chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Expired Monovalent vaccine after 30-day Use By Date; No adverse event; Received Expired Monovalent vaccine after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (Received Expired Monovalent vaccine after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received Expired Monovalent vaccine after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (Received Expired Monovalent vaccine after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Received Expired Monovalent vaccine after 30-day Use By Date).    No concomitant medication was reported.  HCP reported that some adult patients received expired doses of both Mono and Bivalent vials of Moderna COVID-19 vaccine after 30-day Use By Date. Vials were mix of individual vials or unbroken cartons of size 5.5 ml red cap and 2.5 ml bivalent. Reporter asked if the vials were viable and was there a need to revaccinate.  On 02-Mar-2022, the monovalent vial (lot- 046L21A) was shipped and thawed in a cooler while being transported.  The vial did not undergo any temperature excursions.  Reporter did not notice the vaccine was expired, some of these patients received another Monovalent dose after the expired dose within recommended time.  This case is about patient 2 out of 2 adult patients who received monovalent shots on 13-May-2022 from vial shipped in 02-Mar-2022.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter)
Itchy arm, red rash and hard raised bump. Started 7 days after shot and lasted about 36 hours
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/ allergies were reported. On 13-May-2016, the patient was vaccinated with expired PNEUMOVAX 23 (which had a lot # K019561 and an expiration date of 20-APR-2016; however, dose, dosage number, route of administration and anatomical location were not reported). No concomitant medications were reported. Despite being vaccinated with an expired dose of the vaccine, no adverse effects were reported. Additional information has been requested.
Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report was received from a consumer concerning a 79 years old female patient who experienced  dizziness, tiredness, slurred speech, numbness,  blurred vision, stroke,  very very lethargic and had tingling in face and fingers, lost speech, lost eyesight.  The patient's medical history as reported by the reporter includes hypertensive, diabetic and had circulation problems. Concomitant medications taken by the patient was not provided.  On 25 Feb2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, patient had dizziness, tiredness (which is very unusual for patient), slurred speech numbness and blurred vision and then patient was taken to the ER and diagnosed with having stroke. She was admitted and discharged when her condition improved. As per the follow up report received, the reporter reported that patient ended up in having a stroke which was a medically significant event and she was very very lethargic and had dizziness, felt numbness and tingling in face and fingers. Patient had also  lost speech, lost eyesight which was a medically significant event. Patient went to the hospital where she was diagnosed. Patient was feeling better at the time of reporting and mostly recovered but feeling weak.  Patient went to hospital and treatment activities for events was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers was recovering/resoving and lost speech, lost eyesight  was unknown.; Reporter's Comments: There is not enough information to assess the causal association between the reported events and the administration of the mRNA-1273 vaccine.  Critical details such as the onset date of the event is lacking.  Event is also confounded by the patient's advanced age and underlying medical conditions of hypertensive, diabetic and had circulation problems.
rash on stomach, back and neck; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a female patient (daughter) that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced rash on stomach, back and neck. The patient underwent lab tests and procedures which included sars-cov-2 test was negative. The event outcome was unknown. She wanted to know if it was ok to still receive second dose scheduled 19Feb2021.  Follow-up (12MAY2021): Follow-up attempts were completed. No further information was expected.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored GARDASIL (lot # K006960, expiration date: 19-FEB-2017; dose and route were not provided. The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On the first shot - just arm sore. On the second shot - day 2 massive fatigue, no energy, and headaches/migraines.  Headaches/migraines have persisted daily since receiving shot.
it was a numb pain; couldn't lift his arm and his shoulder with his arm; couldn't lift his arm and his shoulder with his arm; left arm/ arm was sore; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 27Mar2021 (Lot number: EP6955) at the age of 44 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot, for immunisation, reaction: "arm was sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Mar2021, outcome "not recovered", described as "left arm/ arm was sore"; HYPOAESTHESIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "it was a numb pain"; MOBILITY DECREASED (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious) all with onset 30Mar2021, outcome "not recovered" and all described as "couldn't lift his arm and his shoulder with his arm". Therapeutic measures were taken as a result of pain in extremity, hypoaesthesia, mobility decreased, joint range of motion decreased.  Additional information: The patient reported that his arm was bothering him when he took the first dose. They gave the shot in his left arm and for two days, his arm was sore. So, he thought that it would be there and it was just like when you get a regular flu shot and your arm is sore from the shot. Third day, he couldn't lift his arm and his shoulder with his arm and till this date (at the time of report) it hurt. It was like when he was taking a shower and try to lift his left arm going over his right shoulder, it was sore and he didn't want to say painful but it was a numb pain like you want to bring your arm back because you don't want to stretch it so far. The patient further stated that it was like he could not lift it up all the way and he want to bring it down because it gives pain. Also, if he try to lift it up all the way and if he go to workout or say he lift something kind of heavy, he was not able to do with that arm. The patient used ibuprofen 200 mg for the events and he took two tablets.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician via sales representative refers to a 21 year old female patient. On an unknown date the patient was vaccinated with the first GARDASIL (Lot # not reported) (dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL and subsequently fainted and maybe had some seizure activity. The outcome of the patient maybe had some seizure activity and was administered her first dose of GARDASIL and subsequently fainted was unknown. The relation between the events and therapy with GARDASIL was unknown. Upon internal review the patient maybe had some seizure activity was considerd to be other important medical event. Additional information has been requested.
Fever, headache, chills, tiredness, arm sensitive to touch. All these from second day of taking second vaccine to currently 2 weeks later.
This spontaneous report as received from a consumer via Clinic refers to a currently 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-SEP-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M044350, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    No concomitant medication information was provided.  The vial was initially stored in refrigerator on 07-Jun-2022. The vial did not undergo any temperature excursions. The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.   The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses.  No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-589423 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-589423:Master case
Saturday I had a low fever and congestion and a headache. Sunday I still had the headache a little and a little tightness in my chest like gas pain and a cough, And I took an at home test and it came back positive. Since that time yesterday I still had a fever of 101.7 and still a dry cough. This morning I had a very slight fever its was 98.8 no headache a small cough. I felt tired the whole time and didn't feel like eating anything.
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  Treatment for the event included Tylenol and Benadryl.
Initial report received from a consumer on 23 October 2013. A 52-year-old female patient, whose medical history and concomitant medication was not reported, had received a dose of FLUZONE (batch number U4709AA, expire date 6/30/14) route anatomical site of administration and number in series was not reported on 16 October 2013 at 10 am by a Healthcare Professional. On 16 October 2013, -4 hours after receiving the patient developed rash inside of my arms. Within -24 hours the rash had spread throughout the patient's body. Patient was currently under the care of primary physician for the treatment of the allergic reaction. Corrective treatments and laboratory investigations were not reported. At the time of this report, the patient was recovering from the event. Documents held by sender: none.
The most concerning symptoms were shortness of breath and chest pressure/pain. These began the morning of Saturday May 22, and lasted until the evening of Sunday, May 23. The shortness of breath was alleviated for a couple seconds when the posture was adjusted and a long, slow, deep breath was taken. Other symptoms appeared as well. There was fatigue and muscle pain that began a couple hours after the shot was administered; these also lasted until the evening of Sunday, May 23. A mild fever occurred on Saturday evening.
Cellulitis of upper left extremity. Patient prescribed 10 day course of Augmentin
Swelling, redness, pain where shot was given. Redness, swelling rash on face. Redness and soreness at site and itching on face still present 5 days later.
Information was received on 28-JUN-2017 from a license practical nurse who was reporting on a 41 year old male patient. Medical history includes Chronic Obstructive Pulmonary Disease (COPD) and there were no relevant concomitant medications. On 27-JUN-2017, the patient received two 1.0 ml doses of RECOMBIVAX HB (lot M046373, expires 04-NOV-2018) in the left deltoid for prophylaxis against Hepatitis B for planned travel. The patient has not had laboratory work in almost one year. The LPN reported that the patient was only supposed to received one dose of RECOMBIVAX HB and that a second 1.0 ml dose was provided in error. The intention was to provide a hepatitis A vaccination in addition to the hepatitis B vaccine. The nurse stated "Due to my lack of paying much attention, the patient received the two doses instead of one each of the Hepatitis A and Hepatitis B." The LPN stated that the patient has not reported any adverse reactions and that no treatments have been provided. As of 28-JUN-2017, it was unknown if the patient will continue on RECOMBIVAX HB and the outcome of receiving two 1.0 ml doses on 27-JUN-2017 is unknown. Additional information has been requested.
Rash / rash on the face and body; This case was reported by a nurse via sales rep and described the occurrence of rash in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a day after receiving Bexsero, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The vaccine lot number and expiry date was unknown. The nurse reported to a field representative that a patient reported a rash within days of Bexsero administration.  The patient developed a rash after having Bexsero, not itchy, on the face and body. No other information was available. The reporter consented to follow up. This is 1 of the 5 linked cases reported by the same reporter.
Information has been received from a registered nurse referring to an unknown number of 27 year old patients. No relevant medical history was reported. On unspecified dates, these patients started the GARDASIL, (lot number, expiry date, route, dose and frequency were not reported) series at the age of 26 years old. But they did not complete the series until they were 27 years old (inappropriate schedule of drug administration). No adverse experiences reported. Additional information has been requested.
Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 12Jan2021 at 16:00 at a single dose in the clinic for COVID-19 immunization. The patient received the first dose on 22Dec2020 at 16:00 on the left arm for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination and did not have COVID prior to vaccination. Concomitant medication included ibuprofen and tramadol.  The patient experienced very painful lymphnode in arm of injection, pain radiating down arm into fingers on 13Jan2021 at 17:00. Outcome of the events was not recovered.  Information of lot/batch number has been requested.
No other AE and no PQC; Healthcare professional calling to report an administration of ROTATEQ following a temperature excursion.; This spontaneous report has been received from a nurse, regarding a patent of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported  On 16-MAY-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: 1932216, which was determined to be valid, with an expiration date on 12-APR-2024) (strength, dose, scheme, and route of administration were not reported).  The administered dose underwent a temperature excursion during unreported date on unreported temperature. There was a no previous temperature excursion reported. No additional adverse effect was reported.
Pain, swelling, redness at injection site- still present 52 hours after injection Fever, headache, body aches, feeling tired and weak- Improved after 48 hours
tightness; very little minimal arm pain/got her 1st dose and had experienced minimal pain; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "tightness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "very little minimal arm pain/got her 1st dose and had experienced minimal pain". Additional information: her 2nd dose is scheduled on 01June2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax;w/in 1 hr,exp weakness & discomfort in arm & HA;pt was hosp;recv propoxyphene napsylate-acetaminophen for pain;
*Cramping and light vaginal bleeding (12/24 PM) *Severe cramping and light vaginal bleeding (12/25 AM & PM) multiple tests run (Ultrasound, pelvic exam, blood and urine tests) in E.R.  *Severe cramping and moderate vaginal bleeding (12/26 AM & PM) *Moderate cramping and moderate vaginal bleeding (12/27 AM & PM) Ultrasound and blood test for HCG level indicate miscarriage *Light cramping and moderate vaginal bleeding (12/28 AM & PM) *Severe cramping and moderate vaginal bleeding (12/29 AM & PM) Follow up with family physician for pelvic exam and blood test for HCG levels (continuing to drop) *Moderate cramping and moderate vaginal bleeding (12/30 and 12/31 AM & PM) Ultrasound at Hospital on 12/30) *Light vaginal bleeding (1/1/10-1/4/10 AM & PM)
red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2402883. The original narrative from the sender is as follows:  Per mother the child woke up this morning 8/5 with an red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed. The child was examined by the Doctor and Mom was instructed on how to handle the inflammation and what to do if it worsened.  The reporter did not assess the causal relationship between Vaxelis and "red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed."  No further information is expected.