chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness at arm of injection after second dose; Sore arm; Redness at arm of injection after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness at arm of injection after second dose), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at arm of injection after second dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness at arm of injection after second dose), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at arm of injection after second dose). At the time of the report, INJECTION SITE PRURITUS (Itchiness at arm of injection after second dose), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at arm of injection after second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment with Cleocin 300 for redness and itchiness usage, were provided by the patient.   This case was linked to MOD-2021-082369 (E2B Linked Report). This case was linked to MOD-2021-082369 (Patient Link).; Sender's Comments:  MOD-2021-082369:1st dose
overall chronic muscle body aches since getting vaccine booster with particular pain and loss of movement in shoulders. Vaccine shot was given very high up on arm almost on shoulder.
Case number PHEH2014US020326 an initial spontaneous report received  from a nurse on 07 OCT 2014. This report refers to a 08 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX 2014/2015 (batch number: not reported) intramuscularly at a dose of 0.5 ml on 03 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Patient received the Pfizer Covid vaccine 1st dose. After the 15 minutes of observation, his wife notified staff he was feeling "dizzy and light headed". Patient stated he was having trouble breathing in his chest and thought he was having a little difficulty swallowing. EMS was called. Rph checked patient's BP which was 142/127. EMS arrived shortly after and took patient to ED.
Patient received the pfizer covid-19 vaccination here at facility on 3/4. On review of chart, he received a hep b vaccine, as prescribed by provider on 3/11. There was not an interval of 2 weeks, between vaccinations.
. 24 hours after the Covid  Vaccine. first dose  given on 3/2/21. Pt Reports." I was driving and  had to pull over experienced. SOB and suddenly my heart felt like it  was jumping out of my chest" Clarified. rapid HR."Lasted about 25  minutes. with tightness of my throat'.  I did not go to the doctor at  the time.becuase it was such a short time and went away. " I have had  no problems since".
ON 12/10/2019 I had the 2nd of 2 shingrix vaccines. On 12/16/19 I noticed a sudden and obvious hearing loss, overnight. I also started hearing sounds echo. I visited a care facility on 12/28/19 and they were unable to diagnose, they prescribed a 10 day regiment of Amoxicillin, with no change in hearing after treatment. On 1/13/2020 I went to an ENT and had a hearing and ear pressure test. They identified significant hearing loss in the L ear and attribute it to nerve damage. Shingrix is a treatment for shingles, a nerve disease and it's predecessor, Zostavax, has caused hearing issues. Please feel free to contact my ENT
I had lumps that appeared on my legs and they were painful to the touch. I had a telehealth consultation and the doctor diagnosed me with Erythema Nodosum. It took about a month to completely disappear.
Per parent child developed generalized rash 2 days after receiving vaccination. No fevers, no other symptoms. Otherwise child well. Rash resolving within 4 days.
Pt experienced pain, redness and swelling at injection site worsening after 2 days of flu & pneumo injection. TYLENOL for pain.
ROTATEQ oral vaccine administered. Approx 10 minutes later child's lips noted to be swollen as well as the soft tissue surrounding the lips. Oral mucosa affected only regarding the inside of the lips and only slightly. She recovered spontaneously after 15-20 min observation.
Information has been received from a physician concerning a patient who on an unknown date, received 2 doses of VARIVAX (Oka/Merck) (lot # not provided) and had a negative antibody.  The patient sought medical attention in the office.  Additional information has been requested.
Myocarditis caused chest pain and labored breathing after football practice. Patient is a collegiate athlete. His trainer told him to go to the er. From there they found a infection in the heart muscle and discovered a birth defects  a bicuspid aortic valve. They recommended a valve replacement. We asked for discharge to see Dr. at hospital. They  want to wait to perform the valve replacement to see if the infection and lack of activity would help the heart. In December he was cleared to play football and the heart is recovering.
Firm mass at injection site. Gradually increasing in size. Warmth, itching at site. Currently 4cmx2cm. Tender to touch, no discoloration. Symptoms are localized to injection site.
Foggy feeling in head; Inappropriate schedule of vaccine administered; Mobility decreased/ Could not move; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy feeling in head), MOBILITY DECREASED (Mobility decreased/ Could not move) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VALPROATE SEMISODIUM (DEPAKOTE) tablet for Hormonal imbalance.    Patient was not an alcohol user. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Concurrent medical conditions included Cigarette smoker (A pack of cigarette per day) since 1976 and Drug allergy.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started VALPROATE SEMISODIUM (DEPAKOTE) (Oral) 500 milligram. In June 2021, the patient experienced MOBILITY DECREASED (Mobility decreased/ Could not move). On 28-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In March 2022, the patient experienced FEELING ABNORMAL (Foggy feeling in head). In June 2021, MOBILITY DECREASED (Mobility decreased/ Could not move) had resolved. At the time of the report, FEELING ABNORMAL (Foggy feeling in head) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication was reported by reporter.  Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for Depakote for brain fog was not provided, for leg pain, body ache, flu and could not move was no reasonable possibility.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-629402 (Patient Link).
Hearing difference/difficulty; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Jul2021 at 13:15 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to medications, food, or other products which was unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Multivitamins (MANUFACTURER UNKNOWN) from unknown date and for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jul2021 at 23:00 the patient experienced hearing difference/difficulty. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hearing difference/difficulty was not resolved at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up
On January 7, 2017 (roughly two weeks after patient received the flu vaccine), I noticed patient was clenching his fists. Patient had never done this before. When I asked him why, he said it was because his hands were bothering him. I can send a timeline I have prepared, but over the next two weeks, the pain spread to his head (including at least two instances of blurry vision) and feet. We've had three blood tests since January 2017 (including one on January 21), an EMG and an MRI. The exams do not show a cause for his symptoms and patient continues to suffer from continuous hand and feet "tingling", as well as headaches. Medical Center Infectious Disease told us, there is "no way" his symptoms are caused by a bacteria or virus. At times, patient's symptoms become more painful. He has been seen by Medical Center Neurology, Infectious Disease and Immunology Departments. No definitive cause has been determined, but when I ask if it could be the flu vaccine, I have been told yes. Given that patient did not have a fever in December 2017 - April 2017 and his blood work does not show a bacterial or viral cause, the only cause my husband and I can think of is a potential adverse reaction to the flu vaccine. Medical journals note the flu vaccine may cause neurological issues and that such issues may present weeks after the vaccine. We have been told his symptoms may never go away. We are still seeking medical advice and will also visit the neurology department at another Hospital. I would be happy to submit copies of all medical exams done to date. Please note patient has no other developmental/emotional issues (no autism, disabilities, allergies).
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) in an adult female patient 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. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Vaccination during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a pharmacist concerning a 67 year old female pt with no known allergies who on 10/24/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The pharmacist reported that within 24 hours, approx. 10/27/01, the pt had trouble breathing, was itchy and swollen, had a yellow tinged arm, and was vomiting. On 10/27/01, the pt went to the ER and was monitored and then released to home on therapy with Atarax. The pt was last seen for an office visit on 10/30/01. Additional information has been requested.
Case number PHEH2016US008627, is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 6 year old female patient. Medical history and concomitant medication were not reported. This patient under the age of 18 was vaccinated FLUCELVAX (batch number: 174087A) intramuscularly on 01 Dec 0215 instead of FLURIX (manufacturer: unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following this maladministration (wrong drug administered). Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event (wrong drug administered), deleted the event inappropriate age at vaccine administration and update narrative accordingly.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On 13-JUL-2017, the patient was vaccinated with M-M-R II lot # L024265 for prophylaxis. Concomitant therapies included sterile diluent. On 13-JUL-2017, the patient experienced expired product administered. The patient experienced no adverse event.
Patient presented to ED with dyspnea, incessant cough. Patient tested positive 1 week prior to ED visit. Patient still receiving inpatient treatment.
Deep vein thrombosis in the left calf; This is a spontaneous report received from a contactable consumer (patient).  A 73-year-old male patient received the second single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 06Feb2021 (Lot Number: EM9810), at the age of 73 years old, for COVID-19 immunisation. The patient had previously received the first single dose of BNT162b2 in the left arm on 16Jan2021 (lot number: EL8482). The patient had not received any other vaccines within 4 weeks prior to the BNT162b2 administration. Prior to vaccination, the patient had never been diagnosed with COVID-19. The patient's medical history included essential thrombocythaemia and benign prostatic hyperplasia. There were no allergies to report. Concomitant medications included hydroxyurea, simvastatin, mirtazapine, and acetylsalicylic acid (ASPIRIN). The patient stated developing deep vein thrombosis in the left calf on 15Feb2021, at 06:00 (10 days after 2nd shot), requiring a visit to ER. The patient was treated with enoxaparin (LOVENOX), followed by dabigatran etexilate (PRADAXA). Since the vaccination, the patient not been tested for COVID-19. The patient was recovering from the event.   Follow-up Information has been requested.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 960 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
patient has dime-sized blister around injection site in addition to redness & swelling. potentially related to vaccine or adhesive on bandage. patient did not notice until bandage removed.
Mild palpitation; faint feeling; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first single dose of BNT162B2 (Pfizer, lot number: EL0140, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 05Jan2021 for COVID-19 immunization. Facility type vaccine: Hospital. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination. On 05Jan2021, 30 min after injection, felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days, he had several additional mild to weak palpitations. The strong one that he experienced was 12-14 hours after receiving the first dose, did not show. The patient also experienced arm soreness after the first dose (Jan2021). The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021.
Injection was administered too high in the arm, and not into the deltoid muscle. Experienced sharp pain at time of the injection, which appears to have been administered into the bursa. Immediately following, experienced vasovagal syncope, profuse sweating, dizziness, and inability to stand up. Vasovagal symptoms resolved within several minutes. At this time, full range of motion remains at the joint where injection was administered. Will continue to monitor.
Patient received Hep A vaccine on 02/16/05. Developed symptoms of leg trembling and redness on leg on 02/21/05. Examined 02/25/05, noted ataxia and possible hypersensitivty.
Patient was given a Janssen Covid 19 shot on 7/5/21 around noon. After the shot we talked about different side affects and he had a few questions about adverse reactions. I had him sit down for 15 minutes while I finished his paperwork. As i was walking back from the immunization room toward the pharmacy I saw him drop his phone and he fell to the ground. I tried to reach for him but was not close enough to break his fall. I saw his eye roll back and his face turn very red. He was breathing very fast and loud. He regained consciousness and I told him 911 way on the way and to please try to relax his breathing. His brother was with me the whole time talking to him and reassuring that everything was ok. The paramedics came and hooked up a monitor. They were asking all sorts of questions to everyone in the area. I went back into the pharmacy and he walked out to the ambulance with his family and was taken to the hospital.
2nd dose-  Fever, joint pain, severe neck and chest pain for 36 hours
Patient complained of dizziness, shakiness, and a tight chest.  Vitals taken over several minutes and patient eventually complains of nausea.   EMS is called at 3:57 pm.  Complaints of chest pain 9/10.  4:03 pm EMS arrives and Epi pen administered (0.3 mg).  Patient complains of itchy lips and eyes appear swollen.  Transferred by ambulance to Hospital.
Patient under 65 received incorrect flu vaccine. Patient received Fluad. No adverse events reported at this time.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021 at 4:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Jan-2021 at 4:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 49.23  Concomitant products were not provided.  On 05-Jan-2021, the vaccines were moved to fridge. On 06-Jan-2021, three vials were moved to clinic. On the same day at 03 PM, the vials underwent temperature excursion with temperature 35 degrees Fahrenheit. was The vaccine beyond use date was reported as 27-Jan-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
pt recv vax 27OCT97 & the following day pt devel urticaria;
This spontaneous report was received from a nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In approximately 2016, the patient was vaccinated with a dose of GARDASIL 9 lot number H013831 (strength, dose, route and expiration date were not reported) for prophylaxis. It was reported that on approximately 08-NOV-2017, the patient was in the office for their second dose of GARDASIL 9. No adverse effects were reported. Lot number H013831 is an invalid lot number for GARDASIL 9. Follow up information has been received from the nurse on 14-NOV-2017. The reporter stated that patient was 12 years old.
By mistake gave Hep A to infant: no symptoms of adverse reactions. State and parents notified.
Arms ached later same day - next day had numbness/paresthesias hands. 1/30/11 developed aching then numbness plantar (R) foot and distal (L) stump. Fingertip numbness persisted 3 days. Foot still feels numb with weight bearing. Also developed nausea/vomiting day after vaccine -> today.