chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COLD SORES ON THE EDGE OF LIPS; SORES ON OUTSIDE OF THE BRIDGE OF HIS NOSE; LOST APPETITE; PAIN IN SPINE (BACK) FROM TOP TO BOTTOM; FELT TIRED; HEADACHE; ARM FELT SORE/ACHY FOREARM; FAINTING; STRANGE DREAMS; BLUISH-GREEN MARK AT THE INJECTION SITE; FELT SLEEPY; ENERGY WAS LOW; ACHY  ELBOW; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included sick, fatigue, mood swings, depressive symptoms, headache, and joint pain, and concurrent conditions included allergies, shingles, Lyme's disease, brain fog, loss of smell, irritability, and sense of taste improved but not 100%. On DEC-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. On MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 in total administered on 06-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-APR-2021, the subject experienced fainting (dizziness) and dizziness at the vaccination facility. He drank juice and his blood pressure was checked. On the same day, his arm felt sore/achy forearm and during night he had strange dreams. On 07-APR-2021, the subject experienced pain in spine (back) from top to bottom, lost appetite, felt tired and headache. On an unspecified date in APR-2021, the subject experienced felt sleepy, energy was low, achy elbow, bluish-green mark at the injection site. On 11-APR-2021, the subject experienced sores on outside of the bridge of his nose (they were small, red, not leaky and tender to touch - felt like a skin eruption), cold sores on the edge of lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting, and dizziness on 06-APR-2021, and the outcome of strange dreams, arm felt sore/achy forearm, headache, felt tired, lost appetite, sores on outside of the bridge of his nose, achy elbow, felt sleepy, energy was low, cold sores on the edge of lips, bluish-green mark at the injection site and pain in spine (back) from top to bottom was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428769-covid-19 vaccine ad26.cov2.s -fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
PATIENT REPORTED ON 1/30/21 THAT STARTING AT BEDTIME ON 1/17/21  AND SINCE AT NIGHT HAS BEEN HAVING PAIN IN THE UPPER LEFT ARM AND IS UNABLE TO LAY ON IT.  NO REDNESS/ BRUISING/ KNOTS/ OR SHOTING PAIN NOTED.  JUST A CONSTANT DISCOMFORT.  IN THE DAYTIME PT STATES IS ABLE TO MOVE IT AROUND AND EASE SOME OF THE PAIN, BUT IT WORSENS AT NIGHT.  HAS BEEN TAKING LEFT OVER OXYCODONE/APAP AND REGULAR TYLENOL TO RELIEVE DISCOMFORT WITH MINIMAL RELIEF.  PATIENT IS INTENDING TO FOLLOW UP WITH PRIMARY CARE ON MONDAY (2/1)
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored doses of ROTATEQ (lot # 1028645, expiry date 25-MAY-2017 and lot #K010323, expiry date 10-MAY-2016) (strength, dosing details, anatomical location were unknown). The vaccine was stored at a temperature of 31.6 degree Fahrenheit for 30 minutes and 55.4 degree Fahrenheit for 30 minutes. No adverse affects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter.  Additional information has been requested.
Injection site red, hot and raised morning following vaccine. Seen 10-23-15 - area is 8 x  cm pink area wthn 2 x 3 area of induration and deeper redness in center. No fluid - tx - BENADRYL and ice.
Rash on arm, hot itchy just below (L) shoulder joint and down arm slightly.
Left thigh swelling and redness, with fever 100.8 - 101 degrees for 4 days.
The pain was like a burning sensation; sore arm / pain returned, this time in his thigh; muscle pain in the outside of his right upper leg/ muscle pain in another part of his right upper leg; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a month after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the patient experienced burning sensation and pain in arm. The patient was treated with naproxen. On an unknown date, the outcome of the muscle pain and burning sensation were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the muscle pain, burning sensation and pain in arm to be related to Shingrix. Additional information received were as follows: The patient had sore arm post vaccination. Around mid to late November 2019, the patient started having muscle pain in the outside of his right upper leg.  After a week the patient took some naproxen and the pain resolved.  About 3 to 4 weeks later the pain returned, this time in his thigh, but still his right upper leg.  The pain was like a burning sensation and it was sporadic. The pain was not always present. The patient tried Naproxen again and the pain eventually resolved. At the time of reporting the patient had muscle pain in another part of his right upper leg. It was not as bad, but still has that burning sensation.  The patient does not notice the pain when sitting, but felt it when walking.  On 3rd February 2020, the patient received the 2nd dose of Shingrix today. The reporter consented to follow up.
After the first dose, I had COVID-19 arm I went to the doctor, and they said it was normal. A couple of days after I received the first dose, I broke out in rashes all over my body. I had to go to urgent care, and they gave me a lotion and it still did not go away for over a month. I went to the dermatologist, and they said we could only do a biopsy. They could not find anything. It happened again after the second dose, which I received on 05/08/2021 (023C21A) and third dose, which I received in 11/09/2021 (023F21A). So now I know for sure it is from the vaccine. After the second dose, I had a bad headache that lasted for over week. I went to the doctor, and they did an MRI and it showed nothing.
HYPOtension & Bradycardia Narrative: within 15 min of booster felt lightheaded/nauseated/cold/clammy 2 40 pm-  bp 87/84 mmhg; hr 54/min spO2 99%. 2 45pm-bp80/42mmhg;hr 62/min 3 01 pm: bp109/72mmhg; hr 62/min. symptoms resolved in 25 mins.
Vaccine was mixed with wrong diluent. The medical assistant mixed vaccine with the sterile diluent (sterile water) instead of the sterile solution (citrate bicarbonate buffer).
Information has been received form a lawyer regarding a case in litigation which was reported in a literature article concerning a 47 year old female patient who on 20-MAY-1998 was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown). Concomitant medication was not reported. The special master reported that there was a logical sequence of cause and effect in patient's having received the vaccination and then experiencing optic neuritis, the first symptom of her Devic's disease of variant of multiple sclerosis (MS). It was reported that two months after getting the second dose of the vaccine the patient noted retro-orbital pressure in her left eye followed by decreased visual function. On July 27, 1998, she noted a curtain over the superior visual field in her left eye. On 25-JAN-2009 she had an magnetic resonance imaging (MRI) scan of brain which was negative, although there was an abnormal signal in the upper cervical spinal cord. The physician diagnosed neurologic syndrome involving her optic nerves and spinal cord. The medical records during the patient's final hospitalization reflected that she died from demyelinating disease. It was reported that patient had a vaccine injury and her death was also vaccine related. The patient died in May (Year not reported) at age of 47. The reporter felt that Devic's disease and demyelinating disease were related to the therapy with RECOMBIVAX HB. No other information is available.
pt states she started with severe pain in hands and could not move her hands- progressed into arms o the point she could not bath herself. Symptoms started the night she was give the vaccine within hours.  Then for 3 mos  she had severe muscle pains t/o body and joints.
Confirmed Breakthrough  1st Dose- 3/3/2021 - Moderna - 010a21a 2nd Dose - 3/31/2021  - Moderna - 025b21a 3rd Dose - 11/17/2021 - Moderna - 067f21a
dysautonomia; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "unknown", described as "dysautonomia". Additional information: approximately one month after receiving the bivalent booster, the patient went on a cruise and got COVID. After getting COVID, the patient was diagnosed with dysautonomia.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): US-PFIZER INC-PV202300030089 same patient/drug, different event.
The patient is a 63 yo male with a history of Afibb, HTN who received Fluarix brand vaccine  on 13 OCT 2020 (lot #LP9HK) to his left deltoid as a PAIVED study subject (vaccine is FDA approved,  not investigational)  and reports Shingrix receipt 1 week later ( I cannot retrieve record per Agency). He experienced CP day0 and near syncope day 15 (day 8 post shingrix),  both requiring ER visits. Per chart review he had a negative cardiac cath within the past 6 months.  On 28 OCT 20 (day 15) he reports he was again seen in Er for near syncope event. He experienced lightheadedness and racing heart. He was again seen in ER who put him on metoprolol, but he never took it per instructions of his cardiologist. These symptoms were present prior to vaccine receipt and he has current pending referral to ENT and neurology.   He also reports he received Shingrix vaccine 1 week after IIV (not in Agency records). He experienced no immediate adverse event. That evening he experienced chills, and malaise, but denies fever, rash, SOB, CP, dizziness. itching, urticaria. He reports symptoms were resolved by morning.  He was diagnosed with flu vaccine reaction by ER.
Pt was given a HIB instead of a Meningitis. Nurse misread the front of the box and saw the word Meningitis in the descrioption and thought it was the correct vaccine.
Patient reported as being at POD for first dose and was given a dose of Pfizer vaccine. When went to document, found patient had previous dose of Moderna.
Redness that spread from shoulder to jawline - right arm. Hives were present on shoulder and neck. Experienced itching and some flushing. Patient took some BENADRYL to treat itching and hives. Last almost 24 hours.
Since the very first day I?ve had extreme body chills, aches, headaches and fever but now it feels as if there?s a burning sensation in my head and it?s preventing me from my sleep.
606 doses were given after expiration date; expired vaccine was stored and then administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine was stored and then administered) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (expired vaccine was stored and then administered). On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine was stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  It was mentioned that the date place in refrigerator was on 04-Nov-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medication was provided by the reporter.
Vertigo, dizziness, headache, stomach cramps, aches, muscle pain, joint pain, fatigue, malaise.
Fluid was leaking out of the syringe while administering the vaccine. Approximately 0.25ml(half of the dose) was given.
I received my Pfizer booster on 09/27/2022.  I came down with a Flu on 12/16/2022. I had intestinal stomach issue  and upper respiratory issue  at the same time. I had a severe headache, fever, chills,  nausea, and vomiting. .The next day 12/17/2022 I had all the same symptoms which continued till 1 week. On 12/19/2022 I did a telehealth with my doctor. He prescribed me with Albuterol 4-5 days  as per needed, Antibiotics ( Levofloxacin) , Prednisone for 5 days  and Ondansetron.  As of today 12/28/2022 I am still recovering.
Initial report received on 20 January 2009 from a consumer, who is the patient's parent.  A 5 month old male patient, with a history of environmental and food allergies, received a second leg injection of ACT-HIB (lot number MF342AB, which is not a valid sanofi Pasteur lot number) on 30 April 2008.  The patient had no concomitant medications and no illness at the time of vaccination.  He had previously received a second right leg injection of DAPTACEL (lot number C2799AA) and a right leg injection of PREVNAR (other manufacturer, lot number not reported) on 18 April 2008 and had later developed leg redness and swelling and "full body tremors".  After an unspecified amount of time on the day of ACT-HIB vaccination (30 April, 2008), the patient's leg became extremely swollen and red at the injection site, lasting for two days.  Also, the patient had inconsolable crying lasting two to three hours on the day of vaccination.  No other information was provided.  Case 2008-00223 was created to capture the events of leg swelling and redness and "full body tremors" which had occurred after the DAPTACEL and PREVNAR injections on 18 April 2008.
Skin rash that felt like ants crawling on my skin, took about a week to go away. I took zyrtec. I have low blood sugar and it would "drop" very quickly for about 10 days. Fever, chills, and nausea that lasted for 10 days. Severe headaches for about a week.  Fatigue that lasted for 21 days
Dizziness, Headache, Myalgia & NauseaVomiting Narrative: sore throat, headache, and chills.   Other Relevant History:
Two days post 5th vax, pt developed same dry cough as in July. Yellow mucous developed. Resolved 7-10 days later. Soreness and aching in right thumb joints. Mid February, noticed more pronounced soreness. Still persists.
On Tuesday June 7, 2022, I felt very tired , run down and nauseous, the next day I had a runny nose, chest congestion, I also had very itchy skin. I took a home COVID 19 test it came back negative. On June 9th I woke up feeling even worse, I went to Urgent Care to have PCR COVID 19 test that came back positive. I was prescribed medication for my itchy skin, Hydroxyzine HCL. I am still tired but I am starting to feel better, I have that post cold tired feeling.
COVID recurred/ on 17-May-2022 had COVID test was again positive; Lack of drug effect; rhinorrhea; This spontaneous case was reported by a physician and describes the occurrence of RHINORRHOEA (rhinorrhea), COVID-19 (COVID recurred/ on 17-May-2022 had COVID test was again positive) and DRUG INEFFECTIVE (Lack of drug effect) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included ESTRADIOL and HCTZ for an unknown indication.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced RHINORRHOEA (rhinorrhea). On an unknown date, the patient experienced COVID-19 (COVID recurred/ on 17-May-2022 had COVID test was again positive) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, RHINORRHOEA (rhinorrhea) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and COVID-19 (COVID recurred/ on 17-May-2022 had COVID test was again positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had took Pfizer from 06-May-2022 to 11-May-2022 for the COVID-19 treatment.  The COVID-19 was recurred.  On 10-May-2022, the patient was tested negative and symptoms gone.  On 17-May-2022, the patient had rhinorrhea and COVID test was again positive  Company Comment: This is a spontaneous case concerning  a  73-year-old, female patient with no relevant medical history, who experienced the unexpected non serious events of Rhinorrhoea, Covid-19, Drug ineffective. As per available statements, the events occurred 38 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. It was noted on the case narrative that Test was negative on may 10 and symptoms gone. Then on May 17 had rhinorrhea and COVID test was again positive.  The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Further information is requested.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  73-year-old, female patient with no relevant medical history, who experienced the unexpected non serious events of Rhinorrhoea, Covid-19, Drug ineffective. As per available statements, the events occurred 38 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. It was noted on the case narrative that Test was negative on may 10 and symptoms gone. Then on May 17 had rhinorrhea and COVID test was again positive.  The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Further information is requested.
Paperwork from the day's clinic was reviewed, and it was discovered that the visitor, patient, was not 18 years of age. COVID-19 Vaccine Clinic Director immediately called the number listed on the consent form, and director spoke with patient's mother. Director emphasized the importance of patient following up with the pediatrician since the Moderna vaccine is not currently indicated for those less than 18 years of age. Mother verbalized understanding. Patient did not experience any adverse effects while waiting in the post-vaccination fifteen minute monitoring area or when she got home.
Nursing student administered flu shot at flu shot clinic. I noticed immediately that she placed shot too high. Once vaccine was injected, there was much pain, like she hit a nerve.  One hour later, I was unable to move my arm and unable to lift arms ove head to get dressed.  Today 10/15/12, I have continued pain and tingling down my arm and hands.
The patient developed a severe diarrhea on the 14th-15th which would be 4 days after he received the second Moderna COVID vaccine. He described the diarrhea as having foul odor. He has decreased appetite and mild abdominal pain.
Arm feels hard at area where I received the shot; Arm is itchy at area where I received the shot; Chills; Headache; My arm is red around the area I received the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Arm feels hard at area where I received the shot), VACCINATION SITE PRURITUS (Arm is itchy at area where I received the shot), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (My arm is red around the area I received the shot.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Arm feels hard at area where I received the shot), VACCINATION SITE PRURITUS (Arm is itchy at area where I received the shot), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (My arm is red around the area I received the shot.). At the time of the report, VACCINATION SITE INDURATION (Arm feels hard at area where I received the shot), VACCINATION SITE PRURITUS (Arm is itchy at area where I received the shot), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (My arm is red around the area I received the shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided.  Treatment information was not reported.