUT LENGHTWISE AND PUT UNDER MY SKIN. THE LUMP FELT LIKE A DR SCHOLLS  SILICONE GEL HEEL PAD INSERT.  THE SITE WAS ONLY VERY SLIGHTLY SORE.  IT IS OVER SIX WEEKS AND THE LUMP HAS NOT GONE DOWN OR CHANGED AT ALL IN ALL THIS TIME.  OCCASIONALLY THE SITE IS SOMEWHAT SORE WERE THE LUMP IS.  I REDIEVED MY SECOND INJECTIION IN THE RIGHT ARM AND HAD ONLY VERY SHORT LIVED MINOR SEWELLING.
Patient reported on 2-6-2021 that she experienced a irregular shaped red rash on left arm. Area was warm and hot to the touch. Patient described that it felt like a bee sting. Patient also reported as itchy.
received the 1st dose of Shingrix 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the date of reporting, before Covid pandemic).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. At the time of reporting, the patient wanted the 2nd dose. The reporter did not have the patient's date of birth or the exact date of vaccination. The reporter consented to follow up.
Rash/ hives 3 weeks after 2nd dose all over arms,legs,feet,back,stomach. Very itchy feels like posion ivy
Hives; Headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and HEADACHE (Headache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache). On 25-Mar-2021, the patient experienced URTICARIA (Hives). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 25-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Acetaminophen for headache. No relevant concomitant medications reported.
Mild like pain in my heart; I haven't been feeling well, I am feeling very weak today; I haven't been feeling well, I am feeling very weak today; Spasms in my foot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old patient of an unspecified gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for inejction, Batch/Lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on 21Aug2021 as DOSE 1, SINGLE for covid-19 immunisation; gabapentin (GABAPENTIN "PCD", Batch/Lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on an unspecified date for an unspecified indication.  The patient's medical history and concomitant medications were not reported. The reporter stated 'I had a shot (Covid-19 Vaccine) but I am calling to find out if you have to have that shot in your system and ever since then I haven't been feeling well, I am feeling very weak today but, because I took, are you supposed to take, I have to take a Gabapentin, I tried it today and I am really super dizzy today, like really dizzy, am I not allowed? Should I not take that pill more'. The patient also stated 'Well, wonder if you should mix that drug after you had a Pfizer shot because I had it a week ago, like last Saturday and I actually had some spasms in my foot and I had mild like pain in my heart and I am 60 years old, I am going to be 61, so that concerns me that I should be mixing the drug right now, just after a week, because I was kind of sick from that, a little sick and I have to have the second shot and I am kind of afraid to have it and I am living on street, I am living in my car and no body is helping me out'. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of GABAPENTIN in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of GABAPENTIN has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
3RD DOSE MODERNA COVID VACCINE GIVEN 12/20/21, #067H21A; 4TH DOSE MODERNA COVID VACCINE GIVEN 7/15/22, #059M21A; pt brought to ED 8/21/22; increasing SOB and fever; found to be positive for COVID; CXR showed postobstructive pneumonia or worsening pulmonary neoplasm; given ABX, IV Flds, steroids, Remdesivir, bronchodilators, thromboembolic prophylaxis; O2 supplementation; BiPAP; ICU; developed acute renal failure due to shock issues; hemodialysis; cardiogenic shock; vasopressors; transitioned to DNR/DNI; pt passed away in the hospital
Patient started with a rash on both arms , face and neck. Her face was flushed. She felt lightheaded and her arms hurt. She also became anxious.  Initial VS: pulse ox:97% on RA, pulse: 102, BP: 102/64; 5 minutes later: pulse ox:96% on RA, pulse: 106 5 minutes later: Zyrtec 10 mg po given; 5 minutes later: pulse ox:99% on RA, pulse: 68; 10 minutes later: pulse ox:98% on RA, pulse: 91, BP: 104/62: lungs were CTA the entire time; no tongue swelling. Water given, a lollipop and brownie given. After 30 minutes; rash almost completely gone and pulse ox:97% on RA, pulse: 87. Patient discharged home with Mom and walked out of the office.
A physician reported that a patient received an injection of Flu Shield (2001-2002 Formula). Approximately 6 to 9 days later, the patient had an INR of approximately 4.2 to 5.6. The reporter noted that the patients INR had been stable at approximately 2.5 to 3 before immunization. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 8 patients experienced this event; however they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Received a dose of MMR that had expired on 1/12/22.  No adverse event noted/ treatment given.
Vomiting, diarrhea, chills, fog head, tiredness, slight sore arm
Red, swollen, hot at the site where shot was administered. Over 4 days, redness spread lower on arm, from left shoulder to elbow. Nerve pain, numbness in fingers followed initial reaction.
On 1/7/2021 had severe headache all over head and neck.  Aspirin did not do anything. I don't get headaches. After a few hours it went away on its own. On 1/13/2021  started out in the morning with itching on area where shot was given. Then a rash in that same area. Then by the afternoon my arm swelled up covering a large area around where shot was given. It was hard like a knot. Today, 1/14/2021 it is still itching, red around swollen area. Swollen area is not as large as yesterday.
Painful left axillary lymphadenopathy (1.5 x 2 inch); Fever; Chills; Sweats; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 32-year-old female patient received second dose of bnt162b2 (Solution for injection, lot number: EL1283), intramuscularly at Left arm on 22Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included subclinical hypothyroidism and allergies to penicillin from an unknown date. The patient is not pregnant. Concomitant medication included levothyroxine. The patient previously took first dose of bnt162b2 on 02Jan2021 09:00 AM at 32-year-old Intramuscularly at left arm; took BACTRIM and experienced allergies to BACTRIM. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced painful left axillary lymphadenopathy (1.5 x 2 inch), fever, chills, sweats, body aches, headache, fatigue from 22Jan2021 10:00 PM. No treatment. The outcome of the events was recovering.   Information on the batch/lot number has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # N031003, expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA000594: US-009507513-1809USA000595: US-009507513-1809USA000596: US-009507513-1809USA000592: US-009507513-1809USA000587:
Information has been received from a physician concerning a male patient who on 19-JUN-2006 was vaccinated with a dose of Varivax (Oka/Merck). Concomitant vaccination included a dose of MMR II (MSD). Subsequently, on 07-JUL-2006, eighteen days after vaccination, the patient developed a rash. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.