chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe shooting pain to his neck; severe shooting pain down his left arm/sever shooting pain down to his left hand/severe shooting pain in his toes; severe shooting pain in his left shoulder, to his neck, down his left arm, to his hand, knee joints and toes.; severe shooting pain in his left shoulder//severe shooting pain in his knee joints; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe shooting pain to his neck), PAIN IN EXTREMITY (severe shooting pain down his left arm/sever shooting pain down to his left hand/severe shooting pain in his toes), PAIN (severe shooting pain in his left shoulder, to his neck, down his left arm, to his hand, knee joints and toes.) and ARTHRALGIA (severe shooting pain in his left shoulder//severe shooting pain in his knee joints) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced NECK PAIN (severe shooting pain to his neck), PAIN IN EXTREMITY (severe shooting pain down his left arm/sever shooting pain down to his left hand/severe shooting pain in his toes), PAIN (severe shooting pain in his left shoulder, to his neck, down his left arm, to his hand, knee joints and toes.) and ARTHRALGIA (severe shooting pain in his left shoulder//severe shooting pain in his knee joints). On 10-Feb-2021, NECK PAIN (severe shooting pain to his neck), PAIN IN EXTREMITY (severe shooting pain down his left arm/sever shooting pain down to his left hand/severe shooting pain in his toes), PAIN (severe shooting pain in his left shoulder, to his neck, down his left arm, to his hand, knee joints and toes.) and ARTHRALGIA (severe shooting pain in his left shoulder//severe shooting pain in his knee joints) had resolved.            Concomitant product was not provided by the reporter  Treatment information was not provided   This case was linked to MOD-2021-261775 (Patient Link).
Patient experienced nausea and vomiting for 1 full day and a fever of 100.4 degrees F that would not go away.   Patient stopped vomiting  24 hours later and fever went down.
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 03-Jan-2013. The reporter reported that patient was lying down when receiving FLUMIST with their eyes closed. A drop of FLUMIST dripped out of patient's nose and into the eye area which started on 03-Jan-2013. On follow up, the reporter stated that there were no eye problems with his eye. The outcome of the event of FLUMIST DRIPPED OUT OF PATIENTS NOSE AND INTO THE EYE AREA is unknown. The report was considered to be non-serious. Summary of insignificant follow-up information received 04-Mar-2013 from Health Professional: Narrative updated. Corrected report: 14-Mar-2013: Action taken of the suspect drug changed from unknown to not applicable. Association updated: Drug start date added. Reporter as responsible physician added. Patient initials added.
Episode of atrial fibrillation documented by my husband, a physician.  He could not find a pulse after I had 2 near syncopal episodes.  He listened to my chest and heard the abnormal rhythm .  By the time I arrived at the ER, I had converted into normal sinus rhythm.  We are both physicians.  I am currently being evaluated by my PCP.
2ND DOSE FOR COVID VACCINE WAS ADMINISTERED TWO WEEKS EARLY. NO ADVERSE SYMPTOMS OR SIGNS AT THE TIME VACCINE WAS ADMINISTERED.
Significant redness and increased temperature of the inside upper arm of arm administered; not consistent with site of administration.
Has had site soreness since day after immunization. Call to office today 7/5/2018 to report continued site soreness. No problem with range of motion. Will continue to monitor and follow-up as needed.
Tested positive for COVID-19 on 23-Jun-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19 on 23-Jun-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID-19 on 23-Jun-2022). At the time of the report, COVID-19 (Tested positive for COVID-19 on 23-Jun-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2022, SARS-CoV-2 test: (Positive) Positive with  test type- Abbott ID NOW.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  It was reported as Inquiry was strictly regarding validity of vaccine dose administered after greater than 24 hour exposure to room temperature approximately 27 hours.  No treatment drug were reported.  Company comment: This spontaneous case concerns a 79-year-old female patient with relevant medical history of Type 2 diabetes mellitus, who experienced the unexpected non-serious AESI of Covid-19, 7 months 22 days after receiving the 3rd dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. The outcome was reported as unknown. Details of clinical course, further investigation reports and treatment were not provided. Elderly age and medical history of type2 diabetes mellitus could be risk factors. Nine months prior to the 3rd dose, the patient had received the primary doses of mRNA-1273 vaccine. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-610672 (Patient Link).; Sender's Comments: This spontaneous case concerns a 79-year-old female patient with relevant medical history of Type 2 diabetes mellitus, who experienced the unexpected non-serious AESI of Covid-19, 7 months 22 days after receiving the 3rd dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. The outcome was reported as unknown. Details of clinical course, further investigation reports and treatment were not provided. Elderly age and medical history of type2 diabetes mellitus could be risk factors. Nine months prior to the 3rd dose, the patient had received the primary doses of mRNA-1273 vaccine. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # N003536, expiry date 02-NOV-2019 or lot # 003701, expiry date 01-NOV-2019 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 38 minutes and from 47F to 77F for 3 hours and 14 minutes . No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA010540: US-009507513-1709USA010541: US-009507513-1709USA010539:
Started getting muscle spasms in my left eyelid. Has been happening now for two months. Never had them before.
03Jan91 pt vax w/ MMR; 14Jan91 mom stated that pt was breaking out all over body like measles + had intermittent low-grade fever.  was seen by MD 17Jan91 + rash remitted.
No adverse event; Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Oct-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 monovalent vaccine for their third booster dose instead of the bivalent vaccine).    No concomitant medication was reported.    The Pharmacist did not have any information on the patient's primary series or their first Moderna booster dose.    No treatment information was reported.
cardiac arrest. Heart stopped, I fell to the ground, and was administered CPR by Police. I was admitted to hospital unresponsive and induced in a coma for two days. MRI results indicated I had a virus in my heart which caused Myocarditis. On 1/25/2021 i Had a cadiac catharization that indicated no blockages, or scar tissue. A defibrillator was surgically  implanted in my chest on 1/27/21. Admitted to hospital 1/20/2021.  Released 1/28/2021.
Initial unsolicited report received from a consumer on 19 September 2015. This case involves a 05-months-old female patient who was vaccinated with a dose of Meningococcal vaccine [batch number, route, dose in series and site of administration were not reported] on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed streptococcal pneumonia meningitis, strokes, seizures, 2 brain surgery and loss hearing 100 percent in her right ear and 1/2 in her left and some speech delays. It was reported that due to streptococcal pneumonia meningitis the patient went from happy baby to death doors within hours. The patient was in the hospital for a month and half fighting for her life. Laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from streptococcal pneumonia meningitis, strokes, seizures and loss hearing 100 percent in her right ear and 1/2 in her left. The patient was not recovered from some speech delays. Upon medical review, the case was considered as serious due to important medical event: some speech delays and loss hearing 100 percent in her right ear and 1/2 in her left. List of documents held by sender: none.
The pt complained of discomfort to the arm pit, inner aspect, LUE when raising arm up. The pt had palpable lymph nodes X 3 in left arm pit. No neuro deficit. Neurological checks equal bilateral adequate ROM.
little touch of loose stools; stomach that makes noise; dull headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (little touch of loose stools), ABDOMINAL DISCOMFORT (stomach that makes noise) and HEADACHE (dull headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (dull headache). On an unknown date, the patient experienced DIARRHOEA (little touch of loose stools) and ABDOMINAL DISCOMFORT (stomach that makes noise). At the time of the report, DIARRHOEA (little touch of loose stools), ABDOMINAL DISCOMFORT (stomach that makes noise) and HEADACHE (dull headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 99 (High) 99F. On an unknown date, Body temperature: 97 (normal) always normal temperature was 97F and 98.4 (Inconclusive) week later temperature was 98.4F.         No concomitant medication was reported. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Reporter Contact details updated. On 05-Aug-2021: Source document has no new information. On 09-Aug-2021: NNI Follow up received.
UNSPECIFIED SIDE EFFECTS OF VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced unspecified side effects of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects of vaccine was not reported. This report was non-serious.
Fever approximately 103, Sweating, Bad headache, Full body aches, Shortness of breath  Runny nose, Coughing
Patient presented the morning after getting vaccinated with redness and a bit of swelling at the injection site. I informed the patient that injection site reactions can occur with this vaccine. I told her if she feels bad she can either take an over the counter NSAID or APAP. Also mentioned that if the site is irritated that she can place a cool pack on the site for 15 mins. She knows to keep an eye on it and if it worsens or spreads to take some BENADRYL and go to her PCP.
WHAT IF IS HAS BEEN 9 MONTHS SINCE MY FIRST SHOT WILL THE SECOND ONE BE AFFECTIVE / DO I REQUIRE TO START OVER/?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of Shingrix received 9 month ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingix, which led to incomplete course of vaccination. The patient asked, would be the second dose affective or he or she required to start over the procedure of first shot. No further information was reported.
nausea, headache, fatigue on 4/19/21. He begin having difficulty concentrating today, 4/20/21 and admits to sleeping poorly last night. He has not taken anything for his symptoms.  It was advised for him to obtain quality restful sleep tonight, take multivitamin with D and C, APAP/NSAID for pain/fever, drink plenty of fluids. 4/21-Woke up this morning feeling better after a restful nights sleep. He did not take anything for his symptoms and his symptoms resolved completely.
Suspected pertussis allergy high pitched, inconsolable cry in 2 month infant lasting 1 hour. No treatment.
Moderna vaccine 2/2/21 & 3/2/21. Booster 10/28/21.  Presented to ED 1/15 dehydrated, decreased oral intake. Admitted to ICU. Coded x2
On 5APR92 (10-11 days post vax) pt devel urticaria, 106cm lesions over the entire body, no fever; no new folds & no meds had been given on 10APR92; There were many 1cm macules w/some bullseye 1 cm lesions; no fever or enanthem;
he had lost his taste and smell,; he had lost his taste and smell,; had cold sweats; pain in back and legs so bad could not walk.; pain in back and legs so bad could not walk.; pain in back and legs so bad could not walk.; This is a spontaneous report received from a contactable consumer (Patient) from Pfizer. A 48-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Apr2021 as dose 2, single for COVID-19 immunization. No Medical history reported.  He has went to an urgent care and to his doctor and they were unable to find anything that could be wrong and the Covid shot is the only thing different from his regular routine. The patient's concomitant medications were not reported.  The patient reported that he had lost his taste and smell, had cold sweats, pain in back and legs so bad could not walk, he went back to work the next week but still has no energy, is still in pain and having cold sweats. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fatigue and severe headache x 2 days. Moderate arm pain x 4 days. Slept for 2 days straight
Since having all three GARDASIL shots my daughter has suffered from severe migraines and had to a neurologist to get them under control and now has to take daily medication.
This spontaneous report was received from a pharmacist referring to a patient of an unknown age and an unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On 23-APR-2019, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 lot # M033583 with expiration date 14-APR-2019, intramuscularly (dose detail was not reported) for prophylaxis. No adverse effect was reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 23-JAN-2017, the patient was vaccinated with expired dose of ZOSTAVAX vial 19400 Plaque forming units (PFU), lot # L040443, expiry date 15-JAN-2017 (route of administration, dose and anatomical location were not reported). No adverse effects reported.  Additional information has been requested.
Right thigh with 10cm X 8cm induration and erythema seen around site of DTAP injection. Non-tender.
Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-contactable consumer (patient's Sister). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. On 27Dec2020 patient experienced an "intermittent stabbing headache" and her arm was very sore but much better the day of the report. Patient would not take paracetamol (TYLENOL) because she was still very functional. Outcome of the events was unknown. Information about lot/Batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
Narrative:  Per Neurology Progress note on 11/3/22, "clinical history, neurologic exam and EMG do support a diagnosis of brachial plexitis/Parsonage-Turner syndrome on the left, abnormalities on EMG are supportive of either a left upper trunk brachial plexopathy or C5/C6 radiculopathy. Imaging not strongly suggestive of cervical radiculopathy. It is probably not a coincidence that patient received Moderna COVID-19 booster in left deltoid on 02/18/2022 and then developed clinical symptoms of left brachial plexitis in 04/2022. Advised caution with any future COVID 19 boosters"
Two days after receiving these immunizations, patient began to experience pain in his face on the right side, where he has previously had shingles. Stated pain makes it difficult to close his mouth and patient's wife stated that he felt that it was a similar type of pain to his previous shingles infection. After consulting with the patient, it was determined that he has not had a shingles outbreak recently and the most recent was several years ago. Patient was directed to make an appointment with their primary care doctor to evaluate.
Pain; Rash; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Apr2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and heart disease, unspecified. The patient had allergies to walnuts and pecans. The patient previously took bactrim, trulicity and invokana and was allergic. Concomitant medications included metformin (MANUFACTURER UNKNOWN), apixaban (ELIQUIS), furosemide (LASIX), carvedilol (CARVIDOL) and insulin human injection, isophane (INSULIN N) from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 06:00, the patient experienced pain and rash. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken was not reported. The clinical outcome of the events pain and rash was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itching and hives to right upper arm around injection site. Reports soreness to right arm.
Information has been received from a mother concerning her 14 year old daughter, with inflammatory bowel disease and not known drug reactions/allergies, no pertinent medical history and ; who on 29-SEP-2008 was vaccinated with a dose of GARDASIL and on 06-DEC-2008 was vaccinated with another dose of GARDASIL.  Concomitant therapy included NASONEX and ALBUTEROL.  The parent reported that her daughter had inflammatory bowel disorder since August 2008.  Symptoms included diarrhea and canker sores.  An unspecified test was performed which showed that inflammatory markers were abnormal.  At the time of the report, the patient had not recovered.  The patient sought medical attention and was seen by the physician.  Additional information has been requested.