chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A,) for COVID-19 vaccination.     The patient's past medical history included Gastroesophageal reflux disease. Concurrent medical conditions included Arthritis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-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 experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient had not had  diagnosed with COVID-19 previously. No treatment information were provided.   This case was linked to MOD-2022-554727, MOD-2022-554797, MOD-2022-554802 (Patient Link).
Tiredness; fever; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The first dose was received on an unspecified date. The patient's medical history and concomitant medications were not reported.  The patient experienced tiredness and fever on 28Jan2021 which resulted in a clinic visit. Outcome of the event was unknown. The reporter considered the events non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax (MFR unk) & w/in 24hr pt devel fever 102 & redness @ the site of pnu-immune 23 & pt felt sick;pt was seen by MD;
No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 (received Moderna original 0.5ml doses instead of the bivalent booster).    Concomitant medications were not reported.  Patient received Moderna original 0.5ml doses instead of the bivalent booster.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-664520, US-MODERNATX, INC.-MOD-2022-664527, US-MODERNATX, INC.-MOD-2022-664529, US-MODERNATX, INC.-MOD-2022-664532 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Live follow up received is significant. Patient details were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664520:Patient 1 Same reporter US-MODERNATX, INC.-MOD-2022-664527:Patient-2 Same reporter US-MODERNATX, INC.-MOD-2022-664529:Patient-3 Same reporter US-MODERNATX, INC.-MOD-2022-664532:Patient-5 Same reporter
6 1/2" width x 5 3/4" Length - reddened, hot area, symptoms started on 6-4-08 after receiving 2nd varicella vaccine, on back of right arm
break through case of covid; break through case of covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02059112.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "break through case of covid". Clinical course: Employee reported that her friend took immunosuppressants (specific product unknown). Employee reported that she was unsure of the brand name of the Covid vaccine that her friend received.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Pt exp pharyngitis & erythema, coryza developing 5 days post vax;
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with GABAPENTIN for Shingles, at a dose of 1 dosage form; PREDNISONE for Shingles, at a dose of 1 dosage form and VALACYCLOVIR [VALACICLOVIR] for Shingles, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            No concomitant medications were reported.
Information has been received from a licensed practical nurse concerning a 12 year old male who on an unspecified date was vaccinated with her first dose of VARIVAX (Merck) and was well tolerated. On 04-Aug-2008, was vaccinated with the second dose of VARIVAX SQ in the left arm (Merck) (lot# 660079/0331X) (in follow up reported as 661445/0525X). On 04-Aug-2008, was vaccinated with the second dose of Hepatitis A virus vaccine inactivated in the left deltoid (Merck). There were no illness at the time of vaccination. On 05-Aug-2008, the patient experienced redness, itching and swelling at the injection site. the patient may have also experienced fever and /or pain and burning while getting injected with the vaccine. On 07-Aug-2008, the patient recovered. The reporter has requested a lot check due the patients having adverse experiences. The patient sought medical attention by calling the office. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This is one of several reports provided by the same source. No additional information is expected.
Much worse tinnitus in my left ear,   Blurry vision for some time after the shot
Very achy; Felt Run Down; In bed for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 84 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 84 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "Very achy"; MALAISE (non-serious), outcome "recovered", described as "Felt Run Down"; BEDRIDDEN (non-serious), outcome "recovered", described as "In bed for 2 days". Additional information: On blood thinners at time of vaccine No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presents with ? Diarrhea     Since last thursday, pt has had diarrhea, weakness and shortness of breath ? Shortness of Breath     HPI patient is a 65-year-old male presents the ED for respiratory distress.  Patient reports he has been having diarrhea since last Thursday.  Patient states has been very weak.  Patient has had worsening shortness of breath.  Patient today is unable to catch his breath and wife convinced him to come to the ER to be evaluated.  Patient's wife reports that she was sick a week ago with flulike symptoms.  Patient reports that they are both vaccinated against Covid.  Patient has a previous history of a kidney transplant, hypertension, hyperlipidemia, A. fib, and GERD.  Patient denies any chest pain, syncope, dizziness, recent trauma.   Review of Systems  CONSTITUTIONAL:  no fever, no chills, no fatigue HEAD:  no headache or loss of consciousness. EYES:  no eye pain, redness or discharge. ENMT:  no ear pain, no throat pain; no rhinorrhea or congestion. CARDIAC:  No chest pain, no exercise intolerance, no palpations, no peripheral edema RESPIRATORY:  no cough, wheezing, shortness of breath or trouble breathing. GI:  no nausea, vomiting, diarrhea or abdominal pain. GU:  no dysuria, no increased frequency, no hesitancy MSK:  no muscle aches, joint pain or injury. NEURO:  no dizziness, no change in vision, no seizure SKIN:  no rashes; no lacerations or abrasions, no bruising.  PSYCH: no recent changes in mood, affect, sleep, or thought processes
Headache, fever, tooth pain, restlessness, chills, nausea, joint pain, sore/heavy feeling arm, swelling at the injection site, loss of appetite, reoccurring dreams
Adminsitration of vaccine at 8:40am; At 8:53; experienced dizziness and diaphoresis.  Placed in supine position and provided a wet cloth for her forehead.  Vital signs and blood pressure remained stable. She was provided a snack and discharged home.
Unable to move right arm; a lot of swelling at injection site; A lot of pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to move right arm), VACCINATION SITE SWELLING (a lot of swelling at injection site) and VACCINATION SITE PAIN (A lot of pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, BUSPIRONE HYDROCHLORIDE (BUSPAR), SITAGLIPTIN PHOSPHATE (JANUVIA), LOVASTATIN, LOSARTAN and HYDROCHLOROTHIAZIDE (HCTZ) for an unknown indication.   On 28-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to move right arm), VACCINATION SITE SWELLING (a lot of swelling at injection site) and VACCINATION SITE PAIN (A lot of pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to move right arm), VACCINATION SITE SWELLING (a lot of swelling at injection site) and VACCINATION SITE PAIN (A lot of pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had been alternating heat and ice, and also taking Tylenol and Zyrtec for treatment. Caller says none of those have helped.
Wheezing - 11-04-09 - 11-10-09 - Oxygen. Muscle aches 11-4-09 - 11-9-09 - Heat.
5/5 73-year-old female with past medical history of hypertension, CKD, multiple CVA most recently in February of this year presents today with dizziness. Discharged with plan for close o/p follow up with pcp and consultants. To return to ER should admission symptoms reoccur.
Stiff neck, neck pain 8/10 with looking side to side and up. Sometimes goes down center of cervical spine when looking up. No swelling/redness. History of neck pain but nothing like this or this long.
After getting the second vaccine on the 5th of March at 7 PM,  he couldn't breath that night during the night,  so had to get out of bed to sit up and short of breath a good portion of Saturday.... also unable to control bowels which is unusual for him and pooped in his pants which was awful for him. He felt dizzy and tired all Saturday and Sunday.  Doing better as of Monday the 8th. He had no adverse affects from the first dose.
Sore arm; Tiredness; This is a spontaneous report from a contactable consumer (patient's son). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on 24Jan2021 13:30 at a single dose for COVID-19 immunization. The patient had no medical history and family medical history. There were no concomitant medications. On 24Jan2021, the patient experienced sore arm and tiredness. Right after the vaccine she noticed her arm was sore. Later she also felt a tiredness. She was scheduled to receive the second dose 14Feb2021, but she was unsure if she will get it. The events did not require a visit to physician or ER. There were no additional vaccines administered on same date of Pfizer suspect. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was in a hospital. No relevant tests done. The event sore arm recovered on 28Jan2021, while the event tiredness on 26Jan2021.
Arm pain; Headache; Fatigue; Was in bed for 2 days after; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for 2 days after), PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (9 months ago). Concurrent medical conditions included Asthma (taking steroids for asthma) and Hypercholesterolaemia. Concomitant products included ATORVASTATIN for Hypercholesterolaemia.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BEDRIDDEN (Was in bed for 2 days after). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, BEDRIDDEN (Was in bed for 2 days after) had resolved and PAIN IN EXTREMITY (Arm pain), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications included steroids for asthma.  At the time patient got his vaccines, he was taking steroids for asthma. So, his doctor said he should be fine to get his third full dose, but he never got it. He reports that with the first two doses, he had bad side effects.  Treatment information was not provided   This case was linked to MOD-2022-509348 (Patient Link).
Sickness; First Dose adminstered 06-Apr-2021 and second Dose adminstered after 54 days on 30-May-2021; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose adminstered 06-Apr-2021 and second Dose adminstered after 54 days on 30-May-2021) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 30-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose adminstered 06-Apr-2021 and second Dose adminstered after 54 days on 30-May-2021). On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose adminstered 06-Apr-2021 and second Dose adminstered after 54 days on 30-May-2021) outcome was unknown.            No concomitant medications was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of sickness and Drug ineffective was reasonable possibility. No treatment medications was provided by the reporter.  Company comment: This spontaneous case concerns 44 years old female patient, with no relevant medical history reported, who experienced the unexpected non-serious events of Illness and Inappropriate schedule of product administration that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since event onset was not disclosed. It was reported that patient received co-suspect ADALIMUMAB (HUMIRA) for Ankylosing spondylitis unknown date. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 44 years old female patient, with no relevant medical history reported, who experienced the unexpected non-serious events of Illness and Inappropriate schedule of product administration that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since event onset was not disclosed. It was reported that patient received co-suspect ADALIMUMAB (HUMIRA) for Ankylosing spondylitis unknown date. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt a 67 year old male received flu vaccine along with yellow fever and tetanus vaccines on 11/4/2010.  He developed a sore throat initially and URTI with productive cough that lasted 10 days and started 2 days following the vaccines.  Pt was admitted 11/30/2010 with shoulder pain (initial symptom), increased weakness, unsteady gait, bilateral leg and arm numbness.  LP showed CSF had elevated protein levels at 125 mg/dL without increased WBC and Guillain Barre Syndrome was suspected.  Pt received IVIG 0.4 g/kg x 5 days starting 12/2/2010.  EMG results 12/3/2010 showed prolonged F waves which are also indicative of GBS.  Pt's symptoms progressed while inpatient to facial paralysis and respiratory symptoms along with increasing weakness and inability to ambulate.  Symptoms began improving 12/6/2010 and transferred 12/9/2010 for rehab where he was discharged 12/29/2010.  At time of d/c was able to perform ADLs with little to no assistance.
fever; sore injection site arm; red spot at the site of injection; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red spot at the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in March 2020, Back surgery and Knee surgery NOS.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red spot at the site of injection). In 2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red spot at the site of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102 degrees Fahrenheit and 103 degrees Fahrenheit.   The patient received the first vaccine in left arm deltoid muscle. The patient did have fevers of 102 degrees Fahrenheit and 103 degrees Fahrenheit and she cannot remember which Fever occurred after each of the first two doses. Patient did not remember which arm that patient received the second vaccine in. Patient was on several medications and did not wish to discuss patient medications.   This case was linked to MOD-2022-646131, MOD-2022-646134 (Patient Link).
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On 25-AUG-2017, the patients were vaccinated with improperly stored VARIVAX injection, (dose and route unknown) from lot # N001527; expiry date: 13-JAN-2019 for prophylaxis (incorrect product storage). Concomitant therapies included properly stored sterile diluent for reconstitution. The vaccine was exposed to a temperature range of 6 degree Fahrenheit (F) to 14 degree F for 10 minutes and from 15 degree F to 46 degree F (31 F) for 3 hours and 15 minutes. There was no previous excursion. This report was because of data logger. No adverse effects were reported. Product quality complaint was not involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA012645: Original Case : 1708USA012645.
Elevated heart rate 100 beats per minute; chills; fever over 100ºF; Bunch of muscle soreness.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated heart rate 100 beats per minute), CHILLS (chills), PYREXIA (fever over 100ºF) and MYALGIA (Bunch of muscle soreness.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HEART RATE INCREASED (Elevated heart rate 100 beats per minute), CHILLS (chills), PYREXIA (fever over 100ºF) and MYALGIA (Bunch of muscle soreness.). At the time of the report, HEART RATE INCREASED (Elevated heart rate 100 beats per minute), CHILLS (chills), PYREXIA (fever over 100ºF) and MYALGIA (Bunch of muscle soreness.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact