chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequent to receiving one dose of varicella virus vaccine live on 3/3/98, the pt experienced a papular, pustular widespread rash diagnosed as varicella on 4/30/99. The pt also experienced a fever.
Severe itching under my stomach/hips and on both legs; sleepless nights for almost 2 months; Black spots on both of my legs like chicken pox; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 at 15:00 (at the age of 62 year) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. On 01Jun2021 at 22:00, patient experienced severe itching under stomach/hips and on both legs, had sleepless nights for almost 2 months and now have black spots on both of legs like chicken pox. It was reported that no therapeutic measures were taken for the events experienced. The adverse events did not result in emergency room and physician office. The outcome of event sleeplessness was recovered on an unspecified date in 2021 while for rest events was recovering.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
Vaccine given 10/8. Arm 10/9 but 10/10 noted to be swollen and red. My exam 10/10: (L) upper arm red, warm, swollen distal, no streaking, well appearing.
Immediately after the vaccine I felt dizzy for about 30 minutes. Going forward the arm with the vaccine was sore for the next 3 days. The night after getting the vaccine I felt feverish and had a pounding headache. The next morning I also had body aches that lasted throughout the day.
Day 1: 11 hours after injection - severe fatigue, dizziness, diminished ability to mentally focus, severe weakness in legs and diminished ability to control legs. Legs intermittently felt numb and at time with "pins and needles" tingling. Knee joints felt as if in danger of flexing backwards. Arms were similarly affected but not as drastically as legs. Arms had better function and control than legs but with marked weakness.  Day 2: Some improvement. Able to go to work but still have fatigue and leg weakness persist. It takes additional mental and physical effort to walk. Walking does not feel automatic or safe like it was before. Still have high level of fatigue. Symptoms improve  some later in the afternoon. Days 3
Body aches, nausea (extreme), chills, felt hot - 1st 3 1/2 days, sore throat - Day 4; stuffed sinus and headache - Days 5-9; bad cough Days 5-Now. Still sniffling and coughing as of today, 12/11.
a dose of expired PROQUAD was administered.; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-AUG-2021, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, lot # T003835 has been verified to be a valid lot number, expiration date 01-AUG-2021 (formulation, strength, frequency and route of administration were not reported) for prophylaxis. lt was the second dose in the series. No additional adverse event was reported. No product quality complaint (PQC) was involved.
The patient presented with witnessed vasovagal syncope in her car after vaccination in the monitoring area. The patient had a weak radial pulse to palpation. EMS was summoned to the car. The patient was attached to monitor and 12 lead was performed. 12 lead showed no acute changes but sinus bradycardia initially at 33 bpm. BP was 120/95. The patient was supine in her car and given oral hydration. After serial evaluations, she improved with normalization in vitals and resolution of all symptoms. She was discharged home with her husband as a driver.
Had pain/weakness in right leg - she's pretty sure it's related to SHINGRIX vaccine.
what seemed like myocarditis and kidney pain; what seemed like myocarditis and kidney pain; It was reported the patient experienced a migraine; The patient also had a fever and her inflammatory markers were high; The patient also had a fever and her inflammatory markers were high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003937.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported that the patient experienced a migraine. The patient visited urgent care and her primary doctor for what seemed like myocarditis and kidney pain. The patient also had a fever, and her inflammatory markers were high. The patient's doctor stated that she had an inflammatory response, and the vaccine lipid delivery system may have caused it. No kidney infection was found, and the patient tested negative for COVID-19. The events "what seemed like myocarditis and kidney pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Inflammatory marker test: High; SARS-CoV-2 test: Negative. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022; No adverse event; Received expired  2nd dose after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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  2nd dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 and then administered on 01-Aug-2022).    Concomitant drugs were not reported. It was reported that patient received expired 2nd dose (6-11 year) beyond 30 days in the refrigerator.  The 3 doses 1 vial was initially stored in the refrigerator on either 30-Jun-2022 or 01-Jul-2022 not sure which day. The vial did not undergo any temperature excursions. Treatment medications were not provided. This case is created for pediatric patient 2.   This case was linked to US-MODERNATX, INC.-MOD-2022-636320, US-MODERNATX, INC.-MOD-2022-636330 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636320:Paediatric patient -1 US-MODERNATX, INC.-MOD-2022-636330:Paediatric patient -3
First dose on 17June2021 ,second on 11July2021; Fatigue; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17June2021 ,second on 11July2021), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17June2021 ,second on 11July2021), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 17June2021 ,second on 11July2021), FATIGUE (Fatigue), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved.      Patient took medicines for heart and high blood pressure. No treatment medications were provided.   This case was linked to MOD-2021-290279 (Patient Link).
Full body rash for 1 day.  When seen on 6/4 only with swelling on lower lid of right eye with some periorbital swelling.  Diffuse rash around mouth.
Headache started overnight. Debilitating to the point of unable to think clearly without great effort. Aching headache felt on top of head and seems to radiate down to behind the eyes and to the sides of jaws.
itchy whole body; mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy whole body) and PAIN IN EXTREMITY (mild sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (mild sore arm). On 03-May-2021, the patient experienced PRURITUS (itchy whole body). At the time of the report, PRURITUS (itchy whole body) and PAIN IN EXTREMITY (mild sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment medication include Allegra .
7" x 4" area at injection site red, swollen, hot, hard. Headache, fever (101 degrees), body ache.
This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 28-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021 at 11:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021 at 9:59 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 81.05 for dose administered on 11-Jan-2021 and 81.84 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021. Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM and 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and beyond use date for the vial was reported as 29-Oct-2021. Product moved to clinic on 22-Oct-2021.~  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
her muscles have been spasming in her legs and arms since Saturday, she had her second COVID vaccine that day and then that night is when she started having the muscle spasms, she got the Pfizer vaccine, both doses were in the left arm, it is mostly in her legs but a little in her arms, she is not having a single spasm that lasts a long time, she describes it as a "muscle twitch" that happens once in any given location and then goes away, no muscle cramps/pain, no fever, no chills, no previous similar symptoms, she has been under more stress for the last few weeks, the only other recent change she can think of is that her OCP changed to a different generic 8 days ago
Fever, chills, muscle aches --shot was given at 9:00am on 09/27/17 and patient started adverse effects at 11:00am, outcome--unknown at this time...patient stated she would just have to get over it.
gross hematuria relapse in possible IgA nephropathy patient - pending biopsy confirmation of diagnosis
Headache, Fever, Palpitations, arm pain,redness , swelling, discoloration; fatigue; joint pain; lymph node swelling Narrative: employee states; arm pain swelling, redness, discoloration, chest pressure, headache, left ear pain, muscle/joint pain, fatigue noticed within the first day of vaccination by day 2 same symptoms including increased HR. symptoms continued into 3 week after vaccination adding armpit/lymph node swelling and tenderness arm pain has resolved but other symptoms continue 28 days after vaccination
could not get her 2nd dose/ because the vaccine was not available; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Lot and expiration date of Shingrix vaccine was unknown. The patient reported that, she never completed the series of Shingrix vaccination as she could not get her 2nd dose because it was not available during that time, which led to product supply issue. The patient did not consent to follow-up.
Pt recvd vax on 2JUN92 & 24 hrs following vax c/o h/a, nausea & vomiting; pt taken to MD office & was treated w/an unspecified ATB;
Head aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Head aches). At the time of the report, HEADACHE (Head aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Muscle aches, severe chills,  dizziness, fatigue, temperature of 101.7 and severe injection site pain all resolved 24 hours from onset. Treated with Ibuprofen and Naproxen Sodium
Moderate stomach pain over the pancreas and gall bladder region that lasted for 2 days and then reduced to mild level.
Patient began to experience "stroke-like" symptoms approximately 48 hours after vaccination. Patient presented to the emergency room for care.  After evaluation, hospital staff determined no cardiac events present and diagnosed with a Bell's Palsy condition.  Patient was prescribed corticosteroids to address the inflammatory response.
24 hours after immunization, developed 7X8 cm reddened edematous itchy patch above injection site. Resolving after 72 hours.
Headache first, nausea, severe shivvers for 30  minutes, joint aches lasted for 10 hours, slight fever
Received vaccine in right arm-there was redness and swelling and warm to touch; treated with TYLENOL and ibuprofen.
Had low grade fever t105.4 & seen by MD; could be a virus; had sl ear infect also;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 23-FEB-2017, the patient was vaccinated with an improperly store dose of VARIVAX, subcutaneously, lot number M038225 with expiration date 07-SEP-2018 (dose and anatomical location were not reported). The vaccine was exposed to temperatures between 6 F (Fahrenheit) (-14 C (Celsius)) to 14F (-10C) during 6 hours. There was no previous temperature excursion. Data logger was filled. No adverse effects were noted for the patient. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012499: US-009507513-1703USA012499:
About six hours after the vaccine I had a headache. I woke up during the night with all over body aches that were very painful. I also had a headache and fever of 100-102 degrees. I was in bed for three days and I was still very fatigued for a whole week. My hands and legs were swelling off and on. I also had some shortness of breath, coughing and chest pain. I was dizzy and lightheaded. I have been very uncomfortable and unable to sleep. I still have tingling and pain in my feet. I get easily winded and I am still experiencing headaches. It has been almost three weeks. My feet and hands are still swelling and my hands are very red. I am seeing my doctor today for a breathing treatment. Everything seems to be slowly improving but the headaches are still coming and going. I have a weird feeling of bubbles all over.
Information has been received from a physician via medical records concerning a 19 month old male with no prenatal exposure to chicken pox and a history of diaper rash one month ago who in August 2008, was vaccinated with the first dose of VARIVAX (Merck).  The patient was not exposed to chickenpox or herpes zoster recently and had no history of chickenpox.  On 27-MAR-2009 the patient experienced herpes zoster.  Clinic notes dated 30-MAR-2009 reported left upper buttock with crops of erythematous papules, no clear vesicles, some excoriated on top, no surrounding erythema or TTP.  Similar crops of erythematous papules in different stages of formation extending down left inner leg, onto medial surface of foot.  Additional office notes indicated that the rash was on the left buttock and left leg with vesicles at L4, L5.  The patient's mother had stated on 27-MAR-2009 the patient experienced rash on lower back, two days spread to trunk and legs.  The patient was himself except more fussy and irritable.  He had decreased PO, with wet diapers.  There was no fever and he would walk on leg.  The patient was treated with POLYSPORIN.  He also received ACYCLOVIR 80 mg/kg QID X 5 days beginning 31-MAR-2009.  Additionally, he received TYLENOL PRN for pain.  NYSTATIN topical cream 10000 units/gram was to be applied 4 times a day for 14 days.  He was to avoid contact with his infant sibling.  Follow-up was scheduled.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine VZV strain.  The sample of the lesion was collected on 30-MAR-2009.  The results from the lesion specimen identified the Vaccine strain.  No further information is available.
Patient fainted a few minutes after vaccination. The patient told her father she was feeling lightheaded and then her legs became weak. Her father grabbed her to make sure she didn't fall and hit her head. We had the patient sit on the ground. Pulse and color for patient was good.  We gave the patient water and had her sit for about 30 more minutes before releasing her. We checked in with her every few minutes and patient had noi issues.
pt recv vax 6NOV97 & 10NOV97 pt devel a rash;13NOV97 pt had full blown varicella, 30 to 50 lesions;pt primary complaint was itching;no fever was noted;
Patient had episode concerning for seizure. Was found on floor with stiffened body, arms extended and upper and lower extremity shaking. Episode lasted 8-10 minutes. Patient  then experienced likely post-ictal period for several hours in which he was more tired than usual and was dragging his Left leg when he walked. Similar event also occurred after first vaccine dose.